Downstream Processing in Biopharmaceuticals - Increased Demand for Biologics Drives Improvement in Cost -effective Purification Technologies
Publisher Name » GBI Research
Published Date » 2010-11-15
No. Of Pages » 91
GBI Research's report, “Down Stream Processing in Biopharmaceuticals - Increased Demand for Biologics Drives Improvement in Cost-effective Purification Technologies”, provides the key data and analyzes the major challenges and drivers for the downstream industry. The report also analyzes the strengths, weaknesses of and opportunities for the stakeholders in the downstream processing of biopharmaceuticals. 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 Down Stream Processing in Biopharmaceuticals.
Scope
The scope of this report includes:
- Opportunities and challenges for manufacturers of Biopharmaceuticals in the pharmaceuticals industry
- Market revenues and forecasts for Down Stream Processing 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.
- Downstream bioprocess involves detailed technological development and possible development in near future.
- Technology trends in downstream bioprocess that shape the biomanufacturing industry
- Qualitative analysis of the market drivers, barriers, future outlook and challenges for the downstream bioprocess.
- Analysis of competitive landscape and the leading market players.
Reasons to buy
- Formulate strategies to increase your company’s growth by understanding the new growth opportunities in the downstream market.
- Work around the technology hurdles by identifying the key trends shaping and driving the market for downstream bioprocess.
- 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
Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Downstream Processing: Introduction 8
2.1 GBI Research Report Guidance 8
3 Downstream Processing Market Overview 9
3.1 Overview of Biopharmaceuticals 9
3.1.1 Cytokines 9
3.1.2 Enzymes 9
3.1.3 Hormones 9
3.1.4 Clotting Factors 9
3.1.5 Vaccines 10
3.1.6 Monoclonal Antibodies 10
3.1.7 Cell Therapies 10
3.1.8 Antisense Drugs 10
3.1.9 Peptide Therapeutics 10
3.2 Overview of Downstream Processing in Biopharmaceuticals 12
3.2.1 A Typical Downstream Processing: 13
3.2.2 Major Check Point during Down Stream Processing 14
3.3 Overview of Downstream Industry 15
4 Downstream Processing : Role of Downstream Processing in the Biopharmaceutical Industry 16
4.1 Comparison of Upstream Processing and Downstream Processing 18
4.2 Major Reagents, Reagent Suppliers and Reagent Market Related To Downstream Processing 19
4.2.1 Major Reagents 19
4.2.2 Reagent Suppliers 20
4.2.3 Reagent Market 22
4.3 Major Equipment Suppliers 26
5 Downstream Processing: Downstream Processing Market for CMOs 27
5.1 Global CMO Market Overview 27
5.2 CMO Biopharmaceuticals Market Characterization 27
5.3 CMO Market Size for Downstream Processing 29
6 Downstream Processing : Challenges and Unmet Needs in Downstream Bioprocess 30
6.1 Challenges 30
6.1.1 Chromatographic Capture 30
6.1.2 Reducing the Purification Steps 30
6.1.3 Titer increment /Capacity Bottleneck 31
6.1.4 Virus Clearances 31
6.1.5 Scaling Up 31
6.2 Unmet Needs 32
6.2.1 Unmet Medical Needs 32
6.2.2 Realistic Achievement of Economies of Scale 33
6.2.3 Technological Development of Disposables at Large Scale 34
6.2.4 Reagent Cost and Their Effectiveness 35
7 Downstream Processing : Emerging Technologies and their Implication 36
7.1 Disposable Technology / Single Use Technology 36
7.1.1 Use of Single Use Technology in Downstream Operations 39
7.1.2 Major Benefits of Single use Technology 40
7.1.3 Major Challenges in Single Use Technology 41
7.1.4 Some Recent Products Developed By Major Firms 42
7.2 Membrane Chromatography 42
7.3 Multi-Column Chromatography 44
7.3.1 Advantages 44
7.3.2 Drawbacks 44
7.3.3 Applications 45
7.4 Aqueous Two Phase System 45
7.5 Tangential Flow Filtration 45
7.5.1 Tangential Flow Filtration Applications 46
7.5.2 Few Products Developed By Major Firms 47
7.6 Monoliths 47
7.7 Expanded-Bed Adsorption (EBA) Chromatography 47
7.7.1 Applications 48
7.8 Mixed-Mode Chromatography 48
8 Downstream Processing : Industry Analysis 50
8.1 Key Drivers and Restraints 50
8.1.1 Key Drivers of Downstream Processing Market 50
8.1.2 Key Restraints of Downstream Processing Market 51
8.2 Porter Five Forces Model for Industry Analysis 52
8.3 Impact of Environmental Factors on the Industry 55
8.3.1 International Economy Impact 55
8.3.2 The Natural Environment Impact 55
8.3.3 Technological Impact 55
8.3.4 Political or Governmental Impact 55
8.3.5 Demographic Structure 56
8.3.6 Social Structure 56
8.4 Major Events and Their Impact Analysis 56
9 Downstream Processing: Competitive Landscape 57
9.1 Market Dynamics of Downstream Processing and Impact 57
9.1.1 Market Structure 57
9.1.2 Competitive Analysis of Major CMO Firms 58
9.1.3 Competitive Analysis of Equipment and Reagent Industry 59
9.2 Key Equipment Players 60
9.2.1 Pall Corporation 60
9.2.2 Milipore 63
9.2.3 Sartorius 66
9.2.4 3M Purification Inc. 69
9.3 Key Reagent Players 71
9.3.1 Life Technologies 71
9.3.2 Sigma Aldrich 74
9.3.3 SWOT Analysis 75
9.3.4 M&A Deals 75
9.4 Key CMO Players 77
9.4.1 Lonza 77
9.4.2 Boehringer Ingelheim 80
9.4.3 SWOT Analysis 81
9.4.4 Avecia Biotechnology 83
9.4.5 Diosynth Biotechnology 85
10 Downstream Processing : Appendix 88
10.1 Market Definitions 88
10.2 Abbreviations 88
10.3 Research Methodology 89
10.3.1 Coverage 89
10.3.2 Secondary Research 89
10.3.3 Primary Research 89
10.3.4 Expert Panel Validation 90
10.4 Contact Us 90
10.5 Disclaimer 90
10.6 Sources 91
Table 1: Downstream Processing, Comparison of Upstream and Downstream Process, 2009 18
Table 2: Downstream Processing, Reagent Suppliers, 2009 21
Table 3: Downstream Processing, Comparison of Mammalian and Microbial Culture, 2009 23
Table 4: Downstream Processing, Equipment Suppliers, 2009 26
Table 5: Downstream Processing, Types of Single Use Technologies and Vendors, 2009 38
Table 6: Downstream Processing, Key Equipment Players, Pall Corporation, Major M&A Deals, 2005-2009 62
Table 7: Downstream Processing, Key Equipment Players, Milipore, Major M&A Deals, 2005-2009 65
Table 8: Downstream Processing, Key Equipment Players, Sartorius, Major M&A Deals, 2005-2009 68
Table 9: Downstream Processing, Key Equipment Players, 3M, Major M&A Deals, 2005-2009 70
Table 10: Downstream Processing, Key Reagent Players, Life Technologies, Major M&A Deals, 2005-2009 73
Table 11: Downstream Processing, Key Reagent Players, Sigma Aldrich, Major M&A Deals, 2005-2009 76
Table 12: Downstream Processing, Key CMO Players, Lonza, Major M&A Deals, 2005-2009 79
Table 13: Downstream Processing, Key CMO Players, Boehringer Ingelhiem, Major M&A Deals, 2005-2009 82
Table 14: Downstream Processing, Key Players, Avecia, Major M&A Deals, 2004-2009 85
Table 15: Downstream Processing, Key CMO Players, Diosynth Biotechnology, Major M&A Deals, 2005-09 87
Figure 1: Downstream Processing, Biopharmaceutical Types, 2009 9
Figure 2: Downstream Processing, Overview of General Drug Development Process, 2009 12
Figure 3: Downstream Processing, Technologies Employed Along with Steps, 2009 13
Figure 4: Downstream Processing, Changing Distribution of Cost along with Yield Increment, 2009 16
Figure 5: Downstream Processing, Yield Percentage v/s Number of Purification Steps, 2009 17
Figure 6: Downstream Processing, Cost Breakups of Upstream and Downstream Process, 2009 18
Figure 7: Downstream Processing, Total Reagent Market for Downstream Processing, Revenue ($m), 2009-2016 22
Figure 8: Downstream Processing, CMOs Reagent Market for Mammalian Capacity, Revenue ($m) 2009-2016 23
Figure 9: Downstream Processing, CMOs Reagent Market for Microbial Capacity, Revenue ($m) 2009-2016 24
Figure 10: Downstream Processing, In-house Reagent Market for Mammalian Capacity, Revenue ($m) 2009-2016 25
Figure 11: Downstream Processing, In-house Reagent Market for Microbial Capacity, Revenue ($m) 2009-2016 25
Figure 12: Downstream Processing, CMO Biopharmaceutical Market, Revenue ($bn), 2007-2016 28
Figure 13: Downstream Processing, Downstream Process Market For CMOs, Revenue ($bn), 2007-2016 29
Figure 14: Downstream Processing, Challenges, 2009 30
Figure 15: Downstream Processing, Unmet Medical Needs, 2009 32
Figure 16: Downstream Processing, Unmet Achievement of Economies of Scale, 2009 33
Figure 17: Downstream Processing, Unmet Technological Advancement, 2009 34
Figure 18: Downstream Processing, Unmet Reagent Cost Structure, 2009 35
Figure 19: Downstream Processing, Emerging Technologies and their Likely Adaptation, 2009 36
Figure 20: Downstream Processing, Single Use Technologies Benefits, 2009 40
Figure 21: Downstream Processing, Single Use Technologies Challenges, 2009 41
Figure 22: Downstream Processing, Industry Analysis, Key Drivers and Restraints, 2009 51
Figure 23: Downstream Processing, Industry Analysis, Porter Five Forces Model, 2009 52
Figure 24: Downstream Processing, Industry Analysis, Environmental Factors and Impact, 2009 55
Figure 25: Downstream Processing, Industry Analysis, Major Market Events and their Impact, 2009 56
Figure 26: Downstream Processing, Industry Analysis, Market Dynamics, 2009 58
Figure 27: Downstream Processing, Industry Analysis, Competitive Analysis of Major CMOs, 2009 58
Figure 28: Downstream Processing, Industry Analysis, Competitive Analysis of Major Equipment / Reagent Players, 2009 59
Figure 29: Downstream Processing, Key Equipment Players, Business Overview, Pall Corporation, 2009 60
Figure 30: Downstream Processing, Key Equipment Players, SWOT Analysis, Pall Corporation, 2009 61
Figure 31: Downstream Processing, Key Equipment Players, Business Overview, Milipore, 2009 63
Figure 32: Downstream Processing, Key Equipment Players, SWOT Analysis, Milipore, 2009 64
Figure 33: Downstream Processing, Key Equipment Players, Business Overview, Sartorius, 2009 66
Figure 34: Downstream Processing, Key Equipment Players, SWOT Analysis, Sartorius, 2009 67
Figure 35: Downstream Processing, Key Equipment Players, Business Overview, 3M Purification Inc. , 2009 69
Figure 36: Downstream Processing, Key Equipment Players, SWOT Analysis, 3M Purification Inc. , 2009 70
Figure 37: Downstream Processing, Key Reagent Players, Business Overview, Life Technologies, 2009 71
Figure 38: Downstream Processing, Key Reagent Players, SWOT Analysis, Life Technologies, 2009 72
Figure 39: Downstream Processing, Key Reagent Players, Business Overview, Sigma-Aldrich, 2009 74
Figure 40: Downstream Processing, Key Reagent Players, SWOT Analysis, Sigma-Aldrich, 2009 75
Figure 41: Downstream Processing, Key CMO Players, Business Overview, Lonza, 2009 77
Figure 42: Downstream Processing, Key CMO Players, SWOT Analysis, Lonza, 2009 78
Figure 43: Downstream Processing, Key CMO Players, Business Overview, Boehringer Ingelheim, 2009 80
Figure 44: Downstream Processing, Key CMO Players, SWOT Analysis, Boehringer Ingelheim, 2009 81
Figure 45: Downstream Processing, Key CMO Players, Business Overview, Avecia , 2009 83
Figure 46: Downstream Processing, Key CMO Players, SWOT Analysis, Avecia, 2009 84
Figure 47: Downstream Processing, Key CMO Players, Business Overview, Diosynth Biotechnology, 2009 86
Figure 48: Downstream Processing, Key CMO Players, SWOT Analysis, Diosynth Biotechnology, 2009 87
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Downstream Processing: Introduction 8
2.1 GBI Research Report Guidance 8
3 Downstream Processing Market Overview 9
3.1 Overview of Biopharmaceuticals 9
3.1.1 Cytokines 9
3.1.2 Enzymes 9
3.1.3 Hormones 9
3.1.4 Clotting Factors 9
3.1.5 Vaccines 10
3.1.6 Monoclonal Antibodies 10
3.1.7 Cell Therapies 10
3.1.8 Antisense Drugs 10
3.1.9 Peptide Therapeutics 10
3.2 Overview of Downstream Processing in Biopharmaceuticals 12
3.2.1 A Typical Downstream Processing: 13
3.2.2 Major Check Point during Down Stream Processing 14
3.3 Overview of Downstream Industry 15
4 Downstream Processing : Role of Downstream Processing in the Biopharmaceutical Industry 16
4.1 Comparison of Upstream Processing and Downstream Processing 18
4.2 Major Reagents, Reagent Suppliers and Reagent Market Related To Downstream Processing 19
4.2.1 Major Reagents 19
4.2.2 Reagent Suppliers 20
4.2.3 Reagent Market 22
4.3 Major Equipment Suppliers 26
5 Downstream Processing: Downstream Processing Market for CMOs 27
5.1 Global CMO Market Overview 27
5.2 CMO Biopharmaceuticals Market Characterization 27
5.3 CMO Market Size for Downstream Processing 29
6 Downstream Processing : Challenges and Unmet Needs in Downstream Bioprocess 30
6.1 Challenges 30
6.1.1 Chromatographic Capture 30
6.1.2 Reducing the Purification Steps 30
6.1.3 Titer increment /Capacity Bottleneck 31
6.1.4 Virus Clearances 31
6.1.5 Scaling Up 31
6.2 Unmet Needs 32
6.2.1 Unmet Medical Needs 32
6.2.2 Realistic Achievement of Economies of Scale 33
6.2.3 Technological Development of Disposables at Large Scale 34
6.2.4 Reagent Cost and Their Effectiveness 35
7 Downstream Processing : Emerging Technologies and their Implication 36
7.1 Disposable Technology / Single Use Technology 36
7.1.1 Use of Single Use Technology in Downstream Operations 39
7.1.2 Major Benefits of Single use Technology 40
7.1.3 Major Challenges in Single Use Technology 41
7.1.4 Some Recent Products Developed By Major Firms 42
7.2 Membrane Chromatography 42
7.3 Multi-Column Chromatography 44
7.3.1 Advantages 44
7.3.2 Drawbacks 44
7.3.3 Applications 45
7.4 Aqueous Two Phase System 45
7.5 Tangential Flow Filtration 45
7.5.1 Tangential Flow Filtration Applications 46
7.5.2 Few Products Developed By Major Firms 47
7.6 Monoliths 47
7.7 Expanded-Bed Adsorption (EBA) Chromatography 47
7.7.1 Applications 48
7.8 Mixed-Mode Chromatography 48
8 Downstream Processing : Industry Analysis 50
8.1 Key Drivers and Restraints 50
8.1.1 Key Drivers of Downstream Processing Market 50
8.1.2 Key Restraints of Downstream Processing Market 51
8.2 Porter Five Forces Model for Industry Analysis 52
8.3 Impact of Environmental Factors on the Industry 55
8.3.1 International Economy Impact 55
8.3.2 The Natural Environment Impact 55
8.3.3 Technological Impact 55
8.3.4 Political or Governmental Impact 55
8.3.5 Demographic Structure 56
8.3.6 Social Structure 56
8.4 Major Events and Their Impact Analysis 56
9 Downstream Processing: Competitive Landscape 57
9.1 Market Dynamics of Downstream Processing and Impact 57
9.1.1 Market Structure 57
9.1.2 Competitive Analysis of Major CMO Firms 58
9.1.3 Competitive Analysis of Equipment and Reagent Industry 59
9.2 Key Equipment Players 60
9.2.1 Pall Corporation 60
9.2.2 Milipore 63
9.2.3 Sartorius 66
9.2.4 3M Purification Inc. 69
9.3 Key Reagent Players 71
9.3.1 Life Technologies 71
9.3.2 Sigma Aldrich 74
9.3.3 SWOT Analysis 75
9.3.4 M&A Deals 75
9.4 Key CMO Players 77
9.4.1 Lonza 77
9.4.2 Boehringer Ingelheim 80
9.4.3 SWOT Analysis 81
9.4.4 Avecia Biotechnology 83
9.4.5 Diosynth Biotechnology 85
10 Downstream Processing : Appendix 88
10.1 Market Definitions 88
10.2 Abbreviations 88
10.3 Research Methodology 89
10.3.1 Coverage 89
10.3.2 Secondary Research 89
10.3.3 Primary Research 89
10.3.4 Expert Panel Validation 90
10.4 Contact Us 90
10.5 Disclaimer 90
10.6 Sources 91
List of Tables
Table 1: Downstream Processing, Comparison of Upstream and Downstream Process, 2009 18
Table 2: Downstream Processing, Reagent Suppliers, 2009 21
Table 3: Downstream Processing, Comparison of Mammalian and Microbial Culture, 2009 23
Table 4: Downstream Processing, Equipment Suppliers, 2009 26
Table 5: Downstream Processing, Types of Single Use Technologies and Vendors, 2009 38
Table 6: Downstream Processing, Key Equipment Players, Pall Corporation, Major M&A Deals, 2005-2009 62
Table 7: Downstream Processing, Key Equipment Players, Milipore, Major M&A Deals, 2005-2009 65
Table 8: Downstream Processing, Key Equipment Players, Sartorius, Major M&A Deals, 2005-2009 68
Table 9: Downstream Processing, Key Equipment Players, 3M, Major M&A Deals, 2005-2009 70
Table 10: Downstream Processing, Key Reagent Players, Life Technologies, Major M&A Deals, 2005-2009 73
Table 11: Downstream Processing, Key Reagent Players, Sigma Aldrich, Major M&A Deals, 2005-2009 76
Table 12: Downstream Processing, Key CMO Players, Lonza, Major M&A Deals, 2005-2009 79
Table 13: Downstream Processing, Key CMO Players, Boehringer Ingelhiem, Major M&A Deals, 2005-2009 82
Table 14: Downstream Processing, Key Players, Avecia, Major M&A Deals, 2004-2009 85
Table 15: Downstream Processing, Key CMO Players, Diosynth Biotechnology, Major M&A Deals, 2005-09 87
List of Figures
Figure 1: Downstream Processing, Biopharmaceutical Types, 2009 9
Figure 2: Downstream Processing, Overview of General Drug Development Process, 2009 12
Figure 3: Downstream Processing, Technologies Employed Along with Steps, 2009 13
Figure 4: Downstream Processing, Changing Distribution of Cost along with Yield Increment, 2009 16
Figure 5: Downstream Processing, Yield Percentage v/s Number of Purification Steps, 2009 17
Figure 6: Downstream Processing, Cost Breakups of Upstream and Downstream Process, 2009 18
Figure 7: Downstream Processing, Total Reagent Market for Downstream Processing, Revenue ($m), 2009-2016 22
Figure 8: Downstream Processing, CMOs Reagent Market for Mammalian Capacity, Revenue ($m) 2009-2016 23
Figure 9: Downstream Processing, CMOs Reagent Market for Microbial Capacity, Revenue ($m) 2009-2016 24
Figure 10: Downstream Processing, In-house Reagent Market for Mammalian Capacity, Revenue ($m) 2009-2016 25
Figure 11: Downstream Processing, In-house Reagent Market for Microbial Capacity, Revenue ($m) 2009-2016 25
Figure 12: Downstream Processing, CMO Biopharmaceutical Market, Revenue ($bn), 2007-2016 28
Figure 13: Downstream Processing, Downstream Process Market For CMOs, Revenue ($bn), 2007-2016 29
Figure 14: Downstream Processing, Challenges, 2009 30
Figure 15: Downstream Processing, Unmet Medical Needs, 2009 32
Figure 16: Downstream Processing, Unmet Achievement of Economies of Scale, 2009 33
Figure 17: Downstream Processing, Unmet Technological Advancement, 2009 34
Figure 18: Downstream Processing, Unmet Reagent Cost Structure, 2009 35
Figure 19: Downstream Processing, Emerging Technologies and their Likely Adaptation, 2009 36
Figure 20: Downstream Processing, Single Use Technologies Benefits, 2009 40
Figure 21: Downstream Processing, Single Use Technologies Challenges, 2009 41
Figure 22: Downstream Processing, Industry Analysis, Key Drivers and Restraints, 2009 51
Figure 23: Downstream Processing, Industry Analysis, Porter Five Forces Model, 2009 52
Figure 24: Downstream Processing, Industry Analysis, Environmental Factors and Impact, 2009 55
Figure 25: Downstream Processing, Industry Analysis, Major Market Events and their Impact, 2009 56
Figure 26: Downstream Processing, Industry Analysis, Market Dynamics, 2009 58
Figure 27: Downstream Processing, Industry Analysis, Competitive Analysis of Major CMOs, 2009 58
Figure 28: Downstream Processing, Industry Analysis, Competitive Analysis of Major Equipment / Reagent Players, 2009 59
Figure 29: Downstream Processing, Key Equipment Players, Business Overview, Pall Corporation, 2009 60
Figure 30: Downstream Processing, Key Equipment Players, SWOT Analysis, Pall Corporation, 2009 61
Figure 31: Downstream Processing, Key Equipment Players, Business Overview, Milipore, 2009 63
Figure 32: Downstream Processing, Key Equipment Players, SWOT Analysis, Milipore, 2009 64
Figure 33: Downstream Processing, Key Equipment Players, Business Overview, Sartorius, 2009 66
Figure 34: Downstream Processing, Key Equipment Players, SWOT Analysis, Sartorius, 2009 67
Figure 35: Downstream Processing, Key Equipment Players, Business Overview, 3M Purification Inc. , 2009 69
Figure 36: Downstream Processing, Key Equipment Players, SWOT Analysis, 3M Purification Inc. , 2009 70
Figure 37: Downstream Processing, Key Reagent Players, Business Overview, Life Technologies, 2009 71
Figure 38: Downstream Processing, Key Reagent Players, SWOT Analysis, Life Technologies, 2009 72
Figure 39: Downstream Processing, Key Reagent Players, Business Overview, Sigma-Aldrich, 2009 74
Figure 40: Downstream Processing, Key Reagent Players, SWOT Analysis, Sigma-Aldrich, 2009 75
Figure 41: Downstream Processing, Key CMO Players, Business Overview, Lonza, 2009 77
Figure 42: Downstream Processing, Key CMO Players, SWOT Analysis, Lonza, 2009 78
Figure 43: Downstream Processing, Key CMO Players, Business Overview, Boehringer Ingelheim, 2009 80
Figure 44: Downstream Processing, Key CMO Players, SWOT Analysis, Boehringer Ingelheim, 2009 81
Figure 45: Downstream Processing, Key CMO Players, Business Overview, Avecia , 2009 83
Figure 46: Downstream Processing, Key CMO Players, SWOT Analysis, Avecia, 2009 84
Figure 47: Downstream Processing, Key CMO Players, Business Overview, Diosynth Biotechnology, 2009 86
Figure 48: Downstream Processing, Key CMO Players, SWOT Analysis, Diosynth Biotechnology, 2009 87
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