MBA Final Project

A Project Report

On

“Future Prospect of Indian pharmaceutical industry in context of globalization and suggesting a marketing strategy for launching generic version of pegylated

liposomes of Docetaxel: A lung cancer drug”

Submitted in partial fulfillment of the requirementOf Masters in Business Administration at the

School of Business StudiesSharda University

2012

Submitted By -

Ambuj Shankhdhar

Regd. No. -10SBSMBA133

Guided by- Professor (Dr.) Milindoo Chakarbarti

Head International business, SBS

D E C L A R A T I ON & CERTIFICATION

I hereby declare that the Project work entitled Future Prospect of Indian pharmaceutical industry in context of globalization and suggesting a marketing strategy for launching generic version of pegylated liposomes of Docetaxel: A lung cancer drug Submitted by me for the Final term Project during the Master of Business Administration to School of Business Studies, Sharda University, Greater Noida is my own original work and has not been submitted earlier either to the SBS or to any other Institution for the fulfillment of the requirement for any course of study. I also declare that no chapter of this report in whole or in part is lifted and incorporated in this report from any earlier / other work done by me or others.

Further, I declare that my project is being guided and supervised by the faculty Prof. (Dr.) Milindo Chakarbarti, Professor of School of Business Studies, Sharda University, Greater Noida.

Signature of Student:___________________________

Name of Student: Ambuj Shankhdhar

Signature of Faculty Guide: _____________________

Name of Faculty Guide: Prof. (Dr.) Milindo Chakarbarti, Professor

Place : Date :

ACKNOWLEDGEMENT-

I express my profound gratitude to all Oncologists, Medical Reps. and Stockiest/ Medical Stores who participated in this project.

I am also grateful to Prof. (Dr.) Milindo Chakarbarti – Professor and Head International business, SBS, Greater Noida, who is also my Mentor and guide and I want to give my sincere thanks to his kind advice and guidance that had made my project successful. I would like to thank Prof. (Dr.) Prem S. Vashishtha – Professor and Head of Research and development team, SBS, Greater Noida for their valuable time and concern regarding this project.

Many of the sound advices have been well taken by me and it is largely due to their patience that I was able to achieve my goal successfully.

I would also like to thanks all those learned persons in my Family for sharing valuable information with me, which was very necessary for this project.

Finally, I thankful to my Parents who always shower their blessings on me and help me to complete the Project well in time.

Ambuj Shankhdhar Reg. No. 10SBSMBA133 Roll. No. 100251008

Project Title- Future Prospect of Indian pharmaceutical industry in context of globalization and suggesting a marketing strategy for launching generic version of pegylated liposomes of Docetaxel: A lung cancer drug

Motivation for the research-

Being a part of the family where dominant profession is healthcare and with 18 years of academic background in science, pharmaceutical industry always appearing promising to me in terms of market potential and job opportunity, all this along with the sudden death of my father due to lung cancer motivates me to write project report on this topic. 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. Global pharmaceutical sales are estimated to reach $880 billion for 2011, an increase of between 6% to 7% compared to 2010.  The Indian pharmaceuticals market is expected to reach US$ 55 billion in 2020 from US$ 12.6 billion in 2009. This was stated in a report title "India Pharma 2020: Propelling access and acceptance, realising true potential" by McKinsey & Company. In the same report, it was also mentioned that in an aggressive growth scenario, the pharma market has the further potential to reach US$ 70 billion by 2020.

Due to increase in the population of high income group, there is every likelihood that they will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015. This was estimated in a report by Ernst & Young. The domestic pharma market is estimated to touch US$ 20 billion by 2015. The healthcare market in India is expected to reach US$ 31.59 billion by 2020. The sale of all types of pharmaceutical drugs and medicines in the country stands at US$ 9.61 billion, which is expected to reach around US$ 19.22 billion by 2012. Thus India would really become a lucrative destination for clinical trials for global giants.

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 by2012. 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.

(Source:1-http://www.indiainfoline.com/Markets/Company/Fundamentals/Management-Discussions/Panacea-Biotec-Ltd/5313492- http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry).

(Source- http://www.prlog.org/11809536-cancer-drug-market-will-reach-75-billion-in-2012

visiongain-report-predicts.html)

Executive Summary-

The Indian Pharmaceutical industry is world’s third-largest in terms of volume and stands 14th in terms of value. The Indian pharmaceutical industry is expected to grow at a CAGR of around 12.6% as compared to global pharmaceutical market sales of only 6 - 7% compound annual growth rate (CAGR) through 2014. Demand in India is growing markedly due to rising population figures, the increasing number of old people and the development of incomes. As a production location, the country is benefiting from its wage cost advantages over western competitors also when it comes to producing medicines. Since the beginning of 1990s India has been exporting more pharmaceuticals than it imports. Over the last ten years the export surplus has widened from EUR 450 m to EUR 2 .7 bn. At 38% in 2010, the export ratio was about twice as high as in 2000 and will likely rise further in the coming years. With new patent regulation in India in 2005 a reorientation was required in India’s pharmaceutical industry which now focuses on drugs developed in-house and contract research or contract production for western drug makers. Infrastructure is the major issue in hampering the growth of the industry apart from qualitative and quantitative shortcomings in the energy and transport sectors.

Despite of good annual growth rate India’s share in the world pharmaceutical market would only come to slightly over 2% (Germany: 7%) by 2015. In Asia, India looks set to lose market share, as other Asian countries are registering even stronger growth.

Cancer of all kinds are becoming prevalent more often thanks to deteriorating human values and lifestyle. Anti cancer drugs are very costly so generic drugs must be given preference.

Source- (general reading)

Scope of study-

With many blockbuster drugs patent expiry become a major concern for the world pharmaceutical companies and their low cost generic version proves to be very useful for other companies my project report will help in knowing as the company desires to expand to newer markets with new products, 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.

OBJECTIVE OF PROJECT REPORT-

My Project report consists of two parts -

PART 1- Indian pharmaceutical market in course for Globalization – Government initiative (when)? Private sector initiative

Factors which leads to Globalization of IPM. 5 major players?

a) Percentage share in total market Domestic market Foreign marketb) What is the role of small, medium [and micro too] enterprises?

What is the regional/ geographical concentration of production? Within the country Abroad

Similarly, what is the regional/geographical concentration of sales. Within the country Foreign market

What has triggered the rise of the industry under consideration? Policy (government) Private initiative Discuss policy aspect and strategy for

all FDI New technology

Local/Indigenous (Developed in home country)

Technology transfer What is the role of new Foreign Trade Policy(FTP)?

Role of SEZ? Shortcomings of SEZ? New manufacturing policy (NMP)? Which new initiatives in NMP and FTP -

2009-14? Have the constraints being faced by the industry been addressed in the new

policy documents? Study and offer critical comments on the WTO provision relevant to pharmaceutical

industry/ product under consideration:

Is sustainability or environmental degradation a major issue in the industry addressed? If yes, how is it being addressed? Is any government subsidy involved for preserving the environment?

