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市場調査レポート

世界のバイオ医薬品向けバイオ分離システム市場

Bioseparation Systems for Global Biopharmaceutical Markets

発行 TriMark Publications 商品コード 278632
出版日 ページ情報 英文 153 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.50円で換算しております。
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世界のバイオ医薬品向けバイオ分離システム市場 Bioseparation Systems for Global Biopharmaceutical Markets
出版日: 2013年08月01日 ページ情報: 英文 153 Pages
概要

バイオ分離システムは、クロマトグラフィー、膜/フィルターおよび遠心分離機の3つの種類に分類できます。シングルユーズ製品の需要が増加しており、世界のバイオ分離市場の成長を刺激しています。

当レポートでは、世界のバイオ医薬品向けバイオ分離システム市場について調査し、地域別の市場収益と予測、シングルユーズ製品、製造能力、後工程におけるバイオ分離のアプリケーション、後工程の障壁および新しいバイオ分離技術に関する詳細な分析を提供しており、競合情勢、機会、産業動向、および主要企業のプロファイルなどをまとめ、概略下記の内容でお届けいたします。

第1章 イントロダクション

第2章 概要

  • イントロダクション
  • バイオ医薬品産業の環境
  • バイオ分離の動向
  • 世界のバイオ医薬品製造統計

第3章 開発中の生物製剤

  • モノクロナール抗体
  • ワクチン
  • 動物用ワクチン
  • 組み換えタンパク質・ペプチド
  • 血漿分別
  • 細胞療法
  • 遺伝子治療
  • アンチセンス

第4章 バイオ分離製品・システム

  • クロマトグラフィー
  • 膜・フィルター
  • 遠心分離機
  • バイオ分離製品・システムの主要メーカー

第5章 バイオ医薬品製造プロセス

  • 前工程
  • 後工程
  • 後工程向けバイオ分離製品のアプリケーション
  • 後工程の開発
  • 生物製剤製造の優れた実践と規制要件
  • バイオ製造コストの検討事項
  • 後工程の障壁

第6章 生物製剤の製造に用いられるバイオ分離プロセス

  • 哺乳類細胞による遺伝子組み換えタンパク質の分離と精製
  • 微生物細胞培養による遺伝子組み換えタンパク質の分離と精製
  • ワクチン精製
  • 血漿分画
  • トランスジェニック動物・植物:生物製剤製造の新興技術

第7章 世界のバイオ分離市場分析

  • 世界のバイオ分離市場規模
  • 世界のバイオ分離市場規模・製品
  • バイオ分離市場:消耗品・備品別

第8章 世界のバイオ分離市場:地域別

  • 北米
  • 西欧
  • アジア太平洋地域
  • BRIC

第9章 競合情勢

  • GE Healthcare Life Sciences
  • Merck Millipore
  • Pall Corporation
  • Sartorius
  • 3M CUNO

第10章 産業分析

  • 近年の産業発展
  • 新興技術
  • 格差・課題
  • 機会
  • 戦略的提言

第11章 シングルユーズのバイオ分離システム・製品

  • シングルユーズ技術の促進因子・阻害因子
  • モノクロナール抗体の後精製向けシングルユーズ技術
  • ワクチン製造向けシングルユーズ技術
  • 後工程向けシングルユーズシステム・スキッド
  • 後工程向けプレパッククロマトグラフィーカラム
  • 後工程向けシングルユーズ膜吸収体
  • 後工程向けシングルユーズ接線流限外ろ過
  • ウィルス削減膜
  • 後工程向けシングルユーズデプスフィルター
  • 後工程向けシングルユーズ遠心分離機

第12章 バイオ分離向けクロマトグラフィー

  • クロマトグラフィーの規模・成長率
  • クロマトグラフィー市場の促進因子・阻害因子
  • 主なクロマトグラフィーメーカー
  • 分離の原理
  • 液体クロマトグラフィー媒体
  • バイオ分離向けクロマトグラフィーのメリットとデメリット
  • バイオ分離向けクロマトグラフィーの主なメーカー

第13章 バイオ分離に用いられるフィルター・膜

  • ろ過・膜市場の規模・成長率
  • ろ過・膜市場の促進因子・阻害因子
  • 主な膜・ろ過装置メーカー
  • 分離の原理
  • 膜・フィルターの構成材料
  • 限外ろ過
  • 精密ろ過
  • デプスフィルター
  • 膜吸収体
  • ウィルス除去膜
  • 消毒フィルター
  • セラミック膜・モジュール
  • バイオ医薬品製造向け膜アプリケーション
  • 膜・フィルターのメリット・デメリット

第14章 後工程向け工業用遠心分離機

  • 遠心分離機市場規模・成長率
  • 分離の原理
  • 遠心分離機のタイプ
  • 後工程における遠心分離機のアプリケーション
  • 遠心分離機のメリットとデメリット
  • 競合
  • 主なメーカーと製品

第15章 企業プロファイル

付録

図表

目次
Product Code: TMRBIOS13-0801

Abstract

Description

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 playersÕ strengths and weaknesses, opportunities, gaps and industry trends. Detailed tables and charts with sales forecasts and marketshare data are also included.

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 òBiomanufacturing on Demandó 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 CountriesÕ 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 ManufacturersÕ Market Share 29
  • Table 4.3: Leading Bioseparations ManufacturersÕ 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 CountriesÕ 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 CompetitorsÕ 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 CompaniesÕ Ultrafiltration Membranes 123
  • Table 13.5: Leading CompaniesÕ Microporous Membranes 124
  • Table 13.6: Leading CompaniesÕ Depth Filters 125
  • Table 13.7: Leading CompaniesÕ Membrane Absorbers 126
  • Table 13.8: Leading CompaniesÕ 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 ManufacturersÕ Centrifuges for Downstream Processing 139
  • Table 14.5: Leading ManufacturerÕs 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 ManufacturerÕs 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 CountriesÕ Bioseparations Market Share by Country 67
  • Figure 8.6: Emerging CountriesÕ Bioseparations Market Projected by Country, 2013-2018 68
  • Figure 8.7: Emerging CountriesÕ 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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