Table of Contents
The CMO market outlook
Executive Summary 8
The contract manufacturing market 8
CMO market analysis 9
Emerging regions in the CMO market 10
Key players in the CMO market 11
The future of the CMO market 12

Chapter 1 The contract manufacturing market 14
Summary 14
Introduction 14
Current market drivers 18
Sale of captive plants 18
Cost pressures encourage outsourcing 18
Increasing number of products in development 19
Consolidation in the pharmaceutical industry 20
Increase in biopharmaceuticals market 20
Growth of emerging pharmaceutical markets 21
Current market restraints 22
Overcapacity 22
Financial pressures 22
Increased competition - low barriers to entry 23
Conclusions 25

Chapter 2 CMO market analysis 28
Summary 28
Introduction 29
Primary manufacturing 30
Secondary manufacturing 30
Structure of the CMO market 31
Advantages of small and medium sized vs. large CMOs 34
Industry strategies 36
Strategic outsourcing 36
Diversification 38
Biopharmaceutical manufacturing 38
Overcapacity 41
Pilot plants 41
Conclusion 42

Chapter 3 Emerging regions in the CMO market 44
Summary 44
Introduction 45
China 45
Drivers of the Chinese contract manufacturing market 47
Challenges of the Chinese contract manufacturing market 48
China’s regulatory framework 50
Intellectual property protection 51
Counterfeit drugs 53
China’s major contract manufacturing organizations 54
CMOs offering finished drugs services 56
Biopharmaceutical contract manufacturing in China 57
India 57
Size of the Indian CMO market 59
Patent situation and implications for foreign direct investment 61
Challenges in current patent law 62
India as a preferred offshoring destination 63
The new, integrated business model of Indian CMOs 64
Challenges facing the CRAMS business model 68
Expansion strategies of India’s major contract manufacturing organizations 68
Conclusions 70

Chapter 4 Key players in the CMO market 74
Summary 74
Introduction 75
Methodology 75
Catalent 75
Company profile 75
Business description 75
Partnering collaborations and recent deals 76
Lonza 76
Company profile 76
Business description 77
Partnering collaborations and recent deals 77
Boehringer Ingelheim (BI) 77
Company profile 77
Business description 78
Partnering collaborations and recent deals 78
DSM 78
Company profile 78
Business description 79
Partnering collaborations and recent deals 79
Evonik 79
Company profile 79
Business description 79
Partnering collaborations and recent deals 80
Patheon 80
Company profile 80
Business description 80
Partnering collaborations and recent deals 81
Jubilant 81
Company profile 81
Business description 82
Partnering collaborations and recent deals 82
BASF 82
Company profile 82
Business description 83
Partnering collaborations and recent deals 83
Fareva 83
Company profile 83
Business description 83
Partnering collaborations and recent deals 84
Wockhardt 84
Company profile 84
Business description 84
Partnering collaborations and recent deals 84

Chapter 5 The future of the CMO market 86
Summary 86
Introduction 86
Strategic partnerships 87
Biomanufacturing 88
Disposable equipment 89
Offshoring 90
Market outlook 94

Chapter 6 Appendix 96
Selected bibliography 96
Index 97

List of Figures
Figure 1.1: Contract manufacturing market ($bn), 2006-14e 15
Figure 1.2: Pharmaceutical manufacturing process 16
Figure 1.3: Services performed by CMOs and CDMOs 17
Figure 1.4: Number of FDA approvals (NCEs), 1990-2008 19
Figure 1.5: Number of products in development by phase, 1998-2009 20
Figure 1.6: The contract biomanufacturing market ($bn), 2009-14e 21
Figure 2.7: Stages of pharmaceutical manufacturing 29
Figure 2.8: Outsourced biological vs. non-biological manufacturing market, 2009-14e 34
Figure 2.9: Sponsors employing strategic outsourcing (%) 37
Figure 2.10: Installed bioreactor capacity (KL), 2006-13e 39
Figure 2.11: Geographical distribution of bioreactor capacity (%), 2008-13e 40
Figure 3.12: Share of pharmaceutical sales growth by region, 2006-09f 45
Figure 3.13: Chinese API exports, $bn 2007-14e 46
Figure 3.14: Chinese finished form pharmaceuticals exports 2007-14e, $bn 47
Figure 3.15: India’s finished dose exports ($bn), 2007-14e 60
Figure 3.16: India’s API exports ($bn), 2007-14e 60
Figure 3.17: Indian CRAMS market ($bn), 2007-14e 67
Figure 3.18: Three waves of Indian opportunity 71
Figure 5.19: Expectations of outsourcing expenditure change, 2009 94

List of Tables
Table 1.1: New entrants in the pharmaceutical CMO market 23
Table 2.2: Structure of the CMO industry 32
Table 2.3: Cost of inaccurate capacity planning 41
Table 3.4: Selected partnering agreements with Chinese manufacturers 56
Table 3.5: Selected contract manufacturing/ research deals in India 64
Table 3.6: Strategic options for Indian pharmaceutical companies 66