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Page 1: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

www.ibef.org

P H A R M AC E U T I C A L SOctober 2007

Page 2: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

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MARKET OVERVIEW

Page 3: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Indian Pharmaceutical Market – A US$ 7.3 billion opportunity

Domestic Pharma Retail Market (US$ billion)• India is among the fastest growing pharmaceutical markets in the world

• The domestic pharmaceutical market recorded sales of US$ 7.3 billion in 2006, grew by 17.5% over the previous year*

• Retail sales of pharmaceuticals were US$ 6.2 billion while institutional sales were estimated around US$ 1.1 billion in 2006

Forecasted Indian Pharmaceutical Retail Market (US$ billion)

Source: Compiled from Industry Sources

2012

2006

12-13

6.2 CAGR12-14%

* Source: Biospectrum

Source: US Census Bureau, EIU & World Trade Atlas

2006

2005

2004

2003

2002

2001

6.2

5.3

4.6

4

3.7

3.2

0 1 2 3 4 5 6 7

0 2 4 6 8 10 12 14

Page 4: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Indian Pharmaceutical Market – US$ 7.3 billion Opportunity

Source: IPA, E&Y analysis

n Domestic Retail Market

n Institutional Sales

n Exports

48%

9%

43%

Break up of Indian Pharma Industry• The Domestic retail market is expected to cross US$ 10 billion mark in 2010 and would reach US$ 12-13 billion in 2012

• Domestic consumption accounted for nearly 57% of the total industry revenues, while exports accounted for the remaining 43%

(For the year 2006-07)

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 5: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Anti-Infectives - Largest Therapeutic Category

(as on December 2006)• Anti-infectives have the highest contribution (18%) to total domestic sales

• Cephalosporins, penicillins and quinolones are key drug classes among anti-infectives

• Gastrointestinal and Cardiovascular are the 2nd and 3rd largest therapeutic categories, respectively

• Oral anti diabetics and anti-peptic ulcerants are the fastest growing segments under alimentary and metabolism therapeutic categories

Source: CRIS INFAC, E&Y Analysis

n Anti-Infectives n Gastro Intestinal

n Cardiovascular n Respiratory n Vitamins/Minerals n Analgesics

n Gynae n CNS

n Dermatology n Anti Diabetic

n Others

18%

11%

10%

9%9%

9%

5%

5%

4%

13%

5%

Market Share of Key Therapeutic Categories

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 6: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Anti-Infectives - Largest Therapeutic Category

• Cholesterol reducers emerged as a key class of cardiovascular drugs in the last few years

• Anti depressants accounted for 17% of the total revenues of the CNS segment in 2005-06

• Anti-inflammatory and anti-rheumatic category account for 70% of the total musculo-skeletal segment revenues in 2005-06

Market Share of Key Drug Classes (%)

n Cephalosporins n Anti-rheumatic non-steriodal n Anti-ulcerant n Cough preparations n Ampicillin/Amoxycillin n Quinolones

n Oral anti-diabetic n Haematinics n Anti-epileptics

n Vitamin B complex n Other

65

7.4

4.7

3.6

3.6

3.3

3.2

3.2

2.22

1.7

For the year (2005-06)

Source: CRIS INFAC, E&Y Analysis

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 7: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Acute Therapy Dominates Sales, Chronic Segment to Fuel Growth

Acute vs Chronic Sales Mix of Top 10 Indian Pharmaceutical Companies

Source: CRIS INFAC

• Chronic therapy contributes to 23% of total revenues, while acute therapy dominates with 77% share

• New products launched in chronic therapy segment out numbered the launches in acute segments in 2006

• Acute segment to grow at a steady pace due to its mass therapy nature and the unresolved

0 20 30 40 50 60 70 80 90 10010

n Acute n Chronic

Industry 77%23%

73%27%

68%

89%

94%6%

38%62%

33% 67%

28% 72%

57%43%

18% 82%

95%

DRL

Lupin

Pfizer

Alkem

Sun

Zydus

NPIL

Cipla

Ranbaxy

GSK

32%

11%

5%

percent

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 8: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Acute Therapy Dominates Sales, Chronic Segment to Fuel Growth

Key Drivers of Chronic Therapy Segments

• Growing geriatric population - 4.9% of total Indian population in 2005 consisted of 65+ age group. This is further expected to increase to 6.4% by 2015 and 7.5% by 2020

• Rapid urbanisation leading to increase in the number of people suffering from lifestyle diseases such as diabetes, obesity, depression etc. Urban population has grown by 31% – from 217 million in 1991 to 285 million in 2001 - as against 18% population growth in rural areas issues of sanitation and hygiene in the country

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 9: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Exports, the mainstay of Indian Pharmaceuticals

• Export revenues were estimated at around US$ 5.2 billion in 2005-06

• In 2005-06, formulation exports constituted 46% of the total revenue pie, 4% was constituted by bulk drugs

• Revenues from formulation exports expected to surpass those from bulk drugs by 2010-11

Pharmaceuticals Export Revenues

n Formulations n Bulk Drugs

Source: CRIS INFAC

2010-11

0 4 6 8 10 12 14 16 18 20

2005-06

2

8.79.6

2.82.4

CAGR 32% CAGR 25%

US$ billion

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 10: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Exports, the mainstay of Indian Pharmaceuticals

Demand from regulated markets bound to increase

• Exports to regulated markets surged by a CAGR of 33% as compared to a CAGR of 15% in the semi-regulated markets during 2000-05

• Formulation exports to regulated markets expected to grow at a high CAGR of over 41% to reach US$ 4.7 billion by 2010-11

• Demand from semi-regulated region estimated to grow at a modest CAGR of around 26% to reach US$ 4.9 billion in the same period

Formulation Exports Demand Outlook

n Regulated markets

n Semi regulated markets

Source: CRIS INFAC

2010-11

0 4 6 8 10 12

2005-06

2

4.94.7

1.6

US$ billion

2.4

9.6

0.8CAGR 32.1%

CAGR 41.1% CAGR 25.6%

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 11: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Generics to Drive Growth of Exports from India

• By 2010-11, share of Indian players in the US market is expected to cross 10% from 1.9% in 2005-06

• Formulation exports to US are expected to grow by a CAGR of 49% to reach around US$ 2.6 billion in 2010-11

• Exports to Europe are likely to grow at a healthy CAGR of 32% to reach US$ 1.8 billion by 2010-11

Expected Market Share of Indian Players in the US Generics Market

n Market share of Indian Players n Market share of Indian players based on incremental sales

