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    Asia Business Generator Project

    (Osaka International Business Promotion Center)

    Overview of Indian Pharmaceutical Industry

    Submitted by

    (A division of TATA Industries Ltd)

    Nirmal 18th Floor, Nariman Point, Mumbai 400021, India

    Tel 91-22-6637 6789 / 42 Fax 91-22-6637 6600

    URL: www.tsmg.com Email: [email protected]

    STRATEGIC MANAGEMENT GROUPSTRATEGIC MANAGEMENT GROUP

    mailto:[email protected]:[email protected]
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    Pharmaceutical Market Overview

    The global pharmaceutical market was estimated at USD 700 billion in 2007 and is expected to grow at6% CAGR1 to reach USD 937 billion in 2012. Generic drugs constituted USD 92 billion of global

    pharmaceutical sales and is expected to grow at 11% CAGR to reach USD 155 billion in 2012.

    The Indian pharmaceutical industry is ranked 4th in the world in terms of production volume and 13th interms of domestic consumption value. The Indian pharmaceutical market is expected to grow from USD13 billion in FY 20072 to USD 34 billion in FY 2012. The key drivers for this growth are expected to beincreased per capita spend on pharmaceuticals, improved medical infrastructure, greater healthinsurance penetration and shift in disease profiles.

    3.7

    9.4

    4.4

    0.9

    2001-02 2006-07

    API & Intermediates

    Formulations (Generics + Patented)

    CAGR (FY02-FY07)

    20%5 13

    33%

    16%

    Today the Indian pharmaceutical sector meets 95% of the countrys medical needs. The domesticpharmaceutical industry has evolved from being purely reverse engineering focused to being researchdriven, export oriented and globally competitive.

    The Indian pharmaceutical industry consists of both domestic companies and subsidiaries ofmultinational corporations. Indian companies manufacture a wide range of generic drugs (branded andnon-branded), intermediates and bulk drugs/Active Pharmaceutical Ingredients (API). However genericdrugs continue to remain the mainstay of the industry.

    Recently, Indian pharmaceutical companies have been scaling up their presence in other businesssegments such as drug discovery & development, contract research & manufacturing and are focusingon developing competencies in several areas of the pharmaceutical value chain.

    1Compounded Annual Growth Rate

    2FY 2007 - Financial Year, Apr 1

    st2006 to Mar 31

    st2007

    Indian Pharmaceutical Industry (US $Billion)

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    Indian Formulations Industry

    Formulations are broadly categorized into patented drugs and generic drugs. A patented drug is aninnovative formulation that is patented for a period of time (usually 20 years) from the date of its

    approval. A generic drug is a copy of an expired patented drug that is similar in dosage, safety, strength,method of consumption, performance and intended use.

    The Indian formulations market was estimated to be USD 9.4 billion in FY 2007 comprising of domesticconsumption of USD 6.2 billion and exports of USD 3.2 billion. The formulations market is expected togrow at 17% CAGR to reach USD 21 billion in FY 2012. Nearly 97% of Indias drug market in volumeterms consists of second-and-third generation drugs no longer subject to patent protection in thedeveloped world.

    Over the last 30 years, Indias pharmaceutical industry has evolved from being a marginal global playerto becoming a world leader in the production of high quality generic drugs. India exports pharmaceuticalproducts to more than 200 countries, primarily the United States, Russia, China and the United

    Kingdom. Indias single largest export market continues to be the United States, which is the worldslargest generic drug market.

    Generic drugs are 40-75% lower in costs as compared to patented drugs. Low production costs giveIndia an edge over other generics-producing nations. In recent years, Indian pharmaceutical companieshave invested substantial part (about 30%) of their total global investment in generic manufacturingcapacity. Indian firms now account for over 35% of Drug Master File (DMF) applications and 25% of allUS Abbreviated New Drug Application (ANDA) filings submitted to the FDA. These filings give Indiangeneric companies an advantage over other generic producing nations. India also has the largest

    number of US FDA approved manufacturing sites outside the US.

    Russia

    12%

    Brazil

    7%

    USA30%China

    8%Nigeria

    5%

    UK

    9%

    Others

    29%

    Exports by Region (2005)

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    Company Principal products: API and generic drugs Percent of sales

    Ranbaxy Labs Anti-infectives, cardiovascular, gastrointestinal, central nervous API: 22%,

    (diazepam , m idazolan), ophthalm ic & ointm ents, urologicals, nutritionals, Generic: 78%

    sex hormones, analgesics, anti-asthma, cough & cold, vaccines.

    Dr. Reddys Cardiovascular, gastrointestinal, anti-infectives, pain management API: 40%Generic: 60%

    Cipla Antibiotics, anti-asthmatics, anti-AIDs and TB drugs, anabolic steroids, API 7%,

    analgesics-antipyretics, antacids, anti -arthri tis, ant i- inflammatory, anticancer, Gener ic : 93%

    antidepressant agents, anti-diabetic, anit-epileptic, anti-fungal,

    anti-malarial.

    Wockhardt Anti-infectives, pain management, nutraceuticals API : 19%

    Generic: 81%

    Pfizer India Nutritionals, cough syrup, anti-arthritis, anti-infectives, cardiovascular Generic: 100%

    Sun Pharm a Neuro-psychiatry, cardiovascular, gastrointestinal, diabetic, gynecological, API: 18%

    anti-a llergic , antidepressants, cholesterol reducers, anti -asthma, Parkinson, Gener ic : 82%

    ADD, pain.

    GSK Anti-infective, anti-inflammatory, analgesic, gastro-enterological, antiallergic, Generic: 100%

    dermatological.

