Organ and Tissue Transplantation and Alternatives

The global market for transplantation products, devices, and pharmaceuticals was valued at nearly $54 billion in 2010 and is projected to grow at an 8.3% compound annual growth rate (CAGR) to reach $80 billion in 2015.

BCC projects that the fastest growing areas of the transplantation market are in tissue typing and tissue products.  Tissue typing technologies are expected to grow at a compound annual growth rate (CAGR) of 12% through the forecast period, from a value of $313 million in 2010 to $553 million in 2015. Tissue product development should grow at a CAGR of 10.8%, from 15.6 billion in 2010 to more than $26 billion by 2015. 

Alternatives to organ and tissue transplantation continue to add options for cardiac and orthopedic patients, among others. The alternative technologies sector was valued at nearly $29 billion in 2010 and is expected to increase at a 6.9% compound annual growth rate (CAGR) to reach $40 billion in 2015.

INTRODUCTION




REASONS FOR DOING THE STUDY

The objective of this study is to provide an in-depth analysis and forecast of the solid organ and tissue transplantation markets. The focus is on products and procedures used or under development for organ and tissue transplantations, including techniques, therapies, drugs, and diagnostics. Additionally, a market analysis of alternative transplantations with devices such as ventricular assist devices (VAD), total artificial hearts (TAH), and orthopedic replacement and reconstruction devices will be explored.

STUDY GOALS AND OBJECTIVES

Organ transplantation is a dynamic field, with continuing progress in the development of artificial organs and transplantation methods that reduce rejection and infection. There are increased pressures to ensure transplantation methods are as efficient and effective as possible because the need for organ donors far outstrips the availability of organs and tissues

In theory, transplantation is the last therapeutic option available to people in the final stage of an organ or tissue failure. In reality, the supply of organs or tissues is so limited that for the vast majority of people, transplantation is not an option. Despite the lack of organs, the transplantation business continues to innovate through better harvesting and procurement techniques, vastly improved immunosuppression regimens, advanced tissue matching, and effective anti-infective regimens, all of which have helped build the organ and tissue transplantation business to a maturing stage.

This report will focus on procurement and preservation, solid organ transplantation, tissue transplantation, immunosuppressives and other pharmaceuticals, post-transplantation concerns, and alternatives to transplantation. Although the organ transplantation business faces tough challenges, it also offers exciting fields of research and tremendous opportunities to meet growing market demand.

With transplant recipients living much longer, there is a growing need for post-transplant immunosuppression and monitoring. This aspect of the transplantation process will be covered, describing post-transplant drug regimens and patient and graft survival rates.

This report is a valuable tool for anyone assessing the organ and tissue transplantation market and attempting to devise a strategy to successfully compete in this market. This report provides a thorough background on the structure of the organ and tissue transplantation market and the chief challenges and opportunities it faces. It offers the information needed to understand the current market and to address the emerging one.

This is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investing consultants, and others interested in the tissue and transplantation market, its products, its participants, and its future.

SCOPE OF REPORT

This report offers forecasts, by product segment, from 2010 through 2015, including supporting analyses for projections. Product segments covered consist of solid organ (e.g., kidneys, liver, heart-lung, pancreas, intestines) and the tissue transplantation (e.g., bone, skin, cornea, heart valves) markets, along with the pharmaceuticals that accompany each market.

Also included are experimental xenografts and artificial organs; tissue transplants; and cell transplants (e.g., bone marrow, cord blood, peripheral blood, islet cell). The report touches on the use of fetal cells, stem cells, and altered cancer cells.

The arrangement of this report offers an overview of the key elements in the transplantation process: tissue typing, procurement and preservation, immunosuppressants for solid organ and tissue transplants, and postoperative monitoring. International markets are discussed, and information is provided on industry structure and the regulatory environment.

Within each section are discussions of commercialization opportunities for each segment of the market. New or emerging devices, techniques, and pharmaceuticals are highlighted.

Profiles of more than 50 leading companies involved with solid organ transplantation, tissue transplantation, and alternative technologies are included. The report provides information on company placement within the market and strategic analyses of the companies’ available and emerging products.

An appendix featuring various terms and processes used in transplantation is provided at the end of the report.

This report cites autologous products only in relation to their impact on the market for allografts. It does not include blood products, with the exception of peripheral and umbilical cord blood as a source of stem cells.

METHODOLOGIES AND INFORMATION SOURCES

Information for this report was derived from a variety of primary and secondary research sources, including industry analysts, annual reports and Securities and Exchange Commission (SEC) reports, the United Network for Organ Sharing (UNOS), the Organ Procurement and Transplantation Network (OPTN), the Scientific Registry of Transplant Recipients (SRTR), the Center for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), the Centers for Disease Control (CDC), other government agencies, and journal articles. Secondary sources include literature searches; product literature; and press releases.

When precise information was not available, a consensus was made using reasonable assumptions and estimates based on historical data.

ANALYST CREDENTIALS

Peggy S. Lehr is the BCC Research analyst of this report. Ms. Lehr has worked with the publishing arms of for-profit and not-for-profit organizations for more than 25 years, and she specializes in marketing reports on the medical industry. She has contributed several reports on the medical industry for BCC, including reports on the global market for catheters, the sterilization market, reports on pediatric and eldercare markets, and her most recent report on the cardiovascular surgical industry.

Global Blood Supply, Tissue Banking And Transplantation Industry

Chapter- 1: INTRODUCTION

REASONS FOR DOING THE STUDY 1
STUDY GOALS AND OBJECTIVES 1
SCOPE OF REPORT 2
METHODOLOGIES AND INFORMATION SOURCES 3
ANALYST CREDENTIALS 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 4
DISCLAIMER 4

Chapter-2: SUMMARY

SUMMARY 5
SUMMARY TABLE PROJECTED GLOBAL MARKET FOR TRANSPLANTATION PRODUCTS AND DEVICES, THROUGH 2015 ($ MILLIONS) 6
SUMMARY FIGURE PROJECTED GLOBAL MARKET SHARES OF TRANSPLANTATION PRODUCTS AND DEVICES, 2010 AND 2015 (%) 7
SUMMARY FIGURE (CONTINUED) 8

Chapter-3: INDUSTRY OVERVIEW

HISTORY OF TRANSPLANTATION 9
TABLE 1 TIMELINE OF ORGAN TRANSPLANTATION HISTORY, 1900–2010 10
INDUSTRY ACQUISITIONS 11
TABLE 2 SELECTED TRANSPLANT INDUSTRY ACQUISITIONS, 2006–2010 ($ MILLIONS) 11
NECESSARY COMPONENTS TO ORGAN AND TISSUE TRANSPLANTATION 11
TISSUE TYPING 11
PRESERVATION 12
Tissue Preservation 12
IMMUNOSUPPRESSION 13
Newer Immunosuppressive Drugs 13
POSTOPERATIVE INFECTION CONTROL 14
OVERVIEW OF THE DONATION PROCESS 14
BLACK MARKET DONORS 15
THE TRANSPLANTATION PROCESS 15
PREPARATION 16
The Role of the Organ Procurement Organization 16
SURGERY 16
RECUPERATION 17
MAINTENANCE 17
New Studies on Maintenance Immunosuppression 18
SOLID ORGANS 18
COST OF SOLID ORGAN TRANSPLANTATION IN THE U.S. 18
TABLE 3 U.S. ORGAN TRANSPLANTS: AVERAGE FIRST YEAR COST, ESTIMATED NUMBER OF PROCEDURES, AND VALUE BY TYPE OF ORGAN TRANSPLANT, 2008 19
KIDNEY TRANSPLANTS IN THE U.S. 19
Living Donor Efforts 20
Necessary Inputs for Successful Kidney Transplantation 20
LIVER TRANSPLANTATION IN THE U.S. 20
Promising Treatments 20
Necessary Inputs for Successful Liver Transplantation 20
HEART TRANSPLANTS IN THE U.S. 21
Necessary Inputs for Successful Heart Transplantation 21
INTESTINE TRANSPLANTATION IN THE U.S. 21
Necessary Inputs for Successful Intestine Transplantation 21
PANCREAS TRANSPLANTATION IN THE U.S. 22
Current Research 22
Necessary Inputs for Successful Pancreas Transplantation 23
TISSUE TRANSPLANTATION IN THE U.S. 23
TRANSPLANTATION TRENDS OUTSIDE THE U.S. 23
ORGAN DONATION IN EUROPE 23
Establishing Death in the EU 24
Transplant Organizations in the EU 24
JAPANESE ORGAN TRANSPLANT CRITERIA 25
Three Key Elements of Conventional Death in Japan 25
TRENDS IN LIVING AND CADAVERIC DONATIONS OUTSIDE THE U.S. 26
SOLID ORGAN TRANSPLANTATION OUTSIDE THE U.S. 26
TABLE 4 NUMBER OF DONATED CADAVERIC ORGANS BY SELECTED REGION, 2004–2008 27
TISSUE TRANSPLANTATION OUTSIDE THE U.S. 27
Brazil 27
China 27
Austria 27
South Korea 28
Slovakia 28
Tunisia 28
India 28
LIMITED SUPPLY CURTAILS TRANSPLANTATIONS 28
LIVING DONOR PROGRAMS 28
KEY FACTORS IN INDUSTRY GROWTH 29
REDUCING DEMAND 29
INCREASING PATIENT SURVIVAL RATES 29
TABLE 5 ADJUSTED U.S. GRAFT SURVIVAL RATES BY ORGAN FOR TRANSPLANTS PERFORMED, 2000–2007 (%) 30
TABLE 6 ADJUSTED U.S. PATIENT SURVIVAL RATES BY ORGAN FOR TRANSPLANTS PERFORMED, 2000–2007 (%) 30
DEVELOPING ORGAN SUBSTITUTES 31
Organs from Animals: Xenotransplantation 31
Emotional/Ethical Implications of Xenotransplantation 31
Organ Primordia 32
KEY FACTORS INHIBITING GROWTH 33
LACK OF DONORS 33
ALTERNATIVE THERAPIES 33
PHARMACEUTICAL TREATMENTS 33
CULTURAL STIGMAS 34
Opt-in Consent and Presumed Consent 34

Chapter-4: TISSUE TYPING TECHOLOGIES

PANEL REACTIVE ANTIBODIES 35
TISSUE TYPING TECHNOLOGIES 36
TABLE 7 TISSUE TYPING TECHNOLOGIES 36
SEQUENCE TYPING 37
PCR-Sequence Specific Oligonucleotides 37
PCR-Sequence Specific Primers 37
GLOBAL TISSUE TYPING MARKET 37
TABLE 8 PROJECTED GLOBAL MARKET FOR TISSUE TYPING, THROUGH 2015 ($ MILLIONS) 38
COMMERCIALIZATION OPPORTUNITIES IN TISSUE TYPING 38
MARKET LEADERS 38
FIGURE 1 GLOBAL MARKET SHARES IN TISSUE TYPING TECHNOLOGIES BY MARKET LEADER, 2010 (%) 39

Chapter-5: SOLID ORGAN PROCUREMENT AND PRESERVATION

DEFINITION OF BRAIN DEATH 40
ORGANS OBTAINED FOR TRANSPLANT 40
INCREASING SUPPLY IN THE U.S. 41
THE TRANSPLANT GROWTH AND MANAGEMENT COLLABORATIVE 41
SUPPLY MANAGEMENT 42
REDUCING WASTE AND REJECTION 42
FIGHTING REJECTION 42
TABLE 9 U.S. ORGAN RECIPIENTS WHO PREVIOUSLY HAD A TRANSPLANT: ALL ORGANS, 2003–2007* 43
INCREASING THE HARVEST 43
TABLE 10 RECOVERED ORGANS NOT USED BY TYPE IN U.S., 2003–2007 43
NON-BEATING HEART DONORS 44
LESS WASTE 44
ORGAN PROCUREMENT OUTSIDE THE U.S. 44
MANAGEMENT OF DONATED ORGANS IN THE EU 44
CHINA 45
JAPAN 45
ALLOCATION CRITERIA IN THE U.S. 45
MELD/PELD SYSTEM 46
ALLOCATION CRITERIA IN THE EU 47
MELD/PELD IN THE U.K. 48
SOLID ORGAN PRESERVATION 48
TABLE 11 PRESERVATION TIME FOR TRANSPLANTED ORGANS (HOURS) 49
ORGAN PRESERVATION METHODS 49
Rinse and Preservation Solutions 50
TABLE 12 MAJOR ORGAN PRESERVATION SOLUTIONS 51
FIGURE 2 GLOBAL MARKET SHARE OF ORGAN PRESERVATION SOLUTIONS BY MANUFACTURER, 2009 (%) 51
FIGURE 2 (CONTINUED) 52
CELSIOR 52
COLLINS SOLUTION 52
CUSTODIOL 52
HYPOTHERMOSOL 52
VIASPAN 53
MARKET FOR PRESERVATION SOLUTIONS 53
TABLE 13 PROJECTED GLOBAL MARKET FOR ORGAN PRESERVATION SOLUTIONS (NOT INCLUDING THE PAPWORTH COCKTAIL) BY GEOGRAPHIC REGION, THROUGH 2015 ($ MILLIONS) 54
MACHINE PERFUSION 54
MACHINE PERFUSION (CONTINUED) 55

