Clinical Trials Market 2006, The

Summary

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The global clinical trials industry is currently worth an estimated $10 billion and has the potential for considerable growth in the future. Global revenues from clinical trials have increased by almost 15% in the last year and the industry is prepared for an extended period of healthy growth. Concern over safety and an extremely competitive pharmaceutical market has driven demand for large clinical trials but will also radically change how clinical trials are regulated and designed. This report discusses the dynamic future of the clinical trials market.

Will the current trend to outsource clinical trials to Asia be successful? How will the emerging discipline of pharmacogenomics affect drug development in the future? What kind of restrictions will authorities such as the FDA and the EMEA impose in the future? Read visiongain's brand new report to find out.

The report investigates these key issues:

• How changes to the attitudes of regulatory authorities will effect the nature of clinical trials
• The role of public education for improved patient recruitment?
• An assessment of clinical trials in developing countries, including SWOT analysis
• A review of clinical trials in India and China
• A financial forecast for the global clinical trials market 2005-2011
• A geographic breakdown of the clinical trials market, including US, Europe, and Asia (including Japan) 2005-2011
• The growth of contract research organisations in clinical trials: including company profiles of the top 10 CROs
• How can new technology such as electronic data capture (EDC) and pharmacogenomics be successfully integrated into clinical trials?

Why you should buy this report

The world pharmaceutical market looks set to undergo a major transformation following the ensuing loss of present blockbuster drugs. Efficient clinical trials are going to be vital for success and all pharmaceutical companies and CROs need to remain responsive to future changes in this fast moving market. This report gives invaluable insight into what visiongain believes are the major challenges for clinical trials in the years to come.

