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Organ and Tissue Transplantation - Global Strategic Business Report Product Image

Organ and Tissue Transplantation - Global Strategic Business Report

  • Published: February 2012
  • Region: Global
  • 428 Pages
  • Global Industry Analysts, Inc

This report analyzes the worldwide markets for Organ and Tissue Transplantation by Number of Procedures. The global and other markets (except the US) are analyzed only by Organ Type - Heart, Kidneys, Liver, Pancreas, and Lungs. The US market is analyzed both by Organ Type (Heart, Kidneys, Liver, Pancreas, Lungs, & Intestine) and Tissue Type (Cornea, Heart Valve, Skin Grafts, Vascular Grafts, Bone Marrow, and Bone Grafts). Also, the report further analyzes the US market for Bone Graft Transplantation both by Graft Type (Autologous Graft, Allograft, and Other Materials), and by Application Type (General Orthopedics, Spinal Fusions, and Cranio/Maxillofacial). The report provides separate comprehensive analytics for the US, Canada, Europe, Asia, Latin America, and Rest of World. 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 75 companies including many key and niche players such as Abiomed, Inc., CryoLife, Inc., Exactech, Inc., Fresenius Medical Care AG & Co. KGaA, Gambro AB, Genzyme Corporation, Jarvik Heart, Inc., LifeCell Corporation, Medtronic, Inc., MicroMed READ MORE >

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Tissue and Organ Transplantation I-3
Bone Graft Transplantation I-4
Product Definitions I-4
Organ Transplantation I-4
Heart Transplantation I-4
Kidney Transplantation I-5
Liver Transplantation I-5
Pancreas Transplantation I-5
Small Intestine Transplantation I-5
Lungs I-5
Tissue Transplantation I-6
Corneal Transplantation I-6
Blood Stem Cell Transplantation I-6
Bone Marrow Transplantation I-6
Heart Valves Transplantation I-6

II. Executive Summary

1. MARKET OVERVIEW II-1
A Quick Primer II-1
Demand and Supply Imbalance II-1
Measures to Address Organ Shortage II-2
Cardiac Arrest Death Patients: The Untapped Potential Donors II-2
Transplantation Expenses II-2

2. MARKET TRENDS II-3
Living Donor Organs on the Rise II-3
Combined Organ Transplantation - Gaining Attention II-3
Increasing Consent Rates - A Key Factor II-3
Alliances to Play a Key Role II-4
Graying Population and Chronic Diseases Surge Need for
Transplants II-4
Fetal Tissue for Bionic Devices - Assuming Importance II-4

3. MAJOR ISSUES IMPACTING TRANSPLANTATION MARKET II-5
Organ Rejection - A Major Barrier to Transplantation II-5
Scarcity of Donor Organs - A Stumbling Block in Organ
Transplantation II-5
Other Issues for Organ Transplantation II-5
Ethical Concerns in Transplants II-5
Bioethical Issues Hinder Organ Donation Process II-6
Lack of Requisite Expertise - Hindering Implantation Process II-6
Corneal Transplantation in Developing Countries: Key Challenges II-6

4. PRODUCT OVERVIEW II-7
Organ and Tissue Transplantation II-7
Organ Transplantation II-7
Heart Transplantation II-7
Heart Diseases and Disorders II-8
Post Operative Complications and Consequences of Heart
Transplants II-8
Bleeding II-8
Infection II-8
Arrythymia II-8
Heart Attack II-9
Coronary Artery Disease II-9
Respiratory Dysfunction II-9
Renal Dysfunction II-9
Graft Rejection and Dysfunction II-9
Death II-9
Kidney Transplantation II-9
Kidney Disorders and Diseases II-10
Donor Evaluation II-10
Waiting List II-10
Surgery/Post-Operation II-10
Post-Operative Supervision and Issues II-10
Liver Transplantation II-11
Liver Disorders and Diseases II-12
Pancreas Transplantation II-12
Post Operative Complications and Consequences of Pancreas
Transplants II-13
Small Intestine Transplantation II-13
Intestine Disorders and Diseases II-13
Heart-and-Lung Transplantation II-13
Lung Transplantation II-14
Lung Diseases and Disorders II-14
Lung Patients Survival Statistics II-14
Tissue Transplantation II-15
Types of Grafts II-15
Autograft II-15
Allograft / Homograft II-15
Transplant Tolerance II-16
Isograft II-16
Xenograft II-16
Corneal Transplantation II-16
Penetrating Keratoplasty II-17
Lamellar (Non-Penetrating) Keratoplasty II-17
Aftercare II-17
Risks Associated with Corneal Transplants II-18
Transplantation Outcomes II-18
Morbidity and Mortality Rates II-18
Alternatives II-18
Blood Stem Cells II-19
Peripheral Blood Stem Cell Transplant II-19
Umbilical Cord Blood Stem Cell Transplant II-19
Bone Marrow and Hematopoietic Stem Cells II-19
Bone and Tissue Transplantation II-19
Bone Marrow Transplants II-20
Stem Cell Therapy II-20
Human Heart Valves II-21
Atrioventricular Valves II-21
Mitral Valve II-21
Tricuspid Valve II-21
Semilunar Valves II-21
Aortic Valve II-21
Pulmonic Valve II-22
Pathology of Valves II-22
Prosthetic Heart Valves II-22
Prosthetic Mechanical Valve II-22
Advantages II-23
Disadvantages II-23
Prosthetic Biologic Valve II-23
Advantages II-24
Disadvantages II-24
Fetal Cells II-24
Fetal Tissue for Transplantation II-24
Storage Duration Time II-25
Storage Time Period for Organs and Tissues II-25
Cold Ischemia Time II-25
Transplantation Immunology II-25
Acute Cellular Rejection II-25
Chronic Rejection II-26
Post Transplant Observations II-26
Types of Donors II-26
Alive Donors II-26
Related Donors II-27
Good Samaritans II-27
Rewarded/Forced Donors II-27
Deceased Donors II-27
Directed / Allocated II-27
Organs and Tissues Transplanted by Type of Donor II-28
Organ/Tissue Donation and Eligibility Criteria II-28
Factors Considered for Matching Recipients to Donor Organs II-29
Testing II-29
Blood Typing II-29
Tissue Typing II-29
Histocompatibility - A Major Barrier for Organ Transplantation II-29
Transplantation - Safety Requirements II-30
Waiting List II-31
Active Waiting List Patients II-31
Inactive Waiting List Patients II-31
History II-31
Major Milestones in Organ Transplantation II-33

5. ARTIFICIAL ORGANS II-34
Artificial Organs Revolutionize Medical Technology Industry II-34
Artificial Organs II-34
Categorization of Artificial Organs II-34
External Artificial Organs II-35
Internal or Implantable Artificial Devices II-35
Artificial Heart II-35
Total Artificial Heart (TAH) II-35
Ventricle Assist Device (VAD) II-35
Right Ventricular Assist Systems (RVAS) II-35
Left Ventricular Assist Systems (LVAS) II-35
Various Ventricle Assist Devices Approved in the Recent Past II-36
Artificial Kidney (Dialyzer) II-37
Limitations of Artificial Kidney II-37
Artificial Liver II-37
Various Liver Assist Devices II-37
Categorization of Liver Devices II-38
Mechanical Systems II-38
Bio-Artificial Systems II-38
Artificial Pancreas II-38
Artificial Lungs (Oxygenator) II-38
Types of Artificial Lung II-39
Artificial Cornea II-39
Keratoprostheses II-39
Tissue Engineered Corneas II-39
Artificial Skin/Skin Replacement Products II-39
AlloDerm Regenerative Tissue Matrix II-39
Apligraf II-39
Cymetra Micronized AlloDerm Tissue II-40
Dermagraft II-40
Epicel II-40
Integra Products II-40
OrCel II-40
TransCyte II-40
Core Competitive Factors II-41
Market Outlook for Artificial Organs II-41

6. PRESERVATION SOLUTIONS & IMMUNOSUPPRESSANT DRUGS II-43
Organ Preservation Solutions II-43
Celsior Solution II-43
Collins Solution II-43
Euro Collins Solution II-43
Custodiol® HTK Solution II-43
Hypothermosol II-43
ViaSpan II-44
Immunosuppressant Drugs II-44
Antibody Products for Treatment of Organ Transplant Rejection II-44
Antithymocyte Globulin II-44
ATGAM II-44
Campath/MabCampath II-45
Thymoglobulin II-45
Therapeutic Antibody Products II-45
Antiproliferative Agents II-45
Azathioprine II-45
CellCept II-45
Certican II-45
Myfortic II-46
Calcineurin Inhibitors II-46
Cyclosporine II-46
Gengraf II-46
Neoral II-46
Pulminiq II-46
Tacrolimus II-46
Prograf II-47
TOR Inhibitors II-47
Side Effects of Immunosuppression Therapy II-47
Select Immunosuppressant Drug Players II-47
Astellas Pharma US, Inc. (USA) II-47
F.Hoffmann-La Roche Ltd. (Switzerland) II-47
Novartis AG (Switzerland) II-48
Wyeth (USA) II-48

7. REGULATORY ENVIRONMENT II-49
Transplant Center II-49
Organ Procurement Organization (OPO) II-49
Health Resources and Services Administration (HRSA) II-49
Division of Transplantation (DoT) II-49
United Network for Organ Sharing (UNOS) II-49
Organ Procurement and Transplantation Network (OPTN) II-49
University Renal Research and Education Association (URREA) II-50
Scientific Registry of Transplant Recipients (SRTR) II-50
Funding Sources II-50
Patient Education and Advocacy Organizations II-50
Legal Framework for Transplantation II-51
Legislation Covering Organ Transplant II-51
Organ Transplantation and Ethics II-52
Regulations Governing Artificial Organs II-53

