Artificial Organs

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
• 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 Dialyzers Market (2007): 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 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 - Leads the 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

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

• Gambro Unveils AK 96™ 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
• Ventracor Completes Pilot 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

9. Recent Industry Activity

• Thoratec Receives FDA Approval for HeartMate II®
• Asahi Kasei Institutes a Sales Subsidiary in Taiwan
• Arbios Seeks CE Marking for SEPET™
• Gambro Teams up with Debiotech for Developing Peritoneal Dialysis Cycler
• Arbios Obtains US FDA Approval for Initiating Clinical Trial for SEPET™
• Abiomed Obtains HDE Supplement Approval from FDA for AbioCor® Implantable Artificial Heart
• Ventracor Obtains CE Marking for VentrAssist™ LVAD
• Fresenius Medical Care Takes Over Renal Solutions, Inc.
• Arbios Inks Exclusive Agreement with NxStage for SEPET™
• WorldHeart Completes First Multi-Day Animal Study of PediaFlow™ VAD
• Xcorporeal, Inc. Completes Merger with CT Holdings
• Nikkiso Collaborates with Nipro for Overseas Launch of its 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® TAH-t Mobile Driver with CardioWest™ TAH-t in Europe
• FDA Grants Approval for Medtronic' s Guardian® 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 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
• 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
• 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™ 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
• 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

10. Focus on Select Global Players

• Abbott Laboratories (USA)
• Abiomed Inc (USA)
• Arbios Systems, 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.
  • Fresenius Kawasumi (Japan)
  • Gambro AB (Sweden)
  • HepaLife Technologies, Inc. (USA)
  • 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 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, Artificiasl 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, 2008 & 2012 (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 2003,2008 & 2012 (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, 2008 & 2012 (includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE