Single-Use Technologies for Biopharmaceuticals: Global Markets

NEW YORK, Dec. 19, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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INTRODUCTION

Eliminating the risk of contamination is the greatest challenge faced by manufacturers of biopharmaceuticals, and currently this requires high level monitoring of critical manufacturing processes. Single-use technology (SUT) aids biopharmaceutical manufacturers in overcoming this challenge by reducing or eliminating the need for sterilization between batches, thereby improving operational efficiency. Time to market for biopharmaceutical drugs is extremely important given the developmental costs involved. Single-use technologies help lower these costs by reducing the number of validation steps and also shorten the length of the production process. Growth of single-use technologies in biopharmaceutical manufacturing is expected to be significant over the forecast period due to the increasing evidence of their cost-saving benefits.STUDY GOALS AND OBJECTIVES

The objective of the report is to provide an intensive assessment of the market for single-use technologies specifically used in biopharmaceutical production. Specific goals include:

Identifying key technologies, applications and end-user segments that are expected to achieve significant sales by 2017 with respect to single-use technologies.Assessing and identifying the key market dynamics that drive and restrain growth, markets that provide lucrative opportunities and factors that pose challenges to market participants.To understand and provide details with respect to market intelligence, key market participants and top strategies adopted by SUT players.Market estimates through 2017.Identifying and profiling key companies and patents.

INTENDED AUDIENCE

The report provides an in-depth study of the following supply chain participants: contract manufacturing organizations, biopharmaceutical companies/manufacturers and system integrators. The study includes a product portfolio analysis, case studies, market estimates and recent developments, which will be immensely useful to SUT manufacturers and academia. The report presents an in-depth-patent analysis of single-use technologies used in the manufacture of biopharmaceuticals. Single-use technologies currently under investigation or newly approved for use by the Food and Drug Administration (FDA) are also discussed.

SCOPE AND FORMAT

The report includes the following key market segments:

Single-use bioreactors (SUBs).

Membrane adsorbers.

Mixing.

Tangential flow filtration.

Tubing.

Connectors.

Preassembled tubing and rigging.

Depth filtration.

Buffer containers.

Waste containers.

Samplers.

Media bags.

Filter cartridges and other key markets.

The study includes the following major elements:

Executive summary.

Revenues forecast through 2017.

Analysis of the key factors influencing market demand.

Market intelligence.

Key trends across geographies.

Key trends, opportunities and market estimates within each of the markets specified.

General assessment of expected market trends in the longer term (2012 to 2017).

Competitive environment—Key companies, top strategies and recent developments and market intelligence.

Company profiles.

Patent analysis.

Specifically excluded from the report are market estimates of biopharmaceutical drugs and devices. However, an overview of the market for biopharmaceutical drugs is given to provide a holistic view of the market. The report covers only single-use technologies or disposables used in biopharmaceutical manufacturing. The report also excludes control software or custom designed software used with single-use biopharmaceutical manufacturing technologies.

INFORMATION SOURCE AND METHODOLOGY

Information sources were derived through both primary and secondary research. Secondary sources included government websites, industry associations, company websites, biopharmaceutical magazines and recent conferences. Primary research was conducted to evaluate the market quantitatively as well as qualitatively and its impact on market growth. The greatest challenges were in deriving the revenues for micro markets; however, that was achieved through an intensive study of historical sales, current adoption levels and expected future market potential validated through primary research.

Growth within the SUT market is significantly varied, as some technologies are increasing at a compounded annual growth rate (CAGR) of nearly 35% with some technologies increasing at a CAGR below 5% through the forecast period. Therefore, an analysis of comparative market growth has been performed.

Mahi Dutta has seven years of experience in the field of business research and consulting exclusively in high-growth markets in the healthcare and life sciences markets. She has authored several reports on emerging markets such as molecular diagnostics, emerging medical device technologies, microfluidics and MEMS, wireless healthcare technologies, biotechnology devices and software markets and so on. Ms. Dutta's expertise is in tracking and estimating market revenues for emerging and high-growth markets, providing market intelligence and strategic analysis of key technologies. She has also provided consulting services and training programs for healthcare service providers and other clients.TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 1

STUDY BACKGROUND 1

STUDY GOALS AND OBJECTIVES 1

INTENDED AUDIENCE 1

SCOPE AND FORMAT 1

INFORMATION SOURCE AND METHODOLOGY 2

ANALYST CREDENTIALS 2

RELATED BCC RESEARCH REPORTS 3

BCC ONLINE SERVICES 3

DISCLAIMER 3

CHAPTER 2 SUMMARY 5

SUMMARY TABLE GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, THROUGH 2017 ($

MILLIONS)

5

SUMMARY FIGURE GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, 2011-2017 ($

MILLIONS)

