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New PublicationsARTIFICIAL ORGANS MCP-1126
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Artificial Organs I-3
Artificial Heart I-3
Artificial Kidneys I-4
Artificial Liver I-4
Artificial Pancreas I-4
Artificial Lungs I-4
II. EXECUTIVE SUMMARY
1. Industry Overview II-1
Artificial Organs Revolutionize Medical Technology Industry II-1
Current and Future Analysis II-1
Market Outlook II-2
Opportunities Abound for Bioartificial Organs II-2
Bionics to Play Crucial Role II-3
Economic Situation Plays a Pivotal Role in ESRD Treatment
Accessibility II-3
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) II-4
Growth Drivers II-4
Growth Inhibitors II-5
2. Market Trends and Issues II-6
Higher Development Costs and Lengthy Regulatory Process -
Stumbling Blocks for Product Commercialization II-6
Lack of Requisite Expertise - Hindering Implantation Process II-6
Alliances to Play a Key Role II-6
Aging Population - A Boosting Factor II-6
Anemia - A Growing Concern among Renal Failure Patients II-6
Swelling ESRD Patient Population Spurs Dialyzers Growth II-7
Growing Need for Efficient Control and Easy Usage II-7
Expiry of Warranty Provides New Opportunities II-7
Xenotransplantation - Other Alternative to Donor Organ Shortage II-7
Artificial Organs from Cloned Animal Cells - A Promising Trend II-7
Immunosuppressants Hold Promise in Artificial Organs Market II-8
Move Towards Smaller Implantable Devices II-8
Barriers to Entry Significantly High in Dialyzers Market II-8
Reuse of Dialyzers - A Major Issue in Dialysis Industry II-8
Poor Reimbursement Environment Stymies Innovation II-8
Pricing Trends in Artificial Organs II-9
3. Competitive Scenario II-10
Competition Heating Up in Artificial Pancreas Domain II-10
Fresenius Medical Care - Leads the Worldwide Dialysis
Equipment and Supplies Market II-10
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) II-11
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) II-11
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) II-11
Competitive Landscape of Artificial Kidney or Dialyzers Market II-11
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) II-12
Synthetic Dialyzers to Attain Mainstay II-13
Asahi Kasei Medical Dominates Japanese Dialyzers Market II-13
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) II-13
Competitive Landscape of Ventricular Assist Devices II-13
Various Ventricle Assist Devices II-14
Thoratec - Leads the VADs Market II-14
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) II-15
Liver Assist Devices Competitive Landscape II-15
Various Liver Assist Devices II-16
Core Competitive Factors II-16
4. Product Overview II-17
Artificial Organs II-17
Categorization of Artificial Organs II-17
External Artificial Organs II-17
Internal or Implantable Artificial Devices II-17
Artificial Heart II-17
Total Artificial Heart (TAH) II-18
Ventricle Assist Device (VAD) II-18
Table 8: Distribution of Various Uses of VADs (includes
corresponding Graph/Chart) II-18
Right Ventricular Assist Systems (RVAS) II-18
Left Ventricular Assist Systems (LVAS) II-18
Categorization of LVAS II-18
First Generation LVAS II-18
Second Generation LVAS II-19
Third Generation LVAS II-19
Benefits of LVAS II-20
Major Limitations and Complications of VADs II-20
Infection II-21
Internal Bleeding II-21
Thrombus II-21
Dependability II-21
Cost II-21
Table 9: Average Selling Price per Unit (includes
corresponding Graph/Chart) II-22
Table 10: Distribution of Direct Costs for Heart Failure
in the US (2004) (includes corresponding Graph/Chart) II-22
Natural Human Heart II-22
Heart Diseases II-23
Congenital Heart Disease II-23
Congestive Heart Failure II-23
Types of Heart Failure II-23
Diastolic Heart Failure II-23
Systolic Heart Failure II-23
