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Clinical Trials in India

Cygnus Business Consulting and Research
September 1, 2011
304 Pages - SKU: CYG6771700

Abstract Table of Contents Search inside this report Related Reports

Countries covered: India

Clinical Trial industry in India touched US$400 million in 2010 and is expected to touch US$1.09 billion by 2014.

Clinical Trials market in India has shown significant growth in the recent past. Clinical Trial industry in India touched US$400 million in 2010, up from US$230 million in 2008 and is expected to touch US$1.09 billion by 2014. The cost of conducting clinical trials in developing countries like India and China is far lower when compared to their developed counterparts. The simple reasons are: Due to the multitude of benefits it offers, India has huge patient base, low cost advantage; can complete clinical trials on time; is improving its infrastructure with a strong government support.

In view of the growth potential and India's strength in pharmaceuticals to qualify for clinical trials, Cygnus has launched the latest edition (7th edition) of Industry Insight - Clinical Trials in India.

SCOPE OF THE REPORT

The report mostly captures secondary information collected from various reliable sources and covers market information, company specific information, regulatory framework, issues and challenges, growth drivers and future outlook.

REASONS TO BUY

Providing an overall view of the industry - Global as well as Indian Clinical Trials Market.
Useful to understand the potential and capabilities of Indian Market
Useful to understand the business opportunities in overseas market
Major Therapeutic R&D Pipeline
Emerging trends in drug dev
Vital details on 32 major players in Indian Market ( listed and Unlisted both in BSE & NSE)
New Regulatory Policies
An analytical report with trends charts & graphs to help you in taking informed decision
Throwing light on the measures being used in the industry to reduce cost and enhance R&D productivity.
Major private equity funding in clinical research in last 5 years

FOR WHOM

Pharma and Biotech companies who want to understand Indian clinical research industry.
Research analysts in the clinical research space,
Investors interested in clinical research based companies,
Students for clinical research who want to pursue career in CROs

Related reports -

Indian Pharmaceuticals
Indian Bulk Drugs
Top 200 Indian Pharma Companies
CRAMS in India
CRO Directory
Clinical Trials in India
Medical Devices & Equipments in India
Monthly Monitors on Pharmaceuticals, Healthcare & medical devices
Quarterly Analysis on Pharmaceuticals, Healthcare & medical devices

EXECUTIVE SUMMARY
HIGHLIGHTS
1. INTRODUCTION: 1.1 A Brief History; 1.2 Effectiveness and Safety; 1.3 Benefits galore; 1.4 Global Scenario; 1.5 Indian Scenario
2. MARKET SCENARIO: 2.1 Global Scenario; 2.2 R&D Expenditure; 2.3 Drug withdrawals/Clinical Trial failures; 2.4 Research on Drug Price Controls; 2.5 Indian Scenario
3. MAJOR PLAYERS: 3.1 The Players; 3.2 Support services
4. TECHNOLOGY: 4.1 Drug Development; 4.2 Biochemistry of the Drugs; 4.3 Drug Design; 4.4 Animal Studies; 4.5 Field Studies; 4.6 Bioavailability (BA) / Bioequivalence (BE) studies; 4.7 Recent Trends in Technology
5. GROWTH DRIVERS: 5.1 Claims of Superiority; 5.2 Availability of Patients; 5.3 Infrastructure Facilities; 5.4 Drug development and price control; 5.5 Reduction in R&D expenses; 5.6 Decrease in Time-to-Market Clinical Trials; 5.7 Regulations and Support from Local Bodies; 5.8 FDA Approval
6. CRITICAL SUCCESS FACTORS: 6.1 Infrastructure; 6.2 Research Design; 6.3 Speed and Quality of Trials; 6.4 Professionally Trained Manpower; 6.5 Hospitals; 6.6 Role of Radiology; 6.7 Product Pricing and Market Analysis; 6.8 Drug Imports; 6.9 Multiple tasks in approvals; 6.10 Government Procedures/Sanctions; 6.11 Obstacles for Indian Biosimilar players; 6.12 Capacity Planning for Drug Developers
7. REGULATORY ISSUES: 7.1 Government Regulations; 7.2 Patent Regime; 7.3 Customs Duty; 7.4 GATT / TRIPS / WTO; 7.5 Clinical Evaluation of Herbal Remedies and Medicinal Plants; 7.6 Unsafe Drugs; 7.7 Industry's Growing Influence over Research; 7.8 Academia & Industry - Eroding Boundaries; 7.9 Regulatory System in India; 7.10 Regulation of Ethical Issues; 7.11 The Fair Prescription Drug Competition Act of 2007; 7.12 Relationships With Hospitals for Trial Sponsors; 7.13 CLINICAL Trials with Controlled drugs; 7.14 Conclusion
8. ISSUES AND CHALLENGES: 8.1 Training for Clinical Trials; 8.2 Clinical Trials - Design & Management; 8.3 Quality of Clinical Trial Data; 8.4 Finding people for trials is always difficult; 8.5 Segmenting Physicians; 8.6 Protecting Research and Research Participants; 8.7 Ethical Problems; 8.8 Illegal Clinical Trials; 8.9 Studies in the Developing World; 8.10 Data Protection; 8.11 Assessing Risks and Benefits; 8.12 Host Country’s Capacity to Review and Conduct Clinical Trials; 8.13 Additional FDA guidelines for conducting trials; 8.14 Clinical Trials in India - Challenges
9. FUTURE OUTLOOK
Annexure 1 BIBLIOGRAPHY
Annexure 2 Glossary
Annexure 3 Good Clinical Practices (GCP)
Annexure 4 A Comparison of FDA versus ICH Regulations
Annexure 5 Good Manufacturing Practices
Annexure 6 A New Chapter Opens
Annexure 7
Annexure 8
List of Figures: Figure 1.1: Global clinical trials expected growth; Figure 1.2: Global CRO market-2010; Figure 1.3: India Clinical trials Market (2006-10); Figure 1.4: Phase wise Distribution of Outsourced Clinical Trials in India-2010; Figure 1.5: Clinical Studies in India till July 2009; Figure 2.1: New molecular Entities (NMEs) Approvals; Figure 2.2: NME Application Filed; Figure 2.3: Percentage Share of Clinical Trials-2010; Figure 2.4: Allocation of R&D Investment-2010; Figure 2.5: R&D budget break up in percentage-2010; Figure 5.1: Transition probabilities for clinical phase; Figure 9.1: India clinical trials market projections (2010-14); Figure 9.2: Demand-Supply Gap 2011 in India
List of Tables: Table 1.1: R&D Expenditure (2008-10) Rs in billion; Table 1.2: Change in number of new trials registration for selected countries; Table 1.3: Cost of clinical trials in US vis-a-vis India; Table 1.4: Clinical Trials without volunteers’ concern (illegal clinical trials in India) 2009. Table 2.1: Ranking by disease-wise in drug development-2010. Table 2.2: R&D Expenditure in 2009& 2010. Table 2.3: Major private equity funding in clinical research. Table 2.4: strength and weakness of services offered by CRO in India and China; Table 2.5: Advantages offered by India in clinical trials; Table 2.6: Leading Indian contract research organizations; Table 3.1: Educational qualifications of personnel employed in the Chemicals and Pharmaceuticals Segments; Table 5.1: Key Therapeutic Areas; Table 5.2: Top R&D spenders-2010; Table 5.3: Stages of Trials; Table 7.1: List of drugs withdrawn from commercial activities; Table 7.2: Targeted Timelines for Approvals

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