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Reportlinker Adds Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies
Date:8/31/2010

NEW YORK, Aug. 31 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies

http://www.reportlinker.com/p0286301/Manufacturing-of-Biologics---Increasing-Demand-for-Monoclonal-Antibodies-and-Recombinant-Proteins-Drives-Increases-in-Capacities-and-Innovative-Production-Technologies.html

Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies

Summary

GBI Research's report, "Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies", provides the key data and analyzes the major challenges and drivers for the biomanufacturing industry. The report also analyzes the strengths, weaknesses of and opportunities for the stakeholders in the manufacturing of biologics. The report also discusses the key market drivers and barriers for the growth of biomanufacturing in the pharmaceutical and biotech industry.

The report is based on proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts to provide a comprehensive view of the manufacturing of biologics.

Scope

The Scope of this report includes:

- Opportunities and challenges for manufacturers of biologics in the pharmaceuticals industry

- Market revenues and forecasts for biologics manufacturing in the global pharmaceutical industry from 2009 to 2016.

- The key geographies including the US, Europe, Japan and Emerging Hotspots such as India, Singapore and China.

- Processes involving the manufacturing of biologics including upstream and downstream bioprocessing.

- Technology trends in upstream and downstream bioprocessing that shape the biomanufacturing industry and regulatory trends in the key markets.

- Production capacities for the mammalian and microbial manufacturing facilities in the key regions.

- Qualitative analysis of the market drivers, barriers, future outlook and challenges for the manufacturing of biologics in the pharmaceutical industry

- Analysis of competitive landscape and the leading market players.

Reasons to buy

The report will enhance your decision making capability. It will allow you to:

- Formulate strategies to increase your company's growth by understanding the new growth opportunities in the market for manufacturing of biologics

- Work around the regulatory and technology hurdles by identifying the key trends shaping and driving the market for biomanufacturing.

- Differentiate yourself from competitors and develop new solutions for the biomanufacturing industry by understanding the current competitive landscape and how it is evolving to meet the increasing demands

- Draft efficient strategies by understanding best practices, identifying key winners and losers and who is best positioned to take advantage of the emerging market opportunities.

- Make more informed business decisions from the insightful and in-depth analysis of the market for biomanufacturing by analyzing the key technology trends that shape the growth of this market

1 Table of Contents 3

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 10

2.1 GBI Research Report Guidance 10

3 Biologics Manufacturing – Overview 11

3.1 Overview of Biologics 11

3.1.1 Therapeutic Functions of Biologics 11

3.2 Overview of Manufacturing 12

3.3 Overview of the Biologics Manufacturing Process 12

3.3.1 Evolution of Biologics Manufacturing 13

3.3.2 Overview of Microbial Fermentation 14

3.3.3 Overview of Mammalian Cell Culture Systems 14

3.3.4 Overview of Upstream Bioprocessing 14

3.3.5 Overview of Downstream Bioprocessing 15

3.4 Overview of the Biologics Manufacturing Industry 15

4 Role of Manufacturing in the Biologics Industry 16

4.1 Comparison of Manufacturing in Pharmaceutical and Biotechnology Industries with Manufacturing in Other Industries 16

4.2 Comparison of the Manufacture of Biologics with the Manufacture of Small Molecules 18

4.3 Manufacturing Models 19

4.3.1 Transgenic model 20

4.3.2 Advantages 22

4.3.3 Disadvantages 22

4.4 Mammalian Model 23

4.5 Microbial Model 25

4.5.1 Major Challenges during Microbial Manufacturing Process 26

4.6 Stakeholders for Biologics Manufacturing 27

4.6.1 R&D Division 27

4.6.2 Marketing Division 28

4.6.3 Sales Division 28

4.6.4 Manufacturing Division 30

4.7 Stakeholders for Manufacturing within the Industry 31

4.7.1 Raw Material Suppliers 31

4.7.2 Packaging Suppliers 32

4.7.3 Distributors 33

5 Biologics Manufacturing Processes 35

5.1 Raw Materials 35

5.2 Upstream Bioprocessing 37

5.2.1 Key Considerations While Initiating Upstream Processes 37

5.2.2 Emerging Production Systems in Upstream Bioprocess 38

5.3 Downstream Bioprocess 39

5.3.1 Major Check Point during Down Stream Processing 41

5.3.2 Emerging Technologies in Downstream Processing 42

5.4 Packaging 44

5.4.1 Various Packaging Strategies for Biologics According to Different Time Periods 44

5.5 Storage and Security 45

5.6 Disposal of Wastes 46

5.7 Supporting Technology 47

5.7.1 Process Analytical Technology 47

5.8 Key Positions in Biologics Manufacturing and their Roles 48

5.9 Challenges and Unmet Needs in Biologics Manufacturing 49

5.9.1 Challenges 49

5.9.2 Technological challenges 50

5.9.3 Capital Challenges 51

5.9.4 Regulatory Challenges 51

5.10 Unmet Needs in Biologics Manufacturing 52

5.10.1 High Yield Maintenance 53

5.10.2 Cost 53

5.10.3 Time 55

5.10.4 Regulatory Ease 56

6 Biologics Manufacturing Industry 57

6.1 Market Characterization of Biologics Manufacturing Industry 57

6.1.1 Historical Scenario 57

6.1.2 Present Scenario 57

6.1.3 Probable Future Scenario 58

6.2 Market Forecast 59

6.3 Industry Analysis 61

6.3.1 Barriers to Entry 61

6.3.2 Determinant of Buyers' Power 62

6.3.3 Determinant of suppliers' power 62

6.3.4 Threat of substitute Products 62

6.3.5 Rivalry among Existing Firms 63

6.4 Drivers and Restraints for Growth of Biologics Manufacturing 63

6.4.1 Drivers 64

6.4.2 Restraints 66

6.5 Biologics Manufacturing Capacity 68

6.6 Contract Biologics Manufacturing Market 71

6.6.1 Major Reasons for CMOs Growth 73

6.6.2 Need of CMO's 73

6.6.3 The Fragmentation of the Biologics Industry 74

6.6.4 Required Features of an Effective CMO 76

6.7 US Biologics Manufacturing Market 76

6.7.1 Key Drivers for US Biologic Market 77

6.7.2 Key Restraints 78

6.8 European Biologics Manufacturing Market 79

6.8.1 Key Drivers and for European Biologics Manufacturing Market 80

6.8.2 Key Constraints 81

6.9 Japanese Biologics Manufacturing Market 82

6.9.1 Key Drivers for Japanese Biologics Market 83

6.9.2 Key Constraints 85

6.10 Profiles of Key Players across the World in Biologics Manufacturing 86

6.10.1 Lonza Group Ltd 86

6.10.2 Boehringer Ingelheim 88

6.10.3 Sandoz 90

6.10.4 Avecia 92

6.10.5 Diosynth Biotechnology 94