Chapter-6: TISSUE PRODUCTS

REGIONAL GROWTH IN TISSUE PRODUCTS 56
TABLE 14 PROJECTED GROWTH IN TISSUE MARKET REVENUES BY REGION, THROUGH 2015 ($ MILLIONS) 56
FIGURE 3 GLOBAL TISSUE MARKET SHARES BY REGION, 2010 AND 2015 (%) 57
SOFT TISSUE ALLOGRAFT MARKET 58
OPPORTUNITIES IN THE TISSUE MARKET 58
TABLE 15 PROJECTED GLOBAL TISSUE GRAFTING BY TISSUE TYPE, THROUGH 2015 ($ MILLIONS) 58
HEART VALVES 59
ADVANTAGES/DISADVANTAGES OF MECHANICAL, BIOLOGICAL, AND HOMOGRAFT HEART VALVES 59
Mechanical 59
Biological/Tissue 59
Homograft 59
GROWTH IN THE HEART VALVE MARKET 60
TABLE 16 GLOBAL HEART VALVE MARKET, THROUGH 2015 ($ MILLIONS) 60
TABLE 17 LEADING HEART VALVE SUPPLIERS, 2009 ($ MILLIONS) 61
HEART VALVE MARKET IN THE FUTURE 61
CORNEA 61
CORNEAL TRANSPLANTS IN THE U.S. 62
GLOBAL CORNEAL TRANSPLANT MARKET 62
TABLE 18 PROJECTED GLOBAL GROWTH OF CORNEAL TRANSPLANT MARKET, THROUGH 2015* ($ MILLIONS) 62
COMPETITION IN THE CORNEAL TRANSPLANT MARKET 63
BLOOD STEM CELLS 63
HISTORY 64
First Successful Transplant 64
DONOR REGISTRIES 65
GLOBAL STEM CELL TRANSPLANT ACTIVITY 65
INDICATIONS FOR STEM CELL TRANSPLANTS 66
REJECTION 66
GLOBAL MARKET FOR BLOOD STEM CELL TRANSPLANTATION 67
TABLE 19 PROJECTED GLOBAL MARKET FOR BLOOD STEM CELL TRANSPLANTATION, THROUGH 2015 ($ MILLIONS) 68
POTENTIAL COMPLICATIONS OF STEM CELL TRANSPLANTATION 68
CORD BLOOD 68
CORD BLOOD BANKING 69
WORLDWIDE INCIDENCE OF PROCEDURES 69
TABLE 20 PROJECTED GLOBAL HEMATOPOIETIC STEM CELL TRANSPLANT PROCEDURES, THROUGH 2015 70
THE ORTHOBIOLOGICS MARKET 70
TABLE 21 PROJECTED GLOBAL MARKET FOR ORTHOBIOLOGICAL PRODUCTS, THROUGH 2015 ($ MILLIONS) 71
BASE TISSUE 71
DEMINERALIZED BONE MATRIX PRODUCTS 71
MACHINED IMPLANTS 72
INTERNATIONAL BONE MARROW DONATION 72
TABLE 22 NUMBER OF BONE MARROW DONORS BY COUNTRY, 2010 72
TABLE 22 (CONTINUED) 73
SKIN AND COLLAGEN TRANSPLANTS 73
APPLICATIONS 74
MARKET FOR SKIN AND COLLAGEN TRANSPLANTS 74
FIGURE 4 GLOBAL MARKET SHARES OF SELECTED MARKET LEADERS IN THE SKIN AND COLLAGEN TRANSPLANT MARKET, 2009 (%) 75
TABLE 23 PROJECTED GLOBAL GROWTH OF SKIN AND COLLAGEN TRANSPLANTS, THROUGH 2015 ($ MILLIONS) 76
VASCULAR TISSUE TRANSPLANTATION IN THE U.S. 76
USES FOR VASCULAR TISSUE TRANSPLANTATION 76
WAITING LIST 77
PRODUCTS 77
GLOBAL MARKET FOR VASCULAR TISSUE 77
TABLE 24 PROJECTED GLOBAL VASCULAR TISSUE TRANSPLANTATION MARKET, THROUGH 2015 ($ MILLIONS) 77
COMMERCIAL OPPORTUNITIES IN TISSUE TRANSPLANTATION 78
TABLE 25 SELECTED COMMERCIAL OPPORTUNITIES IN TISSUE TRANSPLANTATION, 2010 78