8. PRODUCT DEVELOPMENT/INNOVATIONS II-54
Dr. Reddys to Launch Tacrolimus Capsules in US II-54
ApaTech® Unveils Actifuse® MIS Bone Graft Delivery System II-54
DePuy Spine Introduces HEALOS® Fx Injectable Bone Graft
Replacement II-54
Watson Laboratories Receives FDA Approval for Tacrolimus 5 mg II-55
RTI Biologics Introduces Osteochondral Allograft in San Francisco II-55
Pluristem Develops New Cell Graft for Cancer Patients II-55
CryoLife Develops Cryopreserved Orthopaedic Tissues Implants II-56
Japanese Innovators Develop New Prognostic Scoring Model for
Liver Transplants II-56
EUREKA project E! 2674 MIDAS Develops New Test to Improve
Graft Survival II-56

9. RECENT INDUSTRY ACTIVITY II-57
Sanofi-Aventis Snaps Up Genzyme Corp. II-57
International Stem Cell Inks Partnership Deal with Sankara
Nethralaya II-57
BGS Global Hospitals Inaugurates New Multi-Organ Transplants
Center in India II-57
Vietnamese Ministry of Health to Establish Organ Transplant
Coordination Center II-57
Novartis Secures US FDA Approval for Zortress Oral Tablets II-58
Humacyte Enters into Strategic Alliance with Xcellerex II-58
Osteotech Signs Agreement with Community Tissue Services II-58
Tissue Banks International Enters into a Partnership with
Northwest Tissue Services II-59
Roche Secures FDA Approval for Valcyte II-59
Astellas Pharma Secures FDA Clearance for Prograf and MMF Drug
Combination II-59
Astellas Pharma Receives Additional Approval for Prograf II-59
Novadaq® Obtains US FDA Approval for SPY® System II-60
Teleflex Acquires Arrow International II-60
St. Jude Medical's Heart Valve Obtains US FDA Approval II-60
Zimmer and Tutogen Expand Distribution Partnership II-60

10. CORPORATE ACTIVITY IN THE RECENT PAST- A PERSPECTIVE BUILDER II-62
Leman Cardiovascular Acquires Hancock Jaffe Laboratories II-62
Nabi Acquires Commercialization Rights of ATG-Fresenius S for
North America II-62
Cytopia and Novartis Ink Research Collaboration and Global
License Agreement II-62
ZLB Behring Inks Agreement with MedImmune II-63
Japanese Team To Perform Liver Transplants in Hyderabad II-63
Nabi Bags Approval for HB Intravenous in Liver Transplant
Patients II-63
Schering-Plough Announces PROTECT study Initiation II-63
Allegheny General Hospital To Establish Adult Liver
Transplantation Center in Oakland II-63
Global Hospitals to Setup an Organ Transplant Center in Kolkata II-64
GCC to Establish Organ Transplant Center II-64
Delhi-Based Hospital Offers Help in Setting Up of Liver
Transplant Center in Lahore II-64
Kaiser To Shut Down Kidney Transplant Center II-64
Abiomed Obtains FDA Approval for Selling Artificial Hearts II-64
Astellas Bags FDA Approval to Use Prograf in Heart Transplant
Patients II-64
New York State Department of Health Approves Program for
Kidney Transplant for Queen's Community II-65
National Heart Institute Conducts First Double Lung Transplant
in Malaysia II-65
The Netherlands Obtains Orphan Drug Designations for Treatment
of DGF II-65
Papworth Transplants First Beating Human Heart in the UK II-65
Enzon to Return ATG-Fresenius S Rights to Fresenius Biotech II-66
Schering-Plough to Conduct ‘PROTECT' Study II-66
Community Tissue Services Selects NOVA 2200 Supercritical
Carbon Dioxide Sterilization Technology II-66
CryoLife Inks Agreement with The Magdi Yacoub Institute to
Enhance Xenografts in Human Transplantation II-67
ReGen Inks Exclusive Marketing Deals with Polymedic and Xmedica II-67
University of California-Irvine Announces Closure of Liver-
Transplantation Program II-67
Swedish Health Services Bags Approval for Liver Transplant
Program II-68
New Organ Transplant Research Center in South Korea II-68
Child Lung Transplant Unit to be opened in Melbourne Hospital II-68
Narayana Hrudayalaya Health City Establishes Exclusive Organ
Transplant Hospital II-68
Liver Transplant Facility in Delhi Region II-68
First Liver Transplant Research Institute in China II-68
PIMS to establish Liver Transplant Unit II-69
Liver Transplant Programme in Pakistan II-69
Isotechnika Gains FDA Approval II-69
FDA Offers Approval for Brain Stem Cell Transplant Trial II-69
Methodist Specialty and Transplant Hospital Gains Approval to
Execute Liver Transplants II-69
Cubist Pharma Enters into Licensing Agreement with XTL
Biopharmaceuticals II-69
Jackson Memorial Receives Approval from the U.S. Centers for
Medicare and Medicaid Services II-70
Royal Perth Hospital to Open Lung Transplant Unit in Perth II-70
Mater Hospital Opens Lung Transplant Unit in Dublin II-70
Genzyme Makes a Synergistic Purchase of Ilex Oncology II-71
NIAID Sets Up Clinical Consortium to Enhance Organ Transplants
Success II-71
Chiron files NDA for Pulminiq Inhalation Solution II-71
Roche Acquires IL-15 Antagonist II-71
Genzyme Completes Acquisition of SangStat II-72

