Artificial Organs - Global Strategic Business Report

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 54 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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ARTIFICIAL ORGANS

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-4
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
Market Outlook II-1
Opportunities Abound for Bioartificial Organs II-2
Bionics to Play Crucial Role II-2
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-3
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-7
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-8
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-9
Poor Reimbursement Environment Stymies Innovation II-9
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 (2011) - 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 (2011) - Percentage Breakdown
of Sales for Fresenius Medical Care, Gambro, Baxter and
Others (includes corresponding Graph/Chart) II-11
Competitive Landscape of Artificial Kidney or Dialyzers Market II-11

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) II-12
Synthetic Dialyzers to Attain Mainstay II-12
Asahi Kasei Medical Dominates Japanese Dialyzers Market II-13

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) II-13
Competitive Landscape of Ventricular Assist Device II-13
Select Ventricle Assist Devices II-14
Thoratec - Leads the VADs Market II-15

Table 6: Leading Players in the Worldwide VADs Market (2011)-
Percentage Breakdown of Sales for Thoratec, Abiomed,
WorldHeart and Others (includes corresponding Graph/Chart) II-15
Liver Assist Devices Competitive Landscape II-15
Select 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 7: 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-19
Second Generation LVAS II-19
Third Generation LVAS II-19
Benefits of LVAS II-20
Major Limitations and Complications of VADs II-21
Infection II-21
Internal Bleeding II-21
Thrombus II-21
Dependability II-21
Cost II-22
Table 8: Average Selling Price per Unit in the Recent
Years (includes corresponding Graph/Chart) II-22

Table 9: Distribution of Direct Costs for Heart Failure in
the US (2011) (includes corresponding Graph/Chart) II-23
Natural Human Heart II-23
Heart Diseases II-23
Congenital Heart Disease II-23
Congestive Heart Failure II-23
Types of Heart Failure II-24
Diastolic Heart Failure II-24
Systolic Heart Failure II-24
Artificial Heart - A Historical Perspective II-24
Major Milestones in Artificial Heart Development II-25
Jarvik-7 II-25
AbioCor Total Artificial Heart II-25
Major Advancements in AbioCor Over Jarvik-7 II-26
CardioWest Temporary Total Artificial Heart II-27
DuraHeart LVAS II-27
HeartSaverVAD II-28
VentrAssist Left Ventricular Assist Device II-28
Artificial Kidney (Dialyzer) II-29
Limitations of Artificial Kidney II-29
Types of Dialysis II-29
Hemodialysis II-29
Peritoneal Dialysis II-30
Advancements in Artificial Kidney Technology II-31
Bioartificial Kidneys II-31
Limitations of Bioartificial Kidneys II-32
Hindrances to Develop Implantable Artificial Kidney II-32
Artificial Kidneys - A Historical Perspective II-32
Artificial Liver II-33
Overdose of Drugs - A Leading Cause for Liver Damage II-34
Categorization of Liver Devices II-34
Mechanical Systems II-34
Liver Dialysis Unit™ II-34
Molecular Adsorbents Recirculating System II-35
SEPET II-35
Bio-Artificial Systems II-36
Capillary Hollow Fiber Systems II-37
Direct Perfusion Systems II-37
Entrapment Based Systems II-37
Major BAL Devices II-38
Extracorporeal Liver Assist Device (ELAD) II-38
Cellular Components II-38
Types of Bioreactor II-38
HepatAssist-2™ Bioartificial Liver System II-38
Hybrid Artificial Liver Support System II-39
History of Artificial Liver II-39
Liver Assist Devices - Major Milestones II-40
Nonbiological Method Introduction Time Line II-40
Biological Method Introduction Time Line II-40
Artificial Pancreas II-40
Insulin Pumps - Historical Perspective II-41
Bioartificial Pancreas II-42
Nanotechnology in Artificial Pancreas II-42
Medtronic's Products II-43
External Artificial Pancreas II-43
Implantable Artificial Pancreas II-43
MiniMed Paradigm® REAL-Time Insulin Pump and CGM System II-43
Guardian® RT CGM System II-44
Abbott Products II-44
FreeStyle Navigator CGM System II-44
Smith Medical II-44
CozMore Insulin Technology System II-44
Artificial Lungs (Oxygenator) II-44
About Human Lungs II-45
Types of Artificial Lung II-45
Intravenous Membrane Oxygenator II-45
Hattler Respiratory Catheter II-46
MC3 Pulmonary Assist Device II-46
In-Series II-46
In-Parallel II-46
BioLung II-46
Heart-Lung Bypass Machine II-47
Role of Artificial Lungs during Surgery II-47
Direct Contact Device II-47
Indirect-Contact Type-Membrane Devices II-47
Biorubber to be used in Artificial Lungs II-47
History of Artificial Lungs II-48
An Overview of Tissue Engineering II-48

