Bioseparation Systems for Global Biopharmaceutical Markets

  • August 2013
  • -
  • TriMark Publications
  • -
  • 153 pages

Bioseparations systems can be categorized into three types: chromatography, membranes/filters and centrifuges. The demand for single use products is increasing and fueling growth of the global bioseparations market. New biosimilars are driving the increase in global biomanufacturing capacity. Blockbuster biologics are going off patent, leaving the market open for developing and manufacturing low cost biosimilars. This TriMark Publications report provides market revenue size and growth rates for North America, Europe, Asia-Pacific (Japan, South Korea, Singapore) and the emerging BRICs (Brazil, Russia, India, China). Single-use products, manufacturing capacity, applications of bioseparations in downstream processing, downstream processing bottlenecks and emerging bioseparations technologies are covered in detail. The report also analyzes the competitive landscape, including key players’ strengths and weaknesses, opportunities, gaps and industry trends. Detailed tables and charts with sales forecasts and marketshare data are also included.

Table Of Contents

TABLE OF CONTENTS

1. Introduction 10
1.1 Statement of Report 10
1.2 About this Report 10
1.3 Objectives 11
1.4 Scope of Report 12
1.5 Methodology 12
1.6 Executive Summary 13

2. Overview 15
2.1 Introduction 15
2.2 Biopharmaceutical Industry Environment 15
2.2.1 Investment in Healthcare Worldwide 15
2.2.2 Diseases and Development of New Biologics 15
2.2.3 High Cost of Development and Manufacturing a Biological 15
2.2.4 Economics and Reimbursement for Biological Therapies 16
2.2.5 Strict Regulation of Biologics Manufacturing 16
2.3 Trends in Bioseparations 16
2.3.1 Single-Use Biomanufacturing Technology is Enabling the Biologics Factory
of the Future 16
2.3.2 Emerging and Disruptive Bioprocessing Technologies Have Potential to
Reduce Downstream
Processing Bottlenecks 17
2.3.3 Asia is Becoming a Global Manufacturing Hub 17
2.3.4 Contract Manufacturing Organizations Offering “Biomanufacturing on Demand”
18
2.3.5 Biosimilars are in Demand Globally 18
2.4 Global Biomanufacturing Demographics 19
2.4.1 Global Biologics Producers 19
2.4.2 Global Biomanufacturing Capacity 21

3. Biologics in the Development Phase 23
3.1 Monoclonal Antibodies 24
3.2 Vaccines 24
3.3 Veterinary Vaccines 25
3.4 Recombinant Proteins and Peptides 25
3.5 Blood Plasma Fractionation 26
3.6 Cell Therapy 26
3.7 Gene Therapy 26
3.8 Antisense 26

4. Bioseparations Products and Systems 27
4.1 Chromatography 27
4.2 Membranes and Filters 27
4.3 Centrifuges 27
4.4 Leading Manufacturers of Bioseparations Products and Systems 28

5. The Biopharmaceutical Manufacturing Process 32
5.1 Upstream Processing 32
5.1.1 Host Cell Lines 32
5.1.2 Bioreactors 33
5.1.3 Productivity Improvements in Upstream Processing 33
5.2 Downstream Processing 33
5.2.1 Remove Insolubles 33
5.2.2 Isolation 33
5.2.3 Capture and Purification 34
5.2.4 Polishing 34
5.3 Application of Bioseparations Products for Downstream Processing 35
5.4 Downstream Process Development 35
5.4.1 Laboratory Development 35
5.4.2 Pilot and Scale Up 36
5.4.3 Manufacturing Scale 36
5.4.4 Process Validation 36
5.4.5 Role of Bioseparations Vendors in Process Development 36
5.5 Good Manufacturing Practices and Regulatory Requirements for Manufacture of
Biologicals 37
5.6 Biomanufacturing Cost Considerations 37
5.7 Downstream Bottlenecks 38