Chapter-7: IMMUNOSUPPRESSANTS

TOLERANCE OF TRANSPLANTED ORGANS 79
ANTISENSE THERAPY 79
COSTIMULATION 80
CHIMERISM 80
USUAL ANTI-REJECTION DRUG PROTOCOLS 81
TYPES OF IMMUNOSUPPRESSANTS 81
TABLE 26 PROJECTED GLOBAL MARKET FOR IMMUNOSUPPRESSANTS USED IN TRANSPLANTS BY TYPE, THROUGH 2015 ($ MILLIONS) 82
FIGURE 5 PROJECTED GLOBAL MARKET SHARES OF IMMUNOSUPPRESSIVES BY TYPE, THROUGH 2015 (%) 82
FIGURE 5 (CONTINUED) 83
TABLE 27 IMMUNOSUPPRESSANT DRUGS APPROVED IN THE U.S., THE EU, AND JAPAN, 2009 84
TABLE 28 IMMUNOSUPPRESSANTS BY DRUG CLASS, GENERIC NAME, BRAND NAME AND MANUFACTURER 84
TABLE 28 (CONTINUED) 85
CALCINEURIN INHIBITORS 85
CYCLOSPORIN 85
Generic Cyclosporine 86
TACROLIMUS 86
TABLE 29 GLOBAL MARKET FOR CALCINEURIN INHIBITORS TO TREAT ORGAN TRANSPLANT REJECTION, THROUGH 2015 ($ MILLIONS) 86
ANTI-PROLIFERATIVE AGENTS 86
AZATHIOPRINE 87
MYCOPHENOLATE MOFETIL 87
MYCOPHENOLATE SODIUM 88
Cyclophosphamide 88
TABLE 30 GLOBAL MARKET FOR ANTI-PROLIFERATIVE AGENTS TO TREAT ORGAN TRANSPLANT REJECTION, THROUGH 2015 ($ MILLIONS) 88
M-TOR INHIBITORS 88
SIROLIMUS 89
TEMSIROLIMUS 89
EVEROLIMUS (AFFINITOR) 89
EVEROLIMUS (CERTICAN) 90
TABLE 31 PROJECTED GLOBAL MARKET FOR M-TOR INHIBITORS TO TREAT ORGAN TRANSPLANT REJECTION, THROUGH 2015 ($ MILLIONS) 90
MONOCLONAL, POLYCLONAL ANTIBODIES 90
TABLE 32 ANTIBODY PRODUCTS FOR TREATMENT OF ORGAN TRANSPLANT REJECTION 91
MONOCLONAL ANTIBODY PRODUCTS 91
Muromomab-CD3 91
Basiliximab 92
Alemtuzumab 92
Off-label Medications 92
Rituximab 92
Daclizumab 93
TABLE 33 PROJECTED GLOBAL MARKET FOR MONCLONAL ANTIBODY PRODUCTS, THROUGH 2015 ($ MILLIONS) 93
POLYCLONAL ANTIBODY PRODUCTS 93
Thymoglobulin 93
TABLE 34 PROJECTED GLOBAL MARKET FOR POLYCLONAL ANTIBODY PRODUCTS, THROUGH 2015 ($ MILLIONS) 94
TREATMENTS BY STAGE OF PROCEDURE 94
INDUCTION THERAPY 95
Disadvantages of Induction Therapy 95
Standard Treatments 95
TABLE 35 IMMUNOSUPPRESSANT USE FOR INDUCTION BY ORGAN IN U.S., 2007 96
MARKET COMMERCIALIZATION POSSIBILITIES 96
MAINTENANCE THERAPY 97
TABLE 36 IMMUNOSUPPRESSANT USE FOR MAINTENANCE (UP TO 2 YEARS POST TRANSPLANT) BY ORGAN, 2006* (%) 98
TABLE 36 (CONTINUED) 99
TABLE 36 (CONTINUED) 100
IMMUNOSUPPRESSANT USE IN REJECTION THERAPY 100
TABLE 37 IMMUNOSUPPRESSANT USE FOR REJECTION THERAPY FOLLOWING SOLID ORGAN TRANSPLANTATION BY ORGAN, 2006* (%) 101
TABLE 37 (CONTINUED) 102
MARKET POSSIBILITIES FOR FUTURE TRANSPLANTATION DRUGS 102
IMMUNOSUPPRESSIVE AGENTS IN DEVELOPMENT 103
TABLE 38 SELECTED IMMUNOSUPPRESSIVE AGENTS IN DEVELOPMENT, 2010 103

Chapter-8: ANTI-INFECTIVES AND POST-TRANSPLANT MONITORING IN ORGAN AND TISSUE TRANSPLANTATION

ANTI-INFECTIVES AND IMMUNOSUPPRESSANTS 104
TABLE 39 COMMON ANTI-INFECTIVE AND IMMUNOSUPPRESSANT AGENTS AND INTERACTIONS, 2009 105
TABLE 39 (CONTINUED) 106
MARKET FOR ANTI-INFECTIVES IN TRANSPLANTATION 106
TABLE 40 POST-TRANSPLANT INFECTIONS BY TYPE OF TRANSPLANT, WITH COMMON TIME FRAMES FOR INFECTION 106
TABLE 40 (CONTINUED) 107
TABLE 40 (CONTINUED) 108
POST-TRANSPLANT MONITORING 108
TABLE 41 RECOMMENDED POST-TRANSPLANT CARE, 2009 108
TABLE 41 (CONTINUED) 109
TABLE 41 (CONTINUED) 110
MARKET OPPORTUNITIES FOR POSTOPERATIVE MONITORING 111
TABLE 42 ONE-YEAR ADJUSTED PATIENT SURVIVAL BY ORGAN FOR TRANSPLANTS, 2007 (%) 111
TABLE 43 SELECTED PHARMACEUTICAL PIPELINE FOR ANTI-INFECTIVES FOR TRANSPLANT RECIPIENTS, 2010 112

