1. Executive Summary
1.1 This Report Provides Crucial, Hard-to-Find Clinical Trials Data
1.2 Summary Points of This Report
1.3 Aims, Scope and Format of Report
1.3.1 Market Growth or Rising Costs?
1.3.2 Chapter Outlines
1.4 Research and Analysis Methods
2. Introduction to Clinical Trials
2.1 Costs of Clinical Trials
2.2 Brief History of Clinical Trials
2.2.1 The Nuremberg Code
2.2.2 The Declaration of Helsinki
2.2.2.1 The Declaration of Helsinki and Consent
2.2.2.2 The Declaration of Helsinki and the Use of Placebo
2.2.2.3 The Declaration of Helsinki and Individuals vs. Society
2.2.2.4 The Declaration of Helsinki Replaced with Alternative Documents
2.2.3 Council for International Organizations of Medical Sciences (CIOMS)
2.2.4 Establishing International Standards for Good Clinical Practice
2.2.5 The FDA's New Rules for Acceptable Foreign Clinical Studies
2.3 Pre-Clinical Drug Studies
2.3.1 Animal Models
2.3.2 The FDA's Phase 0
2.4 Standard Clinical Phases: Phase I-III Trials
2.4.1 Phase I Trials
2.4.2 Phase II Trials
2.4.3 Phase III Trials
2.4.4 Phase IV Trials: Post-Marketing Surveillance
2.5 Basic Principles of Clinical Trial Design
2.5.1 The Placebo Effect
2.5.2 Inclusion Criteria and Exclusion Criteria
2.5.3 Randomisation of Subjects
2.5.4 Blinded Trials
2.5.5 Endpoints
2.6 Adaptive Clinical Trial Designs
2.6.1 Adaptive Trials and Staging
2.6.2 Adaptive Trials and Blending Phases
2.6.3 Adaptive Trials, the FDA and the EMA
2.6.4 Academia Setting the Standard?
2.7 Clinical Trials and Genetic Tests
2.7.1 Genetics and Micro-Arrays
2.7.2 Toxicity Libraries
2.8 Clinical Data Management Systems
2.8.1 Clinical Trials Data Management Systems: Electronic Data Capture
2.8.2 Hurdles Faced by Investigators in Implementing EDC
2.8.3 Clinical Data Interchange Standards Consortium
3. Global Clinical Trials Sector, 2009-2025
3.1 Global Clinical Trials Sector in 2009
3.1.1 Leading National Sectors for Clinical Trials, 2009
3.1.2 Trials Overseen by In-House Clinical Development Teams
3.2 Global Clinical Trials Spending Forecast, 2010-2025
3.2.1 Fighting the Economic Crisis
3.2.2 The Global Clinical Trials Sector: How Much Expansion is Possible?
3.2.3 Sector Growth from 2020-2025
3.2.4 Changing Shares in the Sector – Where Will be the Highest Gains?
3.3 US and Canada: Spending Prospects
3.3.1 North America Spending Share 2010 to 2025
3.4 Western Europe: Spending Prospects
3.4.1 Western Europe Spending Share 2010 to 2025
3.5 Central and Eastern Europe (CEE): Spending Prospects
3.5.1 CEE and Russia Share Rising Significantly
3.5.2 Russia: Prospects from 2010
3.6 India: The Fastest-Growing Outsourcing Destination?
3.6.1 India's Spending Share 2010 to 2025
3.6.2 India as a Case-Study
3.6.2.1 Benefits and Concerns for India as a Location for Clinical Research
3.6.2.2 India Needs More Research Personnel
3.6.2.3 Short- and Long-Term Personnel Goals
3.7 China: Promising but Problematical
3.7.1 China's Share Growing: Prospects from 2010 to 2025
3.8 Other Emerging Clinical Trial Destinations
3.8.1 Latin America
4. Clinical Research Outsourcing Market, 2010-2025
4.1 Contract/Clinical Research Organisations (CROs)
4.2 Global CRO Market, 2009
4.2.1 Value by Phase of Clinical Development, 2009
4.2.2 Value by Sponsor Type, 2009
4.2.3 Value by Leading Company, 2009
4.3 Global CRO Market Forecast, 2010-2025
4.3.1 Value of CROs Rising
4.3.2 Increasing CRO Market Penetration from 2010 to 2025?
5. Leading Companies in the Global CRO Market
5.1 Quintiles
5.1.1 Overview
5.1.2 Recent Development and Growth Strategies
5.1.2.1 Quintiles Increases Capacity in Africa
5.1.2.2 Expanded Phase I Capacity
5.1.2.3 Strategic Alliances
5.2 Covance
5.2.1 Overview
5.2.2 Financial Performance
5.2.3 Recent Development and Growth Strategies
5.2.3.1 Preclinical and Phase I Sites
5.2.3.2 Geographical Expansion into Emerging Markets
5.2.3.3 Expansion into Biomarker and Drug Discovery Services
5.2.3.4 Covance and Eli Lilly
5.3 PPD
5.3.1 Overview
5.3.2 Financial Performance
5.3.3 Recent Development and Growth Strategies
5.3.3.1 Expansion in Emerging Regions
5.3.3.2 Capturing Opportunities in Biologics and Vaccines Development
5.3.3.3 Risk Sharing to Proprietary Drug Development
5.4 Charles River Laboratories (CRL)
5.4.1 Overview
5.4.2 Financial Performance
5.4.3 Recent Development and Growth Strategies
5.4.3.1 Increasing Operational Efficiency in PCS Segment
5.5 Parexel
5.5.1 Overview
5.5.2 Financial Performance
5.5.3 Recent Development and Growth Strategies
5.5.3.1 Expanding Capacity and Capabilities for Early-Phase Research
5.5.3.2 Operational Developments in China
5.6 ICON
5.6.1 Overview
5.6.2 Financial Performance
5.6.3 Recent Development and Growth Strategies
5.6.3.1 Extension of Partnership with Eli Lilly
5.6.3.2 Expanding Capacity and Capabilities for Early-Phase Research
5.6.3.3 Increasing Presence in Asia
5.7 Kendle
5.7.1 Overview
5.7.2 Financial Performance
5.7.3 Recent Development and Growth Strategies
5.7.3.1 Kendle and DecisionLine
5.7.3.2 Focus on High-Growth Regions
5.8 PRA International
5.8.1 Overview
5.8.2 Financial Performance
5.8.3 Recent Development and Growth Strategies
5.8.3.1 Operational Expansion in Latin America and Asia
5.9 PharmaNet Development Group (Formerly SFBC International Inc.)
5.9.1 Overview
5.9.2 Financial Performance
5.9.3 Recent Development and Growth Strategies
5.9.3.1 Expanding Geographical Footprint
5.10 ReSearch Pharmaceutical Services (RPS)
5.10.1 Overview
5.10.2 Financial Performance
5.10.3 Recent Development and Growth Strategies
5.10.3.1 RPS Acquired Four CROs in Four Months
5.11 MDS Pharma Services
5.12 CMIC
5.13 Omnicare Clinical Research
5.14 The Clinical Trial Company (TCTC)
5.15 Chiltern International, Ltd.
5.15.1 Financial Performance
5.15.2 Recent Development and Growth Strategies
5.15.2.1 Expanding Presence in Latin America
5.16 Averion International Corp.
5.16.1 Averion Doubled Workforce by Acquiring Hesperion
5.17 Veeda Clinical Research
5.18 Synexus Clinical Research
5.19 Clininvent/TCG Lifesciences
5.20 Amarex
6. Industry Trends from 2010
6.1 Globalisation of Clinical Trials/Off-Shoring
6.1.1 Emerging Regions Achieve Increase in Clinical Activity
6.1.2 International Investigation Sites Registering for FDA Approval
6.1.3 CROs Leveraging the Benefits of Emerging Markets
6.2 Changing CRO Business Models
6.3 Consolidation of the CRO Industry
6.4 Technology Trends
6.4.1 Patient-Centred Clinical Trials
6.5 Biomarkers
7. SWOT Analysis of the Clinical Trials Sector
7.1 Strengths and Weaknesses of the Sector
7.2 Opportunities
7.2.1 The Effect of Thinner R&D Pipelines in the Pharma Industry
7.2.2 Growing Demand for Biotech Drugs and Targeted Therapy
7.2.3 Development of Biosimilars
7.2.4 Adaptive Trials
7.2.5 Outsourcing of New Services
7.2.5.1 Drug Discovery
7.2.5.2 Biomarkers
7.2.6 Electronic Data Capture (EDC): Complementing Strategic Outsourcing
7.2.7 Strains on the Blockbuster Model
7.3 Threats
7.3.1 Tightening Regulations
7.3.2 Continuing Challenges for Emerging Outsourcing Markets
7.3.2.1 Genetic/Ethnic Differences and their Relevance for Pharmacotherapy
7.3.2.2 Ethics for Outsourced Trials – Challenges and Developments
7.4 Pharmaceutical Companies and CROs – Synergies and Challenges
7.4.1 Increasing Competition: Potential Threat to CROs
7.5 Perspectives on Benefits/Gains: Pharmaceutical Companies and CROs
8. Opinion from Industry Experts
8.1 Dr Fabio Thiers, Director, Global Clinical Trials Research Program, MIT
8.1.1 Future of Clinical Trials Market and Attractiveness of Emerging Destinations
8.1.2 The Future of Outsourcing
8.1.3 Outsourcing Opportunities by Phase of Development
8.1.4 Outsourcing Opportunities by Therapeutic Area
8.1.5 CRO Market Consolidation
8.1.6 Regulations and Clinical Trials Market
8.1.7 Industry Drivers and Restraints
8.2 Dr Kevin Schulman, Associate Director, Duke Clinical Research Institute; Director, Fuqua Health Sector Management Program, Duke University
8.2.1 Future of Clinical Trials Market and Attractiveness of Emerging Destinations
8.2.2 The Future of Off-Shoring
8.2.3 The Future of Outsourcing
8.2.4 Outsourcing Opportunities by Phase of Development
8.2.5 Outsourcing Opportunities by Therapeutic Area
8.2.6 CRO Market Consolidation
8.2.7 Industry Drivers and Restraints
9. Conclusions
9.1 Global Clinical Trials Market
9.1.1 Off-Shoring and Outsourcing
9.2 The Growth of CROs
9.2.1 Increasing Competition Among CROs
9.2.2 Increased Regional Competition
9.3 The Short-Term Future of the Sector
9.4 The Longer-Term Future of the Sector
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