6. Bioseparation Processes Used for Biologics Manufacturing 39
6.1 Separation and Purification of Recombinant Proteins from Mammalian Cells 39
6.1.1 Monoclonal Antibody Therapeutics 39
6.1.2 Recombinant Erythropoietin 40
6.2 Separation and Purification of Recombinant Proteins from Microbial Cell
Culture 40
6.2.1 Recombinant Insulin 40
6.3 Vaccine Purification 42
6.3.1 Microbial Vaccines and Toxoids 42
6.3.2 Viral and Capsid Vaccines 42
6.3.3 Polysaccharide Vaccines and Conjugates (Pneumococcal Vaccines) 42
6.3.4 Recombinant Protein Vaccines 43
6.3.5 DNA Vaccines and Gene Therapy 44
6.3.6 Viral Vector Vaccines 44
6.4 Plasma Fractionation 44
6.5 Transgenic Animals and Plants: Emerging Technologies for Producing Biologics
45
6.5.1 Downstream Processing of Transgenically Produced Biologics 46
6.5.2 Specialty Bioseparations Products for Purification of Biologics Produced
from Transgenic Animals or Plants 47

7. Global Bioseparation Market Analysis 48
7.1 The Global Bioseparations Market Size 48
7.2 Global Bioseparations Market Size by Product 48
7.3 Bioseparations Market by Consumables and Equipment 50

8. The Global Bioseparations Market by Region 52
8.1 North America Bioseparations Market 55
8.1.1 The Market Situation 55
8.1.2 Regulatory 56
8.1.3 Biomanufacturing in North America 56
8.1.4 New Construction and Capacity 57
8.1.5 Blood Plasma Fractionation 57
8.1.6 Vaccines 57
8.1.7 Biosimilars 58
8.2 Western Europe Bioseparations Market 58
8.2.1 Bioseparations Manufacturers in Europe 58
8.2.2 The Market Situation 58
8.2.3 Regulatory 59
8.2.4 Biomanufacturing in Western Europe 59
8.2.5 Biosimilars 61
8.2.6 Vaccines 61
8.2.7 Blood Plasma Fractionation 62
8.3 Asia-Pacific Bioseparations Markets 62
8.3.1 Japanese Bioseparations Market 63
8.3.2 Singaporean Bioseparations Market 65
8.3.3 South Korean Bioseparations Market 66
8.4 BRIC Emerging Countries’ Bioseparations Markets 67
8.4.1 Chinese Bioseparations Market 69
8.4.2 Indian Bioseparations Market 72
8.4.3 Brazilian Bioseparations Market 76
8.4.4 Russian Bioseparations Market 78

9. Competitive Landscape 80
9.1 GE Healthcare Life Sciences 80
9.1.1 Strategy 80
9.1.2 Bioseparations Product Mix and Brands 80
9.1.3 Platforms and Product Groups 81
9.1.4 Process Development and Technical Support 82
9.1.5 New Product Launches 82
9.2 Merck Millipore 83
9.2.1 Strategy 83
9.2.2 Bioseparations Product Mix and Brands 84
9.2.3 Platforms and Product Groups 85
9.2.4 Training and Support 86
9.2.5 New Product Launches 86
9.3 Pall Corporation 87
9.3.1 Strategy 87
9.3.2 Bioseparations Product Mix and Brands 87
9.3.3 Platforms and Product Groups 88
9.3.4 Training and Support 88
9.3.5 New Product Introductions 89
9.4 Sartorius 89
9.4.1 Strategy 89
9.4.2 Bioseparations Product Mix and Brands 90
9.4.3 Platforms and Product Groups 91
9.4.4 Training and Support 91
9.4.5 New Product Launches 92
9.5 3M CUNO 92
9.5.1 Strategy 92
9.5.2 Bioseparations Product Mix and Brands 92
9.5.3 Training and Support 93

