医療用メンブレン・デバイス：市場と技術

Abstract

INTRODUCTION

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

SCOPE OF STUDY

This report contains:

• Industry structure covering, membrane device manufacturers, technology companies, distribution channels, and customers
• Company profiles
• Medical membrane device technology
• Patent analysis
• History, overview, company sales and five-year market forecasts for the following five product areas: hemodialyzers, blood oxygenators, IV filters, diagnostic devices and blood microfilters

METHODOLOGY

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

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 report emphasizes areas under research and the resulting trends. It makes projections for each market in terms of constant dollars. Historical values are presented for the given year, with a focus on the U.S. market.

Overseas activity is mentioned briefly, to put the U.S. market into global context. Estimates of the membrane areas used for particular applications were obtained either from surveys or estimates by knowledgeable industry participants. Final analyses and projections are based upon a combination of a consensus among primary contacts combined with BCC Research' s understanding of the impact of trends from a historical perspective.

INFORMATION SOURCES

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

Table of Contents

• INTRODUCTION
  • STUDY GOAL AND OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • CONTRIBUTIONS OF THE STUDY AND FOR WHOM
  • SCOPE AND FORMAT
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYSTS CREDENTIALS
  • RELATED BCC PUBLICATIONS
  • DISCLAIMER
• SUMMARY
  • Summary Table:
  • SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, THROUGH 2012 ($ MILLIONS)
  • Summary Figure:
  • SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, 2000-2012 ($ MILLIONS)
• OVERVIEW
  • OVERVIEW
  • Table 1 MEDICAL MEMBRANE DEVICES
    • OVERVIEW (CONTINUED)
• INDUSTRY STRUCTURE
  • MEMBRANE AND DEVICE MANUFACTURERS
    • OEM MANUFACTURERS
      • OEM Membranes
  • Table 2 MANUFACTURERS OF OEM MEMBRANES AND PRODUCTS
  • Table 2 (CONTINUED)
  • Table 2 (CONTINUED)
  • Table 2 (CONTINUED)
    • OEM Devices
  • COMBINED MEMBRANE AND DEVICE MANUFACTURERS
  • HEALTHCARE PRODUCT OR MEDICAL TECHNOLOGY COMPANIES
    • DISTRIBUTION CHANNELS
  • UPSTREAM SUPPLIERS
  • PRODUCT DISTRIBUTION (MARKETING AND SALES)
  • Table 3 MEDICAL MEMBRANE DEVICE DISTRIBUTION CHANNELS
    • CUSTOMERS
      • Healthcare Customers
      • Downstream Manufacturing Customers
      • Distributors or Partnership-type Customers
      • Home Users
    • INDUSTRY PARTICIPANTS
  • Table 4 MEDICAL MEMBRANE DEVICE MANUFACTURERS AND PRODUCT SALES, 2006
  • Table 4 (CONTINUED)
    • COMPANY PROFILES
      • 3M
      • CUNO, INC.
      • ABBOTT LABORATORIES
      • ASAHI KASEI
      • AVITAR, INC.
      • BAXTER INTERNATIONAL
      • BECTON, DICKINSON & CO.
      • B.BRAUN MEDICAL INC.
      • CANTEL MEDICAL
      • CARDIOTECH INTERNATIONAL
      • DADE BEHRING
      • ENZO BIOCHEM
      • EPS, INC.
      • ESCO TECHNOLOGIES
      • FENWAL, INC.
      • FRESENIUS AG
      • GAMBRO AB
      • GENBIO
      • GENERAL ELECTRIC
      • W.L.GORE & ASSOCIATES
      • F. HOFFMAN-LA ROCHE
      • IMMUNETICS, INC.
      • INVERNESS MEDICAL INNOVATIONS, INC.
      • JOHNSON & JOHNSON
      • KANEKA CORP.
      • KURARAY CO, LTD.
      • MEDTRONIC
      • MILLIPORE CORP.
      • NOVOSCI
      • PALL CORP.
      • QUIDEL CORP.
      • RESPONSE BIOMEDICAL
      • SARTORIUS AG
      • SIEMENS MEDICAL SOLUTIONS
      • SORIN GROUP
      • SPECTRAL DIAGNOSTICS, INC.
      • TERUMO CORP.
      • THERMO FISHER SCIENTIFIC
      • TORAY INDUSTRIES, INC.
      • VARIAN, INC.
      • WHATMAN
    • TRENDS IN DEVICE MANUFACTURE
    • MARKET BARRIERS
      • MEDICAL DEVICE INDUSTRY REGULATION
        • Class I
        • Class II
        • Class III
        • Legal Liability
    • HEALTHCARE SYSTEM CONSIDERATIONS
  • Table 5 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1960-2015 (%)
  • Figure 1 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1960-2015 (%)
    • WHERE THE MONEY GOES
  • Table 6 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2006 AND 2015
  • Figure 2 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2006 AND 2015 ($ BILLIONS)
    • WHY COSTS ARE RISING
    • ACCESS TO CARE
  • Table 7 HEALTHCARE COVERAGE IN THE U.S., 2006
  • Figure 3 HEALTHCARE COVERAGE IN THE U.S., 2006
    • MANAGED CARE
    • MANAGED CARE (CONTINUED)
      • Capitation-type Reimbursement
      • Consolidation and Commercialization
    • HOW MANAGED CARE AFFECTS THE MEDICAL DEVICE MARKET
    • VERTICAL INTEGRATION OF PRODUCT AND CARE MARKETS
      • Vertical Integration of ... (Continued)
  • RECENT LEGISLATION
    • MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
  • Table 8 DEVICE REVIEW USER FEES (FY 2007)
  • Table 9 FDA PERFORMANCE GOALS UNDER THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
  • Table 9 (CONTINUED)
    • MEDICARE MODERNIZATION ACT OF 2003
• MEDICAL MEMBRANE DEVICE TECHNOLOGY
  • MEMBRANE MANUFACTURING
    • POLYMERS
  • Table 10 APPROPRIATE POLYMERS FOR MEDICAL MEMBRANES
  • Table 10 (CONTINUED)
    • Medical Use Criteria for Polymers
  • MANUFACTURING TECHNIQUES
  • Table 11 MEMBRANE MANUFACTURING METHODS
    • MEMBRANE STRUCTURES
  • Table 12 MEMBRANE MORPHOLOGIES AND PROPERTIES
    • MEMBRANE GEOMETRIES
  • Table 13 HOLLOW FIBER AND FLAT SHEET MEMBRANES AND DEVICES
    • Membrane Geometries (Continued)
  • TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES
  • Table 14 TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES
    • DEVICE MANUFACTURING
      • MARKET ANALYSIS
      • DEVICE CONCEPT
      • DEVICE DESIGN
      • DEVICE PROTOTYPE
      • PRODUCT SPECIFICATION
      • TRANSFER TO PRODUCTION
      • PRODUCTION RATIONALIZATION
      • MARKET INTRODUCTION
    • PRICING
  • Table 15 AVERAGE PRICES FOR MEDICAL MEMBRANE DEVICES
    • COMPETITIVE TECHNOLOGIES
    • COMPETITIVE TECHNOLOGIES (CONTINUED)
  • Table 16 MEDICAL MEMBRANE DEVICES AND COMPETING TECHNOLOGIES
• PATENT SURVEY
  • INTRODUCTION
  • BY APPLICATION
  • Table 17 PATENTS BY APPLICATION
  • Figure 4 PATENTS BY APPLICATION (%)
    • BY COMPANY
  • Table 18 PATENTS BY COMPANY
  • Figure 5 PATENTS BY COMPANY (%)
• HEMODIALYZERS
  • MARKET SIZE AND GROWTH
    • MARKET SIZE AND GROWTH (CONTINUED)
    • MARKET SIZE AND GROWTH (CONTINUED)
  • Table 19 SALES AND PROJECTIONS FOR HEMODIALYZERS, THROUGH 2012 ($ MILLIONS)
  • Figure 6 SALES AND PROJECTIONS FOR HEMODIALYZERS, 2000-2012 ($ MILLIONS)
    • HISTORY
    • OVERVIEW
      • DIALYZERS
      • DIALYZER SPECIFICATIONS
  • Table 20 U.S. DIALYZER MARKET BY MEMBRANE TYPE
    • HEMODIALYSIS MODES
    • MEASURING DIALYZER PERFORMANCE
    • DIALYZER REUSE
    • COMPETITIVE TECHNOLOGIES
  • COMPANIES ACTIVE IN THE DIALYZER INDUSTRY
  • Table 21 MANUFACTURERS OF DIALYZERS AND RELATED PRODUCTS
    • HEMODIALYZERS: MARKET SHARE
  • Table 22 HEMODIALYZERS MARKET SHARE, 2007
  • Figure 7 HEMODIALYZERS MARKET SHARE, 2007
• BLOOD OXYGENATORS
