Description
Market research process is the process used to obtain information regarding market opportunity & problem and there by making strategies for the business. Our purpose is to launch a new brand of PEGYLATED LIPOSOMES OF DOXORUBICINE
1
CHAPTER 1
RESEARCH METHODOLOGY
2
RESEARCH PROPOSAL
Macro Objective
To study & analyze overall domestic market for OVARIAN & CERVICAL CANCER DRUGS.
Micro Objective
1. To analyze price incorporation strategy of drugs in pharmaceutical industry
2. To study & analyze overall domestic market for generic version of PEGYLATED
LIPOSOMES OF DOXORUBICINE & compare it with other existing brands of
OVARIAN CANCER DRUGS in terms of available dosage forms, efficacy & price
3. To suggest an appropriate launch strategy to launch a new generic version of the
DOXORUBICINE
3
Motivation for the research
Pharmaceutical is one of the most intense “Knowledge Driven” industries. It is a life
line industry, which plays a very crucial role in building a strong human capital of a country, and
is very essential for economic growth and development. In 2008, global spending on prescription
drugs topped $700 billion, even as growth slowed somewhat in Europe and North America. The
United States accounts for almost half of the global pharmaceutical market, with $300 billion in
annual sales followed by the EU and Japan. Emerging markets such as China, Russia, South
Korea and Mexico outpaced that market, growing a huge 81 percent.
The pharmaceutical industry is one of the fastest growing sectors in Indian economy. The
size of the Indian pharmaceutical industry is estimated at US $ 7.76 billion. It is growing at an
average rate of 14.1 %. The pharmaceutical industry has shown a robust growth of 13% in 2007
and has grown by 12% in 2008. It is expected to continue growing at the rate of 12% in 2009.
(Source: ORG IMS SSA May 2008).
Medicines in the cancer therapeutic area account for the third largest source of revenue
within the pharma industry. The cancer market has experienced significant innovative change in
recent years, creating attractive opportunities for a range of new and established biotechnology
players as well as established pharma companies. Although new product development continues
to involve substantial levels of risk, innovation is the key driving force in the market, and has led
to the competitive exclusion of several of the industry’s traditional competitors. With successful
launches now being applied to multiple indications faster than ever before, subsequent increases
in product sales volumes are rapidly changing the competitive landscape of the cancer market.
The cancer market expanded by 19.9% during 2009 and is forecast to reach $40.9b by
2012. The highest growth will occur in the antineoplastic class of drugs, which is expected to
become the primary growth driver of the cancer market over the next four years.
4
Research Objective
To study & analyze overall domestic market for OVARIAN & CERVICAL CANCER
DRUGS.
Introduction
Market research process is the process used to obtain information regarding market
opportunity & problem and there by making strategies for the business. Our purpose is to launch
a new brand of PEGYLATED LIPOSOMES OF DOXORUBICINE .Therefore; we need to do
market analysis of the current payers of the same & their strategies. Thus, it will help us making
strategies for launching a new brand of DOXORUBICINE Detailed process for research
methodology is discussed below
Our research will answer the following questions:
What is ovarian & cervical cancer?
Epidemiology of ovarian & cervical cancer.
What are the different dosage forms available of ovarian & cervical cancer drugs?
What are the existing brands of ovarian & cervical cancer drugs?
Which are the generic players of ovarian & cervical cancer drugs?
Who are the top players of ovarian & cervical cancer drugs & what about their markets?
Statistical analysis of price comparison for ovarian & cervical cancer drugs.
Indian market share for doxorubicin in Cancer drugs and its expansion capacity
How we will launch our brand & its positioning?
What will be the promotional, communication & operational strategies for our brand?
Analysis and Finding
Recommendation and Suggestions
5
Research Methodology
Research Type: Exploratory followed by Descriptive
The Researchers will use exploratory followed by descriptive research design to define
the opportunity & to develop an approach for international market for generic drugs. The
researcher will use both qualitative & quantitative data for the research work. The researcher will
use secondary as well as primary data for marketing research. The reason for choosing this type
of data is, qualitative research provides insights & understanding of problem setting, while
quantitative research seeks to quantify the data & typically applies some form of statistical
analysis.
Figure 1.1
6
Data Sources
Secondary Data
This data will be collected from journals, internet, reports, industry publications and
dissertations.
Primary Data
This data include both qualitative and quantitative data. Data are generated through
interaction with various doctors who has handle cancer cases. Data for the price strategy and
distribution related data are generated by interaction with druggist, stockiest and carrying and
forwarding agent.
a) Research Approach:
Survey Method: Primary data are collected through survey of doctors, stockiest, carrying and
forwarding agent and stockiest
b) Research Instrument:
Questionnaire: It includes both open ended and closed ended questions. Close ended includes
different scaling technique.
c) Types of Questionnaire:
Structured
d) Type of Questions:
Open-ended and Close-ended questions
e) Sampling Plan:
Sampling Unit:
• For price analysis C & F agents, stockiest & retailers.
• Drug related information through doctors who have handled cancer cases
Sample Size:
• 30 doctors (20 Oncologists & 10 Consultant Physiologists)
• 05 Carrying & Forwarding agents
• 30 stockiest & 30 retailers
Sampling Procedure:
• Non?probability convenience
Contact Method: Personal
7
f) Mode of collecting data:
The respondents will be chosen randomly and requested to. The questions will then be
asked in a predetermined sequence.
g) Data Processing:
A number of tables and charts to be prepared to bring out the main characteristic
of the collected data.
Inferences to be drawn from the data collected.
Analysis and Finding
Method of data analysis
Data analysis is done through the primary data gathered from the survey of
doctors, stockiest, c & f Agent and retailer. It includes presentation through table and
chart preparation.
8
CHAPTER 2
INTRODUCTION TO PHARMACEUTICAL
INDUSTRY
9
PHARMACEUTICAL INDUSTRY-OVERVIEW:
Pharmaceutical is one of the most intense “Knowledge Driven” industries, which is
continuously in a state of dynamic transition. Defined as a complex matrix of processes,
operations and organizations involved in the discovery, development and manufacture of drugs
and medications, the pharmaceutical industry is a life line industry, which plays a very crucial
role in building a strong human capital of a country, and is very essential for economic growth
and development.
2.1 Origins and Evolution:
The modern pharmaceutical industry is a highly competitive non-assembled1 global
industry. Its origins can be traced back to the nascent chemical industry of the late
nineteenth century in the Upper Rhine Valley near Basel, Switzerland when dyestuffs were
found to have antiseptic properties. A host of modern pharmaceutical companies all started
out as Rhine-based family dyestuff and chemical companies e.g. Hoffman-La Roche,
Sandoz, Ciba-Geigy (the product of a merger between Ciba and Geigy), Novartis etc. Most
are still going strong today.
Over time many of these chemical companies moved into the production of
pharmaceuticals and other synthetic chemicals and they gradually evolved into global
players. The introduction and success of penicillin in the early forties and the relative
success of other innovative drugs, institutionalized research and development (R&D) efforts
in the industry. The industry expanded rapidly in the sixties, benefiting from new
discoveries and a lax regulatory environment. During this period healthcare spending
boomed as global economies prospered.
These included the first oral contraceptive, "The Pill", Cortisone, blood-pressure
drugs and other heart medications. MAO Inhibitors, chlorpromazine (Thorazine), Haldol
(Haloperidol) and the tranquilizers ushered in the age of psychiatric medication. Valium
(diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most
prescribed drug in history, prior to controversy over dependency and habituation.
10
2.2 Research and development:
Drug discovery is the process by which potential drugs are discovered or designed.
In the past most drugs have been discovered either by isolating the active ingredient from
traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on
understanding the metabolic pathways related to a disease state or pathogen, and
manipulating these pathways using molecular biology or Biochemistry.
Drug development refers to activities undertaken after a compound is identified as a
potential drug in order to establish its suitability as a medication. Objectives of drug
development are to determine appropriate Formulation and Dosing, as well as to establish
safety. Research in these areas generally includes a combination of in vitro studies, in vivo
studies, and clinical trials. The amount of capital required for late stage development has
made it a historical strength of the larger pharmaceutical companies.
2.3 Industry revenues:
In 2009, global spending on prescription drugs topped $680 billion, even as growth
slowed somewhat in Europe and North America. The United States accounts for almost half of
the global pharmaceutical market, with $290 billion in annual sales followed by the EU and
Japan. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market,
growing a huge 81 percent.
2.4 Marketing:
Pharmaceutical companies commonly spend a large amount on advertising, marketing
and lobbying. Pharmaceutical companies generally employ sales people (often called 'med. reps'
or, an older term, 'detail men') to market directly and personally to physicians and other
healthcare providers.
11
INDIAN PHARMACEUTICAL INDUSTRY
Indian pharmaceutical industry is mounting up the value chain. From being a pure reverse
engineering industry focused on the domestic market, the industry is moving towards basic
research-driven, export-oriented global presence, providing wide range of value added quality
products and services.
The first Indian pharmaceutical company, Bengal Chemicals and Pharmaceutical Works,
which still exists today as one of 5 government-owned drug manufacturers, appeared in Calcutta
in 1930. The government started to encourage the growth of drug manufacturing by Indian
companies in the early 1960s, and with the Patents Act in 1970, enabled the industry to become
what it is today.
This patent act removed composition patents from food and drugs, and though it kept
process patents, these were shortened to a period of five to seven years. The lack of patent
protection made the Indian market undesirable to the multinational companies that had
dominated the market, and while they streamed out, Indian companies started to take their
places. They carved a niche in both the Indian and world markets with their expertise in reverse-
engineering new processes for manufacturing drugs at low costs.
As in the present scenario, only a few people can afford costly drugs, which have
increased price sensitivity in the pharmaceutical market. Now the companies are trying to
capture the market by introducing high quality and low price medicines and drugs. With the
Product Patent Act, which came into action in January 2005, this industry is able to attract big
MNCs to India. Earlier these big firms had apprehensions in launching new drugs in the Indian
market.
Approvals given by Foods and Drugs Administration (FDA) and ANDA (Abbreviated
New Drug Application)/DMF (Drug Master File) have played an important role in making India
a cost-effective and high quality product manufacturer. Furthermore, the changes that took place
in the patent law, change of process patent to product patent, have helped in reducing the risk of
loss for intellectual property.
12
2.1 Market Overview:
The size of the Indian pharmaceutical industry is estimated at US $ 7.76 billion. It is
growing at an average rate of 14.1 %. The pharmaceutical industry has shown a robust
growth of 13% in 2007 and has grown by 12% in 2008. It is expected to continue growing at
the rate of 12% in 2009. (Source: ORG IMS SSA May 2008)
Despite the economic slowdown the Indian Pharmaceutical sector will be worth US $ 20
billion by 2015. The revenues from the Indian healthcare sector account for 5.2% of the GDP,
making it the third largest growth segment in India. Consumer spending on healthcare increased
from 4% of the GDP in 1995 to 7% in 2007.
The Indian pharmaceutical industry contributes 8 percent in volume but less than 2
percent in value terms to the global pharmaceutical sales as drug prices in India are one of the
lowest in the world. Indian Pharmaceutical Industry is worlds’ 4
th
largest producer in terms of
volume and 11th in value terms globally. (Source: www.prlog.org)
The Indian pharmaceutical industry has 300 medium and large size researches and
development (R&D) based pharmaceutical companies including multinationals, government
owned and Indian private companies. In addition to these large companies, it is estimated that
there are 10,000 smaller licensed generic manufacturers. There are 74 US FDA approved
manufacturing facilities and 5 central public sector unit.
This highly fragmented industry has resulted in with no players controlling more than 7
percent of the retail formulation market. However, similar to the global trends, mergers and
acquisitions in the Indian pharmaceutical industry has resulted in the 10 top formulation firms
accounting for 37 percent of the retail formulation market.
The industry manufactures about 400 bulk drugs and almost the entire range of
formulations.
(Source: www.export.gov.il/2351 the Indian Pharmaceutical Market.docm)
13
2.2 Market Trends:
The industry has enormous growth potential. Factors listed below determine the
rising demand for pharmaceuticals.
The growing population of over of a billion
• Increasing income
• Aggressive market penetration
• Health insurance penetration
• Medical infrastructure build up
• Demand for quality healthcare service
• Changing lifestyle has led to change in disease patterns, and increased
demand for new medicines to combat lifestyle related diseases
(Source:www.export.gov.il/2351 the Indian Pharmaceutical Market.docm)
2.3 Important Developments after Liberalization Process in 2006:
Following are some of the important developments that have taken place in
pharmaceutical sector after the process of liberalization of the Indian economy was initiated
by the Government in the year 1991.
Industrial Licensing: Industrial licensing for all kinds of drugs has been abolished.
However the need for obtaining manufacturing licence under Drugs and Cosmetics Act,1940
continues for all units whether organized or small scale. The State Drug Controllers are
authorized to issue such licences in most cases.
Foreign Direct Investment: FDI up to 100% is permitted, subject to stipulations laid
down from time to time in the Industrial Policy.
Foreign Technology Agreement: Automatic approval for Foreign Technology
Agreement (FTA) is already available in the case of all the bulk drugs cleared by Drug
Controller General (India) .
Imports: Imports of drugs and pharmaceuticals are regulated through EXIM Policy
in force and presently all items except those requiring clearance under The Narcotics and
14
Psychotropic Substances Act , 1985 are allowed under OGL. Further, a centralized system of
registration has been introduced under the Drugs & Cosmetics Act and Rules made there
under, administered by Ministry of Health and Family Welfare.
Exports: Exports are permitted in accordance with the EXIM Policy and relevant
procedures/rules formulated for the purpose by the Directorate General of Foreign Trade.
Exports are also subject to laws prevalent in importing countries. Also, the exporters are
allowed imports of inputs on duty-free basis for export production. The industry has shown
commendable export performance, the trade balance being positive. Over the last few years
the compounded annual growth rate in exports has been 22.7 percent.
2.4 Government Support:
Export Promotion Cell: An Export Promotion cell in this sector has been incorporated
with the objective of
• Boosting Pharmaceutical exports
• Function as a nodal centre
• Promotional Activities aiming at accelerating pharma exports.
• Suggestions for modifications in the EXIM Policy.
• Seminars / Workshops on standards, quality control requirements etc
Pharma Export Promotion Council (Pharmexcil): The Pharma Export Promotion
Council (Pharmexcil) has been constituted with the objective of
• Facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbal
Medicines, Diagnostics
• Export thrust to various products through workshops, conferences and seminars and
delegate visits.
15
Foreign Direct Investment (FDI) in Drugs and Pharmaceuticals:
• FDI upto 74% in the case of bulk drugs, their intermediate Pharmaceuticals and formulations
(except those produced by the use of recombinant DNA technology) would be covered under
automatic route. FDI above 74% for manufacture of bulk drugs will be considered by the
Government on case to case basis for manufacture of bulk drugs from basic stages and their
intermediates and bulk drugs produced by the use of recombinant DNA technology as well as the
specific cell/tissue targeted formulations provided it involves manufacturing from basic stage.
2.5 Pharma Parks/SEZs for Pharma Industry:
In order to enable India to achieve a leading position as the Drug Maker of the World it is
essential that a World class infrastructure is provided for the accelerated growth of the industry.
In order to provide the required infrastructure it is essential to have a scheme where Central
Government, State Governments and industry are participants. A special scheme for setting up
pharmaceutical parks in the country (separate for bulk and for formulations) in the next 5 years is
proposed. This would be broadly on the lines of Scheme for Integrated Textile Parks.
Each park would be set up in a minimum area of 250 acres for bulk and 100 acres for
formulations. It would be expected to have about 50 to 100 units, investment of Rs 1000 crs to
Rs 2000 crs and likely employment of about 20,000 persons.
Where an SEZ is to be set up the minimum size criterion for pharma SEZs would be 50
hectares for the next 3 years. This would encourage quick setting up of such parks and for
demonstration effect. After a successful take-off of the scheme minimum size may be increased
suitably all environmental approvals in the case of pharma parks would be granted at the State
level only.
16
2.6 Strengths of Indian Pharmaceutical Industry & its Players:
• Capital Investment in Technology: Owing to the availability of advanced technology at
low costs, the companies can produce drugs at lower costs.
• Cost Effective: The filing cost of ANDAs (Abbreviated New Drug Application) and
DMFs (Drug Master File) is comparatively low for the Indian companies.
• Manpower: There is a large pool of technical experts available at modest salaries.
• Contract Research & Contract Manufacturing: There is a good scope for contract
research and contract manufacturing.
• Infrastructure: There is a well-developed infrastructure for the pharmaceutical industry.
• Generic Drugs: In the last few years, the generic drug-manufacturing segment has
received huge investments, in the process making it more competitive and efficient.
2.7 Challenges:
All of these changes are ultimately good for the Indian pharmaceutical industry, which
suffered in the past from inadequate regulation and large quantities of spurious drugs. They force
the industry to reach a level necessary for global competitiveness.
However, they have also exposed some of the inadequacies in the industry today. Its main
weakness is an underdeveloped new molecule discovery program. Even after the increased
investment, market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of
their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research
budget last year was greater than the combined revenues of the entire Indian pharmaceutical
industry.
17
This disparity is too great to be explained by cost differentials, and it comes when
advances in genomics have made research equipment more expensive than ever. The drug
discovery process is further hindered by a dearth of qualified molecular biologists.
Due to the disconnect between curriculum and industry, Pharma in India also lack the
academic collaboration that is crucial to drug development in the West.
2.8 Major Players in India:
Aurobindo Pharma:
Aurobindo Pharma manufactures generics and APIs in the antibiotic, antiretroviral,
cardiovascular, central nervous system, gastroenterological and anti-allergy fields, and markets
them in over 100 countries.
Aventis Pharma:
50.1 percent of Aventis Pharma is held by European drug major Sanofi-Aventis and, in
early April 2006, it was reported that UB Holdings had sold its 10 percent holding in the firm to
Variegate Trading, a UB subsidiary. The firm's major products are in the anti-infective, anti-
inflammatory, cancer, diabetes and allergy market segments
Cipla:
India's second-largest drug manufacturer was originally established in 1935 as The
Chemical, Industrial and Pharmaceutical Laboratories. Until 2000 its business was primarily
domestic, but exports, to more than 150 countries.
Dr Reddy's Laboratories:
Dr Reddy's Laboratories is an emerging global pharmaceutical and biotechnology
company, which was founded by Chairman Anji Reddy in 1984. It operates in over 60 countries,
although India and the USA each accounts for around a third of the firm's total sales.
18
Lupin:
Lupin is one of the world's largest manufacturers of APIs and finished formulations for
TB, bacterial infections and cardiovascular disease. Its products are sold in more than 50
countries.
Nicholas Piramal:
Nicholas Piramal is the flagship company of Piramal Enterprises (PEL), one of India's
largest diversified business houses. It was formed in 1988 when PEL acquired Nicholas
Laboratories (NPIL) a small formulations company, from Sara Lee.
Ranbaxy Laboratories:
India's largest pharmaceutical company is ranked among the top 10 generics
manufacturers worldwide and aiming to be in the top five with sales of $5 billion by 2012.
Sun Pharma:
Sun Pharma, established in 1983, makes specialty pharmaceuticals and APIs for use in
chronic therapy areas such as cardiology, ovarian, cervical cancer, gastroenterology, diabetes and
respiratory conditions, sold in 26 markets worldwide.
Wockhardt: The overseas ambitions of this Mumbai-based pharmaceutical and biotechnology-
based company have already been covered elsewhere in this report, but in mid-March 2006
Zydus Cadila:
Zydus Cadila is India's fifth largest pharmaceutical company. Cadila was founded in
1952 and, following restructuring, the Zydus Cadila Group was established in 1995. The
operating environment for medium-sized generic drug manufacturers is changing rapidly as the
industry matures and growth focuses on new market opportunities. Consolidation continues to
affect companies, as acquisition becomes the instrument of choice in the drive for market share.
19
Ranbaxy
Ranbaxy is number one player in India, both in terms of market capitalization and in
terms of sales. Other major players are Cipla, DRL, Glaxo etc. Though Pfizer is world’s number
one company with a market share of approximately 11% and sales almost 10 times of the whole
of Indian pharma industry, it has not done so well in India so far. But this can be attributed to
poor intellectual property protection provisions in India which prevented MNCs like Pfizer,
Novartis and Eli Lilly from introducing their blockbuster drugs in India, but now with the arrival
of patent regime things can be very different.
Intas Pharmaceutical Ltd.
Intas pharmaceutical Ltd. is located near ahmedabad. Its turnover is 1200 cr. The
company has is involved in various diseases with some of the top brands. It has diverse portfolio
of pharmaceutical products. It is involved in cardio. Diabeto & CNS segments.
20
CHAPTER 3
ASSIGNED PROJECT SCOPE
21
Background
The project involved analyzing the market potential of OVARIAN & CERVICAL
CANCER DRUGS. It also includes the statistics of various players of brands of
DOXORUBICINE & its effectiveness for particular disease thereby promoting it into that
segment. It also includes analyzing competitors’ strategy.
Product
DOXORUBICINE
Objective
Evaluating the Market Potential for DOXORUBICINE and Surveying doctors for
promotion of the drug into particular segments.
Suggesting brand launching strategies and promotional strategies after evaluating the
competing brands and target market..
Answers sought for following questions
What type of price incorporation strategy is there in pharmaceutical industry?
Statistics of Ovarian & Cervical Cancer in India
What are the existing brands of OVARIAN & CERVICAL DRUGS?
Which are the generic players of DOXORUBICINE?
Who are the top players & what about their markets?
How will we launch our brand & its positioning?
What will be the promotional, communication & operational strategies for our brand?
22
Benefits:
It will help in knowing as the company desires to expand to newer markets, the data
collected would be of supreme importance to the company to formulate strategies and plan out
future action plans. Understanding competitor’s strategies, competing with them, building
successful import export patterns with logistical success would also help the company to cut
down costs and increase efficiency and productivity. Analysis would also help to gauge which
products are most feasible and demanded in the desired markets, thereby enabling the company
to focus on such products wholly
23
CHAPTER 4
KEY FINDINGS & ANALYSIS
24
PHARMACOLOGICAL REVIEW
What is Ovarian Cancer?
Ovarian cancer is a disease in which malignant or cancerous cells are found in the
ovaries. An ovary is one of two small, almond-shaped organs located on each side of the uterus
that store eggs or germ cells and produce female hormones estrogen and progesterone.
Cancer Basics
Cancer develops when cells in a part of the body (in this case the ovary) begin to grow
out of control. Although there are many kinds of cancer, they all start because of out-of-control
growth of abnormal cells.
Normally, cells in your body divide, and form new cells to replace worn out or dying
cells and to repair injuries. Because cancer cells continue to grow and divide, they are different
from normal cells. Instead of dying, they outlive normal cells and continue to create new
abnormal cells forming a tumor. Tumors can put pressure on other organs lying near the ovaries.
Cancer cells sometimes can travel to other parts of the body where they begin to grow
and replace normal tissue. This process, called metastasis, occurs as the cancer cells move into
the bloodstream or lymph vessels of our body. Cancer cells that spread from other organ sites
(such as breast or colon) to the ovary are not considered ovarian cancer
There are many types of tumors that can start in the ovaries. Some are benign, or
noncancerous, and the patient can be cured by surgically removing one ovary or the part of the
ovary containing the tumor. Some are malignant or cancerous. The treatment options and the
outcome for the patient depend on the type of ovarian cancer and how far it has spread before it
is diagnosed.
25
What is the general outlook for women diagnosed with ovarian cancer?
In women age 35-74, ovarian cancer is the fifth leading cause of cancer-related deaths.
An estimated one woman in 58 will develop ovarian cancer during her lifetime. The American
Cancer Society estimates that in 2008, there will be 21,650 new cases of ovarian cancer and
15,520 women will die from ovarian cancer.
Because each woman diagnosed with ovarian cancer has a different profile, it is
impossible to give a general prognosis. If diagnosed and treated early, when the cancer is
confined to the ovary, the 5-year survival rate is over 90%.9 out of 10 women are cured.
Unfortunately, due to ovarian cancer's non-specific symptoms and lack of early detection tests,
the only 19% of all cases are found at this early stage. If caught in stage III or higher, the
survival rate can be as low as 29%.(Source: American Cancer Society)
Types of Ovarian Cancer
There are more than 30 different types of ovarian cancer which are classified according to
the type of cell from which they start. Cancerous ovarian tumors can start from three common
cell types:
• Surface Epithelium - cells covering the lining of the ovaries
• Germ Cells - cells that are destined to form eggs
• Stromal Cells - Cells that release hormones and connect the different structures of the
ovaries
Common Epithelial Tumors - Epithelial ovarian tumors develop from the cells that cover
the outer surface of the ovary. Most epithelial ovarian tumors are benign (noncancerous). There
are several types of benign epithelial tumors, including serous adenomas, mucinous adenomas,
and Brenner tumors.
26
Cancerous epithelial tumors are carcinomas - meaning they begin in the tissue that lines
the ovaries. These are the most common and most dangerous of all types of ovarian cancers.
Unfortunately, almost 70 percent of women with the common epithelial ovarian cancer are not
diagnosed until the disease is advanced in stage.
There are some ovarian epithelial tumors whose appearance under the microscope does
not clearly identify them as cancerous. These are called borderline tumors or tumors of low
malignant potential (LMP tumors).
Epithelial ovarian carcinomas (EOCs) account for 85 to 90 percent of all cancers of the
ovaries. We must continue research and expand our knowledge about this group of cancers in
order to improve treatment and save lives.
Germ Cell Tumors - Ovarian germ cell tumors develop from the cells that produce the
ova or eggs. Most germ cell tumors are benign (non-cancerous), although some are cancerous
and may be life threatening. The most common germ cell malignancies are maturing teratomas,
dysgerminomas, and endodermal sinus tumors. Germ cell malignancies occur most often in
teenagers and women in their twenties. Today, 90 percent of patients with ovarian germ cell
malignancies can be cured and their fertility preserved.
Stromal Tumors - Ovarian stromal tumors are a rare class of tumors that develop from
connective tissue cells that hold the ovary together and those that produce the female hormones,
estrogen and progesterone. The most common types are granulosa-theca tumors and Sertoli-
Leydig cell tumors. These tumors are quite rare and are usually considered low-grade cancers,
with approximately 70 percent presenting as Stage I disease (cancer is limited to one or both
ovaries).
27
Primary Peritoneal Carcinoma
The removal of one's ovaries eliminates the risk for ovarian cancer, but not the risk for a
less common cancer called Primary Peritoneal Carcinoma. Primary Peritoneal Carcinoma is
closely rated to epithelial ovarian cancer (most common type). It develops in cells from the
peritoneum (abdominal lining) and looks the same under a microscope. It is similar in symptoms,
spread and treatment.
Stages of Ovarian Cancer
Once diagnosed with ovarian cancer, the stage of a tumor can be determined during
surgery, when the doctor can tell if the cancer has spread outside the ovaries. There are four
stages of ovarian cancer - Stage I (early disease) to Stage IV (advanced disease). Your treatment
plan and prognosis (the probable course and outcome of your disease) will be determined by the
stage of cancer you have.
Stage I - Growth of the cancer is limited to the ovary or ovaries.
Stage IA - Growth is limited to one ovary and the tumor is confined to the inside of the ovary.
There is no cancer on the outer surface of the ovary. There are no ascites present containing
malignant cells. The capsule is intact.
Stage IB - Growth is limited to both ovaries without any tumor on their outer surfaces. There are
no ascites present containing malignant cells. The capsule is intact.
Stage IC - The tumor is classified as either Stage IA or IB and one or more of the following are
present: (1) tumor is present on the outer surface of one or both ovaries; (2) the capsule has
ruptured; and (3) there are ascites containing malignant cells or with positive peritoneal
washings.
28
Stage II - Growth of the cancer involves one or both ovaries with pelvic extension.
Stage IIA - The cancer has extended to and/or involves the uterus or the fallopian tubes, or both.
Stage IIB - The cancer has extended to other pelvic organs.
Stage IIC - The tumor is classified as either Stage IIA or IIB and one or more of the following
are present: (1) tumor is present on the outer surface of one or both ovaries; (2) the capsule has
ruptured; and (3) there are ascites containing malignant cells or with positive peritoneal
washings.
Stage III - Growth of the cancer involves one or both ovaries, and one or both of the following
are present: (1) the cancer has spread beyond the pelvis to the lining of the abdomen; and (2) the
cancer has spread to lymph nodes. The tumor is limited to the true pelvis but with histologically
proven malignant extension to the small bowel or omentum.
Stage IIIA - During the staging operation, the practitioner can see cancer involving one or both
of the ovaries, but no cancer is grossly visible in the abdomen and it has not spread to lymph
nodes. However, when biopsies are checked under a microscope, very small deposits of cancer
are found in the abdominal peritoneal surfaces.
Stage IIIB - The tumor is in one or both ovaries, and deposits of cancer are present in the
abdomen that are large enough for the surgeon to see but not exceeding 2 cm in diameter. The
cancer has not spread to the lymph nodes.
Stage IIIC - The tumor is in one or both ovaries, and one or both of the following is present: (1)
the cancer has spread to lymph nodes; and/or (2) the deposits of cancer exceed 2 cm in diameter
and are found in the abdomen.
Stage IV - This is the most advanced stage of ovarian cancer. Growth of the cancer involves one
or both ovaries and distant metastases (spread of the cancer to organs located outside of the
peritoneal cavity) have occurred. Finding ovarian cancer cells in pleural fluid (from the cavity
which surrounds the lungs) is also evidence of stage IV disease.
29
These statistics, and the information regarding tumor stage and grade, demonstrate that
there is a critical need to establish an agenda for more research into the areas of basic and
translational research, genetic susceptibility and prevention, diagnostic imaging, screening and
diagnosis, and therapy. These could hold the most promise for future discoveries that will lead to
improved prevention, detection, and treatment of ovarian cancer, particularly the common
epithelial.
Symptoms of Ovarian Cancer
Ovarian cancer is difficult to detect, especially, in the early stages. This is partly due to
the fact that these two small, almond shaped organs are deep within the abdominal cavity, one on
each side of the uterus. These are some of the potential signs and symptoms of ovarian cancer:
• Bloating
• Pelvic or abdominal pain
• Trouble eating or feeling full quickly
• Feeling the need to urinate urgently or often
Other symptoms of ovarian cancer can include:
• Fatigue
• Upset stomach or heartburn
• Back pain
• Pain during sex
• Constipation or menstrual changes
If symptoms persist for more than two weeks, one should consult physician.
30
Persistence of Symptoms
When the symptoms are persistent, when they do not resolve with normal interventions
(like diet change, exercise, laxatives, rest) it is imperative for a woman to see her doctor.
Persistence of symptoms is key. Because these signs and symptoms of ovarian cancer have been
described as vague or silent, only around 19% of ovarian cancer is found in the early stages.
Symptoms typically occur in advanced stages when tumor growth creates pressure on the bladder
and rectum, and fluid begins to form.
• A rectovaginal pelvic examination is when the doctor simultaneously inserts one finger in
the rectum and one in the vagina.
• It is helpful to take a mild laxative or enema before the pelvic exam.
• Have a comprehensive family history taken by a physician knowledgeable in the risks
associated with ovarian cancer. 5% to 10% of ovarian cancer has a familial link.
Every woman should undergo a regular rectal and vaginal pelvic examination. If an
irregularity of the ovary is found, alternatives to evaluation include transvaginal sonography
and/or tumor markers. The most common tumor marker is a blood test called the CA-125.
Research
New Blood Tests
New blood tests (serum and plasma tumor markers) are being developed that can identify
early stage ovarian cancer by the presence of newly identified tumor markers that circulate in the
blood of women with advanced stage ovarian cancer. Therefore, the presence of these tumor
markers in apparently healthy women could lead to the diagnosis of early stage rather than late
stage ovarian cancer.
31
The following are examples tumors markers that may play a role in the early detection of
ovarian cancer:
• Lysophospholipids (such as LPA)
• Growth factor (such as EGFRs)
• Soluble urinary-type plasminogen activator (such as suPAR)
• Matrix metalloproteinases (such as MMPs)
• Hypermenthylated gene products
• Extra cellular matrix proteins.
Ovarian Pap test
The "Ovarian Pap Test" is a new diagnostic test performed to detect pre-cancerous or
early cancerous changes on the ovaries. Using minimally invasive office laparoscopy, the
"Ovarian Pap Test" directly visualizes the ovaries and collects cells from the surface of the ovary
and from the surface of the abdomen, similar to the cervical Pap test that collects surface
epithelium from the cervix.
32
CERVICAL CANCER
The outlook for preventing one of the world's top female cancer killers is better than it
has ever been. Cervical cancer kills one woman in the world every two minutes. The good news
is that there is now a way to stop cervical cancer before it starts - with vaccination against the
challenging virus which causes the cancer, the human papillomavirus.
Cervical Cancer Today
Cervical cancer is a major cause of death in women around the world. In the UK there
are around 2,800 new cases and 1,100 cervical cancer deaths a year. While in the US there are
10,000 new cases and 3,700 deaths per year. Around the world, every two minutes a woman is
dying of cervical cancer.
Looking at cervical cancer across the globe, over 80 per cent of the deaths from cervical
cancer occur in the developing world. Sub-Saharan Africa is the worst-affected region. In
Zambia, for example, cervical cancer strikes 63 women in 100,000, which is almost ten times
Australia's rate of 7 per 100,000 women.
Relatively high rates are also seen in some of the former Eastern block states – notably
Romania and Bulgaria. It has been found that increased cases of cervical cancer are apparent in
countries where either no or poorly maintained screening programs exist.
Cervical cancer commonly strikes women early, often in their mid-thirties, at an age
when they are in the prime of their lives. Many affected women will be caring for young
children and extended families, so one death from cervical cancer can devastate the lives of
many people.
Worldwide cervical cancer affects over 1.4 million women, is the second most common cancer
in women aged 15-45 and the third leading cause of cancer death among women, after breast and
lung cancer.
33
Most of the deaths occur in the developing world. In women who do not undergo regular
screening, cervical cancer can be a silent killer as it can take many years to develop and women
may not experience symptoms for a long time. By the time symptoms appear the disease is often
Symptoms and prognosis of cervical cancer
The pre-cancerous stages and earlier stages of cervical cancer are usually symptom-less, which is
why it is important for women to have regular pap smear tests, also known as cervical screening.
In the absence of screening, the most common sign of invasive cervical cancer is bleeding from
the vagina at times other than during menstruation.
Between 1975 and1995, average five-year survival rates for women diagnosed with
cervical cancer in the UK rose from around 50 per cent to 65 per cent – but for those diagnosed
with more advanced stages of the disease in which the cancer has spread, the outlook is even
worse.
VIRUS
Cervical cancer is caused by a virus called human papillomavirus (HPV) which is caught through
sexual activity. Unfortunately condoms do not fully protect women from HPV infection since the
spread of the virus does not depend on full intercourse only but may also occur simply through
skin-to-skin contact in the genital area.
There are about 100 known types of HPV but only about 15 can cause cervical cancer.
Together four cancer-causing virus types (16, 18, 45 and 31) are the most common, accounting
for more than 80 percent of all cervical cancer cases worldwide.
HPV 16, 18 and 45 are particularly concerning since these three are associated with
nearly 90 per cent of cases of adenocarcinoma, a particularly aggressive form of cervical cancer.
34
Figure 4.1
HPV is very common: it is estimated that up to 80 per cent of women will acquire an
HPV infection in their lifetime and up to 50 per cent of these will be with a cancer-causing virus
type. Luckily most infections resolve spontaneously but when the infection persists the risk of
developing cervical cancer rises sharply.
A persistent infection with a cancer-causing virus type may cause the development of
abnormal and pre-cancerous cervical cell changes which over time can develop into cancer.
HPV is a challenging virus because the natural immune response, following infection
with a cancer-causing virus type, may not be strong enough to protect against subsequent
infection. What is more, as immune function gets weaker with age, infections are more likely to
persist and hence progress to cancer as a woman gets older.
Screening- Cervical cancer
The strongest weapon in the fight against cervical cancer is prevention. Where it is available,
regular screening using smear testing provides an early warning system, detecting evidence of
abnormal or pre-cancerous cells and allowing in some instances to remove the diseased tissue.
While screening helps detect abnormalities, around 20 percent of abnormal cases remain
undetected. It is also significant that receiving an abnormal smear test result can be a traumatic
and unsettling experience for women, as can the surgical procedures used to eliminate the
affected cells.
35
In the developed world, potentially dangerous changes in the cervix are usually spotted
before cancer emerges which is predominantly attributed to national screening programs. The
British system is a good example of a successful screening program. It prevents around 4,500
deaths each year in the UK, by detecting cervical disease when it is still at the easily treatable,
pre-cancerous stage.
Similar programs in North America, Western Europe and Australasia have also seen the
number of cervical cancer cases fall dramatically.
In the UK, women are supposed to be called by their General Practitioner to be screened
every three years from the age of 25 onwards for pap smear tests. Cervical cancer experts warn,
however, that in recent years attendance for cervical smears has fallen. Between 2000 and 2005,
the coverage of the screening program among the women aged 25-29, fell from 77 per cent to
71.6 per cent.
Smear tests may seem straightforward to health professionals but there is evidence that
some women do not know the importance of a smear test, find them embarrassing or even
traumatic, and in part this may explain why screening fails to reach everyone who is at risk.
However, in many poorer countries screening is less consistent and in most developing
countries, screening is virtually non-existent. This is why the death rates from cervical cancer
may be ten times higher in East Africa than in some countries in Western Europe. This lack of
screening makes the need for a vaccine against cervical cancer even more pressing.
Vaccination against cervical cancer
Because HPV is no ordinary virus and poses particular challenges by managing to hide
from the natural immune system, it is important to ensure that the immune response induced by
vaccination is consistently strong and long-lasting that it protects against the most common and
aggressive cancer-causing virus types.
36
To stop infections with cancer-causing human papillomavirus types from occurring,
vaccination before a first sexual encounter is recommended, but, since a woman can come across
the virus at any point in her life, nearly all women could benefit from vaccination.
Worldwide, cervical cancer affects more women under 45 than any other malignancy
apart from breast cancer. So it’s surprising that the disease, known also as cancer of the cervix,
is in most cases unknown by women.
On the whole, most women do not know that cervical cancer is caused by a virus but
there is a definite eagerness to know more about this preventable disease within the female
community.
Despite the positive impact cervical cancer screening has had in managing this disease,
cervical cancer continues to have a high prevalence. However, a feeling of optimism is
emerging as for the first time, revolutionary vaccines will make it possible to prevent most cases
of this disease.
Treatment Options
After your diagnosis, your doctor will develop your customized treatment plan. Women
should always discuss their treatment options with a physician, because the best and most
appropriate treatment will be different based on the stage of disease, the woman's age and the
overall condition of her health.
1) Surgery - Surgery to remove the cancerous growth is the most common method of
diagnosis and therapy for ovarian cancer. It is best performed by a qualified gynecologic
oncologist.
2) Chemotherapy - Chemotherapy is the treatment of cancer using chemicals
(medications) that travel through the bloodstream to destroy cancer cells or stop them from
growing both in and outside the ovaries. Chemotherapy is used in the majority of cases as a
follow-up therapy to surgery.
37
3) Radiation Therapy - Radiation therapy uses high-energy X-rays to kill cancer cells and
shrink tumors (only rarely used in the treatment of ovarian cancer in the United States).
Complementary Therapies
Some women with ovarian cancer turn toward the whole-body approach of
complementary therapy to enhance their fight against the disease, as well as to relieve stress and
minimize side effects such as fatigue, pain and nausea.
Complementary therapies are diverse practices and products that are used in conjunction
with conventional medicine. Many women have tried and benefited from the following
complementary therapies. You might want to speak with other women with cancer or your
healthcare team to see which therapies they found most helpful or might work best for you and
your lifestyle.
Acupuncture - An ancient Chinese method of healing in which small sterilized needles
are inserted into the body's energy centers to promote healing.
Aromatherapy - The use of essential oils from flowers, herbs and trees to promote health and
wellbeing.
Herbal Medicine - Use of remedies using plant parts to treat symptoms and illnesses.
(Consult your healthcare professional prior to using herbal medicine).
Massage - Manipulating the body's muscle and connective tissue through rubbing, kneading and
patting to promote relaxation and well being.
Massage - Manipulating the body's muscle and connective tissue through rubbing,
kneading and patting to promote relaxation and well being.
Meditation - Conscious relaxation and focused breathing to relax the mind and body.
38
Qi Gong (chee-GUNG) - A type of Chinese medicine that combines movement,
meditation and breathing to enhance the flow of qi (an ancient term given to what is believed to
be vital energy) in the body, improve blood circulation and enhance immunefunction.
Stress Reduction - Use of stress reduction methods such as exercise, meditation, etc.
which have been found to be beneficial in reducing cancer progression and recurrence.
Yoga, Tai Chi - Postures, movements and breathing exercises to strengthen and heal the
body, mind and spirit.
Safe Use of Complementary Therapy
There are questions about most complementary therapies that have not yet been answered
through well-designed scientific studies, such as clinical trials. Before beginning any
complementary therapy, it is important to discuss the approach with your healthcare team and
complementary therapy practitioner.
39
CANCER STATISTIC IN INDIA
Human papillomavirus (HPV) infection is now a well-established cause of cervical
cancer and there is growing evidence of HPV being a relevant factor in other anogenital cancers
(anus, vulva, vagina and penis) and head and neck cancers. HPV types 16 and 18 are responsible
for about 70% of all cervical cancer cases worldwide. HPV vaccines that prevent against HPV 16
and 18 infection are now available and have the potential to reduce the incidence of cervical and
other anogenital cancers.
India has a population of 366.58 millions women ages 15 years and older who are at risk
of developing cervical cancer. Current estimates indicate that every year 132082 women are
diagnosed with cervical cancer and 74118 die from the disease. Cervical cancer ranks as the 1st
most frequent cancer among women in India, and the 1st most frequent cancer among women
between 15 and 44 years of age. About 7.9% of women in the general population are estimated
to harbour cervical HPV infection at a given time, and 82.5% of invasive cervical cancers are
attributed to HPVs 16 or 18.
Cancer of the cervix uteri is the second most common cancer among women worldwide,
with an estimated 493,000 new cases and 274,000 deaths in 2002. About 83% of the cases occur
in developing countries, representing 15% of female cancers. Worldwide, mortality rates of
cervical cancer are substantially lower than incidence with a ratio of mortality to incidence to
55%. The majority of cases are squamous cell carcinoma and adenocarcinomas are less common.
40
Table 4.1
From the above table, it can be inferred that dearth rate because of cervical cancer is
more than 50%. Same way, by 2025, cervical cancer patients would more than 90 % than current
cases.
Oral contraceptives are major factor responsible for cervical cancer followed by smoking
& total fertility rate.
41
Table 4.2
India is more prone to cervical cancer as we can see from the above data. Around ¼ of
the cases are from India alone of the total cases from the world. This only shows increasing
growth of dangerous cervical cancer.
42
CHART 4.1
Crude Incidence ratio is found out by finding the probability of a new case occurring
during a stated time interval. India is also in a dangerous state as can be observed from the graph
CHART 4.2
Standardized incidence ratio is a using direct method & world population as
reference. Rates are per 100,000 populations. India is highest in this aspect also.
43
Table 4.3
CHART 4.3
As we can see New Delhi & Mumbai are having more cases compared to other cities of
India. These are metro cities. So, changing life style (like late marriages, working women,
smoking etc) is responsible for cervical cancer.
44
CHART 4.4
Incidence of cervical cancer in india among other cancer in women
45
CHART 4.5
Age-specific cervical cancer incidence compared to age-specific incidence of other
cancers among women 15-44 years of age in India
46
CHART 4.6
47
CHART 4.7
Annual number of new cases of cervical cancer by age group in India and Southern Asia
48
CHART 4.8
49
CHART 4.9
Estimated number of deaths of cervical cancer in India by age group, in 2002 and projected in
2025
50
CHART 4.10
51
Factors contributing to cervical cancer
HPV is a necessary cause of cervical cancer, but it is not a sufficient cause. Other
cofactors are necessary for progression from cervical HPV infection to cancer. Tobacco
smoking, high parity, long-term hormonal contraceptive use, and co-infection with HIV have
been identified as established cofactors. Co-infection with Chlamydia trachomatis and herpes
simplex virus type-2, immunosuppression, and certain dietary deficiencies are other probable
cofactors. Genetic and immunological host factors and viral factors other than type, such as
variants of type, viral load and viral integration, are likely to be important but have not been
clearly identified.
Table 4.5
Factors contributing to cervical carcinogenesis (cofactors) in India
Table 4.6
Estimated coverage of cervical cancer screening in India
52
Available drugs for the treatment of ovarian & cervical drugs
Table 4.7
GENERIC
NAME
BRAND NAME COMPANY
STRENGTH
(MG)
DOSAGE
FORM
Cisplatin Cytoplatin Cipla 10/50 Injection
Platin Cadila 0.5/1 Injection
Peclitaxel Paclitax Cipla 30/100/250 Injection
Cytax Intas 30/100 Injection
5-Fluorouracil Fludin Biological E 250/500 Injection
Fluracil BIOCHEM 250/500
Injection,
Capsule
Tamoxifane Temofane Dabur 10 Tablet
Cytutam Cipla 10/20 Tablet
Bleomycin Bleocip Cipla 15 Injection
Bleochem Biochem 15 Injection
Doxorubicine Cadria Cadila 10/50 Injection
Levadox Nicholas Piramal 10/50 Injection
(Source: Indian Drug Review, Oct-Nov, 2009 & Survey of Doctors, Retailers & Stockiest)
53
EXISTING BRANDS OF DOXORUBICINE
Table 4.8
SR.
NO.
BRAND COMPANY
PRICE (RS),
(10/50 MG PER 5/25 ML PER
VIAL RESPECTIVELY)
1 Oncodox Cipla 289/1274
2 Adrim Dabur 192/910 (2 mg/ml)
3 Adriamycin Upjohn 310/1540
4 Cadria, Doxomed Cadila 250/1085, 250/1025
5 Doxolem Elder Pharma 240/1190
6 Dxocare Citricare 251.63/1157.47
7 Tevadox Nicholas Piramal 250/950
8 Oncodria Sun Pharma 205/950
9 Dobixin German Remedies 265/1188 (2 mg/ml)
10 Dobicin Chandra Bhagat Pharma 250/950
11 Doxobin Biological E 234/1062
12 Doxorex Samarth 270/975
14 Duxocin, Doxorubicin Inj. Biochem 278/1008, 234/1062
16 Rubinat Natco 254/1103.34
17 Lyphidox Alkem 292/954
18 Doxil Alza 198/887
19 Rubex Bristol 375/1278
20 Zodox Intas 190/925
21 Tumodox Max 284.70/1186.25
23 Adrosol-RD VHB Life Sciences 210/895
(Source: Indian Drug Review, Oct-Nov, 2009 & Survey Of Doctors, Retailers & Stockiest)
54
PEGYLATED LIPOSOMAL DOXORUBICIN
Pegylated liposomal doxorubicin (PLD) is doxorubicin HCl encapsulated in long-
circulating STEALTH® liposomes (Doxil®). PLD achieves good response rates and many
patients maintain long-lasting stable disease (SD), which is one of the advantages. In addition,
the clinical benefit is high in platinum-resistant disease, and PLD is thus considered to be the
first option.
PLD is associated with a number of adverse events, but these events are mild to
moderate. PLD is safer for heavily pretreated patients than topotecan and gemcitabine due to
mild bone-marrow toxicity, but that nonhematotoxity, such as PPE, stomatitis, mucositis, and
other cutaneous reactions were the most common side effects attributable to PLD. Based on a
review of previous studies, there are no differences in efficacy between 50 and 40 mg/m2 of
PLD, therefore, a dose of 40 mg/m2 is preferable in patients with platinum resistant disease to
reduce adverse events.
The 1-hour infusion schedule every 4 weeks makes PLD easy to administer. A rational
approach to combine PLD with other drugs should take the slow accumulation and delayed peak
of PLD in tumors into consideration. When combined with other useful agents, the lower dose of
PLD (30 to 35 mg/m2) with a 3-week schedule may reduce severe PPE and stomatitis with
negligible effects on the level of DI and the therapeutic efficacy.
Epithelial ovarian cancer is sensitive to chemotherapy and approximately 75% of patients
achieve complete clinical remission after the initial treatment. However, most patients have a
recurrence, which results in death after a chronic course.
The progression-free survival (PFS) for advanced ovarian cancer patients with optimal
residual disease range from 18 to 24 months, while PFS for patients with suboptimal residual
disease is 18 months.1–5 The PFS of dose-dense paclitaxel/carboplatin therapy improved to 28
months for patients with both optimal and suboptimal disease in our study (JGOG3016).
55
In the treatment of recurrent cancer, the issues to consider are the treatment-free interval
(TFI), toxicity continuously observed from the initial treatment, recurrent tumor diameter and
increased CA125.
The TFI is the most important for selecting drugs or regimens, and the longer the TFI,
the higher the response rate.7,8 When the TFI is 6 months or longer, the tumor is considered to
be sensitive to chemotherapy, but when the TFI is less than 6 months, the tumor is considered
resistant to chemotherapy. However, 6 to 12 months of TFI is considered to be a gray zone, and
such tumors require more careful consideration when selecting drugs or regimens.
Recommended therapies for tumors sensitive to drugs, based on the results of
randomized controlled trials (RCT) and meta-analyses, are carboplatin-combination therapy such
as carboplatin/ paclitaxel, carboplatin/gemcitabine, and carboplatin/ pegylated liposomal
doxorubicin (PLD).9–11 For patients with TFI of 6 to 12 months, a non-platinum drug is one
option for prolonging the platinum-free interval and reducing toxicity. However, patients must
therefore be carefully observed to determine when the switch from non-platinum chemotherapy
to platinum combination therapy should be made.
A phase III trial has been recently launched comparing carboplatin/paclitaxel versus PLD
in the above cited clinical setting (NCT00657878). On the other hand, for patients with a drug-
resistant tumor, a drug without cross-resistance to paclitaxel and carboplatin must be selected.
The goal of therapy is to delay progression, relieve symptoms and improve the QOL, and
monotherapy is generally chosen for the most favorable toxicity profile. PLD, topotecan, and
weekly paclitaxel are drugs that have been approved by the Food and Drug Administration
(FDA), and gemcitabine (GEM), oral etoposide, and docetaxel can also be used. In Japan,
weekly irinotecan (CPT-11) is widely used.
When selecting drugs, the differences in toxicity must be fully understood. It is usually
difficult to completely cure recurrent disease with one drug or one regimen with high efficacy
and low toxicity, and the drugs must therefore be changed as required while assessing the effect
and toxicity.
56
Topotecan and GEM are highly hemotoxic, and patients should be monitored for non-
hemotoxic events that reduce the QOL when PLD and irinotecan are used. There is concern
about palmar-plantar erythrodysesthesia (PPE) and stomatitis, both of which can occur with PLD
treatment, diarrhea due to irinotecan, and peripheral neuropathy and arthralgia during weekly
paclitaxel therapy.
PLD was approved in 1999 by the FDA and in 2000 by the European Medicines
Evaluation Agency as a treatment for chemorefractory and chemoresistant epithelial ovarian
cancer, and has been used worldwide as the first option for patients with chemorefractory and
chemoresistant epithelial ovarian cancer.
Mechanism of Action, Metabolism and Pharmacokinetic Profile
PLD consists of doxorubicin encapsulated in N-(carbonyl- methoxypolyethylene glycol
2000)-1, 2- distearoyl-sn-glycero-3- phosphoethanolamine sodium salt (MPEG-DSPE) coated
liposome (STEALTH® liposome). Liposomes have the advantage of biocompatibility and
versatility of formulation for intravenous use.
However, the disadvantages of liposomes are rapid uptake by the reticuloendothelial
system (RES) and removal from the circulatory system, thus reducing the amount of drug that
reaches the tumor. MPEG-DSPE is a hydrophilic material and characteristically decreases RES
uptake.