10. Industry Analysis 94
10.1 Recent Industry Developments 94
10.2 Emerging Technologies 95
10.2.1 Simulated Moving Bed Chromatography/Continuous Countercurrent Flow 95
10.2.2 Monolith Chromatography 96
10.2.3 High Performance Tangential Flow 96
10.2.4 Expanded Bed Adsorption Chromatography 97
10.2.5 Novel Affinity Separations for Blood Plasma Fractionation 97
10.3 Gaps and Challenges 97
10.3.1 Downstream Bottlenecks 97
10.3.2 Single-Use Technologies in Downstream Processing 98
10.4 Opportunities 98
10.4.1 Platform Technologies and Turn Key Biomanufacturing 98
10.4.2 Bioseparations for Biologics Produced from Transgenic Animals and
Genetically
Engineered Plants 98
10.5 Strategic Recommendations 99
10.5.1 Competing in the Bioseparations Market 99
10.5.2 Competing in Emerging and Developing Countries 99
11. Single-Use Bioseparations Systems and Products 100
11.1 Drivers and Restrictors for Single Use Technology 100
11.2 Single-Use Technology for Downstream Purification of Monoclonal Antibodies
101
11.3 Single-Use Technology For Vaccine Production 101
11.4 Single-Use Systems and Skids for Downstream Processing 101
11.5 Pre-Packed Chromatography Columns for Downstream Processing 102
11.6 Single-Use Membrane Absorbers for Downstream Processing 102
11.7 Single-Use Tangential Flow Ultrafiltration for Downstream Processing 103
11.8 Virus Reduction Membranes 104
11.9 Single-Use Depth Filters for Downstream Processing 105
11.10 Single-Use Centrifuges for Downstream Processing 105

12. Chromatography for Bioseparations 107
12.1 Chromatography Size and Growth 107
12.2 Chromatography Market Drivers and Restrictors 107
12.3 Leading Chromatography Manufacturers 108
12.4 Principle of Separation 108
12.5 Liquid Chromatography Media 109
12.5.1 Ion Exchange 110
12.5.2 Affinity 110
12.5.3 Immobilized Metal Ion Chromatography 110
12.5.4 Hydrophobic Interaction Chromatography 110
12.5.5 Size Exclusion Chromatography or Gel Filtration 111
12.5.6 Mixed- or Multi-Mode Chromatography 111
12.6 Advantages and Disadvantage s of Chromatography for Bioseparations 112
12.7 Leading Manufacturers of Chromatography for Bioseparations 113

13. Filters and Membranes Used for Bioseparations 117
13.1 Filtration and Membrane Market Size and Growth 117
13.2 Filtration and Membrane Market Drivers and Restrictors 118
13.3 Leading Membrane and Filtration Manufacturers 118
13.4 Principle of Separation 119
13.4.1 Normal Flow Filtration 119
13.4.2 Tangential Flow Filtration of Crossflow 120
13.5 Membrane and Filter Materials of Construction 120
13.5.1 Polyethersulfone 120
13.5.2 Regenerated Cellulose 120
13.5.3 Cellulose Acetate 120
13.5.4 Polytetrafluorethylene 120
13.5.5 Polyvinylidene Difluoride 120
13.5.6 Nylon 121
13.5.7 Depth Filtration Media 121
13.6 Ultrafiltration 121
13.7 Microfiltration 123
13.8 Depth Filters 124
13.9 Membrane Absorbers 126
13.10 Virus Removal Membranes 126
13.11 Sterilizing Filters 127
13.12 Ceramic Membranes and Modules 128
13.13 Membrane Applications for Biopharmaceutical Manufacturing 129
13.13.1 Cell Harvesting and Clarification 129
13.13.2 Concentration and Diafiltration 129
13.13.3 Purification 129
13.13.4 Virus Reduction 129
13.13.5 Endotoxin Removal and Sterile Filtration 129
13.13.6 Sterile Filtration 130
13.14 Advantages and Disadvantages of Membranes and Filters 131
13.14.1 Ultrafiltration 131
13.14.2 Microfiltration 132
13.14.3 Depth Filters 132
13.14.4 Ceramic Membranes 132
13.14.5 Virus Removal Membranes 132

14. Industrial Centrifuges for Downstream Processing 134
14.1 Centrifuge Market Size and Growth 134
14.2 Principle of Separation 135
14.3 Centrifuge Types 135
14.3.1 Disc Stacked Centrifuges 135
14.3.2 Tubular Bowl Centrifuges 135
14.3.3 Vertical Basket Centrifuge 136
14.4 Application of Centrifuges in Downstream Processing 136
14.4.1 Recovery of Extracellular Recombinant Proteins and Monoclonal Antibodies
136
14.4.2 Recovery of Intracellular Recombinant Proteins and Inclusion Bodies 136
14.4.3 Fractionation of Plasma Proteins 136
14.4.4 Vaccine Production 137
14.5 Centrifuge Advantages and Disadvantages 137
14.6 Competition 138
14.7 Leading Manufacturers and Products 138
14.7.1 Alfa Laval 138
14.7.2 Alfa Wasserman 138
14.7.3 Carr Centritech 138
14.7.4 Celeros Separations 138
14.7.5 Flottweg Separation Technology 139
14.7.6 Hitachi Koki Ltd 139
14.7.7 New Brunswick 139
14.7.8 Westfalia 139

15. Company Profiles 141
15.1 Agilent Technologies 141
15.2 Alfa Wassermann Separation Technologies 141
15.3 Applied Biosystems Corporation (Life Technologies) 141
15.4 Asahi Kasei 141
15.5 Bio-Rad Laboratories 142
15.6 Carr Centritech 142
15.7 Celeros 142
15.8 Dow Chemical Company 142
15.9 DSM Biologics 143
15.10 Flottweg Separations Technology 143
15.11 G-Con Manufacturing 143
15.12 GEA Westfalia Separator Group 143
15.13 GE Healthcare Life Sciences 144
15.14 Hitachi Koki Co. LTD 144
15.15 Knauer 144
15.16 Kronlab (YMC Europe) 145
15.17 Life Technologies 145
15.18 Meissner Filtration Products, Inc. 147
15.19 Merck Millipore 147
15.20 3M Cuno 147
15.20.1 Overview 148
15.20.2 Operating Segments 148
15.20.3 Products 149
15.21 Novasep Life Sciences Manufacturing Solutions 149
15.22 Novavax 150
15.23 NuSep Holdings Ltd 150
15.24 Pall Corporation 150
15.25 ProMetic Life Sciences Inc. 151
15.26 Sartorius Stedim Biotech 151
15.27 SciLog 151
15.28 Spectrum Laboratories 152
15.29 Tarpon Biosystems 152
15.30 Tosoh Bioscience 152
15.31 U.S. Filter Control Systems, Inc. 153
15.32 Waters Corporation 153


INDEX OF TABLES

Table 3.1: Biologics Market Size and Projected Growth by Therapeutic Class 24
Table 4.1: Comparison of Chromatography, Filtration and Centrifugation for
Downstream Processing 28
Table 4.2: Leading Bioseparations Manufacturers’ Market Share 29
Table 4.3: Leading Bioseparations Manufacturers’ Product Lines 29
Table 4.4: North American Companies Participating in the Bioseparations Market
30
Table 4.5: European Companies Participating in the Bioseparations Market 30
Table 4.6: Asian Companies Participating in the Bioseparations Market 31
Table 5.1: Optimal Host Cell Line Characteristics 32
Table 7.1: Bioseparations Systems Market Size and Projected Growth, 2012-2018 48
Table 7.2: Drivers and Restrictors of the Global Bioseparations Market 48
Table 7.3: Global Bioseparations Market by Product: Projected Growth 2012-2018
49
Table 7.4: Global Bioseparations Market: Consumables and Equipment Projected
Growth, 2012-2018 50
Table 8.1: The Global Bioseparations Market by Region: Projected Size, 2012-2018
52
Table 8.2: North America Bioseparations Market: Projected Size, 2012-2018 55
Table 8.3: Drivers and Restrictors of the Bioseparation Systems Market in North
America 56
Table 8.4: Largest Biomanufacturing Sites and Capacity in United States 56
Table 8.5: Major CMOs Manufacturing Capacity in North America 57
Table 8.6: Western Europe Bioseparations Market: Projected Size, 2012-2018 58
Table 8.7: Drivers and Restrictors of the Bioseparations Market in Western
Europe 59
Table 8.8: Biomanufacturing Sites and Capacity in Western Europe 60
Table 8.9: Major CMOs Biomanufacturing Capacity in Western Europe 61
Table 8.10: Major Vaccine Manufacturing Sites in Western Europe 62
Table 8.11: Western Europe Blood Fractionation Facilities 62
Table 8.12: Asia-Pacific Biomanufacturing Market: Projected Size, 2012-2018 63
Table 8.13: Drivers and Restrictors of the Bioseparations Market in Japan 63
Table 8.14: Alliances and Manufacturing Capacity of Selected Japanese
Biopharmaceutical Companies 64
Table 8.15: Singaporean Biomanufacturing Capacity 65
Table 8.16: South Korean Biomanufacturing Capacity 67
Table 8.17: Emerging Countries’ Bioseparations Systems Market Projected by
Country 2012-2018 68
Table 8.18: Chinese Bioseparations Market: Projected Size, 2012-2018 70
Table 8.19: Drivers and Restrictors of the Bioseparations Market in China 70
Table 8.21: Indian Bioseparations Market: Projected Size, 2012-2018 72
Table 8.22: Drivers and Restrictors of the Bioseparations Market in India 73
Table 8.23: Indian Biomanufacturing Companies and Capacity 75
Table 8.24: Brazilian Bioseparations Market: Projected Size, 2012-2018 76
Table 8.25: Drivers and Restrictors of the Bioseparation Systems Market in
Brazil 76
Table 8.26: Russian Bioseparations Market: Projected Size, 2012-2018 78
Table 8.27: Drivers and Restrictors of the Bioseparation Systems Market in
Russia 78
Table 9.1: GE Healthcare Life Sciences Strengths and Weaknesses 81
Table 9.2: GE Healthcare Life Sciences Bioseparations Products and Brands 81
Table 9.3: Merck Millipore Strengths and Weaknesses 84
Table 9.4: Merck Millipore Bioseparations Products and Brands 84
Table 9.5: Merck Millipore Mobius Single-Use Platform 85
Table 9.3: Pall Corporation Strengths and Weaknesses 87
Table 9.4: Pall Corporation Bioseparations Products and Brands 88
Table 9.5: Sartorius Strengths and Weaknesses 90
Table 9.6: Sartorius Bioseparations Products and Brands 90
Table 9.7: 3M Cuno Strengths and Weaknesses 92
Table 9.8: 3M Cuno BioseparationsProducts and Brands 93
Table 11.1: Drivers and Restrictors for Single-Use Technology 100
Table 11.2: Single-Use Systems for Clinical Scale Downstream Processing 102
Table 11.3: Pre-Packed Chromatography Columns for Downstream Processing 102
Table 11.4: Single-Use Membrane Absorbers for Downstream Processing 103
Table 11.5: Single-Use Tangential Flow Ultrafiltration for Downstream Processing
104
Table 11.6: Viral Reduction Membranes for Downstream Processing 104
Table 11.7: Single-Use Depth Filters for Downstream Processing 105
Table 11.8: Single-Use Centrifuges for Downstream Processing 106
Table 12.1: Projected Growth for Global Chromatography Market for
Bioseparations, 2012-2018 107
Table 12.2: Chromatography Market Drivers and Restrictors 108
Table 12.3: Manufacturers of RP-HPLC Chromatography Media for Bioseparations 109
Table 12.4: Bioseparations by Chromatography Type 112
Table 12.5: Chromatography Advantages and Disadvantages 113
Table 12.6: GE Healthcare Life Sciences Process Scale Chromatography Media and
Columns 114
Table 12.7: Merck Millipore Process Scale Chromatography Media and Columns 114
Table 12.8: Pall Corporation Process Scale Chromatography Media and Columns 115
Table 12.9: Life Technologies Applied Biosystems Process Scale Chromatography
Media and Columns 115
Table 12.10: Bio-Rad Process Scale Chromatography Media and Columns 116
Table 12.11: Second Tier Competitors’ Process Scale Chromatography Media and
Columns 116
Table 13.1: Projected Growth of the Global Market for Membranes and Filters for

