Global Organ and Tissue Transplantation Market

  • September 2014
  • -
  • Global Industry Analysts
  • -
  • 251 pages

This report analyzes the worldwide markets for Organ and Tissue Transplantation in Number of Procedures. The global and regional markets (except the US) for 'Organ and Tissue Transplantation' in this report are analyzed by the following Product Segments - Organ Tranplantation (Heart, Kidneys, Liver, Pancreas, and Lungs). The US market for 'Organ and Tissue Transplantation' in this report is analyzed by the following Product Segments: Organ Type (Heart, Kidneys, Liver, Pancreas, Lungs, and Intestine), Tissue Type (Cornea, Heart Valve, Skin Grafts, Vascular Grafts, Bone Marrow, and Bone Grafts), and Bone Graft Transplantation (By Graft Type: Autologous Graft, Allograft, and Other Materials; By Application Type: General Orthopedics, Spinal Fusions, and Cranio/Maxillofacial). The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 24 companies including many key and niche players such as -

CryoLife, Inc.
Exactech, Inc.
Folio Biosciences
Köhler Chemie
LifeCell Corporation

Table Of Contents




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


II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW II-1
A Quick Primer II-1
Europe and the United States Lead the Global Organ Transplants
Market II-1
Table 1: Global Organ Transplants by Leading Country in Terms
of No. of Transplants Per Million Population (PMP) for the
Year 2012 (includes corresponding Graph/Chart) II-2
Kidney and Liver Transplants Top the Organ Transplants Worldwide II-2
Table 2: Global Kidney Transplants from Deceased Donor by
Select Countries (2013): No. of Transplants Per Million
Population (PMP) by Country (includes corresponding
Graph/Chart) II-3

Table 3: Global Kidney Transplants from Living Donor by
Select Countries (2013): No. of Transplants per Million
Population (PMP) by Country (includes corresponding
Graph/Chart) II-3

Table 4: Global Liver Transplants from Deceased Donor by
Select Countries (2013): No. of Transplants per Million
Population (PMP) by Country (includes corresponding
Graph/Chart) II-4

Table 5: Global Liver Transplants from Living Donor by Select
Countries (2013): No. of Transplants per million population
(PMP) by Country (includes corresponding Graph/Chart) II-4

Table 6: Global Heart Transplants by Select Countries (2013):
No. of Transplants Per million population (includes
corresponding Graph/Chart) II-5

Table 7: Global Lung Transplants by Select Countries (2013):
Number of Transplants Per Million Population (includes
corresponding Graph/Chart) II-5

Table 8: Global Pancreas Transplants by Select Countries
(2013): Number of Transplants Per Million Population
(includes corresponding Graph/Chart) II-6
Demand and Supply Imbalance II-6
Table 9: European Organ Transplantation Waiting Lists: No. of
Waiting Patients by Organ Type (2012) (includes corresponding
Graph/Chart) II-6

Table 10: US Waiting List of Patients for Organ Transplants
by Organ Type: As of August 2014 (includes corresponding
Graph/Chart) II-7
Measures to Address Organ Shortage II-7
Cardiac Arrest Death Patients: The Untapped Potential Donors II-8
Table 11: Leading Countries in Terms of Number of Donors
after Cardiac Death (DCD) in 2013 (includes corresponding
Graph/Chart) II-8
Donation after Circulatory Death - Rife with Ethical Issues II-8
Living Donor Organs on the Rise II-9
Table 12: Global Living Organ Donors by Leading Country in
Terms of No. of Donors Per Million Population (PMP) for the
Year 2013 (includes corresponding Graph/Chart) II-9

Table 13: Global Deceased Organ Donors by Leading Country in
Terms of No. of Donors Per Million Population (PMP) for the
Year 2013 (includes corresponding Graph/Chart) II-10
Transplantation - Expenditure and Regional Variations II-10
Table 14: US Organ Transplantation Charges - Total Billed
Charges per Transplant by Type (2011) (includes
corresponding Graph/Chart) II-11
Bone Grafts: An Overview II-12
Table 15: Fractures by Age Group (2012): Percentage Share
Breakdown of Number of Fractures by Age Group (includes
corresponding Graph/Chart) II-13

Table 16: Global Orthopedic Market by Segment (2013E):
Percentage Breakdown of Value Sales for Spine, Trauma, Knees,
Hips, Orthobiologics, Extremities and Others (includes
corresponding Graph/Chart) II-13
Key Statistics in Global Orthopedics Industry II-14
Table 17: Worldwide Orthopedic Market (2013E): Percentage
Market Share Breakdown of Value Sales by Company for DePuy
Synthes, Stryker, Zimmer, Smith and Nephew, Medtronic, and
Others (includes corresponding Graph/Chart) II-14

