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市場調查報告書
全球的人工臟器市場
Artificial Organs
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本報告已在2012年04月11日停止出版。
更改為出版
Artificial Organs
出版日期 : 2012年04月
商品編碼: 236739
本報告書內容包括:全球的人工臟器市場的市場趨勢及各地區市場的趨勢內容綱要摘記如下:
第1章 介紹、調查方法、及產品定義
第2章 業界概要
- 人工臓器引起醫療技術業界的革命
- 現在及未來分析
- 市場展望
- 生物人工臟器的機會
- 生體工學的重要腳色
- ESRD治療的連結性受經濟趨勢很大的影響
- 成長牽引因素
- 成長阻礙因素
第3章 市場趨勢和課題
- 開發成本的高騰和法律規範過程的長短
- 必要的專門性缺陷
- 合作成為重要的角色
- 高齡化
- 貧血：腎功能衰竭患者的大擔憂 其他
第4章 競爭發展情境
第5章 產品概要
- 人工臟器
- 人工心臟
- 人工腎臟
- 人工肝臟
- 人工胰臟
- 人工肺
- 組織工程學概要
第6章 生物材料的引進
第7章 臟器移植
第8章 法律規範環境
第9章 產品革新・引進
第10章 最近的業界趨勢
第11章 主要企業
第12章 全球市場的展望
競爭介紹：56公司
Abstract
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 2015. 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., Arbios Systems, 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., 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., WorldHeart Corp., and Xenogenics Corp. Market data and
analytics are derived from primary and secondary research. Company profiles
are mostly extracted from URL research and reported select online sources.
Table of Contents
1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
- Study Reliability and Reporting Limitations 1
- Disclaimers 2
- Data Interpretation & Reporting Level 3
- Quantitative Techniques & Analytics 3
- Product Definitions and Scope of Study 3
- Artificial Organs 3
- Artificial Heart 4
- Artificial Kidneys 4
- Artificial Liver 4
- Artificial Pancreas 4
- Artificial Lungs 4
2. INDUSTRY OVERVIEW 5
- Artificial Organs Revolutionize Medical Technology Industry 5
- Current and Future Analysis 5
- Market Outlook 6
- Opportunities Abound for Bioartificial Organs 6
- Bionics to Play Crucial Role 7
- Economic Situation Plays a Pivotal Role in ESRD Treatment Accessibility 7
- Table 1: Number of Dialysis Patients by GeographicRegion - US, Canada,
Japan, Europe, Asia-Pacific,Latin America and Rest of World for the Year
2006(includes corresponding Graph/Chart) 8
- Growth Drivers 8
- Growth Inhibitors 9
3. MARKET TRENDS AND ISSUES 10
- Higher Development Costs and Lengthy Regulatory Process - Stumbling Blocks
for Product Commercialization 10
- Lack of Requisite Expertise - Hindering Implantation Process 10
- Alliances to Play a Key Role 10
- Aging Population - A Boosting Factor 10
- Anemia - A Growing Concern among Renal Failure Patients 11
- Swelling ESRD Patient Population Spurs Dialyzers Growth 11
- Growing Need for Efficient Control and Easy Usage 11
- Expiry of Warranty Provides New Opportunities 11
- Xenotransplantation - Other Alternative to Donor Organ Shortage 11
- Artificial Organs from Cloned Animal Cells - A Promising Trend 12
- Immunosuppressants Hold Promise in Artificial Organs Market 12
- Move Towards Smaller Implantable Devices 12
- Barriers to Entry Significantly High in Dialyzers Market 12
- Reuse of Dialyzers - A Major Issue in Dialysis Industry 13
- Poor Reimbursement Environment Stymies Innovation 13
- Pricing Trends in Artificial Organs 13
4. COMPETITIVE SCENARIO 14
- Competition Heating Up in Artificial Pancreas Domain 14
- Fresenius Medical Care - Leads the Worldwide Dialysis Equipment and
Supplies Market 14
- Table 2: Leading Players in the Worldwide DialysisEquipment and Supplies
Market (2008) - Percentage Breakdown of Sales for Fresenius Medical
Care,Baxter, Gambro and Others (includes corresponding Graph/Chart) 15
- 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 correspondingGraph/Chart) 15
- Table 4: Leading Players in the Worldwide PeritonealDialysis Equipment
and Supplies Market (2006) -Percentage Breakdown of Sales for Baxter,
FreseniusMedical Care, Sonstige and Gambro (includescorresponding
Graph/Chart) 15
- Competitive Landscape of Artificial Kidney or Dialyzers Market 15
- Table 5: Leading Players in the Global Dialyzers Market (2008):
Percentage Breakdown of Unit Output forFresenius Medical Care, Gambro and
Others(includes corresponding Graph/Chart) 16
- Synthetic Dialyzers to Attain Mainstay 16
- Asahi Kasei Medical Dominates Japanese Dialyzers Market 17
- Table 6: Leading Players in the Japanese Kidney Dialyzers Market (2005
& 2006) - Percentage Breakdown of Salesfor Asahi Kasei, Nipro, Kawasumi,
Toray and Others (includes corresponding Graph/Chart) 17
- Competitive Landscape of Ventricular Assist Device 18
- Various Ventricle Assist Devices 18
- Thoratec - Leads the VADs Market 19
- 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) 19
- Liver Assist Devices Competitive Landscape 20
- Various Liver Assist Devices 20
- Core Competitive Factors 21
5. PRODUCT OVERVIEW 22
- Artificial Organs 22
- Categorization of Artificial Organs 22
- External Artificial Organs 22
- Internal or Implantable Artificial Devices 22
- Artificial Heart 22
- Total Artificial Heart (TAH) 23
- Ventricle Assist Device (VAD) 23
- Table 8: Distribution of Various Uses of VADs(includes corresponding
Graph/Chart) 23
- Right Ventricular Assist Systems (RVAS) 23
- Left Ventricular Assist Systems (LVAS) 23
- Categorization of LVAS 23
- First Generation LVAS 24
- Second Generation LVAS 24
- Third Generation LVAS 24
- Benefits of LVAS 25
- Major Limitations and Complications of VADs 26
- Infection 26
- Internal Bleeding 26
- Thrombus 26
- Dependability 26
- Cost 27
- Table 9: Average Selling Price per Unit in the RecentYears (includes
corresponding Graph/Chart) 27
- Table 10: Distribution of Direct Costs forHeart Failure in the US
(2004) (includescorresponding Graph/Chart) 28
- Natural Human Heart 28
- Heart Diseases 28
- Congenital Heart Disease 28
- Congestive Heart Failure 28
- Types of Heart Failure 29
- Diastolic Heart Failure 29
- Systolic Heart Failure 29
- Artificial Heart - A Historical Perspective 29
- Major Milestones in Artificial Heart Development 30
- Jarvik-7 30
- AbioCor Total Artificial Heart 30
- Major Advancements in AbioCor Over Jarvik-7 31
- CardioWest Temporary Total Artificial Heart 32
- DuraHeart LVAS 32
- HeartSaverVAD 33
- VentrAssist Left Ventricular Assist Device 33
- Artificial Kidney (Dialyzer) 33
- Limitations of Artificial Kidney 34
- Types of Dialysis 34
- Hemodialysis 34
- Peritoneal Dialysis 35
- Advancements in Artificial Kidney Technology 36
- Bioartificial Kidneys 36
- Limitations of Bioartificial Kidneys 37
- Hindrances to Develop Implantable Artificial Kidney 37
- Artificial Kidneys - A Historical Perspective 37
- Artificial Liver 38
- Overdose of Drugs - A Leading Cause for Liver Damage 39
- Categorization of Liver Devices 39
- Mechanical Systems 39
- Liver Dialysis Unit(tm) 39
- Molecular Adsorbents Recirculating System 40
- SEPET 40
- Bio-Artificial Systems 41
- Capillary Hollow Fiber Systems 42
- Direct Perfusion Systems 42
- Entrapment Based Systems 42
- Major BAL Devices 42
- Extracorporeal Liver Assist Device (ELAD) 42
- Cellular Components 43
- Types of Bioreactor 43
- HepatAssist-2(tm) Bioartificial Liver System 43
- Hybrid Artificial Liver Support System 44
- History of Artificial Liver 44
- Liver Assist Devices - Major Milestones 45
- Nonbiological Method Introduction Time Line 45
- Biological Method Introduction Time Line 45
- Artificial Pancreas 45
- Insulin Pumps - Historical Perspective 46
- Bioartificial Pancreas 47
- Nanotechnology in Artificial Pancreas 47
- Medtronic Minimed, Inc Products 48
- External Artificial Pancreas 48
- Implantable Artificial Pancreas 48
- MiniMed Paradigm(r) REAL-Time Insulin Pump and CGM System 48
- Guardian(r) RT CGM System 49
- Abbott Products 49
- FreeStyle Navigator CGM System 49
- CozMore Insulin Technology System 49
- Artificial Lungs (Oxygenator) 49
- About Human Lungs 50
- Types of Artificial Lung 50
- Intravenous Membrane Oxygenator 50