Source: CRIS INFAC

2010

2009

2008

2007

2006

2005

0 2 4 6 8 10 12

10.51 12.0

12.0

9.1

7.24.4

7.43

7.45

5.94

3.84

1.92

Per cent

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 12: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Generics to Drive Growth of Exports from India

India to maintain focus on bulk drug exports• India is the world’s fifth largest producer

of bulk drugs

• Demand for bulk drugs has grown at a CAGR of 31% since 2000-01 to reach US$ 2.8 billion in 2005-06

• Share of Indian companies in the total DMFs filed with US FDA increased to 44% in 2006

• Semi-regulated markets account for a majority of bulk drugs exports with 60% share

DMF Fillings from India

Source: US FDA

2001 51

2006

2005

2004

2003

2002

0 50 100 150 200 300 350

10.51 306

2747.43

7.45

5.94

66

250

195

114

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 13: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Changing Paradigm: Indian Pharmaceutical Industry

• Revenues from domestic market dominated the total pharmaceutical revenues in 2006-07

• Exports contribution is expected to surpass the domestic turnover by 2010

• Pharma sector would witness an upswing in the revenues from service segment, due to the increase in outsourcing of Contract Research & Manufacturing Services (CRAMS) to India

PharmaceuticalIndustry Revenues

Services Products

Domestic Exports

PharmaceuticalIndustry Revenues

Services Products

Domestic Exports

2006 2010

12% 88%

38% 62%

6.6% 93.4%

57% 43%

Source: E&Y Analysis

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 14: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Advantage India: Significant Cost Arbitrage

Basic Production Cost in India up to 50% lower than in the US

• 30 – 50% lower depreciation

* FDA approved plants can be constructed in India for 30 – 50% lower costs

* Higher utilisation of equipment due to improved processes (not quantified)

• 85-90% manpower cost savings

* Labour costs in India typically 10-15 % of the cost in the USA

* Savings applicable across all hierarchal levels (e.g., operators, research scientists, etc)

* Improved, more efficient processes contribute to lower labour costs per unit (not quantified)

India’s Cost Arbitrage

Source: OPPI – Adapted from Monitor Group, Study on Outsourcing Opportunities in Indian Pharmaceutical Industry

n Raw Material n Manpower n Depreciation n Other Site Costs

Product Cost per Unit

IndianManufacturer

100US Manufacturer

10 20 30 40 50 60 70 80 90 100

45-50

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 15: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Advantage India: Significant Cost Arbitrage

• 40-50% savings in raw materials

* Bulk drugs can be manufactured in house at 40-50% of ethical’s cost

* Excipients and intermediates sourced locally at 20-30% lower costs

* Most other raw materials can be sourced

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 16: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Established Infrastructure for Pharma R&D and Manufacturing

Ahmedabad

Ankleshwar,

Vapi

Vadodara

Mumbai

Tarapur

Aurangabad

Pune

Hyderabad,

Medak

Vizag

Chennai

Pondicherry

Baddi

Bangalore

Mysore

Goa

Pantnagar

Haridawar

Ahmedabad

Ankleshwar,

Vapi

Vadodara

Mumbai

Tarapur

Aurangabad

Pune

Hyderabad,

Medak

Vizag

Chennai

Pondicherry

Baddi

Bangalore

Mysore

Goa

Pantnagar

Haridawar

Key Manufacturing Clusters

Source: E&Y Analysis

Traditional Bulk Drugs Cluster Gujarat - Ahmedabad

Ankleshwar, Vapi, Vadodara

Maharastra - Mumbai,

Tarapur, Aurangabad, Pune

Andhra Pradesh - Hyderabad

Tamil Nadu - Chennai

Pondicherry

Karnataka - Mysore, Bangalore

Goa - Panaji

Traditional Formulation Cluster Goa, Mumbai, Pune, Hyderabad

Emerging Bulk Drugs Cluster Andhra Pradesh - Visakhapatnam

Emerging Formulation Cluster Himachal Pradesh - Baddi

Uttaranchal - Patnagar

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 17: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Established Infrastructure for Pharma R&D and Manufacturing

Ahmedabad

Mumbai

Aurangabad

Pune

Hyderabad,

Chennai

NCR

Bangalore

Ahmedabad

Mumbai

Aurangabad

Pune

Hyderabad,

Chennai

NCR

Bangalore

Key R&D Clusters

Source: E&Y Analysis

Captive R&D Units National Capital Region

Ahmedabad

Mumbai

Aurangabad

Hyderabad

Bangalore

Chennai

Contract R&D Units Mumbai

Hyderabad

Bangalore

Chennai

Ahmedabad

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 18: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Enabling Research Infrastructure

• The Country has over 450 institutes/colleges and departments imparting pharmacy education

• More than 25,000 pharmacy graduates pass out from these institutes every year

Key Research Institutes in India

Central Drug Research Institute (CDRI), Lucknow

National Institute of Pharmaceutical Education & Research (NIPER), Mohali

Indian Institutes of Chemical Technology (IICT), Hyderabad

Centre for Cell & Molecular Biology (CCMB), Hyderabad

Indian Institute of Chemical Biology (IICB), Kolkata

Indian Toxicology Research Institute (ITRI), Lucknow

Institute of Genomic and Integrated Biology (IGIB), New Delhi

Institute of Microbial Technology (IMTECH), Chandigarh

National Chemical Laboratory (NCL), Pune

National Centre for Biological Sciences (NCBS), Bangalore

Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore

Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad

Indian Institute of Science (IISc), Bangalore

National Institute of Immunology (NII), New Delhi

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 19: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Source: CRIS INFAC

Enabling Research Infrastructure

Talent Statistics

• Around 1,000 biotech and biochemistry postgraduates pass out every year

• Around 10,000 chemistry post graduate students every year

• Around 2,500 chemical engineering students pass out every year. India had a pool of around 50,000 chemical engineering graduates till 2004-05

• Around 4,500 students pursue PhDs in various science streams

• 1,000, students pursue PhDs in engineering stream

• 1,000 PhDs in Chemistry

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 20: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Case Study: Government to introduce 4 more NIPERS

Case Study: Government to introduce four more NIPERS

• The National Institute of Pharmaceutical Education & Research, India, was established by the Government of India to cater to the long-standing demand for setting up a dedicated nodal institution for quality higher education and advanced research in the pharmaceutical sciences. The benefits delivered by NIPER have prompted the Government to set up 4 new NIPERs at Kolkata, Ahmedabad, Hyderabad and Hajipur (Bihar) in 2007

MARKET OVERVIEWPHARMACEUTICALS • October 2007

Page 21: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

www.ibef.org

POLICY

Page 22: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Drug Regulatory Environment in India in Transition