6.10.6 DSM Biologics 96

6.10.7 SAFC Pharma 97

6.10.8 Amgen Inc. 98

6.10.9 Genentech 100

6.10.10 Genzyme Corporation 102

6.10.11 Biogen Idec Inc 104

6.11 Other Prominent Players within Europe and Japan 106

6.12 Future Players in Biologics Manufacturing 107

6.12.1 Teva 107

6.12.2 Biocon Ltd 108

6.12.3 Biopartners 109

6.12.4 Cangene 110

6.12.5 Phage Biotechnology 111

6.12.6 Reliance GeneMedix plc. 112

6.12.7 STADA Arzneimittel AG 113

6.12.8 Dr. Reddy's 114

6.13 Strategies in Biologics Manufacturing 115

6.13.1 Strategic alliances for Biologics Manufacturing 115

6.13.2 M&A for Biologics Manufacturing 116

6.13.3 In-House manufacturing 118

6.13.4 Outsourcing or Contract Manufacturing 119

7 Regulatory Landscape 123

7.1 Unifying Approach towards Regulatory Procedures among Major Nations (USA Japan and Europe) 123

7.1.1 Similarity Requirement 124

7.2 The US Regulatory Landscape 124

7.2.1 Regulatory Framework of the US for Biopharmaceutical Industry 124

7.2.2 Process for Getting the Approval 125

7.3 Europe Regulatory Landscape 127

7.3.1 Regulatory Framework for Biologics 127

7.3.2 The Committee for Medicinal Products for Human Use (CHMP) 128

7.3.3 Biologics Working Party 129

7.3.4 EMEA Guidelines 130

7.3.5 Key Changes in EMEA Guidelines 131

7.3.6 Types of Guidelines within the Biologics Legislative 131

7.3.7 Conclusion 132

7.4 Japan 133

7.4.1 Japanese Regulatory Framework 134

7.4.2 Health Policy Bureau 134

7.4.3 Office of Biologics 1 135

7.4.4 Office of Biologics 2 135

7.4.5 Review and guidelines 136

8 Manufacturing of Biologics- Emerging Countries 137

8.1 China 137

8.1.1 Foreign Manufacturing Setup Process 139

8.1.2 Key Growth Factors 139

8.1.3 Key Restraints 141

8.1.4 Key Biologics Manufacturers in China 141

8.2 India 143

8.2.1 Indian Regulatory System 144

8.2.2 Key Drivers 145

8.2.3 Key Constraints 147

8.2.4 Key Biologics Manufacturers in India: 148

8.2.5 Conclusion 149

8.3 Singapore 150

8.3.1 Regulations 150

8.3.2 Key Drivers 150

8.3.3 Key Biologics Manufacturers in Singapore 152

9 Manufacturing of Biologics– Appendix 154

9.1 Market Definitions 154

9.2 Abbreviations 154

9.3 Research Methodology 154

9.3.1 Coverage 155

9.3.2 Secondary Research 155

9.3.3 Primary Research 155

9.3.4 Expert Panel Validation 156

9.4 Contact Us 156

9.5 Disclaimer 156

9.6 Sources 156

1.1 List of Tables

Table 1: Biologics Manufacturing, Comparison of Biologics Manufacturing and FMCG Manufacturing, 2009 16

Table 2: Biologics Manufacturing, Comparison of Biologics Manufacturing and Small Molecules Manufacturing, 2009 18

Table 3: Biologics Manufacturing, Comparison of Models of Biologics Manufacturing, 2009 19

Table 4: Biologics Manufacturing, Economic Consideration of Mammalian v/s Transgenic, 2009 22

Table 5: Biologics Manufacturing, Differences between Microbial and Mammalian, 2009 24

Table 6: Biologics Manufacturing, Comparison among Various Hosts, 2009 26

Table 7: Biologics Manufacturing, Raw Material Suppliers, 2009 31

Table 8: Biologics Manufacturing, Packaging Suppliers, 2009 32

Table 9: Biologics Manufacturing, Key Distributors, 2009 33

Table 10: Biologics Manufacturing, Product Wise Suppliers for Raw Materials, 2009 36

Table 11: Biologics Manufacturing, Chromatography Types, 2009 40

Table 12: Biologics Manufacturing, Packaging Strategies For Biologics, 2009 44

Table 13: Biologics Manufacturing, Types of Wastes And Disposal Techniques, 2009 46

Table 14: Biologics Manufacturing, Key Roles in Production, 2009 48

Table 15: Biologics Manufacturing,( Logistics & Purchasing) Key Roles in Production, 2009 49

Table 16: Biologics Manufacturing, Unmet needs, Cost of Biologics, 2009 53

Table 17: Biologics Manufacturing, The US, Recent Biologics Product Expiry, 2009 76

Table 18: Biologics Manufacturing, Regulatory Landscape, Comparison, 2009 123

1.2 List of Figures

Figure 1: Biologics Manufacturing, Biologics Classification, 2009 11

Figure 2: Biologics Manufacturing, Biologics Manufacturing Steps, 2009 13

Figure 3: Biologics Manufacturing, Evolution of Biologics, 1999–2009 13

Figure 4: Biologics Manufacturing, Transgenic Model, Process Steps, 2009 20

Figure 5: Biologics Manufacturing, Mammalian Model, Process Steps, 2009 23

Figure 6: Biologics Manufacturing, Microbial Model, Process Steps, 2009 25

Figure 7: Biologics Manufacturing, Stakeholders, 2009 27

Figure 8: Biologics Manufacturing, Success Rate for Biologics by Phases, 2009 28

Figure 9: Biologics Manufacturing, Sales Models, 2009 29

Figure 10: Biologics Manufacturing, Experimental Strategies, Upstream Processing, 2009 37

Figure 11: Biologics Manufacturing, Features And Benefits Of Filtration Technology,2009 43

Figure 12: Biologics Manufacturing, Benefits of PAT, 2009 47

Figure 13: Biologics Manufacturing, Challenges, 2009 49

Figure 14: Biologics Manufacturing, Unmet Needs, 2009 52

Figure 15:Biologics Manufacturing, Major Components of Cost of Sales for Biologics, 2009 54

Figure 16: Biologics Manufacturing, Industry, Time Line for A New Biologics Drug, 2009 55

Figure 17: Biologics Manufacturing, Industry, Influenza Vaccine Time Line, 2009 56

Figure 18: Biologics Manufacturing, Global Biologics Revenue, 2007-2016 59

Figure 19: Biologics Manufacturing, Geographical Split, Biologics Revenue, 2009-2016 60

Figure 20: Biologics Manufacturing, Industry Analysis, 2009 61

Figure 21: Biologics Manufacturing, Industry, Key Drivers and Restraints, 2009 63

Figure 22: Biologics Manufacturing, Increasing Uptake of Biologics, 2006-2015 64

Figure 23: Biologics Manufacturing, Industry, Biocluster Benefits, 2009 65

Figure 24: Biologics Manufacturing, Manufacturing Capacity, 2007-2016 68

Figure 25: Biologics Manufacturing, Mammalian Manufacturing Capacity, 2007-2016 69

Figure 26: Biologics Manufacturing, Microbial Manufacturing Capacity, 2007-2016 70

Figure 27: Biologics Manufacturing, CMO Biologics Market, 2007-2016 71

Figure 28: Biologics Manufacturing, CMO Biologics Market, Geographical Split, 2009-2016 72

Figure 29: Biologics Manufacturing, CMO Fragmentation, 2009 75

Figure 30: Biologics Manufacturing, Key Drivers and Restraints, The US, 2009 77

Figure 31: Biologics Manufacturing, The US ,Biocluster, 2009 78

Figure 32: Biologics Manufacturing, Key Drivers and Restraints, Europe, 2009 80

Figure 33: Biologics Manufacturing, Key Drivers and Restrains, Japan, 2009 83

Figure 34: Biologics Manufacturing, Japan, Biologics Clusters, 2009 84

Figure 35: Biologics Manufacturing, Profiles of Key Players, Lonza, 2009 86

Figure 36: Biologics Manufacturing, Profiles of Key Players, Lonza, SWOT, 2009 87

Figure 37: Biologics manufacturing, Profiles of Key Players, BI, 2009 88

Figure 38: Biologics Manufacturing, Profiles of Key Players, BI, SWOT, 2009 89

Figure 39: Biologics Manufacturing, Profiles of Key Players, Sandoz, 2009 90

Figure 40: Biologics Manufacturing, Profiles of Key Players, Sandoz, SWOT, 2009 91

Figure 41: Biologics Manufacturing, Profiles of Key Players, Avecia, 2009 92

Figure 42: Biologics Manufacturing, Profiles Of Key Players, Avecia, SWOT, 2009 93

Figure 43: Biologics Manufacturing, Profiles Of Key Players, Diosynth, 2009 94

Figure 44: Biologics Manufacturing, Profiles of Key Players, Diosynth, SWOT, 2009 95

