INTRODUCTION

REASONS FOR DOING THE STUDY

Membrane technology is used in all phases of the pharmaceutical development processes, from laboratory research to large-scale pharmaceutical manufacturing. Applications include lab-scale DNA and protein separation and analysis, sample preparation, drug screening, cell culturing and examination, laboratory and process water purification, virus removal, and bench-, pilot-, and production-scale drug manufacturing.

Substantial changes in the pharmaceutical and biopharmaceutical industries have made membrane separations processes an important part of the production of drugs. Membrane separation processes help ensure safety and efficacy of drugs by eliminating contaminants from the laboratory through large-scale production.

This study is an update of a previous report from 2005; it combines bio-pharmaceutical, life science research, and pharmaceutical membrane separation technologies.

STUDY GOALS AND OBJECTIVES

This report provides an in-depth analysis of the market for membrane technology in pharmaceuticals, life sciences, and biopharmaceutical applications. Areas in the report include laboratory analysis (e.g., gene and protein analysis, drug candidate screening, laboratory separations and water treatment), biopharmaceutical development (e.g., cell culturing, protein purification, virus removal) and pharmaceutical manufacturing.

Technical and market drivers are considered in evaluating the current value of the technologies and in projecting growth and trends over the next five years. Conclusions are illustrated with statistical information on markets, applications, industry structure and dynamics, and technological developments.

In addition to coverage of membrane technology by type, the report will segment the market by region, including the Americas (U.S., Canada, Latin America, South America); Europe, Middle East, Russia, and Africa (EMRA); and Asia (Japan, Australia/New Zealand, India, China, other Asia-Pacific areas).

SCOPE AND FORMAT

The study is intended for individuals requiring an in-depth analysis of the life science, pharmaceutical, and biopharmaceutical membrane separation technology industries. It traces significant developments and forecasts important trends, quantifies the various market sectors, and highlights companies active in those areas.

The report will not cover membranes used in the healthcare or medical diagnostics fields, or membranes used in air and gas venting on medical devices.

INTENDED AUDIENCE

This study will be of interest to membrane device manufacturers, membrane material manufacturers, and venture capitalists and financial institutions involved in the healthcare industry.

METHODOLOGIES AND INFORMATION SOURCES

Both primary and secondary research methodologies were used in preparing this study. A comprehensive literature, patent, and Internet search was conducted. Additionally, business, scientific, and industry journals; government reports; annual reports; conference literature; and Securities and Exchange Commission (SEC) reports were consulted. Industry experts were consulted as necessary.

Growth rates were calculated based on existing and proposed device and equipment sales during the forecast period. Membrane consumables were also taken into account.

Values are given in U.S. dollars; forecasts are made in constant U.S. dollars, and growth rates are compounded. Calculations do not include design nor installation costs or validation expenses.