11. FOCUS ON SELECT GLOBAL PLAYERS II-73
Abiomed, Inc. (USA) II-73
CryoLife, Inc.(USA) II-73
Exactech, Inc. (USA) II-74
Fresenius Medical Care AG & Co. KGaA (Germany) II-74
Gambro AB (Sweden) II-74
Genzyme Corporation (USA) II-75
Jarvik Heart, Inc. (USA) II-75
LifeCell Corporation (USA) II-75
Medtronic, Inc. (USA) II-76
MicroMed Cardiovascular, Inc. (USA) II-76
Organogenesis, Inc. (USA) II-77
SynCardia Systems (USA) II-77
Terumo Corporation (Japan) II-77
Teleflex Inc. (USA) II-78
Thoratec Corporation (USA) II-78
WorldHeart Corporation (USA) II-79

12. GLOBAL MARKET PERSPECTIVE II-80
Table 1: World Recent Past, Current & Future Market Analysis
for Organ Transplantation by Geographic Region - US, Canada,
Europe, Asia (including Japan), Latin America and Rest of
World Independently Analyzed by Number of Procedures for Years
2009 through 2017 (includes corresponding Graph/Chart) II-80

Table 2: World Historic Review for Organ Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-81

Table 3: World 15-Year Perspective for Organ Transplantation
by Geographic Region - Percentage Breakdown of Number of
Procedures for US, Canada, Europe, Asia-Pacific (including
Japan), Latin America and Rest of World Markets for Years
2003, 2011 & 2017(includes corresponding Graph/Chart) II-82

Table 4: World Recent Past, Current & Future Market Analysis
for Heart Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding Graph/Chart) II-83

Table 5: World Historic Review for Heart Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-84

Table 6: World 15-Year Perspective for Heart Transplantation
by Geographic Region - Percentage Breakdown of Number of
Procedures for US, Canada, Europe, Asia-Pacific (including
Japan), Latin America and Rest of World Markets for Years
2003, 2011 & 2017 (includes corresponding Graph/Chart) II-85

Table 7: World Recent Past, Current & Future Market Analysis
for Kidney Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding Graph/Chart) II-86

Table 8: World Historic Review for Kidney Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-87

Table 9: World 15-Year Perspective for Kidney Transplantation
by Geographic Region - Percentage Breakdown of Number of
Procedures for US, Canada, Europe, Asia-Pacific (including
Japan), Latin America and Rest of World Markets for Years
2003, 2011 & 2017 (includes corresponding Graph/Chart) II-88

Table 10: World Recent Past, Current & Future Market Analysis
for Liver Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding Graph/Chart) II-89

Table 11: World Historic Review for Liver Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-90

Table 12: World 15-Year Perspective for Liver Transplantation
by Geographic Region - Percentage Breakdown of Number of
Procedures for US, Canada, Europe, Asia-Pacific (including
Japan), Latin America and Rest of World Markets for Years
2003, 2011 & 2017 (includes corresponding Graph/Chart) II-91

Table 13: World Recent Past, Current & Future Market Analysis
for Pancreas Transplantation by Geographic Region - US,
Canada, Europe, Asia-Pacific (including Japan), Latin America
and Rest of World Independently Analyzed by Number of
Procedures for Years 2009 through 2017 (includes corresponding
Graph/Chart) II-92

Table 14: World Historic Review for Pancreas Transplantation
by Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-93

Table 15: World 15-Year Perspective for Pancreas
Transplantation by Geographic Region - Percentage Breakdown of
Number of Procedures for US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets for
Years 2003, 2011 & 2017 (includes corresponding Graph/Chart) II-94

Table 16: World Recent Past, Current & Future Market Analysis
for Lung Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding Graph/Chart) II-95

Table 17: World Historic Review for Lung Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-96

Table 18: World 15-Year Perspective for Lung Transplantation
by Geographic Region - Percentage Breakdown of Number of
Procedures for US, Canada, Europe, Asia-Pacific (including
Japan), Latin America and Rest of World Markets for Years
2003, 2011 & 2017 (includes corresponding Graph/Chart) II-97

Table 19: World Recent Past, Current & Future Market Analysis
for Corneal Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding Graph/Chart) II-98

Table 20: World Historic Review for Corneal Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World
Independently Analyzed by Number of Procedures for Years 2003
through 2008 (includes corresponding Graph/Chart) II-99

Table 21: World 15-Year Perspective for Corneal
Transplantation by Geographic Region - Percentage Breakdown of
Number of Procedures for US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets for
Years 2003, 2011 & 2017 (includes corresponding Graph/Chart) II-100

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
A Few Organ Transplant Facts and Figures in the US III-1
Sources of Donor Organs III-1
Table 22: US Kidney Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) III-1

Table 23: US Liver Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) III-2

Table 24: US Heart Donations by Cadaveric Donor Type for
Years 2003 through 2008 (includes corresponding
Graph/Chart) III-2

Table 25: US Lung Donations by Donor Type - Cadaveric and
Living for Years 2003 through 2008 (includes corresponding
Graph/Chart) III-3

Table 26: US Pancreas Donations by Donor Type - Cadaveric
and Living for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-3