5. INTRODUCTION TO BIOMATERIALS II-50

6. ORGAN TRANSPLANTATION II-52
Sources of Donor Organs II-52
Table 10: US Kidney Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-52

Table 11: US Liver Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-53

Table 12: US Heart Donations by Cadaveric Donor Type for
Years 2003 through 2008 (includes corresponding Graph/Chart) II-53

Table 13: US Lung Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-54

Table 14: US Pancreas Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-54

Table 15: US Intestine Donations by Donor Type - Cadaveric
and Living for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-55
Major Milestones in Organ Transplantation II-56
Shortage of Donor Organs Restricts Transplantation Procedures II-56
Table 16: Waiting List of Patients in the US by Organ Type:
As of July 2010 (includes corresponding Graph/Chart) II-57

Table 17: Waiting List of Active and Inactive Patients by
Organ Type: 2008 (includes corresponding Graph/Chart) II-58
Organ Rejection - A Major Barrier to Transplantation II-58
Other Issues for Organ Transplantation II-59
Combined Organ Transplantation - Gaining Attention II-59

7. REGULATORY ENVIRONMENT II-60
Regulatory Environment in the US II-60
Regulatory Environment in Europe II-61

8. PRODUCT INNOVATIONS/INTRODUCTIONS II-62
Medtronic to Launch Paradigm Veo, An Artificial Pancreas II-62
Gambro Unveils AK 96™ Dialyzer II-62
Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets II-62
University of Michigan Develops Artificial Lungs II-62
USC Researchers Develop Argus II Retinal Prosthesis System for
Retinal Implant II-62
Researchers Develop Cell Manipulation Technique for Organ
Regeneration Process II-63
Terumo to Introduce First CE Mark LVAS in Europe II-63
Advanced Technique for Nerve Re-Growth Developed II-64
JDRF Develops Artificial Pancreas II-64
Direct Attachment of Artificial Limbs Technique Developed II-64
Artificial Pancreas to Generate Hope for Young Diabetics II-64
Artificial Liver Developed Using Stem Cells II-65
Artificial Liver Device from HepaLife II-65
Researchers Develop Human Nephron Filter II-65

9. RECENT INDUSTRY ACTIVITY II-66
HepaLife Technologies Changes Name to Alliqua II-66
Fresenius Medical Care Acquires Gambro's Peritoneal Dialysis
business II-66
Fresenius Takes Over Xcorporeal II-66
Nipro to Establish Production Site in China II-66
JDRF Partners with Animas II-67
Arbios Systems Files for Bankruptcy II-67
HeartWare Obtains CE Mark Approval for HeartWare® Ventricular
Assist System II-67

10. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-68
Thoratec Receives FDA Approval for HeartMate II® II-68
Asahi Kasei Institutes a Sales Subsidiary in Taiwan II-68
Arbios Seeks CE Marking for SEPET™ II-68
Gambro Teams up with Debiotech for Developing Peritoneal
Dialysis Cycler II-68
Arbios Obtains US FDA Approval for Initiating Clinical Trial
for SEPET™ II-69
Abiomed Obtains HDE Supplement Approval from FDA for AbioCor®
Implantable Artificial Heart II-69
Ventracor Obtains CE Marking for VentrAssist™ LVAD II-69
Fresenius Medical Care Takes Over Renal Solutions, Inc. II-69
Arbios Inks Exclusive Agreement with NxStage for SEPET™ II-70
WorldHeart Completes First Multi-Day Animal Study of
PediaFlow™ VAD II-70
Xcorporeal Completes Merger with CT Holdings II-70
Nikkiso Collaborates with Nipro for Overseas Launch of
Dialysis Systems II-70
Ege University to Initiate Artificial Heart Project II-70
Vascutek Buys Kohler Chemie's Heart Valve Business II-70
NovaThera Partners with NovaLung to Develop Advanced
Artificial Lung II-71
Aksys Quits Kidney Dialysis Machines Business II-71
Twardowski Terminates License Agreement with Aksys II-71
Asahi Kasei Medical Fortifies Competence in Artificial Kidney
Production II-71
Fresenius Medical Care Enhances Dialyzer Output II-71
HepaLife Appoints Stem Cell Systems for Bioreactor Development II-71
Hanger Orthopedic Acquires Regional Artificial Limb & Brace II-72
Gambro Acquires Hemapure II-72
Fresenius Medical Care Snaps Up Renal Care Group II-72
CLSI Teams Up with DTS II-72
Abiomed to Foray into the Indian Market II-72
Asahi Kasei Medical to Double Artificial Kidney Production in
China II-73
Thoratec Bags FDA Approval for IDE Supplement for HeartMate II
Phase II Trial under CAP II-73
SynCardia Systems Obtains CE Mark to Sell EXCOR® TAH-t Mobile
Driver with CardioWest™ TAH-t in Europe II-73
FDA Grants Approval for Medtronic's Guardian® Real- Time CGM
System II-73
DexCom Bags FDA Approval for STS Continuous Glucose Monitoring
System II-74
Vital Therapies Obtains FDA Guidance to Ship ELAD to China II-74
MC3 Secures Phase I STTR Grant from NHLBI to Develop Pump-
Oxygenator II-74
Pauley Heart Center Implants First CardioWest TAH-t on East Coast II-74
LDS Hospital Team Implants WorldHeart's New Artificial Heart
Device in Greece II-75
Novacor LVAS Support Recipient Completes Five Years II-75
SynCardia Systems to Increase CardioWest TAH-t Transplant
Hospitals II-75
National Quality Care Divests Dialysis Unit to Kidney Dialysis
Center II-75
Medtronic Gains FDA Approval for MiniMed Paradigm® REAL-Time
System II-75
MicroMed Receives CE Mark Extension for DeBakey VAD® System II-76
Thoratec Files Data On HeartMate II LVAS for Pre-Market Approval II-77
Arbios Systems Receives FDA Allowance to Expand Eligibility
Criteria for SEPET™ Liver Assist Device II-77
Abiomed's AbioCor® Artificial Heart Receives FDA Approval II-77
Abiomed's IMPELLA 5.0 Receives Conditional IDE Approval II-78
WorldHeart Makes Synergistic Purchase of MedQuest II-79
Nipro Takes Over Artificial Lung Business from Dainippon Ink
and Chemicals II-79
Baxter Inks Pact with Gambro Renal Products II-79
Xenogenics Bags Patent for Synthetic Bio-Liver Device II-79
Gambro Bags FDA Approval for MARS for Drug Overdose and Poisoning II-79
Einstein Medical Center Participates in Artificial Liver
Support Device's Clinical Trail II-80
SynCardia Announces First CardioWest TAH-t Implantation at The
Cleveland Clinic II-80
SynCardia Announces Implantation of CardioWest™ TAH-t for
Destination Therapy in Germany II-80
Australian Patients Receive Jarvik 2000 II-80
WorldHeart Bags Three Patents for Ventricular Assist Pumps II-80
Asahi Kasei Medical's First APS™ Dialyzers Assembly Line
Commences Operations II-81
Arrow International Halts LionHeart LVAS II-81

