Global Artificial Organs Industry

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Global Artificial Organs Industry

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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.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONSStudy Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-2Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3Artificial Organs I-3Artificial Heart I-4Artificial Kidneys I-4Artificial Liver I-4Artificial Pancreas I-4Artificial Lungs I-4II. 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-6Higher Development Costs and Lengthy Regulatory Process -Stumbling Blocks for Product Commercialization II-6Lack of Requisite Expertise - Hindering Implantation Process II-6Alliances to Play a Key Role II-6Aging Population - A Boosting Factor II-6Anemia - A Growing Concern among Renal Failure Patients II-7Swelling ESRD Patient Population Spurs Dialyzers Growth II-7Growing Need for Efficient Control and Easy Usage II-7Expiry of Warranty Provides New Opportunities II-7Xenotransplantation - Other Alternative to Donor Organ Shortage II-7Artificial Organs from Cloned Animal Cells - A Promising Trend II-8Immunosuppressants Hold Promise in Artificial Organs Market II-8Move Towards Smaller Implantable Devices II-8Barriers to Entry Significantly High in Dialyzers Market II-8Reuse of Dialyzers - A Major Issue in Dialysis Industry II-9Poor Reimbursement Environment Stymies Innovation II-9Pricing 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 HemodialysisEquipment and Supplies Market (2011) - Percentage Breakdownof Sales for Fresenius Medical Care, Gambro, Baxter andOthers (includes corresponding Graph/Chart) II-11Competitive 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 DialyzersMarket (2011) - Percentage Breakdown of Sales for AsahiKasei, Nipro, Kawasumi, Toray and Others (includescorresponding Graph/Chart) II-13Competitive Landscape of Ventricular Assist Device II-13Select Ventricle Assist Devices II-14Thoratec - 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-17Artificial Organs II-17Categorization of Artificial Organs II-17External Artificial Organs II-17Internal or Implantable Artificial Devices II-17Artificial Heart II-17Total Artificial Heart (TAH) II-18Ventricle Assist Device (VAD) II-18Table 7: Distribution of Various Uses of VADs (includescorresponding Graph/Chart) II-18Right Ventricular Assist Systems (RVAS) II-18Left Ventricular Assist Systems (LVAS) II-18Categorization of LVAS II-18First Generation LVAS II-19Second Generation LVAS II-19Third Generation LVAS II-19Benefits of LVAS II-20Major Limitations and Complications of VADs II-21Infection II-21Internal Bleeding II-21Thrombus II-21Dependability II-21Cost II-22Table 8: Average Selling Price per Unit in the RecentYears (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 andLiving for Years 2003 through 2008 (includes correspondingGraph/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 andLiving for Years 2003 through 2008 (includes correspondingGraph/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 - Cadavericand Living for Years 2003 through 2008 (includescorresponding Graph/Chart) II-55Major Milestones in Organ Transplantation II-56Shortage of Donor Organs Restricts Transplantation Procedures II-56Table 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-60Regulatory Environment in the US II-60Regulatory 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-66HepaLife Technologies Changes Name to Alliqua II-66Fresenius Medical Care Acquires Gambro's Peritoneal Dialysisbusiness II-66Fresenius Takes Over Xcorporeal II-66Nipro to Establish Production Site in China II-66JDRF Partners with Animas II-67Arbios Systems Files for Bankruptcy II-67HeartWare Obtains CE Mark Approval for HeartWare® VentricularAssist 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-82Abbott Diabetes Care (USA) II-82Abiomed, Inc. (USA) II-82Asahi Kasei Kuraray Medical Co., Ltd (Japan) II-82Baxter International, Inc. (USA) II-83F.Hoffmann-La Roche Ltd. (Switzerland) II-83Fresenius Medical Care AG & Co. KGaA (Germany) II-84Fresenius Medical Care North America Inc (USA) II-84Fresenius Kawasumi (Japan) II-84Gambro AB (Sweden) II-84HeartWare International, Inc. (USA) II-85Alliqua, Inc. (USA) (Formerly Hepalife Technologies, Inc.) II-85Jarvik Heart, Inc. (USA) II-86MC3, Inc. (USA) II-86Medtronic, Inc. (USA) II-86MicroMed Cardiovascular, Inc. (USA) II-87Nikkiso Co., Ltd. (Japan) II-87Nipro Corporation (Japan) II-88SynCardia Systems, Inc. (USA) II-88Terumo Corp. (Japan) II-88Thoratec Corp. (USA) II-89Toray Medical Co., Ltd. (Japan) II-89Vital Therapies, Inc. (USA) II-89WorldHeart 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 byProduct Segment -Artificial Heart, Artificial Kidneys,Artificiasl Liver, Artificial Pancreas and Artificial LungsMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2003 through 2008 (includescorresponding 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 forArtificial Kidneys/Dialyzers by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), MiddleEast and Latin American Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (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 ArtificialKidneys/Dialyzers by Geographic Region- Percentage Breakdownof Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific(excluding Japan), Middle East, and Latin American Markets forYears 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 MarketsIndependently Analyzed with Annual Sales Figures in US$Million for Years 2003 through 2008 (includes correspondingGraph/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 40Canada 1Japan 10Europe 13France 1Germany 6The United Kingdom 2Italy 2Rest of Europe 2Asia-Pacific (Excluding Japan) 1------------------------------------------

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