Table 27: US Intestine Donations by Donor Type - Cadaveric
and Living for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-4
Key Market Trends III-4
Innovative Means of Organ Procurement to Increase Organ
Donations III-4
A New Technique to Enhance and Extend Kidney Transplants III-4
California Stands Up Against Insurance on HIV Patients'
Transplantation III-5
Awareness Programs to Address Shortage of Minority Donors III-5
Organs and Tissues on A Recovery Spree III-5
Unexamined Human Tissue Transplants - A Major Threat III-5
Defective Medical Implants - A Health Hazard III-6
Eye Infections from Usage of MoistureLoc Leads to Corneal
Transplants III-6
Incidence of Organ Transplants III-6
Table 28: Incidence of Organ Transplant per 1 Million
Population in the US by Type - Kidney, Liver, Heart, Lung,
Pancreas, Intestine, and Heart-Lung Transplants, for the
Year 2003 through 2008 (includes corresponding Graph/Chart) III-6

Table 29: Incidence of Organ Transplants (Kidney, Liver,
Heart, Lung, Pancreas, Intestine, and Heart- Lung) per 1
Million Population in the US by Recipient Race (White,
African American, Asian, Hispanic, and Other) for 2008
(includes corresponding Graph/Chart) III-7

Table 30: Incidence of Organ Transplants (Kidney, Liver,
Heart, Lung, Pancreas, Intestine, and Heart-Lung) per 1
Million Population in the US by Recipient Gender (Male, and
Female) for 2008 (includes corresponding Graph/Chart) III-7

Table 31: Incidence of Organ Transplants (Kidney, Liver,
Heart, Lung, Pancreas, Intestine, and Heart-Lung) per 1
Million Population in the US by Recipient Age (65+ Years,
50-64 Years, 35-49 Years, 18-34 Years, 11-17 Years, 6-10
Years, 1-5 Years, <1 Year) for 2008 (includes corresponding
Graph/Chart) III-8
Heart Transplantation III-8
Table 32: Heart Transplant Life Expectancy in the US
(2009): As of 2009 (includes corresponding Graph/Chart) III-9
Lung Transplantation III-9
Heart-Lung Transplantation III-10
Waiting List III-10
Table 33: Waiting List of Patients As of July 2010
(includes corresponding Graph/Chart) III-10

Table 34: Waiting List of Active and Inactive Patients for
the Year 2008 (includes corresponding Graph/Chart) III-11
Waiting List for Heart Transplants III-11
Table 35: Waiting List of Active Patients for Heart for
Years 2000 to 2008 (includes corresponding Graph/Chart) III-12
Categorized by Diseases III-12
Categorized by Age III-12
Categorized by Race III-12
Death Rates on the Waiting Lists III-12
Kidney Transplantation Waiting List III-13
Categorized by Age III-13
Categorized by Race III-13
Waiting List for Liver Transplants III-13
Categorized by Age III-13
Categorized by Race III-14
Categorized by Gender III-14
Categorized by Diseases III-14
Categorized by Re-Transplant Necessity III-14
Pancreas Transplant Waiting List III-14
Simultaneous Pancreas Kidney Transplantation Waiting List III-14
Waiting List for Lung Transplants III-14
Categorized by Age III-15
Categorized by Primary Diagnoses III-15
Categorized by Gender and Ethnic Makeup III-15
Waiting List for Intestine Transplants III-15
Death Rates on Waiting List III-15
Patient Survival Rate III-15
Table 36: Unadjusted Patient Survival Rate (*) by Organ
Type for 1-Year and 5-Years (includes corresponding
Graph/Chart) III-16
Multi-Organ Transplant Gaining Momentum III-17
Table 37: Multi-Organ Transplants in the US: 2005-2008
(includes corresponding Graph/Chart) III-17
Immunosuppression Therapy III-17
Immunosuppression Therapy for Heart Transplant Recipients III-17
Table 38: Usage Rates of Major Immunosuppressants at
Discharge by Organ Type for the Year 2008 (includes
corresponding Graph/Chart) III-18
Immunosuppression Therapy for Kidney Transplant Recipients III-18
Immunosuppression Therapy for Pancreas Transplants III-18
Immunosuppression Therapy for Lung Transplant Recipients III-18
Table 39: Usage Rates of Induction Drugs For Lung
Transplant Recipients in 2008 (includes corresponding
Graph/Chart) III-19

Table 40: US Recent Past, Current & Future Market Analysis
for Immunosuppressive Drug Therapy Following Bone Marrow
Transplantation by Category - For GVHD and Maintenance
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-19

Table 41: US Historic Review for Immunosuppressive Drug
Therapy Following Bone Marrow Transplantation by Category -
For GVHD and Maintenance Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2003 through
2008 (includes corresponding Graph/Chart) III-20

Table 42: US 15-Year Perspective for Immunosuppressive
Drug Therapy Following Bone Marrow Transplantation by
Category - Percentage Breakdown of Dollar Sales For GVHD
and Maintenance Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003, 2011, and 2017 III-20
Immunosuppression Therapy, Following Blood Stem Cell
Transplantation III-21
Table 43: US Recent Past, Current & Future Market Analysis
for Immunosuppressive Drug Therapy Following Blood Stem
Cell Transplantation by Category - For GVHD and
Maintenance Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) III-21

