NEW YORK, Dec. 19, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Single-Use Technologies for Biopharmaceuticals: Global Marketshttp://www.reportlinker.com/p01057702/Single-Use-Technologies-for-Biopharmaceuticals-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical
INTRODUCTION
STUDY BACKGROUND STUDY GOALS AND OBJECTIVESIdentifying 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.
ANALYST CREDENTIALS Mahi Dutta TABLE OF CONTENTSSTUDY 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
LIST OF TABLESSUMMARY 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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