11. FOCUS ON SELECT GLOBAL PLAYERS II-82
Abbott Diabetes Care (USA) II-82
Abiomed, Inc. (USA) II-82
Asahi Kasei Kuraray Medical Co., Ltd (Japan) II-82
Baxter International, Inc. (USA) II-83
F.Hoffmann-La Roche Ltd. (Switzerland) II-83
Fresenius Medical Care AG & Co. KGaA (Germany) II-84
Fresenius Medical Care North America Inc (USA) II-84
Fresenius Kawasumi (Japan) II-84
Gambro AB (Sweden) II-84
HeartWare International, Inc. (USA) II-85
Alliqua, Inc. (USA) (Formerly Hepalife Technologies, Inc.) II-85
Jarvik Heart, Inc. (USA) II-86
MC3, Inc. (USA) II-86
Medtronic, Inc. (USA) II-86
MicroMed Cardiovascular, Inc. (USA) II-87
Nikkiso Co., Ltd. (Japan) II-87
Nipro Corporation (Japan) II-88
SynCardia Systems, Inc. (USA) II-88
Terumo Corp. (Japan) II-88
Thoratec Corp. (USA) II-89
Toray Medical Co., Ltd. (Japan) II-89
Vital Therapies, Inc. (USA) II-89
WorldHeart Corp. (USA) II-90

12. GLOBAL MARKET PERSPECTIVE II-91
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) II-91

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) II-92

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) II-93

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) II-94

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) II-95

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) II-96

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) II-97

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) II-98

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) II-99

III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 54 (including Divisions/Subsidiaries - 65)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 40
Canada 1
Japan 10
Europe 13
France 1
Germany 6
The United Kingdom 2
Italy 2
Rest of Europe 2
Asia-Pacific (Excluding Japan) 1
------------------------------------------

With decades of research and advancements in technology, artificial organs have become the viable alternative to effectively address donor organ shortage problem. Artificial organs have been radically changing the facet of medical technology industry. Besides sustaining life and minimizing disease burden, artificial organs have been playing a crucial role in enhancing patient's quality of life. Additionally, artificial organs are not only enhancing patient outcomes and accelerating recovery times, but also minimizing the overall healthcare expenditure. In addition to the external artificial assist devices, miniature size advanced implantable devices are also being developed. However, only few implantable devices have been approved for clinical use, while several other devices are still in clinical trials, awaiting approvals. Nevertheless, it is opined that with the developments in artificial organs, all human organs would eventually be replaced by their artificial counterparts for permanent implantation to assist organ failure patients.

The market for artificial organs, in the ensuing years, is expected to witness robust growth, primarily due to the ever increasing number of patients on the waiting lists for organ transplants. Further, the emerging artificial organs market is on the cusp of significant transformation, with the development of new advanced technologies that would play an influential role in future market growth. While only few products are presently approved by the FDA, other artificial organs are in developmental stage or under clinical trials. With commercialization of these life-saving, life-sustaining products for bridge as well as destination therapy, stupendous growth is likely to be witnessed by the artificial organs market.

Global market for artificial organs is led by Artificial Kidneys, as stated by the new market research report on Artificial Organs. In developed regions, such as the US and Europe, poor lifestyle continues to be a major factor leading to renal failure, which makes an increasing number of people dependent on dialyzers at some point of time. Growth in the artificial organs market, would, however be spearheaded by Artificial Liver. Sales in the segment are projected to clock the fastest growth over the analysis period. Major strides in the field of bioengineering and technological advances are expected to develop implantable Artificial Pancreas in the coming years. Further, public and private collaborations are fuelling advancement towards artificial pancreas development. With over 100 million people across the world suffering from diabetes mellitus, artificial pancreas is expected to witness lucrative growth prospects. Artificial lungs market worldwide is projected to post a CAGR of 7.81% during the analysis period.

Bioartificial organs are increasingly gaining prominence. After several decades of research, researchers are developing artificial organs by employing human or porcine cells. These cells, enclosed in a capsule, perform the functions of original human organs. Researchers are developing several bioartificial organs, including bioartificial kidney, liver, pancreas, and lungs. The bioartificial organs are intended to be used in patients suffering from organ failures as bridge to transplantation or long-term replacement devices. With increasing gulf between the donor organs and number of people requiring them, there lies a large potential market for bioartificial organs.

Key players operating in the marketplace include Abbott Diabetes Care, Asahi Kasei Kuraray Medical Co., Ltd., Baxter International, F.Hoffmann-La Roche Ltd., Fresenius Medical Care AG & Co. KgaA, Gambro AB, Alliqua Inc., Jarvik Heart Inc., Medtronic Inc., Terumo Corporation, Thoratec Corporation, Toray Medical Co., Ltd., Vital Therapies Inc., SynCardia Systems Inc., among others.

Global Industry Analysts ©