  • MARKET SIZE AND GROWTH
    • MARKET SIZE AND GROWTH (CONTINUED)
  • Table 23 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, THROUGH 2012 ($ MILLIONS)
  • Figure 8 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2012 ($ MILLIONS)
    • HISTORY
    • OVERVIEW
      • BLOOD OXYGENATORS
      • OXYGENATOR SPECIFICATIONS
      • COMPETITIVE TECHNOLOGIES
    • COMPANIES ACTIVE IN THE BLOOD OXYGENATOR MARKET
  • Table 24 MEMBRANE OXYGENATOR MANUFACTURERS AND PRODUCTS
    • BLOOD OXYGENATORS: MARKET SHARE
  • Table 25 BLOOD OXYGENATORS MARKET SHARE, 2007
  • Figure 9 BLOOD OXYGENATORS MARKET SHARE, 2007 (%)
• IV FILTERS
  • MARKET SIZE AND GROWTH
    • MARKET SIZE AND GROWTH (CONTINUED)
  • Table 26 SALES AND PROJECTIONS FOR IV FILTERS, THROUGH 2012 ($ MILLIONS)
  • Figure 10 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2012 ($ MILLIONS)
    • HISTORY
    • OVERVIEW
      • ENDOTOXIN REMOVAL
      • NUTRIENT ADMIXTURE FILTRATION
      • INLINE BLOOD COMPONENT FILTRATION
      • EMULSION DRUGS
  • Table 27 DRUGS FOR WHICH FILTRATION IS RECOMMENDED DURING ADMINISTRATION
  • Table 27 (CONTINUED)
    • INFANT IV THERAPY
  • COMPANIES ACTIVE IN THE IV FILTER MARKET
  • Table 28 MANUFACTURERS OF IV FILTERS AND PRODUCTS
  • Table 28 (CONTINUED)
    • IV FILTERS: MARKET SHARE
• DIAGNOSTIC DEVICES
  • MARKET SIZE AND GROWTH
    • MARKET SIZE AND GROWTH (CONTINUED)
  • Table 29 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, THROUGH 2012 ($ MILLIONS)
  • Figure 11 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, 2000-2012 ($ MILLIONS)
    • HISTORY
    • OVERVIEW
      • CLINICAL DIAGNOSTICS
      • POINT-OF-CARE TESTING (POC)
  • Table 30 CONDITIONS DETECTED BY IN VITRO DIAGNOSTICS
    • HOME TESTING
    • ASSAY TYPES
      • Challenges in Assay Design
  • TECHNOLOGY
  • COMPETITIVE TECHNOLOGIES
  • Table 31 ALTERNATIVE METHODS OF IN VITRO TESTING
  • Table 32 MEMBRANE APPLICATIONS IN MOLECULAR DIAGNOSTICS
    • TRENDS AND TECHNICAL DEVELOPMENTS
      • AUTOMATION
      • NONINVASIVE SAMPLING
      • THE DISAPPEARING SAMPLE
    • COMPANIES ACTIVE IN THE DIAGNOSTIC DEVICE MARKET
  • Table 33 MANUFACTURERS OF DIAGNOSTIC DEVICES AND PRODUCTS
    • DIAGNOSTIC DEVICES: MARKET SHARE
  • Table 34 DIAGNOSTIC DEVICES MARKET SHARE, 2007
  • Figure 12 DIAGNOSTIC DEVICES MARKET SHARE, 2007 (%)
• BLOOD MICROFILTERS
  • MARKET SIZE AND GROWTH
  • Table 35 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, THROUGH 2012 ($ MILLIONS)
  • Figure 13 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, 2000-2012 ($ MILLIONS)
    • HISTORY
    • OVERVIEW
      • OVERVIEW (CONTINUED)
  • Table 36 THERAPEUTIC APHERESIS OUTCOMES AND GUIDELINES
  • Table 36 (CONTINUED)
    • TECHNOLOGY
  • Table 37 COMPARISONS OF BLOOD FRACTIONATION TECHNOLOGY
  • Table 37 (CONTINUED)
    • TRENDS AND TECHNICAL DEVELOPMENTS
  • Table 38 THERAPEUTIC APHERESIS DEVELOPMENTS
  • Table 39 POTENTIAL APPLICATIONS FOR THERAPEUTIC APHERESIS
  • Table 39 (CONTINUED)
    • COMPANIES ACTIVE IN THE BLOOD MICROFILTER MARKET
  • Table 40 MANUFACTURERS OF BLOOD MICROFILTERS AND PRODUCTS
    • MARKET SHARE: BLOOD MICROFILTERS
  • Table 41 BLOOD MICROFILTERS: 2007 MARKET SHARE
• THE OVERSEAS MEDICAL MEMBRANE DEVICE MARKET
  • THE OVERSEAS MEDICAL MEMBRANE DEVICE MARKET
    • THE OVERSEAS MEDICAL MEMBRANE ...(CONTINUED)
• APPENDIX I
  • Table 42 PATENT SURVEY
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
  • Table 42 (CONTINUED)
• LIST OF TABLES
  • Summary Table:
  • SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, THROUGH 2012 ($ MILLIONS)