Table 18: Worldwide Market for Orthopedic Implants in Spinal
Procedures (2013E): Percentage Market Share Breakdown of
Value Sales by Company for Medtronic, JandJ and Others
(includes corresponding Graph/Chart) II-14

Table 19: Worldwide Market for Orthopedic Implants for
Reconstructive Procedures (2013E): Percentage Market Share
Breakdown of Value Sales by Company for Zimmer, JandJ,
Stryker, Biomet, Smith and Nephew, and Others (includes
corresponding Graph/Chart) II-14

Table 20: Worldwide Market for Orthopedic Implants for
Trauma Procedures (2013E): Percentage Market Share Breakdown
of Value Sales by Company for JandJ, Stryker, Biomet Smith and
Nephew, Zimmer, and Others (includes corresponding
Graph/Chart) II-15

Table 21: Global Joint Replacement Market (2013E):
Percentage Market Share Breakdown of Sales for Zimmer, DePuy
Synthes, Stryker, Biomet, Smith and Nephew, and Others
(includes corresponding Graph/Chart) II-15
Orthopedic Grafts - Regional Market Variations II-15

2. MARKET TRENDS II-16
Combined Organ Transplantation - Gaining Attention II-16
Table 22: Multiple Organ Transplants in the US - No. of
Transplants by Type (2010-2014) II-16
Illegal Organ Trafficking - A Risky Proposition II-16
Increasing Consent Rates - A Key Factor II-17
Transplant Tourism - Creating Brighter Avenues II-17
Alliances to Play a Key Role II-17
Graying Population and Chronic Diseases Surge Need for
Transplants II-17
Table 23: Aged Population (65+ Years) as a Percentage of the
Total Population: 2000 Vis-a-vis 2025 (includes corresponding
Graph/Chart) II-18

Table 24: Aged Population (65+ Years) as a Percentage of the
Total Population by Region: 2000 Vis-a-vis 2025 (includes
corresponding Graph/Chart) II-19

Table 25: Global Aging Population by Age Group: 1975-2050
(includes corresponding Graph/Chart) II-20

Table 26: Aging Population by Age Group in More Developed
Countries: 1975-2050 (includes corresponding Graph/Chart) II-21

Table 27: Aging Population by Age Group in Less Developed
Countries: 1975-2050 (includes corresponding Graph/Chart) II-22

Table 28: Aging Population by Age Group in Least Developed
Countries: 1975-2050 (includes corresponding Graph/Chart) II-23
Rising Incidences of Degenerative Intervertebral Disc Diseases
Promote Tissue Transplantation II-23
Table 29: % of Women Affected by Osteoporosis (includes
corresponding Graph/Chart) II-24
Fetal Tissue for Bionic Devices - Assuming Importance II-24
LVADs - Gaining Significance for Impending Heart Transplants II-24
Stem Cell Based Bone Grafts - Fastest Growing Bone Graft
Substitute Segment II-25
Synthetic Bone Graft - The Latest Trend II-25
Stem Cell Therapies - Expanding the Horizon of Transplantation II-26
Rising Cancer Incidence to Drive Stem Cell Transplants II-26
Table 30: Number of New Cancer Cases Worldwide by Affected
Site: 2012 (in Thousands) (includes corresponding
Graph/Chart) II-27
Demineralized Bone Matrix (DBM): Strong Growth but Tough
Competition II-27
Bone Morphogenetic Protein - Safety Concerns Affect Growth
Prospects II-28
Dental Bone Grafting - A High Potential Market II-28
Table 31: Global Dental Regeneration Market (2013E):
Percentage Share Breakdown of Value Sales for Bone
Allografts, Membranes, Tissue Regeneration (includes
corresponding Graph/Chart) II-29

3. TECHNOLOGICAL INNOVATIONS II-30
3-D Bioprinting II-30
Preloaded Corneal Tissue Cartridges II-30
Lung Perfusion Technology II-30

4. MAJOR ISSUES IMPACTING TRANSPLANTATION MARKET II-31
Organ Rejection - A Major Barrier to Transplantation II-31
Scarcity of Donor Organs - A Stumbling Block in Organ
Transplantation II-31
Other Issues for Organ Transplantation II-31
Ethical Concerns in Transplants II-31
Bioethical Issues Hinder Organ Donation Process II-32
Lack of Requisite Expertise - Hindering Implantation Process II-32
Corneal Transplantation in Developing Countries: Key Challenges II-32