- Hattler Respiratory Catheter 50
- MC3 Pulmonary Assist Device 51
- In-Series 51
- In-Parallel 51
- BioLung 51
- Heart-Lung Bypass Machine 51
- Role of Artificial Lungs during Surgery 52
- Direct Contact Device 52
- Indirect-Contact Type-Membrane Devices 52
- Biorubber to be used in Artificial Lungs 52
- History of Artificial Lungs 53
- An Overview of Tissue Engineering 53
6. INTRODUCTION TO BIOMATERIALS 55
7. ORGAN TRANSPLANTATION 57
- Sources of Donor Organs 57
- Table 11: US Kidney Donations by Donor Type -Cadaveric and Living for
Years 2003 through 2008(includes corresponding Graph/Chart) 57
- Table 12: US Liver Donations by Donor Type -Cadaveric and Living for
Years 2003 through2008 (includes corresponding Graph/Chart) 58
- Table 13: US Heart Donations by CadavericDonor Type for Years 2003
through 2008(includes corresponding Graph/Chart) 58
- Table 14: US Lung Donations by Donor Type -Cadaveric and Living for
Years 2003 through2008 (includes corresponding Graph/Chart) 59
- Table 15: US Pancreas Donations by Donor Type -Cadaveric and Living for
Years 2003 through 2008(includes corresponding Graph/Chart) 59
- Table 16: US Intestine Donations by Donor Type -Cadaveric and Living for
Years 2003 through 2008(includes corresponding Graph/Chart) 60
- Major Milestones in Organ Transplantation 60
- Shortage of Donor Organs Restricts Transplantation Procedures 61
- Table 17: Waiting List of Patients in the US byOrgan Type: As of July
2010 (includescorresponding Graph/Chart) 61
- Table 18: Waiting List of Active and InactivePatients by Organ Type:
2008 (includescorresponding Graph/Chart) 62
- Organ Rejection - A Major Barrier to Transplantation 62
- Other Issues for Organ Transplantation 63
- Combined Organ Transplantation - Gaining Attention 63
8. REGULATORY ENVIRONMENT 64
- Regulatory Environment in the US 64
- Regulatory Environment in Europe 65
9. PRODUCT INNOVATIONS/INTRODUCTIONS 66
- Medtronic to Launch Paradigm Veo, An Artificial Pancreas 66
- Gambro Unveils AK 96(tm) Dialyzer 66
- Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets 66
- University of Michigan Develops Artificial Lungs 66
- USC Researchers Develop Argus II Retinal Prosthesis System for Retinal
Implant 66
- Researchers Develop Cell Manipulation Technique for Organ Regeneration
Process 67
- Terumo to Introduce First CE Mark LVAS in Europe 67
- Advanced Technique for Nerve Re-Growth Developed 68
- JDRF Develops Artificial Pancreas 68
- Direct Attachment of Artificial Limbs Technique Developed 68
- Artificial Pancreas to Generate Hope for Young Diabetics 68
- Artificial Liver Developed Using Stem Cells 69
- Artificial Liver Device from HepaLife 69
- Researchers Develop Human Nephron Filter 69
- Ventracor Completes Pilot Trial of VentrAssist 70
- National Cardiovascular Center Develops Completely Implantable Wireless
Artificial Heart 70
- InnovaMedica Reveals Prototype for Economical Artificial Heart 70
- Researchers Develop Membrane-Based Microscopic Device 70
10. RECENT INDUSTRY ACTIVITY 71
- Fresenius Takes Over Xcorporeal 71
- Nipro to Establish Production Site in China 71
- JDRF Partners with Animas 71
- HeartWare Obtains CE Mark Approval for HeartWare(r) Ventricular Assist
System 72
- Thoratec Receives FDA Approval for HeartMate II(r) 72
- Asahi Kasei Institutes a Sales Subsidiary in Taiwan 72
- Arbios Seeks CE Marking for SEPET(tm) 73
- Gambro Teams up with Debiotech for Developing Peritoneal Dialysis Cycler 73
- Arbios Obtains US FDA Approval for Initiating Clinical Trial for SEPET(tm)
73
- Abiomed Obtains HDE Supplement Approval from FDA for AbioCor(r)
Implantable Artificial Heart 73
- Ventracor Obtains CE Marking for VentrAssist(tm) LVAD 73
- Fresenius Medical Care Takes Over Renal Solutions, Inc. 74
- Arbios Inks Exclusive Agreement with NxStage for SEPET(tm) 74