Contents

• 1. Executive Summary
  • 1.1 Aims and Scope of The Clinical Trials Market 2006 Report
• 2. Introduction
  • 2.1 Brief History of Clinical Trials
    • 2.1.1 The Nuremberg Code and The Declaration of Helsinki
    • 2.1.2 Establishing Standards for Good Clinical Practice and the International Conference on Harmonisation
  • 2.2 Different Stages of Clinical Trials
    • 2.2.1 Phase I Trials
    • 2.2.2 Phase II Trials
    • 2.2.3 Phase III Trials
    • 2.2.4 Phase IV Trials (post-marketing surveillance)
    • 2.2.5 Further Division of Trials
  • 2.3 Basics Principles in the Design of Clinical Trials
    • 2.3.1 The Placebo Effect
    • 2.3.2 Inclusion Criteria and Exclusion Criteria
    • 2.3.3 Randomisation of Subjects and Blinded Trials
    • 2.3.4 Endpoints
  • 2.4 The World Branded Pharmaceutical Market
    • 2.4.1 Summary of the Global Pharmaceutical Market
    • 2.4.2 Leading Branded Drugs and Pharmaceutical Companies
  • 2.5 The Branded Pharmaceutical Industry Will Struggle to Maintain Considerable Growth
• 3. Outsourcing Clinical Trials to Developing Countries
  • 3.1 A SWOT Analysis of Outsourcing Clinical Trials
  • 3.2 Many Factors are Considered When Deciding Clinical Trial Location but Quality of Data Should Be Paramount
  • 3.3 India as a Model for Rapid Growth in the Clinical Trials Industry
    • 3.3.1 Expanding Pharmaceutical Investment in India is Led by Clinical Trials
    • 3.3.2 Changes to the Law Have Caused Rapid Growth of Clinical Research
    • 3.3.3 Rapid Recruitment is Driven by a Large Willing Patient Population and an Organised Healthcare System 3.3.4 Ethical Considerations
    • 3.3.5 What is India Doing to Promote Clinical Research?
    • 3.3.6 Forecast: What is the Future of Indian Clinical Research?
  • 3.4 China Faces Real Challenges to Establish Itself in the Clinical Trials Market
    • 3.4.1 China's Large Treatment-Nave Population is Attracting Investment but Healthcare Infrastructure Needs to be Improved
    • 3.4.2 Rapid Growth of the Pharmaceutical Market Will Drive Clinical Research in China
    • 3.4.3 Enforcement of Intellectual Property Law is the Most Pressing Issue for China
    • 3.4.4 Lack of Clinical Trial Standardisation Will Also Inhibit Growth
    • 3.4.5 It Will Take Time for China to Fulfil its Potential
  • 3.5 Central and Eastern Europe: Location and Quality Are Key Issues
• 4. How Regulatory Bodies Will Reform the Governance of Clinical Trials
  • 4.1 The FDA - Gatekeepers to the Largest Pharmaceutical Market in the World
    • 4.1.1 The FDA is Under Pressure to Tighten Up Drug Approval Procedures
  • 4.2 Europe: The European Medicines Agency (EMEA)
    • 4.2.1 The EU Clinical Trials Directive
  • 4.3 Japan Has a High Level of Regulation
    • 4.3.1 Re-examination and Re-evaluation - Concepts that Could Establish Themselves Globally
  • 4.4 Safety and Speed are Now Pressing Issues for Regulatory Authorities
  • 4.5 The Use of Phase IV Clinical Trials is Set to Soar
  • 4.6 Phase IV Studies are Growing Due to Safety Concerns
  • 4.7 Self-Monitoring of Patients Will Become More Established 4.7.1 The Yellow Card System is a Well Established Example of Post-approval Monitoring
  • 4.8 Stringent Assessment of Risk will Require More Patients and Better Indicators of Risk 4.9 Education is a Key Issue
  • 4.10 Summary: Changes in the Way Drugs are Regulated Will Change the Nature of Clinical Trials
• 5. Patient Recruitment
  • 5.1 Patient Recruitment is Key to Cost and Quality
  • 5.2 Patient Attitude to Trials Inhibits Recruitment
    • 5.2.1 Education and Communication Can Help Both Patient Recruitment and Retention
    • 5.2.2 Advertising Must Provide Value for Money
    • 5.2.3 Safety Is Now a Major Issue for Recruitment
  • 5.3 The Physician Also Has a Vital Role to Play in Patient Recruitment
• 6. The Top Ten Global CROs
  • 6.1 An Example of a Global CRO - Quintiles Reflects the Changes in the Clinical Trials Market
    • 6.1.1 A Global Company is Required for Global Trials: Quintiles Fulfils that Role 6.1.2 Sale of Business Units Indicates a Strong Emphasis on Late Phase Trials 6.2 Covance Successfully Combines Pre-Clinical Research with Late Phase Organisation 6.3 PPD: The Third-Largest CRO
  • 6.4 MDS Pharma Services Expands Early-Phase Development
  • 6.5 PAREXEL Has Recovered From a Period of Low Growth
  • 6.6 SFBC International Will Continue to Have High Growth
  • 6.7 Icon's Growth Rates Have Stalled
  • 6.8 PRA Has the Second-Lowest Growth Rates of all CROs in the Top Ten
  • 6.9 Kendle International Returns to Growth After Reorganisation Slump
  • 6.10 Omnicare Clinical Research
  • 6.11 Summary: The Top Ten CROs Take 50% of the Global Clinical Trials Market
• 7. Technological Advances and Clinical Trial Design
  • 7.1 Electronic Data Capture (EDC)
    • 7.1.1 EDC Promises to Streamline Clinical Trials
    • 7.1.2 Training and Security are Barriers to EDC Conversion 7.1.3 The Clinical Trials Industry Must Take the Initiative on EDC Standards
  • 7.2 Pharmacogenomics and Molecular Profiling
    • 7.2.1 Pharmacogenomics has the Potential to Revolutionise the Pharmaceutical Industry
    • 7.2.2 The Progress of Pharmacogenomics Has Been Slow
    • 7.2.3 Identification of Expression Profiles in Pre-Clinical Models