Existing Drug Regulatory System

• India has a bifurcated drug regulatory system. Regulatory functions are divided between the Centre and State authorities

• Existing infrastructure at the Centre and the State is inadequate to perform the assigned functions of drug administration with efficiency and speed

POLICYPHARMACEUTICALS • October 2007

Page 23: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Drug Regulatory Environment in India in Transition

Proposed New System

• The Central Cabinet approved the formation of Central Drug Authority (CDA) in January 2007

• Proposed organisational structure of the CDA would be analogous to the US FDA

• Strong, well equipped, empowered, independent and professionally managed body

• Expected to facilitate upgradation of the national drugs regulator, uniformity of licensing, and enforcement and improvement in drug regulations

• Efficiency and efficacy of drug administration is expected to be much higher post this transition

POLICYPHARMACEUTICALS • October 2007

Page 24: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Central Drug Authority (CDA) – India’s New Drug Regulator

Existing Proposed

Central Drug Administration- 3 Joint drug controllers

- 2 Deputy drug controllers

- 6 Assistant drug controllers

- 50 Drug Inspectors

- 5 technical experts

- 1 Administrative officer

- 1 Accounts officer

Responsibilities:

- Regulatory affairs and environment

- New drugs and clinical trails

- Biologicals and Biotechnology

products

- Pharmacovigilance

- Medical Devices & Diagnostics

- Imports

- Organisational services

- Training & Empowerment

- Quality control affairs

- Legal & Consumer affairs

- Drug Controller General of India

(Expert Committee)

Responsibilities:

- Broad Policy / Issues

State Drug Authorities

(State Drug Controller and Food & Drug Inspectors)

Responsibilities:

- Licensing & Monitoring manufacturing

- Legal cell

- Spurious drug monitoring

- Pharmacies

Central Government

State Governments

POLICYPHARMACEUTICALS • October 2007

Page 25: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Budget 2007-08: Pharmaceutical Industry Perspective

• Reduction in import duty on medical equipment to 7.5%

• Section 35 (2AB) that allows a weighted deduction of 150% for expenditure relating to in-house research and development extended for 5 more years, until March 2012

• Life saving vaccines exempt from excise duty

• Free samples not under the purview of Fringe Benefit Tax (FBT)

POLICYPHARMACEUTICALS • October 2007

Page 26: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

* Exchange Rate 1US$ = INR 42

Budget 2007-08: Pharmaceutical Industry Perspective

• Clinical trials of new drugs exempt from service tax to make India a preferred destination for drug testing

• Provision of US$ 215 million* for AIDS control program

• Provision of US$ 288 million* in FY-08 to fund polio rounds and vaccines for better outreach/penetration in the 20 high risk districts of Uttar Pradesh and 10 districts of Bihar

POLICYPHARMACEUTICALS • October 2007

Page 27: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

www.ibef.org

KEY TRENDS & DRIVERS

Page 28: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Changing Growth Fundamentals of Domestic Market

Increasing penetration driving growth

• Expansion of healthcare facilities in the rural and far flung areas has enhanced accessibility

• Increased Government spending on roads, telecommunication and health infrastructure has facilitated the foray of pharmaceutical companies into relatively distant pockets of the market

• With sales revenues of US$ 1.4 billion, Indian pharmaceutical market in rural areas witnessed a growth of 39% as compared to the growth of 18% in the overall domestic market in November 2006*

• New product launches in 2006-07 contributed to only 1% of the market while 15% of the growth is being contributed by volume growth

* Source: The Economic Times, 26.1.2007

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 29: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

** Source: E&Y FICCI Healthcare Report

Changing Growth Fundamentals of Domestic Market

Expansion of private sector healthcare driving accessibility

• Medical Value Travel has led to an investment spurt in the private healthcare services in the country

• Accelerated investment from the private sector in healthcare facilities across Tier-I & II cities in the country

• Estimated 1 million beds would be added by 2012 taking the total beds available in the country to over 2 million**

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 30: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Changing Growth Fundamentals of Domestic Market

• Estimated US$ 69.7 billion would be invested by private sector in healthcare infrastructure by 2012

• Number of patients visiting Indian hospitals is expected to rise by 30% to 22 million by 2015

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 31: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Changing Growth Fundamentals of Domestic Market

Increasing penetration of Medical Insurance

• Penetration of medical insurance would grow at a higher pace due to increasing influx of foreign players

• Favourable regulatory changes such as permitting Foreign Direct Investment (FDI) of 51% in the stand alone health insurance companies and setting the minimum capital requirement at US$ 5.4 million

• Indian middle class with its increasing purchasing potential is expected to become a major buyer segment

• Increasing penetration of customised insurance plans would drive the affordability, influencing the consumption of medical and healthcare products

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 32: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Rising Disposable Income to Drive Drug Consumption

• 16.4 million middle class households with annual income ranging between US$ 4849 – US$ 24,242 in 2006

• Segment expected to grow at a CAGR of 14% to touch 28.4 million by 2010 and be the key driver of consumption

• 1.7 million households in the upper income group with annual income greater than US$ 24,242 in 2006

• Aggregated household expenditure on healthcare services increased at a CAGR of 9.3% in the period 1993-94 & 2001-02*

• Healthcare expenditure is expected to rise by 15% per annum*

*Source: E&Y FICCI Healthcare Report

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 33: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Rising Disposable Income to Drive Drug Consumption

• High purchasing potential of the burgeoning Indian middle class to drive consumption of healthcare services including pharmaceuticals which constitutes 22.6% of total healthcare expenditure in 2007*

Segment FY-1996 FY-2002 FY-2006 FY-2010 CAGR

Rich (Annual income greater than US$ 24,242)

807,000

Middle Class (Annual income between US$ 4,849-24,242)

Aspirers (Annual income bewtween US$ 2,182-4,849

Deprived (Annual income less than US$ 2,182)

268,000

4.5 million

28.9 million

1.7 million 3.8 million21%

14%

7%

1%131.2 million

135.4 million

41.3 million

10.7million

132.2 million

53.3 million

16.4 million

28.4 million

75.3 million

114.4 million

Source: “The Great Indian Market”, August 2005, National Council of Applied Economic Research

Income Distribution Across Households

*Source: Espicom

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 34: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Focus of Indian Companies Shifting from the US

• Pricing pressures and shrinking margins in the generics space and the increasing litigation instances in the US are compelling Indian companies to consider opportunities beyond US

• Indian companies have invested more than US$ 1.2 billion in the European markets

Increasing Focus on Japan

• Japan is the world’s second largest pharmaceutical market after the US

• With sales worth US$ 60 billion in 2006, it constitutes around 11% of the global market