5. PRODUCT OVERVIEW II-33
Organ and Tissue Transplantation II-33
Organ Transplantation II-33
Heart Transplantation II-33
Heart Diseases and Disorders II-34
Post-Operative Complications and Consequences of Heart
Transplants II-34
Bleeding II-34
Infection II-34
Arrythymia II-34
Heart Attack II-34
Coronary Artery Disease II-35
Respiratory Dysfunction II-35
Renal Dysfunction II-35
Graft Rejection and Dysfunction II-35
Death II-35
Kidney Transplantation II-35
Kidney Disorders and Diseases II-36
Donor Evaluation II-36
Waiting List II-36
Surgery/Post-Operation II-36
Post-Operative Supervision and Issues II-36
Liver Transplantation II-37
Liver Disorders and Diseases II-38
Pancreas Transplantation II-38
Post-Operative Complications and Consequences of Pancreas
Transplants II-39
Small Intestine Transplantation II-39
Intestine Disorders and Diseases II-39
Heart-and-Lung Transplantation II-39
Lung Transplantation II-40
Lung Diseases and Disorders II-40
Lung Patients Survival Statistics II-40
Tissue Transplantation II-40
Types of Grafts II-40
Autograft II-40
Allograft / Homograft II-41
Transplant Tolerance II-41
Isograft II-41
Xenograft II-42
Corneal Transplantation II-42
Penetrating Keratoplasty II-43
Lamellar (Non-Penetrating) Keratoplasty II-43
Aftercare II-43
Risks Associated with Corneal Transplants II-43
Transplantation Outcomes II-43
Morbidity and Mortality Rates II-44
Alternatives II-44
Blood Stem Cells II-44
Peripheral Blood Stem Cell Transplant II-44
Umbilical Cord Blood Stem Cell Transplant II-44
Bone Marrow and Hematopoietic Stem Cells II-44
Bone and Tissue Transplantation II-45
Bone Marrow Transplants II-45
Stem Cell Therapy II-45
Human Heart Valves II-46
Atrioventricular Valves II-46
Mitral Valve II-46
Tricuspid Valve II-46
Semilunar Valves II-47
Aortic Valve II-47
Pulmonic Valve II-47
Pathology of Valves II-47
Prosthetic Heart Valves II-47
Prosthetic Mechanical Valve II-48
Advantages II-48
Disadvantages II-48
Prosthetic Biologic Valve II-48
Advantages II-49
Disadvantages II-49
Fetal Cells II-49
Fetal Tissue for Transplantation II-50
Storage Duration Time II-50
Storage Time Period for Organs and Tissues II-50
Cold Ischemia Time II-50
Transplantation Immunology II-50
Acute Cellular Rejection II-50
Chronic Rejection II-51
Post Transplant Observations II-51
Types of Donors II-51
Alive Donors II-51
Related Donors II-52
Good Samaritans II-52
Rewarded/Forced Donors II-52
Deceased Donors II-52
Directed / Allocated II-52
Organs and Tissues Transplanted by Type of Donor II-52
Organ/Tissue Donation and Eligibility Criteria II-53
Factors Considered for Matching Recipients to Donor Organs II-53
Testing II-54
Blood Typing II-54
Tissue Typing II-54
Histocompatibility - A Major Barrier for Organ Transplantation II-54
Transplantation - Safety Requirements II-55
Waiting List II-55
Active Waiting List Patients II-56
Inactive Waiting List Patients II-56
History II-56

6. ARTIFICIAL ORGANS - AN ALTERNATIVE TO SOLID ORGAN TRANSPLANTS II-59
Artificial Organs Revolutionize Medical Technology Industry II-59
Artificial Organs II-59
Categorization of Artificial Organs II-59
External Artificial Organs II-59
Internal or Implantable Artificial Devices II-60
Artificial Heart II-60
Total Artificial Heart (TAH) II-60
Ventricle Assist Device (VAD) II-60
Right Ventricular Assist Systems (RVAS) II-60
Left Ventricular Assist Systems (LVAS) II-60
Various Ventricle Assist Devices Approved in the Recent Past II-61
Artificial Kidney (Dialyzer) II-61
Limitations of Artificial Kidney II-62
Artificial Liver II-62
Various Liver Assist Devices II-62
Categorization of Liver Devices II-62
Mechanical Systems II-62
Bio-Artificial Systems II-63
Artificial Pancreas II-63
Artificial Lungs (Oxygenator) II-63
Types of Artificial Lung II-63
Artificial Cornea II-63
Keratoprostheses II-64
Tissue Engineered Corneas II-64
Artificial Skin/Skin Replacement Products II-64
AlloDerm Regenerative Tissue Matrix II-64
Apligraf II-64
Cymetra Micronized AlloDerm Tissue II-64
Dermagraft II-64
Epicel II-65
Integra Products II-65
OrCel II-65
TransCyte II-65
Core Competitive Factors II-65
Market Outlook for Artificial Organs II-66

7. PRESERVATION SOLUTIONS and IMMUNOSUPPRESSANT DRUGS II-67
Organ Preservation Solutions II-67
Celsior Solution II-67
Collins Solution II-67
Euro Collins Solution II-67
Custodiol® HTK Solution II-67
Hypothermosol II-67
ViaSpan II-68
Immunosuppressant Drugs II-68
Antibody Products for Treatment of Organ Transplant Rejection II-68
Antithymocyte Globulin II-68
ATGAM II-68
Thymoglobulin II-69
Therapeutic Antibody Products II-69
Antiproliferative Agents II-69
Azathioprine II-69
CellCept II-69
Certican II-69
Myfortic II-69
Calcineurin Inhibitors II-69
Cyclosporine II-70
Gengraf II-70
Neoral II-70
Prograf (Tacrolimus) II-70
TOR Inhibitors II-70
Side Effects of Immunosuppression Therapy II-70
Select Players Engaged in Immunosuppressant Drugs/Anti-
Rejection Therapy/ Bridge-to- Transplantation Devices II-71
Astellas Pharma US, Inc. (USA) II-71
F.Hoffmann-La Roche Ltd. (Switzerland) II-71
Novartis AG (Switzerland) II-71
Wyeth (USA) II-72
Abiomed, Inc. (USA) II-72
Fresenius Medical Care AG and Co. KGaA (Germany) II-72
Gambro AB (Sweden) II-73
Genzyme Corporation (US) II-73
Jarvik Heart, Inc. (US) II-74
ReliantHeart (US) II-74
SynCardia Systems (US) II-74
Terumo Corporation (Japan) II-74
Teleflex Inc. (US) II-75
Thoratec Corporation (US) II-76
Heart Ware International, Inc. (US) II-76

8. REGULATORY ENVIRONMENT II-77
Transplant Center II-77
Organ Procurement Organization (OPO) II-77
Health Resources and Services Administration (HRSA) II-77
Division of Transplantation (DoT) II-77
United Network for Organ Sharing (UNOS) II-77
Organ Procurement and Transplantation Network (OPTN) II-77
University Renal Research and Education Association (URREA) II-78
Scientific Registry of Transplant Recipients (SRTR) II-78
Funding Sources II-78
Patient Education and Advocacy Organizations II-78
Legal Framework for Transplantation II-79
Legislation Covering Organ Transplant II-79
Organ Transplantation and Ethics II-79

9. PRODUCT DEVELOPMENT/INNOVATIONS II-81
AlloSource Introduces AlloMendâ„¢ II-81
Synergy Biomedical Launches Bonegraft Product BioSphere Putty II-81
K2M Launches Venado Bonegraft Systems II-81
OTS Launches LifeCradle® Heart Perfusion System II-81
BioHorizons Launches MinerOss® Cancellous Dental Grafts II-81
K2M Launches Vesuvius Graft Systems II-81
OTTR Launches Pediatric BMT System II-82
Amedica to Begin Distribution of Dynamic Bone II-82
BioMimetic Introduces Augmatix Bonegraft II-82
Integra Introduces Integra® Allograft Wedge System II-82

10. RECENT INDUSTRY ACTIVITY II-83
ThermoGenesis and TotipotentRX Complete 20th Pediatric BMT II-83
LifeCell Acquires Adipose Tissue Injector from Tau Tona Group II-83
FBiH Signs Agreement with Croatia II-83
AlloSource and HumaCyte Enter Manufacturing Agreement II-83
PSF Partners with MTF for Research Grants II-83
Wright Medical Partners with BioMimetic Therapeutics II-83
Pharmalink Signs Manufacturing Agreement with GP Pharm II-84
Isotechnika Pharma Ends Agreement with ILJIN II-84
Veloxis Starts STRATO Study in Kidney-Transplant Recipients II-84
Isotechnika Signs Voclosporin License Agreement with Vifor Pharma II-84