    • 7.2.4 Phase I and II Clinical Trials Will Incorporate More Complex Screening Techniques
• 8. Clinical Trials Market Forecast
  • 8.1 Market Forecast 2005-2011
    • 8.1.1 The Global Clinical Trials Market Will Display Strong Growth
    • 8.1.2 The US and Europe Will Lose Market Share to Asia
    • 8.1.3 Increased Costs and Numbers of Clinical Trials Will Drive the Market 8.2 Summary
• 9. Conclusion: The Clinical Trials Market Will Experience Substantial Growth and Change
  • 9.1 The Clinical Trials Market in Asia Will Expand - India and China Will Lead the Way
  • 9.2 Safety Concerns and Development Pressures Will Change the Structure of Clinical Trials
• List of Tables
  • Table 2.1, Key Stages in the History of Clinical Trials
  • Table 2.2, World Pharmaceutical Market ($bn), 2000-2004
  • Table 2.3, World Pharmaceutical Market ($bn) by Region, 2004
  • Table 2.4, Top Ten Countries by Pharmaceutical Revenue, 2004
  • Table 2.5, Top Ten Drugs by Revenue ($m), 2004
  • Table 2.6, Top Ten Pharmaceutical Companies by Revenue, 2004
  • Table 2.7, Top Ten Drug Categories by Revenue ($m), 2004
  • Table 2.8, Drugs in Development Pipeline by Therapeutic Area
  • Table 3.1, SWOT Analysis of Outsourcing to Developing Countries, 2006
  • Table 3.2, Estimated Cost ($m) of Clinical Trials in the US and India, 2006
  • Table 3.3, Comparison of Disease Prevalence (m) in the US and India
  • Table 3.4, Disease Prevalence (m) in China, 2006
  • Table 4.1, Drug Approvals Agencies Within the EU, 2006
  • Table 5.1, Reasons Given for Non-Participation in Clinical Trials, 2006
  • Table 6.1, Leading CROs by Total Revenue ($m), 2004-2005
  • Table 6.2, Leading CROs by Clinical Trial Revenue Only ($m), 2004-2005
  • Table 6.3, Growth of Covance Revenues ($m) for Early and Late Development, 2002-2005 Table 6.4, Revenues ($m) for PPD, 2002-2005 Table 6.5, Revenues ($m) for MDS Pharma, 2002-2005 Table 6.6, Revenues ($m) for PAREXEL, 2002-2005
  • Table 6.7, Revenues ($m) for SFBC International, 2002-2005
  • Table 6.8, Revenues ($m) for Icon, 2002-2005
  • Table 6.9, Revenues ($m) for PRA, 2002-2005
  • Table 6.10, PRA Clinical Trial Revenues ($m) by Country, 2004
  • Table 6.11, Revenues ($m) for Kendle International, 2002-2005
  • Table 6.12, Kendle International Clinical Trial Revenues ($m) by Country, 2004
  • Table 6.13, Revenues ($m) for Omnicare CR, 2002-2005
  • Table 7.1, Assessment of EDC Solutions, 2006
  • Table 8.1, Clinical Trials Revenue ($m), 2004-2011
  • Table 8.2, Market Shares and CAGR for the Clinical Trials Market by Country/Region, 2004-2011
  • Table 9.1, The Clinical Trials Industry by Revenue ($m) and Country Region, 2011
• List of Figures
  • Figure 3.1, Factors Affecting Clinical Trial Location
  • Figure 3.2, Clinical Trial Revenues ($m) in India, 2005-2011
  • Figure 3.3, Clinical Trial Growth Rates (%) in India, 2005-2011
  • Figure 3.4, Profile of the Chinese Pharmaceutical Market, 2000
  • Figure 3.5, Profile of the Chinese Pharmaceutical Market, 2010
  • Figure 5.1, Delay Observed in Clinical Trials, 2006
  • Figure 5.2, Clinical Trials Recruitment Spending ($m), 1998-2002
  • Figure 5.3, Attitude of the Public to Volunteering for Clinical Trials, 2005
  • Figure 6.1, Global Top Ten CROs by Revenue ($m), 2005
  • Figure 6.2, Top Ten CROs by Market Share (%), 2005
  • Figure 6.3, Revenues ($m) from Quintiles Developmental Services Group, 2002-2005
  • Figure 6.4, Growth Rate (%) for Quintiles Clinical Services Revenues, 2003-2005
  • Figure 6.5,Revenues ($m) for Covance, 2002-2005
  • Figure 6.6, Revenues ($m) for PPD, 2002-2005
  • Figure 6.7, Clinical Service Revenues ($m) for MDS Pharma Services, 2002-2005
  • Figure 6.8, Clinical Service Revenues ($m) for PAREXEL, 2002-2005
  • Figure 6.9, Total Revenues ($m) SFBC International, 2002-2005
  • Figure 6.10, Total Revenues ($m) Icon, 2002-2005
  • Figure 6.11, PRA Clinical Trials Revenues ($m), 2002-2005
  • Figure 6.12, PRA Clinical Trial Revenues ($m) by Country, 2004
  • Figure 6.13, Kendle International Clinical Trials Revenues ($m), 2002-2005
  • Figure 6.14, Kendle International Clinical Trial Revenues ($m) by Country, 2004
  • Figure 6.15, Omnicare CR Clinical Trials Revenues ($m), 2004-2005
  • Figure 8.1, Total Clinical Trials Revenue ($m), 2004- 2011
  • Figure 8.2, Clinical Trial Market Share (%) by Region, 2004
  • Figure 8.3, Clinical Trial Market Share ($%) by Region, 2011
  • Figure 8.4, Revenues ($m) of the Clinical Trials Industry by Region, 2004-2011
  • Figure 8.5, Growth Rates (%) for the Clinical Trials Market by Region, 2005-2011
  • Figure 8.6, Median Cost per Patient by Therapeutic Area (US), 2003
  • Figure 8.7, Number of Clinical Trials Worldwide, 2000-2003
• Companies Mentioned
  • Abbot Laboratories
  • Aptuit
  • AstraZeneca
  • Beacon Bioscience
  • Bristol-Myers Squibb
  • Charles River
  • Covance
  • Eli Lilly
  • FALCO Biosytems
  • GFI clinical services
  • GlaxoSmithKline
  • Icon
  • Johnson & Johnson
  • Kendle International
  • MDS Pharma Services
  • Merck and Co.
  • Novartis
  • Omnicare CR
  • PAREXEL
  • Pfizer PRA
  • Quintiles
  • Roche
  • Sanofi-Aventis
  • SFBC International
  • West Pharmaceutical Services, Inc
  • Wyeth