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.
Table of Contents
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
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)
Artificial Organs published by Global Industry Analysts, Inc. in April 1, 2012. This report consists of Pages: 289 and the price starts from US $ 4500.
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