Is the product /industry being subsidized by the government? If yes, is the subsidy being given to the producer or to the consumer ?How is the subsidy being delivered- directly in the form of cash or by subsidizing imports used or by allowing the firm /industry to sell the product at subsidized price and reimburse the subsidy to the producer(retailer)?

PART 2- Marketing strategy for launching generic version of PEGYLATED LIPOSOMES OF DOCETAXEL: A lung cancer drug

To study and analyze Overall domestic market size for lung cancer drugs. To analyze price incorporation strategy of drugs in pharmaceutical industry. To study & analyze overall domestic market for generic version of PEGYLATED

LIPOSOMES OF DOCETAXEL & compare it with other existing brands of LUNG CANCER DRUGS in terms of available dosage forms, efficacy & price.

To suggest an appropriate launch strategy to launch a new generic version of the DOCETAXEL.

CHAPTER - 1

INTRODUCTION

Introduction to Global Pharma Market-

Global pharmaceutical sales are estimated to reach $940 billion for 2012, an increase of about 5% to 7% compared to 2011. The 2011 global pharmaceutical market is expected to have grown by between 4% and 5% compared to 2010. Varying growth rates for different types of countries - pharmaceutical growth is expected to progress at different rates, with 17 pharmerging countries expanding at between 15% and 17% next year to $170-180 million. Many pharmerging countries are spending considerably more on healthcare. These countries are experiencing broader public and private healthcare funding, resulting in higher demand and access to medications.China alone, currently the third largest pharmaceutical market, is expected to expand by 25% to 27% in 2012 to over $60 billion.

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.

Source- http://en.wikipedia.org/wiki/Pharmaceutical_industry_in_Indiahttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/http://www.pharmaceutical-drug-manufacturers.com/articles/indian-pharmaceutical-industry.html

Developed nations - Germany, France, Italy, Spain and the United Kingdom, Europe's five major markets, as well as Canada are estimated to expand by 1% to 3%. The Japanese market has a forecast of 5% to 7% growth. The world's largest market, the USA will most likely see growth of 3% to 5%, with pharmaceutical sales reaching between $320 and $330 billion.Shift to generics as patents expire - a large number of blockbusters will have reached the end of their patent lives by 2011, making way for generics. The report calculates that about $30 billion's worth of current sales will face generic competition. The authors stress that the largest impact of generic competition will probably be felt in the following year, in 2012.

Measures to reduce expenditure - national governments worldwide are trying to bring down their drug bill in their drive towards budgetary control. This will have an impact on several markets next year. Countries, such as Canada and Spain have attained considerable discounts in generic prices relative to their branded counterparts - in these countries generic pharmacy rebates may be done away with. In an effort to deal with rising healthcare costs, health plans in the USA are increasing their use of pre-authorizations and cost sharing provisions.

Growth in new drugs that meet areas of unmet need - next year, new medications, many of which are specialist pharmaceutical products, will most likely fulfill patients' unmet needs. This may have a considerable impact on the way some therapy areas are treated, such as stroke prevention, MS (multiple sclerosis), hepatitis C, melanoma, and breast cancer.

Source- http://www.medicalnewstoday.com/articles/203765.php

World Leading Pharma Companies- The following is a list of the twelve largest healthcare companies ranked here by revenue as of March 2010 according to their released 2009 annual reports.

Sr. no. Company Country Revenue USD

1 Johnson & Johnson United States 61.9

2 Pfizer United States 50.01

3 Roche Switzerland 47.35

4 GlaxoSmithKline United Kingdom 45.83

5 Novartis Switzerland 44.27

6 Sanofi France 41.99

7 AstraZeneca UK/Sweden 32.81

8 Abbott Laboratories United States 30.76

9 Merck & Co. United States 27.43

10 Bayer HealthCare Germany 22.3

Source- http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies

Direct Competitor Comparison

  PFE BAYRY.PK MRK NVS Industry

Market Cap: 161.53B 60.38B 116.74B 130.92B 1.58B

Employees: N/A N/A 86,000 1,23,686 1.28k

Qtrly Rev Growth

(yoy): -3.50% 2.00% 1.70% 3.70% 10.50%

Revenue (ttm): 67.42B 48.21B 48.05B 59.38B 3.37B

Gross Margin (ttm): 78.84% 50.85% 65.86% 68.72% 51.53%

EBITDA (ttm): 27.56B 9.42B 17.40B 17.52B 163.56M

Operating Margin

(ttm): 29.32% 12.65% 21.99% 21.49% 11.92%

Net Income (ttm): 8.70B 3.26B 6.26B 9.11B N/A

EPS (ttm): 1.27 3.95 2.02 3.78 2.02

P/E (ttm): 16.85 18.5 18.99 14.39 14.63

PEG (5 yr expected): 3.37 1.73 2.75 2.42 0.78

P/S (ttm): 2.39 1.26 2.4 2.19 1.85

BAYRY.PK = Bayer AG

MRK = Merck & Co. Inc.

NVS = Novartis AG

Industry = Drug Manufacturers – Major

Source- http://in.finance.yahoo.com/q/co?s=PFE

1- Introduction to Indian Pharma Industry-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 and can be defined as a complex matrix of processes, operations and organizations involved in the discovery, development and manufacture of drugs and medications.The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously. Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past 53 years and helped to put India on the pharmaceutical map of the world.

Characteristics of Indian Pharmaceutical Industry-The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control.The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical formulations. Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market.(Source- http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/)

2- Major Players in India:

Competition is mainly from the domestic manufacturers and imports from China because of the low manufacturing cost. With the new patent regulations the industry expects to see a major structural shift with the entry of foreign pharmaceutical manufacturers.There are five government-owned companies the Indian public sector. These companies are the Indian Drugs and Pharmaceuticals, Hindustan Antibiotics Limited, Bengal Chemicalsand Pharmaceuticals Limited, Bengal Immunity Limited and Smith StanistreetPharmaceuticals Limited. Some of the major Indian private companies are Alembic Chemicals, Aurobindo Pharma, Ambalal Sharabhai Limited, Cadila Healthcare, Cipla, Dr. Reddy’s, IPCA Laboratories, Jagsonpal Pharma, J.B. Chemicals, Kopran, Lupin Labs, Lyka Labs, Nicholas Piramal, Ranbaxy Labs, Matrix Laboratories, Orchid Chemical and Pharmaceuticals, Sun Pharmaceuticals, Ranbaxy Laboratories, Torrent Pharma, TTK Healthcare, Unichem Labs, and Wockhardt.The foreign companies in India include Abott India, Astra Zeneca India, Aventis Pharma India, Burrough-Wellcome, Glaxo SmithKline, Merck India, Novartis, Pfizer Limited, and Wyeth Ledele India.India also exports pharmaceuticals to numerous countries around the world, including to the U.S., Germany, France, Russia and UK.