• Generics penetration has been extremely low till date in Japan

• Government has initiated a string of pro-generics legislation reforms to increase the penetration upto 40% from the present 16%

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 35: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Focus of Indian Companies Shifting from the US

Key Pro-Generic Reforms in Japan

• Generics substitution allowed

• Physicians are incentivised to prescribe generics medications over branded ones

• Regulatory body to expedite drug approval

• Removal of obligations to manufacture locally

Key Initiatives of Indian companies in Japan

Cadila Healthcare acquired Nippon Universal Pharmaceutical Ltd

Lupin has acquired a majority stake in Japanese generic drug maker Kyowa Pharmaceutical

Dishman has established a Joint Venture (JV) with Azzuro Corporation, in 2007

Ranbaxy has established a JV with Nippon Chemiphar

Strides has entered into a JV with Sorm Corporation Ltd

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

Page 36: PHARMACEUTICALS - IBEF · PDF filePHARMACEUTICALS • October 2007 ... Pharmaceutical Companies Source: ... Pune Hyderabad, Medak Vizag Chennai Pondicherry Baddi

Indian Companies Preferring the Inorganic Growth Route

• M&A has been the key strategy adopted by Indian companies to gain a foothold in the export markets

• Large Indian companies have increased their foothold in the regulated markets

• Small and medium sized players are focusing on semi-regulated markets

• Increased penetration, access to an established distribution network and increase in buyer confidence due to localised presence have been the key factors driving acquisition led growth

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Indian Companies Preferring the Inorganic Growth RouteM&A Deals of Indian Companies (2006)

Acquirer Target Price (US$million)

Natco Pharma Ltd. Nick’s Drug Store NA

Aurobindo Pharma Ltd. Milpharm Limited NA

Dr. Reddy’s Laboratories Betapharm Arzneimittel GmbH 597.33

Marksans Pharma Ltd. Novo Pharmaceuticals Australasia PTY Limited NA

Ranbaxy Laboratories Ltd. Unbranded generic business of Allen S.p.A (GSK unit) NA

Ranbaxy Laboratories Ltd. Terpia S.A 321.11

Ranbaxy Laboratories Ltd. Ethimed NV NA

Shasun Chemicals & Drugs Ltd. Rhodia Pharma solutions NA

Lifecell - Associate of Shasun Chemicals & Drugs Saneron CCELL Therapeutics Inc NA

Dishman Pharmaceutical & Chemicals Ltd. Solutia Inc. 74.50

Nicholas Piramal Pfizer manufacturing unit at Morpeth in UK NA

Ranbaxy Laboratories Ltd. Mundogen generics business (GSK) NA

Aurobindo Pharma Ltd. US FDA compliant GMP facility 19.00

Orchids Chemicals & Pharmaceuticals Ltd. Bexel Pharmaceuticals 3.00

Serum Institute India Ltd. Lipoxen PLC 4.98

Kernwell Pvt. Ltd. Pfizer’s Swedish Plant NA

Dr. Reddy’s Laboratories Litaphar SA 4.45

Bilcare Ltd. DHP Ltd. 5.00

Stride Acrolab Pvt. Ltd. Drug House of Australia (Asia) Pvt Ltd. 12.48

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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PHARMACEUTICALSOctober 2007

Indian Companies Preferring the Inorganic Growth Route

Acquirer Target Price (US$ million)

Wockhardt Ltd. Pinewood Laboratories 150

Nicholas Piramal India Ltd. Boots Piramal Healthcare Pvt Ltd. 3.96 (51% stake)

Wanbury Ltd. Cantabria Pharma 62.22

VVF Ltd. Colgate Palmolive’s American Plant NA

Ranbaxy Laboratories Ltd. Be-Tab Pharmaceuticals 70.00

Panacea Biotech Ltd. Cambridge Biostability Ltd 3.78

Reliance Life Science GeneMedix Plc 63.2

JB Chemical & Pharmaceuticals Ltd. Biotech Laboratories Ltd 5.10

Source: Grant Thronton Deal Tracker

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Rising Confidence of Global Innovator Pharmacos in the Indian Market

Breakup of Indian Pharmaceutical Market

Source: E&Y Research

n Domestic n MNCs

78-80%

20-22%

• Enactment of Product Patent in 2005 has reposed the confidence of innovator pharmaceutical companies in the Indian market

• Since January 2005, about 8 patented products have been launched in the country

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Rising Confidence of Global Innovator Pharmacos in the Indian Market

Product Company Therapeutic Category Launch Date

VFend Pfizer SystemicAnti-Fungal

Feb 05

Viagra Pfizer Erectile Dysfunction Dec 05

Lyrica Pfizer Neuropathic Jan 06

Caduet Pfizer Cardiovascular Feb 06

Macugen Pfizer Wet Age-Related Macular Degeneration

-

Carvedilol GSK Cardiovascular Mar 06

Tamiflu Roche Bird flu Apr 06

Pegasys Roche Hepatitis C May 06

• Innovators are treading a cautious path and are awaiting further clarity on several issues such as data protection, patenting of derivatives and pre and post-grant opposition

Source: E&Y Research

Patented Molecule Launches in India after Enactment of Product Patent Regime in 2005

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Global Pharmaceutical Companies Establishing Local Presence

Company Area of Focus in India Investment (US$ million)

Allergan Inc Inflammatory, infection, urological indications

3 – 5

Eisai Pharmaceuticals API processes 120

Dupont Molecular biology, bio-informatics and polymer synthesis

23

Ratiopharm GmbH Basic processes 36

Teva Basic processes 3 – 4

AstraZeneca TB & NCE research, process and development

15

BMS-Syngene Basic drug discovery N/A

Pliva Basic studies for generics 1

Nektar Therapeutics Pre-clinical and bio-analytical development

10

Case Study: AMRI extends its R&D centere at Hyderabad, India*

• Albany Molecular Research, Inc. (AMRI), a global drug discovery company that provides chemistry services to pharmaceutical and biotechnology companies, has announced the construction of a new 50,000 sq. ft. research and development centre at the Shapoorji Pallonji Biotech Park in Hyderabad, India. Slated to be completed in the latter part of 2007, the new R&D centre would conduct contract projects in early stage drug discovery research, including custom chemical synthesis and medicinal chemistry

Source: Business Standard: August 27, 2007

Recent Global players to enter the Indian market

*Source: E&Y USAIC Position Paper “Pharma-Biotech Research: Decoding the Indian link”

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Global Pharmaceutical Companies Establishing Local Presence

