SPI Infoamtion

Table of Contents

Executive Summary

The global contract research organization market
CRO market analysis
Established regions in the global CRO market
Emerging regions in the global CRO market
Leading players in the global CRO market
The future of contract research

Chapter 1 The global contract research organization market

Summary
Introduction

The CRO contribution to drug development
Market overview
Key market drivers
Key market restraints
Conclusions and key findings

Overview of the global CRO market

Total revenue forecasts
Global R&D expenditure and CRO market size
Global clinical development outsourcing
The contribution of CRO to drug development

Current market drivers

Growth of R&D expenditure from biotech and pharma
Cost pressures encourage R&D outsourcing
Long term growth and R&D expenditure of biotechnology companies
Growing regulatory burden and safety concerns

US
EU

Patient recruitment
Increasing number of products in development
The development of biomarkers

Current market restraints

Near term reductions in biotech R&D spending
Growing competition and customer consolidation
New financial realities alter biopharmaceutical outsourcing landscape
Shortage of clinical research personnel
Electronic data capture: a threat to CRO revenue

Key market trends

Globalization
EDC evolution
Strategic alliances

Chapter 2 CRO market analysis

Summary
Introduction
Market conditions
Competitive analysis

Market share analysis
Competitive dynamics

Academic medical centers
Site management organizations
Laboratory analytical services
Non-CRO niche service providers
Conclusion

CRO service models

Introduction
The full service model

SWOT analysis

The niche model

SWOT analysis

Industry strategies

Consolidation: Mergers & acquisitions in the CRO industry
Expanding the continuum of services: vertical integration

Forward integration
Backward integration

Industry challenges

Consolidation within the CRO industry: a threat to close customer
relationships
Strategic outsourcing: demonstrating clear value to clients
Co-development: sharing the risk

Chapter 3 Established regions in the global CRO market

Summary
Introduction
The US CRO market

Overview
Drivers of the US CRO market
Challenges of the US CRO market
Competitive dynamics

The CRO market in Western Europe

Overview
Infrastructure and local regulations
Drivers of the CRO market in Western Europe
Challenges of the CRO market in Western Europe
Competitive dynamics

Chapter 4 Emerging regions in the global CRO market

Summary
Introduction
The Central and Eastern European CRO market

Overview
Infrastructure and local regulations
Benefits of outsourcing to CEE
Challenges of outsourcing to CEE
Competitive dynamics

The CRO market in China

Overview
Infrastructure and local regulations
Benefits of outsourcing to China
Challenges of outsourcing to China
Competitive dynamics

The CRO market in India

Overview
Infrastructure and local regulations

Intellectual property
Legislative reforms

Benefits of outsourcing to India
Challenges of outsourcing to India
Competitive dynamics

The CRO market in Latin America

Overview
Infrastructure and local regulations

Argentina
Brazil
Mexico

Benefits of outsourcing to Latin America
Challenges of outsourcing to Latin America
Competitive dynamics

The CRO markets in South Korea and Turkey

Overview
Infrastructure and local regulations
Benefits of outsourcing to South Korea
Challenges of outsourcing to South Korea
Benefits of outsourcing to Turkey
Challenges of outsourcing to Turkey
Competitive dynamics

Chapter 5 Leading players in the global CRO market

Summary
Introduction

The client perspective
Capabilities of leading CROs

Quintiles Transnational Corp

Company profile
Business description
Partnering collaborations and recent deals

Covance

Company profile
Business description
Partnering collaborations and recent deals

PPD Inc.

Company profile
Business description
Partnering collaborations and recent deals

Charles River Laboratories

Company Profile
Business description
Partnering collaborations and recent deals

PAREXEL International

Company profile
Business description
Partnering collaborations and recent deals

ICON plc.

Company profile
Business description
Partnering collaborations and recent deals

MDS Inc

Company profile
Business description
Partnering collaborations and recent deals

Kendle International

Company profile
Business description
Partnering collaborations and recent deals

PRA International

Company profile
Business description
Partnering collaborations and recent deals

PharmaNet Development Group

Company profile
Business description
Partnering collaborations and recent deals

Chapter 6 The future of contract research

Summary
Introduction
The shift towards a strategic model
Emerging markets
Phases I and IV growth activity
Electronic data capture
Biomarkers

Selected acquisitions/partnerships
Conclusion

Key findings and conclusions

Chapter 7 Appendix

Selected bibliography
Index

List of Figures
Figure 1.1: Estimated CRO market ($bn), 2003-2015e
Figure 1.2: Global development expenditure and CRO market forecast ($bn), 2008-2014e
Figure 1.3: Global outsourcing market by phase, 2006
Figure 1.4: CRO usage and number of days by which projects overrun
Figure 1.5: Global pharmaceutical R&D expenditure ($bn), 2000-2014e
Figure 1.6: Number of FDA approvals 1990-2008
Figure 1.7: Comparison of drug development cost estimates
Figure 1.8: Global biotech R&D expenditure ($bn), 2004-2012e
Figure 1.9: Number of products in development by phase 1998-2009
Figure 1.10: CRO/Sponsor relationship models
Figure 2.11: Market share of major players, 2008
Figure 2.12: Typical full service CRO model
Figure 3.13: R&D expenditures of PhRMA members and non-member companies ($bn), 1980-2009
Figure 3.14: Overall indexed clinical trial costs by region, 2006-2008
Figure 3.15: The European CRO market - revenue forecast ($bn), 2008-2012e
Figure 3.16: Pharmaceutical R&D expenditure in Europe ($bn), 1990-2008
Figure 4.17: Geographic distribution of clinical trials, 2005 to 2009f
Figure 4.18: Clinical trial costs of European countries compared to the UK
Figure 4.19: Comparison of trial registration periods in CEE countries (days)
Figure 4.20: CRO market in China ($m), 2007-2012e
Figure 4.21: China's capabilities across the value chain
Figure 4.22: India's capabilities across the value chain
Figure 4.23: Number of clinical trials in Latin America, 2000-2008
Figure 4.24: Clinical trials in South Korea, 2005-2009e
Figure 5.25: Revenue growth of top public CROs in 2007-2008
Figure 5.26: Capabilities of leading CROs, 2009
Figure 6.27: Regional presence of major CROs
Figure 6.28: Attractiveness of selected countries for clinical trials
Figure 6.29: Global numbers of phase IV trials 2006-2009e
Figure 6.30: Electronic data capture market size ($m), 2006E-2012e
Figure 6.31: Clinical trials using predictive biomarkers, 2005-2009

List of Tables
Table 1.1: Functions commonly performed by CROs
Table 2.2: The global R&D outsourcing market: five major segments
Table 2.3: SWOT analysis: the full service model
Table 2.4: SWOT analysis: the niche model
Table 2.5: Key deals in the CRO sector
Table 4.6: Major CROs operating in Eastern Europe, 2009
Table 4.7: Domestic Chinese CROs
Table 4.8: Major domestic CROs operating in Latin America, 2009
Table 4.9: Selected domestic CROs in South Korea and Turkey
Table 5.10: Revenues ($m) and growth of major CROs, 2007-2008