5

CHAPTER 3 MARKET OVERVIEW 10

BRIEF HISTORY OF BIOPROCESS DISPOSABLES 10

FIGURE 1 EVOLUTION OF SINGLE-USE TECHNOLOGIES USED IN BIOPHARMACEUTICAL

MANUFACTURING 10

SINGLE-USE TECHNOLOGIES 11

TABLE 1 DEVELOPMENTS IN SINGLE-USE TECHNOLOGIES 12

MARKET DYNAMICS 13

MARKET DRIVERS 13

Quicker Time to Market Due to Reduction in the Product Development Process Time

Line 13

REDUCTION IN COSTS OF LABOR, MATERIAL AND UTILITY 14

Improved Process Efficiency and Increased Productivity 14

Faster Process Times and Reduced Risk of Contamination 15

Regulatory Compliance and Industry Standards 15

Simplification of Change Control Filings 16

Outsourcing for Cost Savings 16

ADVANTAGES OF SUTS OVER CONVENTIONAL TECHNOLOGIES 16

Environmental Advantages 16

Acceptability of Materials 17

Supported Products and Platforms 17

Probes, Sensors and Sampling 17

Coupling and Transfer 18

Use of SUTs Instead of Clean-in-Place Cycles 18

QbD and PAT 18

TABLE 2 SUT GAP ANALYSIS 19

OTHER MARKET CONSIDERATIONS 20

Flexibility 20

Availability at Multiple Scales 20

Applicability across All Biopharmaceutical Processes 20

RESTRAINTS 20

Extractables and Leachables 20

Breakage of Bags 21

Environmental Concerns 21

Cost of Disposables Need to Be Lower 21

SUT Does Not Support Flexibility in Production Cycle 21

Single Vendor 21

Material Incompatibility 22

SUTs Are Not Completely Dynamic 22

Skills Gap in Developing Economies 22

Others 22

CHALLENGES 23

MARKET OPPORTUNITIES 23

STAINLESS STEEL PROCESSORS VERSUS DISPOSABLES IN BIOPHARMACEUTICAL

MANUFACTURE 24

TABLE 3 BIOREACTOR FACILITY COSTS: SINGLE-USE VERSUS STAINLESS STEEL SYSTEMS 25

SINGLE-USE TRANSFER LINES INCREASING DYNAMICITY OF SUTS 25

ECONOMIC DOWNTURN IS A FACTOR IN THE ADOPTION OF SUTS 26

STEADY SUT ADOPTION IN EMERGING ECONOMIES 27

BIOPHARMACEUTICAL INDUSTRY TRENDS: STEADY TRANSITION FROM

PHARMACEUTICALS TO BIOPHARMACEUTICALS 27

ECONOMIC TRENDS BOOSTING THE BIOPHARMACEUTICAL MARKET 28

FIGURE 2 COST OF NEW DRUG DEVELOPMENT, 1997-2013 ($ BILLIONS) 28

Outsourcing Trends 29

Limitations of Outsourcing 30

BIOPHARMACEUTICAL APPROVALS 30

BIOPHARMACEUTICAL MANUFACTURING: MARKET DYNAMICS 30

Slower Drug Development Time yet Increasing FDA Approvals 30

Expansion and Internationalization 31

OTHER FACTORS IMPACTING THE BIOPHARMACEUTICAL MARKET 31

Affordable Drug Price Key Consideration for Success 31

High Level Quality and Compliance Needs 31

Market Challenges Encourage the Uptake of SUTs 32

OTHER MARKET FACTORS 32

Implementation of Quality Management 32

Increase in Training Budgets 32

SUT IMPLEMENTATION 32

SINGLE-USE TECHNOLOGY SUPPORTS FOLLOW-ON BIOLOGICS 33

IMPLEMENTATION OF CUSTOMIZED SINGLE-USE SOLUTIONS FOR CELL THERAPY

PRODUCTION 33

ADVANTAGES OF CUSTOM SINGLE-USE CLOSED KITS 34

LEGAL FRAMEWORK AND STANDARDS 34

Functional Units of the Global Regulatory Affairs Organization 35

Global Regulatory Affairs 35

Development Areas: Headquarters and Regional 35

Chemistry, Manufacturing and Controls (CMC), Compliance, Conformance 36

Policy and Regulatory Intelligence 36

Promotion and Advertisement 36

Regulatory Submissions Management 36

Product Labeling 36

EU GMP Annex 1 states that: 37

SINGLE-USE BIOREACTORS LEADING THE FUTURE MARKET 37

FIGURE 3 GROWTH ANALYSIS OF THE SUT MARKET 38

PATENT ANALYSIS 39

FIGURE 4 THE U.S. AND EUROPEAN PATENTS ON SINGLE-USE TECHNOLOGIES, 2010-2012

(NO.) 39

FIGURE 5 U.S. PATENTS ON SINGLE-USE TECHNOLOGIES BY YEAR, 2010 TO JUNE 2012 (%) 39

FIGURE 6 EUROPEAN PATENTS BY YEAR, 2010 TO JUNE 2012 (%) 40

CASE STUDY I 41

FIGURE 7 BIOPHARMACEUTICAL MANUFACTURE OF MONOCLONAL ANTIBODIES 41

Specific Challenges: Disposable Processes 42

Product and Process Comparability 42

Conclusion 42

CASE STUDY -II 43

Challenges 43

Conclusion 43

STRATEGIC RECOMMENDATIONS 43

Intensive Training in Emerging Economies 43

Marketing Based on Tangible Factors 44

Needed Innovation 44

FUTURE MARKET TRENDS AND GROWTH POTENTIAL 44

CHAPTER 4 MARKET BY TECHNOLOGY 47

TABLE 4 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY USED IN THE MANUFACTURE