• In addition, the new facility would house a scale-up laboratory, which would be used to develop efficient methods for producing larger quantities of active pharmaceutical ingredients and intermediates. When fully staffed, the new facility would add over 100 employees to the company’s existing Hyderabad operations, which currently has 19 employees in the facility at ICICI Knowledge Park. The current facility can accommodate up to 40 employees and is expected to reach full capacity in the coming months

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Strategic Partnerships on the Rise

Select Strategic Alliances with Indian Companies

Indian Company Overseas Company Description

Advinus Therapeutics

Merck & Co. Discovery and clinical development collaboraion in metabolic disorders

Nicholas Piramal Biosyntech Inc The collaboration centres on the drug ‘BST - InPod’ which is being developed to alleviate chronic heel pain

Morvus Technology To undertake research in the area of cancer, diabetes, arthritis

GVK Biosciences Wyeth To provide a range of services in synthetic chemistry research

INC Research JV will establish a dedicated resource capability to offer phase I-IV clinical development programmes in India

Ranbaxy Glaxosmithkline Ranbaxy will advance leads beyond candidate selection to completion of clinical proof of concept. GSK thereafter will conduct further clinical development for each program and take resulting products through the regulatory approval process to final commercialization

Medicine for Malaria Ventures

Research for descovering new medicines for treating malaria

Source: E&Y Research

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Strategic Partnerships on the Rise

Source: E&Y Research

Select Strategic Alliances with Indian Companies

Biocon’s syngene BMS Syngene International, will work with Bristol - Myers Squibb to establish a research facility in Bangalore with more than 400 scientists to help advance Bristol - Myers Squibb’s discovery and early drug development

Jubilant Organosys ELi Lilly Collaboration in the area of discovery research

Connexios Rheoscience Developing anti-diabetes molecules

Suven Life Sciences

Eli Lilly NCE research for nervous system disorders

Zydus Cadila Onconova For research in the field of oncology

Dr. Reddy’s Rheoscience Developing anti-diabetes molecule

Argenta Reserach in the field of respiratory diseases

Clin Tech Development of anti-cancer compound

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Strategic Partnerships on the Rise

Source: E&Y Research

Select out-licensing deals by Indian companies

India firm Partner Molecule/ Technology Deal Value (US$ million)

Year Development Phase

Ranbaxy Baye Cipro XR (NDDS) 65 1999 NA

PPD Inc. RBx 10558 (Dyslipidemia) 44 2007 NA

Torrent Novartis Age Breaker (diabetic) 3 2001 Development stage

Glenmark

Forest (for N. America)

Oglen ilast (Asthma/COPD)

190 2004 Phase I

Tejin (for Jana) GRC 3886 (Asthma/COPD)

53 2005 Phase II

Merck GRC 8200 247 2006 Phase II

Lupin Cornerstone Biopharm

Anti-infective (NDDS) 10.5 2005 NA

Laboratories Servier

IP data on Perindopril 26.7 2007 NA

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Increasing Quest for New Chemical Entities (NCEs)

• Indian pharmaceutical companies striving to move up the value chain and make place for themselves in the innovator league

• Enhanced level of investment in R&D capabilities and infrastructure by the industry and the Government

• Dr Reddy’s Laboratories’ NCE Balaglitazone is India’s first indigenously developed molecule to enter the Phase III trial

• Growing R&D pipeline of Indian companies presents significant in-licensing opportunities for global companies

Indian Pharmaceutical R&D Expenditure

Source: Assocham

2000-01

0 100 200 300 400 500 600

495.2

392.4

280

175.3

130.5

97.8

US$ million

CAGR 38%

2001-02

2002-03

2003-04

2004-05

2005-06

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Increasing Quest for New Chemical Entities (NCE)

Source: E&Y Research, *expected to enter

Drug Development Pipeline of Key R&D Companis in India

Discovery/Preclinical Phase Phase I Phase II Phase III

Ranbaxy 4-6 0 1 0

Dr. Reddys 2 3 1 1

Glenmark 3 1 2 0

Wockhardt 4 1 1 0

Zydus Cadilla 1 2 2 0

Nicholas Piramal 2 1 2 0

Lupin 0 1 2 1

Orchid 12 2* 1* 0

Sun 3 0 1 0

Torrent 7 0 0 0

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Improving Private Equity (PE) Scenario

• In 2006, PE investment rose by over 230% to US$7.46 billion compared to US$2.26 billion invested in 2005

• More than US$ 4 billion worth of private equity deals materialised in the life sciences space, in India, in 2006

• Life Sciences has emerged as one of the leading recipients of all Venture Capital & PE investments

• Increasing appetite of Indian companies for cross-border deals would influence the capital requirement and further attract PE funds

Private Equity Deal in Pharma & Healthcare (2006)

Investors Investee % Stake Deal Value US$ million

Carlyle Group Claris Lifesciences NA 20.0

Xenox & Agnus Grandix Pharmaceuticals 30% 2.0

Actis Paras Pharmaceuticals 23% 42

Actis Capitals LLP Add Life Medical Institute Ltd.

NA 15.50

Aureos India Accutest Research Labs NA 4.11

Bennett Coleman & Co. Ltd. Thyrocare Technologies Ltd.

NA NA

Chrys Capital Intas Pharmaceuticals 12.47% 11.78

Citi Venture Capital Elder Pharm 4.50% NA

Fidelity Investment Avesthagen 12-14% 11.00

Gujarat Venture Finance Ltd. Celestial Biologicals Ltd. NA 0.45

HSBC Global Investment Fund Glenmark Pharmaceuticals

6.70% 67.56

ICICI Venture Funds Metropolis Health Services

NA 7.78

Source: Grant Thronton Deal Tracker

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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Improving Private Equity (PE) Scenario

Private Equity Deal in Pharma & Healthcare (2006)

Investors Investees % Stake Deal Value US$ million

ICICI Venture Funds Management Co. Ltd.

Arch Pharmalabs Increasing to 33%

22.0

IDFC Private Equity Healthcare Global Enterprises NA 11.11

IDFC Pvt. Equity Manipal Health System Pvt. Ltd. NA 20.0

International Finance Corporation

Ocium Biosolutions Minority Stake

6.50

New Vernon Pvt. Equity Ltd. Unichem Laboratories Ltd. 5.20% 12.44

Nomura Group Dishman Pharmaceuticals 5.0% 11,30

Paul Capital Partners Glenmark Pharmaceuticals Ltd. NA 27.0

Sequoia Capital India Paras Pharmaceuticals NA 12.0

Soros Pvt. Equity Partners and Blue River Capital

Fortis Healthcare 6.00 33.33

Swiss Reinsurance Company (Swiss Re)

TTK Healthcare Services Pvt. Ltd.