Source- Wikipedia

Rank Company Revenue 2011(USD millions)1 Cipla 1348.512 Ranbaxy 1327.563 Dr. Reddy's Laboratories 11784 Lupin Ltd 929.845 Aurobindo Pharma 865.196 Dabur 700.37 Sun Pharmaceutical 673.998 Cadila Healthcare 629.459 Jubilant Lifesciences 561.03

10 Piramal Healthcare 480.2611 GlaxoSmithKline Ph. Ltd 475.812 Ipca Laboratories 39013 Wockhardt 381.2314 Torrent Pharmaceuticals 380.215 Sterling Bio 358.116 Biocon 340.3817 Orchid C & P Ltd. 320.6218 Alembic 270.6219 Aventis Pharma 263.7520 Glenmark Pharmaceuticals 260.14

Aventis Pharma:50.1 percent of Aventis Pharma is held by European drug major Sanofi-Aventis and, inearly 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.

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.

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.

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.

Zydus Cadila:Zydus Cadila is India's fifth largest pharmaceutical company. Cadila was founded in1952 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.

RanbaxyRanbaxy 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. Diabetes & CNS segments.

Source- Companies website

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.

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.(Source- www.pharmaceuticalchiller.com/industry.html)

Market Trends:

The industry has enormous growth potential. Factors listed below determine the rising demand for pharmaceuticals.

The growing population of over 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)

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 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. The exports which have grown very significantly to over Rs 45,000 crores in 2010‐11, is projected to touch around 130,000 crores by the end of 12th five year plan.Year Exports Growth Domestic Growth% Total Growth%Mar 06 21230 23.23 39989 17.17 61219 19.21Mar 07 25666 20.89 45367 13.45 71033 16.03Mar 08 29354 14.37 50946 12.30 80300 13.04Mar 09 39821 35.66 55454 8.85 95275 18.65Mar 10 42154* 5.86 62055 11.90 104209 9.38Source- IMS2- http://planningcommission.nic.in/aboutus/committee/wrkgrp12/wg_pharma2902.pdf

Global Share-The emerging markets are targeted to grow at 14%. In this context, the Indian market is projected to grow at 18%. Accordingly given the current demand and the ability of the Indian pharma manufacturing sector to continue to meet the demand push, it is expected that the Indian pharma sector would be of about US$ 60 billion size in 2017. Hence it is expected that Indian Pharmaceuticals industry will have a share of 5% in global pharmaceutical industry by the end of 12th Five Year Plan.(Source- 1- www.fas.org/sgp/crs/row/RL34161.pdf

2- Planning Commission of India Website.)

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.

Foreign Direct Investment (FDI) in Drugs and Pharmaceuticals:FDI up to 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.

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.(Source- http://www.cci.in/pdf/surveys_reports/indias_pharmaceutical_industry.pdf)

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.(Source- http://www.mckinsey.com/locations/india/mckinseyonindia/pdf/india_pharma_2015.pdf)

Role of Small and medium enterprises-As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies are cutting back on outsourcing and what business is left is shifting to companies with facilities in the four tax-free states - Himachal Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand. Consequently a large number of pharmaceutical manufacturers shifted their plant to these states, as it became almost impossible to continue operating in non tax free zones. But in a matter of a couple of years the excise duty was revised on two occasions, first it was reduced to 8% and then to 4%. As a result the benefits of shifting to a tax free zone were negated. This resulted in, factories in the tax free zones, to start up third party manufacturing. Under this these factories produced goods under the brand names of other parties on job work basis.As SMEs wrestled with the tax structure, they were also scrambling to meet the July 1 deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax.(Source- http://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India)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.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.(Source- http://www.cfses.com/documents/pharma/01-Business_Strategy.PDF)

EFFECT OF PRODUCT PATENTS ON INDIAN PHARMACEUTICAL INDUSTRY: RAPID STRIDES IN PHARMA R & D, BUT TRIPS FLEXIBILITIES REMAIN IMPORTANT, SAYS WTO CENTRE STUDY-The growth of the Indian pharmaceutical industry was largely contributed by the Patents Act of 1970, which had two key features. First, only process patents were allowed for chemical entities, including pharmaceuticals; in other words the patent regime did not allow granting of product patents in India. And two, the term of patent protection was made shorter for pharmaceutical patents. This meant that generic manufacturers were able to make products using Following implementation of the commitments undertaken by India under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as part of the Uruguay Round accord, India's patent regime was amended. A study undertaken by the Centre for WTO Studies, titled “Effect of Product Patents on the Indian Pharmaceutical Industry” has analysed the performance of the pharmaceutical industry in the post-TRIPS regime since 1995, i.e., the year of India's accession to the World Trade Organization (WTO). The study, by Prof. Biswajit Dhar of the Centre for WTO Studies, and K.M.Gopakumar of Centad, showed that leading generic firms of the Indian pharmaceutical industry have demonstrated considerable dynamism since 1995 and especially noteworthy has been the increase in R & D spending in the sector. The increase in patenting activities of Indian firms coupled with the increased efforts by the government to promote R & D in industry with a view to strengthening the technological sinews of the generic manufacturers should stand the industry in good stead as it evolves strategies to meet the challenges posed by the post-TRIPS patent regime, the study says, adding also that one area where the industry has got its act in place is the market for anti-retroviral (ARV) drugs and that these successful forays have to be assessed in the context of accessing medicines at affordable prices. An important policy lesson for developing countries, the study points out, is the need to provide sufficient flexibilities in the patent laws so that domestic pharmaceutical industries get a chance to develop. “These countries can provide an enabling environment for the domestic industries by carefully designing provisions that relate to patentable subject matter and compulsory licensing”, the study concludes. It also analyses the implications of introducing a data exclusivity regime in India (i.e., protection of test and other data submitted to the authorities for obtaining market approval) while implementing Article 39.3 of the TRIPS Agreement, and cautions that ramifications of a data exclusivity regime of the kind prevailing in the US and the European Union can be quite considerable on the Indian generic industry.

The Two ExemptionsSection 107 A of the Patents Act, 1970, as amended contains two notable exemptions. The first relates to what is better known as the 'Bolar exemptions' and the second exemption seeks to define the contours of parallel imports.

Bolar Exemption

One of the less focused areas of the Indian Patents Act as amended is the provision for the so-called 'Bolar exemption'. The basic idea behind it is to create conditions so that the generic drug manufacturers can introduce their products immediately after the patent on a drug lapses.Parallel importsThe Agreement on TRIPS allows for the parallel imports, although the specific circumstances under which such imports can take place have not been defined. The Indian patents Act, 1970 has taken the initiative to include the provisions of parallel imports under Section 107A(b) as follows:“Importation of patented products by any person from a person who is duly authorized under the law to produce and sell or distribute the product”. As has been explained by the government, this provision of parallel import of patented product was introduced for 'ensuring availability of patented products at cheaper price to the consumers'. In particular, the law' to produce and sell or distribute the product seems to indicate that parallel imports may exclude such possibility, limiting parallel imports to products marketed abroad with the consent of the patent holder. The TRIPS Agreement is silent on this issue.

PPP initiatives should address distribution gap-It is ironic that with more than 400 million connections the penetration of cellular phones is better than that of the distribution of life saving drugs. Smarter use of existing resources could offer some solutions, says Venkat Jasti, VC & CEO, Suven Life Sciences .India is called the 'pharmacy of the world' but is unable to deliver medications to more than 70 percent of its huge population of over 1.1 billion mainly living in rural areas. Since independence, there have been considerable improvement in health standards, such as life expectancy, child mortality, infant mortality etc; but problems still abound. Millions of poor people in rural India fall sick and die because they lack access to medicines, vaccines and diagnostics needed to treat, prevent and identify debilitating diseases.Reasons for poor accessThis lack of access to medicines is mainly due to the distribution system (highly fragmented nature of the distribution network, lack of cold-chain management practices and multilayered distribution practices) followed by lack of buying power. Also another reason is that pharma companies do not develop drugs that are needed in rural areas like for tropical diseases and infectious diseases because of the non remunerative nature of such drugs.Some solutionsThe organized retail pharmacies are in a nascent stage in India, but have started making inroads into the distribution system. Though organized retail faces strong resistance from the traders lobby, it has a great potential for making medicines accessible especially to the rural population. Under the NRHM, some states in India have developed an intranet-based drug distribution monitoring system whereby drug requirement, gathering as well as disbursement to district and sub district levels can be easily tracked. This will help outlining the requirement and avoid stock out positions. But not many initiatives with distribution at the retail level from the government's side have taken place. In addition to government initiatives like ‘Jan Aushadhi’, PPP based model is the need of the hour especially in distribution system. PPP in healthcare is working well but not much has been attempted in the availability of affordable medications. Partnerships with social networks like 'Rotary' or 'Lions', with professional associations like Indian Pharmaceutical Association, with NGO organizations, pharmacy colleges will certainly enhance the distribution of drugs to the rural masses.Using existing resourcesOne of the ways Indian government can take advantage of the various pharmacy colleges and their locations is by funding them with mobile vans and stocking them with essential

medicines which can be utilized not only for effective distribution of medicines at affordable prices in rural areas but also allows students to get practical training, under the supervision of a teacher while the institution earns in the process. For those unmet medical needs of the diseases which are common to the Indian rural population and to other tropical regions, industry and government should collaborate together with academia with appropriate funding and incentives to develop drugs treating those ailments rather than waiting for international organizations like WHO or Bill and Melinda Gates Foundation to sponsor them.With all the above initiatives we can certainly achieve access to affordable medicines at every level. (Source- http://www.expresspharmaonline.com/20100131/2010businessagenda12.shtml)

SWOT ANALYSIS OF INDIAN PHARMA INDUSTRY -

Strengthsi. Cost competitiveness; the cost of developing a new molecule in India is less than 30% of the American cost. Clinical trials cost approximately $300 to $350 million abroad, while it costs only about $ 20 million (Rs 100 crores) in India (Mr. Vijay Moza, Vice‐Chairman Institute of Clinical Research, India).ii. Edge in reverse engineering for generic products and global ANDA filingiii. Well developed chemistry R&D and manufacturing infrastructureiv. Low cost English speaking workforcev. Large, diverse, therapy‐naïve pool of patient population in all kind of acute/chronic disease segments: An ideal for clinical research

Weaknessi. Lack of development skills in complex and difficult to duplicate generic product technologiesii. Lack of culture for innovationiii. Poor industry‐ academia interaction and all around infrastructure, including educational institutionsiv. Low doctor to patient ratio in hospitals, rendering them non‐available for clinical researchv. Lack of experience, capability and resources in industry and institutions engaged in new drug discoveryvi. Low capability and motivation for cutting edge research, especially in areas related to understanding of disease, and platform technologies for drug productsvii. Poor infrastructure, training and non availability of trained manpower for clinical researchviii. Low appetite to risk and R&D investmentix. Ratio of Ph D to Masters degree holders in R&D is low (1:10) against target (1:5)x. Low level of education & training in the pharmacy institutions and universitiesxi. Small, inefficient and in‐experienced workforce lacking competency and capacity in our conservative regulatory environment is unable to support innovation & new drug discovery.

Opportunitiesi. Development of critical and high‐tech manpower (capacity building) for pharma R&D and allied sectorsii. Converting low cost generic to value added branded generic by SME sectoriii. Develop platform technologies (New drug delivery systems) for improvising conventional genericsiv. Development of new bio‐ molecules, vaccines and bio‐similar

v. Exploitation of clinical research potential of India. According to "Booming Clinical Trials Market in India <http://www.rncos. com/>", a new research report by RNCOS, a number of factors such as low cost, large patient pool, easy recruitment, strong government support and strengthening of its intellectual property environment will enable India to conduct nearly 5% of the global clinical trials by 2012.vi. India assuming leadership role amongst developing countries for pharma research, manpower development etc.

ThreatsChina is quite ahead in API, natural remedies and herbals, Clinical research and medical devices.(Source - Planning Commission of India.)

Porter`s Five Force model is Indian Pharmaceutical sector-The Indian Pharmaceutical industry is world’s third-largest in terms of volume and stands 14th in terms of value. The Indian pharmaceutical industry is expected to grow at a CAGR of around 12.6% as compared to global pharmaceutical market sales of only 6 - 7% compound annual growth rate (CAGR) through 2014. Demand in India is growing markedly due to rising population figures, the increasing number of old people and the development of incomes. As a production location, the country is benefiting from its wage cost advantages over western competitors also when it comes to producing medicines.1- Industry Rivalry-

Pharma industry is one of the most competitive industries in the country with as many as 20,000 registered units.

Expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market

leader holding nearly 7% of the market share and top player in the country has only 6% market share, and the top five players together have about 18% market share.

Extremely fragmented market with severe price competition and government price control.

The entry barriers to pharma industry are very low. The fixed cost requirement is low but the need for working capital is high. The fixed asset turnover, which is one of the gauges of fixed cost requirements, tells

us that in bigger companies this ratio is in the range of 3.5 to 4 times. For smaller companies, it would be even higher.

Many smaller players that are focused on a particular region, have a better hang of the distribution channel, making it easier to succeed, albeit in a limited way.

Volume growth has been consistent over a period of time, value growth has not followed in tandem.

With reverse engineering Indian drug companies benefited the masses and make cost of drug low as compared to world`s MNC.

2- Bargaining power of buyers The unique feature of pharma industry is that the end user of the product is different

from the influencer i.e doctor. The consumer has no choice but to buy what doctor says. However, when we look at

the buyer's power, we look at the influence they have on the prices of the product. In pharma industry, the buyers are scattered and they as such does not wield much

power in the pricing of the products.

Government with its policies, plays an important role in regulating pricing through the NPPA (National Pharmaceutical Pricing Authority).

3- Bargaining power of suppliers The pharma industry depends upon several organic chemicals. The chemical industry

is again very competitive and fragmented. The chemicals used in the pharma industry are largely a commodity.

The suppliers have very low bargaining power and the companies in the pharma industry can switch from their suppliers without incurring a very high cost.

Forward integration of Companies like Orchid Chemicals and Sashun Chemicals which were basically chemical companies, turned themselves into pharmaceutical companies.