ANALYST CREDENTIALS

Peggy S Lehr is the BCC Research analyst of this report. Ms. Lehr holds a BS in Journalism from the University of Colorado, Boulder, and an MS in Communication from the University of Denver. Ms. Lehr has worked in the publishing industry for both for-profit and not-for-profit organizations, and she has completed more than 20 reports for BCC.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1
REASONS FOR DOING THE STUDY 1
STUDY GOALS AND OBJECTIVES 1
SCOPE AND FORMAT 1
INTENDED AUDIENCE 2
METHODOLOGIES AND INFORMATION SOURCES 2
ANALYST CREDENTIALS 2
RELATED BCC REPORTS 2
BCC ON-LINE SERVICES 2
DISCLAIMER 3
CHAPTER 2 SUMMARY 5
MEMBRANE TECHNOLOGY AND THE PHARMACEUTICAL INDUSTRY 5
SUMMARY TABLE GLOBAL MARKET FOR MEMBRANE TECHNOLOGY, THROUGH 2016 ($
MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET FOR MEMBRANE TECHNOLOGY, 2011 AND 2016 (%) 6
CHAPTER 3 OVERVIEW 9
ABBREVIATIONS USED IN THE MEMBRANE SEPARATION INDUSTRY 9
TABLE 1 ABBREVIATIONS USED IN MEMBRANE SEPARATION INDUSTRY 9
MARKET TRENDS IN THE PHARMACEUTICAL AND BIOPHARMACEUTICAL MARKETS 10
GLOBAL DEMOGRAPHIC TRENDS 10
BIOMANUFACTURING TRENDS 10
Investments in Personalized Medicine 11
PHARMACEUTICAL SECTOR TRENDS 11
TABLE 2 DRUGS THAT LOSE PATENT PROTECTION BETWEEN 2010 AND 2012 11
EXPANSION OF SINGLE-USE TECHNOLOGIES 12
EXPANSION OF INDICATIONS 13
BRIEF HISTORY OF MEMBRANE TECHNOLOGY 13
DEVELOPMENT OF PHARMACEUTICALS 13
PHARMACEUTICALS AND BIOPHARMACEUTICALS 13
Small Molecule Pharmaceuticals 13
Development of Biopharmaceuticals 14
Table 3 BIOLOGIC DRUG DEVELOPMENT VERSUS CONVENTIONAL DRUG DEVELOPMENT 14
DRUG DISCOVERY, DEVELOPMENT, AND MANUFACTURING 14
Drug Discovery 15
FIGURE 1 NEW DRUGS: FROM DISCOVERY TO MANUFACTURING 15
DRUG DEVELOPMENT COSTS 15
RESEARCH FUNDING 16
European Research Funding 16
Biopharmaceutical Pipeline 16
HARMONIZATION 16
GLOBAL DEVELOPMENT OF COMPOUNDS 16
CHAPTER 4 COMPETITION WITHIN THE GLOBAL MEMBRANE INDUSTRY 18
FIGURE 2 MARKET SHARE OF GLOBAL MEMBRANE TECHNOLOGY MANUFACTURERS, 2011
(%) 18
RESEARCH AND DEVELOPMENT SPENDING 18
TABLE 4 GLOBAL RandD SPENDING BY TOP 10 COUNTRIES, 2012 ($ BILLIONS/%) 19
TABLE 5 MAJOR MANUFACTURERS OF MEMBRANE PRODUCTS AND PRODUCT TYPES 19
PURCHASERS OF DISPOSABLE MEMBRANES 20
ECONOMICS OF DISPOSABLE FILTRATION SYSTEMS 20
DISPOSABLE DEMAND AND GOVERNMENT REGULATIONS 21
DISPOSABLE DEMAND AND APPLICATION POTENTIAL 21
CONCERNS REGARDING SUT 21
COMPETITIVE TECHNOLOGIES 21
CHROMATOGRAPHY 22
CENTRIFUGATION 22
Disadvantages of Centrifugation 22
ELECTROPHORESIS 22
MEMBRANE CHROMATOGRAPHY 22
ADVANTAGES/DISADVANTAGES OF MEMBRANE CHROMATOGRAPHY 23
Disadvantages of Membrane Chromatography 23
DIFFERENCES IN SCALING-UP PROCEDURES 24
MARKET SIZES OF MEMBRANE AND COMPETITIVE METHODS 24
FIGURE 3 ESTIMATED GLOBAL MARKET SIZE FOR MEMBRANE CHROMATOGRAPHY AND
COMPETITIVE BIOSEPARATION METHODS IN PHARMACEUTICAL AND
BIOPHARMACEUTICAL PRODUCTION, 2011 (%)
24
ACQUISITIONS IN THE MEMBRANE TECHNOLOGY MARKET 25
TABLE 6 SELECTED ACQUISITIONS WITHIN THE MEMBRANE TECHNOLOGY MARKET,
JANUARY 2005 THROUGH APRIL 2012 ($ MILLIONS) 25
REGIONAL ANALYSIS OF REGULATORY AND REIMBURSEMENT ENVIRONMENTS 26
REGULATORY ENVIRONMENTS 26
The Americas 26
EMRA 26
Asia 27
Japan 27
Australia 27
China 27
India 27
REIMBURSEMENT ENVIRONMENTS 28
The Americas 28
EMRA 28
Asia 28
Japan 28
China 29
India 29
INTRODUCTION OF RAPID MICROBIOLOGICAL METHODS 29
MARKET FOR MEMBRANE TECHNOLOGY, BY GEOGRAPHIC REGION 29
TABLE 7 PROJECTED MARKET FOR MEMBRANE TECHNOLOGY, BY REGION, THROUGH 2016
($ MILLIONS) 29
THE AMERICAS 30
Canadian Pharmaceutical Manufacturing Market 30
South American Pharmaceutical Manufacturing Market 30