26.00 NA

The Blackstone Group Emcure Pharmaceuticals NA 50.0

Trikona Capital Fortis Healthcare NA 18.0

Source: Grant Thronton Deal Tracker

KEY TRENDS AND DRIVERSPHARMACEUTICALS • October 2007

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www.ibef.org

KEY PLAYERS

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Key Players

Top 20 Pharmaceutical Companies Sales Dec 2006 (US$ mn)*

Ranbaxy Laboratories Ltd. 997.29

Cipla Ltd. 738.96

Dr. Reddy’s Laboratories Ltd. 557.42

Lupin Ltd. 408.91

Glaxosmithkline Pharmaceuticals Ltd. 408.02

Nicholas Piramal India Ltd. 359.14

Aurobindo Pharma Ltd. 351.36

Sun Pharmaceutical Inds. Ltd. 322.43

Cadila Healthcare Ltd. 318.76

Wockhardt Ltd. 255.03

Aventis Pharma Ltd. 231.16

Orchid Chemicals & Pharmaceuticals Ltd. 210.28

Ipca Laboratories Ltd. 195.34

Pfizer Ltd. 189.95

Matrix Laboratories Ltd. 187.73

Torrent Pharmaceuticals Ltd. 177.22

Biocon Ltd. 173.48

Alembic Ltd. 158.57

Glenmark Pharmaceuticals Ltd. 147.83

U S V Ltd. 138.48 Source: Prowess

KEY PLAYERSPHARMACEUTICALS • October 2007

* Exchange rate 1US$ = INR 42

KEY MNC companies in India

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Select Domestic Players

Ranbaxy

• Incorporated in 1961

• Ranked among the top 10 generics companies in the world

• Ground operations in 49 countries and manufacturing operations in 11 nations

• Exports contribute to around 80% of the total revenues in the domestic market

• Revenue in 2006 was US$ 1.33 billion

• Aspires to become a research based pharmaceutical company with revenues of US$ 5 billion by 2012

• Envisions becoming a top 5 global generics player by 2012

• TC presence: Anti-Infectives, CVS, Diabetes, Dermatological, Neuro-Psychiatry, Pain Management, GI & Nutritional

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Domestic Players

Dr. Reddy’s Labs

• Established in 1984

• Ranked among the top 15 generics players in the world

• First pharmaceutical company in Asia-Pacific (outside Japan) to be listed on NYSE

• Presence in 35 countries with operations in over 115 countries

• Generated revenues of US$ 1.5 billion in 2007

• Overseas business contributes to around 86% of the total revenues

• Aspires to become a discovery led global pharmaceutical company and one of the top 10 generic companies in the world

• TC presence: Anti-Infectives, CVS, diabetes, dermatological, pain management, GI, nutritional, dental, urological and oncology

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Domestic Players

CIPLA

• Set up in 1935

• World’s largest manufacturer of cost effective anti-retroviral drugs

• Cipla’s products are bought by over 170 countries across all the continents

• Partnerships with 9 companies for over 125 products

• Recorded a turnover of US$ 800 million in 2007

• Exports account for over 50% of the overall sales

• Over 100 Drug Master File (DMF) registrations in the U.S. and over 85 in Europe

• Presence across most of the therapeutic category

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Domestic Players

Nicholas Primal India Ltd. (NPIL)

• Came into existence in 1988

• 4th largest pharmaceutical company and is the leader in the CVS segment

• Has grown primarily on the basis acquisitions, mergers and alliances in the last 15 years

• Merged with Global Bulk Drugs and Fine Chemicals (India) in 2003

• Acquired Pfizer’s custom manufacturing plant located in Morpeth (UK)

• NPIL recorded a turnover of US$ 335 million

• Domestic market accounts for approximately 87 % of the company’s annual sales

• TC presence: Anti-Infectives, CVS, diabetes, dermatological, pain management, GI, respiratory, nutritional, CNS and urological

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Foreign Players

GlaxoSmithKline

• 2 manufacturing units in India, located at Nasik and Thane

• 2,000-strong field and a nation wide network of over 4,000 stockists

• Net sales of the pharmaceuticals business segment was US$ 326 million which constitutes 92% of the Company’s total sales

• It exported bulk drugs and formulations worth US$ 7.1 million

• 2 R&D centres which are approved by the Department of Scientific and Industrial Research, Government of India

• TC presence: anti-infectives, CVS, diabetes, dermatological, pain management, CNS, GI, nutritional, gynecological, respiratory, sera & immunoglobulin, hormones

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Foreign Players

Pfizer India

• Forayed in the Indian market in 1950

• Manufacturing facility at Thane, Maharashtra

• Launched 5 patented products since 2005 - Vfend, Viagra, Lyrica, Caduet and Macugen

• 7 of the Pfizer’s brands feature among the top 100 pharmaceutical brands

• Pfizer Limited (India) has a turnover of US$ 172 million (November 2006)

• Clinical research investments of US$ 15.75 million in India

• TC presence: anti-infectives, CVS, dermatological, sera & immunoglobulin, pain management, diabetes, CNS, GI, nutritional, gynecological and respiratory

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Foreign Players

AstraZeneca

• R&D, manufacturing and marketing offices in Bangalore

• R&D centre is dedicated to the ‘Discovery of Novel Therapies for the Developing World Diseases’ with more than 90 scientists

• Added a state-of-the art process R&D facility employing more than 50 scientists

• Sales turnover of US$ 62.9 million in 2006 with a PAT of US$ 11.5 million

• TC presence: focus on respiratory, maternal health, oncology, infection, pain control and anaesthesia

KEY PLAYERSPHARMACEUTICALS • October 2007

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Select Foreign Players

Sanofi Aventis

• Incorporated in1956 under the name Hoechst Fedco Pharma Pvt. Ltd.

• 1,840 employees

• Manufacturing facilities in Ankleshwar and Goa

• TC presence: CVS, thrombosis, oncology, metabolic disorders, CNS, internal medicine and vaccines

KEY PLAYERSPHARMACEUTICALS • October 2007

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Company Services Portfolio Clients

Advinus Therapeutic Drug discovery , medicinal chemistry, toxicology studies Development projects for Merck.