4- Barriers to entry Pharma industry is one of the most easily accessible industries for an entrepreneur in

India. The capital requirement for the industry is very low. Creating a regional distribution network is easy, since the point of sales is restricted in

this industry in India. Creating brand awareness and franchisee amongst doctors is the key for long-term

survival. quality regulations by the government may put some hindrance for establishing new manufacturing operations.

New patent regime had raise the barriers to entry but with generics it is more or less compensable.

5- Threat of substitutes This is one of the great advantages of the pharma industry. Whatever happens,

demand for pharma products continues and the industry thrives. One of the key reasons for highcompetitiveness in the industry is that as an ongoing

concern, pharma industry seems to have an infinite future. But the advances made in the field of biotechnology, can prove to be a threat to the

synthetic pharma industry.

Conclusion-In Short, Porter`s Five forces model gives a fair idea about the industry in which a company operates and the various external forces that influence it.

Any industry is not static in nature. It's dynamic and over a period of time the model, which have used to analyze the pharma industry may itself evolve.

Competition wil increase in future but is of different nature. It will be between large players (with economies of scale) and it may be possible that some kind of oligopoly or cartels come into play.

This is owing to the fact that the industry will move towards consolidation. The larger players in the industry will survive with their proprietary products and strong franchisee.

In the Indian context, companies like Cipla, Ranbaxy Lupin and Glaxo are likely to be key players. Though consolidation within the current big names is not ruled out. Smaller fringe players, who have no differentiating strengths, are likely to either be acquired or cease to exist.

Barrier to entry will also increase further. Government too will have bigger role to play.

Blue print for future growth-

Responsibilities and Resources would make an important beginning in the transition of efficient and effective use of pharmaceutical in building a prosperous and healthy India. In doing so, following issues have been identified for realizing the Pharma Vision 2020.

• The Indian pharmaceutical industry shall ensure that essential drugs at affordable prices are available to the vast population of this sub-continent and also continue providing employment for millions.

• India shall implement all the rules and regulations, which guide, monitor and control the activities of the providers of the healthcare system in the country and shall Corporate Catalyst of India’s Pharmaceutical Industry, examine the way to bring them up to international standards. The government should implement the recommendations of Mashelkar committee and constitute the Central Drug Authority at the earliest.

• The basic course of education should be designed to ensure that the newly qualified pharmacist has the necessary knowledge and skills to commence practicing competently in a variety of settings including community and hospital pharmacy and the pharmaceutical industry. Continuing professional development must then be a lifelong commitment for every practicing pharmacist. Concept of National schools of pharmacy should be established to develop and introduce model curriculum.

• Pharmacists should become knowledgeable to participate in medication management and outcome monitoring. Pharmacy profession should orient concept of pharmacy practice at community and hospital pharmacies through appropriate training and compensation.

• The pharmacy profession will make the clinical trial industry in India to grow to over a billion dollars in the next five years and position itself as a destination of choice for CRO services by way of strict implementation of patent laws, single window clearance of clinical trial protocols by regulatory clearances and shall accord industry status to this sector.

• India will emerge as a major global player in the field of pharmaceuticals exports and as a provider of quality medicines at low costs. It shall also emerge as a major player in the generic drugs market in USA and Europe.

• India shall attain new heights in herbal drugs research in shaping Indian Systems of Medicine into a popular system of medicine of the future for holistic health care and ensuring health care for all - especially for the welfare of the poor.

• India’s Patents Act should ensure that it does not exceed the requirements of TRIPS, and that prioritizes access to medicines and public health, while retaining the right to participate in the compulsory license scenario. India should lead movement of developing nations and create a TRIPS south and G-20 alliance is a step in that direction.The Government should take immediate steps to remove the anomalies in the Indian Pharmacopoeia Commission created by it, and give necessary teeth to truly function as an independent and autonomous scientific body.

(Source- http://www.cci.in/pdf/surveys_reports/indias_pharmaceutical_industry.pdf)

Environmental issues in Pharmaceutical Industry-

Various issues that are faced by the pharmaceutical sector and enumerated the following

points:

Presence of APIs can not be detected with Bioassay test.

Microbiological tests need to be adopted to test the presence of antibiotics,

therefore tests need to be validated which are recommended in the legislation.

World over CETPs treat homogenous effluent, whereas in India the effluent

generated is from a mix of industries, therefore it is heterogeneous in

composition.

When a high concentration of drugs is present in the effluent they kill the

bacteria that would help in treating the wastewater.

The industry also faces a huge problem of sulphide emissions which cause

odour.

There is a need to separately incinerate chemical and bio-hazard wastes

Green processing, green engineering and green chemistry needs to be

encouraged through offering incentives

Education and training needs to be provided at all levels

Waste generated from households and hospitals also need to be treated as

important sources of waste generation

(Source- http://pharmaceuticals.gov.in/envproceedings.pdf)

Research Objective- 2

To study & analyze overall domestic market for Lung cancer and launching a new generic brand for Docetaxel: A Lung cancer drug.

IntroductionMarketing strategy can be formed only by knowing the market by following proper marketing research process and knowing opportunity and problems facing by the industry and competitor strategy. My sole purpose is to launch a new brand of PEGYLATED LIPOSOMES OF DOCETAXEL .For this I need to do market analysis of the current players

of the same & their strategies that will help me making strategies for launching a new brand of DOCETAXEL.

Detailed process for research methodology is discussed below

My research will answer the following questions: What is Lung cancer? Epidemiology of Lung cancer. What are the different dosage forms available of Lung cancer drugs? What are the existing brands of Lung cancer drugs? Which are the generic players of Lung cancer drugs? Who are the top players of Lung drugs & what about their markets? Doing Statistical analysis of price comparison for Lung cancer drugs? Indian market share for docetaxel in Cancer drugs and its expansion capacity? Launching with my preferred brand name & its positioning? What will be the promotional, communication & operational strategies for my brand? Analysis and Finding Recommendation and Suggestions

Cancer Drug Market-

Cancer drug market will reach $75 billion in 2012' visiongain report predicts that overall revenues for anti-cancer treatments will increase strongly from 2012 to 2022. Individual drugs will benefit too. Roche will continue to be the leading company in the cancer-treating drugs market throughout the study’s forecast period. Through emerging technologies and increasing demand in developed and developing countries, the future of cancer treatments holds great promise. That revenue growth will be mainly owing to the worldwide increase in cancer incidence and prevalence. New opportunities for cancer treatment exist, with high sales likely from many drugs – small-molecule products and biological agents (biologicals) – to 2022. Also, R&D pipelines in oncology are strong, including those for monoclonal antibodies (MAbs).

Source- http://www.visiongain.com/Report/770/Leading-Anti-Cancer-Drugs-and-Associated-Market-2012-2022

Cancer is a leading cause of death worldwide and accounted for 7.6 million deaths (around 13% of all deaths) in 2008. The main types of cancer are:

lung (1.37 million deaths) stomach (736 000 deaths) liver (695 000 deaths) colorectal (608 000 deaths) breast (458 000 deaths)

cervical cancer (275 000 deaths) About 70% of all cancer deaths occurred in low- and middle-income countries. Deaths from cancer worldwide are projected to continue to rise to over 13.1 million in 2030.