Chapter-9: ALTERNATIVE DEVICES AND TECHNOLOGIES

TABLE 44 PROJECTED GLOBAL MARKET FOR TRANSPLANTATION ALTERNATIVE DEVICES, THROUGH 2015 ($ MILLIONS) 114
ALTERNATIVES TO CORNEAL TRANSPLANTATION 114
SURGICAL 114
Artificial Corneas 114
Retinal Transplants 115
Cellular Transplants 115
Electronic Implants 116
ALTERNATIVES TO INTESTINAL TRANSPLANTATION 116
MEDICAL 116
CELLULAR 116
ALTERNATIVES TO PANCREAS TRANSPLANTATION 117
SURGICAL 117
Islet Cell Transplantation 117
Difficulties of Islet Cell Transplantation 117
Cell Encapsulation 118
ReNeuron 118
ARTIFICIAL 119
Bioartificial Pancreas 119
Cerco Medical 120
CELLULAR 120
Cultured Stem Cells 120
DIMINISHED NEED FOR TRANSPLANTATION IN THE FUTURE 120
ALTERNATIVES TO LIVER TRANSPLANTATION 120
TABLE 45 INDICATIONS FOR BIOARTIFICIAL LIVER TRANSPLANTATION 121
ALTERNATIVES TO LUNG TRANSPLANTATION 121
MEDICAL 121
SURGICAL 122
ALTERNATIVES TO BONE GRAFTS 122
MEDICAL 123
SYNTHETIC MATERIALS 123
Orthovita 123
SPINE WAVE 124
REGEN BIOLOGICS 124
ALTERNATIVES TO VASCULAR TRANSPLANTATION 124
ANIMAL 124
Stentless Valves 125
Calcification 125
SURGICAL 125
Angioplasty and Stents 126
MEDICAL 126
MECHANICAL/SYNTHETIC 127
ALTERNATIVES TO VASCULAR TRANSPLANTATION 127
TISSUE ENGINEERING OF VASCULAR GRAFTS 127
GENE THERAPY 128
Areas of Research 128
ALTERNATIVES TO SKIN TRANSPLANTATION 128
ANIMAL-BASED PRODUCTS 128
Biobrane 128
OaSIS 129
GROWTH FACTORS 129
ARTIFICIAL SKIN/SKIN REPLACEMENT PRODUCTS 129
ALTERNATIVES TO HEART TRANSPLANTATION 130
MEDICAL 130
SURGICAL 130
Cardiac Support Devices 130
Passive Support Systems 130
Heart Regeneration 131
MECHANICAL 131
Ventricular Assist Devices 131
Generations of Designs 132
Ambulatory, Implantable Devices 132
TABLE 46 GLOBAL MARKET FOR ARTIFICIAL HEART DEVICES, THROUGH 2015 ($ MILLIONS) 133
TOTAL ARTIFICIAL HEARTS 133
AbioMed 133
Syncardia 134
TABLE 47 GLOBAL MARKET FOR TOTAL ARTIFICIAL HEARTS, THROUGH 2015 ($ MILLIONS) 134
VENTRICULAR ASSIST DEVICES 134
Regeneration Instead of Replacement 135
TABLE 48 GLOBAL MARKET FOR VADS, THROUGH 2015 ($ MILLIONS) 135
VAD as Destination Therapy 136
VAD Development Outside the U.S. 136
ORTHOPEDIC DEVICES FOR TRANSPLANTATION 136
OPPORTUNITIES IN THE ORTHOPEDIC DEVICE MARKET 136
TABLE 49 SELECTED GLOBAL COMMERCIAL OPPORTUNITIES FOR NEW DEVICES IN THE FUTURE 137
TABLE 50 PROJECTED GLOBAL MARKET FOR ORTHOPEDIC DEVICES USED IN TRANSPLANTATION, THROUGH 2015 ($ MILLIONS) 138
FIGURE 6 GLOBAL MARKET FOR ORTHOPEDIC DEVICES, 2010 AND 2015 (%) 138
FIGURE 6 (CONTINUED) 139
HIP 139
COSTS OF HIP REPLACEMENT SURGERIES 140
ALTERNATIVES TO HIP REPLACEMENT/RECONSTRUCTION 140
TABLE 51 PROJECTED GLOBAL MARKET FOR HIP REPLACEMENTS, THROUGH 2015 ($ MILLIONS) 140
KNEE 140
TABLE 52 PROJECTED GLOBAL MARKET FOR KNEE REPLACEMENTS, THROUGH 2015 ($ MILLIONS) 141
SPINE 141
TABLE 53 PROJECTED GLOBAL MARKET FOR SPINAL RECONSTRUCTIVE PRODUCTS, THROUGH 2015 ($ MILLIONS) 142
FIGURE 7 GLOBAL MARKET SHARES OF THE SPINAL RECONSTRUCTION MARKET BY COMPANY, 2009 (%) 142
FIGURE 7 (CONTINUED) 143
EXTREMITIES 143
Market Drivers 143
TABLE 54 PROJECTED GLOBAL MARKET FOR EXTREMITY REPAIR/REPLACEMENTS, THROUGH 2015 ($ MILLIONS) 144

Chapter-10: REGULATIONS AND REIMBURSEMENT

REGULATIONS IN THE U.S. 145
HISTORY OF REGULATION IN THE U.S. 146
REGULATIONS OUTSIDE THE U.S. 146
TRANSPLANT “TOURISM” 146
REIMBURSEMENT IN THE U.S. 147
ORGAN ACQUISITION COSTS 147
REIMBURSEMENT FOR HOSPITAL COSTS 148
REIMBURSEMENT FOR PHYSICIAN SERVICES 148
REIMBURSEMENT FOR IMMUNOSUPPRESSANTS IN THE U.S. 148
TABLE 55 IMMUNOSUPPRESSIVE DRUGS CURRENTLY COVERED BY MEDICARE* 149
TABLE 56 OVERVIEW OF MEDICARE IMMUNOSUPPRESSIVE DRUG COVERAGE 150
REIMBURSEMENT OUTSIDE THE U.S. 150
TREATMENT IN EU COUNTRIES 150