OF BIOPHARMACEUTICALS BY SEGMENT, THROUGH 2017 ($ MILLIONS) 47

MEMBRANE ADSORBER 48

TABLE 5 GLOBAL MARKET FOR MEMBRANE ADSORBERS BY GEOGRAPHIC REGION,

2012–2017 ($ MILLIONS) 48

BIOREACTORS 49

TABLE 6 GLOBAL MARKET FOR BIOREACTORS BY TECHNOLOGY, THROUGH 2017 ($

MILLIONS) 49

TABLE 7 GLOBAL MARKET FOR BIOREACTORS BY GEOGRAPHIC REGION, THROUGH 2017 ($

MILLIONS) 50

PRODUCTION AND SEED BIOREACTORS 50

TABLE 8 GLOBAL MARKET FOR SEED BIOREACTORS BY GEOGRAPHIC REGION, THROUGH

2017 ($ MILLIONS) 51

TABLE 9 GLOBAL MARKET FOR PRODUCTION BIOREACTORS BY GEOGRAPHIC REGION,

THROUGH 2017 ($ MILLIONS) 51

DISPOSABLE MIXING SYSTEMS 52

TABLE 10 GLOBAL MARKET FOR DISPOSABLE MIXING SYSTEMS BY GEOGRAPHIC REGION,

THROUGH 2017 ($ MILLIONS) 52

TANGENTIAL FLOW FILTRATION 53

TABLE 11 GLOBAL MARKET FOR TANGENTIAL FLOW FILTRATION SYSTEMS BY

GEOGRAPHIC REGION, THROUGH 2017 ($ MILLIONS) 54

TUBING AND CONNECTORS 54

TABLE 12 GLOBAL MARKET FOR TUBING BY GEOGRAPHIC REGION, THROUGH 2017 ($

MILLIONS) 55

TABLE 13 GLOBAL MARKET FOR CONNECTORS BY GEOGRAPHIC REGION, 2012–2017 ($

MILLIONS) 56

PREASSEMBLED TUBING AND RIGGING 56

TABLE 14 GLOBAL MARKET FOR PREASSEMBLED TUBING AND RIGGING BY GEOGRAPHIC

REGION, THROUGH 2017 ($ MILLIONS) 57

DEPTH FILTRATION 57

TABLE 15 GLOBAL MARKET DEPTH FILTRATION SYSTEMS BY GEOGRAPHIC REGION,

THROUGH 2017 ($ MILLIONS) 58

BUFFER CONTAINERS 58

TABLE 16 GLOBAL MARKET FOR BUFFER CONTAINERS BY EQUIPMENT TYPE, THROUGH

2017 ($ MILLIONS) 58

TABLE 17 GLOBAL MARKET FOR BUFFER CONTAINERS BY GEOGRAPHIC REGION,

THROUGH 2017 ($ MILLIONS) 59

WASTE CONTAINERS 59

TABLE 18 GLOBAL MARKET FOR WASTE CONTAINERS BY GEOGRAPHIC REGION, THROUGH

2017 ($ MILLIONS) 59

SAMPLERS 60

TABLE 19 GLOBAL MARKET FOR SAMPLERS BY GEOGRAPHIC REGION, THROUGH 2017 ($

MILLIONS) 60

MEDIA BAGS AND FILTER CARTRIDGES 61

TABLE 20 GLOBAL MARKET FOR MEDIA BAGS BY TYPE, THROUGH 2017 ($ MILLIONS) 61

TABLE 21 GLOBAL MARKET FOR MEDIA BAGS BY GEOGRAPHIC REGION, 2012–2017 ($

MILLIONS) 62

FILLED MEDIA BAGS 62

TABLE 22 GLOBAL MARKET FOR FILLED MEDIA BAGS BY GEOGRAPHIC REGION, THROUGH

2017 ($ MILLIONS) 62

DRY MEDIA BAGS 62

Benefits 63

TABLE 23 GLOBAL MARKET FOR DRY MEDIA BAGS BY GEOGRAPHIC REGION, THROUGH

2017 ($ MILLIONS) 63

FILTER CARTRIDGES 63

TABLE 24 GLOBAL MARKET FOR FILTER CARTRIDGES BY GEOGRAPHIC REGION, THROUGH

2017 ($ MILLIONS) 64

OTHER SINGLE-USE TECHNOLOGIES 64

TABLE 25 GLOBAL MARKET FOR OTHER SINGLE-USE TECHNOLOGIES BY GEOGRAPHIC

REGION, THROUGH 2017 ($ MILLIONS) 64

CHAPTER 5 MARKET BY APPLICATION 66

TABLE 26 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY FOR USE IN

BIOPHARMACEUTICAL MANUFACTURE BY APPLICATION, THROUGH 2017 ($ MILLIONS) 66

MONOCLONAL ANTIBODIES 67

TABLE 27 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTION

OF MONOCLONAL ANTIBODIES, THROUGH 2017 ($ MILLIONS) 68

VACCINES 68

TABLE 28 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTION

OF VACCINES, THROUGH 2017 ($ MILLIONS) 69

GENE THERAPY 70

TABLE 29 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN GENE THERAPY,

THROUGH 2017 ($ MILLIONS) 71

RECOMBINANT PROTEINS 71

TABLE 30 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTION

OF RECOMBINANT PROTEIN, THROUGH 2017 ($ MILLIONS) 72

BLOOD DERIVATIVES 72

TABLE 31 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BLOOD DERIVATIVES, THROUGH 2017 ($ MILLIONS) 73

ANTICANCER DRUGS 73

TABLE 32 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF ANTICANCER DRUGS, THROUGH 2017 ($ MILLIONS) 73

OTHERS 74

TABLE 33 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN OTHER

APPLICATION AREAS, THROUGH 2017 ($ MILLIONS) 74

CHAPTER 6 MARKET BY END USERS 76

TABLE 34 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY END USER, 2012–2017 ($ MILLIONS) 76

CMOS VERSUS BIOPHARMACEUTICAL MANUFACTURERS 76

FIGURE 8 SELECTED AVERAGE FACILITY BUDGETS FOR SINGLE-USE

DEVICES-BIOTHERAPEUTICS DEVELOPERS VS. CMOS ($) 77

TABLE 35 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BY

BIOPHARMACEUTICAL CMOS, THROUGH 2017 ($ MILLIONS) 78

TABLE 36 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BY

BIOPHARMACEUTICAL MANUFACTURERS BY REGION, THROUGH 2017 ($ MILLIONS) 79

NORTH AMERICAN BIOMANUFACTURERS VERSUS THOSE IN EUROPE AND THE

ROW 79

R&D 80

TABLE 37 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY END USER SEGMENT, THROUGH 2017 ($

MILLIONS)

80

TABLE 38 GLOBAL R&D SPENT ON SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, THROUGH 2017 ($

MILLIONS)

81

GMP 81

TABLE 39 GLOBAL EXPENDITURES ON GOOD MANUFACTURING PRACTICES FOR

SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTURE OF BIOPHARMACEUTICALS BY

REGION, THROUGH 2017 ($ MILLIONS)