Table 44: US Historic Review for Immunosuppressive Drug
Therapy Following Blood Stem Cell Transplantation by
Category - For GVHD and Maintenance Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2003
through 2008 (includes corresponding Graph/Chart) III-22

Table 45: US 15-Year Perspective for Immunosuppressive
Drug Therapy Following Blood Stem Cell Transplantation by
Category - Percentage Breakdown of Dollar Sales For GVHD
and Maintenance Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003, 2011, and 2017 III-22
The United Network for Organ Sharing III-23
The American Association of Tissue Banks (AATB) III-23
Accredited Banks from Select US States III-23
Eye Banks from Select US States III-25
Number of Transplant Center Programs III-26
Table 46: Number of Transplant Center Programs for the
Years 1990, 1997 and 2000 (includes corresponding
Graph/Chart) III-26

Table 47: Average Number of Transplants Per Program for the
Years 1990, 1997 and 2000 (includes corresponding
Graph/Chart) III-27
B.Market Analytics III-28
Table 48: US Recent Past, Current & Future Market Analysis
for Organ Transplantation by Organ Type - Heart, Kidney,
Liver, Pancreas, Lung and Intestine Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) III-28

Table 49: US Historic Review for Organ Transplantation by
Organ Type - Heart, Kidney, Liver, Pancreas, Lung and
Intestine Independently Analyzed with Annual Sales Figures
in US$ Million Years 2003 through 2008 (includes
corresponding Graph/Chart) III-29

Table 50: US 15-Year Perspective for Organ Transplantation
by Organ Type - Percentage Breakdown of Dollar Sales for
Heart, Kidney, Liver, Pancreas, Lung and Intestine Markets
for Years 2003, 2011 & 2017(includes corresponding
Graph/Chart) III-30

Table 51: US Recent Past, Current & Future Market Analysis
for Tissue Transplantation by Tissue Type - Cornea, Heart
Valves and Skin Grafts Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) III-31

Table 52: US Historic Review for Tissue Transplantation by
Tissue Type - Cornea, Heart Valves and Skin Grafts
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) III-32

Table 53: US 15-Year Perspective for Tissue Transplantation
by Tissue Type - Percentage Breakdown of Dollar Sales for
Cornea, Heart Valves and Skin Grafts Markets for Years 2003,
2011 & 2017 (includes corresponding Graph/Chart) III-33
By Number of Procedures III-34
Table 54: US Recent Past, Current & Future Market Analysis
for Organ Transplantation by Organ Type - Heart, Kidney,
Liver, Pancreas, Lung and Intestine Independently Analyzed
by Number of Procedures for Years 2009 through 2017
(includes corresponding Graph/Chart) III-34

Table 55: US Historic Review for Organ Transplantation by
Organ Type - Heart, Kidney, Liver, Pancreas, Lung and
Intestine Independently Analyzed by Number of Procedures for
Years 2003 through 2008 (includes corresponding Graph/Chart) III-35

Table 56: US 15-Year Perspective for Organ Transplantation
by Organ Type - Percentage Breakdown of Number of Procedures
for Heart, Kidney, Liver, Pancreas, Lung and Intestine
Markets for Years 2003, 2011 & 2017 (includes corresponding
Graph/Chart) III-36

Table 57: US Recent Past, Current & Future Market Analysis
for Tissue Transplantation by Tissue Type - Cornea, Heart
Valves, Skin Grafts, Vascular Grafts, Bone Marrow and Bone
Grafts Independently Analyzed by Number of Procedures for
Years 2009 through 2017 (includes corresponding
Graph/Chart) III-37

Table 58: US Historic Review for Tissue Transplantation by
Tissue Type - Cornea, Heart Valves, Skin Grafts, Vascular
Grafts, Bone Marrow and Bone Grafts Independently Analyzed
by Number of Procedures for Years 2003 through 2008
(includes corresponding Graph/Chart) III-38

Table 59: US 15-Year Perspective for Tissue Transplantation
by Tissue Type - Percentage Breakdown of Number of
Procedures for Cornea, Heart Valves, Skin Grafts, Vascular
Grafts, Bone Marrow and Bone Grafts Markets for Years 2003,
2011 & 2017 (includes corresponding Graph/Chart) III-39

Table 60: US Recent Past, Current & Future Market Analysis
for Bone Graft Transplantation by Graft Type - Autologous
Graft, Allograft and Other Materials Independently Analyzed
by Number of Procedures for Years 2009 through 2017
(includes corresponding Graph/Chart) III-40

Table 61: US Historic Review for Bone Graft Transplantation
by Graft Type - Autologous Graft, Allograft and Other
Materials Independently Analyzed by Number of Procedures for
Years 2003 through 2008 (includes corresponding Graph/Chart) III-41

Table 62: US 15-Year Perspective for Bone Graft
Transplantation by Graft Type - Percentage Breakdown of
Number of Procedures for Autologous Graft, Allograft and
Other Materials Markets for Years 2003, 2011 & 2017(includes
corresponding Graph/Chart) III-42