Therefore, the STEALTH® liposome achieves prolonged circulation time without rapid
uptake by RES, and PLD has made prolonged delivery of doxorubicin and prolonged circulation
time possible. Gabzon et al undertook a pilot clinical study about the pharmacokinetics compared
with PLD and free (unencapsulated) doxorubicin (DOX), and reported that the AUC of PLD in
plasma was approximately 250-fold higher than that of DOX.12 Furthermore, the diameter of
PLD of approximately 100 mm makes it generally difficult are involved in doxorubicin
metabolism are NADPHdependent aldo-keto reductase and microsomal glycosidase.
57
Figure 4.2
58
Price incorporation strategy in pharmaceutical industry:
Generally, in pharma industry, after complete process of manufacturing and packaging,
various drugs go to market through following chain:
Carry & forwarding agents (C & F Agents)
Stockiest (Wholesalers)
Retailers
By surveying above channels we found out following information about them & their
price incorporation strategy:
(1) Carry & forwarding agents (C & F Agents)
They are appointed by companies in a particular state.
Every company has their own C & F agents.
They supply drugs to wholesalers.
Their margin is around 1.5-2%.
(2) Stockiest (Wholesalers)
As the name suggest, they keep drugs of various companies & supply
them to retailers.
Their margin is around 8-9 %.
(3) Retailers
They are the one who supply drugs to patients.
Their margin is around 20-22%.
From, the above information, we can say that price of various drugs includes
approximately 20-22% mark up cost which includes cost & profit. Incase of branded drugs,
margin is very less compared to local drugs..Incase of ovarian & cervical cancer drugs, they are
more costly & their side effects are very high. So, mostly they are given in combinations. So,
overall therapy (which is called chemotherapy treatment) is vey costly.
59
We also checked the feasibility of E-PROCUREMENT & DIGITAL DISPLAY by
surveying above channels.
90% of the retailers denied for E-PROCUREMENT as it does not provide medicines on time &
without middle channels it is not possible to procure drugs directly from the company.
60% of the retailers denied service to digital promotion t does not benefit them much.
60
MARKET ANLYSIS
GENERIC CANCER MARKET:
Tthe generic cancer market, defined to include cytotoxics, antihormonal therapies,
immunostimulating agents, targeted therapies and supportive care products (growth factors), was
worth $1.3 billion across the seven major pharmaceutical markets in 2004. Forecasts this market
to reach $10.9 billion in value by 2014, achieving a CAGR of 23.5%.
This staggering level of growth is attributable to upcoming patent expiries on key
products, as well as the imminent introduction of a regulatory pathway for biogenerics, which
will open a previously untapped market that is currently worth billions; a large number of
anticancer products were granted regulatory approvals in the 1990s and early 2000s, totaling 48
(FDA Oncology Tools). As a natural progression from this high volume of product approvals is
an increase in the number of impending patent expiries in the coming years.
Several of these products currently achieve blockbuster sales, while others are forecast to
break the $1 billion sales barrier in the forecast period of this report, thus representing a highly
lucrative opportunity for generics manufacturers. Has identified 2009 as the year with the
greatest potential for generics manufacturers, when nearly $15 billion worth of oncology product
sales will be at risk from generic erosion. As a result of this, the impact of generics on the cancer
market will become dramatically amplified in the next five years; upon entry to the market,
generic drugs will generally rapidly cannibalize sales of the original branded product.
In addition, no delay in revenue growth will occur while clinical recognition is achieved,
as efficacy and safety of the original product will already have been established by the time the
generic enters the market.
61
Last four years’ trend
Table 4.8
(SOURCE: ORG SURVEY APRIL’09)
BRAND
APR-09 MAT
(Rs Cr.)
APR-08 MAT
(Rs Cr.)
APR-07 MAT
(Rs Cr.)
APR-06 MAT
(Rs Cr.)
DOXORUBICINE 73.02 60.7 48.5 40.24
ONCODOX 18.56 17.67 15.98 13.24
TEVADOX 12.28 11 9.6 8.41
ONCODRIA 10.5 8.74 7.89 7
CADRIA 9.45 7.24 6.56 5.98
ADRIM 7.9 6.86 5.65 4.67
62
CHART 4.11
Market of Doxorubicine molecule is growing at approximately 23% every year. Also,
Overall market in April’09 is more than 80% of April’06. This indicates good market
opportunity.
63
CHART 4.12
Generic market of the Doxorubicine is also strong. All the generic drugs have more than
80% market within 4 years from April’06 to April’09. Oncodox from Cipla is at the top.
64
Growth Projection of DOXORUBICINE:
Table 4.9
YEAR
DOXORUBICINE
MARKET
(Rs. Crores)
GROWTH (%)
2006-07
40.24
22
2007-08
48.5
23
2008-09
60.7
22.5
2009-10
73.02
23.5
2010-11 90.17 27
2011-12 114.51 27
65
CHART 4.13
Growth projection forecasts market to be Rs. 114.51 crore with a growth rate of 27%
indicating great opportunity in generic cancer market by 2012.
66
Regional analysis
Table 4.10
VALUE
(Rs. Cr)
%MS
% GROWTH
ALL INDIA 47.00 100 23
NORTH 15.04 32 24
EAST 12.00 25.53 18
SOUTH 11.00 23.40 28
WEST 9.00 19.14 12
(SOURCE: ORG SURVEY, DEC. 2009)
67
CHART 4.14
North is highest with 16% especially New Delhi & Mumbai with more affected
68
PRESCRIPTION ANALYSIS OF OVARIAN & CERVICAL
CANCER DRUGS
Table 4.11 ONCOLOGIST Rx Response share trend (C-MARC)
MOLECULES NOV-FEB‘08 MAR-JUN‘08 JULY-OCT‘08 NOV-FEB‘09
ANTI CANCER DRUGS 9,O02= 100 % 9126 =100 % 8898 =100 % 8909=100 %
DOXORUBICINE 44.9 44.5 42.8 43.3
CYCLOPLATIN 16.8 16.9 16.6 16.6
PACLITAXEL 9.4 9.7 8.2 7.8
DECOTAXEL 8.3 8.3 9.1 8.4
5-FLUROURACIL 6.1 7.9 3.2 2.9
MEGESTEROL ACETATE 5.4 5.5 5.1 4.9
TAMOXIFEN 3.4 2.4 2.1 2.2
BLEOMYCIN 0.9 2.5 0.6 0.5
VINCRISTIN 4.5 1.3 2.0 2.3
VINBLASTIN 0.3 1.0 0.3 0.2
VACCINE (FOR CERVICAL
CANCER)
4.3 2.3 1.0 0.3
69
Table 4.12 CONS PHYSIO Rx Response share trend (C-MARC)
MOLECULES NOV-FEB ‘08 MACH-JUNE ‘08 JULY-OCT ‘08 NOV-FEB ‘09
ANTI CANCER DRUGS 2318= 100 % 2397 =100 % 2232 =100 % 2324=100 %
DOXORUBICINE 56.7 56.2 56.5 54.7
CYCLOPLATIN 19.8 20.0 19.4 19.3
PACLITAXEL 2.7 4.8 3.3 4.6
DECOTAXEL 4.3 4.8 4.5 4.6
5-FLUROURACIL 3.6 3.3 2.6 2.2
MEGESTEROL ACETATE 3.4 2.9 1.8 3.6
TAMOXIFEN 2.2 2.6 1.9 2.0
BLEOMYCIN 0.6 0.7 0.9 0.9
VINCRISTIN 2.4 2.0 2.3 2.5
VINBLASTIN 0.6 1.2 2.2
VACCINE (FOR CERVICAL
CANCER)
2.3 1.2 0.6
70
SWOT ANALYSIS
Strengths
• Well accepted formulation
• High demand
• Better perception in ovarian cancer
• Side effects are less
Weaknesses
• Very High Cost
• Stiff competition from well known
corporate brands
Opportunities
• Consolidate in every type of cancer
• Untapped Gyneclology segment
Threats
• Intense competition from cheap
drugs
71
SURVEY OF DOCTORS
SURVEY FINDINGS: Opinion of total of 20 expert oncologists’ doctors was taken
with sample questionnaire for Doxorubicine.
Table 4.13 Oncologists’ survey
Parameters for
Doxorubicin
(No. of response from doctors)
Doxorubicine is the
proffered first drug of
choice for particular
disease
Ovarian Cancer
(3)
Cervical cancer
(3)
Breast cancer
(2)
Lung cancer
(2)
All of them
(10)
Doxorubicine is
preferred because of
its
Efficacy
(08)
Potency
(04)
Better half life
(02)
Lesser side
effects
(02)
Rapid onset of
action
(04)
Most preferred
strength of
Doxorubicine is
10 mg
(10)
50 mg
(07)
100 mg
(02)
250 mg
(01)
Doxorubicine is
widely used as a
Plain drug
(00)
In combination
(20)
Doxorubicine is
preferred most in
dosage form
Injections
(10)
Oral solid tab
(06)
Capsule
(04)
Any Other
(00)
The criteria doctors
keep in mind while
writing a particular
brand is
Efficacy
(06)
Reputation of
brand
(04)
Broad spectrum
of the drug
(03)
Benefits to the
patients
(07)
72
SURVEY FINDINGS: Opinion of total of 10 expert Consultant Physiologists’ was
taken with sample questionnaire for Doxorubicine.
Table 4.14 Consultant Physiologists’ survey
Parameters for
Doxorubicin
(No. of response from doctors)
Doxorubicine is the
proffered first drug of
choice for particular
disease
Ovarian Cancer
(0)
Cervical cancer
(0)
Breast cancer
(0)
Lung cancer
(0)
All of them
(10)
Doxorubicine is
preferred because of
its
Efficacy
(03)
Potency
(03)
Better half life
(00)
Lesser side
effects
(02)
Rapid onset of
action
(02)
Most preferred
strength of
Doxorubicine is
10 mg
(05)
50 mg
(03)
100 mg
(01)
250 mg
(01)
Doxorubicine is
widely used as a
Plain drug
(00)
In combination
(10)
Doxorubicine is
preferred most in
dosage form
Injections
(06)
Oral solid tab
(03)
Capsule
(01)
Any Other
(00)
The criteria doctors
keep in mind while
writing a particular
brand is
Efficacy
(03)
Reputation of
brand
(02)
Broad spectrum
of the drug
(01)
Benefits to the
patients
(04)
73
CHART 4.15
Doxorubicine is the preffered choice of drug for all type of cancer. This is a good opportunity as
it can be projected in all type of cancers.
74
CHART 4.16
Doxorubicine is most prefferd because of its efficacy & potency followed by rapid onset of
action. However because of its liposomal form side effects are reduced,
75
CHART 4.17
Around 50% doctors said preferred strength is 10 mg/5 ml followed by 50 mg/25 ml for needed
higher dose.
76
CHART 4.18
Not only Doxorubicine, almost all the cancer drugs are prescribed in combination therapy
because of high side effects. However, Doxorubicine is having less side effects because of its
liposomal form compared to traditional dosage forms
77
CHART 4.19
Injections are most preferred because of rapid onset of action followed by tablets & capsules.
Most of the available anticancer drugs are in the Injecteble. (Ref: Table no. 4.7 & 4.8)
78
CHART 4.20
Doctors while writing a particular brand benefit to patients which also include economical
benefits & efficacy for a particular brand followed brand reputation spectrumn & brand
reputation
79
CHAPTER 5
CONCLUSION
80
Due to changing life style (especially for women who are working & marrying at older
age), there has been rapid increase in ovarian & cervical cancer drugs. However, due
rapid change & development in technology, it has been possible to get catch on cancer.
Ovarian and cervical cancer are detected in first past and second stage which is too late in
most of the cases, makes them life threatening disease.
Report of cancer statistics from WHO indicates there will be more than 226084 case of
cervical cancer by 2025, indicate rising number of women more prone to cervical cancer
As we have seen, there has been increasing market of ovarian & cervical cancer drugs.
Secondary data of generic cancer drugs shows forecast of $10.9 billion market by 2014
with CAGR OF 23.5%
Also data of C-MARC from Table 4.11 to 4.16 shows Doxorubicine is the preferred
choice of drug for ovarian & cervical cancer drugs.
From the table 4.8, it can be observed increasing growth of Doxorubicine. There has been
approximate 40% growth in april-09 from april-06. . This indicates good market
opportunity
Table 4.9, shows growth projection of 25% every year which will lead to Doxorubicine
market to 115 crore in 2011-12. This shows Doxorubicine is at its peak of growth which
favors launching a new brand for Doxorubicine. So, from the above references of market
we can be optimistic for good growing market of Doxorubicine We can be optimistic
about good market share.
Prescription analysis shows Doxorubicine is the drug of choice for ovarian & cervical
cancer & also for other types of cancer. while there is also good scope in cons. physicians
& Gynecology segment.
81
CHAPTER 6
SUGGESTIONS & RECOMMENDATIONS
82
BRAND LAUNCH & POSITIONING
4Ps of marketing which are product, place, price & promotion for new brand launch of
Doxorubicine SHOULD BE as follows:
(1) PRODUCT:
Our product will be PEGYLATED LIPOSOMES OF DOXORUBICINE (10/50 mg) in
the form injection.
Preferred brand name will be DOXALITE.
The product will be made available in VIAL of 5 & 10 ml.
(2) PLACE:
DOXALITE will be placed for ovarian ,cervical & other types of cancer disease as a
monotherapy as well as adjunctive therapy.
(3) PRICE:
Following price is recommended for various strength of DOXALITE
STRENGTH PRICE (RS)
10 mg/ 5ml 300/ VIAL
50 mg/ 25ml 1200/VIAL
(4) PROMOTION:
DOXALITE should be promoted with positioning theme
“NOW REMAI N I N LI GHT WI TH DOXALI TE”
“NEW LI GHT I N LI FE WI TH DOXALITE”
83
PROMOTIONAL STRATEGY
DOXALITE should be promoted in following 3 ways:
(1) Brand promotion
(2) Advertising promotion
(3) Sales promotion
(1) Brand promotion: Promo plan for DOXALITE brand amongst doctors
should be as follows:
Dr segmentation
• Oncologist
• Gynecologist
• Consultant physiologist
Positioning theme (with payoff line)
• “NOW REMAI N I N LI GHT WI TH DOXALI TE”
• “NEW LI GHT I N LI FE WI TH DOXALITE”
Action Plan
• In-clinic involvement of the DOCTOR
• Comparison with Cisplatin, Paclitaxel and highlighting the benefit of
DOXALITE without addiction
• Aggressive brand conversion of the market leader-Oncodox,
Levidox,,Cadria, Oncodria & others
• Mailers
• Visual Aid
• Leave Behind Literature(LBL)
• Promotional input
84
• Product monograph
• Abstract of journals
• References
Promotional inputs for doctors
(1) Mailer: (As Brand Recall)
6 Pocket shape mailer representing convenience (Two in a month)
Anxiety/Phobia-relating convenience
Which facilitated use of DOXALITE
Melt in Mouth Activity
Small Size
(2) Visual Aid: (As Brand Energizer)
(Communication theme for DOXALITE)
Diseases like ovarian, cervical & other type of cancers shown as various heads of
“RAVAN” (Character from ‘RAMAYAN’) & DOXALITE (DOXORUBICINE)
as a killing soldier (showing having weapon in hand & body of tablet wearing cap
on head)
A woman shown in jovial mood because of DOXALITE molecule.
• ONCOLOGIST & CONSULTANT PHYSIOLOGIST
Start early with DOXALITE
A convenient formulation for all the type of cancers
Effective drug of choice ovarian & cervical cancer
Rapid onset of action
Reduced side effects
• GYNECOLOGIST
A Perfect Quick solution that rapidly stabilizes acute symptoms of cancer
Effective drug of choice ovarian & cervical cancer
Highly efficient
Reduced side effects
Immediate relief
85
(3) Leave behind Literature (LBL): (As Brand Recall)
(4) Promotional input: (As Brand Recall)
Promotional inputs like calendars, chart etc highlighting packing of DOXALITE
& its indications, benefits etc.
(5) Product monograph: (As Brand Energizer)
(6) Abstract of journals: (As Brand Energizer)
(7) References: (As Brand Energizer)
(8) Diagnosed the situation campaign for physician only: (As Brand Recall)
(9) Prescription pads with brand name DOXALITE
As Brand Recall)
(2) ADVERTISING PROMOTION:
DOXALITE should be promoted by advertising it in various pharmaceutical &
medical publications like IPA, Indian Drug Review (IDR), Drug Today, MIMS.
LANCET etc.
DOXALITE should be promoted online in various pharmaceutical & medical websites
(3) SALES PROMOTION
Promo plan for stockiest/retailers
(1) Promotional inputs
(2) Promotional schemes like
Order for-
• 100 VIALS & get 2 VIAL free
• 300 VIALS & get 5VIAL free
• 500 VIALS & get 7VIAL free
• 2 % discount to patient on continuous therapy which will be added to fund for welfare of
cancer patients.
(3) Gifts like letter pads, diaries, ball pens
86
OPERATIONAL PLAN
Modus operandi..
1. 10 Doctor/Field sales officer
2. Can be done in first week of every month.
3. Will focus mainly on DOXALITE during the call
4. FSE need to send to send back a report of completion of the campaign by the second week of
every month in the given format
Series
Modus Operandi
1. 15 Dr/Field sales offocer (Mini.5 CPs) apart from AASHA- a new lifecampaign.
2. Regular visit after every 10 days to maintain the continuity in the campaign
Drug interaction Chart/LBLs/Mailer
1 .O (Their will be 2 type of chart one for Physician & other for oncologist)
doc_559371619.pdf
Market research process is the process used to obtain information regarding market opportunity & problem and there by making strategies for the business. Our purpose is to launch a new brand of PEGYLATED LIPOSOMES OF DOXORUBICINE
1
CHAPTER 1
RESEARCH METHODOLOGY
2
RESEARCH PROPOSAL
Macro Objective
To study & analyze overall domestic market for OVARIAN & CERVICAL CANCER DRUGS.
Micro Objective
1. To analyze price incorporation strategy of drugs in pharmaceutical industry
2. To study & analyze overall domestic market for generic version of PEGYLATED
LIPOSOMES OF DOXORUBICINE & compare it with other existing brands of
OVARIAN CANCER DRUGS in terms of available dosage forms, efficacy & price
3. To suggest an appropriate launch strategy to launch a new generic version of the
DOXORUBICINE
3
Motivation for the research
Pharmaceutical is one of the most intense “Knowledge Driven” industries. It is a life
line industry, which plays a very crucial role in building a strong human capital of a country, and
is very essential for economic growth and development. In 2008, global spending on prescription
drugs topped $700 billion, even as growth slowed somewhat in Europe and North America. The
United States accounts for almost half of the global pharmaceutical market, with $300 billion in
annual sales followed by the EU and Japan. Emerging markets such as China, Russia, South
Korea and Mexico outpaced that market, growing a huge 81 percent.
The pharmaceutical industry is one of the fastest growing sectors in Indian economy. The
size of the Indian pharmaceutical industry is estimated at US $ 7.76 billion. It is growing at an
average rate of 14.1 %. The pharmaceutical industry has shown a robust growth of 13% in 2007
and has grown by 12% in 2008. It is expected to continue growing at the rate of 12% in 2009.
(Source: ORG IMS SSA May 2008).
Medicines in the cancer therapeutic area account for the third largest source of revenue
within the pharma industry. The cancer market has experienced significant innovative change in
recent years, creating attractive opportunities for a range of new and established biotechnology
players as well as established pharma companies. Although new product development continues
to involve substantial levels of risk, innovation is the key driving force in the market, and has led
to the competitive exclusion of several of the industry’s traditional competitors. With successful
launches now being applied to multiple indications faster than ever before, subsequent increases
in product sales volumes are rapidly changing the competitive landscape of the cancer market.
The cancer market expanded by 19.9% during 2009 and is forecast to reach $40.9b by
2012. The highest growth will occur in the antineoplastic class of drugs, which is expected to
become the primary growth driver of the cancer market over the next four years.
4
Research Objective
To study & analyze overall domestic market for OVARIAN & CERVICAL CANCER
DRUGS.
Introduction
Market research process is the process used to obtain information regarding market
opportunity & problem and there by making strategies for the business. Our purpose is to launch
a new brand of PEGYLATED LIPOSOMES OF DOXORUBICINE .Therefore; we need to do
market analysis of the current payers of the same & their strategies. Thus, it will help us making
strategies for launching a new brand of DOXORUBICINE Detailed process for research
methodology is discussed below
Our research will answer the following questions:
What is ovarian & cervical cancer?
Epidemiology of ovarian & cervical cancer.
What are the different dosage forms available of ovarian & cervical cancer drugs?
What are the existing brands of ovarian & cervical cancer drugs?
Which are the generic players of ovarian & cervical cancer drugs?
Who are the top players of ovarian & cervical cancer drugs & what about their markets?
Statistical analysis of price comparison for ovarian & cervical cancer drugs.
Indian market share for doxorubicin in Cancer drugs and its expansion capacity
How we will launch our brand & its positioning?
What will be the promotional, communication & operational strategies for our brand?
Analysis and Finding
Recommendation and Suggestions
5
Research Methodology
Research Type: Exploratory followed by Descriptive
The Researchers will use exploratory followed by descriptive research design to define
the opportunity & to develop an approach for international market for generic drugs. The
researcher will use both qualitative & quantitative data for the research work. The researcher will
use secondary as well as primary data for marketing research. The reason for choosing this type
of data is, qualitative research provides insights & understanding of problem setting, while
quantitative research seeks to quantify the data & typically applies some form of statistical
analysis.
Figure 1.1
6
Data Sources
Secondary Data
This data will be collected from journals, internet, reports, industry publications and
dissertations.
Primary Data
This data include both qualitative and quantitative data. Data are generated through
interaction with various doctors who has handle cancer cases. Data for the price strategy and
distribution related data are generated by interaction with druggist, stockiest and carrying and
forwarding agent.
a) Research Approach:
Survey Method: Primary data are collected through survey of doctors, stockiest, carrying and
forwarding agent and stockiest
b) Research Instrument:
Questionnaire: It includes both open ended and closed ended questions. Close ended includes
different scaling technique.
c) Types of Questionnaire:
Structured
d) Type of Questions:
Open-ended and Close-ended questions
e) Sampling Plan:
Sampling Unit:
• For price analysis C & F agents, stockiest & retailers.
• Drug related information through doctors who have handled cancer cases
Sample Size:
• 30 doctors (20 Oncologists & 10 Consultant Physiologists)
• 05 Carrying & Forwarding agents
• 30 stockiest & 30 retailers
Sampling Procedure:
• Non?probability convenience
Contact Method: Personal
7
f) Mode of collecting data:
The respondents will be chosen randomly and requested to. The questions will then be
asked in a predetermined sequence.
g) Data Processing:
A number of tables and charts to be prepared to bring out the main characteristic
of the collected data.
Inferences to be drawn from the data collected.
Analysis and Finding
Method of data analysis
Data analysis is done through the primary data gathered from the survey of
doctors, stockiest, c & f Agent and retailer. It includes presentation through table and
chart preparation.
8
CHAPTER 2
INTRODUCTION TO PHARMACEUTICAL
INDUSTRY
9
PHARMACEUTICAL INDUSTRY-OVERVIEW:
Pharmaceutical is one of the most intense “Knowledge Driven” industries, which is
continuously in a state of dynamic transition. Defined as a complex matrix of processes,
operations and organizations involved in the discovery, development and manufacture of drugs
and medications, the pharmaceutical industry is a life line industry, which plays a very crucial
role in building a strong human capital of a country, and is very essential for economic growth
and development.
2.1 Origins and Evolution:
The modern pharmaceutical industry is a highly competitive non-assembled1 global
industry. Its origins can be traced back to the nascent chemical industry of the late
nineteenth century in the Upper Rhine Valley near Basel, Switzerland when dyestuffs were
found to have antiseptic properties. A host of modern pharmaceutical companies all started
out as Rhine-based family dyestuff and chemical companies e.g. Hoffman-La Roche,
Sandoz, Ciba-Geigy (the product of a merger between Ciba and Geigy), Novartis etc. Most
are still going strong today.
Over time many of these chemical companies moved into the production of
pharmaceuticals and other synthetic chemicals and they gradually evolved into global
players. The introduction and success of penicillin in the early forties and the relative
success of other innovative drugs, institutionalized research and development (R&D) efforts
in the industry. The industry expanded rapidly in the sixties, benefiting from new
discoveries and a lax regulatory environment. During this period healthcare spending
boomed as global economies prospered.
These included the first oral contraceptive, "The Pill", Cortisone, blood-pressure
drugs and other heart medications. MAO Inhibitors, chlorpromazine (Thorazine), Haldol
(Haloperidol) and the tranquilizers ushered in the age of psychiatric medication. Valium
(diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most
prescribed drug in history, prior to controversy over dependency and habituation.
10
2.2 Research and development:
Drug discovery is the process by which potential drugs are discovered or designed.
In the past most drugs have been discovered either by isolating the active ingredient from
traditional remedies or by serendipitous discovery. Modern biotechnology often focuses on
understanding the metabolic pathways related to a disease state or pathogen, and
manipulating these pathways using molecular biology or Biochemistry.
Drug development refers to activities undertaken after a compound is identified as a
potential drug in order to establish its suitability as a medication. Objectives of drug
development are to determine appropriate Formulation and Dosing, as well as to establish
safety. Research in these areas generally includes a combination of in vitro studies, in vivo
studies, and clinical trials. The amount of capital required for late stage development has
made it a historical strength of the larger pharmaceutical companies.
2.3 Industry revenues:
In 2009, global spending on prescription drugs topped $680 billion, even as growth
slowed somewhat in Europe and North America. The United States accounts for almost half of
the global pharmaceutical market, with $290 billion in annual sales followed by the EU and
Japan. Emerging markets such as China, Russia, South Korea and Mexico outpaced that market,
growing a huge 81 percent.
2.4 Marketing:
Pharmaceutical companies commonly spend a large amount on advertising, marketing
and lobbying. Pharmaceutical companies generally employ sales people (often called 'med. reps'
or, an older term, 'detail men') to market directly and personally to physicians and other
healthcare providers.
11
INDIAN PHARMACEUTICAL INDUSTRY
Indian pharmaceutical industry is mounting up the value chain. From being a pure reverse
engineering industry focused on the domestic market, the industry is moving towards basic
research-driven, export-oriented global presence, providing wide range of value added quality
products and services.
The first Indian pharmaceutical company, Bengal Chemicals and Pharmaceutical Works,
which still exists today as one of 5 government-owned drug manufacturers, appeared in Calcutta
in 1930. The government started to encourage the growth of drug manufacturing by Indian
companies in the early 1960s, and with the Patents Act in 1970, enabled the industry to become
what it is today.
This patent act removed composition patents from food and drugs, and though it kept
process patents, these were shortened to a period of five to seven years. The lack of patent
protection made the Indian market undesirable to the multinational companies that had
dominated the market, and while they streamed out, Indian companies started to take their
places. They carved a niche in both the Indian and world markets with their expertise in reverse-
engineering new processes for manufacturing drugs at low costs.
As in the present scenario, only a few people can afford costly drugs, which have
increased price sensitivity in the pharmaceutical market. Now the companies are trying to
capture the market by introducing high quality and low price medicines and drugs. With the
Product Patent Act, which came into action in January 2005, this industry is able to attract big
MNCs to India. Earlier these big firms had apprehensions in launching new drugs in the Indian
market.
Approvals given by Foods and Drugs Administration (FDA) and ANDA (Abbreviated
New Drug Application)/DMF (Drug Master File) have played an important role in making India
a cost-effective and high quality product manufacturer. Furthermore, the changes that took place
in the patent law, change of process patent to product patent, have helped in reducing the risk of
loss for intellectual property.
12
2.1 Market Overview:
The size of the Indian pharmaceutical industry is estimated at US $ 7.76 billion. It is
growing at an average rate of 14.1 %. The pharmaceutical industry has shown a robust
growth of 13% in 2007 and has grown by 12% in 2008. It is expected to continue growing at
the rate of 12% in 2009. (Source: ORG IMS SSA May 2008)
Despite the economic slowdown the Indian Pharmaceutical sector will be worth US $ 20
billion by 2015. The revenues from the Indian healthcare sector account for 5.2% of the GDP,
making it the third largest growth segment in India. Consumer spending on healthcare increased
from 4% of the GDP in 1995 to 7% in 2007.
The Indian pharmaceutical industry contributes 8 percent in volume but less than 2
percent in value terms to the global pharmaceutical sales as drug prices in India are one of the
lowest in the world. Indian Pharmaceutical Industry is worlds’ 4
th
largest producer in terms of
volume and 11th in value terms globally. (Source: www.prlog.org)
The Indian pharmaceutical industry has 300 medium and large size researches and
development (R&D) based pharmaceutical companies including multinationals, government
owned and Indian private companies. In addition to these large companies, it is estimated that
there are 10,000 smaller licensed generic manufacturers. There are 74 US FDA approved
manufacturing facilities and 5 central public sector unit.
This highly fragmented industry has resulted in with no players controlling more than 7
percent of the retail formulation market. However, similar to the global trends, mergers and
acquisitions in the Indian pharmaceutical industry has resulted in the 10 top formulation firms
accounting for 37 percent of the retail formulation market.
The industry manufactures about 400 bulk drugs and almost the entire range of
formulations.
(Source: www.export.gov.il/2351 the Indian Pharmaceutical Market.docm)
13
2.2 Market Trends:
The industry has enormous growth potential. Factors listed below determine the
rising demand for pharmaceuticals.
The growing population of over of a billion
• Increasing income
• Aggressive market penetration
• Health insurance penetration
• Medical infrastructure build up
• Demand for quality healthcare service
• Changing lifestyle has led to change in disease patterns, and increased
demand for new medicines to combat lifestyle related diseases
(Source:www.export.gov.il/2351 the Indian Pharmaceutical Market.docm)
2.3 Important Developments after Liberalization Process in 2006:
Following are some of the important developments that have taken place in
pharmaceutical sector after the process of liberalization of the Indian economy was initiated
by the Government in the year 1991.
Industrial Licensing: Industrial licensing for all kinds of drugs has been abolished.
However the need for obtaining manufacturing licence under Drugs and Cosmetics Act,1940
continues for all units whether organized or small scale. The State Drug Controllers are
authorized to issue such licences in most cases.
Foreign Direct Investment: FDI up to 100% is permitted, subject to stipulations laid
down from time to time in the Industrial Policy.
Foreign Technology Agreement: Automatic approval for Foreign Technology
Agreement (FTA) is already available in the case of all the bulk drugs cleared by Drug
Controller General (India) .
Imports: Imports of drugs and pharmaceuticals are regulated through EXIM Policy
in force and presently all items except those requiring clearance under The Narcotics and
14
Psychotropic Substances Act , 1985 are allowed under OGL. Further, a centralized system of
registration has been introduced under the Drugs & Cosmetics Act and Rules made there
under, administered by Ministry of Health and Family Welfare.
Exports: Exports are permitted in accordance with the EXIM Policy and relevant
procedures/rules formulated for the purpose by the Directorate General of Foreign Trade.
Exports are also subject to laws prevalent in importing countries. Also, the exporters are
allowed imports of inputs on duty-free basis for export production. The industry has shown
commendable export performance, the trade balance being positive. Over the last few years
the compounded annual growth rate in exports has been 22.7 percent.
2.4 Government Support:
Export Promotion Cell: An Export Promotion cell in this sector has been incorporated
with the objective of
• Boosting Pharmaceutical exports
• Function as a nodal centre
• Promotional Activities aiming at accelerating pharma exports.
• Suggestions for modifications in the EXIM Policy.
• Seminars / Workshops on standards, quality control requirements etc
Pharma Export Promotion Council (Pharmexcil): The Pharma Export Promotion
Council (Pharmexcil) has been constituted with the objective of
• Facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbal
Medicines, Diagnostics
• Export thrust to various products through workshops, conferences and seminars and
delegate visits.
15
Foreign Direct Investment (FDI) in Drugs and Pharmaceuticals:
• FDI upto 74% in the case of bulk drugs, their intermediate Pharmaceuticals and formulations
(except those produced by the use of recombinant DNA technology) would be covered under
automatic route. FDI above 74% for manufacture of bulk drugs will be considered by the
Government on case to case basis for manufacture of bulk drugs from basic stages and their
intermediates and bulk drugs produced by the use of recombinant DNA technology as well as the
specific cell/tissue targeted formulations provided it involves manufacturing from basic stage.
2.5 Pharma Parks/SEZs for Pharma Industry:
In order to enable India to achieve a leading position as the Drug Maker of the World it is
essential that a World class infrastructure is provided for the accelerated growth of the industry.
In order to provide the required infrastructure it is essential to have a scheme where Central
Government, State Governments and industry are participants. A special scheme for setting up
pharmaceutical parks in the country (separate for bulk and for formulations) in the next 5 years is
proposed. This would be broadly on the lines of Scheme for Integrated Textile Parks.
Each park would be set up in a minimum area of 250 acres for bulk and 100 acres for
formulations. It would be expected to have about 50 to 100 units, investment of Rs 1000 crs to
Rs 2000 crs and likely employment of about 20,000 persons.
Where an SEZ is to be set up the minimum size criterion for pharma SEZs would be 50
hectares for the next 3 years. This would encourage quick setting up of such parks and for
demonstration effect. After a successful take-off of the scheme minimum size may be increased
suitably all environmental approvals in the case of pharma parks would be granted at the State
level only.
16
2.6 Strengths of Indian Pharmaceutical Industry & its Players:
• Capital Investment in Technology: Owing to the availability of advanced technology at
low costs, the companies can produce drugs at lower costs.
• Cost Effective: The filing cost of ANDAs (Abbreviated New Drug Application) and
DMFs (Drug Master File) is comparatively low for the Indian companies.
• Manpower: There is a large pool of technical experts available at modest salaries.
• Contract Research & Contract Manufacturing: There is a good scope for contract
research and contract manufacturing.
• Infrastructure: There is a well-developed infrastructure for the pharmaceutical industry.
• Generic Drugs: In the last few years, the generic drug-manufacturing segment has
received huge investments, in the process making it more competitive and efficient.
2.7 Challenges:
All of these changes are ultimately good for the Indian pharmaceutical industry, which
suffered in the past from inadequate regulation and large quantities of spurious drugs. They force
the industry to reach a level necessary for global competitiveness.
However, they have also exposed some of the inadequacies in the industry today. Its main
weakness is an underdeveloped new molecule discovery program. Even after the increased
investment, market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-10% of
their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer, whose research
budget last year was greater than the combined revenues of the entire Indian pharmaceutical
industry.
17
This disparity is too great to be explained by cost differentials, and it comes when
advances in genomics have made research equipment more expensive than ever. The drug
discovery process is further hindered by a dearth of qualified molecular biologists.
Due to the disconnect between curriculum and industry, Pharma in India also lack the
academic collaboration that is crucial to drug development in the West.