Artificial Heart - A Historical Perspective II-23
Major Milestones in Artificial Heart Development II-24
Jarvik-7 II-24
AbioCor Total Artificial Heart II-25
Major Advancements in AbioCor Over Jarvik-7 II-25
CardioWest Temporary Total Artificial Heart II-26
DuraHeart LVAS II-26
HeartSaverVAD II-27
VentrAssist Left Ventricular Assist Device II-27
Artificial Kidney (Dialyzer) II-27
Limitations of Artificial Kidney II-28
Types of Dialysis II-28
Hemodialysis II-28
Peritoneal Dialysis II-29
Advances in Artificial Kidney Technology II-29
Bioartificial Kidneys II-30
Limitations of Bioartificial Kidneys II-30
Hindrances to Develop Implantable Artificial Kidney II-31
Artificial Kidneys - A Historical Perspective II-31
Artificial Liver II-31
Overdose of Drugs - A Leading Cause for Liver Damage II-32
Categorization of Liver Devices II-32
Mechanical Systems II-33
Liver Dialysis Unit II-33
Molecular Adsorbents Recirculating System II-33
SEPET II-33
Bio-Artificial Systems II-34
Capillary Hollow Fiber Systems II-35
Direct Perfusion Systems II-35
Entrapment Based Systems II-35
Major BAL Devices II-36
Extracorporeal Liver Assist Device (ELAD) II-36
Cellular Components II-36
Types of Bioreactor II-36
HepatAssist-2 Bioartificial Liver System II-36
Hybrid Artificial Liver Support System II-37
History of Artificial Liver II-37
Liver Assist Devices - Major Milestones II-38
Nonbiological Method Introduction Time Line II-38
Biological Method Introduction Time Line II-38
Artificial Pancreas II-38
Insulin Pumps - Historical Perspective II-39
Bioartificial Pancreas II-40
Nanotechnology in Artificial Pancreas II-40
Medtronic Minimed, Inc Products II-41
External Artificial Pancreas II-41
Implantable Artificial Pancreas II-41
MiniMed Paradigm REAL-Time Insulin Pump and CGM System II-41
Guardian RT CGM System II-41
Abbott Products II-41
FreeStyle Navigator CGM System II-41
CozMore Insulin Technology System II-42
Artificial Lungs (Oxygenator) II-42
About Human Lungs II-42
Types of Artificial Lung II-42
Intravenous Membrane Oxygenator II-43
Hattler Respiratory Catheter II-43
MC3 Pulmonary Assist Device II-43
In-Series II-43
In-Parallel II-43
BioLung II-43
Heart-Lung Bypass Machine II-44
Role of Artificial Lungs during Surgery II-44
Direct Contact Device II-44
Indirect-Contact Type-Membrane Devices II-44
Biorubber to be used in Artificial Lungs II-45
History of Artificial Lungs II-45
An Overview of Tissue Engineering II-45
5. Introduction to Biomaterials II-47
6. Organ Transplantation II-48
Sources of Donor Organs II-48
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) II-48
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) II-49
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) II-49
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) II-49
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) II-50
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) II-50
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) II-50
Major Milestones in Organ Transplantation II-51
US Organ Transplant Facts II-51
Shortage of Donor Organs Restricts Transplantation Procedures II-51
Table 18: Survival Percentage of Transplanted Organs (
includes corresponding Graph/Chart) II-52
Table 19: Waiting List of Patients in the US as of July 2007
(includes corresponding Graph/Chart) II-53
Table 20: Waiting List of Active and Inactive Patients in the
US for Years 2004 & 2005 (includes corresponding Graph/Chart) II-53
Organ Rejection - A Major Barrier to Transplantation II-53
Other Issues for Organ Transplantation II-54
Combined Organ Transplantation - Gaining Attention II-54
7. Regulatory Environment II-55
Regulatory Environment in the US II-55
Regulatory Environment in Europe II-56
8. Product Innovations/Introductions II-57
Gambro Unveils AK 96 Dialyzer II-57
Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets II-57
University of Michigan Develops Artificial Lungs II-57
USC Researchers Develop Argus II Retinal Prosthesis System for
Retinal Implant II-57
Researchers Develop Cell Manipulation Technique for Organ
Regeneration Process II-58
Terumo to Introduce First CE Mark LVAS in Europe II-58
Advanced Technique for Nerve Re-Growth Developed II-58
JDRF Develops Artificial Pancreas II-58
Direct Attachment of Artificial Limbs Technique Developed II-59
Artificial Pancreas to Generate Hope for Young Diabetics II-59
Artificial Liver Developed Using Stem Cells II-59
Artificial Liver Device from HepaLife II-59
Researchers Develop Human Nephron Filter II-60
Ventracor Completes Pilot Trial of VentrAssist II-60
National Cardiovascular Center Develops Completely Implantable
Wireless Artificial Heart II-60
InnovaMedica Reveals Prototype for Economical Artificial Heart II-61
Researchers Develop Membrane-Based Microscopic Device II-61
9. Recent Industry Activity II-62
Thoratec Receives FDA Approval for HeartMate II II-62
Asahi Kasei Institutes a Sales Subsidiary in Taiwan II-62
Arbios Seeks CE Marking for SEPET II-62
Gambro Teams up with Debiotech for Developing Peritoneal
Dialysis Cycler II-62
Arbios Obtains US FDA Approval for Initiating Clinical Trial
for SEPET II-63
Abiomed Obtains HDE Supplement Approval from FDA for AbioCor
Implantable Artificial Heart II-63
Ventracor Obtains CE Marking for VentrAssist LVAD II-63
Fresenius Medical Care Takes Over Renal Solutions, Inc. II-63
Arbios Inks Exclusive Agreement with NxStage for SEPET II-63
WorldHeart Completes First Multi-Day Animal Study of
PediaFlow VAD II-64
Xcorporeal, Inc. Completes Merger with CT Holdings II-64
Nikkiso Collaborates with Nipro for Overseas Launch of its
Dialysis Systems II-64
Ege University to Initiate Artificial Heart Project II-64
Vascutek Buys Kohler Chemie's Heart Valve Business II-64
NovaThera Partners with NovaLung to Develop Advanced
Artificial Lung II-64
Aksys Quits Kidney Dialysis Machines Business II-65
Twardowski Terminates License Agreement with Aksys II-65
Asahi Kasei Medical Fortifies Competence in Artificial Kidney
Production II-65
Fresenius Medical Care Enhances Dialyzer Output II-65
HepaLife Appoints Stem Cell Systems for Bioreactor Development II-65
Hanger Orthopedic Acquires Regional Artificial Limb & Brace II-65
Gambro Acquires Hemapure II-66
Fresenius Medical Care Snaps Up Renal Care Group II-66
CLSI Teams Up with DTS II-66
Abiomed to Foray into the Indian Market II-66
Asahi Kasei Medical to Double Artificial Kidney Production in
China II-66
Thoratec Bags FDA Approval for IDE Supplement for HeartMate II
Phase II Trial under CAP II-66
SynCardia Systems Obtains CE Mark to Sell EXCOR TAH-t Mobile
Driver with CardioWest TAH-t in Europe II-67
FDA Grants Approval for Medtronic's Guardian Real- Time CGM
System II-67
DexCom Bags FDA Approval for STS Continuous Glucose Monitoring
System II-67
Vital Therapies Obtains FDA Guidance to Ship ELAD to China II-67
MC3 Secures Phase I STTR Grant from NHLBI to Develop Pump-
Oxygenator II-68
Pauley Heart Center Implants First CardioWest TAH-t on East Coast II-68
LDS Hospital Team Implants WorldHeart's New Artificial Heart
Device in Greece II-68
Novacor LVAS Support Recipient Completes Five Years II-68
SynCardia Systems to Increase CardioWest TAH-t Transplant
Hospitals II-69
National Quality Care Divests Dialysis Unit to Kidney Dialysis
Center II-69
Medtronic Gains FDA Approval for Mini Med Paradigm REAL-Time
System II-70
MicroMed Receives CE Mark Extension for DeBakey VAD System II-70
Thoratec Files Data On HeartMate II LVAS for Pre-Market Approval II-70
Arbios Systems Receives FDA Allowance to Expand Eligibility
Criteria for SEPET Liver Assist Device II-70
