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Clinical Trials


Clinical Trails in India


Publication Date   January 2008
Publisher   Cygnus
Product Type   Report
Pages   130
ISBN Number   not applicable
Product Code   CYG076
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Price £600.00

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Summary


A clinical trial is a research study, comprising human volunteers, to test the effectiveness of a new drug. In other words, clinical trials are carried out to find out if proposed treatments work on human beings. A clinical trial for a specific drug takes nearly 9 to 10 years to reach the completion stage.The global clinical trials market is expected to be worth USD16 billion by 2008, up from USD10 billion in 2005 and is growing at 15-18%. Clinical research industry in India touched USD140 million in 2006, up from USD70-80 million in 2001-02 and has been estimated to touch USD200 million by 2007 and USD500-600 m by 2010.

A clinical trial is a long-drawn out process, globally costing anywhere between USD350 and USD500 million. Not surprisingly, a significant share (30%) of clinical trials is now outsourced to Contract Research Organisations (CROs).At a given time, over 3,500 drugs are under development and about 4,000 clinical trial projects are in progress for new drug applications.The report presents Global and indian scenario for clinical trials market in terms of recent trends,major diseases,Pre-clinical trails,regulatory developments etc.

The report covers market scenario in terms of R&D expenditure,drug withdrawals,research on drug price controls etc. The Report profiles listed and unlisted major players with Introduction,Clinical trails expertise,regulatory approvals & recognitions,Collaborations,Financial details etc.Clinical trails report presents information on technology aspects in the industry such as drug design,biochemistry of drugs etc.clinical trails report has highlighted the major growth drivers in the industry along with critical success factors.

It provides information on the regulatory issues in india.clinical trails report presents the information on the issues & challenges in the industry.At the end It presents the future outlook of the clinical trails industry .