Tobacco use is the single most important risk factor for cancer causing 22% of global cancer deaths and 71% of global lung cancer deaths. In many low-income countries, up to 20% of cancer deaths are due to infection by HBV and HPV.

Source- http://www.who.int/mediacentre/factsheets/fs297/en/

Lung cancer-

Lung cancer is the most common form of cancer in terms of incidence and number of deaths. It is a disease wherein the cell lining of lung tissue grows uncontrollably and leads to the formation of tumor. There are two main types of lung cancer; small cell lung cancer that accounts for about 20% and non-small cell lung cancer (NSCLC) that accounts for about 80% of the total lung cancers.The lung cancer drugs market was valued at around $4 billion in 2010 and is expected to reach about $13 billion by 2020, growing at a CAGR of 13.5% from 2015 to 2020. The market was dominated by drugs such as Avastin, Iressa, Gemzar, and Tarceva in 2010. However, by 2020, the market is expected to be dominated by talactoferrin (Agennix), an immunomodulatory drug; followed by Xalkori (Pfizer), and by ARQ 197 (ArQule/Daiichi Sankyo).According to WHO, lung cancer prevalence is expected to grow in the emerging markets such as the BRIC countries and other Asian and African markets due to an increase in the use of tobacco products. Tobacco is the primary cause of around 80% of all lung cancers. The other causes such as radon gas exposure, asbestos can be causative factor for developing lung cancer.The U.S. dominates the lung cancer drug market in North America with 93.5% share; whereas Germany dominates the market of Europe with 32.4% share.Major players in the market include F. Hoffmann-La Roche Ltd (Switzerland), AstraZeneca Plc (U.K.), Eli Lilly and Company (U.S.), Sanofi-Aventis (France), Pfizer Inc. (U.S.), GlaxoSmithKline Pharmaceuticals Limited (U.K.), ArQule Inc. (U.S.), Daiichi Sankyo Co. Ltd. (Japan), Agennix AG (Germany), and Boehringer Ingelheim GmbH (Germany).

Source-http://www.prnewswire.com/news-releases/marketsandmarkets-lung-cancer-drugs-market-in-g7-countries-worth-13-billion-by-2020-133600333.html

DOCETAXEL -

Generic Name: DocetaxelPronunciation: DOE-se-TAX-elTrade Name(s): 

India- Celtere Vial, Daxotel Vial, Detaxl Vial, Docecad 120mg Inj, Docecad 20mg Vial, Docecad 80mg Vial, Docefrez Vial, Docet Vial, Docetax Inj, Docetec Vial, Docetere Vial, Doxel Vial, Ferdotax Vial, Taceedo Vial, Taxotere Vial, Taxuba Vial, Tubitere Vial,

Wintaxel Vial, Zenotere Vial.

International- Taxotere.

Docetaxel, a taxane type anticancer drug, developed by Sanofi-Aventis and marketed under the brand name of Taxotere, lost its molecule patent protections in US and major European jurisdictions last month.  Docetaxel is considered the largest oncology product ever developed with global market value at $4 billion in 2011.  It is also arguably predicted that Docetaxel will lead the taxane market for the next decade since Docetaxel represents the reaching of a plateau stage in taxane development and further R&D in taxanes is unlikely to be cost effective. The loss of protection on the molecule patent will inevitably attract significant generic activity in the months and years to come.

Source- www.genericsweb.com/index.php?object_id=921

Indication : This medication is an anti- cancer agent, mainly used for the treatment of non-small cell lung cancer, breast, ovarian, gastric cancer, head and neck cancer and prostate cancer either alone or with other medications. It belongs to taxane group. It stops the growth and spread of cancer cells.

Contraindications : 

Contraindicated in patients with previous severe hypersensitivity reaction to this drug, the solvent or polysorbate 80, severe decrease in white blood cells, pregnancy, severe liver impairment.

Pregnancy Category :A B C D X

Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Recommended Dose: IV- The recommended dose is 100 mg/m2 over 1 hour infusion, repeat it for 3 weeks.

Mode of Delivery: It comes as a liquid to be given intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually given over 1 hour once every 3 weeks.Special Instruction: *You may develop muscle or joint pain, numbness, tingling, burning, or weakness in the hands, arms, legs, or feet. Contact your healthcare provider immediately if these symptoms occur.*Monitor liver blood function and blood counts regularly.

*Treatment with corticosteroids before starting this medication is recommended.*Caution needed during pregnancy and breastfeeding.

Side Effects: Heart- Low blood pressure, abnormal heart rhythm, blood clot in deep vein, ECG abnormalities, heart attack, blood clot in the lung, and fainting.Central Nervous System- Weakness, neurosensory and neuromotor symptoms, confusion, seizures, transient loss of consciousness.Skin- Hair losses, severe allergic reactions, nail color changes.Eye and ENT- Inflammation of conjunctiva, tears, transient visual disturbances including flashes, flashing lights, and blurred vision.Gastrointestinal- Mouth ulcer, severe diarrhea, nausea, vomiting, taste perversion, abdominal pain, loss of appetite, inflammation small intestine of colon, constipation, dehydration associated with GI reactions, duodenal ulcer, GI hemorrhage, GI perforation, ileus, intestinal obstruction.Genitourinary- Kidney failure.Blood- Decrease in white blood cells, platelets, anemia, bleeding episodes.Liver- Increased level of liver enzymes, hepatitis.Hypersensitivity- Severe hypersensitivity reactions.Local- Infusion-site reactions, inflammation of vein, redness or dryness of skin, and swelling of vein.Metabolic- Fluid retention.Musculoskeletal- Joint pain, muscle pain.Respiratory- Acute lung swelling, acute respiratory distress syndrome, difficulty in breathing, stiffening and scarring of lung tissue.Miscellaneous- Infection, fever in absence of infection, death due to infection, non septic death, chest pain, diffuse pain, radiation recall phenomenon.Other Precautions: *Avoid vaccination while taking this medication.

Storage Conditions: Injection: Store at 2-25 C. It is usually handled and stored by a health care provider.