Chapter-11: EMERGING PROCEDURES AND PRODUCTS IN DEVELOPMENT

MACHINE PERFUSION OF SOLID ORGANS 151
WATERS MEDICAL SYSTEMS 151
TRANSMEDICS, INC. 152
ORGAN PRESERVATION SOLUTIONS IN DEVELOPMENT 152
SOMAH 152
REGENERATIVE MEDICINE 152
APPLICATIONS IN LIVER TRANSPLANTS 153
ENGINEERED TISSUE 153
ISLET CELL TRANSPLANTATION 154
CELLULAR THERAPIES 154
TABLE 57 TYPES OF REGENERATIVE CELLULAR THERAPIES 154
ORGAN REJECTION STRATEGIES 154
STEM CELL RESEARCH 155
U.S. MORATORIUM ON STEM CELL RESEARCH FUNDING 155
ADVANCES IN CARDIOVASCULAR TREATMENTS 156
FIBROBLAST GROWTH FACTORS 156
CARDIOVASCULAR BIOTHERAPEUTIC, INC. 157
CARDIOVASCULAR GENE THERAPY 157
Major Approaches to Gene Transfer 158
Naked Plasmid DNA Transfer 159
Adenoviral Vectors 159
PHARMACEUTICAL PIPELINE DEVELOPMENT 160
TABLE 58 PHARMACEUTICAL PIPELINE/DEVICE BY MANUFACTURER, TYPE OF PRODUCT, INDICATIONS FOR USE, AND STAGE OF CLINICAL TESTING 161