Content


  • Executive
  • Summary
  • Highlights
  • 1.Introduction
    • 1.1a Brief History
    • 1.2 Effectiveness and Safety
    • 1.3 Clinical Trials: Benefits Galore
    • 1.3.1 Research and Innovation
    • 1.3.2 Increasing R&D Spend of Indian Companies
    • 1.3.3 Investigational New Drug Application (Ind)
    • 1.4 Global Scenario
    • 1.5 Indian Scenario
    • 1.5.1 Rising Tide of Research and Clinical Trials
    • 1.5.2 India as A Destination for Cros
    • 1.5.3 Potential of Cro Industry
    • 1.5.5 Major Diseases
    • 1.5.6 Infrastructure Facilities
    • 1.5.7 Competitors in The Sector
    • 1.5.8 Laboratory Trials (Pre-Clinical Trials)1.5.9 Recent Trends
    • 1.5.10 Trends in Drug Development
    • 1.5.11 Regulatory Developments
    • 1.5.12 Ethical Review Boards
  • 2. Market Scenario
    • 2.1 Global Scenario
    • 2.1.1 Worldwide New Drug Launches
    • 2.1.2 Biotech/Biological Launches
    • 2.1.3 Laboratory-Developed Tests
    • 2.1.4 Inspections
    • 2.1.5 Education and Training Requirements
    • 2.1.6 Quality Control
    • 2.2 R&D Expenditure
    • 2.3 Drug Withdrawals/Clinical Trial Failures
    • 2.4 Research on Drug Price Controls
    • 2.4.1 Loss of Future Drug Therapy
    • 2.4.2 Slowdown in Drug Availability
    • 2.5.1 Indian Companies
    • 2.5.2 Multinational Companies
    • 2.5.3 Business Model (Models of Clinical Trials Outsourcing)using Subsidiary Medical Departments; Setting up in House Delicate Clinical Operations; Back Office Services Support; Providing Infrastructure for The Clinical Trials
    • 2.5.4 Target Customers
    • 2.5.5 R& Budget Break up
    • 2.5.6advantages Offered by India in Clinical Trials Domain
    • 2.5.4 Outsourcing Clinical Trials
    • 2.5.5 Clinical Trial Components
    • 2.5.5 Support Services in Clinical Trials
    • 2.5.6 Market Related Factors
  • 3. Major Players
    • 3.1 Market Size
    • 3.2 Tata Memorial Centre
    • 3.3 The Players Listed in Bse / Nse
    • 3.3.1 Clinigene
    • 3.3.2 Dr Reddy's Laboratories Limited
    • 3.3.3 Glaxosmithkline
    • 3.3.4 Lupin Limited
    • 3.3.5 Novartis
    • 3.3.6 Pfizer Limited
    • 3.3.7 Ranbaxy Laboratories Limited
    • 3.3.8 Torrent Pharmaceuticals Limited
    • 3.3.9 Vimta Labs Limited
    • 3.3.10 Cadila Healthcare Unlisted in Bse / Nse
    • 3.3.11 Asian Clinical Trials Limited
    • 3.3.12 Bioserve Clinical Research Pvt. Ltd
    • 3.3.13 Clininvent Research Pvt. Ltd.,
    • 3.3.14 Clintec International
    • 3.3.15 Eli Lilly and Company (India) Pvt. Ltd
    • 3.3.16 Igate Clinical Research International
    • 3.3.17 Intas Pharmaceuticals
    • 3.3.18 Johnson & Johnson, India
    • 3.3.19 Lambda Therapeutic Research Ltd
    • 3.3.20 Lotus Labs Pvt. Ltd.
    • 3.3.21 Matrix Laboratories Ltd.
    • 3.3.22 Merck Limited
    • 3.3.23 Novo Nordisk India Private Ltd.
    • 3.3.24 Pharmanet
    • 3.3.25 Quintiles Research (India) Private Limited
    • 3.3.26 Reliance Clinical Research Services
    • 3.3.27 Roche India Ltd.,3.3.28 Sanofi-Aventis (Aventis Pharma Limited)
    • 3.3.29 Siro Clinpharm Pvt Ltd.
    • 3.3.30 Srl Ranbaxy
    • 3.3.31 Sristek
    • 3.3.32 Synchron Research Pvt. Ltd.
    • 3.4 Support Services
    • 3.4.1 Companies Entering into Support Services
    • 3.4.2 It-Pharma Ventures
    • 3.4.3 Other It/Ites Companies' Bio-Initiatives
    • 3.4.4 Future of Support Services
  • 4. Technology
    • 4.1 Drug Development
    • 4.2 Biochemistry of The Drugs
    • 4.3 Drug Design
    • 4.3.1 The Challenges in Drug Design
    • 4.3.2 Computers in Drug Design
    • 4.3.3 Rachel Software Package
    • 4.4 Animal Studies
    • 4.5 Field Studies
    • 4.6 Bioavailability (Ba) / Bioequivalence (Be) Studies
    • 4.6.1 Types of Studies
    • 4.6.2 Facilities for Conducting Bioavailability and/or Bioequivalence Studies
    • 4.7 Recent Trends in Technology
  • 5. Growth Drivers
    • 5.1 Claims of Superiority
    • 5.2 Availability of Patients
    • 5.3 Infrastructure Facilities
    • 5.3.1 Availability of Animal Houses
    • 5.3.2 Hospitals
    • 5.3.3 Facilities for Clinical Trials
    • 5.3.4 Biotechnology Laboratories
    • 5.4 Drug Development and Price Control
    • 5.4 Reduction in R&D Expenses
    • 5.5 Decrease in Time-to-Market Clinical Trials
    • 5.6 Regulations and Support from Local Bodies
    • 5.7 Fda Approval
    • 5.7.1 Clinical Trials and Fda
    • 5.7.2 Clinical Trial Process
  • 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
  • 7. Regulatiory Issues
    • 7.1 Government Regulations
    • 7.1.1 Fda
    • 7.2 Patent Regime
    • 7.2.1 Importance of Intellectual Property Rights (Ipr)
    • 7.3 Customs Duty
    • 7.4 Gatt / Trips / Wto
    • 7.5 Clinical Evaluation of Herbal Remedies and Medicinal Plants
    • 7.5.1 Categories of Herbal Products
    • 7.5.2 Guidelines
    • 7.6 Unsafe Drugs
    • 7.7 Industry's Growing Influence over Research
    • 7.8 Academia & Industry - Eroding Boundaries
    • 7.9 Regulatory System in India
    • 7.9.1 Exemption of Customs Duty
    • 7.9.2 Tax Benefit
    • 7.9.3 Role of Iacuc
    • 7.10 Regulation of Ethical Issues
    • 7.10.1 Ethics of Patenting Dna
    • 7.10.2 Mental Disorders and Genetics
    • 7.10.3 Animal-to-Human Transplants: Ethics of Xenotransplantation
    • 7.10.4 Human Tissue: Ethical and Legal Issues
    • 7.10.5 Clinical Trials without Ethical Review
    • 7.11 The Fair Prescription Drug Competition Act of 2007
    • 7.12 Relationships with Hospitals for Trial Sponsors
  • 8. Issues and Challenges
    • 8.1 Training for Clinical Trials
    • 8.1.1 Training Opportunities
    • 8.2 Clinical Trials - Design & Management
    • 8.2.1 Good Clinical Practices (Gcp)
    • 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
    • 8.7.1 The Role of Ethics in Clinical Trials
    • 8.7.2 Three Major Ethical Problems
    • 8.7.3 Scientific and Ethical Standards
    • 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
    • 8.13.1 Clinical Trials Conducted outside United States
    • 8.13.2 Clinical Trial Registration
    • 8.13.3 Computerized Clinical Research Systems
    • 8.14 Clinical Trials in India - Challenges
    • 8.14.1 Shortage of Trained Manpower
    • 8.14.2 Segmenting Physicians
    • 8.14.3 Addressing The Challenges Funding:
  • 9.Future Outlook Bibiliography Glossary Annexure