  • Table 1 MEDICAL MEMBRANE DEVICES
  • Table 2 MANUFACTURERS OF OEM MEMBRANES AND PRODUCTS
  • Table 3 MEDICAL MEMBRANE DEVICE DISTRIBUTION CHANNELS
  • Table 4 MEDICAL MEMBRANE DEVICE MANUFACTURERS AND PRODUCT SALES, 2006
  • Table 5 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1960-2015 (%)
  • Table 6 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2006 AND 2015
  • Table 7 HEALTHCARE COVERAGE IN THE U.S., 2006
  • Table 8 DEVICE REVIEW USER FEES (FY 2007)
  • Table 9 FDA PERFORMANCE GOALS UNDER THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
  • Table 9 (CONTINUED)
  • Table 10 APPROPRIATE POLYMERS FOR MEDICAL MEMBRANES
  • Table 11 MEMBRANE MANUFACTURING METHODS
  • Table 12 MEMBRANE MORPHOLOGIES AND PROPERTIES
  • Table 13 HOLLOW FIBER AND FLAT SHEET MEMBRANES AND DEVICES
  • Table 14 TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES
  • Table 15 AVERAGE PRICES FOR MEDICAL MEMBRANE DEVICES
  • Table 16 MEDICAL MEMBRANE DEVICES AND COMPETING TECHNOLOGIES
  • Table 17 PATENTS BY APPLICATION
  • Table 18 PATENTS BY COMPANY
  • Table 19 SALES AND PROJECTIONS FOR HEMODIALYZERS, THROUGH 2012 ($ MILLIONS)
  • Table 20 U.S. DIALYZER MARKET BY MEMBRANE TYPE
  • Table 21 MANUFACTURERS OF DIALYZERS AND RELATED PRODUCTS
  • Table 22 HEMODIALYZERS MARKET SHARE, 2007
  • Table 23 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, THROUGH 2012 ($ MILLIONS)
  • Table 24 MEMBRANE OXYGENATOR MANUFACTURERS AND PRODUCTS
  • Table 25 BLOOD OXYGENATORS MARKET SHARE, 2007
  • Table 26 SALES AND PROJECTIONS FOR IV FILTERS, THROUGH 2012 ($ MILLIONS)
  • Table 27 DRUGS FOR WHICH FILTRATION IS RECOMMENDED DURING ADMINISTRATION
  • Table 28 MANUFACTURERS OF IV FILTERS AND PRODUCTS
  • Table 29 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, THROUGH 2012 ($ MILLIONS)
  • Table 30 CONDITIONS DETECTED BY IN VITRO DIAGNOSTICS
  • Table 31 ALTERNATIVE METHODS OF IN VITRO TESTING
  • Table 32 MEMBRANE APPLICATIONS IN MOLECULAR DIAGNOSTICS
  • Table 33 MANUFACTURERS OF DIAGNOSTIC DEVICES AND PRODUCTS
  • Table 34 DIAGNOSTIC DEVICES MARKET SHARE, 2007
  • Table 35 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, THROUGH 2012 ($ MILLIONS)
  • Table 36 THERAPEUTIC APHERESIS OUTCOMES AND GUIDELINES
  • Table 37 COMPARISONS OF BLOOD FRACTIONATION TECHNOLOGY
  • Table 38 THERAPEUTIC APHERESIS DEVELOPMENTS
  • Table 39 POTENTIAL APPLICATIONS FOR THERAPEUTIC APHERESIS
  • Table 40 MANUFACTURERS OF BLOOD MICROFILTERS AND PRODUCTS
  • Table 41 BLOOD MICROFILTERS: 2007 MARKET SHARE
  • Table 42 PATENT SURVEY
• LIST OF FIGURES
  • Summary Figure:
  • SALES AND PROJECTIONS FOR MEDICAL MEMBRANE DEVICES, 2000-2012 ($ MILLIONS)
  • Figure 1 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1960-2015 (%)
  • Figure 2 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2006 AND 2015 ($ BILLIONS)
  • Figure 3 HEALTHCARE COVERAGE IN THE U.S., 2006
  • Figure 4 PATENTS BY APPLICATION (%)
  • Figure 5 PATENTS BY COMPANY (%)
  • Figure 6 SALES AND PROJECTIONS FOR HEMODIALYZERS, 2000-2012 ($ MILLIONS)
  • Figure 7 HEMODIALYZERS MARKET SHARE, 2007
  • Figure 8 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2012 ($ MILLIONS)
  • Figure 9 BLOOD OXYGENATORS MARKET SHARE, 2007 (%)
  • Figure 10 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2012 ($ MILLIONS)
  • Figure 11 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES, 2000-2012 ($ MILLIONS)
  • Figure 12 DIAGNOSTIC DEVICES MARKET SHARE, 2007 (%)
  • Figure 13 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, 2000-2012 ($ MILLIONS)