Emerging Pharmaceutical Market in India - Strategic Partnerships Between Domestic and International Pharmaceutical Players are the Driving Force

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Emerging Pharmaceutical Market in India - Strategic Partnerships Between Domestic and International Pharmaceutical Players are the Driving Force

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Emerging Pharmaceutical Market in India - Strategic Partnerships Between Domestic and International Pharmaceutical Players are the Driving Force

Summary

GBI Research's report, "Emerging Pharmaceutical Market in India - Strategic Partnerships Between Domestic and International Pharmaceutical Players are the Driving Force", provides in-depth analysis of trends, issues and challenges in the Indian pharmaceutical industry. The report analyzes effective strategies adopted by industry participants that shape industry dynamics. Further, the report provides competitive benchmarking for the leading companies and analyzes the M&A and strategic partnerships that shape the Indian pharmaceutical market. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Scope

The scope of this report includes -

- Overall pharma, biotech and outsourcing market structure.

- Market characterization, including market size

- CMO & CRO market size and growth

- Key drivers and barriers that have a significant impact on the market.

- Competitive benchmarking of leading companies.

- Key M&A activities and strategic partnership deals that have taken place in 2009

Reasons to buy

The report will enhance your decision making capability. It will allow you to -

- Align your product portfolio to the markets with high growth potential.

- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments poised for strong growth.

- Device a more tailored country strategy through the understanding of key drivers and barriers of the country's pharmaceutical market.

- Develop key strategic initiatives by understanding the key focus areas of leading companies.

- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 7

2 Emerging Pharmaceutical Market: India – Introduction 9

2.1 GBI Research Report Guidance 9

3 Emerging Pharmaceutical Market: India – Macroeconomic Environment 10

3.1 Demographic Analysis 10

3.1.1 Population Size, Growth, and Structure 10

3.1.2 Mortality Rate 11

3.1.3 Changes in Life Expectancy at Birth 12

3.1.4 Improved Child Survival 13

3.2 PESTLE Analysis 14

3.2.1 Political Factors 14

3.2.2 Economic Factors 14

3.2.3 Social Factors 14

3.2.4 Technological Factors 15

3.2.5 Legal 15

3.2.6 Environmental 15

4 Emerging Pharmaceutical Market: India – Industry Performance 16

4.1 Macroeconomic Indicators 16

4.2 Population Profile 16

4.2.1 High Population and Economic Growth 17

4.2.2 Emergence of the Middle Class 18

4.3 Disease Profile 18

4.3.1 Shift in Disease Profile 18

4.4 Healthcare Expenditure 19

4.5 Healthcare Regulation 20

4.5.1 The Union Ministry of Health and Family Welfare (MoHFW) 20

4.5.2 National Programs and Schemes 21

4.5.3 Highlights of Budget 2010-2011 23

4.5.4 Health Insurance Regulation 24

4.6 Import & Exports 24

4.6.1 Imports 24

4.6.2 Exports 25

4.6.3 Top 10 Destinations of Indian Products 26

4.7 Branded & Generic Drugs 27

4.7.1 Peak Years of Patent Expiries to Bring Revenues to Indian Pharmaceutical Companies 27

4.7.2 Massive Decline in Sales of Big Pharma Companies 28

4.8 Skilled Manpower 29

5 Emerging Pharmaceutical Market: India – Pharmaceutical and Biotech Industry 30

5.1 Introduction 30

5.2 Pharmaceutical Market Size and Growth in India 30

5.2.1 Domestic Market Size 31

5.3 Biotech Market Size in India 32

5.4 Pharmaceutical R&D in India 32

5.4.1 Forces that Drive Drug Discovery in India 33

5.5 Key Pharmaceutical Regulations in India 36

5.5.1 The Central Drugs Standard Control Organization (CDSCO) 36

5.5.2 State Drug Regulatory Authority (SDRA) 37

5.6 Pricing and Reimbursement in India 38

5.6.1 Pricing of Pharmaceutical Drugs in India 38

5.6.2 Reimbursements of Pharmaceutical Drugs in India 38

5.7 Intellectual Property Rights in India 42

5.7.1 Effect of Patent Laws on Pharmaceutical Production in India 43

5.7.2 Key Impact of the New Patent Laws on India 44

5.7.3 Patent Act 2005 – First Step towards Improving IP Protection 45

5.7.4 IPR Enforcement Rules, 2007 45

5.7.5 Trademarks Bill 2007 46

5.7.6 Drugs and Cosmetics Act (Amendment) 2008 46

5.7.7 EIPR (Enforcers of Intellectual Property Rights) – Ensuring IPR Laws Implementation in India 47

5.7.8 Key Takeaways 48

5.8 Key Marketing and Distribution Channels in India 49

5.9 Mergers and Acquisitions 50

5.9.1 Deals by Year 50

5.9.2 Deals by Type 51

5.9.3 Deal by Value 51

5.9.4 Top 10 M&A Deals 52

5.10 Licensing Agreements 55

5.10.1 Deals by Year 55

5.10.2 Deals by Value 56

5.10.3 Key Takeaway 56

5.10.4 Top 10 Licensing Deals 56

5.11 Key Players – Foreign 59

5.11.1 Sanofi-Aventis 59

5.11.2 F. Hoffmann-La Roche Ltd/Genentech, Inc. 61

5.11.3 AstraZeneca 63

5.11.4 GlaxoSmithKline 64

5.11.5 Abbott Laboratories 66

5.12 Key Players – Domestic 68

5.12.1 Dr. Reddy's Lab 68

5.12.2 Piramal Healthcare 69

5.12.3 Biocon Limited 71

5.12.4 Cipla Ltd. 72

5.12.5 Ranbaxy Laboratories Limited 73

5.13 Market Drivers 75

5.13.1 M&As Pick Up Speed 75

5.13.2 Established Generics Industry 75

5.14 Market Restraints 75

5.14.1 Weak Infrastructure 75

5.14.2 Financial Disparity 75

5.14.3 Intellectual Property (IP) Concerns 76

5.14.4 Effect of Counterfeit Medicines 76

5.14.5 Currency Fluctuation and Financial Problems will Make It Difficult to Sustain the Growth 77

5.14.6 Regulatory Hurdles 78

5.15 SWOT Analysis of Indian Pharmaceutical Sector 78

6 Emerging Pharmaceutical Market: India – Service Industries – CMO, CRO 79

6.1 CMO Market Size and Growth in India 79

6.1.1 Overview of Indian Contract Manufacturing Organization (CMO) Market 79

6.2 Key Players – Domestic 80

6.2.1 Piramal Healthcare 80

6.2.2 Jubilant Organosys 80

6.2.3 BASF 81

6.3 Key Players - Foreign 81

6.3.1 Lonza 81

6.3.2 Evonik 82

6.3.3 DSM 82

6.4 CMO Market Drivers 83

6.4.1 Low-Cost Skilled Labor 83

6.4.2 Increase in Generics 83

6.4.3 Product Patent Regime 83

6.4.4 Vertically Integrated Business Model 83

6.4.5 Strategic Partnerships 83

6.5 CMO Market Restraints 84

6.5.1 Increasing Competition from China 84

6.5.2 Time-Consuming Development Periods 84

6.5.3 Need for Robust Execution Strategy 84

6.5.4 Poor Intellectual Property Protection and Regulatory Framework 85

6.5.5 Threat of Counterfeit Medicines Originating from India 85

6.5.6 Varied Compliance With cGMP Guidelines Across the Nation 85

6.5.7 High Effective Tax Rates 85

6.6 Clinical Research Organization (CRO) Market Size and Growth in India 85

6.6.1 Major CRO Locations in India 86

6.6.2 Clinical Trials Registered in 2009 in India 86

6.7 Key Players – Foreign 88

6.7.1 Quintiles 88

6.7.2 Paraxel 88

6.7.3 Pharmaceutical Product Development (PPD) Inc. 89

6.8 Key Players – Domestic 89

6.8.1 SIRO Clinpharm Pvt Ltd 89

6.8.2 Veeda Clinical Research Ltd 90

6.8.3 GVK Biosciences Pvt Ltd 91

6.8.4 Ecron Acunova 92

6.8.5 Synchron Research Services Pvt Ltd 93

6.9 CRO Market Drivers 94

6.9.1 High Risks and Costs Associated With Drug Development 94

6.9.2 Escalating Cost of Clinical Trials 95

6.9.3 Increase in Multinational Sites to Conduct Clinical Trials Will Drive the Clinical Trials Market in India 96

6.9.4 Increased Patient Availability due to Major Diseases 97

6.9.5 Global Increase in the Number of Clinical Trials Conducted 97

6.9.6 Restructuring the R&D 98

6.9.7 Increased Screening Rates During R&D 99

6.9.8 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 99

6.10 CRO Market Restraints 99

6.10.1 Lack of Training for Clinical Trial Professionals 99

6.10.2 Quality of Clinical Trial Data 99

6.10.3 ICH GCP vs. Indian GCP 99

6.10.4 Ethical Issues 100

6.10.5 The Need for Proposed Additional Documents for Importing Drugs 101

6.11 Major CRO Acquisitions 101

7 Emerging Pharmaceutical Market: India – Health Care IT in India 102

7.1.1 IT Outsourcing to India 102

7.1.2 Cost of Setting Up A Clinical Data Management Setup In India 103

8 Emerging Pharmaceutical Market: India – Appendix 104

8.1 Market Definitions 104

8.2 Abbreviations 104

8.3 Research Methodology 106

8.3.1 Macroeconomic Environment 106

8.3.2 Industry Performance 106

8.3.3 Pharmaceutical and Biotech Industry 107

8.3.4 Service Industries – CMO, CRO 107

8.3.5 Health Care IT 107

8.4 Contact Us 107

8.5 Disclaimer 107

8.6 Sources 108

1.1 List of Tables

Table 1: Emerging Pharmaceutical Market - India, Population Growth in India, (Millions), 2000-2020 10

Table 2: Emerging Pharmaceutical Market - India, Demographic Profile - 2010 16

Table 3: Emerging Pharmaceutical Market - India, Population Age Structure, India (million), 2000–2020 17

Table 4: Emerging Pharmaceutical Market - India, Health Indicators, India, 2010 18

Table 5: Emerging Pharmaceutical Market - India, Price Difference Between Brand Name Drugs (Average Wholesale Price) and Generic Drugs, $, August 2008 35

Table 6: Emerging Pharmaceutical Market - India, Deals Landscape, M&A Deals, 2004-2010 52

Table 7: Emerging Pharmaceutical Market - India, SWOT Analysis, 2011 78

Table 8: Emerging Pharmaceutical Market - India, Number of Industry Sponsored Clinical Trials, BRIC, 2010 87

Table 9: Emerging Pharmaceutical Market - India, Global BLA and NME Approvals vs R&D Spending, ($bn), 1995-2009 94

Table 10: Emerging Pharmaceutical Market - India, Number of Local and Multinational Sites, India, 2005-2009 96

Table 11: Emerging Pharmaceutical Market - India, DALY Rate Per 100,000, Global, 2008 97

Table 12: Emerging Pharmaceutical Market - India, Acquisitions by Indian CROs, Global, 2005-2008 101

Table 13: Emerging Pharmaceutical Market - India, Data Management Set Up Cost in India, 2009 103

1.2 List of Figures

Figure 1: Emerging Pharmaceutical Market - India, Population Growth in India, (Millions), 2000-2020) 10

Figure 2: Emerging Pharmaceutical Market - India, Death Rate in Rural and Urban Areas in India, 1980-2008 11

Figure 3: Emerging Pharmaceutical Market - India, Expectation of Life at Birth in India During 1990-2025 12

Figure 4: Emerging Pharmaceutical Market - India, Infant Mortality Rate in India from 1980-2008 13

Figure 5: Emerging Pharmaceutical Market - India, PESTLE Analysis - 2011 14

Figure 6: Emerging Pharmaceutical Market - India, Population Age Structure, India (million), 2000–2020 17

Figure 7: Emerging Pharmaceutical Market - India, Leading Causes of Death, By Therapeutic Area, India (%), 2007 18

Figure 8: Emerging Pharmaceutical Market - India, National Healthcare Expenditure, India, 2008 19

Figure 9: Emerging Pharmaceutical Market - India, The Union Ministry of Health and Family Welfare Structure, India 20

Figure 10: Emerging Pharmaceutical Market - India, Types of Institutions Accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH), India, 2010 22

Figure 11: Emerging Pharmaceutical Market - India, Pharmaceutical Imports, $bn, 2002-2009 24

Figure 12: Emerging Pharmaceutical Market - India, Pharmaceutical Exports, $bn, 2002-2009 25

Figure 13: Emerging Pharmaceutical Market India, Top 10 Destinations of Indian Pharmaceutical Products, $bn, 2010 26

Figure 14: Emerging Pharmaceutical Market - India, 2009 Revenues of Top 10 Drugs that Expire During 2010-2014, (Millions) 27

Figure 15: Emerging Pharmaceutical Market - India, Top 20 Patent Expirations During 2010-2014, Based on US Sales in Dollars 28

Figure 16: Emerging Pharmaceutical Market - India, Indian Talent Pool -2010 29

Figure 17: Emerging Pharmaceutical Market - India, Pharmaceutical Market Size, Revenue, $bn, 2002-2009 30

Figure 18: Emerging Pharmaceutical Market - India, Domestic Market Size, $bn, 2002-2009 31

Figure 19: Emerging Pharmaceutical Market - India, Comparison of CAGR of R&D Expenditure versus Turnover for the Top 5 Pharmaceutical Companies, 2004–2008 33

Figure 20: Emerging Pharmaceutical Market - India, Increasing Cost of Introducing an NME in the US, Millions, 1976-2008 34

Figure 21: Emerging Pharmaceutical Market - India, Price Difference Between Brand Name Drugs (Average Wholesale Price) and Generic Drugs, $, August 2008 35

Figure 22: Emerging Pharmaceutical Market - India, Regulatory Landscape, Functions of CDSCO India, 2010 36

