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
- Analysis of the leading therapeutic areas under clinical research in India
- Key drivers and barriers that have a significant impact on the clinical trials market.
- Competitive benchmarking of leading companies.
- Key M&A activities and strategic partnership deals that have taken place in 2009
Table of Contents :
1 Table of Contents 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
For more information, please visit :
http://www.aarkstore.com/reports/Emerging-Markets-for-Clinical-Trials-in-India-Favorable-Regulatory-Environment-and-Cost-Effectiveness-Will-Accelerate-the-Number-of-Clinical-Trials-91893.html
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