11. FOCUS ON SELECT GLOBAL PLAYERS II-85
CryoLife, Inc.(US) II-85
Exactech, Inc. (US) II-85
Folio Biosciences (US) II-86
Köhler Chemie (Germany) II-86
LifeCell Corporation (US) II-86
Medtronic, Inc. (US) II-87
Organogenesis, Inc. (US) II-87
Organ Recovery Systems (US) II-87
Organ Transport Systems (US) II-88
XVIVO Perfusion AB (Sweden) II-88

12. GLOBAL MARKET PERSPECTIVE II-89
Table 32: World Recent Past, Current and Future Analysis for
Organ Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-89

Table 33: World Historic Review for Organ Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-90

Table 34: 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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-91

Table 35: World Recent Past, Current and Future Analysis for
Heart Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-92

Table 36: World Historic Review for Heart Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-93

Table 37: 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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-94

Table 38: World Recent Past, Current and Future Analysis for
Kidney Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-95

Table 39: World Historic Review for Kidney Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-96

Table 40: 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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-97

Table 41: World Recent Past, Current and Future Analysis for
Liver Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-98

Table 42: World Historic Review for Liver Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-99

Table 43: 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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-100

Table 44: World Recent Past, Current and Future Analysis for
Pancreas Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-101

Table 45: World Historic Review for Pancreas Transplantation
by Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-102

Table 46: 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 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-103

Table 47: World Recent Past, Current and Future Analysis for
Lung Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-104

Table 48: World Historic Review for Lung Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-105

Table 49: 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
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-106

Table 50: World Recent Past, Current and Future Analysis for
Corneal Transplantation by Geographic Region - US, Canada,
Europe, Asia-Pacific (including Japan), Latin America and Rest
of World Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-107

Table 51: World Historic Review for Corneal Transplantation by
Geographic Region - US, Canada, Europe, Asia-Pacific
(including Japan), Latin America and Rest of World Markets
Independently Analyzed by Number of Procedures for Years 2006
through 2012 (includes corresponding Graph/Chart) II-108

Table 52: 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 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-109


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Organ Transplants Market in the US III-1
Organ Transplants by Donor III-1
Table 53: The US Organ Donors per 1 Million Population by
Type - Kidney, Liver, Heart, Lung, and Pancreas for the
Years 2011, 2012 and 2013 (includes corresponding
Graph/Chart) III-1

Table 54: The US Bone Marrow Donor Registry: Percentage
Breakdown of Adult Donors and Cord Blood Units by
Race/Ethnicity (includes corresponding Graph/Chart) III-2

Table 55: The US Kidney Transplants by Donor Type -
Deceased and Living: Number of Procedures for 2012, 2013,
and 2014 E (includes corresponding Graph/Chart) III-3

Table 56: The US Kidney Transplants by Donor Type -
Deceased and Living: Percentage Share Breakdown of Number
of Procedures for 2012, 2013, and 2014 E (includes
corresponding Graph/Chart) III-3

Table 57: The US Liver Transplants by Donor Type - Deceased
and Living: Number of Procedures for 2012, 2013, and 2014 E
(includes corresponding Graph/Chart) III-4

Table 58: The US Liver Transplants by Donor Type - Deceased
and Living: Percentage Share Breakdown of Number of
Procedures for 2012, 2013, and 2014 E (includes
corresponding Graph/Chart) III-4

Table 59: The US Heart Transplants by Donor Type - Deceased
and Living: Number of Procedures for 2012, 2013, and 2014 E
(includes corresponding Graph/Chart) III-5

Table 60: The US Heart Transplants by Donor Type - Deceased
and Living: Percentage Share Breakdown of Number of
Procedures for 2012, 2013, and 2014 E III-5

Table 61: The US Lung Transplants by Donor Type - Deceased
and Living: Number of Procedures for 2012, 2013, and 2014 E
(includes corresponding Graph/Chart) III-6

Table 62: The US Lung Transplants by Donor Type - Deceased
and Living: Percentage Share Breakdown of Number of
Procedures for 2012, 2013, and 2014 E (includes
corresponding Graph/Chart) III-6

Table 63: The US Pancreas Transplants by Donor Type -
Deceased and Living: Number of Procedures for 2012, 2013,
and 2014 (Aug ’14) (includes corresponding Graph/Chart) III-7

Table 64: The US Pancreas Transplants by Donor Type -
Deceased and Living: Percentage Share Breakdown of Number
of Procedures for 2012, 2013, and 2014 E (includes
corresponding Graph/Chart) III-7

Table 65: The US Intestinal Transplants by Donor Type -
Deceased and Living: Number of Procedures for 2012, 2013,
and 2014 (Aug ’14) (includes corresponding Graph/Chart) III-8

Table 66: The US Intestinal Transplants by Donor Type -
Deceased and Living: Percentage Share Breakdown of Number
of Procedures for 2012, 2013, and 2014 E (includes
corresponding Graph/Chart) III-8
Waiting List III-9
Table 67: Waiting List of Patients for Organ Transplants by
Organ Type: as of August 2014 (includes corresponding
Graph/Chart) III-9
Select Market Trends III-10
Rising Incidence of ESRD in the US: A Business Case for
Kidney Transplants III-10
Table 68: ESRD Patient Prevalence in the US (2010-2015)
(includes corresponding Graph/Chart) III-10
Innovative Means of Organ Procurement to Increase Organ
Donations III-10
KPD Enables Compatibility Factor for Kidney Transplants III-10
Awareness Programs to Address Shortage of Minority Donors III-11
US Organ Procurement Organizations by State III-11
Tissue Transplantation in the US III-13
Dental Bone Graft Substitutes Market: An Overview III-13
Regulatory Challenges Limit Growth in the US Orthopedic
Biomaterials Market III-13
Rising Incidence of Degenerative Intervertebral Disc
Diseases-Opportunity Indicators for Bone Grafts III-13
Osteoporosis III-14
Table 69: Osteoporosis Population in the US: 2002, 2005,
2008 and 2012 (includes corresponding Graph/Chart) III-14

Table 70: Breakdown of Osteoporotic Fractures by Site in
the US (includes corresponding Graph/Chart) III-15
Regulatory Bodies III-15
The United Network for Organ Sharing III-15
The American Association of Tissue Banks (AATB) III-15
National Organ Transplant Act (NOTA) III-18
Good Tissue Practices III-18
Tissue Banking Regulation III-18
FDA Regulations on Xenograft III-18
DBM-based Products in US III-18
Synthetic Bone Graft Substitutes III-19
Product Launches III-19
Strategic Corporate Developments III-21
Select Key Players III-22
B.Market Analytics III-25
By Value Sales III-25
Table 71: The US Recent Past, Current and Future Analysis for
Organ Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas, Lung and Intestine Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) III-25

Table 72: The US Historic Review for Organ Transplantation
by Organ Type - Heart, Kidney, Liver, Pancreas, Lung and
Intestine Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2012
(includes corresponding Graph/Chart) III-26

Table 73: The 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 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-27

Table 74: The US Recent Past, Current and Future Analysis for
Tissue Transplantation Market Analyzed with Annual Sales
Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-28

Table 75: The US Historic Review for Tissue Transplantation
Market Analyzed with Annual Sales Figures in US$ Million
for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-28
By Number of Procedures III-29
Table 76: The US Recent Past, Current and Future Analysis for
Organ Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas, Lung and Intestine Markets Independently Analyzed
by Number of Procedures for Years 2013 through 2020
(includes corresponding Graph/Chart) III-29

Table 77: The US Historic Review for Organ Transplantation
by Organ Type - Heart, Kidney, Liver, Pancreas, Lung and
Intestine Markets Independently Analyzed by Number of
Procedures for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-30

Table 78: The 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 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-31

Table 79: The US Recent Past, Current and Future Analysis for
Tissue Transplantation by Tissue Type - Cornea, Heart
Valves, Skin Grafts, Vascular Grafts, Bone Marrow and Bone
Grafts Markets Independently Analyzed by Number of
Procedures for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-32

Table 80: The US Historic Review for Tissue Transplantation
by Tissue Type - Cornea, Heart Valves, Skin Grafts,
Vascular Grafts, Bone Marrow and Bone Grafts Markets
Independently Analyzed by Number of Procedures for Years
2006 through 2012 (includes corresponding Graph/Chart) III-33

Table 81: The 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 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-34

Table 82: The US Recent Past, Current and Future Analysis for
Bone Graft Transplantation by Graft Type - Autologous
Graft, Allograft and Other Materials Markets Independently
Analyzed by Number of Procedures for Years 2013 through
2020 (includes corresponding Graph/Chart) III-35

Table 83: The US Historic Review for Bone Graft
Transplantation by Graft Type - Autologous Graft, Allograft
and Other Materials Markets Independently Analyzed by
Number of Procedures for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-36

