Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

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Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

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Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

Summary

GBI Research, the leading business intelligence provider, has released its latest report, "Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs", which provides key data, information and analysis of the Contract Manufacturing Organization (CMO) industry. The report provides a comprehensive insight into the size of the CMO market, and includes forecasts, key reasons for outsourcing, the geographical landscape of CMO's, profiles of top CMOs, regulatory frameworks, drivers and restraints and deals analysis.

This report is built using data and information sourced from proprietary databases, primary and secondary research, and uses in-house analysis from GBI Research's team of industry experts.

GBI Research suggests that the global CMO market is set to grow steadily due to increased outsourcing of pharmaceutical production for Western pharmaceutical manufacturers to Asian countries. The global CMO market was valued at $26 billion in 2010. This market grew at a Compound Annual Growth Rate (CAGR) of 10.7% over 2008 when the market was approximately $21.2 billion. The major factor driving this market is the increase in the sourcing of biologics and generic manufacturing. The market is forecast to reach approximate revenues of $59.9 billion by 2018. The market is forecast to grow at a CAGR of 11% between 2010 and 2018.

Scope

- Detailed overview of the CMO industry.

- Annualized market data and forecasts for the CMO market.

- Detailed overview of key reasons behind outsourcing, outsourcing service models and key drivers and restraints of the market.

- Detailed discussion of the regulatory framework.

- Company profiles of major CMOs, including the key services offered by then, their financial information, and details on their worldwide presence.

- Analysis of partnership deals and Merger and Acquisition (M&A) deals involving key companies.

Reasons to buy

- Develop market-entry and market expansion strategies by identifying areas for high growth and opportunities.

- Understand the factors shaping the CMO market.

- Identify the top players in the CMO market, financial revenues, geographical presence and key services offered.

- Analyze the key geographies that are lucrative markets for the outsourcing of CMO.

- Analyze the trends in licensing and M&A deals and explore potential investment opportunities

- Understand upcoming trends that are poised to drive the future growth of the CMO industry.

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Contract Manufacturing Organizations to 2018 - Introduction 9

3 Contract Manufacturing Organizations to 2018 - Industry Overview 10

3.1 Current Status of Pharmaceutical Industry 10

3.2 Cost Optimization Steps for the Pharmaceutical Companies 10

3.2.1 Reduction in Physical Assets 11

3.2.2 Downsizing Manufacturing 11

3.2.3 Reduction in R&D Spending 11

3.3 What CMOs are and Reasons for Outsourcing to Them 13

3.3.1 Different Types of CMOs and the Range of Services Provided by Them 14

3.3.2 How Does Outsourcing to CMOs Take Place? 15

3.3.3 Key Outsourcing Models 17

3.3.4 Key Benefits of Outsourcing 19

4 Contract Manufacturing Organizations to 2018 - Market Characterization 21

4.1 Market Forecasts 21

5 Contract Manufacturing Organizations to 2018 - Geographical Landscape 23

5.1 Introduction 23

5.2 Established Markets 24

5.2.1 The US CMO Market 24

5.2.2 The Eastern European CMO Market 25

5.3 Emerging Markets 27

5.3.1 The Indian CMO Market 27

5.3.2 The Chinese CMO Market 29

6 Contract Manufacturing Organizations to 2018 - Market Drivers and Restraints 31

6.1 Global CMO Market Drivers 32

6.1.1 Availability of Low-cost Skilled Manpower 32

6.1.2 Increasing Government Sanctions are Favoring CMOs 34

6.1.3 Increased Consumption of Generics 34

6.1.4 Better Intellectual Property Rights Protection 39

6.1.5 Increasing Uptake of Biologics and Entry of Biosimilars into Market 40

6.2 Global CMO Market Restraints 41

6.2.1 Capacity Utilization Issues Affecting the Profitability of CMOs 41

6.2.2 Reduced Number of New Drug Approvals 41

6.2.3 Complex Cost Structures in Outsourcing 44

7 Contract Manufacturing Organizations to 2018 - Regulatory Framework 45

7.1 Overview 45

7.2 FDA Guidelines 45

7.2.1 Organization and Personnel 45

7.2.2 Building and Facilities 46

7.2.3 Process Equipment 46

7.2.4 Control of Raw Materials 46

7.2.5 Production and Process Controls 46

7.2.6 Packaging and Labeling 46

7.2.7 Holding and Distribution 46

7.2.8 Key Changes in FDA Guidelines 47

7.3 EMA Guidelines 47

7.3.1 Quality Management 49

7.3.2 Production Activities 49

7.3.3 Buildings and Facilities 49

7.3.4 Process Equipment 50

7.3.5 Materials Management 50

7.3.6 Packaging and Labeling 51

7.3.7 Key Changes in EMA Guidelines 51

7.4 PIC/S 51

8 Contract Manufacturing Organizations to 2018 - Key Aspects of the Upstream and Downstream Processing CMO Industry 53

8.1 Comparison of Upstream Processing and Downstream Processing 53

8.1.1 CMO Market Size for Upstream Processing 54

8.1.2 CMO Market Size for Downstream Processing 55

9 Contract Manufacturing Organizations to 2018 - Key CMO Participants 56

9.1 Catalent Pharma Solutions, Inc. 56

9.2 Lonza Group AG 57

9.3 Royal DSM N.V. 59

9.4 Piramal Healthcare Ltd. 60

9.5 Jubilant Life Sciences 61

9.6 Evonik Industries AG 62

9.7 Patheon Inc. 63

9.8 Fareva Holding 64

9.9 Cambrex 65

9.10 Boehringer Ingelheim 66

10 Contract Manufacturing Organizations to 2018 - Strategic Consolidations within the Global CMO Market 67

10.1 Mergers and Acquisitions 67

10.1.1 Summary of Mergers and Acquisitions 67

10.2 Co-development Deals 68

10.2.1 Summary of Co-development Deals 69

10.3 Licensing Deals 70

10.3.1 Summary of Licensing Deals 71

11 Contract Manufacturing Organizations to 2018 - Appendix 74

11.1 Market Definitions 74

11.2 Abbreviations 74

11.3 Sources 75

11.4 Research Methodology 76

11.4.1 Coverage 76

11.4.2 Secondary Research 76

11.4.3 Primary Research 77

11.4.4 Expert Panel Validation 77

11.5 Contact Us 77

11.6 Disclaimer 77

List of Tables

Table 1: CMO Market, Global, Revenue ($bn), 2008-2011 21

Table 2: CMO Market, Global, Revenue Forecasts ($bn), 2011-2018 21

Table 3: CMO Market, The US, Revenue ($bn), 2008-2011 24

Table 4: CMO Market, The US, Revenue Forecasts ($bn), 2011-2018 24

Table 5: CMO Market, The Central and Eastern Europe, Revenue ($bn), 2008-2011 26

Table 6: CMO Market, The Central and Eastern Europe, Revenue Forecasts ($bn), 2011-2018 26

Table 7: CMO Market, India, Revenue ($bn), 2008-2011 27

Table 8: CMO Market, India, Revenue Forecasts ($bn), 2011-2018 27

Table 9: CMO Market, China, Revenue ($bn), 2008-2011 29

Table 10: CMO Market, China, Revenue Forecasts ($bn), 2011-2018 29

Table 11: CMO Market, Global, Market Drivers, All Employees: Index of Hourly Compensation Costs (United States = 100) 32

Table 12: CMO Market, Global, Market Drivers, Major Drug Patent Expirations, 2012-2018 35

Table 13: CMO Market, Global, Market Restraints, Reduction in Drug Approval Rates by FDA, 1996-2011 42

Table 14: CMO Market, Global, Market Restraints, Opportunities Lost by CMOs Due to Reduced Approval Rates by FDA 43

Table 15: CMO Market, Global, PIC/S Members from Eastern Europe 52

Table 16: CMO Market, Global, Upstream Processing in Biopharmaceuticals, Comparison of Upstream and Downstream Process 53

Table 17: CMO Market, Upstream Processing in Biopharmaceuticals, Revenue Forecast,($bn), 2009-2018 54

Table 18: CMO Market, Downstream Processing in Biopharmaceuticals, Revenue Forecast ($bn), 2009-2018 55

Table 19: CMO Market, Global, M&A, 2009-2011 67

Table 20: CMO Market, Global, Co-development Deals, 2009-2011 68

Table 21: CMO Market, Global, Licensing Deals, 2009-2011 70

List of Figures

Figure 1: CMO Market, Global, Cost Optimization Steps in the Pharmaceutical Industry 12

Figure 2: CMO Market, Global, Impact Analysis of Various Cost Optimization Methods 13

Figure 3: CMO Market, Global, Industry Structure 14

Figure 4: CMO Market, Global, Process for Selection of CMO and Management of Outsourcing Project 15

Figure 5: CMO Market, Global, Key Benefits of Outsourcing to CMOs 19

Figure 6: CMO Market, Global, Revenue Forecasts ($bn), 2008-2018 21

Figure 7: CMO Market, Global, Market Share by Services Provided %, 2010 22

Figure 8: CMO Market, Global, Revenue Split of Global CMO Market by Geography %, 2010 23

Figure 9: CMO Market, The US, Revenue Forecasts ($bn), 2008-2018 24

Figure 10: CMO Market, The Top Five European Countries Vs The Central and Eastern Europe Countries (%), 2010 25

Figure 11: CMO Market, The Central and Eastern Europe, Revenue Forecasts ($bn), 2008-2018 26

Figure 12: CMO Market, India, Revenue Forecasts ($bn), 2008-2018 27

Figure 13: CMO Market, China, Revenue Forecasts ($bn), 2008-2018 29

Figure 14: CMO Market, Global, Contract Manufacturing Organizations, Global Market Driver and Restraints 31

Figure 15: CMO Market, Global, Market Drivers, Difference in Hourly Wage Costs in Euro Area vs. Eastern Europe, 2010 32

Figure 16: CMO Market, Global, Market Drivers, Difference in Hourly Wage Costs in China vs. India, 2002-2008 33

Figure 17: CMO Market, Global, Market Drivers, Increasing Generics Opportunities Due to Patent Expiries for Major Drugs 38

Figure 18: CMO Market, Global, Market Drivers, IPR Protection Eastern European vs. Asian CMO Markets 39

Figure 19: CMO Market, Global, Market Restraints, Reduction in Drug Approval Rates by FDA, 1996-2011 42

Figure 20: CMO Market, Global, Market Restraints, Opportunities Lost by CMOs Due to Reduced Approval Rates by FDA 43

Figure 21: CMO Market, Global, Steps in API Manufacturing Governed by EU GMP Guidelines 48

Figure 22: CMO Market, Upstream Processing in Biopharmaceuticals, Revenue Forecast,($bn), 2009-2018 54

Figure 23: CMO Market, Downstream Processing in Biopharmaceuticals, Revenue Forecast ($bn), 2009-2018 55

Figure 24: CMO Market, Global, Company Profiles - Catalent Inc., 2011 56

Figure 25: CMO Market, Global, Company Profiles - Lonza Group AG, 2011 58

Figure 26: CMO Market, Global, Company Profiles - Royal DSM N.V., 2011 59

Figure 27: CMO Market, Global, Company Profiles - Piramal Healthcare, 2011 60

Figure 28: CMO Market, Global, Company Profiles - Jubilant Life Sciences, 2011 61

Figure 29: CMO Market, Global, Company Profiles - Evonik Industries AG, 2011 62

Figure 30: CMO Market, Global, Company Profiles - Patheon Inc., 2011 63

Figure 31: CMO Market, Global, Company Profiles - Fareva Holding, 2011 64

Figure 32: CMO Market, Global, Company Profiles - Cambrex, 2011 65

Figure 33: CMO Market, Global, Company Profiles - Boehringer Ingelheim, 2011 66

Companies Mentioned

Catalent Pharma Solutions, Inc.

Lonza Group AG

Royal DSM N.V.

Piramal Healthcare Ltd.

Jubilant Life Sciences

Evonik Industries AG

Patheon Inc.

Fareva Holding

Cambrex

Boehringer Ingelheim

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Manufacturing Industry: Contract Manufacturing Organizations to 2018 - Cost Advantages and Improving Quality Standards Build Confidence and Encourage Foreign Investment in Asian CMOs

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