- WorldHeart Completes First Multi-Day Animal Study of PediaFlow(tm) VAD 74
- Xcorporeal Completes Merger with CT Holdings 74
- Nikkiso Collaborates with Nipro for Overseas Launch of Dialysis Systems 74
- Ege University to Initiate Artificial Heart Project 75
- Vascutek Buys Kohler Chemie' s Heart Valve Business 75
- NovaThera Partners with NovaLung to Develop Advanced Artificial Lung 75
- Aksys Quits Kidney Dialysis Machines Business 75
- Twardowski Terminates License Agreement with Aksys 75
- Asahi Kasei Medical Fortifies Competence in Artificial Kidney Production 75
- Fresenius Medical Care Enhances Dialyzer Output 75
- HepaLife Appoints Stem Cell Systems for Bioreactor Development 76
- Hanger Orthopedic Acquires Regional Artificial Limb & Brace 76
- Gambro Acquires Hemapure 76
- Fresenius Medical Care Snaps Up Renal Care Group 76
- CLSI Teams Up with DTS 76
- Abiomed to Foray into the Indian Market 77
- Asahi Kasei Medical to Double Artificial Kidney Production in China 77
- Thoratec Bags FDA Approval for IDE Supplement for HeartMate II Phase II
Trial under CAP 77
- SynCardia Systems Obtains CE Mark to Sell EXCOR(r) TAH-t Mobile Driver
with CardioWest(tm) TAH-t in Europe 77
- FDA Grants Approval for Medtronic' s Guardian(r) Real- Time CGM System 78
- DexCom Bags FDA Approval for STS Continuous Glucose Monitoring System 78
- Vital Therapies Obtains FDA Guidance to Ship ELAD to China 78
- MC3 Secures Phase I STTR Grant from NHLBI to Develop Pump-Oxygenator 78
- Pauley Heart Center Implants First CardioWest TAH-t on East Coast 79
- LDS Hospital Team Implants WorldHeart' s New Artificial Heart Device in
Greece 79
- Novacor LVAS Support Recipient Completes Five Years 79
- SynCardia Systems to Increase CardioWest TAH-t Transplant Hospitals 79
- National Quality Care Divests Dialysis Unit to Kidney Dialysis Center 80
- Medtronic Gains FDA Approval for MiniMed Paradigm(r) REAL-Time System 80
- MicroMed Receives CE Mark Extension for DeBakey VAD(r) System 81
- Thoratec Files Data On HeartMate II LVAS for Pre-Market Approval 81
- Arbios Systems Receives FDA Allowance to Expand Eligibility Criteria for
SEPET(tm) Liver Assist Device 81
- Abiomed' s AbioCor(r) Artificial Heart Receives FDA Approval 82
- Abiomed' s IMPELLA 5.0 Receives Conditional IDE Approval 82
- WorldHeart Makes Synergistic Purchase of MedQuest 83
- Nipro Takes Over Artificial Lung Business from Dainippon Ink and Chemicals
83
- Baxter Inks Pact with Gambro Renal Products 83
- Xenogenics Bags Patent for Synthetic Bio-Liver Device 83
- Gambro Bags FDA Approval for MARS for Drug Overdose and Poisoning 84
- Einstein Medical Center Participates in Artificial Liver Support Device' s
Clinical Trail 84
- SynCardia Announces First CardioWest TAH-t Implantation at The Cleveland
Clinic 84
- SynCardia Announces Implantation of CardioWest(tm) TAH-t for Destination
Therapy in Germany 84
- Australian Patients Receive Jarvik 2000 84
- WorldHeart Bags Three Patents for Ventricular Assist Pumps 85
- Asahi Kasei Medical' s First APS(tm) Dialyzers Assembly Line Commences
Operations 85
- Arrow International Halts LionHeart LVAS 85
- Arbios Systems Takes Over Circe Biomedical' s Bioartificial Liver Assets 85
- Roche Makes a Synergetic Purchase of Disetronic 86
- MultiCell Technologies Merges with Exten Industries 86
- HepaLife Technologies Expands Cooperative Research Agreement Scope 86
- MedQuest Wins Contract from NIH to Develop LVAD for Infants 86
- Jarvik Heart Receives Contract from NIH to Develop VADs for Children 86
- SynCardia Receives FDA Approval for CardioWest(tm) Temporary Total
Artificial Heart 87
- FDA Grants Approval for SynCardia Systems' Partial Artificial Heart 87
- Thoratec Obtains FDA approval for Implantable Ventricular Assist Device 87
- FDA Grants Approval to World Heart' s Novacor(r) LVAS for Destination
Therapy 88