Figure 23: Emerging Pharmaceutical Market - India, Regulatory Landscape, Functions of SDRA India, 2010 37

Figure 24: Emerging Pharmaceutical Market - India, Health Insurance Companies Landscape, India, 2010 39

Figure 25: Emerging Pharmaceutical Market - India, Health Insurance Market by Public and Private Sector, India (%), 2010 40

Figure 26: Emerging Pharmaceutical Market - India, Health Insurance Market Share by Companies, India (%), 2010 40

Figure 27: Emerging Pharmaceutical Market - India, Insured Inpatients, India (% of Population), 2010 41

Figure 28: Emerging Pharmaceutical Market - India, Regulatory Landscape, IPR Protection in India, 1963-2009 42

Figure 29: Emerging Pharmaceutical Market - India, Intellectual Property Rights Protection Framework in India-2010 44

Figure 30: Emerging Pharmaceutical Market - India, Deals Landscape, M&A Deals, Deals by Year, 2006-2010 50

Figure 31: Emerging Pharmaceutical Market - India, Deals Landscape, M&A Deals, Deals by Type, (%), 2004-2010 51

Figure 32: Emerging Pharmaceutical Market - India, Deals Landscape, M&A Deals, Deals By Value, (%), 2004-2010 51

Figure 33: Emerging Pharmaceutical Market - India, Deals Landscape, Licensing Deals, Deals By Year, 2006-2010 55

Figure 34: Emerging Pharmaceutical Market - India, Deals Landscape, Licensing Deals, Deals By Value, (%), 2004-2010 56

Figure 35: Emerging Pharmaceutical Market - India, Key Foreign Players, Sanofi-Aventis, SWOT Profile, 2010 60

Figure 36: Emerging Pharmaceutical Market - India, Key Foreign Players, F. Hoffmann-La Roche Ltd., SWOT Profile, 2010 61

Figure 37: Emerging Pharmaceutical Market - India, Key Foreign Players, AstraZeneca, SWOT Profile, 2010 64

Figure 38: Emerging Pharmaceutical Market - India, Key Foreign Players, GlaxoSmithKline Pharmaceuticals Ltd, SWOT Profile, 2010 65

Figure 39: Emerging Pharmaceutical Market - India, Key Foreign Players, Abbott Laboratories, SWOT Profile, 2010 67

Figure 40: Emerging Pharmaceutical Market - India, Competitive Landscape, Dr. Reddy's, SWOT Profile, 2010 68

Figure 41: Emerging Pharmaceutical Market - India, Piramal Life Sciences, SWOT Profile, 2010 70

Figure 42: Emerging Pharmaceutical Market - India, Biocon Limited, SWOT Profile, 2010 71

Figure 43: Emerging Pharmaceutical Market - India, Cipla Ltd., SWOT Profile, 2010 72

Figure 44: Emerging Pharmaceutical Market - India, Ranbaxy Laboratories, SWOT Profile, 2010 74

Figure 45: Emerging Pharmaceutical Market - India, CMO Market, India, Key Factors Driving Outsourcing, 2010 79

Figure 46: Emerging Pharmaceutical Market - India, CMO Market, India, Key Concerns for Outsourcing, 2010 84

Figure 47: Emerging Pharmaceutical Market - India, CRO Locations, India, 2009 86

Figure 48: Emerging Pharmaceutical Market - India, Distribution of Clinical Trials, India, (%), 2009 86

Figure 49: Emerging Pharmaceutical Market - India, Number of Industry Sponsored Clinical Trials, BRIC, 2010 87

Figure 50: Emerging Pharmaceutical Market - India, SIRO Clinpharm, India, 2010 89

Figure 51: Emerging Pharmaceutical Market - India, Veeda Clinical Research, India, 2010 90

Figure 52: Emerging Pharmaceutical Market - India, GVK Biosciences, India, 2010 91

Figure 53: Emerging Pharmaceutical Market - India, India, 2010 92

Figure 54: Emerging Pharmaceutical Market - India, Synchron Research Services, India, 2010 93

Figure 55: Emerging Pharmaceutical Market - India, Global BLA and NME Approvals vs. R&D Spending, ($bn), 1995-2009 94

Figure 56: Emerging Pharmaceutical Market - India, Number of Local and Multinational Sites, India, 2005-2009 96

Figure 57: Emerging Pharmaceutical Market - India, Death And Disability-Adjusted Life Year (DALY) Rate Per 100,000, Global, 2008 97

Figure 58: Emerging Pharmaceutical Market - India, Activities of R&D Restructuring, 2010 98

Figure 59: Emerging Pharmaceutical Market - India, Supply Chain in Clinical Trials , 2010 102

Figure 60: Emerging Pharmaceutical Market - India, End-to-End Services Offered by Large IT Vendors in India, 2010 102

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