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Artificial Organs

Abstract

This report analyzes the worldwide markets for Artificial Organs in US$ Million by the following Product Segments: Artificial Heart, Artificial Kidneys, Artificial Liver, Artificial Pancreas, and Artificial Lungs. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 56 companies including many key and niche players such as Abbott Diabetes Care, Abiomed Inc., Asahi Kasei Kuraray Medical Co., Ltd., Baxter International, Inc., F. Hoffmann-La Roche Ltd., Fresenius Medical Care AG & Co. KGaA, Fresenius Medical Care North America, Inc., Fresenius Kawasumi, Gambro AB, HeartWare International, Inc., HepaLife Technologies, Inc., Alliqua, Inc., Jarvik Heart, Inc., MC3, Inc., Medtronic, Inc., MicroMed Cardiovascular, Inc., Nikkiso Co., Ltd., Nipro Corporation, SynCardia Systems, Inc., Terumo Corporation, Thoratec Corporation, Toray Medical Co., Ltd., Vital Therapies, Inc., and WorldHeart Corp. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

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Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study
    • Artificial Organs
      • Artificial Heart
      • Artificial Kidneys
      • Artificial Liver
      • Artificial Pancreas
      • Artificial Lungs

    II. EXECUTIVE SUMMARY

    1. INDUSTRY OVERVIEW

    • Artificial Organs Revolutionize Medical Technology Industry
    • Market Outlook
    • Opportunities Abound for Bioartificial Organs
    • Bionics to Play Crucial Role
    • Economic Situation Plays a Pivotal Role in ESRD Treatment Accessibility
      • Table 1: Number of Dialysis Patients by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America and Rest of World for the Year 2006 (includes corresponding Graph/Chart)
    • Growth Drivers
    • Growth Inhibitors

    2. MARKET TRENDS AND ISSUES

    • Higher Development Costs and Lengthy Regulatory Process - Stumbling Blocks for Product Commercialization
    • Lack of Requisite Expertise - Hindering Implantation Process
    • Alliances to Play a Key Role
    • Aging Population - A Boosting Factor
    • Anemia - A Growing Concern among Renal Failure Patients
    • Swelling ESRD Patient Population Spurs Dialyzers Growth
    • Growing Need for Efficient Control and Easy Usage
    • Expiry of Warranty Provides New Opportunities
    • Xenotransplantation - Other Alternative to Donor Organ Shortage
    • Artificial Organs from Cloned Animal Cells - A Promising Trend
    • Immunosuppressants Hold Promise in Artificial Organs Market
    • Move Towards Smaller Implantable Devices
    • Barriers to Entry Significantly High in Dialyzers Market
    • Reuse of Dialyzers - A Major Issue in Dialysis Industry
    • Poor Reimbursement Environment Stymies Innovation
    • Pricing Trends in Artificial Organs

    3. COMPETITIVE SCENARIO

    • Competition Heating Up in Artificial Pancreas Domain
    • Fresenius Medical Care - Leads the Worldwide Dialysis Equipment and Supplies Market
      • Table 2: Leading Players in the Worldwide Dialysis Equipment and Supplies Market (2011) - Percentage Breakdown of Sales for Fresenius Medical Care, Baxter, Gambro and Others (includes corresponding Graph/Chart)
      • Table 3: Leading Players in the Worldwide Hemodialysis Equipment and Supplies Market (2011) - Percentage Breakdown of Sales for Fresenius Medical Care, Gambro, Baxter and Others (includes corresponding Graph/Chart)
    • Competitive Landscape of Artificial Kidney or Dialyzers Market
      • Table 4: Leading Players in the Global Dialyzers Market (2011): Percentage Breakdown of Unit Output for Fresenius Medical Care, Gambro and Others (includes corresponding Graph/Chart)
    • Synthetic Dialyzers to Attain Mainstay
    • Asahi Kasei Medical Dominates Japanese Dialyzers Market
      • Table 5: Leading Players in the Japanese Kidney Dialyzers Market (2011) - Percentage Breakdown of Sales for Asahi Kasei, Nipro, Kawasumi, Toray and Others (includes corresponding Graph/Chart)
    • Competitive Landscape of Ventricular Assist Device
    • Select Ventricle Assist Devices
    • Thoratec - Leads the VADs Market
      • Table 6: Leading Players in the Worldwide VADs Market (2011) - Percentage Breakdown of Sales for Thoratec, Abiomed, WorldHeart and Others (includes corresponding Graph/Chart)
    • Liver Assist Devices Competitive Landscape
    • Select Liver Assist Devices
    • Core Competitive Factors

    4. PRODUCT OVERVIEW

    • Artificial Organs
    • Categorization of Artificial Organs
      • External Artificial Organs
      • Internal or Implantable Artificial Devices
    • Artificial Heart
    • Total Artificial Heart (TAH)
    • Ventricle Assist Device (VAD)
      • Table 7: Distribution of Various Uses of VADs (includes corresponding Graph/Chart)
      • Right Ventricular Assist Systems (RVAS)
      • Left Ventricular Assist Systems (LVAS)
        • Categorization of LVAS
        • First Generation LVAS
        • Second Generation LVAS
        • Third Generation LVAS
        • Benefits of LVAS
      • Major Limitations and Complications of VADs
        • Infection
        • Internal Bleeding
        • Thrombus
        • Dependability
        • Cost
      • Table 8: Average Selling Price per Unit in the Recent Years (includes corresponding Graph/Chart)
      • Table 9: Distribution of Direct Costs for Heart Failure in the US (2011) (includes corresponding Graph/Chart)
    • Natural Human Heart
    • Heart Diseases
      • Congenital Heart Disease
      • Congestive Heart Failure
    • Types of Heart Failure
      • Diastolic Heart Failure
      • Systolic Heart Failure
    • Artificial Heart - A Historical Perspective
    • Major Milestones in Artificial Heart Development
      • Jarvik-7
      • AbioCor Total Artificial Heart
        • Major Advancements in AbioCor Over Jarvik-7
      • CardioWest Temporary Total Artificial Heart
      • DuraHeart LVAS
      • HeartSaverVAD
      • VentrAssist Left Ventricular Assist Device
    • Artificial Kidney (Dialyzer)
    • Limitations of Artificial Kidney
    • Types of Dialysis
      • Hemodialysis
      • Peritoneal Dialysis
    • Advancements in Artificial Kidney Technology
    • Bioartificial Kidneys
      • Limitations of Bioartificial Kidneys
    • Hindrances to Develop Implantable Artificial Kidney
    • Artificial Kidneys - A Historical Perspective
    • Artificial Liver
    • Overdose of Drugs - A Leading Cause for Liver Damage
    • Categorization of Liver Devices
      • Mechanical Systems
        • Liver Dialysis Unit(tm)
        • Molecular Adsorbents Recirculating System
        • SEPET
      • Bio-Artificial Systems
        • Capillary Hollow Fiber Systems
        • Direct Perfusion Systems
        • Entrapment Based Systems
        • Major BAL Devices
        • Extracorporeal Liver Assist Device (ELAD)
        • Cellular Components
        • Types of Bioreactor
        • HepatAssist-2(tm) Bioartificial Liver System
        • Hybrid Artificial Liver Support System
    • History of Artificial Liver
      • Liver Assist Devices - Major Milestones
        • Nonbiological Method Introduction Time Line
        • Biological Method Introduction Time Line
    • Artificial Pancreas
    • Insulin Pumps - Historical Perspective
    • Bioartificial Pancreas
    • Nanotechnology in Artificial Pancreas
    • Medtronic's Products
      • External Artificial Pancreas
      • Implantable Artificial Pancreas
      • MiniMed Paradigm(r) REAL-Time Insulin Pump and CGM System
      • Guardian(r) RT CGM System
    • Abbott Products
      • FreeStyle Navigator CGM System
    • Smith Medical
    • CozMore Insulin Technology System
    • Artificial Lungs (Oxygenator)
    • About Human Lungs
    • Types of Artificial Lung
      • Intravenous Membrane Oxygenator
        • Hattler Respiratory Catheter
      • MC3 Pulmonary Assist Device
        • In-Series
        • In-Parallel
      • BioLung
    • Heart-Lung Bypass Machine
    • Role of Artificial Lungs during Surgery
      • Direct Contact Device
      • Indirect-Contact Type-Membrane Devices
    • Biorubber to be used in Artificial Lungs
    • History of Artificial Lungs
    • An Overview of Tissue Engineering

    5. INTRODUCTION TO BIOMATERIALS

    6. ORGAN TRANSPLANTATION

    • Sources of Donor Organs
      • Table 10: US Kidney Donations by Donor Type - Cadaveric and Living for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 11: US Liver Donations by Donor Type - Cadaveric and Living for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 12: US Heart Donations by Cadaveric Donor Type for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 13: US Lung Donations by Donor Type - Cadaveric and Living for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 14: US Pancreas Donations by Donor Type - Cadaveric and Living for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 15: US Intestine Donations by Donor Type - Cadaveric and Living for Years 2003 through 2008 (includes corresponding Graph/Chart)
    • Major Milestones in Organ Transplantation
    • Shortage of Donor Organs Restricts Transplantation Procedures
      • Table 16: Waiting List of Patients in the US by Organ Type: As of July 2010 (includes corresponding Graph/Chart)
      • Table 17: Waiting List of Active and Inactive Patients by Organ Type: 2008 (includes corresponding Graph/Chart)
    • Organ Rejection - A Major Barrier to Transplantation
    • Other Issues for Organ Transplantation
    • Combined Organ Transplantation - Gaining Attention

    7. REGULATORY ENVIRONMENT

    • Regulatory Environment in the US
    • Regulatory Environment in Europe

    8. PRODUCT INNOVATIONS/INTRODUCTIONS

    • Medtronic to Launch Paradigm Veo, An Artificial Pancreas
    • Gambro Unveils AK 96(tm) Dialyzer
    • Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets
    • University of Michigan Develops Artificial Lungs
    • USC Researchers Develop Argus II Retinal Prosthesis System for Retinal Implant
    • Researchers Develop Cell Manipulation Technique for Organ Regeneration Process
    • Terumo to Introduce First CE Mark LVAS in Europe
    • Advanced Technique for Nerve Re-Growth Developed
    • JDRF Develops Artificial Pancreas
    • Direct Attachment of Artificial Limbs Technique Developed
    • Artificial Pancreas to Generate Hope for Young Diabetics
    • Artificial Liver Developed Using Stem Cells
    • Artificial Liver Device from HepaLife
    • Researchers Develop Human Nephron Filter

    9. RECENT INDUSTRY ACTIVITY

    • HepaLife Technologies Changes Name to Alliqua
    • Fresenius Medical Care Acquires Gambro's Peritoneal Dialysis business
    • Fresenius Takes Over Xcorporeal
    • Nipro to Establish Production Site in China
    • JDRF Partners with Animas
    • Arbios Systems Files for Bankruptcy
    • HeartWare Obtains CE Mark Approval for HeartWare(r) Ventricular Assist System

    10. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER

    • Thoratec Receives FDA Approval for HeartMate II(r)
    • Asahi Kasei Institutes a Sales Subsidiary in Taiwan
    • Arbios Seeks CE Marking for SEPET(tm)
    • Gambro Teams up with Debiotech for Developing Peritoneal Dialysis Cycler
    • Arbios Obtains US FDA Approval for Initiating Clinical Trial for SEPET(tm)
    • Abiomed Obtains HDE Supplement Approval from FDA for AbioCor(r) Implantable Artificial Heart
    • Ventracor Obtains CE Marking for VentrAssist(tm) LVAD
    • Fresenius Medical Care Takes Over Renal Solutions, Inc.
    • Arbios Inks Exclusive Agreement with NxStage for SEPET(tm)
    • WorldHeart Completes First Multi-Day Animal Study of PediaFlow(tm) VAD
    • Xcorporeal Completes Merger with CT Holdings
    • Nikkiso Collaborates with Nipro for Overseas Launch of Dialysis Systems
    • Ege University to Initiate Artificial Heart Project
    • Vascutek Buys Kohler Chemie's Heart Valve Business
    • NovaThera Partners with NovaLung to Develop Advanced Artificial Lung
    • Aksys Quits Kidney Dialysis Machines Business
    • Twardowski Terminates License Agreement with Aksys
    • Asahi Kasei Medical Fortifies Competence in Artificial Kidney Production
    • Fresenius Medical Care Enhances Dialyzer Output
    • HepaLife Appoints Stem Cell Systems for Bioreactor Development
    • Hanger Orthopedic Acquires Regional Artificial Limb & Brace
    • Gambro Acquires Hemapure
    • Fresenius Medical Care Snaps Up Renal Care Group
    • CLSI Teams Up with DTS
    • Abiomed to Foray into the Indian Market
    • Asahi Kasei Medical to Double Artificial Kidney Production in China
    • Thoratec Bags FDA Approval for IDE Supplement for HeartMate II Phase II Trial under CAP
    • SynCardia Systems Obtains CE Mark to Sell EXCOR(r) TAH-t Mobile Driver with CardioWest(tm) TAH-t in Europe
    • FDA Grants Approval for Medtronic's Guardian(r) Real- Time CGM System
    • DexCom Bags FDA Approval for STS Continuous Glucose Monitoring System
    • Vital Therapies Obtains FDA Guidance to Ship ELAD to China
    • MC3 Secures Phase I STTR Grant from NHLBI to Develop Pump-Oxygenator
    • Pauley Heart Center Implants First CardioWest TAH-t on East Coast
    • LDS Hospital Team Implants WorldHeart's New Artificial Heart Device in Greece
    • Novacor LVAS Support Recipient Completes Five Years
    • SynCardia Systems to Increase CardioWest TAH-t Transplant Hospitals
    • National Quality Care Divests Dialysis Unit to Kidney Dialysis Center
    • Medtronic Gains FDA Approval for MiniMed Paradigm(r) REAL-Time System
    • MicroMed Receives CE Mark Extension for DeBakey VAD(r) System
    • Thoratec Files Data On HeartMate II LVAS for Pre-Market Approval
    • Arbios Systems Receives FDA Allowance to Expand Eligibility Criteria for SEPET(tm) Liver Assist Device
    • Abiomed's AbioCor(r) Artificial Heart Receives FDA Approval
    • Abiomed's IMPELLA 5.0 Receives Conditional IDE Approval
    • WorldHeart Makes Synergistic Purchase of MedQuest
    • Nipro Takes Over Artificial Lung Business from Dainippon Ink and Chemicals
    • Baxter Inks Pact with Gambro Renal Products
    • Xenogenics Bags Patent for Synthetic Bio-Liver Device
    • Gambro Bags FDA Approval for MARS for Drug Overdose and Poisoning
    • Einstein Medical Center Participates in Artificial Liver Support Device's Clinical Trail
    • SynCardia Announces First CardioWest TAH-t Implantation at The Cleveland Clinic
    • SynCardia Announces Implantation of CardioWest(tm) TAH-t for Destination Therapy in Germany
    • Australian Patients Receive Jarvik 2000
    • WorldHeart Bags Three Patents for Ventricular Assist Pumps
    • Asahi Kasei Medical's First APS(tm) Dialyzers Assembly Line Commences Operations
    • Arrow International Halts LionHeart LVAS

    11. FOCUS ON SELECT GLOBAL PLAYERS

    • Abbott Diabetes Care (USA)
    • Abiomed, Inc. (USA)
    • Asahi Kasei Kuraray Medical Co., Ltd (Japan)
    • Baxter International, Inc. (USA)
    • F.Hoffmann-La Roche Ltd. (Switzerland)
    • Fresenius Medical Care AG & Co. KGaA (Germany)
    • Fresenius Medical Care North America Inc (USA)
    • Fresenius Kawasumi (Japan)
    • Gambro AB (Sweden)
    • HeartWare International, Inc. (USA)
    • Alliqua, Inc. (USA) (Formerly Hepalife Technologies, Inc.)
    • Jarvik Heart, Inc. (USA)
    • MC3, Inc. (USA)
    • Medtronic, Inc. (USA)
    • MicroMed Cardiovascular, Inc. (USA)
    • Nikkiso Co., Ltd. (Japan)
    • Nipro Corporation (Japan)
    • SynCardia Systems, Inc. (USA)
    • Terumo Corp. (Japan)
    • Thoratec Corp. (USA)
    • Toray Medical Co., Ltd. (Japan)
    • Vital Therapies, Inc. (USA)
    • WorldHeart Corp. (USA)

    12. GLOBAL MARKET PERSPECTIVE

      • Table 18: World Recent Past, Current & Future Analysis for Artificial Organs by Product Segment -Artificial Heart, Artificial Kidneys, Artificial Liver, Artificial Pancreas and Artificial Lungs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)
      • Table 19: World Historic Review for Artificial Organs by Product Segment -Artificial Heart, Artificial Kidneys, Artificiasl Liver, Artificial Pancreas and Artificial Lungs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 20: World 15-Year Perspective for Artificial Organs by Product Segment - Percentage Breakdown of Dollar Sales for Artificial Heart, Artificial Kidneys, Artificial Liver, Artificial Pancreas and Artificial Lungs Markets for Years 2003, 2011 & 2017 (includes corresponding Graph/Chart)
      • Table 21: World Recent Past, Current & Future Analysis for Artificial Kidneys/Dialyzers by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Middle East and Latin American Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)
      • Table 22: World Historic Review for Artificial Kidneys/ Dialyzers by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Middle East and Latin American Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 23: World 15-Year Perspective for Artificial Kidneys/Dialyzers by Geographic Region- Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Middle East, and Latin American Markets for Years 2003, 2011 & 2017 (includes corresponding Graph/Chart)
      • Table 24: World Recent Past, Current & Future Analysis for Insulin Pumps (External) by Geographic Region - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)
      • Table 25: World Historic Review for Insulin Pumps (External) by Geographic Region - US, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)
      • Table 26: World 15-Year Perspective for Insulin Pumps External) by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for Years 2003, 2011 & 2017 (includes corresponding Graph/Chart)

    IV. COMPETITIVE LANDSCAPE

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