Table 63: US Recent Past, Current & Future Market Analysis
for Bone Graft Transplantation by Application - General
Orthopedics, Spinal Fusions and Cranio/Maxillofacial
Independently Analyzed by Number of Procedures for Years
2009 through 2017 (includes corresponding Graph/Chart) III-43

Table 64: US Historic Review for Bone Graft Transplantation
by Application - General Orthopedics, Spinal Fusions and
Cranio/Maxillofacial Independently Analyzed by Number of
Procedures for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-44

Table 65: US 15-Year Perspective for Bone Graft
Transplantation by Application - Percentage Breakdown of
Number of Procedures for General Orthopedics, Spinal Fusions
and Cranio/Maxillofacial Markets for Years 2003, 2011 &
2017(includes corresponding Graph/Chart) III-45

2. CANADA III-46
A.Market Analysis III-46
Canadians More Receptive to Organ Transplants III-46
Waiting List III-46
Table 66: Canadian Patients (Active and Inactive) on
Waiting List by Organ Type for 2009 and 1H 2010
(*)(includes corresponding Graph/Chart) III-46
Organ Donation III-47
Table 67: Canadian Organ Donations by Donor Type -
Cadaveric and Living for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-47
Success Rate of Organ Transplants III-47
Table 68: Success Rate of Organ Transplants After 1-Year
(includes corresponding Graph/Chart) III-47
B.Market Analytics III-48
Table 69: Canadian Recent Past, Current & Future Market
Analysis for Organ Transplantation by Organ Type - Heart,
Kidney, Liver, Pancreas and Lung Independently Analyzed by
Number of Procedures for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-48

Table 70: Canadian Historic Review for Organ Transplantation
by Organ Type - Heart, Kidney, Liver, Pancreas and Lung
Independently Analyzed by Number of Procedures for Years
2003 through 2008 (includes corresponding Graph/Chart) III-49

Table 71: Canadian 15-Year Perspective for Organ
Transplantation by Organ Type - Percentage Breakdown of
Number of Procedures for Heart, Kidney, Liver, Pancreas and
Lung Markets for Years 2003, 2011 & 2017(includes
corresponding Graph/Chart) III-50

3. EUROPE III-51
A.Market Analysis III-51
Table 72: Number of Organ Transplants in Select European
Countries by Organ: 2009 (includes corresponding
Graph/Chart) III-51

Table 73: Number of Deceased Organ Donors in Select
European Countries for 2008 & 2009 (includes corresponding
Graph/Chart) III-51
Focus on Select Regions III-52
The United Kingdom III-52
UK Organ Transplantation System: An Overview III-52
Organ Transplantation in the UK III-52
Table 74: UK Organ Transplantations for the Years 2007
and 2008 (includes corresponding Graph/Chart) III-53

Table 75: Waiting List (Active and Inactive) by Organ in
the UK for the Years 2007 and 2008 (includes
corresponding Graph/Chart) III-53
Corneal Transplantation in the UK III-53
Bladder Transplantation: A Roaring Success III-54
Spain III-54
Organ Transplantation in Spain III-54
France III-55
Table 76: Organ Transplantations in France for the Years
2006 through 2008 (includes corresponding Graph/Chart) III-55

Table 77: Waiting List (Active and Inactive) by Organ in
France for the Years 2006 through 2008 (includes
corresponding Graph/Chart) III-56
Italy III-56
Surge in Organ Transplants III-56
Russia III-56
Organ Transplantations Show a Downward Trend in Russia III-56
Turkey III-56
Akdeniz University - A World-Renowned Transplantation Center III-56
B.Market Analytics III-57
Table 78: European Recent Past, Current & Future Market
Analysis for Organ Transplantation by Organ Type - Heart,
Kidney, Liver, Pancreas and Lung Independently Analyzed by
Number of Procedures for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-57

Table 79: European Historic Review for Organ Transplantation
by Organ Type - Heart, Kidney, Liver, Pancreas and Lung
Independently Analyzed by Number of Procedures for Years
2003 through 2008 (includes corresponding Graph/Chart) III-58

Table 80: European 15-Year Perspective for Organ
Transplantation by Organ Type - Percentage Breakdown of
Number of Procedures for Heart, Kidney, Liver, Pancreas and
Lung Markets for Years 2003, 2011 & 2017 (includes
corresponding Graph/Chart) III-59

