Medical Membrane Devices: Markets and Technologies

• Publication date: July 2009

REPORT HIGHLIGHTS - The medical membrane device market, which includes dialyzers, blood oxygenators, IV filters and blood/apheresis filters, is valued at nearly $2 billion in 2009 and is expected to increase at a compound annual growth rate (CAGR) of 4.6% through 2014 - Sales of dialyzers and blood oxygenators and IV filters are primarily market-driven, while sales of blood/apheresis filters and diagnostic devices are principally...

REPORT HIGHLIGHTS

- The medical membrane device market, which includes dialyzers, blood oxygenators, IV filters and blood/apheresis filters, is valued at nearly $2 billion in 2009 and is expected to increase at a compound annual growth rate (CAGR) of 4.6% through 2014
- Sales of dialyzers and blood oxygenators and IV filters are primarily market-driven, while sales of blood/apheresis filters and diagnostic devices are principally technology-driven
- Sales of diagnostic devices continue to skyrocket. Applauded by managed care, a growing number of point-of-care (POC) and home tests are available for a host of new and existing applications.


STUDY GOAL AND OBJECTIVES

This 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.

Medical Devices Industry in the United States

CHAPTER ONE: INTRODUCTION




STUDY GOAL AND OBJECTIVES
REASONS FOR DOING THIS STUDY
INTENDED AUDIENCE
SCOPE OF REPORT
INFORMATION SOURCES
ANALYSTS CREDENTIALS
RELATED BCC PUBLICATIONS
BCC ONLINE SERVICES
DISCLAIMER




CHAPTER TWO: SUMMARY




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




CHAPTER THREE: OVERVIEW




TABLE 1 MEDICAL MEMBRANE DEVICES




CHAPTER FOUR: INDUSTRY STRUCTURE




MEMBRANE AND DEVICE MANUFACTURERS
OEM MANUFACTURER
OEM Membranes

TABLE 2 MANUFACTURERS OF OEM MEMBRANES AND PRODUCTS
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 DISTRIBUTION CHANNELS FOR MEDICAL MEMBRANE DEVICES
TABLE 3 (CONTINUED)

CUSTOMERS
Healthcare Customers
Downstream Manufacturing Customers
Distributors or Partnership-type Customers
Home Users
INDUSTRY TRENDS
INDUSTRY PARTICIPANTS

TABLE 4 MEDICAL MEMBRANE DEVICE MANUFACTURERS, PRODUCT TYPES, SALES, 2008 ($ MILLIONS)
TABLE 4 (CONTINUED)

COMPANY PROFILES
3M
ABBOTT LABORATORIES
AETHLON MEDICAL
ASAHI KASEI KURARAY MEDICAL CO
BAXTER INTERNATIONAL
BECTON, DICKINSON & CO
B.BRAUN MEDICAL INC
CANTEL MEDICAL
CHF SOLUTIONS, INC
ENZO BIOCHEM
EPS, INC
ESCO TECHNOLOGIES
FENWAL, INC.
FRESENIUS GROUP
Fresenius Group (Continued)
GAMBRO AB
GENBIO
GENERAL ELECTRIC CO
W.L.GORE & ASSOCIATES
GVS GROUP
F. HOFFMAN-LA ROCHE
IMMUNETICS, INC.
INVERNESS MEDICAL INNOVATIONS, INC
JOHNSON & JOHNSON
KANEKA CORP.
MEDOS MEDIZINTECHNIK
MEDTRONIC
MILLIPORE CORP.
NOVOSCI
NXSTAGE MEDICAL
PALL CORP
QUIDEL CORP.
RESPONSE BIOMEDICAL
SARTORIUS AG
SERIM RESEARCH CORP.
SIEMENS HEALTHCARE DIAGNOSTICS INC
SORIN GROUP
SPECTRAL DIAGNOSTICS, INC
TERUMO CORP
THERMO FISHER SCIENTIFIC
TORAY INDUSTRIES, INC.
TRANSVIVO
VARIAN, INC.
TRENDS IN DEVICE MANUFACTURE
MARKET BARRIERS
REGULATION OF THE MEDICAL DEVICE INDUSTRY
Legal Liability
HEALTHCARE SYSTEM CONSIDERATIONS

TABLE 5 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1950-2016 (% OF GNP)
FIGURE 1 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS NATIONAL PRODUCT, 1950-2016 (%)

WHERE THE MONEY GOES

TABLE 6 NATIONAL HEALTH EXPENDITURES BY TYPE, 2009 AND 2014 ($ BILLIONS, %)
FIGURE 2 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2009 AND 2014 ($ BILLIONS)

