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Artificial Organs - Global Strategic Business Report

Price:
USD $3,950.00
ISBN/SKU #:
GIA-MCP1126
Research Group:
Global Industry Analysts
Date of Publication:
May 2008
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Summary

This report analyzes the worldwide markets for Artificial Organs in US$ Million. The major product segments analyzed are Artificial Heart, Artificial Kidneys, Artificial Liver, Artificial Pancreas, and Artificial Lungs. Annual forecasts are provided for the period of 2003 through 2015. The report profiles 55 companies including many key and niche players worldwide such as Abbott Laboratories, 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, 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., Ventracor Limited, Vital Therapies, Inc., WorldHeart Corporation, and Xenogenics Corporation. 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:

ARTIFICIAL 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

Warranty Information

Number of Pages: 270

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