Chapter-12: COMPANY DIRECTORY

ABBOTT LABORATORIES 162
BUSINESS OVERVIEW 162
FINANCIALS 162
PRODUCTS 162
ADVANCED BIOHEALING, INC. 163
BUSINESS OVERVIEW 163
FINANCIALS 163
PRODUCTS 163
ALLOSOURCE 164
BUSINESS OVERVIEW 164
FINANCIALS 164
PRODUCTS 164
BUSINESS OVERVIEW 165
FINANCIALS 165
PRODUCTS 165
ARTHREX, INC. 166
BUSINESS OVERVIEW 166
FINANCIALS 166
PRODUCTS 166
ASTELLAS PHARMA, INC. 166
BUSINESS OVERVIEW 166
FINANCIALS 167
PRODUCTS 167
BIOMET, INC 167
BUSINESS OVERVIEW 167
FINANCIALS 168
PRODUCTS 168
BIORAD LABORATORIES 168
BUSINESS OVERVIEW 168
FINANCIALS 169
PRODUCTS 169
BRISTOL-MYERS SQUIBB 169
BUSINESS OVERVIEW 169
FINANCIALS 169
PRODUCTS 170
CELERA CORP. 170
BUSINESS OVERVIEW 170
FINANCIALS 171
PRODUCTS 171
CENTACOR ORTHO BIOTECH, LTD. 171
BUSINESS OVERVIEW 171
FINANCIALS 172
PRODUCTS 172
CONMED-LINVATEC CORP. 172
BUSINESS OVERVIEW 173
FINANCIALS 173
PRODUCTS 173
CRYOLIFE, INC. 174
BUSINESS OVERVIEW 174
FINANCIALS 175
PRODUCTS 175
DEPUY ORTHOPEDICS 175
BUSINESS OVERVIEW 176
FINANCIALS 176
PRODUCTS 176
DIAGAST 176
BUSINESS OVERVIEW 176
FINANCIALS 177
PRODUCTS 177
DR. F. KÖHLER CHEMIE GMBH 177
BUSINESS OVERVIEW 178
FINANCIALS 178
PRODUCTS 178
EDWARDS LIFESCIENCES 178
BUSINESS OVERVIEW 178
FINANCIALS 178
PRODUCTS 179
EXACTECH 179
BUSINESS OVERVIEW 179
FINANCIALS 179
PRODUCTS 180
FORTICELL BIOSCIENCE 180
BUSINESS OVERVIEW 180
FINANCIALS 181
PRODUCTS 181
GEN-PROBE, INC. 182
BUSINESS OVERVIEW 182
FINANCIALS 182
PRODUCTS 182
GENZYME 183
BUSINESS OVERVIEW 183
FINANCIALS 183
PRODUCTS 183
W.L. GORE & ASSOCIATES 184
BUSINESS OVERVIEW 184
FINANCIALS 184
PRODUCTS 185
HEMOCLEANSE, INC. 185
BUSINESS OVERVIEW 185
FINANCIALS 185
PRODUCTS 185
INTEGRA LIFESCIENCE 186
BUSINESS OVERVIEW 186
FINANCIALS 186
PRODUCTS 187
INVITROGEN (SEE LIFE TECHNOLOGIES) 187
JOHNSON & JOHNSON 187
BUSINESS OVERVIEW 187
FINANCIALS 187
PRODUCTS 187
KIADIS PHARMA 188
BUSINESS OVERVIEW 188
FINANCIALS 188
PRODUCTS 188
KINETIC CONCEPTS, INC. (KCI) 189
BUSINESS OVERVIEW 189
FINANCIALS 189
PRODUCTS 190
LIFEBLOOD MEDICAL, INC. 190
BUSINESS OVERVIEW 190
FINANCIALS 191
PRODUCTS 191
LIFECYCLE PHARMA A/S 191
BUSINESS OVERVIEW 191
FINANCIALS 192
PRODUCTS 192
LIFE TECHNOLOGIES 192
BUSINESS OVERVIEW 193
FINANCIALS 193
PRODUCTS 193
LIVING CELL TECHNOLOGIES, LTD. 193
BUSINESS OVERVIEW 194
FINANCIALS 194
PRODUCTS 194
LUMINEX CORP. 194
BUSINESS OVERVIEW 195
FINANCIALS 195
PRODUCTS 195
MEDTRONIC, INC. 196
BUSINESS OVERVIEW 196
FINANCIALS 197
PRODUCTS 197
NOVARTIS AG 197
BUSINESS OVERVIEW 198
FINANCIALS 198
PRODUCTS 198
ONE LAMBDA, INC. 199
BUSINESS OVERVIEW 199
FINANCIALS 199
PRODUCTS 199
ON-X LIFE TECHNOLGIES, INC. 200
BUSINESS OVERVIEW 200
FINANCIALS 200
PRODUCTS 200
ORGANOGENESIS, INC. 200
BUSINESS OVERVIEW 201
FINANCIALS 201
PRODUCTS 201
ORTHO-CLINICAL DIAGNOSTICS 201
BUSINESS OVERVIEW 202
FINANCIALS 202
PRODUCTS 202
OSTEOTECH 202
BUSINESS OVERVIEW 202
FINANCIALS 203
PRODUCTS 203
PDL BIOPHARMA 204
BUSINESS OVERVIEW 204
FINANCIALS 204
PRODUCTS 204
PFIZER, INC. 204
BUSINESS OVERVIEW 205
FINANCIALS 205
PRODUCTS 205
PROTEOME SCIENCES, PLC 206
BUSINESS OVERVIEW 206
FINANCIALS 206
PRODUCTS 206
ROCHE PHARMACEUTICALS 206
BUSINESS OVERVIEW 206
FINANCIALS 207
PRODUCTS 207
RTI BIOLOGICS 207
BUSINESS OVERVIEW 208
FINANCIALS 208
PRODUCTS 208
SMITH & NEPHEW, PLC 209
BUSINESS OVERVIEW 209
FINANCIALS 210
PRODUCTS 210
SORIN GROUP, S.P.A. 211
BUSINESS OVERVIEW 211
FINANCIALS 211
PRODUCTS 212
ST. JUDE MEDICAL 212
BUSINESS OVERVIEW 213
FINANCIALS 213
PRODUCTS 213
STRYKER CORP. 214
BUSINESS OVERVIEW 214
FINANCIALS 214
PRODUCTS 214
SYNCARDIA SYSTEMS, INC. 215
BUSINESS OVERVIEW 215
FINANCIALS 215
PRODUCTS 215
SYNOVIS SURGICAL INNOVATIONS 216
BUSINESS OVERVIEW 216
FINANCIALS 216
PRODUCTS 216
SYTHES (NORTH AMERICA) 217
BUSINESS OVERVIEW 217
FINANCIALS 217
PRODUCTS 217
TEI BIOSCIENCE 218
BUSINESS OVERVIEW 218
FINANCIALS 218
PRODUCTS 219
TEVA PHARMACEUTICALS, LTD. 219
BUSINESS OVERVIEW 219
FINANCIALS 219
PRODUCTS 219
TERUMO MEDICAL CORP. 220
BUSINESS OVERVIEW 220
FINANCIALS 220
PRODUCTS 220
THORATEC CORP. 221
BUSINESS OVERVIEW 221
FINANCIALS 221
PRODUCTS 221
TORNIER, INC. (U.S.) 222
BUSINESS OVERVIEW 222
FINANCIALS 222
PRODUCTS 222
TRANSMEDICS, INC. 223
BUSINESS OVERVIEW 223
FINANCIALS 223
PRODUCTS 223
VIROPHARMA, INC. 224
BUSINESS OVERVIEW 224
FINANCIALS 224
PRODUCTS 224
WORLDHEART CORP. 225
BUSINESS OVERVIEW 225
FINANCIALS 225
PRODUCTS 226
WRIGHT MEDICAL TECHNOLOGY, INC. 226
BUSINESS OVERVIEW 226
FINANCIALS 226
PRODUCTS 226
WYETH (SEE PFIZER) 227
ZIMMER HOLDINGS, INC. 227
BUSINESS OVERVIEW 227
FINANCIALS 227
PRODUCTS 228

Chapter-13: APPENDIX

APPENDIX 229
DEFINITIONS 229