WHY COSTS ARE RISING
ACCESS TO CARE

TABLE 7 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%)
FIGURE 3 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%)

MANAGED CARE
Capitation-type Reimbursement
Consolidation and Commercialization
HOW MANAGED CARE AFFECTS THE MEDICAL DEVICE MARKET
VERTICAL INTEGRATION OF PRODUCT AND CARE MARKETS
Vertical Integration of Product and … (Continued)
RECENT LEGISLATION
MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002
MEDICARE MODERNIZATION ACT OF 2003
Medicare Modernization Act … (Continued)




CHAPTER FIVE: MEDICAL MEMBRANE DEVICE TECHNOLOGY




MEMBRANE MANUFACTURING
POLYMERS

TABLE 8 APPROPRIATE POLYMERS FOR MEDICAL MEMBRANES

Medical Use Criteria for Polymers
MANUFACTURING TECHNIQUES

TABLE 9 MEMBRANE MANUFACTURING METHODS
TABLE 9 (CONTINUED)

MEMBRANE STRUCTURES

TABLE 10 MEMBRANE MORPHOLOGIES AND PROPERTIES

MEMBRANE GEOMETRIES

TABLE 11 HOLLOW FIBER AND FLAT SHEET MEMBRANES AND DEVICES

Membrane Geometries (Continued)
TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES

TABLE 12 TECHNICAL PARAMETERS OF MEDICAL MEMBRANE DEVICES

DEVICE MANUFACTURING
DEVICE MANUFACTURING (CONTINUED)
PRICING

TABLE 13 AVERAGE PRICES FOR MEDICAL MEMBRANE DEVICES ($)

COMPETITIVE TECHNOLOGIES

TABLE 14 MEDICAL MEMBRANE DEVICES AND COMPETING TECHNOLOGIES




CHAPTER SIX: PATENT SURVEY




BY APPLICATION

TABLE 15 PATENTS BY APPLICATION, NUMBER, AND PERCENTAGE
FIGURE 4 PATENTS BY APPLICATION (%)

BY COMPANY
BY COMPANY (CONTINUED)

TABLE 16 PATENTS, BY COMPANY, NUMBER, AND PERCENTAGE
FIGURE 5 PATENTS BY COMPANY (%)




CHAPTER SEVEN: HEMODIALYZERS




MARKET SIZE AND GROWTH
MARKET SIZE AND GROWTH (CONTINUED)
MARKET SIZE AND GROWTH (CONTINUED)

TABLE 17 SALES AND PROJECTIONS FOR HEMODIALYZERS, THROUGH 2014 ($ MILLIONS)
FIGURE 6 SALES AND PROJECTIONS FOR HEMODIALYZERS, 2000-2014 ($ MILLIONS)

HISTORY
OVERVIEW
DIALYZERS
DIALYZER SPECIFICATIONS

TABLE 18 PRIMARY DIALYZER TYPES AND REPRESENTATIVE PRODUCTS

MODES OF HEMODIALYSIS
MEASURING DIALYZER PERFORMANCE
DIALYZER REUSE
Reuse vs. Single-Use
COMPETITIVE TECHNOLOGIES
COMPANIES ACTIVE IN THE DIALYZER INDUSTRY
MARKET SHARE, HEMODIALYZERS

TABLE 19 MARKET SHARE, HEMODIALYZERS, 2009 (%)
FIGURE 7 MARKET SHARE, HEMODIALYZERS, 2009 (%)




CHAPTER EIGHT: BLOOD OXYGENATORS




MARKET SIZE AND GROWTH
MARKET SIZE AND GROWTH (CONTINUED)

TABLE 20 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2014 ($ MILLIONS)
FIGURE 8 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS, 2000-2014 ($ MILLIONS)

HISTORY
OVERVIEW
BLOOD OXYGENATORS
OXYGENATOR SPECIFICATIONS
COMPETITIVE TECHNOLOGIES
COMPANIES ACTIVE IN THE BLOOD OXYGENATOR MARKET

TABLE 21 MEMBRANE OXYGENATOR MANUFACTURERS AND PRODUCTS

MARKET SHARE, BLOOD OXYGENATORS

TABLE 22 MARKET SHARE: BLOOD OXYGENATORS, 2009 (%)
FIGURE 9 MARKET SHARE, BLOOD OXYGENATORS, 2009 (%)




CHAPTER NINE: IV FILTERS




MARKET SIZE AND GROWTH
MARKET SIZE AND GROWTH (CONTINUED)

TABLE 23 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2014 ($ MILLIONS)
FIGURE 10 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2014 ($ MILLIONS)

