Dallas, TX: ReportsandReports announce Manufacturing of Biologics – Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Market Research Report in its Store.
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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
1.1 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
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