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Medical Membrane Devices: Markets and Technologies

Medical Membrane Devices: Markets and Technologies

Global revenue for medical membrane devices was valued at $25.2 billion in 2013 and $25.6 billion in 2014. The total market is projected to grow at a compound annual growth rate (CAGR) of 2.3% from 2015 through 2020; reach $26.3 billion by 2015 and $29.4 billion by 2020.

This report provides:

An overview of the global markets and technologies for medical membrane devices.

Analyses of global market trends, with data from 2013 and 2014, estimates for 2015, and projections of CAGRs through 2020.

Analysis of the relevant technical and economic drivers for the medical membrane device market by technology type.

Information on the impact of device applications and trends, pricing considerations, research and development (R&D), and environmental influences.

Evaluation of the industry structure.

Analysis of the market's dynamics, specifically growth drivers, inhibitors, and opportunities.

A frame for membrane components of each sector in context with the market dynamics of the overall technology.

Profiles of major companies in the field along with a competitive technology analysis.


SCOPE OF THE STUDY

The scope of this report encompasses key market analysis, market drivers, market constraints and also competitive developments and trends in the market. BCC Research analyzes each market and its applications, regulatory environment, technology, market projections and market shares. This report involves the medical membrane devices used in the medical device industry. This report mainly deals with the medical membrane devices market covering the total market, which includes hemodialyzers, membrane oxygenators, intravenous infusion (IV) infusion filters, blood microfilters/apheresis system and membrane diagnostic devices. The report also covers the use of medical membrane devices for cardiopulmonary treatments, renal diseases, parenteral administration and home care diagnosis. It also covers details about healthcare spending and the U.S. healthcare system.

Excluded from this report are membranes employed in other facets of medicine. These applications and devices include hollow fiber bioreactors employed in the production of monoclonal antibodies, recombinant proteins and drugs, nonseparating membranes used in drug-delivery systems, tissue scaffolding and synthetic skin. In addition, experimental artificial organs (liver, pancreas, implanted lung); apheresis filtration for stem cell recovery, virus filters and other cross-flow filters used in the production of pharmaceuticals; and blotting membranes (excluding their application in diagnostics) will not be considered in this report.

Complete geographical analysis of market is also provided. The emerging market for medical membrane devices includes India, China, Japan, Korea, Taiwan, Canada, Africa, Australia, New Zealand, etc. Profiles of key market players are also included in this report.

Technological issues discussed include latest trends, pipeline products and developments. The key market players include Baxter International, Fresenius Medical Care, NxStage Medical, B. Braun Medical, Toray Industries, Terumo Corp., Medtronic, Sorin Group and diagnostic companies like Abbott, Alere, Quidel, Response Biomedical, Roche, Siemens and several others.

CHAPTER 1 INTRODUCTION
STUDY OBJECTIVES
REASONS FOR DOING THIS STUDY
CONTRIBUTIONS OF THE STUDY AND FOR WHOM
SCOPE OF THE STUDY
METHODOLOGY
INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 EXECUTIVE SUMMARY
SUMMARY TABLE GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES, BY REGION, THROUGH 2020 ($ MILLIONS)
SUMMARY FIGURE GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES BY REGION, 2013-2020 ($ MILLIONS)
CHAPTER 3 OVERVIEW
DEFINITIONS
MEDICAL MEMBRANE DEVICES
HISTORY OF MEDICAL MEMBRANE DEVICES
TABLE 1 EVOLUTION OF MEDICAL MEMBRANE DEVICES
TYPES OF MEDICAL MEMBRANE DEVICES
Hemodialyzers
Dialyzer Specifications
Modes of Hemodialysis
Reusability of Dialyzers
Advantages and Disadvantages of Reusing Dialyzers
TABLE 2 ADVANTAGES AND DISADVANTAGES OF REUSING
DIALYZERS
Membrane Oxygenators
Types of Membrane Oxygenators
Plaque Oxygenator
Spiral Oxygenator
Hollow Fiber Oxygenator
Blood flow circulation
Gas flow circulation
Intravenous Infusion Filters (IV Filters)
Application of IV filters
IV filters for Parenteral Nutrition
IV Filters for Emulsion Drugs
IV Therapy for Infants
Membrane Diagnostic Devices
Traditional Testing or Clinical Diagnosis
Point-of-Care Testing
Advantages of Point-of-Care Testing
Application of Membranes in Diagnostic Devices
Membranes Configuration in Diagnostic Devices
Blood Microfilters/Apheresis Systems
Therapeutic Apheresis
Membrane Configuration in Blood Microfilters
MEDICAL MEMBRANE MANUFACTURING
Manufacturing Techniques
Hollow Fiber Membranes
Melt Spinning
Dry Spinning
Immersion (wet) Spinning
Flat Sheet Membranes
Immersion (wet) Casting
Air (dry) Casting
Melt (TIPS) Casting
TABLE 3 MEMBRANE TYPES AND CORRESPONDING DEVICES
GLOBAL MANUFACTURERS OF OEM (ORIGINAL EQUIPMENT MANUFACTURER) MEMBRANES AND PRODUCTS
TABLE 4 GLOBAL MANUFACTURERS OF OEM (ORIGINAL EQUIPMENT MANUFACTURER) MEMBRANES AND PRODUCTS
CHAPTER 4 REGULATORY ASPECTS
GENERAL CONTROLS
SPECIAL CONTROLS
PREMARKET APPROVAL
TABLE 5 PREMARKET APPROVALS OF MEDICAL MEMBRANE DEVICES, 2010 - FEBRUARY 2015
NEW APPROVALS OF MEDICAL MEMBRANE DEVICES BY 510(K) CLEARANCES NEW APPROVALS OF HEMODIALYZERS
TABLE 6 NEW APPROVALS OF HEMODIALYZERS BY 510 (K) CLEARANCES, 2010 - FEBRUARY 2015
NEW APPROVALS OF MEMBRANE OXYGENATORS
TABLE 7 NEW APPROVALS OF MEMBRANE OXYGENATORS BY 510 (K) CLEARANCES, 2010 - FEBRUARY 2015
NEW APPROVALS OF INTRAVENOUS INFUSION (IV) FILTERS/ SETS
TABLE 8 NEW APPROVALS OF INTRAVENOUS INFUSION FILTERS/ SETS BY 510 (K) CLEARANCES, 2010 - FEBRUARY 2015
NEW APPROVALS OF BLOOD MICROFILTERS/ APHERESIS SYSTEMS
TABLE 9 NEW APPROVALS OF BLOOD MICROFILTERS/APHERESIS SYSTEM BY 510 (K) CLEARANCES, 2010 - FEBRUARY 2015
NEW APPROVALS OF MEMBRANE DIAGNOSTIC DEVICES
TABLE 10 NEW APPROVALS OF MEMBRANE DIAGNOSTIC DEVICES BY 510 (K) CLEARANCES, 2010 - FEBRUARY 2015
RECALLS
TABLE 11 RECALLS OF MEDICAL MEMBRANE DEVICES, 2010 - FEBRUARY 2015
SAFETY ALERTS
TABLE 12 SAFETY ALERT FOR MEDICAL MEMBRANE DEVICES, 2010 - FEBRUARY 2015
CHAPTER 5 NEW DEVELOPMENTS
NEW PRODUCT LAUNCHES
TABLE 13 NEW PRODUCT LAUNCHES IN MEDICAL MEMBRANE DEVICES FOR TOP MANUFACTURERS, 2010 - FEBRUARY 2015
NEW AND COMPETITIVE TECHNOLOGIES
PERITONEAL DIALYSIS
Continuous Ambulatory Peritoneal Dialysis
Automated Peritoneal Dialysis
KIDNEY TRANSPLANTATION
MINIMALLY INVASIVE CARDIAC SURGERIES
DNA ARRAYS
POLYMERASE CHAIN REACTION (PCR)
GENE PROBE
CENTRIFUGAL PLASMAPHERESIS
MERGERS AND ACQUISITIONS
TABLE 14 MERGERS AND ACQUISITIONS OF TOP MEDICAL MEMBRANE
DEVICE COMPANIES, 2010 - TO DATE
CHAPTER 6 GLOBAL MARKET ANALYSIS
MARKET BY TYPE
MARKET OVERVIEW
MARKET REVENUE
TABLE 15 GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES BY TYPE, THROUGH 2020 ($ MILLIONS)
FIGURE 1 GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES BY TYPE, 2013-2020 ($ MILLIONS)
MARKET SHARE
TABLE 16 GLOBAL MARKET SHARE OF MEDICAL MEMBRANE DEVICES BY TYPE, 2014 (%)
FIGURE 2 GLOBAL MARKET SHARE OF MEDICAL MEMBRANE DEVICES BY TYPE, 2014 (%)
MARKET BY REGION
MARKET OVERVIEW
MARKET REVENUE
TABLE 17 GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 3 GLOBAL REVENUE FOR MEDICAL MEMBRANE DEVICES BY REGION, 2013-2020 ($ MILLIONS)
MARKET SHARE
TABLE 18 GLOBAL MARKET SHARE OF MEDICAL MEMBRANE DEVICES BY REGION, 2014 (%)
FIGURE 4 GLOBAL MARKET SHARE OF MEDICAL MEMBRANE DEVICES BY REGION, 2014 (%)
HEMODIALYZERS
MARKET OVERVIEW
MARKET REVENUE
TABLE 19 GLOBAL REVENUE FOR HEMODIALYZERS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 5 GLOBAL REVENUE FOR HEMODIALYZERS BY REGION, 2013-2020 ($ MILLIONS)
MEMBRANE OXYGENATORS
MARKET OVERVIEW
MARKET REVENUE
TABLE 20 GLOBAL REVENUE FOR MEMBRANE OXYGENATORS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 6 GLOBAL REVENUE FOR MEMBRANE OXYGENATORS BY REGION, 2013-2020 ($ MILLIONS)
INTRAVENOUS INFUSION (IV) FILTERS
MARKET OVERVIEW
MARKET REVENUE
TABLE 21 GLOBAL REVENUE FOR INTRAVENOUS INFUSION (IV) FILTERS BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 7 GLOBAL REVENUE FOR INTRAVENOUS INFUSION (IV) FILTERS BY REGION, 2013-2020 ($ MILLIONS)
BLOOD MICROFILTERS/APHERESIS SYSTEMS
MARKET OVERVIEW
MARKET REVENUE
TABLE 22 GLOBAL REVENUE FOR BLOOD MICROFILTERS/ APHERESIS SYSTEM BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 8 GLOBAL REVENUE FOR MICROFILTERS/APHERESIS SYSTEM BY REGION, 2013-2020 ($ MILLIONS)
MEMBRANE DIAGNOSTIC DEVICES
MARKET OVERVIEW
MARKET REVENUE
TABLE 23 GLOBAL REVENUE FOR MEMBRANE DIAGNOSTIC DEVICES BY REGION, THROUGH 2020 ($ MILLIONS)
FIGURE 9 GLOBAL REVENUE FOR MEMBRANE DIAGNOSTIC DEVICES BY REGION, 2013-2020 ($ MILLIONS)
CHAPTER 7 INDUSTRY STRUCTURE
HEMODIALYZERS
MARKET LEADERS
TABLE 24 LEADING MANUFACTURERS/ SUPPLIERS OF HEMODIALYZERS, 2014
MARKET SHARE
TABLE 25 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF HEMODIALYZERS, 2014 (%)
FIGURE 10 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF HEMODIALYZERS, 2014 (%)
MEMBRANE OXYGENATORS
MARKET LEADERS
TABLE 26 LEADING MANUFACTURERS/SUPPLIERS OF MEMBRANE OXYGENATORS, 2014
MARKET SHARE
TABLE 27 GLOBAL MARKET SHARE OF THE MANUFACTURERS/ SUPPLIERS OF MEMBRANE OXYGENATORS, 2014 (%)
FIGURE 11 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF MEMBRANE OXYGENATORS, 2014 (%)
INTRAVENOUS INFUSION (IV) FILTERS
MARKET LEADERS
TABLE 28 LEADING MANUFACTURERS/ SUPPLIERS OF INTRAVENOUS INFUSION (IV) FILTERS, 2014
MARKET SHARE
TABLE 29 GLOBAL MARKET SHARE OF THE MANUFACTURERS/ SUPPLIERS OF INTRAVENOUS INFUSION (IV) FILTERS, 2014 (%)
FIGURE 12 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF INTRAVENOUS INFUSION (IV) FILTERS, 2014 (%)
BLOOD MICROFILTERS/APHERESIS SYSTEMS
MARKET LEADERS
TABLE 30 LEADING MANUFACTURERS/ SUPPLIERS OF BLOOD MICROFILTERS/APHERESIS SYSTEMS, 2014
MARKET SHARE
TABLE 31 GLOBAL MARKET SHARE OF THE MANUFACTURERS/ SUPPLIERS OF BLOOD MICROFILTERS/APHERESIS SYSTEMS, 2014 (%)
FIGURE 13 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF BLOOD MICROFILTERS/APHERESIS SYSTEM, 2014(%)
MEMBRANE DIAGNOSTIC DEVICES
MARKET LEADERS
TABLE 32 LEADING MANUFACTURERS/SUPPLIERS OF MEMBRANE DIAGNOSTIC DEVICES, 2014
MARKET SHARE
TABLE 33 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS
OF MEMBRANE DIAGNOSTIC DEVICES, 2014 (%)
FIGURE 14 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS OF MEMBRANE DIAGNOSTIC DEVICES, 2014 (%)
CHAPTER 8 PATENT ANALYSIS
PATENTS BY YEAR
TABLE 34 NUMBER OF PATENTS BY YEAR, 2010-2015 (FEBRUARY)
FIGURE 15 NUMBER OF PATENTS BY YEAR, 2010-2015 (FEBRUARY)
TABLE 35 PATENT SHARE BY YEAR, 2010-2015 (FEBRUARY) (%)
FIGURE 16 PATENT SHARE BY YEAR, 2010-2015 (FEBRUARY) (%)
PATENTS BY TYPE
TABLE 36 NUMBER OF PATENTS BY TYPE, 2010-2015 (FEBRUARY)
FIGURE 17 NUMBER OF PATENTS BY TYPE, 2010-2015 (FEBRUARY)
PATENTS BY COMPANY
TABLE 37 NUMBER OF PATENTS BY COMPANY, 2010-2015 (FEBRUARY)
PATENTS BY COUNTRY
TABLE 38 NUMBER OF PATENTS BY COUNTRY, 2010-2015 (FEBRUARY)
FIGURE 18 NUMBER OF PATENTS BY COUNTRY, 2010-2015 (FEBRUARY)
TABLE 39 PATENT SHARES BY COUNTRY, 2010-2015 (FEBRUARY)
(NUMBER/%)
FIGURE 19 PATENT SHARES BY COUNTRY, 2010-2015 (FEBRUARY) (%)
PATENTS BY ASSIGNEE
TABLE 40 NUMBER OF PATENTS BY ASSIGNEE, 2010-2015 (FEBRUARY)
FIGURE 20 NUMBER OF PATENTS BY ASSIGNEE, 2010-2015 (FEBRUARY)
CHAPTER 9 CURRENT STATUS - HEALTHCARE AND KEY
CONSIDERATIONS
FACTORS AFFECTING MEDICAL MEMBRANE DEVICES
DRIVERS OF MEDICAL MEMBRANE DEVICES
Increased Medical Care
New Product Launches
Economic Growth
Market Expansion
Increase in Range of Customers
Shifting of Traditional Business Models
Vertical Integration
RESTRAINTS AND CHALLENGES OF THE MARKET
New and Competitive Technologies
Rising Cost Pressure and Reimbursement Policies
Regulatory Pressures
MARKET OPPORTUNITIES
HEALTHCARE SYSTEM CONSIDERATIONS
BREAKDOWN OF HEALTHCARE SPENDING
Hospital Care
Physicians and Clinical Services
Prescription Drugs
Other Spending
TABLE 41 NATIONAL HEALTH EXPENDITURES BY TYPE, 2013 AND 2020 ($ BILLIONS, %)
FIGURE 21 NATIONAL HEALTH EXPENDITURES BY TYPE, 2013 AND 2020 ($ BILLIONS)
REASONS FOR INCREASED HEALTHCARE COSTS
HEALTHCARE COVERAGE IN THE U.S.
TABLE 42 HEALTHCARE COVERAGE IN THE U.S. BY TYPE, 2014 (%)
FIGURE 22 HEALTHCARE COVERAGE IN THE U.S. BY TYPE, 2014 (%)
MANAGED CARE
Health Maintenance Organization
Preferred Provider Organization (PPO)
Point-of-Service Plan
PAYMENT OPTIONS
Global Capitation
Simply Capitated Payment
MANAGED CARE AND THE MEDICAL DEVICE MARKET
RECENT LEGISLATION
Medical Device User Fee and Modernization of Act of 2002
The Patient Protection and Affordable Care Act
EFFECTS OF AFFORDABLE CARE ACT ON MEDICAL DEVICE
MANUFACTURERS
CHAPTER 10 COMPANY PROFILES
3M
ABBOTT LABORATORIES
AETHLON MEDICAL
ALERE
ASAHI KASEI KURARAY MEDICAL CO.
BAXTER INTERNATIONAL INC.
B. BRAUN MEDICAL INC.
BECTON, DICKINSON AND CO.
CANTEL MEDICAL
ENZO BIOCHEM
EPS INC./MEDI-DOSE
FENWAL INC.
FILTERTEK INC.
FRESENIUS GROUP
GAMBRO AB
GENBIO
GENERAL ELECTRIC CO.
W.L. GORE & ASSOCIATES
F. HOFFMAN-LA ROCHE
IMMUNETICS INC.
JOHNSON & JOHNSON
KANEKA CORP.
KIMBERLY-CLARK
MEDOS MEDIZINTECHNIK
MEDTRONIC PLC
EMD MILLIPORE
NOVOSCI
NXSTAGE MEDICAL
PALL CORP.
QUIDEL CORP.
RESPONSE BIOMEDICAL
SARTORIUS STEDIM BIOTECH
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SORIN GROUP
SPECTRAL MEDICAL INC.
TERUMO MEDICAL CORP.
THERMO FISHER SCIENTIFIC INC.
TORAY INDUSTRIES INC.
CHAPTER 11 ABBREVIATIONS

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