The Top 10 Contract Research Organizations

OUTSOURCING The Top 10 Contract Research Organizations Positioning, performance and SWOT analyses Table of Contents

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Table of Contents The Top 10 Contract Research Organizations Executive summary 14 Industry overview 14 Quintiles 15 Covance 15 Pharmaceutical Product Development (PPD) 16 Charles River Laboratories (CRL) 16 ICON Clinical (ICON) 17 Parexel 17 MDS 18 Kendle 18 PharmaNet Development (PharmaNet) 19 PRA International 19 Chapter 1 Introduction 22 What is this report about? 22 Methodology 22 Chapter 2 Industry overview 24 Summary 24 Introduction 25 Market overview 25 Global CRO market: size and growth 25 Global positioning of the top 10 CROs 26 Key market drivers 29 Key market resistors 30 Business models 31 iii

Full-services CROs 31 Niche CROs 31 Trends in the global CRO industry 32 Consolidation in the CRO industry 32 Evolution of software as a service (SaaS) based electronic data capture (EDC) 35 Implementation of biomarkers in clinical trials 36 Participation of private equity players 38 New CRO destinations 39 Asia-Pacific 39 India 39 China Latin America 40 42 Eastern Europe 42 Africa 43 Chapter 3 Quintiles 46 Summary 46 Company overview 47 Recent financial performance 48 Growth strategies 48 Investing in infrastructure 48 Expansion of consulting business 50 Acquisitions and divestments 50 SWOT analysis 51 Strengths 52 Depth in service offerings 52 Strong presence in emerging economies 52 53 Exposure in limited therapeutic areas 53 53 Launch of interactive data analysis tool 53 New facility in India 53 Expansion in Japan 53 54 Stringent regulations 54 Increasing competition 55 Chapter 4 Covance 58 Summary 58 Company overview 59 Recent financial performance 59 iv

Performance by business segment 61 Growth strategies 61 Attaining operational efficiency through six sigma implementation 61 Develop capabilities in emerging markets 62 Acquisitions and divestments 62 SWOT analysis 63 Strengths 63 Global capabilities 63 Stronger therapeutic base 64 Strong liquidity position 64 64 Declining performance in late-stage segment 64 65 Expanding facilities in mature pharmaceutical markets 65 R&D collaboration with Eli Lilly 65 66 Weakening early-stage development segment 66 Regulatory compliance 66 Chapter 5 Pharmaceutical Product Development 68 Summary 68 Company overview 69 Recent financial performance 69 Performance by business segment 70 Growth strategies 71 Collaboration for development of innovative compounds 71 Expansion in central laboratory services 71 Acquisitions and divestments 72 SWOT analysis 73 Strengths 74 Depth in phase II IV service offering 74 Strong financial performance 74 74 Declining revenue contribution from PPD s discovery segment 74 75 Investment in technologies 75 Geographical expansion 75 Outsourcing deal with Merck 76 76 Dependence on a small number of industries and clients 76 v

Chapter 6 Charles River Laboratories 78 Summary 78 Company overview 79 Recent financial performance 79 Performance by business segment 80 Growth strategies 81 Building capabilities for clients 81 Acquisitions and divestments 81 SWOT analysis 82 Strengths 83 Strong technology platforms for pre-clinical testing 83 83 Higher debt burden 83 84 Expansion in China 84 84 Cost cutting in biopharmaceutical industry 84 Chapter 7 ICON 86 Summary 86 Company overview 87 Recent financial performance 87 Performance by business segments 88 Growth strategies 88 Developing global capabilities and reach 88 Acquisitions and divestments 89 SWOT analysis 90 Strengths 90 Strong presence in oncology solutions 90 Technically enhanced service offerings 91 Unconventional service model 91 92 Rising debt load 92 92 Expansion in India 92 Agreement with Phase Forward 92 93 Government regulations 93 Softness in non-critical Path studies 93 vi

Chapter 8 Parexel 96 Summary 96 Company overview 97 Recent financial performance 97 Performance by business segments 98 Growth strategies 99 Expansion in emerging markets 99 Acquisitions and divestments 100 SWOT analysis 101 Strengths 101 Strong global presence 101 Stronger therapeutic presence 102 102 Increased receivable turnover period 102 102 Expansion in early-phase service offerings 102 103 Consolidation in the industry 103 Declining R&D spending growth 103 Chapter 9 MDS 106 Summary 106 Company overview 107 Recent financial performance 107 Performance by business segment 109 Growth strategies 109 Internal restructuring 109 Investment in infrastructure across geographies 110 Acquisitions and divestments 110 SWOT analysis 111 Strengths 111 Robust performance of late-stage contract research services 111 112 Limited therapeutic focus 112 112 Investment in technology 112 Expansion in Asian markets 113 113 Regulatory review 113 vii

Chapter 10 Kendle 116 Summary 116 Company overview 117 Recent financial performance 117 Performance by business segment 119 Growth strategies 119 Participation in mega-trials 119 Acquisitions and divestments 120 SWOT analysis 121 Strengths 121 Strong presence in phase I IV clinical services 121 Growth in operating profit 122 Broader therapeutic exposure 122 123 Rising debt burden 123 123 Growth in the early-stage research segment 123 Expansion in Asia-Pacific 124 124 Highly competitive environment 124 Chapter 11 PharmaNet 126 Summary 126 Company overview 127 Recent financial performance 127 Performance by business segments 129 Growth strategies 129 Global expansion of capacity 129 Early-stage expansion 129 Late-stage expansion Investment in technology 130 130 Acquisitions and divestments 130 SWOT analysis 131 Strengths 131 Extensive services spectrum 131 Diverse client base across geographies 132 133 Late-stage project cancellations 133 133 Investing in laboratory capabilities to analyze complex molecules 133 133 Legal proceedings 133 viii

Refinancing convertible debt 134 Government regulations 134 Chapter 12 PRA International 136 Summary 136 Company overview 137 Recent financial performance 137 Growth strategies 138 Capacity expansion across geographies 138 Increased prominence in oncology 139 Acquisitions and divestments 139 SWOT analysis 140 Strengths 140 Services portfolio 140 141 Limited therapeutic expertise 141 Lower sales growth during 2004 07 141 141 Collaboration with Frontage Laboratories 141 Growing opportunities in India 142 142 Intense competition 142 Regulatory compliance 143 Chapter 13 Other key players 146 Aptuit 146 Company overview 146 Recent financial performance 146 Life Sciences Research 147 Company overview 147 Recent financial performance 147 Omnicare 149 Company overview 149 Recent financial performance 149 SGS 151 Company overview 151 Recent financial performance 151 CMIC 153 Company overview 153 Recent financial performance 153 WuXi Pharmatech 155 ix

Company overview 155 Recent financial performance 155 Galapagos (BioFocus) 157 Company overview 157 Recent financial performance 157 LAB Research 159 Company overview 159 Recent financial performance 159 United BioSource 161 Company overview 161 Recent financial performance 161 Bio-Imaging 162 Company overview 162 Recent financial performance 162 Chapter 14 Appendix 166 Glossary 166 Index 168 List of Figures Figure 2.1: Global CRO market size ($bn), 2008 13 26 Figure 2.2: Top 10 CRO companies market share (%), 2007 27 Figure 2.3: Market position of the global top 10 CROs, 2007 28 Figure 2.4: Comparative analysis of leading CRO companies 29 Figure 2.5: Comparison between India and China CROs 41 Figure 3.6: Quintiles SWOT analysis 51 Figure 4.7: Covance financial performance ($m), 2003 07 60 Figure 4.8: Covance SWOT analysis 63 Figure 5.9: PPD financial performance ($m), 2003 07 70 Figure 5.10: PPD SWOT analysis 73 Figure 6.11: CRL financial performance ($m), 2004 07 80 Figure 6.12: CRL SWOT analysis 82 Figure 7.13: ICON SWOT analysis 90 Figure 8.14: Parexel financial performance ($m), 2004 08 98 Figure 8.15: Parexel SWOT analysis 101 Figure 9.16: MDS financial performance ($m), 2005 07 108 Figure 9.17: MDS SWOT analysis 111 Figure 10.18: Kendle financial performance ($m), 2003 07 118 Figure 10.19: Kendle SWOT analysis 121 Figure 11.20: PharmaNet financial performance ($m), 2004 07 128 Figure 11.21: PharmaNet SWOT analysis 131 Figure 12.22: PRA International financial performance ($m), 2003 07 138 x

