Provides a U.S. market review for medical membrane devices and technologies Offers the current U.S. market status for medical membrane devices and technologies, with trends and forecasts for growth through 2014 Offers sales and five-year market forecasts for five product areas including hemodialyzers, blood oxygenators, IV filters, diagnostic devices and blood microfilters Discusses driving forces in the medical membrane devices industry Profiles leading medical membrane device companies and their sales.

INTRODUCTION

STUDY GOAL AND OBJECTIVES

This BCC Research market opportunity study provides an in-depth analysis of the relevant technical and economic drivers for the medical membrane device market by technology type, forecasting growth and trends in the various sectors over the next 5 years. The conclusions are illustrated with important statistical and analytical information on markets, applications, industry structure and dynamics, as well as technological developments.

REASONS FOR DOING THIS STUDY

This report is intended for those who require a thorough analysis of the medical membrane device industry. It contains significant developments, forecasts, and important trends, and it quantifies the various market sectors and profiles companies active in those areas. Because of the fragmented nature of the industry, it is difficult to find studies that gather extensive data from such diverse resources and evaluate it in the context of one comprehensive document. This analysis contains a unique collection of membrane device-related information that is difficult or impossible to find elsewhere.

INTENDED AUDIENCE

This study aims to provide those interested in investment, acquisition, or expansion in the medical membrane device industry with specific, detailed information crucial to making informed decisions. Senior marketing personnel, venture capitalists, executive planners, research directors, and government officials should find the report of value. Readers who simply wish to understand how regulations, market pressures, and technology interact in the medical membrane device arena also will find this study worthwhile.

SCOPE OF REPORT

Five-year projections for market activity and value are provided. Industry structure, device applications and trends, pricing considerations, R&D, environmental influences, companies, and competitive technologies are included in the study. To simplify and focus on the most promising and clearly relevant technologies, the study concentrates on existing and potentially major uses of the technology. The membranes used in medical devices work in tandem with other materials and processes, adding critical functionality and value. To clarify the dynamic, the report addresses the membrane component of each sector in context with the market dynamics of the overall technology. The report includes comparison of costs for various membrane materials and devices. Current and potential market players are identified and examined.

INFORMATION SOURCES

Research for this report began with an in-depth analysis of technical and business literature, as well as a review of the history of the technology. Information from industry experts, company representatives, government researchers, and university scientists provided the basis for an assessment of the outlook for the medical membrane device industry. Secondary sources of information included product literature from membrane and device suppliers, scientific references, and patent searches.

The study is divided into key Chapters dealing with the structure and properties of five types of medical membrane devices, including critical components, manufacturing processes necessary for their final function, and their applications. The study emphasizes areas under research and the resulting trends. The report makes projections for each market in terms of constant 2009 dollars. Historical values are presented for the given year, with focus on the U.S. market. Overseas activity is briefly mentioned in order to put the U.S. market into the global context. Estimates of the membrane areas used in particular applications were obtained either from surveys or estimates from knowledgeable industry participants. Final analyses and projections are based upon a combination of a consensus among the primary contacts combined with BCC' s understanding of the impact of trends from a historical perspective.

The material presented in this report is based on information gathered from participants in the medical device industry and extensive reviews of secondary sources, such as business, scientific and industry publications, company literature, annual reports, SEC filings, patent literature, and online databases.

Chapter-1: SUMMARY 3

SUMMARY 4
SUMMARY (CONTINUED) 5
SUMMARY TABLE SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, THROUGH 2014 ($ MILLIONS) 6
SUMMARY FIGURE SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, 2000 - 2014 ($ MILLIONS) 6