82

CHAPTER 7 MARKET STRATEGIES AND COMPETITIVE ENVIRONMENT 84

PRODUCT LAUNCHES: TOP STRATEGY 84

TABLE 40 COMPANY STRATEGIES 84

FIGURE 9 TOP STRATEGIES, 2006-2012 (%) 85

TOP COMPANIES FOCUS ON COLLABORATIONS THROUGH MERGERS AND

ACQUISITIONS AND AGREEMENTS 86

FIGURE 10 AGREEMENTS BY COMPANY, 2006-2012 (%) 86

FIGURE 11 MERGERS AND ACQUISITIONS BY COMPANY, 2006-2012 (%) 87

ANALYSIS BY COMPANY 87

FIGURE 12 ANALYSIS BY COMPANY 2006-2012 (%) 87

TABLE 41 COMPANY ANNOUNCEMENTS, 2006 TO JULY 2012 ` 89

CHAPTER 8 GEOGRAPHIC ANALYSIS, LEGISLATION AND GOVERNMENT INITIATIVES-FOCUS

ON EMERGING ECONOMIES 97

THE AMERICAS 97

LATIN AMERICA (ROW) 97

Government Initiatives 97

Research Base 97

Regulation 98

Investment Incentives 98

Access to Capital 98

EUROPE 98

CENTRAL AND EASTERN EUROPE 98

Government Initiatives and Investment Incentives 99

ASIA 99

CHINA 100

Government Initiatives 100

Biotechnology Clusters 101

Increasing Focus on R&D 101

Greater International Collaboration 101

SINGAPORE 101

Regulation 101

Manufacturing Expertise 102

Access to Talent 102

SOUTH KOREA 102

Biotechnology Clusters 102

Investment Incentives 102

TAIWAN 103

Government Initiatives 103

Biotechnology Clusters 103

Regulation 103

Investment Incentives 103

Access to Capital 104

CHAPTER 9 COMPANY PROFILES 106

ADVANCED SCIENTIFICS INC. 106

TABLE 42 ADVANCED SCIENTIFICS INC.: PRODUCT PORTFOLIO 106

ADVANTAPURE 106

TABLE 43 ADVANTAPURE: PRODUCT PORTFOLIO 107

TABLE 44 ADVANTAPURE: RECENT DEVELOPMENTS, 2011–2012 108

APPLIKON BIOTECHNOLOGY 108

ATMI LIFESCIENCES 108

TABLE 47 ATMI LIFESCIENCES: PRODUCT PORTFOLIO 109

TABLE 48 ATMI LIFESCIENCES: RECENT DEVELOPMENTS, 2006-2012 109

TABLE 49 ATMI LIFESCIENCES: FINANCIALS, 2008–2010 ($ MILLIONS) 110

ATOLL 110

TABLE 50 ATOLL: PRODUCT PORTFOLIO 111

BARBLOCK 111

TABLE 51 BARBLOCK: PRODUCT PORTFOLIO 111

BIOPHARMA DYNAMICS 112

TABLE 52 BIOPHARMA DYNAMICS: PRODUCT PORTFOLIO 112

BIOPURE 112

TABLE 53 BIOPURE: PRODUCT PORTFOLIO 113

TABLE 54 BIOPURE: RECENT DEVELOPMENTS 113

BOSCH PACKAGING 113

TABLE 55 BOSCH PACKAGING: PRODUCT PORTFOLIO 114

TABLE 56 BOSCH PACKAGING: RECENT DEVELOPMENTS 114

CELLON 114

TABLE 57 CELLON: PRODUCT PORTFOLIO 115

TABLE 58 CELLON: RECENT DEVELOPMENTS 115

CHARTER MEDICAL 115

TABLE 59 CHARTER MEDICAL: PRODUCT PORTFOLIO 116

TABLE 60 CHARTER MEDICAL: RECENT DEVELOPMENTS 116

CMC BIOLOGICS 116

TABLE 61 CMC BIOLOGICS: SERVICES 117

TABLE 62 CMC BIOLOGICS: RECENT DEVELOPMENTS 117

COLDER PRODUCTS CO. 117

TABLE 63 COLDER PRODUCTS COMPANY: PRODUCT PORTFOLIO 118

TABLE 64 COLDER PRODUCTS CO.: RECENT DEVELOPMENTS, 2011-2012 118

DOW CORNING 119

TABLE 65 DOW CORNING: PRODUCT PORTFOLIO 119

TABLE 66 DOW CORNING: RECENT DEVELOPMENTS, 2009-2011 119

EMD MILLIPORE 120

TABLE 67 EMD MILLIPORE: PRODUCT PORTFOLIO 120

TABLE 68 EMD MILLIPORE: RECENT DEVELOPMENTS, 2006-2012 121

FINESSE SOLUTIONS 121

TABLE 69 FINESSE SOLUTIONS: PRODUCT PORTFOLIO 121

TABLE 70 FINESSE SOLUTIONS: RECENT DEVELOPMENTS, 2009-2011 122

GE HEALTHCARE 122

TABLE 71 GE HEALTHCARE: PRODUCT PORTFOLIO 122

GORE 123

TABLE 72 GORE: PRODUCT PORTFOLIO 124

TABLE 73 GORE: RECENT DEVELOPMENTS, 2011-2012 124

IS SUPPLIES 124

TABLE 74 IS SUPPLIES: PRODUCT PORTFOLIO 125

NOVASEP 125

TABLE 75 NOVASEP: PRODUCT PORTFOLIO 126

TABLE 76 NOVASEP: RECENT DEVELOPMENTS, 2011-2012 126

PALL CORP. 127

TABLE 77 PALL CORP. PRODUCT PORTFOLIO 127

TABLE 78 PALL CORP.: RECENT DEVELOPMENTS, 2011-2012 128

PENDOTECH 128

TABLE 79 PENDOTECH: PRODUCT PORTFOLIO 129

TABLE 80 PENDOTECH: RECENT DEVELOPMENTS, 2011-2012 129

RENOLIT 130

TABLE 81 RENOLIT: PRODUCT PORTFOLIO 130

TABLE 82 RENOLIT: RECENT DEVELOPMENTS 131

REPLIGEN BIOPROCESSING 131

TABLE 83 REPLIGEN BIOPROCESSING: PRODUCT PORTFOLIO 131

SAINT GOBAIN 132

TABLE 84 SAINT GOBAIN: PRODUCT PORTFOLIO 132

TABLE 85 SAINT GOBAIN: RECENT DEVELOPMENTS, 2011-2012 132

SARTORIUS 133

TABLE 86 SARTORIUS: PRODUCT PORTFOLIO 133

TABLE 87 SARTORIUS: RECENT DEVELOPMENTS, 2011-2012 134

TABLE 88 SARTORIUS: FINANCIALS ($ MILLIONS) 135

TARPON BIOSYSTEMS 135

TABLE 89 TARPON BIOSYSTEMS: PRODUCT PORTFOLIO 135

XCELLEREX 136

TABLE 90 XCELLEREX: PRODUCT PORTFOLIO 136

TABLE 91 XCELLEREX: RECENT DEVELOPMENTS, 2011-2012 137

CHAPTER 10 APPENDIX ONE: GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS, AND

U.S. PATENTS FOR SUT, 2010 TO 2012 139

TABLE 92 GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS BY GEOGRAPHIC REGION,