Figure 12.23: PRA International SWOT analysis 140 Figure 13.24: LSR financial performance ($m), 2003 07 148 Figure 13.25: Omnicare financial performance ($m), 2003 07 150 Figure 13.26: SGS financial performance ($m), 2003 07 152 Figure 13.27: CMIC financial performance ($m), 2005 08 154 Figure 13.28: WuXi Pharmatech financial performance ($m), 2003 07 156 Figure 13.29: BioFocus financial performance ($m), 2005 07 158 Figure 13.30: Lab Research financial performance ($m), 2005 07 160 Figure 13.31: Bio-Imaging financial performance ($m), 2003 07 163 List of Tables Table 2.1: Global CRO market size ($bn), 2008 13 26 Table 2.2: Select M&A deals in CRO industry 2007 08 32 Table 2.3: Select private equity deals in CRO industry ($m), 2007 08 38 Table 3.4: Quintiles snapshot 46 Table 3.5: Quintiles financial performance ($m), 2003 07 48 Table 4.6: Covance snapshot 58 Table 4.7: Covance financial performance ($m), 2003 07 59 Table 4.8: Covance business segment performance, 2007 61 Table 5.9: PPD snapshot 68 Table 5.10: PPD financial performance ($m), 2003 07 69 Table 5.11: PPD business segment performance, 2007 70 Table 6.12: CRL snapshot 78 Table 6.13: CRL financial performance ($m), 2004 07 79 Table 6.14: CRL business segment performance, 2007 80 Table 7.15: ICON snapshot 86 Table 7.16: ICON financial performance ($m), 2003 07 87 Table 7.17: ICON business segment performance, 2007 88 Table 8.18: Parexel snapshot 96 Table 8.19: Parexel financial performance ($m), 2004 08 97 Table 8.20: Parexel business segment performance, 2008 99 Table 9.21: MDS snapshot 106 Table 9.22: MDS financial performance ($m), 2005 07 108 Table 9.23: MDS business segment performance, 2007 109 Table 10.24: Kendle snapshot 116 Table 10.25: Kendle financial performance ($m), 2003 07 117 Table 10.26: Kendle business segment performance, 2007 119 Table 11.27: PharmaNet snapshot 126 Table 11.28: PharmaNet financial performance ($m), 2004 07 128 Table 11.29: PharmaNet business segment performance, 2007 129 Table 12.30: PRA International snapshot 136 Table 12.31: PRA International financial performance ($m), 2003 07 137 Table 13.32: Aptuit Snapshot 146 Table 13.33: LSR Snapshot 147 Table 13.34: LSR financial performance ($m), 2003 07 148 Table 13.35: Omnicare Snapshot 149 Table 13.36: Omnicare financial performance ($m), 2003 07 150 xi

Table 13.37: SGS Snapshot 151 Table 13.38: SGS financial performance ($m), 2003 07 152 Table 13.39: CMIC Snapshot 153 Table 13.40: CMIC financial performance ($m), 2005 08 154 Table 13.41: WuXi Pharmatech Snapshot 155 Table 13.42: WuXi Pharmatech financial performance ($m), 2003 07 156 Table 13.43: BioFocus Snapshot 157 Table 13.44: BioFocus financial performance ($m), 2005 07 158 Table 13.45: LAB Research Snapshot 159 Table 13.46: LAB Research financial performance ($m), 2005 07 160 Table 13.47: UBC Snapshot 161 Table 13.48: Bio-Imaging Snapshot 162 Table 13.49: Bio-Imaging financial performance ($m), 2003 07 163 xii