Source: 1- Docetaxel (Taxotere) Drug Information - Indications, Dosage, Side Effects and PrecautionsMedindia http://webcache.googleusercontent.com/search?q=cache:http:// www.medindia.net/doctors/drug_information/docetaxel.htm#ixzz1oMI9QL1l

http://webcache.googleusercontent.com/search?q=cache:http://www.medindia.net/doctors/drug_information/docetaxel.htm

PEGylated liposomes in cancer therapy-

Liposomes, the first nanotechnology to benefit cancer patients, are continuing to evolve as tools for delivering potentially useful drugs to tumors. A group at the Pennsylvania State College of Medicine reports on their work using pegylated liposomes to deliver short-chain ceramide, an analog of a naturally occurring compound that is involved in triggering cell death. Several studies have shown that short-chain ceramide can trigger cell death, or

apoptosis, in a variety of cancer cell types, but delivering this compound to tumor cells in a living animal has proven difficult. Three years ago, two different research groups, one led by Mark Kester, Ph.D., at Penn State, demonstrated that liposome-encapsulated short-chain ceramide was toxic to tumor cells growing in culture. Kester and his collaborators concluded that liposomal short-chain ceramide, when administered intravenously to mice with breast adenocarcinoma, inhibit solid tumor growth. In fact, a 3-week course of therapy produced a greater than six-fold reduction in tumor size compared to tumors in animals treated with empty liposomes. In addition, treatment produced a 50 percent decrease in levels of CD31, a marker of new blood vessel growth in tumors, suggesting that liposome-encapsulated short-chain ceramide inhibits angiogenesis, too.The use of pegylated liposomes also resulted in favorable pharmacokinetics of the potential therapeutic agent, producing a steady concentration of short-chain ceramide in tumor cells. Further examination showed that the drug accumulated in mitochondria and in small indentations in the cellular lipid membrane known as caveolae, which are involved in the initiation of different types of signaling cascades, including the cascades leading to apoptosis. Additional studies demonstrated that short-chain ceramide inhibited a key enzyme that normally prolongs cell life.Another interesting property of liposomes are their natural ability to target cancer. The endothelial wall of all healthy human blood vessels are encapsulated by endothelial cells that are bound together by tight junctions. These tight junctions stop any large particle of in the blood from leaking out of the vessel. Tumour vessels do not contain the same level of seal between cells and are diagnostically leaky. This ability is known as the Enhanced Permeability and Retention effect. Liposomes of certain sizes, typically less than 400nm, can rapidly enter tumour sites from the blood, but are kept in the bloodstream by the endothelial wall in healthy tissue vasculature. Anti-cancer drugs such as Docetaxel, Doxorubicin (Doxil) and Daunorubicin (Daunoxome) are currently being marketed in liposome delivery systems.The use of liposomes for transformation or transfection of DNA into a host cell is known as lipofection.Source-http://www.pharmainfo.net/reviews/review-pegylated-liposome-cancer-therapy-and-delivery-biomaterial

Source- nanopharmaceuticals.org

Branded Docetaxel Drugs-

Celtere from Celon (Vivilon) [Docetaxel]

Strength Volume Presentation Price*   

Celtere20mg/0.5ml 1 Celtere VIAL 3200.00   

Celtere80mg/2ml 1 Celtere VIAL 9990.00   

Celtere120mg/3ml 1 Celtere VIAL 13120.00   

Docecad from Cadila (Oncocare) [Docetaxel]

Strength Volume Presentation Price*   

Docecad20mg/0.5ml 1 Docecad VIAL 4687.52   

Docecad80mg/2ml 1 Docecad VIAL 13541.71   

Docecad120mg/3ml 1 Docecad VIAL 76354.00   

Docel from RPG-LS [Docetaxel]

Strength Volume Presentation Price*   

Docel20mg/0.5ml 1 Docel VIAL 3500.00   

Docel80mg/2ml 1 Docel VIAL 12000.00   

Docel120mg/3ml 1 Docel VIAL 14500.00   

Docetax from Cipla [Docetaxel]

Strength Volume Presentation Price*   

Docetax20mg 0.5ml Docetax INJ 3890.00   

Docetax80mg 2ml Docetax INJ 11900.00   

Docetax120mg 3ml Docetax INJ 15570.00   

Docetere from Dr. Reddy's [Docetaxel]

Strength Volume Presentation Price*   

Docetere20mg/0.5ml 1 Docetere VIAL 3896.00   

Docetere80mg/2ml 1 Docetere VIAL 11930.50   

Docetere120mg/3ml 1 Docetere VIAL 15600.00   

Doxel from Shantha Biotech [Docetaxel]

Strength Volume Presentation Price*   

Doxel20mg/0.5ml 1 Doxel VIAL 3500.00   

Doxel 80mg 1 Doxel VIAL 10800.00   

Taxotere from Sanofi Aventis [Docetaxel]

Strength Volume Presentation Price*   

Taxotere20mg/0.5ml 1 Taxotere VIAL 4400.00   

Taxotere80mg 1 Taxotere VIAL 16800.00   

Taxuba from Glenmark (Onkos) [Docetaxel]

Strength Volume Presentation Price*   

Taxuba 20mg 1 Taxuba VIAL 3202.00   

Taxuba 80mg 1 Taxuba VIAL 10085.60   

Taxuba120mg 1 Taxuba VIAL 14000.00   

Source- http://www.drugsupdate.com/brand/showavailablebrands/815

SWOT ANALYSIS of Docetaxel Drug-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 segment

Threats Intense competition from cheap drugs

RESEARCH METHODOLOGY

Research Methodology for conducting the research-

RESEARCH:-

Research in common parlance refers to search of knowledge. As per Advanced Learner’s Dictionary of Current English lays down the meaning of research as “A careful investigation of inquiry especially through search through search for new facts in any branch of knowledge”, Redman and Mary define research as a “systematized effort to gain new knowledge.” Research is an academic activity and as such the term that should be used in technical sense.

According to D. Slazenger and M Stephenson define Research as ” manipulation of things, concepts or symbols for the purpose of generalizing to extend , correct or verify knowledge, whether that knowledge aids in construction of theory or in practice of an art.”

METHOD OF RESEARCH FOR THE PROJECT:

Exploratory followed by Descriptive

Exploratory research

Exploratory research is a type of research conducted for a problem that has not been clearly defined. Exploratory research helps determine the best research design, data collection method and selection of subjects. It should draw definitive conclusions only with extreme caution. Given its fundamental nature, exploratory research often concludes that a perceived problem does not actually exist. It is also a exploratory research.

Descriptive research:-Descriptive research includes survey and fact finding enquiries of different kinds. The major purpose of descriptive research is description of the state of affairs as it exists at the present. In business research, descriptive research is also known as Ex Post Facto Research. The main characteristic for this method is that the researcher has no control over the variables; he can only report what has happened or what is happening. Method of research was Descriptive as I have to meet with different business personnel and also to define the opportunity & developing an approach for international market for generic drugs.

(Source- http://www.quickmba.com/marketing/research)

Data SourcesSecondary DataThis data will be collected from journals, internet, reports, industry publications and Dissertations.

Primary DataThis 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 andDistribution related data are generated by interaction with druggist, stockiest and marketing executives.

a) Research Approach:Survey Method: Primary data are collected through survey of doctors, stockiest and Marketing Executives.

b) Research Instrument: Questionnaire which 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 - www, Marketing Executives, stockiest & retailers.Drug related information through doctors who have handled cancer cases and also from net.

Sample Size: 20 Oncologists & 15 other specialists 15 Marketing Executives 20 stockiest & retailers

Sampling Procedure: Non‐probability convenience

Contact Method: Personal, telephone and Online.

f) Mode of collecting data: The respondents will be chosen randomly and requested to answer the questions 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, stockists, marketing executives and retailers. It includes presentation through table and chart preparation.

Questionnaire-(To be filled by Oncologists)

1- Docetaxel is the preferred first drug of choice for particular disease –a. Lung cancer b. Breast cancerc. Cervical cancer d. ovarian cancer e. All of them

2- Docetaxel is preferred because of its-a. Efficacy b. Potencyc. better half life d. lesser side effects e. Rapid onset of action

3- Most preferred strength of Docetaxel is-a. 20mg/.5 ml b. 80 mg/2 mlc. 120 mg/3 ml

4- Docetaxel is widely used as a-a. Plain drug b. use in combination with others

5- Docetaxel`s preferred mode of delivery-a. injections b. oral solid tabc. capsule d. Any other

6- The criteria doctors keep in mind while writing a particular brand is-a. Efficacy b. reputation of Brandc. Broad spectrum of drug d. benefits to the patient

CHAPTER

ANALYSIS OF DATA & INTERPRETATION

1- Docetaxel is the preferred first drug of choice for particular disease –

lung cancer 7breast cancer 1cervical cancer 3ovarian cancer 3all of them 6

Interpretation - Docetaxel is the preferred choice of drug for non small cell type of lung cancer as well as can be used in breast, ovarian and cervical cancer. This is a good opportunity as it can be projected in all type of cancers.

2- Docetaxel is preferred because of its-

Effi cacy 8potency 4better half life 2lesser side effects 2rapid onset of action 4

Interpretation - Docetaxel is most preferred because of its efficacy & potency followed by rapid onset of action. However because of its liposomal form side effects are reduced and drugs becomes more effective due to better targeting.

3- Most preferred strength of Docetaxel is-

20 mg/.5 ml 280 mg/2 ml 15120 mg/3 ml 3

Interpretation - Around 75% doctors said preferred strength is 80 mg/2ml followed by 120 mg/3 ml for needed higher dose and 20 mg/.5 ml is mostly used in combination with 80 mg/2 ml.

4- Docetaxel is widely used as a-

plain drug 0use in combination

20

Interpretation - Not only Docetaxel, almost all the cancer drugs are prescribed in combination therapy because of high side effects. However, Docetaxel is having less side effects because of its liposomal form compared to traditional dosage forms.

5- Docetaxel`s preferred mode of delivery-

injections 10oral sloid tab 6capsule 4any other 0

Interpretation - Injections are most preferred because of rapid onset of action followed by tablets & capsules. Most of the available anticancer drugs are in the Injecteble form.

6- The criteria doctors keep in mind while writing a particular brand is-

Effi cacy 6reputation of brand 4broad spectrum of drug 3benefits to the patient 7

Interpretation - Doctors while writing a particular brand take most care to provide benefit to patients which also include economical benefits & efficacy for a particular brand followed by brand reputation and broad spectrum.

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:

Medical Representatives

Stockiest (Wholesalers)

Retailers

By surveying above channels we found out following information about them & their price

incorporation strategy:

(1) Medical Representatives

They are appointed by companies in a particular state.

Every company has their own Medical Representatives.

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. In case of branded drugs, margin is very

less compared to local drugs. In case of Lung 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 very costly.

I 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 as it does not benefit them much.

BRAND LAUNCH & POSITIONING

4Ps of marketing which are product, place, price & promotion for new brand launch ofDocetaxel SHOULD BE as follows:

(1) PRODUCT: Our product will be PEGYLATED LIPOSOMES OF DOCETAXEL (20mg/0.5ml,

80mg/2ml, and 120 mg/3 ml) in the form injection. Preferred brand name will be DOCALITE. The product will be made available in VIAL of 20mg/0.5ml, 80mg/2ml, and 120 mg/3

ml.

(2) PLACE:

DOCALITE will be placed for Lung cancer & other types of cancer disease as a monotherapy as well as adjunctive therapy to all Oncologists and other Consultant Physicians in super speciality, multispecialty and big hospitals in different cities.

(3) PRICE:

Following price is recommended for various strength of DOCALITE

STRENGTH PRICE (RS)20mg/0.5ml 250080mg/2ml 7000120 mg/3 ml. 11000

(4) PROMOTION:DOCALITE should be promoted with positioning theme

“NOW REMAIN IN LIGHT WITH DOCALITE” “NEW LIGHT IN LIFE WITH DOCALITE” “DOCALITE CHANGES LIVES” “DOCALITE ON CANCER SLOWS DOWN”

PROMOTIONAL STRATEGY

DOCALITE should be promoted in following 3 ways:(1) Brand promotion(2) Advertising promotion(3) Sales promotion

(1) Brand promotion: Promo plan for DOCALITE brand amongst doctorsShould be as follows:Doctor Segmentation

Oncologists Consultant physicians

Positioning theme (with payoff line) “NOW REMAIN IN LIGHT WITH DOCALITE” “NEW LIGHT IN LIFE WITH DOCALITE” “DOCALITE CHANGES LIVES” “DOCALITE ON CANCER SLOWS DOWN”

Action Plan In-clinic involvement of the DOCTOR Comparison with Cisplatin, Paclitaxel and highlighting the benefit of DOCALITE

without addiction Aggressive brand conversion of the market leader-Docel, Celtere, Docetere, Taxotere,

Taxuba and Doxel. Mailers Visual Aid Leave Behind Literature(LBL) Promotional input 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 DOCALITE Melt in Mouth Activity Small Size

(2) Visual Aid: (As Brand Energizer)(Communication theme for DOCALITE)

Diseases like Lung & other type of cancers shown as various heads of “RAVAN” (Character from ‘RAMAYAN’) & DOCALITE (DOCETAXEL) as a killing soldier (showing having weapon in hand & body of tablet wearing cap on head)

A patient shown in jovial mood because of DOCALITE molecule.

FOR ONCOLOGIST & CONSULTANT PHYSICIANS Start early with DOCALITE

A convenient formulation for all the type of cancers Effective drug of choice Lung cancer Rapid onset of action Reduced side effects A Perfect Quick solution that rapidly stabilizes acute symptoms of cancer

- Effective drug of choice Lung cancer- Highly efficient- Reduced side effects- Immediate relief

(3) Leave behind Literature (LBL): (As Brand Recall)(4) Promotional input: (As Brand Recall)

Promotional inputs like calendars, chart etc highlighting packing of DOCALITE& 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 DOCALITE :(As Brand Recall)

(2) ADVERTISING PROMOTION:

DOCALITE should be promoted by advertising it in various pharmaceutical & medical publications like IPA, Indian Drug Review (IDR), Drug Today, MIMS. LANCET etc.

DOCALITE should be promoted online in various pharmaceutical & medical websites

DOCALITE should be promoted with Social networking websites.

(3) SALES PROMOTIONPromo plan for stockiest/retailers(1) Promotional inputs(2) Promotional schemes likeOrder for-• 100 VIALS & get 2 VIAL free• 300 VIALS & get 5VIAL free• 500 VIALS & get 7VIAL free• 2 % discount to patient on continuous therapy of the same Molecule.

(3) Gifts like letter pads, diaries, ball pens

OPERATIONAL PLAN1. 12 Field sales officer2. Can be done in first week of every month.3. Will focus mainly on DOCALITE during the call4. FSE should follow Standard Tour Protocol5. FSE need to send back a report of completion of the campaign by the second week of every month in the given format to Sales Officer.