Avra Labs Product chemistry, organic synthesis, chiral synthesis and technology Top 20 big Pharma and Biotech companies

BioArch Research Solutions Medicinal chemistry, custom synthesis and formulations, Preclinical pharmabiology, BA/BE, CRAMs

NA

Aurigene Lead generation and optimisation and early computational chemistry aided ligand design, mining and screening of novel chemical entities. Early animal work involving ADME and toxicity

Collaborative discovery programmes with Novo Nordisk on Diabetes and discovery services with Rheosciences, Denmark

GVK Biosciences Medicinal chemistry, Bioinformatics, clinical trials, custom synthesis and drug discovery Pharma/ biotech companies across US, UK, Germany and Japan; Wyeth, Biogen, Merck & Co (50 projects)

Hikal Ltd. Medicinal chemistry, custom synthesis , CRAM 5 pharma companies also work in agrochemical

Innovasynth Medicinal chemistry, custom synthesis, CRAM Works for big Pharma companies

Jubilant Organosys Bioinformatics, clinical trials, CRAM, medicinal chemistry services, custom synthesis and drug discovery services

60 clients/ 20 projects at any time

Matrix CRAM, medicinal chemistry, custom synthesis and dossier development. Rigen Inc, GSK India, Merck KgaA

Procitius Research Medicinal chemistry, custom synthesis, biology services, clinical trials and CRAM NA

Key Contract Research Organisations in India

Source: E&Y Research

KEY PLAYERSPHARMACEUTICALS • October 2007

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Company Services Portfolio Clients

Sai Life Sciences Medicinal chemistry services, scale up services 200 projects for almost 30 MNC pharmaceutical and biotech companies

Shasun Chemicals & Drugs CRAM, organic chemistry, medicinal chemistry, custom synthesis and biology services like protein purification, microbial fermentation and process optimisation

NA

Suven Life Sciences CRAM, medicinal chemistry services, custom synthesis and clinical trials ( ACT and Sipra), drug discovery services

About 18-20 international clients from across US and Europe

Syngene Medicinal chemistry, custom synthesis and drug discovery, affiliate Clinigene Novartis, Merck & Co.

TCG Silicogene, medicinal chemistry, drug discovery services

Bharavi Labs Medicinal chemistry services, custom synthesis and drug discovery services 20-25 ongoing projects. Works on FTE and ongoing contracts

Key Contract Research Organisations in India

Source: E&Y Research

KEY PLAYERSPHARMACEUTICALS • October 2007

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www.ibef.org

KEY OPPORTUNITIES

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Contract Research – India an Emerging Hotspot

• Contract research recorded a growth of 45% to reach $ 175 million in 2006

• Presently, a major portion of the services is limited to chemistry based lead identification/optimisation, preclinical and clinical research stages

• Select companies provide biology based services for target validation; notable examples are Avesthagen, Ocimum Biosolutions & TCG Lifesciences

• Bioinformatics companies that offer research enabling software technologies are also emerging as a valuable segment

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Contract Research – India an Emerging Hotspot

Scanning

Target Identification Genetics Proteomics Chemoinformatics Bioinformatics Gene Sequencing

Target Validation Functional Genomics Protein Biochemistry Disease Model Genetically Modified Mice Bioimaging

Compound Generation Analogue Prepration Synthesis Drug Design Stuctural Chemistry Analytical Chemistry

Compound Synthesis HTS Assay Development

Lead Optimization Assay Precution SAR Medicinal ChemistryCell-based model for efficacy

Preclinical Development Pharmacology PKDM Toxicology Animal Models

Clinical Development Trial Management Data Management Regulatory Consulting

Source: Offshoring in the Pharmaceutical Industry: Mridula Pore, Yu Pu, Charles Cooney, MIT, E&Y Analysis

Strong

Weak

Disc

over

y Re

sear

chD

evel

omen

t Res

earc

h

Areas Speacialised Segments

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Clinical Research – Leveraging India’s Advantage

• Clinical research market in India was estimated around US$ 200 million in 2006 and is expected to become US$ 400-500 million by 2010, moving with a high CAGR of 30–35%

• Clinical trials for NCEs constitute around 60% of the total revenue mix while the rest 40% is contributed by the BA/BE studies for generics development. However, by volume around 70% of the work is directed towards generic research

• The market for BA/BE studies in India was estimated around US$ 60-70 million in 2006. It is estimated to reach US$ 150-200 million by 2010-11, growing at a CAGR of 18-20%

Indications Incidence

Cardiovascular Diseases 2 million deaths every year

Diabetes An estimated 30 to 35 million diabetics in 2005

Cancer 2 million cases, 500,000 new cases detected each year

Infectious Diseases Represent 51% of deaths (HIV, malaria, tuberculosis, tetanus, diarrhea, acute respiratory infections etc)

Other Medical Conditions 40 million asthmatics, 1.5 million patients of Alzheimer’s, 10 million with major psychiatric disorders

Key Disease Populations

Source: E&Y Research

Forecasted Clinical Research Market

2010

P2007CAGR

30-35%

Bulli

sh

450-500

175-200

Con

serv

ativ

e

650

US$ Million

Source: Compiled from industry sources, P- Projected

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Contract Manufacturing (CM)

• Presently, India has a miniscule share of the global Contract Manufacturing market, with estimated revenues of US$ 445 million in 2005

• The market is estimated to increase to US$ 1 billion by 2010

• By 2010, the demand for contract manufacturing of formulations is likely to be around US$ 210-300 million. While the APIs and intermediate demand is likely to be in the range of US$ 600-700 million by 2010

Key Growth Drivers

• Rise in the confidence of global pharma due to enforcement of product patent

• Large capital investment by Indian companies in building world class production facilities

• Increased service offerings by Indian players

Source: India Infoline

n APls/ intemediates

n Formulations

79%

21%

India Contract Manufacturing Pie (2010)

Source: Assocham

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Oncology – Indian Players Eyeing the Global Opportunity

• Cancer accounts for an estimated 7.6 million deaths globally

• Treatment for cancer is estimated to become the largest sales value area at US$ 55 billion by 2009, from the current US$ 45 billion

• The oncology pipeline is the richest in number and potential in value, with a large number of pharmaceutical and biotech companies focusing on oncology drugs

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Oncology – Indian Players Eying the Global Opportunity

• Over 50 new oncology products are expected to be launched in the next 5 years with new players entering the market

• About 30% of all launches by 2010 will be in oncology

• The global oncology drug market is growing at 17% annually

• Presently, the Indian oncology market stands at US$ 18.6 million and is expected to treble by 2010

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Oncology – Indian Players Eying the Global Opportunity

• Biocon recently launched its monoclonal antibody-based drug BIOMAb-EGFR for treating solid tumours. The company is looking at introducing products in the US and Europe

• Dabur Pharmaceuticals introduced a nano technology based chemotherapy agent, Nanoxel, in the country and plans to take it to the US and the European markets and has already planned clinical trials there

