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Clinical Trials

Industry Insight Clinical Trials in India 2007


Publication Date   May 2007
Publisher   Cygnus
Product Type  
Pages   269
ISBN Number   not applicable
Product Code   CYG074
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Price £400.00

approximately: $614 | €471

Summary


Indian clinical trials market in 2006 was US$ 140m and is growing at a CAGR of 40% for the last 3 years. India is fast emerging as a favoured destination for clinical trials outsourcing, in view of the country's advantages like large pool of patients, faster patient recruitment, well trained English speaking Physicians and IPR protection, besides lower costs. Over 100 pharmaceutical companies, including Fortune 100 companies such as Pfizer and Merck, are currently outsourcing clinical trials in the country. Also, there is an increased awareness regarding ICH-GCP (International Conference on Harmonisation-Good Clinical Practice) guidelines for conduct of clinical research. Besides, India's inherent advantage in IT skills helped in outsourcing of high-end activities like data management. All these advantages will drive the growth of Clinical Trial Outsourcing industry to scale up to US$ 600m by 2010.

  • ? This report discusses in detail the nature of the Indian clinical trials market, its size, costs incurred and Indian advantages and future outlook for the industry.
  • ? The report also examines overview of the Indian clinical trials market scenario and is compared with the global industry size.
  • ? This report also analyses the critical success factors driving the industry and issues relating to infrastructure constraints and technical expertise.
  • ? This report profiles thirty two major Indian companies covering aspects like services offered, key people, clinical phases and financials for the last two years.
  • ? Issues Relating to Government regulations, governing clinical trials, along with details on Good Clinical Practices and ICH Regulations have been covered
  • ? The report talks about future outlook, outsourcing opportunities, industry dynamics and also growth and change in the industry.

The report will be useful to

  • Contract Research Organizations.
  • Pharmaceutical companies
  • Banks & financial companies
  • Investors
  • The pharmaceutical educational institutes
  • Government departments,
  • Research bodies,
  • Industry experts,
  • Associations & consortia
  • Consulting organizations

Content


  • 1. Introduction
    • 1.1 A 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 Advantages 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
      • 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 Zydus Cadila
      • 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 Categor Ies Of Herbal Products
      • 7.5.2 Guidel Ines
    • 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
      • 7.9.4 India Exempts Some Clinical Research From Service Tax
    • 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
  • 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 Cl Inical 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 Countrys 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 Addressing The Challenges
  • 9. Future Outlook