    Lupin Tuberculosis medication, antibiotics, cardiovascular. Generic: 100%

    Cadila Cardiovascular, gastrointestinal, anti-inflammatory/analgesic, Generic: 100%

    antibiotics/anti-infectives, vaccines/immunomodulators, anti-diabetics;

    vitamins.Nicholas Piram al Analgesics-anti-inflam matory, antibiotics, antifungal, antihistam ines, Generic: 100%

    antiseptics, cardiovascular, central nervous system, diabetic, dermatologic,

    endocrinologic, gastro-enterological, vitamins, pulmonary-respiratory,

    trauma-emergency, gastrointestinal, NSAIDs.

    Aurobindo Antibiotics, anti-retrovirals, cardiovascular, central nervous system, gastroenterological, Generic: 100%

    Pharmaceuticals anti-allergy.

    The vast majority of Indias pharmaceutical companies are small by global standards with revenuesless than USD 5 million. The formulations industry is highly fragmented with ~400 units in the organizedsector and ~15,000 units in the unorganized sector. The industry has a range of over 100,000 drugsspanning various therapeutic segments. Indian companies dominate the formulations market - 7 out ofthe top 10 players are Indian. The top 5 companies in formulations (Glaxo SmithKline, Ranbaxy, Cipla,Nicholas Piramal and Zydus Cadila) account for over 23% of the domestic formulations market.

    In geographic terms, manufacturing operations are largely concentrated in West and South India.However, some players have shifted manufacturing base to excise free zones in the North due to shifttowards MRP (maximum retail price)-based excise duty levy.

    In India, approximately 71% of the total formulations sold are for acute illness (short duration) andremaining for chronic illness (prolonged duration). This is true for most developing countries ascompared to developed markets where the growth is led by chronic ailments.

    Therapeutic segments FY 2005 FY 2006 FY 2007 CAGR %

    Anti-infectives 36.9 43.7 49.7 16.0Gastrointestinal 23.1 27.1 30.5 15.0

    Cardio Vascular 21.7 25.3 28.2 14.0

    Pain/Analgesics 19.6 21.4 26.3 15.7

    Respiratory 20.2 22.9 25.8 13.1

    Vitamins/Nutrients 19.5 21.7 23.8 10.7

    Dermatology 11.4 13.2 15.5 16.8

    Gynaecological 11.9 13.4 15.2 13.1

    Central nervous system 10.9 13.3 15.0 17.5

    Anti-diabetic 9.0 10.6 12.5 17.9

    Top 10 Therapeutic Categories 184.1 212.6 242.7 14.8

    Total Domestic Formulation Demand 212.7 244.4 279.0 14.5

    Leading Therapeutic segments in India by Sales (Rs. Billion)

    Principal products of Indias leading drug manufacturers

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    The demand for domestic formulations is expected to be driven by chronic therapeutic segments likeanti-diabetic, central nervous system, cardiovascular system and lifestyle disease profile segments likegastrointestinal. The changing lifestyle in Indian society is expected to result in a rise in the incidence ofchronic ailments.

    Apart from chronic ailments, Anti-infectives and the Pain/Analgesics segments are expected to growsteadily in the long run due to hygiene issues in semi-regulated markets like India.

    Regulatory System

    The Indian pharmaceutical industry is mainly regulated on patents, price and quality.

    Until 2004, the regulatory system in India focused only on process patents. Indian companies thrivedduring this phase by re-engineering products of global pharmaceutical players and launching them inIndia. Indian companies gained process chemistry skills, but de-emphasized research & developmentfor new drug discoveries. In January 2005, India complied with WTO to follow the product patentregime. The Act allowed for only two types of generic drugs in the Indian market: off-patent genericdrugs and generic versions of drugs patented before 1995. The Amendment grants new patent holdersa 20-year monopoly starting on the date the patent was filed and no generic copies can be sold duringthe duration of the patent.

    Other regulations like the Drugs and Cosmetic Act regulate the import, manufacture, distribution andsale of drugs in India. The Drug Price Control Order (DPCO) fixes the ceiling price of some APIs andformulations. Currently 74 bulk drugs and formulations are under the purview of price control.

    Chronic vs. Acute - Sales mix of top 10 Indian players in FY 2006

    0102030

    405060708090

    100

    SunPharma

    SanofiAventis

    Cipla

    ZydusCadila

    Industry

    NicholasPiramal

    Ranbaxy

    AristroPharma

    PfizerIndia

    AlkemL

    abs

    GSK

    Acute Chronic

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    Government Initiatives

    The government has introduced several development programmes to improve access and quality ofhealthcare services in the country. The National Rural Health Mission (NRHM) introduced by the

    government to provide basic healthcare amenities in rural areas is expected to increase access toessential drugs.

    The recent budget (2008-09) has announced a slew of measures for the pharmaceutical sector. Chiefamong them are:

    Cut in excise duty on all pharmaceutical formulation products, from 16% to 8%. This will benefitIndian arms of MNCs who incur higher excise duty.

    Increase in outlay for HIV treatment. This will benefit players like Cipla & GSK who areextensively developing anti-HIV formulations.

    Outlook

    Globally, the trend towards increased use of generics is on the rise and is expected to open uptremendous opportunities for generics players. Governments in many countries are also encouragingthe shift to generics on the back of rising pressure on healthcare budgets.

    The U.S. generics market is currently experiencing intense competition while semi-regulated andemerging markets are expected to become new growth opportunities. While restructuring andrealignment of business models will enable Indian players to survive and grow in the U.S. andEuropean markets, increasing their presence in emerging markets will enhance their market share inthe global generics industry.