Table 84: The 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 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-37

Table 85: The US Recent Past, Current and Future Analysis for
Bone Graft Transplantation by Application - General
Orthopedics, Spinal Fusions and Cranio/Maxillofacial
Markets Independently Analyzed by Number of Procedures for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-38

Table 86: The US Historic Review for Bone Graft
Transplantation by Application - General Orthopedics,
Spinal Fusions and Cranio/ Maxillofacial Markets
Independently Analyzed by Number of Procedures for Years
2006 through 2012 (includes corresponding Graph/Chart) III-39

Table 87: The 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 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-40

2. CANADA III-41
A.Market Analysis III-41
Canadians More Receptive to Organ Transplants III-41
Table 88: Canadian Organ Donors by Donor Type - Deceased
and Living for Years 2011and 2012 (includes corresponding
Graph/Chart) III-41

Table 89: Canadian Deceased Organ Donors by Age Group (2011 and
2012) (includes corresponding Graph/Chart) III-41

Table 90: Canadian Living Organ Donors by Age Group (2011 and
2012) (includes corresponding Graph/Chart) III-42

Table 91: Canadian Multiple Organ Transplants by Type in
Terms of Number of Transplants: 2012 (includes
corresponding Graph/Chart) III-42
Small Intestine Transplants III-43
Table 92: Canadian Intestinal Transplants by Transplant
Type and Age Group (2003-2012) (includes corresponding
Graph/Chart) III-43
Waiting List III-43
Table 93: Canadian Patients on Active Waiting List for
Organ Transplants by Type: 2012 (includes corresponding
Graph/Chart) III-44

Table 94: Canadian Patients on Active Waiting List for
Combination Organ Transplants by Type (2012) (includes
corresponding Graph/Chart) III-44
Success Rate of Organ Transplants III-45
Table 95: Success Rate of Organ Transplants after 1-Year
(includes corresponding Graph/Chart) III-45
Favorable Growth Prospects in Bone Graft Substitutes Market III-45
B.Market Analytics III-46
Table 96: Canadian Recent Past, Current and Future Analysis
for Organ Transplantation by Organ Type - Heart, Kidney,
Liver, Pancreas and Lung Markets Independently Analyzed by
Number of Procedures for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-46

Table 97: Canadian Historic Review for Organ Transplantation
by Organ Type - Heart, Kidney, Liver, Pancreas and Lung
Markets Independently Analyzed by Number of Procedures for
Years 2006 through 2012 (includes corresponding Graph/Chart) III-47

Table 98: 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 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-48

3. EUROPE III-49
A.Market Analysis III-49
Table 99: European Deceased Organ Donor Per Million
Population (PMP) by Country for 2011, 2012 and 2013 (includes
corresponding Graph/Chart) III-49

Table 100: European Living Organ Donor Per Million
Population (PMP) by Country for 2013 (includes
corresponding Graph/Chart) III-49

Table 101: European Single Organ Transplantations by Select
Country and Organ Type: 2013 (includes corresponding
Graph/Chart) III-50

Table 102: European Multi-Organ Transplantations by Select
Country and Transplant Type: 2013 (includes corresponding
Graph/Chart) III-50

Table 103: European Organ Transplantation Waiting Lists:
No. of Waiting Patients by Organ Type (2012) (includes
corresponding Graph/Chart) III-51
Orthopedic Biomaterials Market - Overview III-51
Table 104: European Bone Graft Substitutes Market (2012):
Percentage Share Breakdown of Value Sales for Synthetic,
Allograft, and DBM (includes corresponding Graph/Chart) III-52
Synthetic Bone Graft Market Drives the BGS Market III-52
Dental Biomaterials Market in Europe: An Insight III-52
Medical Tourism Bodes Well for Dental Implants Market III-53
Turkey - Fastest Growing Dental Implant Market III-53
Competitive Scenario III-53
Key Statistical Data III-54
Table 105: European Market for Standard Bone Allografts
(2012): Percentage Share Breakdown of Revenues by Leading
Companies/Organizations (includes corresponding
Graph/Chart) III-54

Table 106: European Market for Machined Bone Allografts
(2012): Percentage Share Breakdown of Revenues by Leading
Companies/Organizations (includes corresponding
Graph/Chart) III-54

Table 107: European Market for Demineralized Bone Matrix
(2012): Percentage Market Share Breakdown of Revenues by
Leading Companies/ Organizations (includes corresponding
Graph/Chart) III-55

Table 108: European Market for Bone Graft Substitutes
(2012): Percentage Share Breakdown of Value Sales by
Leading Players (includes corresponding Graph/Chart) III-55
Regulatory Overview III-56
EU Directive 2003/32/EC on Bone Grafts III-56
DBM-based Products in Europe and Rest of World III-56
Focus On Select Regions III-56
The United Kingdom III-56
UK Organ Transplantation System: An Overview III-56
Organ Transplantation Statistics in the UK III-56
Table 109: The UK Organ Donors by Type (April 2012 and
April 2013) (includes corresponding Graph/Chart) III-57

Table 110: The UK Organ Transplantation by Organ Type:
2012 Vs. 2013 (includes corresponding Graph/Chart) III-57

Table 111: The UK Active Transplant Waiting List by
Organ: As of April 2012 and April 2013 (includes
corresponding Graph/Chart) III-58

Table 112: The UK Deceased Donor Kidney Program (March
2010-March 2013) - No. of Kidney Donors, No. of Patients
on Active Waiting List, and No. of Kidney Transplants
(includes corresponding Graph/Chart) III-59
Corneal Transplantation in the UK III-59
Spain III-59
Organ Transplantation in Spain III-59
France III-60
Table 113: Organ Transplantations in France by Organ Type:
2012 (includes corresponding Graph/Chart) III-60

Table 114: Transplant Waiting List by Organ in France:
2012 (includes corresponding Graph/Chart) III-61

Table 115: Transplants from Living Donors by Organ Type in
France: 2012 (includes corresponding Graph/Chart) III-61
Italy III-62
Surge in Organ Transplants III-62
Russia III-62
Organ Transplantations Show a Downward Trend in Russia III-62
Turkey III-62
Table 116: Turkey - High PMP Numbers of Living Organ
Donors/Transplants (includes corresponding Graph/Chart) III-62
Akdeniz University - A World-Renowned Transplantation Center III-63
Strategic Corporate Developments III-63
Select Key Players III-64
B.Market Analytics III-65
Table 117: European Recent Past, Current and Future Analysis
for Organ Transplantation by Organ Type - Heart, Kidney,
Liver, Pancreas and Lung Markets Independently Analyzed by
Number of Procedures for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-65

Table 118: European Historic Review for Organ
Transplantation by Organ Type - Heart, Kidney, Liver,
Pancreas and Lung Markets Independently Analyzed by Number
of Procedures for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-66

Table 119: 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 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-67

4. ASIA-PACIFIC III-68
A.Market Analysis III-68
Table 120: Asia-Pacific Deceased Organ Donor Per Million
Population (PMP) by Country for 2011, 2012 and 2013 (includes
corresponding Graph/Chart) III-68

Table 121: Asia-Pacific Living Organ Donor Per Million
Population (PMP) by Country for 2011, 2012 and 2013 (includes
corresponding Graph/Chart) III-68
Focus on Select Regions III-69
Australia - One of the Major Organ Transplant Markets in
Asia-Pacific III-69
Key Facts on Organ and Tissue Transplantation in Australia III-69
Australia Registers Highest Success Rate in Transplantation III-69
Table 122: Australia Organ Transplantations by Organ
Type: 2013 (includes corresponding Graph/Chart) III-69

Table 123: Australian Organ Transplants by State: 2013
(includes corresponding Graph/Chart) III-70
Thriving Orthopedic Biomaterials Market in Asia-Pacific III-70
China III-71
Organ Transplantations in China: Years 2010 to 2013 in Review III-71
Origin III-71
Transplantation Tourism in China III-72
Low Transplant Success Rate Due to Unskilled Professionals III-72
Cost Effective Transplant Procedures Lure Foreign Patients III-72
Illegal Activities for Harvesting Organs in China III-72
Regulations on Organ Transplantation III-72
Regulations on Brain Death III-73
India III-73
Overview of Renal Transplantation III-73
Transplantation Expenses in India III-74
Indian Government to Amend Organ Transplantation Rules III-74
Rise in Medical Tourism Drives Bone Grafts Market III-74
Aging Population Boosts the Indian Orthopedic Market III-74
Singapore III-75
Awareness Programs to Increase Living Kidney Donations in
Singapore III-75
Terumo Corporation (Japan) - A Key Player III-75
B.Market Analytics III-76
Table 124: Asia-Pacific Recent Past, Current and Future
Analysis for Organ Transplantation by Organ Type - Heart,
Kidney, Liver, Pancreas and Lung Markets Independently
Analyzed by

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