2.8 Major Players in India:
Aurobindo Pharma:
Aurobindo Pharma manufactures generics and APIs in the antibiotic, antiretroviral,
cardiovascular, central nervous system, gastroenterological and anti-allergy fields, and markets
them in over 100 countries.
Aventis Pharma:
50.1 percent of Aventis Pharma is held by European drug major Sanofi-Aventis and, in
early April 2006, it was reported that UB Holdings had sold its 10 percent holding in the firm to
Variegate Trading, a UB subsidiary. The firm's major products are in the anti-infective, anti-
inflammatory, cancer, diabetes and allergy market segments
Cipla:
India's second-largest drug manufacturer was originally established in 1935 as The
Chemical, Industrial and Pharmaceutical Laboratories. Until 2000 its business was primarily
domestic, but exports, to more than 150 countries.
Dr Reddy's Laboratories:
Dr Reddy's Laboratories is an emerging global pharmaceutical and biotechnology
company, which was founded by Chairman Anji Reddy in 1984. It operates in over 60 countries,
although India and the USA each accounts for around a third of the firm's total sales.
18
Lupin:
Lupin is one of the world's largest manufacturers of APIs and finished formulations for
TB, bacterial infections and cardiovascular disease. Its products are sold in more than 50
countries.
Nicholas Piramal:
Nicholas Piramal is the flagship company of Piramal Enterprises (PEL), one of India's
largest diversified business houses. It was formed in 1988 when PEL acquired Nicholas
Laboratories (NPIL) a small formulations company, from Sara Lee.
Ranbaxy Laboratories:
India's largest pharmaceutical company is ranked among the top 10 generics
manufacturers worldwide and aiming to be in the top five with sales of $5 billion by 2012.
Sun Pharma:
Sun Pharma, established in 1983, makes specialty pharmaceuticals and APIs for use in
chronic therapy areas such as cardiology, ovarian, cervical cancer, gastroenterology, diabetes and
respiratory conditions, sold in 26 markets worldwide.
Wockhardt: The overseas ambitions of this Mumbai-based pharmaceutical and biotechnology-
based company have already been covered elsewhere in this report, but in mid-March 2006
Zydus Cadila:
Zydus Cadila is India's fifth largest pharmaceutical company. Cadila was founded in
1952 and, following restructuring, the Zydus Cadila Group was established in 1995. The
operating environment for medium-sized generic drug manufacturers is changing rapidly as the
industry matures and growth focuses on new market opportunities. Consolidation continues to
affect companies, as acquisition becomes the instrument of choice in the drive for market share.
19
Ranbaxy
Ranbaxy is number one player in India, both in terms of market capitalization and in
terms of sales. Other major players are Cipla, DRL, Glaxo etc. Though Pfizer is world’s number
one company with a market share of approximately 11% and sales almost 10 times of the whole
of Indian pharma industry, it has not done so well in India so far. But this can be attributed to
poor intellectual property protection provisions in India which prevented MNCs like Pfizer,
Novartis and Eli Lilly from introducing their blockbuster drugs in India, but now with the arrival
of patent regime things can be very different.
Intas Pharmaceutical Ltd.
Intas pharmaceutical Ltd. is located near ahmedabad. Its turnover is 1200 cr. The
company has is involved in various diseases with some of the top brands. It has diverse portfolio
of pharmaceutical products. It is involved in cardio. Diabeto & CNS segments.
20
CHAPTER 3
ASSIGNED PROJECT SCOPE
21
Background
The project involved analyzing the market potential of OVARIAN & CERVICAL
CANCER DRUGS. It also includes the statistics of various players of brands of
DOXORUBICINE & its effectiveness for particular disease thereby promoting it into that
segment. It also includes analyzing competitors’ strategy.
Product
DOXORUBICINE
Objective
Evaluating the Market Potential for DOXORUBICINE and Surveying doctors for
promotion of the drug into particular segments.
Suggesting brand launching strategies and promotional strategies after evaluating the
competing brands and target market..
Answers sought for following questions
What type of price incorporation strategy is there in pharmaceutical industry?
Statistics of Ovarian & Cervical Cancer in India
What are the existing brands of OVARIAN & CERVICAL DRUGS?
Which are the generic players of DOXORUBICINE?
Who are the top players & what about their markets?
How will we launch our brand & its positioning?
What will be the promotional, communication & operational strategies for our brand?
22
Benefits:
It will help in knowing as the company desires to expand to newer markets, the data
collected would be of supreme importance to the company to formulate strategies and plan out
future action plans. Understanding competitor’s strategies, competing with them, building
successful import export patterns with logistical success would also help the company to cut
down costs and increase efficiency and productivity. Analysis would also help to gauge which
products are most feasible and demanded in the desired markets, thereby enabling the company
to focus on such products wholly
23
CHAPTER 4
KEY FINDINGS & ANALYSIS
24
PHARMACOLOGICAL REVIEW
What is Ovarian Cancer?
Ovarian cancer is a disease in which malignant or cancerous cells are found in the
ovaries. An ovary is one of two small, almond-shaped organs located on each side of the uterus
that store eggs or germ cells and produce female hormones estrogen and progesterone.
Cancer Basics
Cancer develops when cells in a part of the body (in this case the ovary) begin to grow
out of control. Although there are many kinds of cancer, they all start because of out-of-control
growth of abnormal cells.
Normally, cells in your body divide, and form new cells to replace worn out or dying
cells and to repair injuries. Because cancer cells continue to grow and divide, they are different
from normal cells. Instead of dying, they outlive normal cells and continue to create new
abnormal cells forming a tumor. Tumors can put pressure on other organs lying near the ovaries.
Cancer cells sometimes can travel to other parts of the body where they begin to grow
and replace normal tissue. This process, called metastasis, occurs as the cancer cells move into
the bloodstream or lymph vessels of our body. Cancer cells that spread from other organ sites
(such as breast or colon) to the ovary are not considered ovarian cancer
There are many types of tumors that can start in the ovaries. Some are benign, or
noncancerous, and the patient can be cured by surgically removing one ovary or the part of the
ovary containing the tumor. Some are malignant or cancerous. The treatment options and the
outcome for the patient depend on the type of ovarian cancer and how far it has spread before it
is diagnosed.
25
What is the general outlook for women diagnosed with ovarian cancer?
In women age 35-74, ovarian cancer is the fifth leading cause of cancer-related deaths.
An estimated one woman in 58 will develop ovarian cancer during her lifetime. The American
Cancer Society estimates that in 2008, there will be 21,650 new cases of ovarian cancer and
15,520 women will die from ovarian cancer.
Because each woman diagnosed with ovarian cancer has a different profile, it is
impossible to give a general prognosis. If diagnosed and treated early, when the cancer is
confined to the ovary, the 5-year survival rate is over 90%.9 out of 10 women are cured.
Unfortunately, due to ovarian cancer's non-specific symptoms and lack of early detection tests,
the only 19% of all cases are found at this early stage. If caught in stage III or higher, the
survival rate can be as low as 29%.(Source: American Cancer Society)
Types of Ovarian Cancer
There are more than 30 different types of ovarian cancer which are classified according to
the type of cell from which they start. Cancerous ovarian tumors can start from three common
cell types:
• Surface Epithelium - cells covering the lining of the ovaries
• Germ Cells - cells that are destined to form eggs
• Stromal Cells - Cells that release hormones and connect the different structures of the
ovaries
Common Epithelial Tumors - Epithelial ovarian tumors develop from the cells that cover
the outer surface of the ovary. Most epithelial ovarian tumors are benign (noncancerous). There
are several types of benign epithelial tumors, including serous adenomas, mucinous adenomas,
and Brenner tumors.
26
Cancerous epithelial tumors are carcinomas - meaning they begin in the tissue that lines
the ovaries. These are the most common and most dangerous of all types of ovarian cancers.
Unfortunately, almost 70 percent of women with the common epithelial ovarian cancer are not
diagnosed until the disease is advanced in stage.
There are some ovarian epithelial tumors whose appearance under the microscope does
not clearly identify them as cancerous. These are called borderline tumors or tumors of low
malignant potential (LMP tumors).
Epithelial ovarian carcinomas (EOCs) account for 85 to 90 percent of all cancers of the
ovaries. We must continue research and expand our knowledge about this group of cancers in
order to improve treatment and save lives.
Germ Cell Tumors - Ovarian germ cell tumors develop from the cells that produce the
ova or eggs. Most germ cell tumors are benign (non-cancerous), although some are cancerous
and may be life threatening. The most common germ cell malignancies are maturing teratomas,
dysgerminomas, and endodermal sinus tumors. Germ cell malignancies occur most often in
teenagers and women in their twenties. Today, 90 percent of patients with ovarian germ cell
malignancies can be cured and their fertility preserved.
Stromal Tumors - Ovarian stromal tumors are a rare class of tumors that develop from
connective tissue cells that hold the ovary together and those that produce the female hormones,
estrogen and progesterone. The most common types are granulosa-theca tumors and Sertoli-
Leydig cell tumors. These tumors are quite rare and are usually considered low-grade cancers,
with approximately 70 percent presenting as Stage I disease (cancer is limited to one or both
ovaries).
27
Primary Peritoneal Carcinoma
The removal of one's ovaries eliminates the risk for ovarian cancer, but not the risk for a
less common cancer called Primary Peritoneal Carcinoma. Primary Peritoneal Carcinoma is
closely rated to epithelial ovarian cancer (most common type). It develops in cells from the
peritoneum (abdominal lining) and looks the same under a microscope. It is similar in symptoms,
spread and treatment.
Stages of Ovarian Cancer
Once diagnosed with ovarian cancer, the stage of a tumor can be determined during
surgery, when the doctor can tell if the cancer has spread outside the ovaries. There are four
stages of ovarian cancer - Stage I (early disease) to Stage IV (advanced disease). Your treatment
plan and prognosis (the probable course and outcome of your disease) will be determined by the
stage of cancer you have.
Stage I - Growth of the cancer is limited to the ovary or ovaries.
Stage IA - Growth is limited to one ovary and the tumor is confined to the inside of the ovary.
There is no cancer on the outer surface of the ovary. There are no ascites present containing
malignant cells. The capsule is intact.
Stage IB - Growth is limited to both ovaries without any tumor on their outer surfaces. There are
no ascites present containing malignant cells. The capsule is intact.
Stage IC - The tumor is classified as either Stage IA or IB and one or more of the following are
present: (1) tumor is present on the outer surface of one or both ovaries; (2) the capsule has
ruptured; and (3) there are ascites containing malignant cells or with positive peritoneal
washings.
28
Stage II - Growth of the cancer involves one or both ovaries with pelvic extension.
Stage IIA - The cancer has extended to and/or involves the uterus or the fallopian tubes, or both.
Stage IIB - The cancer has extended to other pelvic organs.
Stage IIC - The tumor is classified as either Stage IIA or IIB and one or more of the following
are present: (1) tumor is present on the outer surface of one or both ovaries; (2) the capsule has
ruptured; and (3) there are ascites containing malignant cells or with positive peritoneal
washings.
Stage III - Growth of the cancer involves one or both ovaries, and one or both of the following
are present: (1) the cancer has spread beyond the pelvis to the lining of the abdomen; and (2) the
cancer has spread to lymph nodes. The tumor is limited to the true pelvis but with histologically
proven malignant extension to the small bowel or omentum.
Stage IIIA - During the staging operation, the practitioner can see cancer involving one or both
of the ovaries, but no cancer is grossly visible in the abdomen and it has not spread to lymph
nodes. However, when biopsies are checked under a microscope, very small deposits of cancer
are found in the abdominal peritoneal surfaces.
Stage IIIB - The tumor is in one or both ovaries, and deposits of cancer are present in the
abdomen that are large enough for the surgeon to see but not exceeding 2 cm in diameter. The
cancer has not spread to the lymph nodes.
Stage IIIC - The tumor is in one or both ovaries, and one or both of the following is present: (1)
the cancer has spread to lymph nodes; and/or (2) the deposits of cancer exceed 2 cm in diameter
and are found in the abdomen.
Stage IV - This is the most advanced stage of ovarian cancer. Growth of the cancer involves one
or both ovaries and distant metastases (spread of the cancer to organs located outside of the
peritoneal cavity) have occurred. Finding ovarian cancer cells in pleural fluid (from the cavity
which surrounds the lungs) is also evidence of stage IV disease.
29
These statistics, and the information regarding tumor stage and grade, demonstrate that
there is a critical need to establish an agenda for more research into the areas of basic and
translational research, genetic susceptibility and prevention, diagnostic imaging, screening and
diagnosis, and therapy. These could hold the most promise for future discoveries that will lead to
improved prevention, detection, and treatment of ovarian cancer, particularly the common
epithelial.
Symptoms of Ovarian Cancer
Ovarian cancer is difficult to detect, especially, in the early stages. This is partly due to
the fact that these two small, almond shaped organs are deep within the abdominal cavity, one on
each side of the uterus. These are some of the potential signs and symptoms of ovarian cancer:
• Bloating
• Pelvic or abdominal pain
• Trouble eating or feeling full quickly
• Feeling the need to urinate urgently or often
Other symptoms of ovarian cancer can include:
• Fatigue
• Upset stomach or heartburn
• Back pain
• Pain during sex
• Constipation or menstrual changes
If symptoms persist for more than two weeks, one should consult physician.
30
Persistence of Symptoms
When the symptoms are persistent, when they do not resolve with normal interventions
(like diet change, exercise, laxatives, rest) it is imperative for a woman to see her doctor.
Persistence of symptoms is key. Because these signs and symptoms of ovarian cancer have been
described as vague or silent, only around 19% of ovarian cancer is found in the early stages.
Symptoms typically occur in advanced stages when tumor growth creates pressure on the bladder
and rectum, and fluid begins to form.
• A rectovaginal pelvic examination is when the doctor simultaneously inserts one finger in
the rectum and one in the vagina.
• It is helpful to take a mild laxative or enema before the pelvic exam.
• Have a comprehensive family history taken by a physician knowledgeable in the risks
associated with ovarian cancer. 5% to 10% of ovarian cancer has a familial link.
Every woman should undergo a regular rectal and vaginal pelvic examination. If an
irregularity of the ovary is found, alternatives to evaluation include transvaginal sonography
and/or tumor markers. The most common tumor marker is a blood test called the CA-125.
Research
New Blood Tests
New blood tests (serum and plasma tumor markers) are being developed that can identify
early stage ovarian cancer by the presence of newly identified tumor markers that circulate in the
blood of women with advanced stage ovarian cancer. Therefore, the presence of these tumor
markers in apparently healthy women could lead to the diagnosis of early stage rather than late
stage ovarian cancer.
31
The following are examples tumors markers that may play a role in the early detection of
ovarian cancer:
• Lysophospholipids (such as LPA)
• Growth factor (such as EGFRs)
• Soluble urinary-type plasminogen activator (such as suPAR)
• Matrix metalloproteinases (such as MMPs)
• Hypermenthylated gene products
• Extra cellular matrix proteins.
Ovarian Pap test
The "Ovarian Pap Test" is a new diagnostic test performed to detect pre-cancerous or
early cancerous changes on the ovaries. Using minimally invasive office laparoscopy, the
"Ovarian Pap Test" directly visualizes the ovaries and collects cells from the surface of the ovary
and from the surface of the abdomen, similar to the cervical Pap test that collects surface
epithelium from the cervix.
32
CERVICAL CANCER
The outlook for preventing one of the world's top female cancer killers is better than it
has ever been. Cervical cancer kills one woman in the world every two minutes. The good news
is that there is now a way to stop cervical cancer before it starts - with vaccination against the
challenging virus which causes the cancer, the human papillomavirus.
Cervical Cancer Today
Cervical cancer is a major cause of death in women around the world. In the UK there
are around 2,800 new cases and 1,100 cervical cancer deaths a year. While in the US there are
10,000 new cases and 3,700 deaths per year. Around the world, every two minutes a woman is
dying of cervical cancer.
Looking at cervical cancer across the globe, over 80 per cent of the deaths from cervical
cancer occur in the developing world. Sub-Saharan Africa is the worst-affected region. In
Zambia, for example, cervical cancer strikes 63 women in 100,000, which is almost ten times
Australia's rate of 7 per 100,000 women.
Relatively high rates are also seen in some of the former Eastern block states – notably
Romania and Bulgaria. It has been found that increased cases of cervical cancer are apparent in
countries where either no or poorly maintained screening programs exist.
Cervical cancer commonly strikes women early, often in their mid-thirties, at an age
when they are in the prime of their lives. Many affected women will be caring for young
children and extended families, so one death from cervical cancer can devastate the lives of
many people.
Worldwide cervical cancer affects over 1.4 million women, is the second most common cancer
in women aged 15-45 and the third leading cause of cancer death among women, after breast and
lung cancer.
33
Most of the deaths occur in the developing world. In women who do not undergo regular
screening, cervical cancer can be a silent killer as it can take many years to develop and women
may not experience symptoms for a long time. By the time symptoms appear the disease is often
Symptoms and prognosis of cervical cancer
The pre-cancerous stages and earlier stages of cervical cancer are usually symptom-less, which is
why it is important for women to have regular pap smear tests, also known as cervical screening.
In the absence of screening, the most common sign of invasive cervical cancer is bleeding from
the vagina at times other than during menstruation.
Between 1975 and1995, average five-year survival rates for women diagnosed with
cervical cancer in the UK rose from around 50 per cent to 65 per cent – but for those diagnosed
with more advanced stages of the disease in which the cancer has spread, the outlook is even
worse.