• Ranbaxy Laboratories Ltd has entered into a strategic alliance with Zenotech Laboratories Ltd. Ranbaxy will market Zenotech’s oncology cytotoxic injectible products under the Ranbaxy label, leveraging its global marketing and distribution network, in the key markets of Latin America including Brazil & Mexico, Russia and other CIS markets

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Pharmaceutical Retail – Emerging Growth Segment

• With revenues of US$ 130-140 million in 2006 07, organised retail constitutes just 2% of the pharmaceutical retail market in India

• It is expected to grow at a high growth of 30-40% and is likely to become US$ 400-530 million market by 2010

• Government contemplating to increase the FDI cap to 51% in the case of single brand product

• Sensing the tremendous potential of organised retail, US retail majors Wal-Mart, Boots and Asian retailer AS Watson are expected to soon make a major foray in to the domestic market

Source: Global Insight

Pharmacy Chains Plans

Apollo Pharmacy (part of the Apollo Hospital Group)

Presently has 450 pharmacies with 50 more to be added by the end of 2007

Subhiksha Presently has 550 shops and expects to touch the 1000 mark by the year-end

Medicine Shoppe (part of Medicine Shoppe International Group)

To double the count to 250 by the end of 2007

Guardian Lifecare Regional player with 65 pharmacies expected to increase to 3,500 by 2015

98.4 Has a presence of close to 60 outlets and plan to more than treble its count to 300 by the end of 2008

Current Players’ Expansion Plans

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Indian Pharmaceutical Players - Retail Plans

Case Study: Reliance Retail

• The Mukesh Dhirubhai Ambani Group is planning a foray into the pharma retail segment. This is part of an overall strategy for building super-malls in 21 zones across India. Through its biopharmaceutical venture, Reliance Life Sciences, the firm is due to increase investments, targeting US$ 33 billion of the local market by 2012

• The company has allocated US$ 2.2 billion for setting up production facilities. The firm is also keen on acquiring small local drug-producing units and companies to offer low-margin drugs at the retail level

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Indian Pharmaceutical Players - Retail Plans

Case Study: AIOCD

• All India Organisation of Chemists and Druggists (AIOCD) is a leading industry association with a membership of around 600,000 pharma retailers and wholesalers in the country. It would facilitate the creation of a centralised procurement system and a Special Purpose Vehicle (SPV) network in each state

• A centralised procurement system is part of a general push by AIOCD towards a network of small pharma retailers, who have dominated the Indian market for decades. This initiative was test-piloted last year in Maharashtra, where the largest network of small pharma retailers exists

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Indian Pharmaceutical Players - Retail Plans

Case Study: Ranbaxy/Fortis

• Ranbaxy-backed Fortis Healthcare has laid plans to enter the pharma retail segment, investing close to US$ 1.7 billion. Fortis will roll out 1,000 shops covering 400 towns across the country in 5 years. The first 250 of these are expected to be operational by the end of 2008. The retail unit will promote products and services offered by both Ranbaxy Laboratories and Fortis Healthcare

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Indian Pharmaceutical Players - Retail Plans

Case Study: Zydus Cadila

• Zydus Cadila plans to create a separate company from its health product lines . The first outlet of this new company would be commissioned in 2007. The company expects to enhance its product range by launching a smoking-cessation product and hopes to improve its revenues by close to 300% to US$ 1 billion from the current US$ 266 million

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Rural Market - Opportunities at the Bottom of the Pyramid

• 65% of the population resides in the rural areas with limited or no access to medicines and other healthcare facilities

• With a growth rate of 39% in 2006, rural market has outstripped the growth in the urban region, across most of the therapeutic categories in both value and volume terms

• General Physician driven segments such as anti-infectives, analgesics etc. have registered high growth compared to the specialist-driven segments such as CNS

• Non-communicable diseases such as cancer, blindness, mental illness, hypertension, diabetes, HIV/AIDS, accidents and injuries are also on the rise

Value Growth (2005-06)

n Rural n Urban

Source: Enam

3025201510

(%)

Pain

CNS

Resp.

CV

AI

GI

Total

Derma

50

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Rural Market - Opportunities at the Bottom of the Pyramid

Lifestyle disease on the rise in rural areas

• According to a recent study conducted by the George Institute for International Health in 45 villages in east and west Godavari districts of Andhra Pradesh, diseases of the cardiovascular system, such as heart attacks and stroke caused 32% of deaths in this region

Volume Growth (2005-06)

n Rural n Urban

Source: Enam

50 3025201510

Pain

CNS

Resp.

CV

AI

GI

Total

Derma

(%)

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Biopharma – Domestic Players Eyeing the Global Bio-similar Market

• Globally, sales of biological drugs are estimated to reach US$ 52 billion by 2010

• Leading Indian companies are intensifying their focus on the biotech segment

• Presently 1 in every 4 drugs under development is biologic

• Moreover, Indian players are also eyeing the huge opportunity presented by biosimilars across the globe

KEY OPPORTUNITIESPHARMACEUTICALS • October 2007

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Biopharma – Domestic Players Eyeing the Global Bio-similar Market

• Leading Indian pharmaceutical companies such as Biocon, Ranbaxy, Dr.Reddy’s, Wockhardt and Glenmark have invested in manufacturing facilities for biosimilars

• A legal framework for biosimilars has been established in the EU

• Further, US is expected to set up an approval framework for biosimilars soon

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Biopharma – Domestic Players Eyeing the Global Bio-similar Market

Key Initiatives of Indian Companies

• Ranbaxy Laboratories has signed a development and marketing agreement with generic injectables company Zenotech Laboratories to produce its first biosimilar G-CSF

• Reliance Life Sciences has bought 74% stake in GeneMedix. The joint entity will develop biosimilar drugs and offer full service in CRAMS

• DRL has created a copy of Roche’s Rituximab which is used to treat Non-Hodgkin’s lymphoma which generated more than $2 billion last year. Marketed by Genentech Inc. and Biogen Idec Inc. as Rituxan in the US

• Dr. Reddy’s sells Grafeel or filgrastim in India, which is used to boost white blood-cell production and is marketed by Amgen in the US

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Biopharma – Domestic Players Eyeing the Global Bio-similar Market

• Glenmark has set up biologics research facility in Switzerland with 25+ European scientists. It expects first biological lead to enter into clinics in 2009 and 2 more by 2010

• Glenmark tied up with US based Dyax to expedite biologics research. Dyax will perform funded research for 3 of Glenmark’s targets in the areas of inflammation and oncology

• Biocon has started clinical trial on Insugen, BIOMAb-EGFR trials in the regulated markets

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PHARMACEUTICALS October 2007

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