Abiomed's AbioCor Artificial Heart Receives FDA Approval II-71
Abiomed's IMPELLA 5.0 Receives Conditional IDE Approval II-71
WorldHeart Makes Synergistic Purchase of MedQuest II-72
Nipro Takes Over Artificial Lung Business from Dainippon Ink
and Chemicals II-72
Baxter Inks Pact with Gambro Renal Products II-72
Xenogenics Bags Patent for Synthetic Bio-Liver Device II-72
Gambro Bags FDA Approval for MARS for Drug Overdose and Poisoning II-73
Einstein Medical Center Participates in Artificial Liver
Support Device's Clinical Trail II-73
SynCardia Announces First CardioWest TAH-t Implantation at The
Cleveland Clinic II-73
SynCardia Announces Implantation of CardioWest TAH-t for
Destination Therapy in Germany II-73
Australian Patients Receive Jarvik 2000 II-73
WorldHeart Bags Three Patents for Ventricular Assist Pumps II-74
Asahi Kasei Medical's First APS Dialyzers Assembly Line
Commences Operations II-74
Arrow International Halts LionHeart LVAS II-74
Arbios Systems Takes Over Circe Biomedical's Bioartificial
Liver Assets II-74
Roche Makes a Synergetic Purchase of Disetronic II-74
MultiCell Technologies Merges with Exten Industries II-75
HepaLife Technologies Expands Cooperative Research Agreement
Scope II-75
MedQuest Wins Contract from NIH to Develop LVAD for Infants II-75
Jarvik Heart Receives Contract from NIH to Develop VADs for
Children II-75
SynCardia Receives FDA Approval for CardioWest Temporary
Total Artificial Heart II-75
FDA Grants Approval for SynCardia Systems' Partial Artificial
Heart II-76
Thoratec Obtains FDA approval for Implantable Ventricular
Assist Device II-76
FDA Grants Approval to World Heart's Novacor LVAS for
Destination Therapy II-76
MicroMed Technology Receives Approval for DeBakey VAD Child
Heart Pump II-77
FDA Awards Orphan Drug Designation for Core Component of Vital
Therapies' ELAD II-77
SynCardia Systems Licenses Technology from MEDOS II-77
MicroMed Technology Announces Implantation of First DeBakey
VAD for Destination Therapy II-77
Vital Therapies Takes Over VitaGen Assets II-77
Advanced Biotherapy Inks Agreement with Russian Federation
Ministry of Health/State Institute of Transplantation and
Artificial Organs II-78
Novalung Signs Agreements with MC3 II-78
10. Focus on Select Global Players II-79
Abbott Laboratories (USA) II-79
Abiomed Inc (USA) II-79
Arbios Systems, Inc. (USA) II-79
Asahi Kasei Kuraray Medical Co., Ltd (Japan) II-80
Baxter International, Inc. (USA) II-80
F. Hoffmann-La Roche Ltd. (Switzerland) II-80
Fresenius Medical Care AG & Co. KGaA (Germany) II-81
Fresenius Medical Care North America, Inc. II-81
Fresenius Kawasumi (Japan) II-82
Gambro AB (Sweden) II-82
HepaLife Technologies, Inc. (USA) II-82
Jarvik Heart, Inc. (USA) II-83
MC3, Inc. (USA) II-83
Medtronic, Inc. (USA) II-83
MicroMed Cardiovascular, Inc. (USA) II-84
Nikkiso Co., Ltd. (Japan) II-84
Nipro Corporation (Japan) II-84
SynCardia Systems, Inc. (USA) II-85
Terumo Corporation (Japan) II-85
Thoratec Corporation (USA) II-85
Toray Medical Co., Ltd. (Japan) II-86
Ventracor Limited (Australia) II-86
Vital Therapies, Inc. (USA) II-86
WorldHeart Corporation (USA) II-87
Xenogenics Corporation (USA) II-87
11. Global Market Perspective II-88
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) II-88
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) II-89
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) II-90
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) II-91
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) II-92
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) II-93
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) II-94
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) II-94
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) II-95
III. COMPETITIVE LANDSCAPE
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