Figure 45: Biologics Manufacturing, Profiles of Key Players, DSM Biologics, 2009 96

Figure 46: Biologics Manufacturing, Profiles of Key Players, DSM Biologics, SWOT, 2009 96

Figure 47: Biologics Manufacturing, Profiles of Key Players, SAFC Pharma, 2009 97

Figure 48: Biologics Manufacturing, Profiles of Key Players, SAFC Pharma, SWOT, 2009 97

Figure 49: Biologics Manufacturing, Profiles of Key Players, Amgen, 2009 98

Figure 50: Biologics Manufacturing, Profiles of key Players, Amgen, SWOT, 2009 99

Figure 51: Biologics Manufacturing, Profiles of Key Players, Genentech, 2009 100

Figure 52: Biologics Manufacturing, Profiles of Key Players, Genentech, SWOT, 2009 101

Figure 53: Biologics Manufacturing, Profiles of Key Players, Genzyme, 2009 102

Figure 54: Biologics Manufacturing, Profiles of Key Players, Genzyme, SWOT, 2009 103

Figure 55: Biologics Manufacturing, Profiles of Key Players, Biogen, 2009 104

Figure 56: Biologics Manufacturing, Profiles of Key Players, Biogen, SWOT, 2009 105

Figure 57: Biologics Manufacturing, Future Emerging Players, Teva, 2009 107

Figure 58: Biologics Manufacturing, Future Emerging Players, Biocon, 2009 108

Figure 59: Biologics Manufacturing, Future Emerging Players, Biopartners, 2009 109

Figure 60: Biologics Manufacturing, Future Emerging Players, Cangene, 2009 110

Figure 61: Biologics Manufacturing, Future Emerging Players, Phage Biotechnology, 2009 111

Figure 62: Biologics Manufacturing, Future Emerging Players, Reliance GeneMedix, 2009 112

Figure 63: Biologics Manufacturing, Future Emerging Players, STADA, 2009 113

Figure 64: Biologics Manufacturing, Future Emerging Players, Dr. Reddy, 2009 114

Figure 65: Biologics Manufacturing, Strategies, 2009 115

Figure 66: Biologics Manufacturing, Strategies, Comparison, 2009 118

Figure 67: Biologics Manufacturing, Strategies, Mixed Sourcing Model, 2009 119

Figure 68: Biologics Manufacturing, Strategies, Key Check Points, CMOs, 2009 121

Figure 69: Biologics Manufacturing, Regulatory Landscape, The US, Process, 2009 125

Figure 70: Biologics Manufacturing, Regulatory Landscape, The US, FDA Process, 2009 126

Figure 71: Biologics Manufacturing, Regulatory Landscape, Europe, Process, 2009 128

Figure 72: Biologics Manufacturing, Regulatory Landscape, Japan, Framework, 2009 134

Figure 73: Biologics Manufacturing, Regulatory Landscape, Japan, Process , 2009 135

Figure 74: Biologics Manufacturing, Emerging markets, China, Regulation Process , 2009 138

Figure 75:Biologics Manufacturing, Emerging Markets, China, Drivers and Restraints, 2009 140

Figure 76: Biologics Manufacturing, Emerging Markets , India, Biologic Clusters, 2009 143

Figure 77:Biologics Manufacturing, Emerging Markets ,India, Key Drivers and restraints , 2009 146

Figure 78: Biologics Manufacturing, Emerging Markets ,Singapore, Key Drivers & Restraints , 2009 151

Companies mentioned

Lonza Group Ltd

Boehringer Ingelheim

Sandoz

Avecia

Diosynth Biotechnology

DSM Biologics

SAFC Pharma

Amgen Inc.

Genentech

Genzyme Corporation

Biogen Idec Inc

Teva

Biocon Ltd

Biopartners

Cangene

Phage Biotechnology

Reliance GeneMedix plc.

STADA Arzneimittel AG

Dr. Reddy's

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Biotechnology Industry: Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies

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