VIRUS
Cervical cancer is caused by a virus called human papillomavirus (HPV) which is caught through
sexual activity. Unfortunately condoms do not fully protect women from HPV infection since the
spread of the virus does not depend on full intercourse only but may also occur simply through
skin-to-skin contact in the genital area.
There are about 100 known types of HPV but only about 15 can cause cervical cancer.
Together four cancer-causing virus types (16, 18, 45 and 31) are the most common, accounting
for more than 80 percent of all cervical cancer cases worldwide.
HPV 16, 18 and 45 are particularly concerning since these three are associated with
nearly 90 per cent of cases of adenocarcinoma, a particularly aggressive form of cervical cancer.
34
Figure 4.1
HPV is very common: it is estimated that up to 80 per cent of women will acquire an
HPV infection in their lifetime and up to 50 per cent of these will be with a cancer-causing virus
type. Luckily most infections resolve spontaneously but when the infection persists the risk of
developing cervical cancer rises sharply.
A persistent infection with a cancer-causing virus type may cause the development of
abnormal and pre-cancerous cervical cell changes which over time can develop into cancer.
HPV is a challenging virus because the natural immune response, following infection
with a cancer-causing virus type, may not be strong enough to protect against subsequent
infection. What is more, as immune function gets weaker with age, infections are more likely to
persist and hence progress to cancer as a woman gets older.
Screening- Cervical cancer
The strongest weapon in the fight against cervical cancer is prevention. Where it is available,
regular screening using smear testing provides an early warning system, detecting evidence of
abnormal or pre-cancerous cells and allowing in some instances to remove the diseased tissue.
While screening helps detect abnormalities, around 20 percent of abnormal cases remain
undetected. It is also significant that receiving an abnormal smear test result can be a traumatic
and unsettling experience for women, as can the surgical procedures used to eliminate the
affected cells.
35
In the developed world, potentially dangerous changes in the cervix are usually spotted
before cancer emerges which is predominantly attributed to national screening programs. The
British system is a good example of a successful screening program. It prevents around 4,500
deaths each year in the UK, by detecting cervical disease when it is still at the easily treatable,
pre-cancerous stage.
Similar programs in North America, Western Europe and Australasia have also seen the
number of cervical cancer cases fall dramatically.
In the UK, women are supposed to be called by their General Practitioner to be screened
every three years from the age of 25 onwards for pap smear tests. Cervical cancer experts warn,
however, that in recent years attendance for cervical smears has fallen. Between 2000 and 2005,
the coverage of the screening program among the women aged 25-29, fell from 77 per cent to
71.6 per cent.
Smear tests may seem straightforward to health professionals but there is evidence that
some women do not know the importance of a smear test, find them embarrassing or even
traumatic, and in part this may explain why screening fails to reach everyone who is at risk.
However, in many poorer countries screening is less consistent and in most developing
countries, screening is virtually non-existent. This is why the death rates from cervical cancer
may be ten times higher in East Africa than in some countries in Western Europe. This lack of
screening makes the need for a vaccine against cervical cancer even more pressing.
Vaccination against cervical cancer
Because HPV is no ordinary virus and poses particular challenges by managing to hide
from the natural immune system, it is important to ensure that the immune response induced by
vaccination is consistently strong and long-lasting that it protects against the most common and
aggressive cancer-causing virus types.
36
To stop infections with cancer-causing human papillomavirus types from occurring,
vaccination before a first sexual encounter is recommended, but, since a woman can come across
the virus at any point in her life, nearly all women could benefit from vaccination.
Worldwide, cervical cancer affects more women under 45 than any other malignancy
apart from breast cancer. So it’s surprising that the disease, known also as cancer of the cervix,
is in most cases unknown by women.
On the whole, most women do not know that cervical cancer is caused by a virus but
there is a definite eagerness to know more about this preventable disease within the female
community.
Despite the positive impact cervical cancer screening has had in managing this disease,
cervical cancer continues to have a high prevalence. However, a feeling of optimism is
emerging as for the first time, revolutionary vaccines will make it possible to prevent most cases
of this disease.
Treatment Options
After your diagnosis, your doctor will develop your customized treatment plan. Women
should always discuss their treatment options with a physician, because the best and most
appropriate treatment will be different based on the stage of disease, the woman's age and the
overall condition of her health.
1) Surgery - Surgery to remove the cancerous growth is the most common method of
diagnosis and therapy for ovarian cancer. It is best performed by a qualified gynecologic
oncologist.
2) Chemotherapy - Chemotherapy is the treatment of cancer using chemicals
(medications) that travel through the bloodstream to destroy cancer cells or stop them from
growing both in and outside the ovaries. Chemotherapy is used in the majority of cases as a
follow-up therapy to surgery.
37
3) Radiation Therapy - Radiation therapy uses high-energy X-rays to kill cancer cells and
shrink tumors (only rarely used in the treatment of ovarian cancer in the United States).
Complementary Therapies
Some women with ovarian cancer turn toward the whole-body approach of
complementary therapy to enhance their fight against the disease, as well as to relieve stress and
minimize side effects such as fatigue, pain and nausea.
Complementary therapies are diverse practices and products that are used in conjunction
with conventional medicine. Many women have tried and benefited from the following
complementary therapies. You might want to speak with other women with cancer or your
healthcare team to see which therapies they found most helpful or might work best for you and
your lifestyle.
Acupuncture - An ancient Chinese method of healing in which small sterilized needles
are inserted into the body's energy centers to promote healing.
Aromatherapy - The use of essential oils from flowers, herbs and trees to promote health and
wellbeing.
Herbal Medicine - Use of remedies using plant parts to treat symptoms and illnesses.
(Consult your healthcare professional prior to using herbal medicine).
Massage - Manipulating the body's muscle and connective tissue through rubbing, kneading and
patting to promote relaxation and well being.
Massage - Manipulating the body's muscle and connective tissue through rubbing,
kneading and patting to promote relaxation and well being.
Meditation - Conscious relaxation and focused breathing to relax the mind and body.
38
Qi Gong (chee-GUNG) - A type of Chinese medicine that combines movement,
meditation and breathing to enhance the flow of qi (an ancient term given to what is believed to
be vital energy) in the body, improve blood circulation and enhance immunefunction.
Stress Reduction - Use of stress reduction methods such as exercise, meditation, etc.
which have been found to be beneficial in reducing cancer progression and recurrence.
Yoga, Tai Chi - Postures, movements and breathing exercises to strengthen and heal the
body, mind and spirit.
Safe Use of Complementary Therapy
There are questions about most complementary therapies that have not yet been answered
through well-designed scientific studies, such as clinical trials. Before beginning any
complementary therapy, it is important to discuss the approach with your healthcare team and
complementary therapy practitioner.
39
CANCER STATISTIC IN INDIA
Human papillomavirus (HPV) infection is now a well-established cause of cervical
cancer and there is growing evidence of HPV being a relevant factor in other anogenital cancers
(anus, vulva, vagina and penis) and head and neck cancers. HPV types 16 and 18 are responsible
for about 70% of all cervical cancer cases worldwide. HPV vaccines that prevent against HPV 16
and 18 infection are now available and have the potential to reduce the incidence of cervical and
other anogenital cancers.
India has a population of 366.58 millions women ages 15 years and older who are at risk
of developing cervical cancer. Current estimates indicate that every year 132082 women are
diagnosed with cervical cancer and 74118 die from the disease. Cervical cancer ranks as the 1st
most frequent cancer among women in India, and the 1st most frequent cancer among women
between 15 and 44 years of age. About 7.9% of women in the general population are estimated
to harbour cervical HPV infection at a given time, and 82.5% of invasive cervical cancers are
attributed to HPVs 16 or 18.
Cancer of the cervix uteri is the second most common cancer among women worldwide,
with an estimated 493,000 new cases and 274,000 deaths in 2002. About 83% of the cases occur
in developing countries, representing 15% of female cancers. Worldwide, mortality rates of
cervical cancer are substantially lower than incidence with a ratio of mortality to incidence to
55%. The majority of cases are squamous cell carcinoma and adenocarcinomas are less common.
40
Table 4.1
From the above table, it can be inferred that dearth rate because of cervical cancer is
more than 50%. Same way, by 2025, cervical cancer patients would more than 90 % than current
cases.
Oral contraceptives are major factor responsible for cervical cancer followed by smoking
& total fertility rate.
41
Table 4.2
India is more prone to cervical cancer as we can see from the above data. Around ¼ of
the cases are from India alone of the total cases from the world. This only shows increasing
growth of dangerous cervical cancer.
42
CHART 4.1
Crude Incidence ratio is found out by finding the probability of a new case occurring
during a stated time interval. India is also in a dangerous state as can be observed from the graph
CHART 4.2
Standardized incidence ratio is a using direct method & world population as
reference. Rates are per 100,000 populations. India is highest in this aspect also.
43
Table 4.3
CHART 4.3
As we can see New Delhi & Mumbai are having more cases compared to other cities of
India. These are metro cities. So, changing life style (like late marriages, working women,
smoking etc) is responsible for cervical cancer.
44
CHART 4.4
Incidence of cervical cancer in india among other cancer in women
45
CHART 4.5
Age-specific cervical cancer incidence compared to age-specific incidence of other
cancers among women 15-44 years of age in India
46
CHART 4.6
47
CHART 4.7
Annual number of new cases of cervical cancer by age group in India and Southern Asia
48
CHART 4.8
49
CHART 4.9
Estimated number of deaths of cervical cancer in India by age group, in 2002 and projected in
2025
50
CHART 4.10
51
Factors contributing to cervical cancer
HPV is a necessary cause of cervical cancer, but it is not a sufficient cause. Other
cofactors are necessary for progression from cervical HPV infection to cancer. Tobacco
smoking, high parity, long-term hormonal contraceptive use, and co-infection with HIV have
been identified as established cofactors. Co-infection with Chlamydia trachomatis and herpes
simplex virus type-2, immunosuppression, and certain dietary deficiencies are other probable
cofactors. Genetic and immunological host factors and viral factors other than type, such as
variants of type, viral load and viral integration, are likely to be important but have not been
clearly identified.
Table 4.5
Factors contributing to cervical carcinogenesis (cofactors) in India
Table 4.6
Estimated coverage of cervical cancer screening in India
52
Available drugs for the treatment of ovarian & cervical drugs
Table 4.7
GENERIC
NAME
BRAND NAME COMPANY
STRENGTH
(MG)
DOSAGE
FORM
Cisplatin Cytoplatin Cipla 10/50 Injection
Platin Cadila 0.5/1 Injection
Peclitaxel Paclitax Cipla 30/100/250 Injection
Cytax Intas 30/100 Injection
5-Fluorouracil Fludin Biological E 250/500 Injection
Fluracil BIOCHEM 250/500
Injection,
Capsule
Tamoxifane Temofane Dabur 10 Tablet
Cytutam Cipla 10/20 Tablet
Bleomycin Bleocip Cipla 15 Injection
Bleochem Biochem 15 Injection
Doxorubicine Cadria Cadila 10/50 Injection
Levadox Nicholas Piramal 10/50 Injection
(Source: Indian Drug Review, Oct-Nov, 2009 & Survey of Doctors, Retailers & Stockiest)
53
EXISTING BRANDS OF DOXORUBICINE
Table 4.8
SR.
NO.
BRAND COMPANY
PRICE (RS),
(10/50 MG PER 5/25 ML PER
VIAL RESPECTIVELY)
1 Oncodox Cipla 289/1274
2 Adrim Dabur 192/910 (2 mg/ml)
3 Adriamycin Upjohn 310/1540
4 Cadria, Doxomed Cadila 250/1085, 250/1025
5 Doxolem Elder Pharma 240/1190
6 Dxocare Citricare 251.63/1157.47
7 Tevadox Nicholas Piramal 250/950
8 Oncodria Sun Pharma 205/950
9 Dobixin German Remedies 265/1188 (2 mg/ml)
10 Dobicin Chandra Bhagat Pharma 250/950
11 Doxobin Biological E 234/1062
12 Doxorex Samarth 270/975
14 Duxocin, Doxorubicin Inj. Biochem 278/1008, 234/1062
16 Rubinat Natco 254/1103.34
17 Lyphidox Alkem 292/954
18 Doxil Alza 198/887
19 Rubex Bristol 375/1278
20 Zodox Intas 190/925
21 Tumodox Max 284.70/1186.25
23 Adrosol-RD VHB Life Sciences 210/895
(Source: Indian Drug Review, Oct-Nov, 2009 & Survey Of Doctors, Retailers & Stockiest)
54
PEGYLATED LIPOSOMAL DOXORUBICIN
Pegylated liposomal doxorubicin (PLD) is doxorubicin HCl encapsulated in long-
circulating STEALTH® liposomes (Doxil®). PLD achieves good response rates and many
patients maintain long-lasting stable disease (SD), which is one of the advantages. In addition,
the clinical benefit is high in platinum-resistant disease, and PLD is thus considered to be the
first option.
PLD is associated with a number of adverse events, but these events are mild to
moderate. PLD is safer for heavily pretreated patients than topotecan and gemcitabine due to
mild bone-marrow toxicity, but that nonhematotoxity, such as PPE, stomatitis, mucositis, and
other cutaneous reactions were the most common side effects attributable to PLD. Based on a
review of previous studies, there are no differences in efficacy between 50 and 40 mg/m2 of
PLD, therefore, a dose of 40 mg/m2 is preferable in patients with platinum resistant disease to
reduce adverse events.
The 1-hour infusion schedule every 4 weeks makes PLD easy to administer. A rational
approach to combine PLD with other drugs should take the slow accumulation and delayed peak
of PLD in tumors into consideration. When combined with other useful agents, the lower dose of
PLD (30 to 35 mg/m2) with a 3-week schedule may reduce severe PPE and stomatitis with
negligible effects on the level of DI and the therapeutic efficacy.
Epithelial ovarian cancer is sensitive to chemotherapy and approximately 75% of patients
achieve complete clinical remission after the initial treatment. However, most patients have a
recurrence, which results in death after a chronic course.
The progression-free survival (PFS) for advanced ovarian cancer patients with optimal
residual disease range from 18 to 24 months, while PFS for patients with suboptimal residual
disease is 18 months.1–5 The PFS of dose-dense paclitaxel/carboplatin therapy improved to 28
months for patients with both optimal and suboptimal disease in our study (JGOG3016).
55
In the treatment of recurrent cancer, the issues to consider are the treatment-free interval
(TFI), toxicity continuously observed from the initial treatment, recurrent tumor diameter and
increased CA125.
The TFI is the most important for selecting drugs or regimens, and the longer the TFI,
the higher the response rate.7,8 When the TFI is 6 months or longer, the tumor is considered to
be sensitive to chemotherapy, but when the TFI is less than 6 months, the tumor is considered
resistant to chemotherapy. However, 6 to 12 months of TFI is considered to be a gray zone, and
such tumors require more careful consideration when selecting drugs or regimens.
Recommended therapies for tumors sensitive to drugs, based on the results of
randomized controlled trials (RCT) and meta-analyses, are carboplatin-combination therapy such
as carboplatin/ paclitaxel, carboplatin/gemcitabine, and carboplatin/ pegylated liposomal
doxorubicin (PLD).9–11 For patients with TFI of 6 to 12 months, a non-platinum drug is one
option for prolonging the platinum-free interval and reducing toxicity. However, patients must
therefore be carefully observed to determine when the switch from non-platinum chemotherapy
to platinum combination therapy should be made.
A phase III trial has been recently launched comparing carboplatin/paclitaxel versus PLD
in the above cited clinical setting (NCT00657878). On the other hand, for patients with a drug-
resistant tumor, a drug without cross-resistance to paclitaxel and carboplatin must be selected.
The goal of therapy is to delay progression, relieve symptoms and improve the QOL, and
monotherapy is generally chosen for the most favorable toxicity profile. PLD, topotecan, and
weekly paclitaxel are drugs that have been approved by the Food and Drug Administration
(FDA), and gemcitabine (GEM), oral etoposide, and docetaxel can also be used. In Japan,
weekly irinotecan (CPT-11) is widely used.
When selecting drugs, the differences in toxicity must be fully understood. It is usually
difficult to completely cure recurrent disease with one drug or one regimen with high efficacy
and low toxicity, and the drugs must therefore be changed as required while assessing the effect
and toxicity.
56
Topotecan and GEM are highly hemotoxic, and patients should be monitored for non-
hemotoxic events that reduce the QOL when PLD and irinotecan are used. There is concern
about palmar-plantar erythrodysesthesia (PPE) and stomatitis, both of which can occur with PLD
treatment, diarrhea due to irinotecan, and peripheral neuropathy and arthralgia during weekly
paclitaxel therapy.
PLD was approved in 1999 by the FDA and in 2000 by the European Medicines
Evaluation Agency as a treatment for chemorefractory and chemoresistant epithelial ovarian
cancer, and has been used worldwide as the first option for patients with chemorefractory and
chemoresistant epithelial ovarian cancer.
Mechanism of Action, Metabolism and Pharmacokinetic Profile
PLD consists of doxorubicin encapsulated in N-(carbonyl- methoxypolyethylene glycol
2000)-1, 2- distearoyl-sn-glycero-3- phosphoethanolamine sodium salt (MPEG-DSPE) coated
liposome (STEALTH® liposome). Liposomes have the advantage of biocompatibility and
versatility of formulation for intravenous use.
However, the disadvantages of liposomes are rapid uptake by the reticuloendothelial
system (RES) and removal from the circulatory system, thus reducing the amount of drug that
reaches the tumor. MPEG-DSPE is a hydrophilic material and characteristically decreases RES
uptake.
Therefore, the STEALTH® liposome achieves prolonged circulation time without rapid
uptake by RES, and PLD has made prolonged delivery of doxorubicin and prolonged circulation
time possible. Gabzon et al undertook a pilot clinical study about the pharmacokinetics compared
with PLD and free (unencapsulated) doxorubicin (DOX), and reported that the AUC of PLD in
plasma was approximately 250-fold higher than that of DOX.12 Furthermore, the diameter of
PLD of approximately 100 mm makes it generally difficult are involved in doxorubicin
metabolism are NADPHdependent aldo-keto reductase and microsomal glycosidase.
57
Figure 4.2
58
Price incorporation strategy in pharmaceutical industry:
Generally, in pharma industry, after complete process of manufacturing and packaging,
various drugs go to market through following chain:
Carry & forwarding agents (C & F Agents)
Stockiest (Wholesalers)
Retailers
By surveying above channels we found out following information about them & their
price incorporation strategy:
(1) Carry & forwarding agents (C & F Agents)
They are appointed by companies in a particular state.
Every company has their own C & F agents.
They supply drugs to wholesalers.
Their margin is around 1.5-2%.
(2) Stockiest (Wholesalers)
As the name suggest, they keep drugs of various companies & supply
them to retailers.
Their margin is around 8-9 %.
(3) Retailers
They are the one who supply drugs to patients.
Their margin is around 20-22%.
From, the above information, we can say that price of various drugs includes
approximately 20-22% mark up cost which includes cost & profit. Incase of branded drugs,
margin is very less compared to local drugs..Incase of ovarian & cervical cancer drugs, they are
more costly & their side effects are very high. So, mostly they are given in combinations. So,
overall therapy (which is called chemotherapy treatment) is vey costly.
59
We also checked the feasibility of E-PROCUREMENT & DIGITAL DISPLAY by
surveying above channels.
90% of the retailers denied for E-PROCUREMENT as it does not provide medicines on time &
without middle channels it is not possible to procure drugs directly from the company.
60% of the retailers denied service to digital promotion t does not benefit them much.
60
MARKET ANLYSIS
GENERIC CANCER MARKET:
Tthe generic cancer market, defined to include cytotoxics, antihormonal therapies,
immunostimulating agents, targeted therapies and supportive care products (growth factors), was
worth $1.3 billion across the seven major pharmaceutical markets in 2004. Forecasts this market
to reach $10.9 billion in value by 2014, achieving a CAGR of 23.5%.
This staggering level of growth is attributable to upcoming patent expiries on key
products, as well as the imminent introduction of a regulatory pathway for biogenerics, which
will open a previously untapped market that is currently worth billions; a large number of
anticancer products were granted regulatory approvals in the 1990s and early 2000s, totaling 48
(FDA Oncology Tools). As a natural progression from this high volume of product approvals is
an increase in the number of impending patent expiries in the coming years.
Several of these products currently achieve blockbuster sales, while others are forecast to
break the $1 billion sales barrier in the forecast period of this report, thus representing a highly
lucrative opportunity for generics manufacturers. Has identified 2009 as the year with the
greatest potential for generics manufacturers, when nearly $15 billion worth of oncology product
sales will be at risk from generic erosion. As a result of this, the impact of generics on the cancer
market will become dramatically amplified in the next five years; upon entry to the market,
generic drugs will generally rapidly cannibalize sales of the original branded product.
In addition, no delay in revenue growth will occur while clinical recognition is achieved,
as efficacy and safety of the original product will already have been established by the time the
generic enters the market.
61
Last four years’ trend
Table 4.8
(SOURCE: ORG SURVEY APRIL’09)
BRAND
APR-09 MAT
(Rs Cr.)
APR-08 MAT
(Rs Cr.)
APR-07 MAT
(Rs Cr.)
APR-06 MAT
(Rs Cr.)
DOXORUBICINE 73.02 60.7 48.5 40.24
ONCODOX 18.56 17.67 15.98 13.24
TEVADOX 12.28 11 9.6 8.41
ONCODRIA 10.5 8.74 7.89 7
CADRIA 9.45 7.24 6.56 5.98
ADRIM 7.9 6.86 5.65 4.67
62
CHART 4.11
Market of Doxorubicine molecule is growing at approximately 23% every year. Also,
Overall market in April’09 is more than 80% of April’06. This indicates good market
opportunity.
63
CHART 4.12
Generic market of the Doxorubicine is also strong. All the generic drugs have more than
80% market within 4 years from April’06 to April’09. Oncodox from Cipla is at the top.
64
Growth Projection of DOXORUBICINE:
Table 4.9
YEAR
DOXORUBICINE
MARKET
(Rs. Crores)
GROWTH (%)
2006-07
40.24
22
2007-08
48.5
23
2008-09
60.7
22.5
2009-10
73.02
23.5
2010-11 90.17 27
2011-12 114.51 27
65
CHART 4.13
Growth projection forecasts market to be Rs. 114.51 crore with a growth rate of 27%
indicating great opportunity in generic cancer market by 2012.
66
Regional analysis
Table 4.10
VALUE
(Rs. Cr)
%MS
% GROWTH
ALL INDIA 47.00 100 23
NORTH 15.04 32 24
EAST 12.00 25.53 18
SOUTH 11.00 23.40 28
WEST 9.00 19.14 12
(SOURCE: ORG SURVEY, DEC. 2009)
67
CHART 4.14
North is highest with 16% especially New Delhi & Mumbai with more affected
68
PRESCRIPTION ANALYSIS OF OVARIAN & CERVICAL
CANCER DRUGS
Table 4.11 ONCOLOGIST Rx Response share trend (C-MARC)
MOLECULES NOV-FEB‘08 MAR-JUN‘08 JULY-OCT‘08 NOV-FEB‘09
ANTI CANCER DRUGS 9,O02= 100 % 9126 =100 % 8898 =100 % 8909=100 %
DOXORUBICINE 44.9 44.5 42.8 43.3
CYCLOPLATIN 16.8 16.9 16.6 16.6
PACLITAXEL 9.4 9.7 8.2 7.8
DECOTAXEL 8.3 8.3 9.1 8.4
5-FLUROURACIL 6.1 7.9 3.2 2.9
MEGESTEROL ACETATE 5.4 5.5 5.1 4.9
TAMOXIFEN 3.4 2.4 2.1 2.2
BLEOMYCIN 0.9 2.5 0.6 0.5
VINCRISTIN 4.5 1.3 2.0 2.3
VINBLASTIN 0.3 1.0 0.3 0.2
VACCINE (FOR CERVICAL
CANCER)
4.3 2.3 1.0 0.3
69
Table 4.12 CONS PHYSIO Rx Response share trend (C-MARC)
MOLECULES NOV-FEB ‘08 MACH-JUNE ‘08 JULY-OCT ‘08 NOV-FEB ‘09
ANTI CANCER DRUGS 2318= 100 % 2397 =100 % 2232 =100 % 2324=100 %
DOXORUBICINE 56.7 56.2 56.5 54.7
CYCLOPLATIN 19.8 20.0 19.4 19.3
PACLITAXEL 2.7 4.8 3.3 4.6
DECOTAXEL 4.3 4.8 4.5 4.6
5-FLUROURACIL 3.6 3.3 2.6 2.2
MEGESTEROL ACETATE 3.4 2.9 1.8 3.6
TAMOXIFEN 2.2 2.6 1.9 2.0
BLEOMYCIN 0.6 0.7 0.9 0.9
VINCRISTIN 2.4 2.0 2.3 2.5
VINBLASTIN 0.6 1.2 2.2
VACCINE (FOR CERVICAL
CANCER)
2.3 1.2 0.6
70
SWOT ANALYSIS
Strengths
• Well accepted formulation
• High demand
• Better perception in ovarian cancer
• Side effects are less
Weaknesses
• Very High Cost
• Stiff competition from well known
corporate brands
Opportunities
• Consolidate in every type of cancer
• Untapped Gyneclology segment
Threats
• Intense competition from cheap
drugs
71
SURVEY OF DOCTORS
SURVEY FINDINGS: Opinion of total of 20 expert oncologists’ doctors was taken
with sample questionnaire for Doxorubicine.
Table 4.13 Oncologists’ survey
Parameters for
Doxorubicin
(No. of response from doctors)
Doxorubicine is the
proffered first drug of
choice for particular
disease
Ovarian Cancer
(3)
Cervical cancer
(3)
Breast cancer
(2)
Lung cancer
(2)
All of them
(10)
Doxorubicine is
preferred because of
its
Efficacy
(08)
Potency
(04)
Better half life
(02)
Lesser side
effects
(02)
Rapid onset of
action
(04)
Most preferred
strength of
Doxorubicine is
10 mg
(10)
50 mg
(07)
100 mg
(02)
250 mg
(01)
Doxorubicine is
widely used as a
Plain drug
(00)
In combination
(20)
Doxorubicine is
preferred most in
dosage form
Injections
(10)
Oral solid tab
(06)
Capsule
(04)
Any Other
(00)
The criteria doctors
keep in mind while
writing a particular
brand is
Efficacy
(06)
Reputation of
brand
(04)
Broad spectrum
of the drug
(03)
Benefits to the
patients
(07)
72
SURVEY FINDINGS: Opinion of total of 10 expert Consultant Physiologists’ was
taken with sample questionnaire for Doxorubicine.
Table 4.14 Consultant Physiologists’ survey
Parameters for
Doxorubicin
(No. of response from doctors)
Doxorubicine is the
proffered first drug of
choice for particular
disease
Ovarian Cancer
(0)
Cervical cancer
(0)
Breast cancer
(0)
Lung cancer
(0)
All of them
(10)
Doxorubicine is
preferred because of
its
Efficacy
(03)
Potency
(03)
Better half life
(00)
Lesser side
effects
(02)
Rapid onset of
action
(02)
Most preferred
strength of
Doxorubicine is
10 mg
(05)
50 mg
(03)
100 mg
(01)
250 mg
(01)
Doxorubicine is
widely used as a
Plain drug
(00)
In combination
(10)
Doxorubicine is
preferred most in
dosage form
Injections
(06)
Oral solid tab
(03)
Capsule
(01)
Any Other
(00)
The criteria doctors
keep in mind while
writing a particular
brand is
Efficacy
(03)
Reputation of
brand
(02)
Broad spectrum
of the drug
(01)
Benefits to the
patients
(04)
73
CHART 4.15
Doxorubicine is the preffered choice of drug for all type of cancer. This is a good opportunity as
it can be projected in all type of cancers.
74
CHART 4.16
Doxorubicine is most prefferd because of its efficacy & potency followed by rapid onset of
action. However because of its liposomal form side effects are reduced,
75
CHART 4.17
Around 50% doctors said preferred strength is 10 mg/5 ml followed by 50 mg/25 ml for needed
higher dose.
76
CHART 4.18
Not only Doxorubicine, almost all the cancer drugs are prescribed in combination therapy
because of high side effects. However, Doxorubicine is having less side effects because of its
liposomal form compared to traditional dosage forms
77
CHART 4.19
Injections are most preferred because of rapid onset of action followed by tablets & capsules.
Most of the available anticancer drugs are in the Injecteble. (Ref: Table no. 4.7 & 4.8)
78
CHART 4.20
Doctors while writing a particular brand benefit to patients which also include economical
benefits & efficacy for a particular brand followed brand reputation spectrumn & brand
reputation
79
CHAPTER 5
CONCLUSION
80
Due to changing life style (especially for women who are working & marrying at older
age), there has been rapid increase in ovarian & cervical cancer drugs. However, due
rapid change & development in technology, it has been possible to get catch on cancer.
Ovarian and cervical cancer are detected in first past and second stage which is too late in
most of the cases, makes them life threatening disease.
Report of cancer statistics from WHO indicates there will be more than 226084 case of
cervical cancer by 2025, indicate rising number of women more prone to cervical cancer
As we have seen, there has been increasing market of ovarian & cervical cancer drugs.
Secondary data of generic cancer drugs shows forecast of $10.9 billion market by 2014
with CAGR OF 23.5%
Also data of C-MARC from Table 4.11 to 4.16 shows Doxorubicine is the preferred
choice of drug for ovarian & cervical cancer drugs.
From the table 4.8, it can be observed increasing growth of Doxorubicine. There has been
approximate 40% growth in april-09 from april-06. . This indicates good market
opportunity
Table 4.9, shows growth projection of 25% every year which will lead to Doxorubicine
market to 115 crore in 2011-12. This shows Doxorubicine is at its peak of growth which
favors launching a new brand for Doxorubicine. So, from the above references of market
we can be optimistic for good growing market of Doxorubicine We can be optimistic
about good market share.
Prescription analysis shows Doxorubicine is the drug of choice for ovarian & cervical
cancer & also for other types of cancer. while there is also good scope in cons. physicians
& Gynecology segment.
81
CHAPTER 6
SUGGESTIONS & RECOMMENDATIONS
82
BRAND LAUNCH & POSITIONING
4Ps of marketing which are product, place, price & promotion for new brand launch of
Doxorubicine SHOULD BE as follows:
(1) PRODUCT:
Our product will be PEGYLATED LIPOSOMES OF DOXORUBICINE (10/50 mg) in
the form injection.
Preferred brand name will be DOXALITE.
The product will be made available in VIAL of 5 & 10 ml.
(2) PLACE:
DOXALITE will be placed for ovarian ,cervical & other types of cancer disease as a
monotherapy as well as adjunctive therapy.
(3) PRICE:
Following price is recommended for various strength of DOXALITE
STRENGTH PRICE (RS)
10 mg/ 5ml 300/ VIAL
50 mg/ 25ml 1200/VIAL
(4) PROMOTION:
DOXALITE should be promoted with positioning theme
“NOW REMAI N I N LI GHT WI TH DOXALI TE”
“NEW LI GHT I N LI FE WI TH DOXALITE”
83
PROMOTIONAL STRATEGY
DOXALITE should be promoted in following 3 ways:
(1) Brand promotion
(2) Advertising promotion
(3) Sales promotion
(1) Brand promotion: Promo plan for DOXALITE brand amongst doctors
should be as follows:
Dr segmentation
• Oncologist
• Gynecologist
• Consultant physiologist
Positioning theme (with payoff line)
• “NOW REMAI N I N LI GHT WI TH DOXALI TE”
• “NEW LI GHT I N LI FE WI TH DOXALITE”
Action Plan
• In-clinic involvement of the DOCTOR
• Comparison with Cisplatin, Paclitaxel and highlighting the benefit of
DOXALITE without addiction
• Aggressive brand conversion of the market leader-Oncodox,
Levidox,,Cadria, Oncodria & others
• Mailers
• Visual Aid
• Leave Behind Literature(LBL)
• Promotional input
84
• Product monograph
• Abstract of journals
• References
Promotional inputs for doctors
(1) Mailer: (As Brand Recall)
6 Pocket shape mailer representing convenience (Two in a month)
Anxiety/Phobia-relating convenience
Which facilitated use of DOXALITE
Melt in Mouth Activity
Small Size
(2) Visual Aid: (As Brand Energizer)
(Communication theme for DOXALITE)
Diseases like ovarian, cervical & other type of cancers shown as various heads of
“RAVAN” (Character from ‘RAMAYAN’) & DOXALITE (DOXORUBICINE)
as a killing soldier (showing having weapon in hand & body of tablet wearing cap
on head)
A woman shown in jovial mood because of DOXALITE molecule.
• ONCOLOGIST & CONSULTANT PHYSIOLOGIST
Start early with DOXALITE
A convenient formulation for all the type of cancers
Effective drug of choice ovarian & cervical cancer
Rapid onset of action
Reduced side effects
• GYNECOLOGIST
A Perfect Quick solution that rapidly stabilizes acute symptoms of cancer
Effective drug of choice ovarian & cervical cancer
Highly efficient
Reduced side effects
Immediate relief
85
(3) Leave behind Literature (LBL): (As Brand Recall)
(4) Promotional input: (As Brand Recall)
Promotional inputs like calendars, chart etc highlighting packing of DOXALITE
& its indications, benefits etc.
(5) Product monograph: (As Brand Energizer)
(6) Abstract of journals: (As Brand Energizer)
(7) References: (As Brand Energizer)
(8) Diagnosed the situation campaign for physician only: (As Brand Recall)
(9) Prescription pads with brand name DOXALITE
As Brand Recall)(2) ADVERTISING PROMOTION:
DOXALITE should be promoted by advertising it in various pharmaceutical &
medical publications like IPA, Indian Drug Review (IDR), Drug Today, MIMS.
LANCET etc.
DOXALITE should be promoted online in various pharmaceutical & medical websites
(3) SALES PROMOTION
Promo plan for stockiest/retailers
(1) Promotional inputs
(2) Promotional schemes like
Order for-
• 100 VIALS & get 2 VIAL free
• 300 VIALS & get 5VIAL free
• 500 VIALS & get 7VIAL free
• 2 % discount to patient on continuous therapy which will be added to fund for welfare of
cancer patients.
(3) Gifts like letter pads, diaries, ball pens
86
OPERATIONAL PLAN
Modus operandi..
1. 10 Doctor/Field sales officer
2. Can be done in first week of every month.
3. Will focus mainly on DOXALITE during the call
4. FSE need to send to send back a report of completion of the campaign by the second week of
every month in the given format
Series
Modus Operandi
1. 15 Dr/Field sales offocer (Mini.5 CPs) apart from AASHA- a new lifecampaign.
2. Regular visit after every 10 days to maintain the continuity in the campaign
Drug interaction Chart/LBLs/Mailer
1 .O (Their will be 2 type of chart one for Physician & other for oncologist)
doc_559371619.pdf