4. ASIA-PACIFIC III-60
A.Market Analysis III-60
Focus on Select Regions III-60
Australia III-60
Key Facts on Organ and Tissue Transplantation in Australia III-60
Australia Registers Highest Success Rate in Transplantation III-60
Table 81: Organ Transplantation in Australia by Organ
Type: 2008 (includes corresponding Graph/Chart) III-61
Table 82: Organ Transplant Waiting List by Organ Type: As
of January 2010 (includes corresponding Graph/Chart) III-61
Kidney Transplantation Snapshots III-61
Organ Donor Register III-62
China III-62
Organ Transplantations in China: Year 2005 & 6 in Review III-62
Transplantation Tourism in China III-62
Low Transplant Success Rate Due to Unskilled Professionals III-62
Cost Effective Transplant Procedures Lure Foreign Patients III-63
Illegal Activities for Harvesting Organs in China III-63
Regulations on Organ Transplantation III-63
Regulations on Brain Death III-64
India III-64
Overview of Renal Transplantation III-64
Transplantation Expenses in India III-65
Indian Government to Amend Organ Transplantation Rules III-65
Singapore III-65
Awareness Programs to Increase Living Kidney Donations in
Singapore III-65
Taiwan III-66
Taiwan Competes with the US in Kidney and Liver Transplant
Survival Rates III-66
B.Market Analytics III-67
Table 83: Asia-Pacific Recent Past, Current & Future Market
Analysis for Organ Transplantation by Organ Type - Heart,
Kidney, Liver, Pancreas and Lung Independently Analyzed by
Number of Procedures for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-67

Table 84: Asia-Pacific Historic Review for Organ
Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas and Lung Independently Analyzed by Number of
Procedures for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-68

Table 85: Asia-Pacific 15-Year Perspective for Organ
Transplantation by Organ Type - Percentage Breakdown of
Number of Procedures for Heart, Kidney, Liver, Pancreas and
Lung Markets for Years 2003, 2011 & 2017 (includes
corresponding Graph/Chart) III-69

5. LATIN AMERICA III-70
A.Market Analysis III-70
Brazil - A Major Transplant Market III-70
B.Market Analytics III-71
Table 86: Latin American Recent Past, Current & Future
Market Analysis for Organ Transplantation by Organ Type -
Heart, Kidney, Liver, Pancreas and Lung Independently
Analyzed by Number of Procedures for Years 2009 through 2017
(includes corresponding Graph/Chart) III-71

Table 87: Latin American Historic Review for Organ
Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas and Lung Independently Analyzed by Number of
Procedures for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-72

Table 88: Latin American 15-Year Perspective for Organ
Transplantation by Organ Type - Percentage Breakdown of
Number of Procedures for Heart, Kidney, Liver, Pancreas and
Lung Markets for Years 2003, 2011 & 2017 (includes
corresponding Graph/Chart) III-73

6. REST OF WORLD III-74
A.Market Analysis III-74
Kuwait - A Rapidly Emerging ‘Third World' Country in Organ
Transplants III-74
South Africa III-74
Key Statistical Findings on Organ and Cornea Transplants III-74
Table 89: Number of Organ and Cornea Transplants in South
Africa for Years 2005 through 2009 (includes corresponding
Graph/Chart) III-74

Table 90: Number of Organ Transplants (Excluding Cornea)
in South Africa by Organ for Years 2008 & 2009 (includes
corresponding Graph/Chart) III-75

Table 91: Number of Organ Transplants in Adult Patients in
South Africa by Organ for yeas 2008 & 2009 (includes
corresponding Graph/Chart) III-75

Table 92: Number of Organ Transplants in Adolescent
Patients in South Africa by Organ for Years 2008 & 2009
(includes corresponding Graph/Chart) III-76

Table 93: Number of Organ Transplants (Excluding Cornea)
in Pediatric Patients in South Africa by Organ for Years
2008 & 2009 (includes corresponding Graph/Chart) III-76

Table 94: Number of Heart Transplants in South Africa for
Years 2005 through 2009 (includes corresponding
Graph/Chart) III-76

Table 95: Number of Kidney Transplants in South Africa for
Years 2005 through 2009 (includes corresponding
Graph/Chart) III-77

Table 96: Number of Lung Transplants in South Africa for
Years 2005 through 2009 (includes corresponding
Graph/Chart) III-77

Table 97: Organ Transplants (Excluding Cornea) in South
Africa by Region (2008 & 2009): Percentage Breakdown of
Volume Procedures for Cape Town, Johannesburg, Durban,
Pretoria and Bloemfontein (includes corresponding
Graph/Chart) III-78

Table 98: Cornea Transplants in South Africa by Region
(2008 & 2009): Percentage Breakdown of Volume Procedures
for Johannesburg, Durban, Cape Town, Pretoria and Port
Elizabeth (includes corresponding Graph/Chart) III-78
B.Market Analytics III-79
Table 99: Rest of World Recent Past, Current & Future Market
Analysis for Organ Transplantation by Organ Type - Heart,
Kidney, Liver, Pancreas and Lung Independently Analyzed by
Number of Procedures for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-79

Table 100: Rest of World Historic Review for Organ
Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas and Lung Independently Analyzed by Number of
Procedures for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-80

Table 101: Rest of World 15-Year Perspective for Organ
Transplantation by Organ Type - Percentage Breakdown of
Number of Procedures for Heart, Kidney, Liver, Pancreas and
Lung Markets for Years 2003, 2011 & 2017 (includes
corresponding Graph/Chart) III-81

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 75 (including Divisions/Subsidiaries - 88)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 58
Canada 2
Japan 10
Europe 16
France 1
Germany 6
The United Kingdom 2
Italy 3
Rest of Europe 4
Asia-Pacific (Excluding Japan) 1
Middle-East 1
------------------------------------------

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