HISTORY
OVERVIEW
ENDOTOXIN REMOVAL
NUTRIENT ADMIXTURE FILTRATION
IN-LINE BLOOD COMPONENT FILTRATION
EMULSION DRUGS

TABLE 24 DRUGS FOR WHICH FILTRATION IS RECOMMENDED DURING ADMINISTRATION (MICRON)

INFANT IV THERAPY
COMPANIES ACTIVE IN THE IV FILTER MARKET

TABLE 25 MANUFACTURERS OF IV FILTERS AND PRODUCTS

MARKET SHARE, IV FILTERS




CHAPTER TEN: DIAGNOSTIC DEVICES




MARKET SIZE AND GROWTH
MARKET SIZE AND GROWTH (CONTINUED)

TABLE 26 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

TABLE 27 CONDITIONS DETECTED WITH IN VITRO DIAGNOSTICS
TABLE 27 (CONTINUED)

HOME TESTING
TYPES OF ASSAYS
Challenges in Assay Design
TECHNOLOGY
AUTOMATION
NON-INVASIVE SAMPLING
COMPETITIVE TECHNOLOGIES

TABLE 28 ALTERNATIVE METHODS OF IN VITRO TESTING
TABLE 29 MEMBRANE APPLICATIONS IN MOLECULAR DIAGNOSTICS

COMPANIES ACTIVE IN THE DIAGNOSTIC DEVICE MARKET

TABLE 30 MANUFACTURERS OF DIAGNOSTIC DEVICES AND PRODUCT TYPES

MARKET SHARE, DIAGNOSTIC DEVICES

TABLE 31 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%)
FIGURE 12 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%)




CHAPTER ELEVEN: BLOOD MICROFILTERS




MARKET SIZE AND GROWTH

TABLE 32 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, THROUGH 2014 ($ MILLIONS)
FIGURE 13 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS, 2000-2014 ($ MILLIONS)

HISTORY
OVERVIEW
OVERVIEW (CONTINUED)

TABLE 33 THERAPEUTIC APHERESIS OUTCOMES AND GUIDELINES
TABLE 33 (CONTINUED)

TECHNOLOGY

TABLE 34 COMPARISON OF BLOOD FRACTIONATION TECHNOLOGY
TABLE 34 (CONTINUED)

TRENDS AND TECHNICAL DEVELOPMENTS

TABLE 35 DEVELOPMENTS IN THERAPEUTIC APHERESIS
TABLE 36 POTENTIAL APPLICATIONS OF THERAPEUTIC APHERESIS
TABLE 36 (CONTINUED)

COMPANIES ACTIVE IN THE BLOOD MICROFILTER MARKET

TABLE 37 MAJOR MANUFACTURERS OF BLOOD MICROFILTERS AND PRODUCTS

MARKET SHARE OF BLOOD MICROFILTERS

TABLE 38 MARKET SHARE, BLOOD MICROFILTERS, 2009 (%)




CHAPTER TWELVE: THE MEDICAL MEMBRANE DEVICE MARKET ABROAD




THE MEDICAL MEMBRANE DEVICE MARKET ABROAD
THE MEDICAL MEMBRANE DEVICE … (CONTINUED)
APPENDIX: PATENT SURVEY

TABLE 39 PATENT SURVEY, APRIL 8, 2004 TO APRIL 7, 2009
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)
TABLE 39 (CONTINUED)




LIST OF TABLES




SUMMARY TABLE SALES AND PROJECTIONS FOR MEDICAL
MEMBRANE DEVICES, THROUGH 2014 ($ MILLIONS)
TABLE 1 MEDICAL MEMBRANE DEVICES
TABLE 2 MANUFACTURERS OF OEM MEMBRANES AND PRODUCTS
TABLE 3 DISTRIBUTION CHANNELS FOR MEDICAL MEMBRANE
DEVICES
TABLE 4 MEDICAL MEMBRANE DEVICE MANUFACTURERS,
PRODUCT TYPES, SALES, 2008 ($ MILLIONS)
TABLE 5 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS
NATIONAL PRODUCT, 1950-2016 (% OF GNP)
TABLE 6 NATIONAL HEALTH EXPENDITURES BY TYPE, 2009 AND
2014 ($ BILLIONS, %)
TABLE 7 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%)
TABLE 8 APPROPRIATE POLYMERS FOR MEDICAL MEMBRANES
TABLE 9 MEMBRANE MANUFACTURING METHODS
TABLE 10 MEMBRANE MORPHOLOGIES AND PROPERTIES
TABLE 11 HOLLOW FIBER AND FLAT SHEET MEMBRANES AND
DEVICES
TABLE 12 TECHNICAL PARAMETERS OF MEDICAL MEMBRANE
DEVICES
TABLE 13 AVERAGE PRICES FOR MEDICAL MEMBRANE DEVICES ($)
TABLE 14 MEDICAL MEMBRANE DEVICES AND COMPETING
TECHNOLOGIES
TABLE 15 PATENTS BY APPLICATION, NUMBER, AND PERCENTAGE
TABLE 16 PATENTS, BY COMPANY, NUMBER, AND PERCENTAGE
TABLE 17 SALES AND PROJECTIONS FOR HEMODIALYZERS,
THROUGH 2014 ($ MILLIONS)
TABLE 18 PRIMARY DIALYZER TYPES AND REPRESENTATIVE
PRODUCTS
TABLE 19 MARKET SHARE, HEMODIALYZERS, 2009 (%)
TABLE 20 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS,
THROUGH 2014 ($ MILLIONS)
TABLE 21 MEMBRANE OXYGENATOR MANUFACTURERS AND
PRODUCTS
TABLE 22 MARKET SHARE: BLOOD OXYGENATORS, 2009 (%)
TABLE 23 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2014 ($
MILLIONS)
TABLE 24 DRUGS FOR WHICH FILTRATION IS RECOMMENDED
DURING ADMINISTRATION (MICRON)
TABLE 25 MANUFACTURERS OF IV FILTERS AND PRODUCTS
TABLE 26 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES,
THROUGH 2012 ($ MILLIONS)
TABLE 27 CONDITIONS DETECTED WITH IN VITRO DIAGNOSTICS
TABLE 28 ALTERNATIVE METHODS OF IN VITRO TESTING
TABLE 29 MEMBRANE APPLICATIONS IN MOLECULAR
DIAGNOSTICS
MEMBRANE APPLICATIONS IN MOLECULAR DIAGNOSTICS
TABLE 30 MANUFACTURERS OF DIAGNOSTIC DEVICES AND
PRODUCT TYPES
TABLE 31 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%)
TABLE 32 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS,
THROUGH 2014 ($ MILLIONS)
TABLE 33 THERAPEUTIC APHERESIS OUTCOMES AND GUIDELINES
TABLE 34 COMPARISON OF BLOOD FRACTIONATION
TECHNOLOGY
TABLE 35 DEVELOPMENTS IN THERAPEUTIC APHERESIS
TABLE 36 POTENTIAL APPLICATIONS OF THERAPEUTIC APHERESIS
TABLE 37 MAJOR MANUFACTURERS OF BLOOD MICROFILTERS AND
PRODUCTS
TABLE 38 MARKET SHARE, BLOOD MICROFILTERS, 2009 (%)
TABLE 39 PATENT SURVEY, APRIL 8, 2004 TO APRIL 7, 2009





LIST OF FIGURES





SUMMARY FIGURE SALES AND PROJECTIONS FOR MEDICAL
MEMBRANE DEVICES, 2000-2014 ($ MILLIONS)
FIGURE 1 HEALTHCARE SPENDING AS A PERCENTAGE OF GROSS
NATIONAL PRODUCT, 1960-2016 (%)
FIGURE 2 NATIONAL HEALTH EXPENDITURES BY SERVICE, 2009
AND 2014 ($ BILLIONS)
FIGURE 3 HEALTHCARE COVERAGE IN THE U.S., BY TYPE, 2008 (%)
FIGURE 4 PATENTS BY APPLICATION (%)
FIGURE 5 PATENTS BY COMPANY (%)
FIGURE 6 SALES AND PROJECTIONS FOR HEMODIALYZERS, 2000-
2014 ($ MILLIONS)
FIGURE 7 MARKET SHARE, HEMODIALYZERS, 2009 (%)
FIGURE 8 SALES AND PROJECTIONS FOR BLOOD OXYGENATORS,
2000-2014 ($ MILLIONS)
FIGURE 9 MARKET SHARE, BLOOD OXYGENATORS, 2009 (%)
FIGURE 10 SALES AND PROJECTIONS FOR IV FILTERS, 2000-2014 ($
MILLIONS)
FIGURE 11 SALES AND PROJECTIONS FOR DIAGNOSTIC DEVICES,
2000-2012 ($ MILLIONS)
FIGURE 12 MARKET SHARE: DIAGNOSTIC DEVICES, 2009 (%)
FIGURE 13 SALES AND PROJECTIONS FOR BLOOD MICROFILTERS,
2000-2014 ($ MILLIONS)