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Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials - Product Image

Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials

  • Published: January 2011
  • Region: India
  • 96 pages
  • GBI Research

Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials

Summary

GBI Research’s new report, “Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials”, provides in-depth analysis of trends, issues and challenges in this industry. The report analyzes the effective strategies that shape the industry dynamics. The report also provides comprehensive insight into the clinical trials cost, infrastructure, regulations and key drivers and barriers that impact the clinical trials market in India. Further, the report provides competitive benchmarking for the leading companies that shape the Indian clinical trials 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:
- Annualized data from 2001 to 2009, forecast forward to 2016.
- Market characterization, including market size
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1 3
1.1 List of Tables 6
1.2 List of Figures 7
2 Emerging Market for Clinical Trials - India - Introduction 9
2.1 GBI Research Report Guidance 9
3 Emerging Market for Clinical Trials - India - Overview 10
3.1 The Clinical Research Process – Overview 10
3.1.1 Drug Discovery Phase 10
3.1.2 Pre-Clinical Phase 10
3.1.3 Phase I 11
3.1.4 Phase II 11
3.1.5 Phase III 11
3.1.6 Review and Approval from the Regulatory Agencies 11
3.1.7 Post-marketing Studies 11
3.2 Clinical Trial Design and Types 11
3.2.1 Types of Design 12
3.3 Role of CROs 18
3.4 Sponsors of Clinical Trials 19
3.5 Intellectual Property Protection in India 20
3.5.1 Patent Act 2005 – First Step towards Improving IP Protection 20
3.5.2 Intellectual Property Rights (IPR) Enforcement Rules, 2007 20
3.5.3 Trademarks Bill 2007 21
3.5.4 Drugs and Cosmetics Act (Amendment) 2008 21
3.5.5 Enforcers of Intellectual Property Rights (EIPR) – Ensuring IPR Laws Implementation in India 21
3.6 The Need for Outsourcing Clinical Trials 22
3.6.1 High Risks and Costs Associated With Drug Development 22
3.6.2 Escalating Costs of Clinical Trials 23
3.6.3 Global Increase in the Number of Clinical Trials Conducted 24
3.6.4 Restructuring the R&D 25
3.6.5 Increased Screening Rates During R&D 26
3.6.6 Expiring Patents Pressurize Pharmaceutical Companies to Reduce Costs 26
4 Emerging Market for Clinical Trials – India - Clinical Trial Trends 27
4.1 Registration of Phase l Clinical Trials 27
4.2 Registration of Phase ll Clinical Trials 28
4.3 Registration of Phase lll Clinical Trials 29
4.4 Registration of Phase lV Clinical Trials 30
4.5 Clinical Trials Registered in 2009 31
4.6 Comparative Analysis of Registered Clinical Trials in BRIC Countries 32
4.7 Comparative Analysis of Industry Sponsored Clinical Trials Started in BRIC Countries 33
4.8 Comparative Analysis of Population Statistics in BRIC Countries 34
4.8.1 Comparative Analysis of Epidemiology and Prevalence of Major Disease 35
5 Emerging Market for Clinical Trials – India - Market Environment Characterization 42
5.1 Increase in Growth of Global CRO Market will Foster the Growth of Indian Clinical Trial Market 42
5.1.1 Increase in Multinational Sites to Conduct Clinical Trials will Drive the Clinical Trial Market in India 43
5.1.2 Access to a Large Patient Pool 44
5.1.3 Patient Availability for Major Diseases 46
5.1.4 Ethnicity and Genetic Diversity 52
5.1.5 Subject Recruitment and Speed of Trials 52
5.1.6 Cost of Conducting Clinical Trials in India is Approximately 55% of the Cost of Conducting a Clinical Trial in the US 52
5.1.7 Infrastructural Facilities Improve the Clinical Trial Environment 53
5.1.8 Facilities for Conducting Clinical Trials 54
5.1.9 Biotechnology Laboratories that Conduct Clinical Trials in India 54
5.1.10 GLP Approved Facilities in India 55
5.1.11 US FDA Approved New Drug Molecules Being Researched in India 56
5.1.12 Increase in Skilled Pool of Healthcare Professionals 57
5.2 Market Restraints 60
5.2.1 Lack of Training for Clinical Trial Professionals 60
5.2.2 Quality of Clinical Trial Data 60
5.2.3 ICH GCP Versus Indian GCP 60
5.2.4 Ethical Issues 61
5.2.5 The Need for Proposed Additional Documents for Importing Drugs 61
5.3 Clinical Trial Market Size in India 62
6 Emerging Market for Clinical Trials – India - Regulatory Landscape 63
6.1 Introduction 63
6.1.1 Drugs and Cosmetics Act 63
6.1.2 The Institutional Ethics Committee (IEC) 64
6.1.3 The Ministry of Health and Family Welfare 64
6.1.4 Central Drug Standard Control Organization (CDSCO) 64
6.1.5 Drug Controller General of India (DCGI) 64
6.1.6 Indian Council of Medical Research (ICMR) 65
6.1.7 Clinical Trials Registry India 65
6.2 Clinical Trial Regulation in India 67
6.2.1 Documents Required for Phase l Clinical Trial Application for Molecules Discovered in India 69
6.2.2 Documents Required for Phase l Clinical Trial (Molecules Discovered Outside India) 71
6.2.3 Documents Required for Phase ll Clinical Trial Application 71
6.2.4 Documents Required for Phase lll Clinical Trials 72
6.3 Time Frame for Approval 72
6.4 Recent Regulatory Changes in Clinical Trials 73
6.4.1 Amended Schedule Y 73
6.4.2 Informed Consent and its Elements 73
6.4.3 Investigator Undertaking 74
6.5 Government Incentives 74
7 Emerging Market for Clinical Trials – India - CRO Landscape 75
7.1 CRO Locations 75
7.2 Service Portfolio and Benchmarking of Indian CROs 76
7.3 Acquisitions by Indian CROs 77
7.4 CRO Profiles 78
7.4.1 Reliance Life Sciences 78
7.4.2 Asian Clinical Trials 79
7.4.3 Diagnosearch Life Sciences 80
7.4.4 Clininvent 81
7.4.5 Synchron Research Services Pvt Ltd 82
7.4.6 Lambda Therapeutic Research Ltd 83
7.4.7 GVK Biosciences Pvt Ltd 84
7.4.8 Sristek 85
7.4.9 Lotus Laboratories Pvt Ltd 86
7.4.10 Veeda Clinical Research Ltd 87
7.4.11 Vimta Labs Ltd 88
7.4.12 Ecron Acunova 89
7.4.13 SIRO Clinpharm Pvt Ltd 90
7.4.14 Catalyst Clinical Services 91
8 Emerging Market for Clinical Trials – India - Appendix 92
8.1 Market Definitions 92
8.2 Abbreviations 92
8.3 Research Methodology 94
8.3.1 Coverage 94
8.3.2 Secondary Research 94
8.3.3 Primary Research 94
8.3.4 Expert Panel Validation 95
8.4 Contact Us 95
8.5 Disclaimer 95
8.6 Sources 96