THROUGH 2017 ($ MILLIONS) 139

TABLE 93 GLOBAL MARKET FOR PREPARATION BUFFER CONTAINERS BY GEOGRAPHIC

REGION, THROUGH 2017 ($ MILLIONS) 139

TABLE 94 U.S. PATENTS FOR SUT, 2010 TO 2012 140

TABLE 95 EUROPEAN SUT PATENTS, 2010 TO 2012 141

CHAPTER 11 APPENDIX TWO: LIST OF ACRONYMS 146

SUMMARY TABLE GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THEMANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, THROUGH 2017 ($MILLIONS)5TABLE 1 DEVELOPMENTS IN SINGLE-USE TECHNOLOGIES 12TABLE 2 SUT GAP ANALYSIS 19TABLE 3 BIOREACTOR FACILITY COSTS: SINGLE-USE VERSUS STAINLESS STEEL SYSTEMS 25TABLE 4 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY USED IN THE MANUFACTURE OFBIOPHARMACEUTICALS BY SEGMENT, THROUGH 2017 ($ MILLIONS) 47TABLE 5 GLOBAL MARKET FOR MEMBRANE ADSORBERS BY GEOGRAPHIC REGION,2012–2017 ($ MILLIONS) 48TABLE 6 GLOBAL MARKET FOR BIOREACTORS BY TECHNOLOGY, THROUGH 2017 ($MILLIONS) 49TABLE 7 GLOBAL MARKET FOR BIOREACTORS BY GEOGRAPHIC REGION, THROUGH 2017 ($MILLIONS) 50TABLE 8 GLOBAL MARKET FOR SEED BIOREACTORS BY GEOGRAPHIC REGION, THROUGH2017 ($ MILLIONS) 51TABLE 9 GLOBAL MARKET FOR PRODUCTION BIOREACTORS BY GEOGRAPHIC REGION,THROUGH 2017 ($ MILLIONS) 51TABLE 10 GLOBAL MARKET FOR DISPOSABLE MIXING SYSTEMS BY GEOGRAPHIC REGION,THROUGH 2017 ($ MILLIONS) 52TABLE 11 GLOBAL MARKET FOR TANGENTIAL FLOW FILTRATION SYSTEMS BY GEOGRAPHICREGION, THROUGH 2017 ($ MILLIONS) 54TABLE 12 GLOBAL MARKET FOR TUBING BY GEOGRAPHIC REGION, THROUGH 2017 ($MILLIONS) 55TABLE 13 GLOBAL MARKET FOR CONNECTORS BY GEOGRAPHIC REGION, 2012–2017 ($MILLIONS) 56TABLE 14 GLOBAL MARKET FOR PREASSEMBLED TUBING AND RIGGING BY GEOGRAPHICREGION, THROUGH 2017 ($ MILLIONS) 57TABLE 15 GLOBAL MARKET DEPTH FILTRATION SYSTEMS BY GEOGRAPHIC REGION,THROUGH 2017 ($ MILLIONS) 58TABLE 16 GLOBAL MARKET FOR BUFFER CONTAINERS BY EQUIPMENT TYPE, THROUGH2017 ($ MILLIONS) 58TABLE 17 GLOBAL MARKET FOR BUFFER CONTAINERS BY GEOGRAPHIC REGION, THROUGH2017 ($ MILLIONS) 59TABLE 18 GLOBAL MARKET FOR WASTE CONTAINERS BY GEOGRAPHIC REGION, THROUGH2017 ($ MILLIONS) 59TABLE 19 GLOBAL MARKET FOR SAMPLERS BY GEOGRAPHIC REGION, THROUGH 2017 ($MILLIONS) 60TABLE 20 GLOBAL MARKET FOR MEDIA BAGS BY TYPE, THROUGH 2017 ($ MILLIONS) 61TABLE 21 GLOBAL MARKET FOR MEDIA BAGS BY GEOGRAPHIC REGION, 2012–2017 ($MILLIONS) 62TABLE 22 GLOBAL MARKET FOR FILLED MEDIA BAGS BY GEOGRAPHIC REGION, THROUGH2017 ($ MILLIONS) 62TABLE 23 GLOBAL MARKET FOR DRY MEDIA BAGS BY GEOGRAPHIC REGION, THROUGH 2017($ MILLIONS) 63TABLE 24 GLOBAL MARKET FOR FILTER CARTRIDGES BY GEOGRAPHIC REGION, THROUGH2017 ($ MILLIONS) 64TABLE 25 GLOBAL MARKET FOR OTHER SINGLE-USE TECHNOLOGIES BY GEOGRAPHICREGION, THROUGH 2017 ($ MILLIONS) 64TABLE 26 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY FOR USE INBIOPHARMACEUTICAL MANUFACTURE BY APPLICATION, THROUGH 2017 ($ MILLIONS) 66TABLE 27 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTIONOF MONOCLONAL ANTIBODIES, THROUGH 2017 ($ MILLIONS) 68TABLE 28 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTIONOF VACCINES, THROUGH 2017 ($ MILLIONS) 69TABLE 29 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN GENE THERAPY,THROUGH 2017 ($ MILLIONS) 71TABLE 30 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE PRODUCTIONOF RECOMBINANT PROTEIN, THROUGH 2017 ($ MILLIONS) 72TABLE 31 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTUREOF BLOOD DERIVATIVES, THROUGH 2017 ($ MILLIONS) 73TABLE 32 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTUREOF ANTICANCER DRUGS, THROUGH 2017 ($ MILLIONS) 73TABLE 33 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN OTHER APPLICATIONAREAS, THROUGH 2017 ($ MILLIONS) 74TABLE 34 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTUREOF BIOPHARMACEUTICALS BY END USER, 2012–2017 ($ MILLIONS) 76TABLE 35 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BYBIOPHARMACEUTICAL CMOS, THROUGH 2017 ($ MILLIONS) 78TABLE 36 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BYBIOPHARMACEUTICAL MANUFACTURERS BY REGION, THROUGH 2017 ($ MILLIONS) 79TABLE 37 GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTUREOF BIOPHARMACEUTICALS BY END USER SEGMENT, THROUGH 2017 ($ MILLIONS) 80TABLE 38 GLOBAL R&D SPENT ON SINGLE-USE TECHNOLOGIES USED IN THEMANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, THROUGH 2017 ($MILLIONS)81TABLE 39 GLOBAL EXPENDITURES ON GOOD MANUFACTURING PRACTICES FORSINGLE-USE TECHNOLOGIES USED IN THE MANUFACTURE OF BIOPHARMACEUTICALS BYREGION, THROUGH 2017 ($ MILLIONS)82TABLE 40 COMPANY STRATEGIES 84TABLE 41 COMPANY ANNOUNCEMENTS, 2006 TO JULY 2012 ` 89TABLE 42 ADVANCED SCIENTIFICS INC.: PRODUCT PORTFOLIO 106TABLE 43 ADVANTAPURE: PRODUCT PORTFOLIO 107TABLE 44 ADVANTAPURE: RECENT DEVELOPMENTS, 2011–2012 108TABLE 47 ATMI LIFESCIENCES: PRODUCT PORTFOLIO 109TABLE 48 ATMI LIFESCIENCES: RECENT DEVELOPMENTS, 2006-2012 109TABLE 49 ATMI LIFESCIENCES: FINANCIALS, 2008–2010 ($ MILLIONS) 110TABLE 50 ATOLL: PRODUCT PORTFOLIO 111TABLE 51 BARBLOCK: PRODUCT PORTFOLIO 111TABLE 52 BIOPHARMA DYNAMICS: PRODUCT PORTFOLIO 112TABLE 53 BIOPURE: PRODUCT PORTFOLIO 113TABLE 54 BIOPURE: RECENT DEVELOPMENTS 113TABLE 55 BOSCH PACKAGING: PRODUCT PORTFOLIO 114TABLE 56 BOSCH PACKAGING: RECENT DEVELOPMENTS 114TABLE 57 CELLON: PRODUCT PORTFOLIO 115TABLE 58 CELLON: RECENT DEVELOPMENTS 115TABLE 59 CHARTER MEDICAL: PRODUCT PORTFOLIO 116TABLE 60 CHARTER MEDICAL: RECENT DEVELOPMENTS 116TABLE 61 CMC BIOLOGICS: SERVICES 117TABLE 62 CMC BIOLOGICS: RECENT DEVELOPMENTS 117TABLE 63 COLDER PRODUCTS COMPANY: PRODUCT PORTFOLIO 118TABLE 64 COLDER PRODUCTS CO.: RECENT DEVELOPMENTS, 2011-2012 118TABLE 65 DOW CORNING: PRODUCT PORTFOLIO 119TABLE 66 DOW CORNING: RECENT DEVELOPMENTS, 2009-2011 119TABLE 67 EMD MILLIPORE: PRODUCT PORTFOLIO 120TABLE 68 EMD MILLIPORE: RECENT DEVELOPMENTS, 2006-2012 121TABLE 69 FINESSE SOLUTIONS: PRODUCT PORTFOLIO 121TABLE 70 FINESSE SOLUTIONS: RECENT DEVELOPMENTS, 2009-2011 122TABLE 71 GE HEALTHCARE: PRODUCT PORTFOLIO 122TABLE 72 GORE: PRODUCT PORTFOLIO 124TABLE 73 GORE: RECENT DEVELOPMENTS, 2011-2012 124TABLE 74 IS SUPPLIES: PRODUCT PORTFOLIO 125TABLE 75 NOVASEP: PRODUCT PORTFOLIO 126TABLE 76 NOVASEP: RECENT DEVELOPMENTS, 2011-2012 126TABLE 77 PALL CORP. PRODUCT PORTFOLIO 127TABLE 78 PALL CORP.: RECENT DEVELOPMENTS, 2011-2012 128TABLE 79 PENDOTECH: PRODUCT PORTFOLIO 129TABLE 80 PENDOTECH: RECENT DEVELOPMENTS, 2011-2012 129TABLE 81 RENOLIT: PRODUCT PORTFOLIO 130TABLE 82 RENOLIT: RECENT DEVELOPMENTS 131TABLE 83 REPLIGEN BIOPROCESSING: PRODUCT PORTFOLIO 131TABLE 84 SAINT GOBAIN: PRODUCT PORTFOLIO 132TABLE 85 SAINT GOBAIN: RECENT DEVELOPMENTS, 2011-2012 132TABLE 86 SARTORIUS: PRODUCT PORTFOLIO 133TABLE 87 SARTORIUS: RECENT DEVELOPMENTS, 2011-2012 134TABLE 88 SARTORIUS: FINANCIALS ($ MILLIONS) 135TABLE 89 TARPON BIOSYSTEMS: PRODUCT PORTFOLIO 135TABLE 90 XCELLEREX: PRODUCT PORTFOLIO 136TABLE 91 XCELLEREX: RECENT DEVELOPMENTS, 2011-2012 137TABLE 92 GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS BY GEOGRAPHIC REGION,THROUGH 2017 ($ MILLIONS) 139TABLE 93 GLOBAL MARKET FOR PREPARATION BUFFER CONTAINERS BY GEOGRAPHICREGION, THROUGH 2017 ($ MILLIONS) 139TABLE 94 U.S. PATENTS FOR SUT, 2010 TO 2012 140TABLE 95 EUROPEAN SUT PATENTS, 2010 TO 2012 141

LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, 2011-2017 ($

MILLIONS)

5

FIGURE 1 EVOLUTION OF SINGLE-USE TECHNOLOGIES USED IN BIOPHARMACEUTICAL

MANUFACTURING 10

FIGURE 2 COST OF NEW DRUG DEVELOPMENT, 1997-2013 ($ BILLIONS) 28

FIGURE 3 GROWTH ANALYSIS OF THE SUT MARKET 38

FIGURE 4 THE U.S. AND EUROPEAN PATENTS ON SINGLE-USE TECHNOLOGIES, 2010-2012

(NO.) 39

FIGURE 5 U.S. PATENTS ON SINGLE-USE TECHNOLOGIES BY YEAR, 2010 TO JUNE 2012 (%) 39

FIGURE 6 EUROPEAN PATENTS BY YEAR, 2010 TO JUNE 2012 (%) 40

FIGURE 7 BIOPHARMACEUTICAL MANUFACTURE OF MONOCLONAL ANTIBODIES 41

FIGURE 8 SELECTED AVERAGE FACILITY BUDGETS FOR SINGLE-USE

DEVICES-BIOTHERAPEUTICS DEVELOPERS VS. CMOS ($) 77

FIGURE 9 TOP STRATEGIES, 2006-2012 (%) 85

FIGURE 10 AGREEMENTS BY COMPANY, 2006-2012 (%) 86

FIGURE 11 MERGERS AND ACQUISITIONS BY COMPANY, 2006-2012 (%) 87

FIGURE 12 ANALYSIS BY COMPANY 2006-2012 (%) 87

To order this report:Biopharmaceutical Industry: Single-Use Technologies for Biopharmaceuticals: Global Markets

Nicolas Bombourg

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