Bioseparations, 2012-2018 117
Table 13.2: Drivers and Restrictors Membranes and Filters of For Bioseparations
118
Table 13.3: Pore Size of Ultrafilters Described by NMWC 122
Table 13.4: Leading Companies’ Ultrafiltration Membranes 123
Table 13.5: Leading Companies’ Microporous Membranes 124
Table 13.6: Leading Companies’ Depth Filters 125
Table 13.7: Leading Companies’ Membrane Absorbers 126
Table 13.8: Leading Companies’ Virus Removal Membranes 127
Table 13.9: Leading Companies Sterilizing Filters 128
Table 13.10: Application of Membranes and Filters for Biopharmaceutical
Manufacturing 131
Table 13.11: Advantages and Disadvantages of Membranes and Filters 133
Table 14.1: Projected Growth of the Global Market for Centrifuges for
Bioseparations, 2012-2018 134
Table 14.2: Drivers and Restrictors 134
Table 14.3: Advantages and Disadvantages of Centrifugation for Cell Harvesting
and Clarification 137
Table 14.4: Leading Manufacturers’ Centrifuges for Downstream Processing 139
Table 14.5: Leading Manufacturer’s Centrifuges for Downstream Processing 140


INDEX OF FIGURES
Figure 2.1: Global Distribution of Biomanufacturing Capacity 22
Figure 3.1: Number of Biologicals in Development in the United States 23
Figure 3.2: Pipeline of Biologics by Therapeutic Class 23
Figure 4.1: Leading Bioseparations Manufacturer’s Market Share 29
Figure 5.1: The Downstream Process for Purifying Biologicals 34
Figure 6.1: Downstream Isolation and Purification of Monoclonal Antibodies 39
Figure 6.2: Downstream Purification of Insulin Produced by the Intracellular
Proinsulin Process 41
Figure 6.3: Downstream Processing of Recombinant Protein Produced from Insect
Cells 43
Figure 6.4: Downstream Processing of Plasmid DNA 45
Figure 7.1: Global Bioseparations Market by Product 49
Figure 7.2: Global Bioseparations Market by Product: Projected Growth, 2012-2018
50
Figure 7.3: Global Bioseparations Market: Projected Growth of Consumables and
Equipment, 2012-2018 51
Figure 8.1: Global Bioseparations Market by Region, 2013 52
Figure 8.2: Global Bioseparations Systems Market by Region, 2018 53
Figure 8.3: Global Bioseparations Market Projected by Region, 2013-2018 54
Figure 8.4: Global Bioseparations Market: Projected Growth by Region, 2012-2018
54
Figure 8.5: Emerging Countries’ Bioseparations Market Share by Country 67
Figure 8.6: Emerging Countries’ Bioseparations Market Projected by Country,
2013-2018 68
Figure 8.7: Emerging Countries’ Bioseparations Market Projected Growth by
Country, 2012-2018 69
Figure 12.1: Global Bioseparations Market for Chromatography by Region 2012 107
Figure 12.2: Process Scale Chromatography Columns 109
Figure 13.1: Global Bioseparation Market for Membranes and Filters by Region,
2012 117
Figure 13.2: Image of a Depth Filter 121
Figure 13.3: Image of a Cross-Section of an Ultrafiltration Membrane 122
Figure 13.4: Image of the Surface of a Microporous Membrane 124
Figure 13.5: Installing Depth Filter Modules for Downstram Processing 125
Figure 13.6: Ceramic Membranes Encapsulated in Stainless Steel Housing 128
Figure 14.1: Global Bioseparations Market for Centrifuges, 2012 134
Figure 14.2: Disc Stack Centrifuge 135
Figure 14.3: Tubular Bowl Centrifuge 136

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