1.1 List of Tables
Table 1: Clinical Trials in India, Global BLA and NME Approvals vs R&D Spending, ($bn), 1995-2009 22
Table 2: Clinical Trials in India, Drug Patent Expiry, Global, ($m), 2009-2016 26
Table 3: Clinical Trials in India, Number of Phase l Clinical Trials Registered, India, 2004-2009 27
Table 4: Clinical Trials in India, Number of Phase ll Clinical Trials Registered, India, 2004-2009 28
Table 5: Clinical Trials in India, Number of Phase lll Clinical Trials Registered, India, 2004-2009 29
Table 6: Clinical Trials in India, Number of Phase lV Clinical Trials Registered, India, 2004-2009 30
Table 7: Clinical Trials in India, Number of Clinical Trials Registered, BRIC, 2010 32
Table 8: Clinical Trials in India, Number of Industry Sponsored Clinical Trials, BRIC, 2010 33
Table 9: Clinical Trials in India, Distribution of World Population among BRIC Countries, (%), 2008 34
Table 10: Clinical Trials in India, Number of Recruiting Sites for Major Therapeutic Areas in Brazil, India and China, 2005-2009 36
Table 11: Clinical Trials in India, Number of Sites Recruited by MNCs, Brazil, India and China, (%), 2005-2009 38
Table 12: Clinical Trials in India, Industry Sponsored Trials Registered with the US Trial Register, India, China, Brazil, 2004-2009 39
Table 13: Clinical Trials in India, Local and Multinational Sites Registered With the US Trial Register, India, China, Brazil, 2004-2009 40
Table 14: Clinical Trials in India, Total Number of Sites Involved in Planning, Recruiting, Ongoing and Completed Clinical Trials in Brazil, India and China, 2004-2009 41
Table 15: Clinical Trials in India, CRO Market, Global, 2006-2015 42
Table 16: Clinical Trials in India, Number of Local and Multinational Sites, India, 2005-2009 43
Table 17: Clinical Trials in India, Population Growth in India, (Millions), 2000-2020 44
Table 18: Clinical Trials in India, Population of Different Countries, Global, (Millions), 2008 45
Table 19: Clinical Trials in India, DALY Rate Per 100,000 Population, Global, 2008 46
Table 20: Clinical Trials in India, Population Forecast for HIV, India, (Millions), 2009-2015 47
Table 21: Clinical Trials in India, Population Forecast for Cardiovascular Diseases, India, (Millions), 2009-2015 48
Table 22: Clinical Trials in India, Population Forecast for Diabetes, India, (Millions), 2009-2015 49
Table 23: Clinical Trials in India, Population Forecast for Cancer, India, (Millions), 2009-2015 50
Table 24: Clinical Trials in India, Population Forecast for COPD and Asthma, India, (Millions), 2009-2015 51
Table 25: Clinical Trials in India, Cost Comparison, The US vs. India, ($’000), 2009 52
Table 26: Clinical Trials in India, Medical Colleges with Number of Students Intake, India, 2009 53
Table 27: Clinical Trials in India, Presence of Facilities in Indian CROs, India, (%), 2007 54
Table 28: Clinical Trials in India, GLP Approved Facilities, India, 2009 55
Table 29: Clinical Trials in India, US FDA Approved New Drug Molecules Being Researched, India, 2009 56
Table 30: Clinical Trials in India, Doctors Registered with MCI, India, (‘000), 2000-2008 57
Table 31: Clinical Trials in India, Dental Surgeons Registered with MCI, India, (‘000), 2000-2007 58
Table 32: Clinical Trials in India, Growth Rate of Principal Investigators, Global, (%), 2002-2008 59
Table 33: Clinical Trials in India, Clinical Trial Market, India, ($m), 2009-2017 62
Table 34: Clinical Trials in India, Documents Required for Phase l Clinical Trial Application (Molecules Discovered in India), India, 2009 69
Table 35: Clinical Trials in India, Documents Required for Phase l Clinical Trials (Molecules Discovered Outside India), India, 2009 71
Table 36: Clinical Trials in India, Documents Required for Phase ll Clinical Trials, India, 2009 71
Table 37: Clinical Trials in India, Documents Required for Phase lll Clinical Trials, India, 2009 72
Table 38: Clinical Trials in India, Time Frame for Approval, India, 2009 72
Table 39: Clinical Trials in India, Service Portfolio and Benchmarking of CROs, India, 2010 76
Table 40: Clinical Trials in India, Acquisitions by Indian CROs, Global, 2005-2008 77

1.2 List of Figures
Figure 1: Clinical Trials in India, Parallel Group Trial Design, 2010 12
Figure 2: Clinical Trials in India, Cross Over Trial Design, 2010 13
Figure 3: Clinical Trials in India, Adaptive Clinical Trial Design, 2010 14
Figure 4: Clinical Trials in India, Wyeth Learn and Confirm Model, 2010 16
Figure 5: Clinical Trials in India, Services Offered by CROs, 2010 18
Figure 6: Clinical Trials in India, Preclinical Research to Market Launch Via Clinical Trials, 2009 19
Figure 7: Clinical Trials in India, Acts Related to Intellectual Property Protection, India, 2005-2008 20
Figure 8: Clinical Trials in India, Global BLA and NME Approvals vs R&D Spending, ($bn), 1995-2009 22
Figure 9: Clinical Trials in India, Activities of R&D Restructuring, 2010 25
Figure 10: Clinical Trials in India, Number of Phase l Clinical Trials Registered, India, 2004-2009 27
Figure 11: Clinical Trials in India, Number of Phase ll Clinical Trials Registered, India, 2004-2009 28
Figure 12: Clinical Trials in India, Number of Phase lll Clinical Trials Registered, India, 2004-2009 29
Figure 13: Clinical Trials in India, Number of Phase lV Clinical Trials Registered, India, 2004-2009 30
Figure 14: Clinical Trials in India, Phase wise Distribution of Clinical Trials, India, (%), 2009 31
Figure 15: Clinical Trials in India, Number of Clinical Trials Registered, BRIC, 2010 32
Figure 16: Clinical Trials in India, Number of Industry Sponsored Clinical Trials, BRIC, 2010 33
Figure 17: Clinical Trials in India, Distribution of World Population among BRIC Countries, (%), 2008 34
Figure 18: Clinical Trials in India, Number of Recruiting Sites for Major Therapeutic Areas in Brazil, India and China, 2005-2009 35
Figure 19: Clinical Trials in India, Number of Sites Recruited by MNCs, Brazil, India and China, (%), 2005-2009 37
Figure 20: Clinical Trials in India, Industry Sponsored Trials Registered with the US Trial Register, India, China, Brazil, 2004-2009 39
Figure 21: Clinical Trials in India, Local and Multinational Sites Registered With the US Trial Register, India, China, Brazil, 2004-2009 40
Figure 22: Clinical Trials in India, CRO Market, Global, ($bn), 2006-2015 42
Figure 23:Clinical Trials in India, Number of Local and Multinational Sites, India, 2005-2009 43
Figure 24: Clinical Trials in India, Population Growth in India, (Millions), 2000-2020 44
Figure 25:Clinical Trials in India, Population of Different Countries, Global, (Million), 2008 45
Figure 26: Clinical Trials in India, DALY Rate Per 100,000 Population, Global, 2008 46
Figure 27: Clinical Trials in India, Population Forecast for HIV, India, (Millions), 2009-2015 47
Figure 28: Clinical Trials in India, Population Forecast for Cardiovascular Diseases, India, (Millions), 2009-2015 48
Figure 29: Clinical Trials in India, Population Forecast for Diabetes, India, (Millions), 2009-2015 49
Figure 30: Clinical Trials in India, Population Forecast for Cancer, India, (Millions), 2009-2015 50
Figure 31: Clinical Trials in India, Population Forecast for COPD and Asthma, India, (Millions), 2009-2015 51
Figure 32: Clinical Trials in India, Medical Colleges with Number of Students Intake, India, 2009 53
Figure 33: Clinical Trials in India, Doctors Registered with MCI, India, (‘000), 2000-2008 57
Figure 34: Clinical Trials in India, Dental Surgeons Registered with MCI, India, (‘000), 2000-2007 58
Figure 35: Clinical Trials in India, Growth Rate of Principal Investigators, Global, (%), 2002-2008 59
Figure 36: Clinical Trials in India, Clinical Trial Market, India, ($m), 2009-2017 62
Figure 37:Clinical Trials in India, Procedure for Registering Clinical Trials with CTRI, India, 2009 66
Figure 38: Clinical Trials in India, Clinical Trial Regulation Approval Process, India, 2009 67
Figure 39: Clinical Trials in India, CRO Locations, India, 2009 75
Figure 40: Clinical Trials in India, Reliance Life Sciences, India, 2010 78
Figure 41: Clinical Trials in India, Asian Clinical Trials, India, 2010 79
Figure 42: Clinical Trials in India, Diagnosearch Life Sciences, India, 2010 80
Figure 43: Clinical Trials in India, Clininvent, India, 2010 81
Figure 44: Clinical Trials in India, Synchron Research Services, India, 2010 82
Figure 45: Clinical Trials in India, Lambda Therapeutics, India, 2010 83
Figure 46: Clinical Trials in India, GVK Biosciences, India, 2010 84
Figure 47: Clinical Trials in India, Sristek, India, 2010 85
Figure 48: Clinical Trials in India, Lotus, India, 2010 86
Figure 49: Clinical Trials in India, Veeda Clinical Research, India, 2010 87
Figure 50: Clinical Trials in India, Vimta Labs, India, 2010 88
Figure 51: Clinical Trials in India, Ecron Acunova, India, 2010 89
Figure 52: Clinical Trials in India, SIRO Clinpharm, India, 2010 90
Figure 53: Clinical Trials in India, Catalyst Clinical Services, India, 2010 91

“Emerging Markets for Clinical Trials in India - Favorable Regulatory Environment and Cost Effectiveness Will Accelerate the Number of Clinical Trials” that provides key data, information and analysis of the major trends and issues affecting the Clinical Trial market in India. The report provides a comprehensive insight of reasons for outsourcing clinical trials to India and the key services provided by the CROs of India. The report also provides a detailed analysis of the Indian market in terms of its size, and major service offerings of the CROs in India. The report also discusses the factors that are driving the clinical trial market in India and China. The report delves into the key regulations, especially with respect to the clinical trial approval process for molecules discovered outside India as well as within India, and how the regulations have benefited the CROs. It also provides an insight into the government support initiatives in India to encourage the clinical trials. The report also provides key alliances and acquisitions between the western CROs and the local CROs of India, and the key trends emerging out of such partnerships. The report also looks into the major challenges that can restrict the growth of the clinical trials market in India.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by a team of industry experts.

Rising Financial and Regulatory Pressures on Western Pharma Will Continue to Drive the Clinical Trial Market Growth in India

The pharmaceutical industries of the US and Europe are facing severe financial constraints since the past few years, which are expected to worsen in the coming years. With pressures such as increasing cost of introducing an NME to reach more than $3 billion in 2008, tightening regulatory pressures resulting in fewer FDA approvals, blockbuster drugs worth more than $100 billion set to expire by 2014 and drying pipelines of the pharmaceutical industry, cost cutting pressures are mounting on pharmaceutical companies, especially big pharma. These pressures are expected to drive these companies towards low-cost countries such as India to perform their R&D activities, one of their major expenses.

India, over the last decade, has developed significant capabilities in clinical trials, along with certain capabilities in project management and data management. India is able to provide significant cost savings in the range of 50-60% for clinical trials. With discovery research occupying close to one-third of the R&D expenditure for the western pharmaceutical industry, outsourcing to low-cost countries is logical. As the financial and regulatory pressures grow on the US and European pharmaceutical industry, it is expected to further propel the growth in the Indian clinical trial market.

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