Artificial Organs

Published by: Global Industry Analysts

Published: Dec. 1, 2007 - 283 Pages

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

Current and Future Analysis

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

Trend towards Innovative Research Aspects

Product Differentiation Set to Diminish in Dialyzers Market

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 (2006) - 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 (2006) - Percentage Breakdown of Sales for Fresenius Medical Care, Gambro, Baxter and Others (includes corresponding Graph/Chart)

Table 4: Leading Players in the Worldwide Peritoneal Dialysis Equipment and Supplies Market (2006) - Percentage Breakdown of Sales for Baxter, Fresenius Medical Care, Sonstige and Gambro (includes corresponding Graph/Chart)

Competitive Landscape of Artificial Kidney or Dialyzers Market

Table 5: Leading Players in the Worldwide Artificial Kidneys (Dialyzers) Market (2006) - Percentage Breakdown of Sales for Fresenius Medical Care, Asahi Kasei, Gambro and Others (includes corresponding Graph/Chart)

Changing Competitive Landscape

Synthetic Dialyzers to Attain Mainstay

Asahi Kasei Medical Dominates Japanese Dialyzers Market

Table 6: Leading Players in the Japanese Kidney Dialyzers Market (2005 & 2006) - Percentage Breakdown of Sales for Asahi Kasei, Nipro, Kawasumi, Toray and Others (includes corresponding graph/chart)

Competitive Landscape of Ventricular Assist Devices

Various Ventricle Assist Devices

Thoratec - Undisputable Leader in VADs Market

Table 7: Leading Players in the Worldwide VADs Market (2005 & 2006) - Percentage Breakdown of Sales for Thoratec, Abiomed, WorldHeart and Others (includes corresponding Graph/Chart)

Liver Assist Devices Competitive Landscape

Various 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 8: 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 9: Average Selling Price per Unit (includes corresponding graph/chart)

Table 10: Distribution of Direct Costs for Heart Failure in the US (2004) (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

Advances 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™

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™ 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 Minimed, Inc Products

External Artificial Pancreas

Implantable Artificial Pancreas

MiniMed Paradigm® REAL-Time Insulin Pump and CGM System

Guardian® RT CGM System

Abbott Products

FreeStyle Navigator CGM System

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

Introduction to Biomaterials

6. Organ Transplantation

Sources of Donor Organs

Table 11: US Recent Past, Current & Future Analysis for Kidney Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 2001 through 2010 (includes corresponding graph/chart)

Table 12: US Historic Review for Kidney Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 1991 through 2000 (includes corresponding graph/chart)

Table 13: US Recent Past, Current & Future Analysis for Liver Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 2001 through 2010 (includes corresponding graph/chart)

Table 14: US Historic Review for Liver Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 1991 through 2000 (includes corresponding graph/chart)

Table 15: US Recent Past, Current & Future Analysis for Heart Transplants -Donations by Cadaveric Donor Type in Units for Years 2001 through 2010 (includes corresponding graph/chart)

Table 16: US Historic Review for Heart Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 1991 through 2000 (includes corresponding graph/chart)

Table 17: US Recent Past, Current & Future Analysis for Pancreatic Transplant Donations by Donor Type - Cadaveric and Living in Units for Years 2000 through 2010 (includes corresponding graph/chart)

Major Milestones in Organ Transplantation

US Organ Transplant Facts

Shortage of Donor Organs Restricts Transplantation Procedures

Table 18: Survival Percentage of Transplanted Organs (includes corresponding graph/chart)

Table 19: Waiting List of Patients in the US as of July 2007 (includes corresponding graph/chart)

Table 20: Waiting List of Active and Inactive Patients in the US for Years 2004 & 2005 (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

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

Biomedical Engineering Research Engages in Artificial Organ Development

Advanced Technique for Nerve Re-Growth Developed

JDRF Develops Artificial Pancreas

Artificial Heart Tissue-Engineering Method Developed for Implanted Heart Muscle

US Researchers Engage in Bionic Arm Development

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

Ventracor Completes Pilot Trial of VentrAssist

Ventracor Initiates Worldwide Trial of VentrAssist

National Cardiovascular Center Develops Completely Implantable Wireless Artificial Heart

InnovaMedica Reveals Prototype for Economical Artificial Heart

Researchers Develop Membrane-Based Microscopic Device

Artificial Lung from Terumo

Joint Research Team Develops Prototype of Implantable Left Ventricular Heart-Assist System

American Scientists Create Working Kidneys Using Cloned Cow Embryo Cells

Researcher from University of Pittsburgh Develops Implantable Artificial Lung

9. Recent Industry Activity

Vascutek Buys Kohler Chemie’s Heart Valve Business

NovaThera Partners with NovaLung to Develop Advanced Artificial Lung

Xcorporeal and National Quality Care Cease Merger Agreement

Aksys Quits Kidney Dialysis Machines Business

Deka Corp. Ceases Agreement with Aksys

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 Acquires Nabi Biopharmaceuticals’ Phosphate Binder Operations

Bayer Diabetes Care Acquires Metrika

Fresenius Medical Care Snaps Up Renal Care Group

Asahi Kasei and Kuraray Decide to Merge

Gambro to be Bifurcated

CLSI Teams Up with DTS

Abiomed to Foray into the Indian Market

Asahi Kasei Medical to Double Artificial Kidney Production in China

Fresenius Medical Care to Divest 100 Dialysis Clinics

Becton, Dickinson’s Patients to Get Abbott’s Blood Glucose Meters

FDA Revokes Import Alert on Roche’s Insulin Pumps in the US

Thoratec Bags FDA Approval for IDE Supplement for HeartMate II Phase II Trial under CAP

SynCardia Systems Obtains CE Mark to Sell EXCOR® TAH-t Mobile Driver with CardioWest™ TAH-t in Europe

FDA Grants 510(k) Clearance to Abbott to Sell Freestyle® Freedom™ Blood Glucose Monitoring System

FDA Grants Approval for Medtronic’s Guardian® Real- Time CGM System

DexCom Bags FDA Approval for STS Continuous Glucose Monitoring System

Novalung to Obtain CE Mark for Biolung

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

Nipro to Open New Manufacturing Facility for Artificial Lungs and Dialysers

Asahi Kasei Medical to Construct Second Assembly Dialyzers Line in China

Boston Scientific Receives FDA Approval for Harmony Ear System

Medtronic Gains FDA Approval for Mini Med Paradigm® REAL-Time System

MicroMed Receives CE Mark Extension for DeBakey VAD® System

Thoratec Files Data On HeartMate II LVAS for Pre-Market Approval

Bayer’s Ascensia® BREEZE® Meter Receives Ease-of-Use Commendation and Product Seal

Arbios Systems Receives FDA Allowance to Expand Eligibility Criteria for SEPET™ Liver Assist Device

Abiomed’s AbioCor® Artificial Heart Receives FDA Approval

Abiomed’s IMPELLA 5.0 Receives Conditional IDE Approval

FDA Limits Baxter Plans, Directs to Seek 510(k) Pre- Market Notification

WorldHeart Makes Synergistic Purchase of MedQuest

Nipro Takes Over Artificial Lung Business from Dainippon Ink and Chemicals

Gambro Divests Gambro Healthcare US to DaVita

Baxter Inks Pact with Gambro Renal Products

Xenogenics Bags Patent for Synthetic Bio-Liver Device

NewCorTec to Manufacture and Market Artificial Heart Devices

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™ 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™ Dialyzers Assembly Line Commences Operations

Arrow International Halts LionHeart LVAS

Arbios Systems Takes Over Circe Biomedical’s Bioartificial Liver Assets

Roche Makes a Synergetic Purchase of Disetronic

MultiCell Technologies Merges with Exten Industries

HepaLife Technologies Expands Cooperative Research Agreement Scope

MedQuest Wins Contract from NIH to Develop LVAD for Infants

Jarvik Heart Receives Contract from NIH to Develop VADs for Children

SynCardia Receives FDA Approval for CardioWest™ Temporary Total Artificial Heart

FDA Grants Approval for SynCardia Systems’ Partial Artificial Heart

Thoratec Obtains FDA approval for Implantable Ventricular Assist Device

FDA Grants Approval to World Heart’s Novacor® LVAS for Destination Therapy

MicroMed Technology Receives Approval for DeBakey VAD Child Heart Pump

FDA Awards Orphan Drug Designation for Core Component of Vital Therapies’ ELAD

SynCardia Systems Licenses Technology from MEDOS

Asahi to Set Up New Subsidiary

Asahi Medical Renames to Asahi Kasei Medical

MicroMed Technology Announces Implantation of First DeBakey VAD for Destination Therapy

Vital Therapies Takes Over VitaGen Assets

Advanced Biotherapy Inks Agreement with Russian Federation Ministry of Health/State Institute of Transplantation and Artificial Organs

Novalung Signs Agreements with MC3

Asahi Kasei to Enhance Artificial Kidney Device Production Capacity

Terumo Sells Hemodialyzer Operations to Asahi

Jostra Snaps Up Life Stream International

Excorp Medical’s Bioartificial Liver Secures Special Orphan Drug Status from FDA

MicroMedical Industries Changes Name to Ventracor

Exten Industries Completes Acquisition of MultiCell Associates

Thoratec Laboratories Merges with Thermo Cardiosystems

Baxter Forms Strategic Alliance with Dainippon Ink & Chemicals

Covalent Group Strikes Deal with VitaGen

Renal Plant Inks Pact with Micronics

Abiomed Wins FDA Approval for Artificial Heart Testing

MicroMedical Industries Bags Second US Patent for VentrAssist Artificial Heart Technology

FDA Grants Approval to Commence Clinical Trails in the US for Arrow LionHeart™ LVAS

Arrow International Announces First US Implant of LionHeart

University of Louisville Implants First AbioCor Implantable Replacement Heart

Kestrel Equity Partners Releases Second Phase of Funding

MultiCell Associates Changes Name to MultiCell Technologies

Thoratec Laboratories Acquires Thermo CardioSystems

McGowan Center Signs Agreement with HemoMax and Alteon

FDA Grants Approval for Innovative Artificial Kidney System

Minntech Commences Second Dialyzer Reprocessing Center

SMAD Invests in Artificial Kidney Line

US Patent and Trademark Office Grants Patent to MedQuest’s Artificial Heart Technology

Kestrel Equity Partners Provides Funds to Exten and Xenogenics

Edwards Lifesciences Divests Novocor Heart Pumps to WorldHeart

10. Focus on Select Global Players

Abbott Laboratories (USA)

Abiomed Inc (USA)

Arbios Systems, Inc. (USA)

Arrow International, Inc. (USA)

Asahi Kasei Medical Co., Ltd. (Japan)

Baxter International, Inc. (USA)

Bayer AG (Germany)

F. Hoffmann-La Roche Ltd. (Switzerland)

Fresenius Medical Care AG & Co. KGaA (Germany)

Fresenius Medical Care Holdings (USA)

Fresenius Kawasumi (Japan)

Fresenius Medical Care Japan K.K. (Japan)

Renal Care Group (USA)

Gambro AB (Sweden)

Gish Biomedical, Inc. (USA)

HepaLife Technologies, Inc. (USA)

Jarvik Heart, Inc. (USA)

Kawasumi Laboratories, Inc. (Japan)

MC3, Inc. (USA)

Medtronic, Inc. (USA)

MicroMed Cardiovascular, Inc. (USA)

Minntech Renal Systems (USA)

Nikkiso Co., Ltd. (Japan)

Nipro Corporation (Japan)

SynCardia Systems, Inc. (USA)

Terumo Corporation (Japan)

Thoratec Corporation (USA)

Toray Medical Co., Ltd. (Japan)

Ventracor Limited (Australia)

Vital Therapies, Inc. (USA)

WorldHeart Corporation (USA)

Xenogenics Corporation (USA)

11. Global Market Perspective

Table 21: 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 2003 through 2010 (includes corresponding graph/chart)

Table 22: World Long-term Projections 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 2011 through 2015 (includes corresponding graph/chart)

Table 23: World 8-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 2003, 2007 & 2010 (includes corresponding graph/chart)

Table 24: World Recent Past, Current & Future Analysis for Artificial Kidneys/Dialyzers by Geographic Region - USA, 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 2010 (includes corresponding graph/chart)

Table 25: World Long-term Projections for Artificial Kidneys/Dialyzers by Geographic Region - USA, Canada, Japan, Europe, Asia-Pacific (excluding Japan), Middle East and Latin American Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding graph/chart)

Table 26: World 8-Year Perspective for Artificial Kidneys/Dialyzers by Geographic Region- Percentage Breakdown of Dollar Sales for USA, Canada, Japan,Europe, Asia-Pacific (excluding Japan), Middle East,and Latin American Markets for Years 2003,2007 & 2010 (includes corresponding graph/chart)

Table 27: World Recent Past, Current & Future Analysis for Insulin Pumps (External) by Geographic Region - USA, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding graph/chart)

Table 28: World Long-term Projections for Insulin Pumps (External) by Geographic Region - USA, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding graph/chart)

Table 29: World 8-Year Perspective for Insulin Pumps (External) by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for 2003, 2007 & 2010 (includes corresponding graph/chart)

III. COMPETITIVE LANDSCAPE

Abstract

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