- MicroMed Technology Receives Approval for DeBakey VAD Child Heart Pump 88
- FDA Awards Orphan Drug Designation for Core Component of Vital Therapies'
ELAD 88
- SynCardia Systems Licenses Technology from MEDOS 88
- MicroMed Technology Announces Implantation of First DeBakey VAD for
Destination Therapy 89
- Vital Therapies Takes Over VitaGen Assets 89
- Advanced Biotherapy Inks Agreement with Russian Federation Ministry of
Health/State Institute of Transplantation and Artificial Organs 89
- Novalung Signs Agreements with MC3 89
11. FOCUS ON SELECT GLOBAL PLAYERS 91
- Abbott Diabetes Care (USA) 91
- Abiomed, Inc. (USA) 91
- Arbios Systems, Inc. (USA) 91
- Asahi Kasei Kuraray Medical Co., Ltd (Japan) 92
- Baxter International, Inc. (USA) 92
- F.Hoffmann-La Roche Ltd. (Switzerland) 93
- Fresenius Medical Care AG & Co. KGaA (Germany) 93
- Fresenius Medical Care North America Inc (USA) 94
- Fresenius Kawasumi (Japan) 94
- Gambro AB (Sweden) 94
- HeartWare International, Inc. (USA) 95
- HepaLife Technologies, Inc. (USA) 95
- Jarvik Heart, Inc. (USA) 95
- MC3, Inc. (USA) 96
- Medtronic, Inc. (USA) 96
- MicroMed Cardiovascular, Inc. (USA) 97
- Nikkiso Co., Ltd. (Japan) 97
- Nipro Corporation (Japan) 97
- SynCardia Systems, Inc. (USA) 98
- Terumo Corp. (Japan) 98
- Thoratec Corp. (USA) 98
- Toray Medical Co., Ltd. (Japan) 99
- Vital Therapies, Inc. (USA) 99
- WorldHeart Corp. (USA) 100
- Xenogenics Corp. (USA) 100
12. GLOBAL MARKET PERSPECTIVE 101
- Table 19: 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
withAnnual Sales Figures in US$ Million for Years 2009through 2015 (includes
corresponding Graph/Chart) 101
- Table 20: World Historic Review for Artificial Organs byProduct Segment
-Artificial Heart, Artificial Kidneys,Artificiasl Liver, Artificial Pancreas
and Artificial LungsMarkets Independently Analyzed with Annual SalesFigures in
US$ Million for Years 2003 through 2008(includes corresponding Graph/Chart) 102
- Table 21: World 11-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 2005, 2010 &2015 (includes corresponding Graph/Chart) 103
- Table 22: World Recent Past, Current & Future Analysisfor Artificial
Kidneys/Dialyzers by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Middle East and Latin American Markets
IndependentlyAnalyzed with Annual Sales Figures in US$ Million for Years 2009
through 2015 (includes corresponding Graph/Chart) 104
- Table 23: World Historic Review for Artificial Kidneys/Dialyzers by
Geographic Region - US, Canada, Japan,Europe, Asia-Pacific (excluding Japan),
Middle East andLatin American Markets Independently Analyzed withAnnual Sales
Figures in US$ Million for Years 2003through 2008 (includes corresponding
Graph/Chart) 105
- Table 24: World 11-Year Perspective for Artificial Kidneys/Dialyzers by
Geographic Region- PercentageBreakdown of Dollar Sales for US, Canada,
Japan,Europe, Asia-Pacific (excluding Japan), Middle East,and Latin American
Markets for Years 2005, 2010 &2015 (includes corresponding Graph/Chart) 106
- Table 25: World Recent Past, Current & Future Analysis for Insulin
Pumps (External) by Geographic Region - US, Europe and Rest of World Markets
Independently Analyzed withAnnual Sales Figures in US$ Million for Years
2009through 2015 (includes corresponding Graph/Chart) 107
- Table 26: World Historic Review for Insulin Pumps(External) by Geographic
Region - US, Europe andRest of World Markets Independently Analyzed withAnnual
Sales Figures in US$ Million for Years2003 through 2008 (includes
correspondingGraph/Chart) 108
- Table 27: World 11-Year Perspective for Insulin PumpsExternal) by
Geographic Region - Percentage Breakdownof Dollar Sales for US, Europe and
Rest of World Marketsfor 2005, 2010 & 2015 (includes
correspondingGraph/Chart) 109
COMPETITIVE LANDSCAPE
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