Chapter-2: OVERVIEW 2

MEMBRANE AND DEVICE MANUFACTURERS 9
OEM MANUFACTURER 9
OEM Membranes 10
TABLE 2 MANUFACTURERS OF OEM MEMBRANES AND PRODUCTS 10
TABLE 2 (CONTINUED) 11
TABLE 2 (CONTINUED) 12
OEM Devices 12
COMBINED MEMBRANE AND DEVICE MANUFACTURERS 12
HEALTHCARE PRODUCT OR MEDICAL TECHNOLOGY COMPANIES 12
DISTRIBUTION CHANNELS 13
UPSTREAM SUPPLIERS 13
PRODUCT DISTRIBUTION (MARKETING AND SALES) 14
TABLE 3 DISTRIBUTION CHANNELS FOR MEDICAL MEMBRANE DEVICES 14
TABLE 3 (CONTINUED) 15
CUSTOMERS 15
Healthcare Customers 15
Downstream Manufacturing Customers 16
Distributors or Partnership-type Customers 16
Home Users 16
INDUSTRY TRENDS 17
INDUSTRY PARTICIPANTS 18
TABLE 4 MEDICAL MEMBRANE DEVICE MANUFACTURERS, PRODUCT TYPES, SALES, 2008 ($ MILLIONS) 19
TABLE 4 (CONTINUED) 20
COMPANY PROFILES 20
3M 20
ABBOTT LABORATORIES 21
AETHLON MEDICAL 22
ASAHI KASEI KURARAY MEDICAL CO. 23
BAXTER INTERNATIONAL 24
BECTON, DICKINSON & CO. 25
B.BRAUN MEDICAL INC. 25
CANTEL MEDICAL 26
CHF SOLUTIONS, INC. 27
ENZO BIOCHEM 28
EPS, INC. 29
ESCO TECHNOLOGIES 29
FENWAL, INC. 30
FRESENIUS GROUP 30
Fresenius Group (Continued) 31
GAMBRO AB 32
GENBIO 32
GENERAL ELECTRIC CO. 33
W.L.GORE & ASSOCIATES 34
GVS GROUP 34
F. HOFFMAN-LA ROCHE 35
IMMUNETICS, INC. 36
INVERNESS MEDICAL INNOVATIONS, INC. 37
JOHNSON & JOHNSON 38
KANEKA CORP. 39
MEDOS MEDIZINTECHNIK 39
MEDTRONIC 40
MILLIPORE CORP. 41
NOVOSCI 42
NXSTAGE MEDICAL 43
PALL CORP. 43
QUIDEL CORP. 44
RESPONSE BIOMEDICAL 45
SARTORIUS AG 46
SERIM RESEARCH CORP. 47
SIEMENS HEALTHCARE DIAGNOSTICS INC. 47
SORIN GROUP 48
SPECTRAL DIAGNOSTICS, INC. 49
TERUMO CORP. 50
THERMO FISHER SCIENTIFIC 51
TORAY INDUSTRIES, INC. 51
TRANSVIVO 52
VARIAN, INC. 52
TRENDS IN DEVICE MANUFACTURE 53
MARKET BARRIERS 53
REGULATION OF THE MEDICAL DEVICE INDUSTRY 54
Legal Liability 55
HEALTHCARE SYSTEM CONSIDERATIONS 56
TABLE 5 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1950 - 2016 (% OF GNP) 56
FIGURE 1 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1950 - 2016 (%) 57
WHERE THE MONEY GOES 57
TABLE 6 NATIONAL HEALTH EXPENDITURES BY TYPE, 2009 AND 2014 ($ BILLIONS, %) 58
FIGURE 2 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2009 AND 2014 ($ BILLIONS) 58
WHY COSTS ARE RISING 59
ACCESS TO CARE 60
TABLE 7 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%) 60
FIGURE 3 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%) 60
MANAGED CARE 61
Capitation-type Reimbursement 62
Consolidation and Commercialization 62
HOW MANAGED CARE AFFECTS THE MEDICAL DEVICE MARKET 63
VERTICAL INTEGRATION OF PRODUCT AND CARE MARKETS 64
Vertical Integration of Product and ... (Continued) 65
RECENT LEGISLATION 66
MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002 66
MEDICARE MODERNIZATION ACT OF 2003 67
Medicare Modernization Act ... (Continued) 68

