1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7
2 Contract Research Outsourcing - Introduction 9
3 Contract Research Outsourcing - Overview 11
3.1 Global Contract Research Outsourcing 11
3.1.1 The Clinical Research Process 12
3.2 Outsourcing of Clinical Research and Trial Processes 13
3.2.1 Clinical Research Outsourcing is Seen as a Solution to Problems Such as Rising Costs or Low Productivity 14
3.2.2 Strategic Outsourcing Delivers Greater Value by Understanding the Core Competencies of the Vendor and Outsourcing Companies 14
3.3 Key Reasons for Outsourcing to Contract Research Organizations 14
3.3.1 Desire to Reduce Costs is a Prime Reason for Contract Research Outsourcing 15
3.3.2 Contract Research Organizations are Engaged in Reducing Time to Market in Order to Achieve a Competitive Edge 15
3.3.3 Outsourcing Critical but Resource and Time Intensive Functions such as Data Management Allows Biopharmaceutical Companies to Focus on Core Competencies 16
3.3.4 Evolving Risk Sharing Agreements Attract Biopharmaceutical Companies to Increase Contract Research Outsourcing 16
3.3.5 Contract Research Organizations are Helping to Improve Clinical Research Quality Through Better Regulatory Understanding and Keeping Pace with Technological Advances 17
3.3.6 Small and Medium Biopharmaceutical Companies can Leverage on the Resources of Contract Research Organizations 17
3.3.7 Biopharmaceutical Companies Benefit from New Technologies that Contract Research Organization Have Access to 17
4 Contract Research Outsourcing - Service Models 19
4.1 Contract Research Outsourcing Service Model 19
4.1.1 Fully Integrated Service Model 19
4.1.2 Functional Service Model 20
4.2 Criteria for Selecting a Contract Research Organization 21
4.3 Early Stage Drug Development Outsourcing 22
4.3.1 Strategic or Tactical Advantages of Outsourcing 22
4.3.2 Case Study 22
4.4 Clinical Stage Drug Development Outsourcing 23
4.4.1 Strategic or Tactical Advantages of Outsourcing 23
4.4.2 Case Studies 23
4.5 Late Stage Development Outsourcing 25
4.5.1 Strategic or Tactical Advantages of Outsourcing 25
5 Contract Research Outsourcing - Market Characterization 27
5.1 The Contract Research Outsourcing Market will Continue to Grow, Driven by the Demand by the Biopharmaceutical Industry 27
5.2 Key Market Drivers 28
5.2.1 Increasing R&D Expenditure and Decreasing Productivity in the Biopharmaceutical Industry - Promoting R&D Outsourcing 28
5.2.2 Stringent Regulations and Complex Clinical Trials Forcing Biopharmaceutical Companies to Leverage on the Contract Research Organizations 31
5.2.3 Restriction on Pricing and Reimbursement of Drugs - Need for Managing Costs from Earliest Stages of Development 31
5.2.4 The Increasing Number of Clinical Trials 32
5.3 Key Market Restraints/ Challenges 33
5.3.1 Quality Concerns 33
5.3.2 Economic Recession 34
5.4 Contract Research Outsourcing - Market Trends 34
5.4.1 The Number of Services Focusing on the Late Stage Clinical Development is Increasing 35
5.4.2 The Clinical Research and Trials are Becoming more Globalized 36
5.4.3 Pharmaceutical Companies are Moving to Strategic Partnerships with Contract Research Organizations 37
5.4.4 Emerging Tools to Enhance Drug Discovery Process Will be Key Drivers in the Future 37
5.5 Contract Research Outsourcing - Unmet Needs 38
5.5.1 High Technology Needs and Integration 38
5.5.2 Lack of Therapeutic Expertise 38
5.5.3 Contract Research Organizations are Short of Experienced Research Professionals to Conduct the Clinical Trial Studies 38
6 Contract Research Outsourcing - Geographical Landscape 39
6.1 Emerging Regions in the Global Contract Research Outsourcing Market 40
6.1.1 Latin America 40
6.1.2 Central and Eastern Europe (CEE) 40
6.1.3 India 41
6.1.4 China 42
7 Contract Research Outsourcing - Regulatory Issues 44
7.1 Contract Research Organizations are Subject to the Same Regulations as Biopharmaceutical Companies 44
7.1.1 Regulation in the Drug Discovery Stage 45
7.1.2 Regulation in the Preclinical Stage 45
7.1.3 Regulation in the Clinical Trials Stage 45
7.2 Regulations Governing Outsourcing to Other Regions 46
8 Contract Research Outsourcing - Competitive Landscape 48
8.1 Overview 48
8.2 Market Share Analysis 49
8.3 Competitive Profiling 50
8.4 Quintiles Transnational Corp. 51
8.4.1 Snapshot 51
8.4.2 Business Description 51
8.4.3 Recent M&A Deals and Strategic Alliances 51
8.5 Covance Inc. 53
8.5.1 Business Description 53
8.5.2 Recent M&A Deals and Alliances 53
8.6 Pharmaceutical Product Development (PPD) Inc. 54
8.6.1 Business Description 54
8.6.2 Recent M&A Deals and Alliances 55
8.7 Charles River Laboratories International, Inc. 56
8.7.1 Business Description 56
8.7.2 Recent M&A Deals and Alliances 57
8.8 PAREXEL International 57
8.8.1 Business Description 58
8.8.2 Recent M&A Deals and Alliances 58
9 Contract Research Outsourcing - Deals Analysis 59
9.1 Mergers and Acquisitions 59
9.1.1 Quintiles Acquires Targeted Molecular Diagnostics 60
9.1.2 Quintiles Acquires Bio-Trials 60
9.1.3 PPD Acquired Magen BioSciences 60
9.1.4 Charles River Laboratories Acquired PPD, Inc.'s Subsidiary Piedmont Research Center for $46m Cash 60
9.1.5 ICON Acquires Prevalere Life Sciences Inc. 60
9.1.6 ICON Acquires DOCS International 61
9.1.7 MDS Inc Acquires Molecular Devices Corporation 61
9.1.8 Kendle Acquires International Clinical Research 61
9.1.9 PRA International Acquires Pharma Bio-Research 61
9.2 Strategic Alliances, Service Agreements and Other Deals 61
9.3 Deals by Year 62
9.4 Deals by Therapeutic Area 63
10 Contract Research Outsourcing - Appendix 65
10.1 Market Definitions 65
10.2 Abbreviations 65
10.3 Sources 66
10.4 Methodology 66
10.4.1 Coverage 67
10.4.2 Secondary Research 67
10.4.3 Primary Research 68
10.4.4 Expert Panel Validation 68
10.5 Contact Us 68
10.6 Disclaimer 68

1.1 List of Tables
Table 1: Drug Development Outsourcing Models, November 2009 19
Table 2: Contract Research Outsourcing Market, Global, Benchmarking Analysis for Top Five Contract Research Organizations, 2008, November 2009 50
Table 3: Major M&A Deals in the Contract Research Outsourcing Market Between 2006-2009 60

1.2 List of Figures
Figure 1: Contract Research Outsourcing Market, Global, Basic Services Provided,
November 2009 11
Figure 2: Clinical Research Process, November 2009 12
Figure 3: Contract Research Outsourcing - Reasons for Outsourcing, November 2009 15
Figure 4: Contract Research Outsourcing - Fully Integrated Service Model, November 2009 19
Figure 5: Contract Research Outsourcing - Functional Service Model, November 2009 20
Figure 6: Key Factors Considered for Evaluating and Selecting a Contract Research Organization, November 2009 21
Figure 7: Strategic or Tactical Advantages in Early Stage Drug Development Outsourcing, November 2009 22
Figure 8: Strategic or Tactical Advantages of Outsourcing in the Clinical Stage of the Drug Development Process, November 2009 23
Figure 9: Strategic or Tactical Advantages of Outsourcing in the Late Stage of the Drug Development Process, November 2009 25
Figure 10: Global Contract Research Outsourcing Market Forecasts, 2006-2015 27
Figure 11: Contract Research Outsourcing Market, Global, Market Share by Phase, 2008 28
Figure 12: Comparison of CAGR of R&D Expenditure vs. Turnover for the Top 5 Companies,
2003-2008 29
Figure 13: Increasing R&D Expenditure and Decline in NME Approvals by the FDA, 1996-2008 30
Figure 14: Impact of Increasing R&D Expenditure and Lower R&D Productivity in the Pharma/Biotech Industry, November 2009 30
Figure 15: Impact of Changing Regulatory Requirements in the Pharma/Biotech Industry, November 2009 31
Figure 16: Impact due to Pricing and Reimbursement of Drugs in the Pharma/Biotech Industry, November 2009 32
Figure 17: Impact of Increasing Number of Clinical Trials in the Pharma/Biotech Industry, November 2009 33
Figure 18: Impact of Quality Concerns on the Biopharmaceutical Industry, November 2009 34
Figure 19: Impact of Economic Recession on the Biopharmaceutical Industry, November 2009 34
Figure 20: Research and Development Expenditure Split by Phases, 2008 35
Figure 21: Value of Spending in Research and Development by Phases, 2008 36
Figure 22: Average Number of Patients Enrolled Per Site by Geography, 2008 37
Figure 23: Clinical Studies by Region, November 2009 39
Figure 24: Outsourcing to Latin America, November 2009 40
Figure 25: Outsourcing to Central and Eastern Europe (CEE), November 2009 41
Figure 26: Outsourcing to India, November 2009 42
Figure 27: Outsourcing to China, November 2009 43
Figure 28: Drug Development Process and Regulation, November 2009 44
Figure 29: Key Guiding Principles of Good Laboratory Practice, November 2009 45
Figure 30: Key Guiding Principles of Good Clinical Practice, November 2009 46
Figure 31: Global Contract Research Outsourcing Market, Revenue Analysis of Major Contract Research Organizations, 2006-2008 48
Figure 32: Contract Research Outsourcing Market, Global Competitive Analysis of Top 5 Players, 2006-2008 49
Figure 33: Contract Research Outsourcing Market, Market Share of Top Service Providers, 2008 49
Figure 34: Quintiles - Snapshot, November 2009 51
Figure 35: Covance - Snapshot, November 2009 53
Figure 36: PPD - Snapshot, November 2009 54
Figure 37: Charles River Laboratories - Snapshot, November 2009 56
Figure 38: PAREXEL International - Snapshot, November 2009 57
Figure 39: Deals Activity of Top Ten Contract Research Organizations, 2006-2009 59
Figure 40: Global Contract Research Outsourcing Market, Major Deals by Phase, 2006-2009 62
Figure 41: Global Contract Research Outsourcing Market, Major Deals by Year, 2006-2009 63
Figure 42: Global Contract Research Outsourcing Market, Major Deals by Therapeutic Area,
2006-2009 64