Americas Market for Membrane Technology Products 30
Table 8 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS BY
REGION, THROUGH 2016 ($ MILLIONS) 30
FIGURE 4 AMERICAS MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, IN 2011 AND
2016 (%) 31
EMRA 32
Western Europe 32
Eastern European 32
Russia 32
Middle East 32
Africa 33
PROJECTED EMRA MEMBRANE TECHNOLOGY MARKET 33
TABLE 9 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY BY REGION,
THROUGH 2016 ($ MILLIONS) 33
FIGURE 5 EMRA MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, 2011 AND 2016 (%) 33
ASIA 35
Japan 35
China 35
Australia 35
PROJECTED ASIAN MEMBRANE TECHNOLOGY MARKET 35
TABLE 10 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS BY
REGION, THROUGH 2016 ($ MILLIONS) 35
FIGURE 6 ASIAN MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, 2011 AND 2016 (%) 36
CHAPTER 5 MEMBRANE MATERIALS AND PROCESSES 39
MEMBRANE MATERIALS 39
TABLE 11 CHARACTERISTICS OF POLYMER MEMBRANE MATERIALS 39
MOLECULAR WEIGHT CUTOFF 40
FLUX 40
FOULING 40
CERAMIC MEMBRANES 40
MODULES 41
MODULE FORMATS 41
Flat Plate Membranes 41
Spiral Wound Membranes 41
Hollow Fiber Membranes 42
Table 12 MODULE MANUFACTURERS/PRODUCTS, 2011 42
CONFIGURATION APPLICATIONS 42
MEMBRANE SEPARATION PROCESSES 43
TABLE 13 FILTERS FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL PROCESSES 43
GLOBAL MARKET FOR MEMBRANE TECHNOLOGY 43
TABLE 14 PROJECTED GLOBAL MARKET FOR MEMBRANES IN PHARMACEUTICAL
PROCESSES, BY TYPE, THROUGH 2016 ($ MILLIONS) 43
REVERSE OSMOSIS 44
PROJECTED GLOBAL MARKET FOR REVERSE OSMOSIS MEMBRANES IN
PHARMACEUTICAL PROCESSES 44
TABLE 15 PROJECTED GLOBAL MARKET FOR REVERSE OSMOSIS MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 44
NANOFILTRATION 44
PROJECTED MARKET FOR NANOFILTRATION MEMBRANES IN PHARMACEUTICAL
PROCESSES 45
TABLE 16 PROJECTED GLOBAL MARKET FOR NANOFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 45
ULTRAFILTRATION 45
PROJECTED GLOBAL MARKET FOR ULTRAFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES 45
TABLE 17 PROJECTED GLOBAL MARKET FOR ULTRAFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 46
MICROFILTRATION 46
PROJECTED GLOBAL MARKET FOR MICROFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES 46
TABLE 18 PROJECTED GLOBAL MARKET FOR MICROFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 47
MICROFILTRATION AND ULTRAFILTRATION IN BIOSEPARATION 47
Ultrafiltration Systems 47
Table 19 BIOPHARMACEUTICAL APPLICATIONS OF UF AND MF 47
ION EXCHANGE MEMBRANES 48
PROJECTED GLOBAL MARKET FOR ION EXCHANGE MEMBRANES IN PHARMACEUTICAL
PROCESSES 48
TABLE 20 PROJECTED GLOBAL MARKET FOR ION EXCHANGE MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 48
METHODS OF FILTRATION 48
PRESSURE-DRIVEN TANGENTIAL FLOW FILTRATION 49
TABLE 21 ACTIONS OF VARIOUS FILTRATION COMPONENTS IN TFF PROCESS 49
TABLE 22 COMPARISON OF SEPARATION METHODS 49
DIRECT-FLOW FILTRATION 50
ELECTRODEIONIZATION 50
CHAPTER 6 MEMBRANE FILTRATION IN PHARMACEUTICAL MANUFACTURING 52
TRENDS IN PHARMACEUTICAL MANUFACTURING 52
RandD IN PHARMACEUTICAL DEVELOPMENT 52
TABLE 23 NUMBER OF DRUGS IN DEVELOPMENT, 2000-2010 52
TABLE 24 RandD EXPENDITURES BY TOP 10 PHARMACEUTICAL COMPANIES BY RandD
SPENDING, 2010 ($ BILLIONS) 53
SHIFTING MARKETPLACE FOR PHARMACEUTICAL MEMBRANE FILTRATION 53
GLOBAL MARKET FOR MEMBRANE FILTRATION IN PHARMACEUTICAL DEVELOPMENT 53
TABLE 25 PROJECTED GLOBAL MARKET FOR MEMBRANE FILTRATION IN THE
PHARMACEUTICAL MARKET, THROUGH 2016 ($ MILLIONS) 54
FIGURE 7 PROJECTED MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION BY TYPE
OF FILTER, 2011 AND 2016 (%) 54
REGIONAL ANALYSIS OF RandD SPENDING FOR THE DEVELOPMENT OF
PHARMACEUTICAL DRUGS 55
FIGURE 8 MARKET SHARE OF GLOBAL R andD SPENDING, BY REGION, 2012 (%) 55
REGIONAL ANALYSIS OF PHARMACEUTICAL MEMBRANE FILTRATION MARKET 56
TABLE 26 PROJECTED MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 56
FIGURE 9 GLOBAL MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY REGION,
2011 AND 2016 (%) 56
GLOBAL PHARMACEUTICAL MEMBRANE FILTRATION MARKET, BY REGION 58
THE AMERICAS 58
TABLE 27 PROJECTED AMERICAS MARKET FOR PHARMACEUTICAL MEMBRANE
FILTRATION, BY REGION, THROUGH 2016 ($ MILLIONS) 58
FIGURE 10 PROJECTED AMERICAS MARKET FOR PHARMACEUTICAL MEMBRANE
FILTRATION, BY TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 58
EMRA 60
TABLE 28 PROJECTED EMRA MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 60
FIGURE 11 PROJECTED EMRA MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION BY
TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 60
ASIA 62
TABLE 29 PROJECTED ASIAN MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 62
FIGURE 12 PROJECTED ASIAN MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION
BY TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 62
CHAPTER 7 MEMBRANE TECHNOLOGY APPLICATIONS IN LIFE SCIENCES RESEARCH 65
PROJECTED GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN THE LIFE SCIENCES 65
TABLE 30 PROJECTED GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN LIFE SCIENCE
APPLICATIONS, BY DEVICE/SYSTEM TYPE, THROUGH 2016 ($ MILLIONS) 66
FIGURE 13 GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN LIFE SCIENCES
RESEARCH, 2011 AND 2016 (%) 66
MEMBRANE CHROMATOGRAPHY 68
Membrane Adsorbers 68
Hydrophobic-Interaction Membrane Chromatography (HIC) 68
MANUFACTURERS OF MEMBRANE CHROMATOGRAPHY PRODUCTS 69
TABLE 31 MANUFACTURERS/PRODUCTS FOR MEMBRANE CHROMATOGRAPHY, 2011 69
ADVANTAGES OF MEMBRANE CHROMATOGRAPHY TECHNOLOGY IN LARGE-SCALE
BIOMANUFACTURING 69
GLOBAL MARKET FOR MEMBRANE CHROMATOGRAPHY IN BIOPHARMACEUTICAL
APPLICATIONS 70
TABLE 32 PROJECTED GLOBAL MARKET FOR MEMBRANE CHROMATOGRAPHY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 70
TRANSFER MEMBRANES 70
Types of Blots 70
Southern Blot 70
Western Blot 71
Colony or Plaque Blots 71
Dot Blots 71
Transfer Membrane Manufacturers/Products 71
Table 33 TRANSFER MEMBRANE MANUFACTURER/PRODUCTS, 2011 71
PROJECTED GLOBAL MARKET FOR TRANSFER MEMBRANES 72
TABLE 34 PROJECTED GLOBAL MARKET FOR TRANSFER MEMBRANE PRODUCTS, THROUGH
2016 ($ MILLIONS) 72
MICROARRAYS 73
PROJECTED GLOBAL MARKET FOR MICROARRAY PRODUCTS 73
TABLE 35 PROJECTED GLOBAL MARKET FOR MICROARRAY PRODUCTS FOR LIFE SCIENCE
APPLICATIONS, THROUGH 2016 ($ MILLIONS) 73
PROTEOMICS AND GENOMICS 73
PROTEOMICS 73
Protein Arrays 74
Protein Array Applications 74
Protein Array Membranes 74
Protein Array Manufacturers/Products 74
Table 36 PROTEIN ARRAY MANUFACTURERS/PRODUCTS, 2011 75
PROJECTED GLOBAL MARKET FOR PROTEIN MICROARRAY PRODUCTS 75
TABLE 37 PROJECTED GLOBAL MARKET FOR PROTEIN MICROARRAY PRODUCTS FOR LIFE
SCIENCE APPLICATIONS, THROUGH 2016 ($ MILLIONS) 76
GENOMICS 76
DNA Macroarrays/Microarrays 76
DNA Microarray Membranes 76
Charging Characteristics of Nylon and NC Membranes 77
DNA Array Manufacturers/Products 77
Table 38 DNA MICROARRAY MANUFACTURERS/PRODUCTS, 2011 77
GLOBAL MARKET FOR DNA MICROARRAY PRODUCTS 78
TABLE 39 PROJECTED GLOBAL MARKET FOR DNA MICROARRAY PRODUCTS FOR LIFE
SCIENCE APPLICATIONS, THROUGH 2016 ($ MILLIONS) 78
DRUG SCREENING 78
THE ODDS AGAINST SUCCESS 78
TOOLS TO ACCESS POTENTIAL PRODUCTS 78
Multiwell Filter Plates 79
ADMET Screening 79
Microwell Plates 79
Solubility Assays 79
Parallel Artificial Membrane Permeation Assays 80
Caco-2 and Other Cell-Based Transport Assays 80
Bound Versus Free Drug Assays 80
Total Drug Analysis 80
DNA Sample Preparation 80
MULTIWELL FILTER PLATE MANUFACTURERS/PRODUCTS 81
TABLE 40 MULTIWELL FILTER PLATE MANUFACTURERS/PRODUCTS, 2011 81
GLOBAL MARKET FOR MULTIWELL FILTER PLATES 84
TABLE 41 PROJECTED GLOBAL MARKET FOR MULTIWELL FILTER PLATES, THROUGH 2016
($ MILLIONS) 84
LAB-SCALE SEPARATIONS 85
GLOBAL MARKET FOR LAB-SCALE MEMBRANE SEPARATION DEVICES 85
TABLE 42 PROJECTED GLOBAL MARKET FOR LAB-SCALE MEMBRANE SEPARATION
DEVICES, THROUGH 2016 ($ MILLIONS) 85
SYRINGE FILTERS 85
Syringeless Filters 86
Syringe /Syringeless Filter Manufacturers/Products 86
Table 43 SYRINGE MEMBRANE FILTER MANUFACTURERS AND PRODUCTS, 2011 86
PROJECTED GLOBAL MARKET FOR SYRINGE FILTERS 87
TABLE 44 PROJECTED GLOBAL MARKET FOR SYRINGE FILTERS, THROUGH 2016 ($
MILLIONS) 87
BOTTLE-TOP FILTERS 87
BOTTLE-TOP FILTER MANUFACTURERS/PRODUCTS 88
TABLE 45 BOTTLE TOP FILTER MANUFACTURERS/PRODUCTS 88
PROJECTED GLOBAL MARKET FOR BOTTLE TOP FILTERS 89
TABLE 46 PROJECTED GLOBAL MARKET FOR BOTTLE TOP FILTERS, THROUGH 2016 ($
MILLIONS) 89
MOLECULAR SEPARATIONS SYSTEMS 89
STIRRED CELL SYSTEMS 89
Stirred Cell Manufacturers/Products 90
Table 47 STIRRED CELL MANUFACTURERS/PRODUCTS 90
CENTRIFUGAL DEVICES 90
Centrifuge Filter Manufacturers/Products 90
Table 48 CENTRIFUGAL FILTER MANUFACTURERS 90
TFF SYSTEMS 91
TFF Replacing Centrifugal, Stirred Cell Systems 91
TFF SYSTEM MANUFACTURERS/PRODUCTS 92
TABLE 49 LAB-SCALE, PILOT-SCALE, SMALL PRODUCTION-SCALE TFF SYSTEMS 92
GLOBAL MARKET FOR MOLECULAR SEPARATION SYSTEMS 93
TABLE 50 PROJECTED GLOBAL MARKET FOR MOLECULAR SEPARATION SYSTEMS,
THROUGH 2016 ($ MILLIONS) 93
LABORATORY WATER SYSTEMS 94
VALIDATING LAB WATER SYSTEMS 94
LAB WATER SYSTEM MANUFACTURERS/PRODUCTS 95
TABLE 51 LABORATORY WATER SYSTEM MANUFACTURERS/PRODUCT 95
PROJECTED MARKET FOR LABORATORY WATER SYSTEMS 95
TABLE 52 PROJECTED GLOBAL MARKET FOR LABORATORY WATER SYSTEMS, THROUGH
2016 ($ MILLIONS) 95
REGIONAL ANALYSIS 96
THE AMERICAS 96
TABLE 53 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES ($ MILLIONS) 96
FIGURE 14 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (%) 96
EMRA 97
PROJECTED MARKET FOR LIFE SCIENCE MEMBRANE TECHNOLOGY IN THE EMRA 98
TABLE 54 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, THROUGH 2011 ($ MILLIONS) 98
FIGURE 15 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (MILLIONS) 98
ASIA 99
PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE SCIENCES 100
TABLE 55 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, THROUGH 2016 ($ MILLIONS) 100
FIGURE 16 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (%) 100
CHAPTER 8 BIOPHARMACEUTICAL APPLICATIONS FOR MEMBRANE TECHNOLOGY 103
DEVELOPMENT OF BIOPHARMACEUTICAL APPLICATIONS FOR MEMBRANE
TECHNOLOGY 103
CONSIDERATIONS FOR SCALE-UP 103
BIOPHARMACEUTICAL PRODUCTS 104
TABLE 56 EXAMPLES OF BIOPHARMACEUTICAL PRODUCTS, BY TYPE, PRODUCT,
COMPONENTS, AND APPLICATION 104
GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN BIOPHARMACEUTICAL
APPLICATIONS 105
TABLE 57 PROJECTED GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN
BIOPHARMACEUTICAL APPLICATIONS, BY PROCESS, THROUGH 2016 ($ MILLIONS) 105
MANUFACTURING PROCESSES 105
FIGURE 17 BIOPHARMACEUTICAL MANUFACTURING PROCESS 105
FIGURE 18 VACCINE MANUFACTURING PROCESS 106
FIGURE 19 VITAMIN, ANTIBIOTIC MANUFACTURING PROCESS 107
MANUFACTURERS USING MEMBRANES IN APPROVED BIOPHARMACEUTICALS 108
TABLE 58 MANUFACTURERS USING MEMBRANES IN APPROVED BIOPHARMACEUTICAL
PRODUCTION 109
BIOMANUFACTURING OBSTACLES 109
EXPANDING CAPACITY 109
PROJECTED MARKET FOR CELL CULTURING SYSTEMS 109
TABLE 59 PROJECTED GLOBAL MARKET FOR CELL CULTURING SYSTEMS, THROUGH 2016
($ MILLIONS) 110
CELL CULTURE SYSTEMS 110
CELL CULTURE INSERTS 110
MEMBRANE INSERT MANUFACTURERS/PRODUCTS 110
TABLE 60 MANUFACTURERS AND PRODUCTS FOR MULTIWELL MEMBRANE INSERTS, 2011 110
CELL CULTURE BIOREACTORS 111
HOLLOW FIBER REACTORS 111
Advantages and Disadvantages of Hollow Fiber Bioreactors 112
CELL CULTURE REACTOR MANUFACTURERS/PRODUCTS 112
TABLE 61 CELL CULTURE REACTOR MANUFACTURERS, 2011 112
DISPOSABLE USE IN CELL CULTURING 113
PROTEIN PURIFICATION MEMBRANES 113
PROJECTED GLOBAL MARKET FOR PROTEIN PURIFICATION WITH MF AND UF 114
TABLE 62 PROJECTED GLOBAL MARKET FOR MICROFILTRATION AND ULTRAFILTRATION
OF PROTEIN SOLUTIONS, THROUGH 2016 ($ MILLIONS) 114
VIRUS FILTERS 115
TABLE 63 VIRAL PURIFICATION MEMBRANE FILTER MANUFACTURERS AND PRODUCTS,
2011 115
PROCESS WATER TREATMENT 115
PROJECTED GLOBAL MARKET FOR PROCESS WATER IN BIOPHARMACEUTICAL
MANUFACTURING 116
TABLE 64 PROJECTED GLOBAL MARKET FOR PROCESS WATER TREATMENTS IN
BIOPHARMACEUTICAL MANUFACTURING, THROUGH 2016 ($ MILLIONS) 116
LARGE-SCALE BIOSEPARATIONS 116
REGIONAL ANALYSIS 116
THE AMERICAS 116
TABLE 65 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 117
FIGURE 20 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 117
EMRA 118
TABLE 66 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 118
FIGURE 21 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 118
ASIA 120
TABLE 67 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 120
FIGURE 22 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 120
CHAPTER 9 EMERGING TECHNOLOGIES AND PATENTS 123
EMERGING TECHNOLOGIES 123
DISPOSABLE MEMBRANE ADSORBERS 123
SALT TOLERANT INTERACTION CHROMATOGRAPHY (STIC) 123
BIOREACTOR BAGS 123
AUTOMATICALLY CONTROLLED FEEDING PROCESS FOR RECOMBINANT PROTEIN
PRODUCTION 124
PATENTS 124
PATENTS, BY COMPANY, 2008 TO 2011 124
TABLE 68 ISSUED PATENTS, BY COMPANY AND NUMBER OF PATENTS, 2008-2011
(NUMBER/%) 125
FIGURE 23 ISSUED PATENTS, BY COMPANY, 2008-2012 (%) 125
PATENTS ISSUED FOR MEMBRANE TECHNOLOGIES, FROM 2008 THROUGH 2012,
BY YEAR 126
TABLE 69 PATENTS ISSUED BETWEEN 2008 AND 2012 BY DATE, PATENT NUMBER,
COMPANY, AND DESCRIPTION OF THE PRODUCT OR PROCESS 126
PATENTS LISTED BY NUMBER 128
TABLE 70 PATENTS ISSUED BETWEEN 2008 AND 2012, BY PATENT NUMBER AND COMPANY 128
PATENT LISTED BY NUMBER AND DESCRIPTION 129
TABLE 71 PATENTS ISSUED BETWEEN 2008 AND 2012 BY DESCRIPTION AND PATENT
NUMBER 129
CHAPTER 10 COMPANY DIRECTORY 131
20/20 GENE SYSTEMS 131
3M HEALTHCARE, MEDICAL DIVISION 131
ADVANTEC MFS, INC. 131
AMGEN 132
AMAZON FILTERS LTD. 132
APPLIKON BIOTECHNOLOGY B.V. 132
ASAHI KASEI CORPORATION 133
ATMI LIFE SCIENCES 133
BECTON DICKINSON BIOSCIENCES 133
BIOVEST INTERNATIONAL 134
CLONTECH/TAKARA BIO, INC. 134
CORNING LIFESCIENCES 134
CUNO, INC. 135
EMD MILLIPORE 135
FIBERCELL SYSTEMS, INC 135
GEN-PROBE, INC. 136
GE HEALTHCARE BIOSCIENCES AB (U.S. OFFICE) 136
GE OSMONICS 136
HIKMA PHARMACEUTICALS PLC 136
INTAS BIOPHARMACEUTICALS 137
BUSINESS OVERVIEW 137
KOCH MEMBRANE SYSTEMS 137
LIFE TECHNOLOGIES 137
MACHEREY-NAGEL GMBH 138
MECO BIOPHARMACEUTICALS 138
MEISSNER FILTRATION PRODUCTS 138
NOVASEP 139
PALL CORP. 139
PANACEA BIOTEC, LTD (INDIA) 140
PBS BIOTECH 140
PROMETIC LIFESCIENCES 140
PROMEGA 141
QIAGEN NV 141
ROCHE DIAGNOSTICS 141
SARTORIUS CORP. 142
BUSINESS OVERVIEW 142
SIEMENS CORPORATION (WATER TECHNOLOGIES) 142
SIGMA ALDRICH CORPORATION 142
SPECTRUM LABORATORIES 143
STERLITECH CORPORATION 143
SYNDER FILTRATION 143
SYNKERA TECHNOLOGIES, INC. 143
SYNTHECON, INC. 144
TAMI INDUSTRIES 144
TRISEP CORP. 145
US. FILTER/SIEMENS WATER TECHNOLOGIES 145
WHATMAN PLC 145
XCELLEREX 145

LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR MEMBRANE TECHNOLOGY, THROUGH 2016 ($
MILLIONS) 6
TABLE 1 ABBREVIATIONS USED IN MEMBRANE SEPARATION INDUSTRY 9
TABLE 2 DRUGS THAT LOSE PATENT PROTECTION BETWEEN 2010 AND 2012 11
TABLE 3 BIOLOGIC DRUG DEVELOPMENT VERSUS CONVENTIONAL DRUG DEVELOPMENT 14
TABLE 4 GLOBAL RandD SPENDING BY TOP 10 COUNTRIES, 2012 ($ BILLIONS/%) 19
TABLE 5 MAJOR MANUFACTURERS OF MEMBRANE PRODUCTS AND PRODUCT TYPES 19
TABLE 6 SELECTED ACQUISITIONS WITHIN THE MEMBRANE TECHNOLOGY MARKET,
JANUARY 2005 THROUGH APRIL 2012 ($ MILLIONS) 25
TABLE 7 PROJECTED MARKET FOR MEMBRANE TECHNOLOGY, BY REGION, THROUGH 2016
($ MILLIONS) 29
TABLE 8 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS BY
REGION, THROUGH 2016 ($ MILLIONS) 30
TABLE 9 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY BY REGION, THROUGH
2016 ($ MILLIONS) 33
TABLE 10 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS BY
REGION, THROUGH 2016 ($ MILLIONS) 35
TABLE 11 CHARACTERISTICS OF POLYMER MEMBRANE MATERIALS 39
TABLE 12 MODULE MANUFACTURERS/PRODUCTS, 2011 42
TABLE 13 FILTERS FOR PHARMACEUTICAL AND BIOPHARMACEUTICAL PROCESSES 43
TABLE 14 PROJECTED GLOBAL MARKET FOR MEMBRANES IN PHARMACEUTICAL
PROCESSES, BY TYPE, THROUGH 2016 ($ MILLIONS) 43
TABLE 15 PROJECTED GLOBAL MARKET FOR REVERSE OSMOSIS MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 44
TABLE 16 PROJECTED GLOBAL MARKET FOR NANOFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 45
TABLE 17 PROJECTED GLOBAL MARKET FOR ULTRAFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 46
TABLE 18 PROJECTED GLOBAL MARKET FOR MICROFILTRATION MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 47
TABLE 19 BIOPHARMACEUTICAL APPLICATIONS OF UF AND MF 47
TABLE 20 PROJECTED GLOBAL MARKET FOR ION EXCHANGE MEMBRANES IN
PHARMACEUTICAL PROCESSES, THROUGH 2016 ($ MILLIONS) 48
TABLE 21 ACTIONS OF VARIOUS FILTRATION COMPONENTS IN TFF PROCESS 49
TABLE 22 COMPARISON OF SEPARATION METHODS 49
TABLE 23 NUMBER OF DRUGS IN DEVELOPMENT, 2000-2010 52
TABLE 24 RandD EXPENDITURES BY TOP 10 PHARMACEUTICAL COMPANIES BY RandD
SPENDING, 2010 ($ BILLIONS) 53
TABLE 25 PROJECTED GLOBAL MARKET FOR MEMBRANE FILTRATION IN THE
PHARMACEUTICAL MARKET, THROUGH 2016 ($ MILLIONS) 54
TABLE 26 PROJECTED MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 56
TABLE 27 PROJECTED AMERICAS MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION,
BY REGION, THROUGH 2016 ($ MILLIONS) 58
TABLE 28 PROJECTED EMRA MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 60
TABLE 29 PROJECTED ASIAN MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY
REGION, THROUGH 2016 ($ MILLIONS) 62
TABLE 30 PROJECTED GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN LIFE SCIENCE
APPLICATIONS, BY DEVICE/SYSTEM TYPE, THROUGH 2016 ($ MILLIONS) 66
TABLE 31 MANUFACTURERS/PRODUCTS FOR MEMBRANE CHROMATOGRAPHY, 2011 69
TABLE 32 PROJECTED GLOBAL MARKET FOR MEMBRANE CHROMATOGRAPHY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 70
TABLE 33 TRANSFER MEMBRANE MANUFACTURER/PRODUCTS, 2011 71
TABLE 34 PROJECTED GLOBAL MARKET FOR TRANSFER MEMBRANE PRODUCTS, THROUGH
2016 ($ MILLIONS) 72
TABLE 35 PROJECTED GLOBAL MARKET FOR MICROARRAY PRODUCTS FOR LIFE SCIENCE
APPLICATIONS, THROUGH 2016 ($ MILLIONS) 73
TABLE 36 PROTEIN ARRAY MANUFACTURERS/PRODUCTS, 2011 75
TABLE 37 PROJECTED GLOBAL MARKET FOR PROTEIN MICROARRAY PRODUCTS FOR LIFE
SCIENCE APPLICATIONS, THROUGH 2016 ($ MILLIONS) 76
TABLE 38 DNA MICROARRAY MANUFACTURERS/PRODUCTS, 2011 77
TABLE 39 PROJECTED GLOBAL MARKET FOR DNA MICROARRAY PRODUCTS FOR LIFE
SCIENCE APPLICATIONS, THROUGH 2016 ($ MILLIONS) 78
TABLE 40 MULTIWELL FILTER PLATE MANUFACTURERS/PRODUCTS, 2011 81
TABLE 41 PROJECTED GLOBAL MARKET FOR MULTIWELL FILTER PLATES, THROUGH 2016 ($
MILLIONS) 84
TABLE 42 PROJECTED GLOBAL MARKET FOR LAB-SCALE MEMBRANE SEPARATION DEVICES,
THROUGH 2016 ($ MILLIONS) 85
TABLE 43 SYRINGE MEMBRANE FILTER MANUFACTURERS AND PRODUCTS, 2011 86
TABLE 44 PROJECTED GLOBAL MARKET FOR SYRINGE FILTERS, THROUGH 2016 ($ MILLIONS) 87
TABLE 45 BOTTLE TOP FILTER MANUFACTURERS/PRODUCTS 88
TABLE 46 PROJECTED GLOBAL MARKET FOR BOTTLE TOP FILTERS, THROUGH 2016 ($
MILLIONS) 89
TABLE 47 STIRRED CELL MANUFACTURERS/PRODUCTS 90
TABLE 48 CENTRIFUGAL FILTER MANUFACTURERS 90
TABLE 49 LAB-SCALE, PILOT-SCALE, SMALL PRODUCTION-SCALE TFF SYSTEMS 92
TABLE 50 PROJECTED GLOBAL MARKET FOR MOLECULAR SEPARATION SYSTEMS, THROUGH
2016 ($ MILLIONS) 93
TABLE 51 LABORATORY WATER SYSTEM MANUFACTURERS/PRODUCT 95
TABLE 52 PROJECTED GLOBAL MARKET FOR LABORATORY WATER SYSTEMS, THROUGH 2016
($ MILLIONS) 95
TABLE 53 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES ($ MILLIONS) 96
TABLE 54 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, THROUGH 2011 ($ MILLIONS) 98
TABLE 55 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, THROUGH 2016 ($ MILLIONS) 100
TABLE 56 EXAMPLES OF BIOPHARMACEUTICAL PRODUCTS, BY TYPE, PRODUCT,
COMPONENTS, AND APPLICATION 104
TABLE 57 PROJECTED GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN
BIOPHARMACEUTICAL APPLICATIONS, BY PROCESS, THROUGH 2016 ($ MILLIONS) 105
TABLE 58 MANUFACTURERS USING MEMBRANES IN APPROVED BIOPHARMACEUTICAL
PRODUCTION 109
TABLE 59 PROJECTED GLOBAL MARKET FOR CELL CULTURING SYSTEMS, THROUGH 2016 ($
MILLIONS) 110
TABLE 60 MANUFACTURERS AND PRODUCTS FOR MULTIWELL MEMBRANE INSERTS, 2011 110
TABLE 61 CELL CULTURE REACTOR MANUFACTURERS, 2011 112
TABLE 62 PROJECTED GLOBAL MARKET FOR MICROFILTRATION AND ULTRAFILTRATION OF
PROTEIN SOLUTIONS, THROUGH 2016 ($ MILLIONS) 114
TABLE 63 VIRAL PURIFICATION MEMBRANE FILTER MANUFACTURERS AND PRODUCTS,
2011 115
TABLE 64 PROJECTED GLOBAL MARKET FOR PROCESS WATER TREATMENTS IN
BIOPHARMACEUTICAL MANUFACTURING, THROUGH 2016 ($ MILLIONS) 116
TABLE 65 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 117
TABLE 66 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 118
TABLE 67 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, THROUGH 2016 ($ MILLIONS) 120
TABLE 68 ISSUED PATENTS, BY COMPANY AND NUMBER OF PATENTS, 2008-2011
(NUMBER/%) 125
TABLE 69 PATENTS ISSUED BETWEEN 2008 AND 2012 BY DATE, PATENT NUMBER,
COMPANY, AND DESCRIPTION OF THE PRODUCT OR PROCESS 126
TABLE 70 PATENTS ISSUED BETWEEN 2008 AND 2012, BY PATENT NUMBER AND COMPANY 128
TABLE 71 PATENTS ISSUED BETWEEN 2008 AND 2012 BY DESCRIPTION AND PATENT
NUMBER 129

LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR MEMBRANE TECHNOLOGY, 2011 AND 2016 (%) 6
FIGURE 1 NEW DRUGS: FROM DISCOVERY TO MANUFACTURING 15
FIGURE 2 MARKET SHARE OF GLOBAL MEMBRANE TECHNOLOGY MANUFACTURERS, 2011
(%) 18
FIGURE 3 ESTIMATED GLOBAL MARKET SIZE FOR MEMBRANE CHROMATOGRAPHY AND
COMPETITIVE BIOSEPARATION METHODS IN PHARMACEUTICAL AND BIOPHARMACEUTICAL
PRODUCTION, 2011 (%)
24
FIGURE 4 AMERICAS MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, IN 2011 AND 2016
(%) 31
FIGURE 5 EMRA MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, 2011 AND 2016 (%) 33
FIGURE 6 ASIAN MARKET FOR MEMBRANE TECHNOLOGY PRODUCTS, 2011 AND 2016 (%) 36
FIGURE 7 PROJECTED MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION BY TYPE OF
FILTER, 2011 AND 2016 (%) 54
FIGURE 8 MARKET SHARE OF GLOBAL R andD SPENDING, BY REGION, 2012 (%) 55
FIGURE 9 GLOBAL MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION, BY REGION,
2011 AND 2016 (%) 56
FIGURE 10 PROJECTED AMERICAS MARKET FOR PHARMACEUTICAL MEMBRANE
FILTRATION, BY TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 58
FIGURE 11 PROJECTED EMRA MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION BY
TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 60
FIGURE 12 PROJECTED ASIAN MARKET FOR PHARMACEUTICAL MEMBRANE FILTRATION BY
TYPE OF FILTER, 2011 AND 2016 (MILLIONS) 62
FIGURE 13 GLOBAL MARKET FOR MEMBRANE TECHNOLOGIES IN LIFE SCIENCES
RESEARCH, 2011 AND 2016 (%) 66
FIGURE 14 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (%) 96
FIGURE 15 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (MILLIONS) 98
FIGURE 16 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN THE LIFE
SCIENCES, 2011 AND 2016 (%) 100
FIGURE 17 BIOPHARMACEUTICAL MANUFACTURING PROCESS 105
FIGURE 18 VACCINE MANUFACTURING PROCESS 106
FIGURE 19 VITAMIN, ANTIBIOTIC MANUFACTURING PROCESS 107
FIGURE 20 PROJECTED AMERICAS MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 117
FIGURE 21 PROJECTED EMRA MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 118
FIGURE 22 PROJECTED ASIAN MARKET FOR MEMBRANE TECHNOLOGY IN
BIOPHARMACEUTICAL APPLICATIONS, 2011 AND 2016 (%) 120
FIGURE 23 ISSUED PATENTS, BY COMPANY, 2008-2012 (%) 125

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