Chapter-3: INDUSTRY STRUCTURE 60

Chapter-4: MEDICAL MEMBRANE DEVICE TECHNOLOGY 13

MEMBRANE MANUFACTURING 69
POLYMERS 69
TABLE 8 APPROPRIATE POLYMERS FOR MEDICAL MEMBRANES 69
Medical Use Criteria for Polymers 70
MANUFACTURING TECHNIQUES 71
TABLE 9 MEMBRANE MANUFACTURING METHODS 71
TABLE 9 (CONTINUED) 72
MEMBRANE STRUCTURES 73
TABLE 10 MEMBRANE MORPHOLOGIES AND PROPERTIES 73
MEMBRANE GEOMETRIES 73
TABLE 11 HOLLOW FIBER AND FLAT SHEET MEMBRANES AND DEVICES 74
Membrane Geometries (Continued) 75
TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES 76
TABLE 12 TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES 77
DEVICE MANUFACTURING 77
DEVICE MANUFACTURING (CONTINUED) 78
PRICING 79
TABLE 13 AVERAGE PRICES FOR MEDICAL MEMBRANE DEVICES ($) 80
COMPETITIVE TECHNOLOGIES 80
TABLE 14 MEDICAL MEMBRANE DEVICES AND COMPETING TECHNOLOGIES 81

Chapter-5: PATENT SURVEY 5

BY APPLICATION 82
TABLE 15 PATENTS BY APPLICATION, NUMBER, AND PERCENTAGE 83
FIGURE 4 PATENTS BY APPLICATION (%) 83
BY COMPANY 83
BY COMPANY (CONTINUED) 84
TABLE 16 PATENTS, BY COMPANY, NUMBER, AND PERCENTAGE 85
FIGURE 5 PATENTS BY COMPANY (%) 86

Chapter-6: HEMODIALYZERS 11

MARKET SIZE AND GROWTH 87
MARKET SIZE AND GROWTH (CONTINUED) 88
MARKET SIZE AND GROWTH (CONTINUED) 89
TABLE 17 SALES AND PROJECTIONS FOR HEMODIALYZERS, THROUGH 2014 ($ MILLIONS) 90
FIGURE 6 SALES AND PROJECTIONS FOR HEMODIALYZERS, 2000 - 2014 ($ MILLIONS) 90
HISTORY 91
OVERVIEW 91
DIALYZERS 92
DIALYZER SPECIFICATIONS 92
TABLE 18 PRIMARY DIALYZER TYPES AND REPRESENTATIVE PRODUCTS 93
MODES OF HEMODIALYSIS 94
MEASURING DIALYZER PERFORMANCE 94
DIALYZER REUSE 94
Reuse vs. Single-Use 95
COMPETITIVE TECHNOLOGIES 96
COMPANIES ACTIVE IN THE DIALYZER INDUSTRY 96
MARKET SHARE, HEMODIALYZERS 96
TABLE 19 MARKET SHARE, HEMODIALYZERS, 2009 (%) 97
FIGURE 7 MARKET SHARE, HEMODIALYZERS, 2009 (%) 97

Chapter-7: BLOOD OXYGENATORS 7

MARKET SIZE AND GROWTH 98
MARKET SIZE AND GROWTH (CONTINUED) 99
TABLE 20 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2014 ($ MILLIONS) 100
FIGURE 8 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2014 ($ MILLIONS) 100
HISTORY 101
OVERVIEW 101
BLOOD OXYGENATORS 101
OXYGENATOR SPECIFICATIONS 102
COMPETITIVE TECHNOLOGIES 102
COMPANIES ACTIVE IN THE BLOOD OXYGENATOR MARKET 103
TABLE 21 MEMBRANE OXYGENATOR MANUFACTURERS AND PRODUCTS 103
MARKET SHARE, BLOOD OXYGENATORS 103
TABLE 22 MARKET SHARE: BLOOD OXYGENATORS, 2009 (%) 104
FIGURE 9 MARKET SHARE, BLOOD OXYGENATORS, 2009 (%) 104

Chapter-8: IV FILTERS 8

MARKET SIZE AND GROWTH 105
MARKET SIZE AND GROWTH (CONTINUED) 106
TABLE 23 SALES AND PROJECTIONS FOR IV FILTERS, 2000 - 2014 ($ MILLIONS) 107
FIGURE 10 SALES AND PROJECTIONS FOR IV FILTERS, 2000 - 2014 ($ MILLIONS) 107
HISTORY 107
OVERVIEW 108
ENDOTOXIN REMOVAL 109
NUTRIENT ADMIXTURE FILTRATION 109
IN-LINE BLOOD COMPONENT FILTRATION 110
EMULSION DRUGS 110
TABLE 24 DRUGS FOR WHICH FILTRATION IS RECOMMENDED DURING ADMINISTRATION (MICRON) 111
INFANT IV THERAPY 111
COMPANIES ACTIVE IN THE IV FILTER MARKET 112
TABLE 25 MANUFACTURERS OF IV FILTERS AND PRODUCTS 112
MARKET SHARE, IV FILTERS 112

Chapter-9: DIAGNOSTIC DEVICES 14

MARKET SIZE AND GROWTH 113
MARKET SIZE AND GROWTH (CONTINUED) 114
TABLE 26 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, THROUGH 2012 ($ MILLIONS) 115
FIGURE 11 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, 2000 - 2012 ($ MILLIONS) 116
HISTORY 116
OVERVIEW 116
CLINICAL DIAGNOSTICS 116
POINT-OF-CARE TESTING 117
TABLE 27 CONDITIONS DETECTED WITH IN VITRO DIAGNOSTICS 117
TABLE 27 (CONTINUED) 118
HOME TESTING 119
TYPES OF ASSAYS 119
Challenges in Assay Design 120
TECHNOLOGY 121
AUTOMATION 122
NON-INVASIVE SAMPLING 122
COMPETITIVE TECHNOLOGIES 123
TABLE 28 ALTERNATIVE METHODS OF IN VITRO TESTING 123
TABLE 29 MEMBRANE APPLICATIONS IN MOLECULAR DIAGNOSTICS 124
COMPANIES ACTIVE IN THE DIAGNOSTIC DEVICE MARKET 124
TABLE 30 MANUFACTURERS OF DIAGNOSTIC DEVICES AND PRODUCT TYPES 125
MARKET SHARE, DIAGNOSTIC DEVICES 125
TABLE 31 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%) 126
FIGURE 12 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%) 126

Chapter-10: BLOOD MICROFILTERS 12

MARKET SIZE AND GROWTH 127
TABLE 32 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, THROUGH 2014 ($ MILLIONS) 128
FIGURE 13 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, 2000 - 2014 ($ MILLIONS) 129
HISTORY 129
OVERVIEW 129
OVERVIEW (CONTINUED) 130
TABLE 33 THERAPEUTIC APHERESIS OUTCOMES AND GUIDELINES 131
TABLE 33 (CONTINUED) 132
TECHNOLOGY 133
TABLE 34 COMPARISON OF BLOOD FRACTIONATION TECHNOLOGY 134
TABLE 34 (CONTINUED) 135
TRENDS AND TECHNICAL DEVELOPMENTS 135
TABLE 35 DEVELOPMENTS IN THERAPEUTIC APHERESIS 136
TABLE 36 POTENTIAL APPLICATIONS OF THERAPEUTIC APHERESIS 136
TABLE 36 (CONTINUED) 137
COMPANIES ACTIVE IN THE BLOOD MICROFILTER MARKET 137
TABLE 37 MAJOR MANUFACTURERS OF BLOOD MICROFILTERS AND PRODUCTS 137
MARKET SHARE OF BLOOD MICROFILTERS 137
TABLE 38 MARKET SHARE, BLOOD MICROFILTERS, 2009 (%) 138

Chapter-11: THE MEDICAL MEMBRANE DEVICE MARKET ABROAD 18

THE MEDICAL MEMBRANE DEVICE MARKET ABROAD 139
THE MEDICAL MEMBRANE DEVICE ... (CONTINUED) 140
APPENDIX: PATENT SURVEY 141
TABLE 39 PATENT SURVEY, APRIL 8, 2004 TO APRIL 7, 2009 141
TABLE 39 (CONTINUED) 142
TABLE 39 (CONTINUED) 143
TABLE 39 (CONTINUED) 144
TABLE 39 (CONTINUED) 145
TABLE 39 (CONTINUED) 146
TABLE 39 (CONTINUED) 147
TABLE 39 (CONTINUED) 148
TABLE 39 (CONTINUED) 149
TABLE 39 (CONTINUED) 150
TABLE 39 (CONTINUED) 151
TABLE 39 (CONTINUED) 152
TABLE 39 (CONTINUED) 153
TABLE 39 (CONTINUED) 154
TABLE 39 (CONTINUED) 155
TABLE 39 (CONTINUED) 156

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Medical Membrane Devices: Markets and Technologies

Introduction

Abstract

This Report: