Organ and Tissue Transplantation and Alternatives

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Organ and Tissue Transplantation and Alternatives

Report price : $ 4 850
Publication date : October 2008

STUDY GOALS AND OBJECTIVES

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.

REASONS FOR DOING THE STUDY

Organ transplantation is a dynamic field, with continued progress being made in artificial organs and transplantation methods that reduce rejection and infection. There is increased pressure to perfect transplantation methods because the need for organ donors far outstrips the availability of organs and tissues and governmental regulations have become more stringent. 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 regimes, and advanced tissue matching, which have helped build the organ and tissue transplantation business to a maturing stage. This report will focus on procurement, transplantation by organ, 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 and to cut costs. This report is a valuable tool for anyone assessing the organ and tissue transplantation market and attempting to devise a strategy to successfully address it.

INTENDED AUDIENCE

This study provides a thorough background on the structure of the organ and tissue transplantation market and the chief issues 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.

CHAPTER 1: INTRODUCTION

STUDY GOAL AND OBJECTIVES

REASONS FOR DOING THE STUDY

INTENDED AUDIENCE

SCOPE OF REPORT

METHODOLOGY

INFORMATION SOURCES

AUTHOR’S CREDENTIALS

RELATED BCC PUBLICATIONS

BCC ONLINE SERVICES

DISCLAIMER

CHAPTER 2: SUMMARY SUMMARY SUMMARY TABLE U.S. MARKET FOR SOLID ORGAN AND TISSUE TRANSPLANTATION, THROUGH 2013 ($ MILLIONS) SUMMARY FIGURE U.S. MARKET FOR SOLID ORGAN AND TISSUE TRANSPLANTATION, 2007-2013 ($ MILLIONS)

CHAPTER 3: INDUSTRY OVERVIEW

INDUSTRY OVERVIEW

HISTORY OF TRANSPLANTATION

TISSUE TYPING

IMMUNOSUPPRESSION

Newer Immunosuppressive Drugs

PRESERVATION

GOVERNMENT REIMBURSEMENT

THE TRANSPLANTATION PROCESS

PREPARATION

SURGERY

RECUPERATION

MAINTENANCE

IMPORTANCE OF THE INDUSTRY

ORGANS

TABLE 1 U.S. ORGAN TRANSPLANTS: AVERAGE FIRST YEAR COST, NUMBER OF PROCEDURES AND VALUE BY TYPE OF ORGAN TRANSPLANT, THROUGH 2013 ($ MILLIONS)

KIDNEY

TABLE 2 LEADING U.S. KIDNEY TRANSPLANT PROGRAMS BY TOTAL NUMBER OF PROCEDURES PERFORMED IN 2007

LIVER

TABLE 3 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS BY TOTAL PROCEDURES PERFORMED IN 2007

HEART

TABLE 4 TOP FIVE U.S. HEART TRANSPLANT PROGRAMS BY TOTAL PROCEDURES PERFORMED IN 2007

LUNG

TABLE 5 TOP FIVE U.S. LUNG TRANSPLANT PROGRAMS BY TOTAL PROCEDURES PERFORMED IN 2007

INTESTINE

TABLE 6 TOP FIVE U.S. INTESTINE/SMALL BOWEL TRANSPLANT PROGRAMS BY TOTAL PROCEDURES PERFORMED IN 2007

PANCREAS

TABLE 7 TOP FIVE U.S. PANCREAS TRANSPLANT PROGRAMS BY TOTAL PROCEDURES PERFORMED IN 2007

TISSUES

DRIVERS IN THE MARKET

TABLE 8 TISSUE GRAFTING IN THE U.S. BY TISSUE TYPE, THROUGH 2013 (MILLION PROCEDURES)

FIGURE 1 U.S. MARKET FOR TISSUE GRAFTING PROCEDURES BY TYPE, 2007-2013 (MILLION PROCEDURES)

CORNEA

BLOOD STEM CELLS

BONE ALLOGRAFTS

HEART VALVES

VASCULAR TISSUE

SKIN AND COLLAGEN

Applications

WAITING LISTS OUTPACE DONATIONS

TABLE 9 PATIENTS ON U.S. WAITING LISTS AT THE END OF THE YEAR BY TYPE OF ORGAN TRANSPLANT, 2003-2006

TRENDS IN U.S. LIVING AND CADAVERIC DONATIONS

TABLE 10 TRENDS IN U.S. LIVING AND CADAVERIC DONATIONS, THROUGH 2013

TRENDS IN TRANSPLANTATION OF ALL ORGANS

TABLE 11 U.S. ORGAN TRANSPLANTS, THROUGH 2006 (NUMBER OF PROCEDURES)

INTERNATIONAL TRENDS

TABLE 12 NUMBERS OF DONATED CADAVERS BY REGION, 2003-2006

LIMITED SUPPLY CURTAILS TRANSPLANTATIONS

Living Donor Programs

KEY FACTORS IN INDUSTRY GROWTH

Reducing Demand

Patient Survival Rates

TABLE 13 ONE-YEAR AND FIVE-YEAR PATIENT SURVIVAL RATES, BY ORGAN FOR TRANSPLANTS PERFORMED, 1997-2004 (%)

TABLE 14 ONE-YEAR AND FIVE-YEAR GRAFT SURVIVAL RATES, BY ORGAN FOR TRANSPLANTS PERFORMED, 1997-2004 (%)

TABLE 14 (CONTINUED)

TABLE 15 NUMBER OF PEOPLE IN THE U.S. LIVING WITH A FUNCTIONING TRANSPLANT BY TYPE, 2000-2005*

Organ Substitutes

Organs from Animals: Xenotransplantation

Organ Primordia

Nuclear Transfer to Eliminate the Rejection Gene

Porcine Endogenous Retrovirus

ARTIFICIAL ORGANS

CELLULAR TRANSPLANTS

KEY FACTORS INHIBITING GROWTH

LACK OF DONORS

ALTERNATIVE THERAPIES

CULTURAL STIGMAS

CHAPTER 4: GOVERNMENT REGULATIONS

GOVERNMENT REGULATIONS

THE MEDICARE DRUG DISCOUNT CARD PROGRAM, MEDICARE DRUG BENEFITS, AND TRANSPLANT PATIENTS

TABLE 16 IMMUNOSUPPRESSIVE DRUGS CURRENTLY COVERED BY MEDICARE*

TABLE 17 MEDICARE IMMUNOSUPPRESIVE DRUG COVERAGE OVERVIEW

CHAPTER 5: TRANSPLANTATION PRODUCTS AND PHARMACEUTICALS

HLA TISSUE TYPING

THE WORLD MARKET FOR HLA TYPING

TABLE 18 WORLD MARKET FOR HLA TYPING, THROUGH 2013 ($ MILLIONS)

THE U.S. MARKET FOR HLA TYPING

TABLE 19 U.S. MARKET FOR HLA TYPING, THROUGH 2013 ($ MILLIONS)

ORGAN PRESERVATION PRODUCTS

TABLE 20 PRESERVATION TIME FOR TRANSPLANTED ORGANS (HOURS)

Custodiol

Warm Organ Perfusion

IMMUNOSUPPRESSION

TABLE 21 IMMUNOSUPPRESSIVE DRUGS APPROVED IN THE U.S. BY CLASS

Antibodies

TABLE 22 ANTIBODY PRODUCTS FOR TREATMENT OF ORGAN TRANSPLANT REJECTION

TABLE 23 COMMONLY USED INTRAVENOUS ANTIBODY IMMUNOSUPPRESIVE DRUGS

TABLE 23 (CONTINUED)

OKT-3

Zenapax

Simulect

Campath/MabCampath

Polyclonal Antibody Products

Atgam

Thymoglobulin

The Market for Antibody Products to Treat Organ Transplant Rejection

TABLE 24 GLOBAL MARKET FOR ANTIBODY PRODUCTS TO TREAT ORGAN TRANSPLANT REJECTION, THROUGH 2013 ($ MILLIONS)

FIGURE 2 GLOBAL MARKET FOR ANTIBODY PRODUCTS USED IN ORGAN TRANSPLANTATION, 2007-2013 ($ MILLIONS)

Antiproliferative Agents

Azathioprine

CellCept

Myfortic

TABLE 25 GLOBAL MARKET FOR ANTIPROLIFERATIVE AGENTS TO TREAT ORGAN TRANSPLANT REJECTION: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)

FIGURE 3 GLOBAL MARKET FOR ANTIPROLIFERATIVE AGENTS, 2007-2013 ($ MILLIONS)

Calcineurin Inhibitors

Tacrolimus

Cyclosporine

Generic Cyclosporine

TABLE 26 GLOBAL MARKET FOR CALCINEURIN INHIBITORS TO TREAT ORGAN TRANSPLANT REJECTION: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)

FIGURE 4 GLOBAL MARKET FOR CALCINEURIN INHIBITORS, 2007-2013 ($ MILLIONS)

Source: BCC Research

M-TOR Inhibitors

Certican

Rapamune

TABLE 27 GLOBAL MARKET FOR M-TOR INHIBITORS TO TREAT ORGAN TRANSPLANT REJECTION: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)

Concern About Generics

TABLE 28 U.S. SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2013 ($ MILLIONS)

FIGURE 5 U.S. SALES OF IMMUNOSUPPRESSIVES, BY CATEGORY, THROUGH 2013 ($ MILLIONS)

IMMUNOSUPPRESSIVE AGENTS IN DEVELOPMENT

TABLE 29 SELECTED IMMUNOSUPPRESSIVE AGENTS IN PHASE 1 OR LATER DEVELOPMENT

TABLE 29 (CONTINUED)

TOLERANCE

Antisense Therapy

Costimulation

Chimerism

USUAL ANTI-REJECTION DRUG PROTOCOLS

TABLE 30 COMMON IMMUNOSUPPRESSIVE REGIMENS

INDUCTION THERAPY

TABLE 31 IMMUNOSUPPRESSANT USE FOR INDUCTION, BY ORGAN IN 2006 (%)

MAINTENANCE THERAPY

TABLE 32 IMMUNOSUPPRESSANT USE FOR MAINTENANCE AT DISCHARGE BY ORGAN IN THE U.S., 2006 (%)

TABLE 33 IMMUNOSUPPRESSANT USE FOR MAINTENANCE AT 1-YEAR POST-TRANSPLANT BY ORGAN IN U.S., 2006 (%)

REJECTION THERAPY

Risks Associated with Immunosuppressive Therapy

Annual Cost of Immunosuppressant Drugs

The World Market for Immunosuppressant Drug Therapy

TABLE 34 WORLDWIDE MARKET FOR IMMUNOSUPPRESSION IN SOLID ORGAN TRANSPLANT RECIPIENTS, THROUGH 2013

TABLE 35 GLOBAL SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2013 ($ MILLIONS)

FIGURE 6 WORLDWIDE SALES OF IMMUNOSUPPRESSANTS BY CATEGORY, 2007-2013 ($ MILLIONS)

TABLE 36 WORLDWIDE SALES OF BRAND NAME IMMUNOSUPPRESSANT DRUGS BY COMPANY, 2006 AND 2007 ($ MILLIONS)

PRODUCTS

ADDRESSING INFECTION

GRAFT-VERSUS-HOST DISEASE

POST-TRANSPLANT INFECTIONS

ViroPharma Incorporated

Cardiovascular Disease

TABLE 37 COMMON POST-TRANSPLANT INFECTIONS

TABLE 38 TIMELINE FOR POST-TRANSPLANT INFECTION

TABLE 39 COMMON POST-TRANSPLANT DRUGS

TABLE 40 WORLD MARKET FOR ANTI-INFECTIVES USED FOR TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLIONS)

POST-TRANSPLANT MONITORING

TABLE 41 U.S. MARKET FOR POST-TRANSPLANT MONITORING, THROUGH 2013 ($ MILLIONS)

Cylex

CHAPTER 6: PROCUREMENT AND HARVESTING

INCREASING SUPPLY

SUPPLY MANAGEMENT

REDUCING WASTE AND REJECTION

INCREASING THE HARVEST

TABLE 42 RECOVERED ORGANS NOT USED BY TYPE, 2003-2006

TABLE 43 CONSENTED ORGANS NOT RECOVERED BY TYPE, 2003-2006

BETTER HARVESTING

DEFINITION OF BRAIN DEATH

PROTECTING HARVESTED ORGANS

HORMONAL RESUSCITATION

NON-HEART-BEATING DONORS

LESS WASTE

PRESERVATION

ORGAN PRESERVATION METHODS

Rinse and Preservation Solutions

TABLE 44 MAJOR ORGAN PRESERVATION SOLUTIONS

Celsior

Collins Solution

Custodiol

Hypothermosol

ViaSpan

Market for Preservation Solutions

TABLE 45 NORTH AMERICAN AND WORLD MARKETS FOR ORGAN PRESERVATION SOLUTIONS (NOT INCLUDING THE PAPWORK COCKTAIL), THROUGH 2013 ($ MILLIONS)

Organ Preservation Products in Development

Human BioSystems

Trophic Solutions

Machine Perfusion

Waters Medical Systems

TransMedics, Inc

FIGHTING REJECTION

TABLE 46 U.S. ORGAN RECIPIENTS WHO PREVIOUSLY HAD A TRANSPLANT: ALL ORGANS, 2003-2006

CHAPTER 7: SOLID ORGAN TRANSPLANTATION

TRANSPLANT CENTERS

TABLE 47 LEADING U.S. TRANSPLANT PROGRAMS BY TOTAL NUMBER OF PROCEDURES PERFORMED IN 2007

TESTING

Blood Typing

Tissue Typing

Panel Reactive Antibodies (PRA)

TABLE 48 TISSUE TYPING TECHNOLOGIES

Advances

TABLE 49 SELECTED COMPETITORS IN THE HLA TYPING MARKET

Plasmapheresis: Transplantation without Matching

Antigens

KIDNEY

MARKET FOR KIDNEY TRANSPLANTS

TABLE 50 U.S. MARKET FOR KIDNEY-ONLY TRANSPLANTATION, THROUGH 2013

MARKET FOR IMMUNOSUPPRESSIVES FOR KIDNEY TRANSPLANTATION

TABLE 51 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR KIDNEY TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLION)

IMMUNOSUPPRESSION

Drugs Used for Induction

TABLE 52 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN KIDNEY TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 53 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BEFORE DISCHARGE AFTER KIDNEY TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance between Discharge and Oneyear Post-transplant

TABLE 54 IMMUNOSUPPRESSION DRUG USE IN THE U.S. FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT FOR KIDNEY TRANSPLANTATION, 2002-2005 (%)

ALTERNATIVES

Mechanical

Medical

Animal

Cellular

PANCREAS

MARKET FOR PANCREAS TRANSPLANTATION

TABLE 55 U.S. MARKET FOR PANCREAS TRANSPLANTATION, THROUGH 2013

WAITING LIST

TABLE 56 U.S. PANCREAS WAITING LIST, THROUGH 2013

IMMUNOSUPPRESSION

TABLE 57 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR PANCREAS TRANSPLANT PATIENTS, THROUGH 2013

Drugs Used for Induction

TABLE 58 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN PANCREAS TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 59 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BEFORE DISCHARGE AFTER PANCREAS TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance between Discharge and Oneyear Post-transplant

TABLE 60 IMMUNOSUPPRESSION DRUG USE IN THE U.S. FOR MAINTENANCE BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT FOR PANCREAS TRANSPLANTATION, 2002-2005 (%)

PREVALANCE OF DIABETES

ALTERNATIVES

HEART

TABLE 61 U.S. HEART TRANSPLANT MARKET, THROUGH 2013 ($ MILLIONS)

SUPPLY

Cultural Backlash

Accepting Brain Death is Crucial

WAITING LISTS

IMMUNOSUPPRESSION

TABLE 62 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR HEART TRANSPLANT PATIENTS, THROUGH 2013

Drugs Used for Induction

TABLE 63 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 64 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART TRANSPLANTATION, 2003-2006 (%)

TABLE 64 (CONTINUED)

Drugs Used for Anti-rejection between Discharge and 1-year Post-transplant

TABLE 65 U.S. IMMUNOSUPPRESSION DRUG USE FOR ANTIREJECTION BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT IN HEART TRANSPLANTATION, 2002-2005

INDICATIONS

TABLE 66 LEADING CAUSES OF HEART FAILURE, 2002-2006 (%)

TISSUE TYPING

PRESERVATION

ALTERNATIVES

LIVER

HISTORY

TRANSPLANT STATISTICS

ORGAN RECOVERY

THE MARKET FOR LIVER TRANSPLANTATION

TABLE 67 U.S. LIVER TRANSPLANT MARKET, FIRST YEAR, THROUGH 2013 ($ MILLIONS)

DONORS

WAITING LISTS

TABLE 68 REGIONAL GROWTH IN LIVER WAITING LISTS, THROUGH 2013

IMMUNOSUPPRESSION

Drugs Used for Induction

TABLE 69 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LIVER TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 70 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LIVER TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance between Discharge and 1-Year Post-transplant

TABLE 71 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 2002-2005 (%)

Drugs Used for Anti-rejection between Transplant and 1-Year Post-Transplant

TABLE 72 U.S. IMMUNOSUPPRESSION DRUG USE FOR ANTIREJECTION BETWEEN TRANSPLANT AND 1-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 2002-2005 (%)

TABLE 72 (CONTINUED)

The Market for Immunosuppressive Drugs in Liver Transplantation

TABLE 73 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR LIVER TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLIONS)

INDICATIONS

Causes of Cirrhosis

TISSUE TYPING

ORGAN REJECTION

TABLE 74 LIVER TRANSPLANT SURVIVAL RATES IN THE U.S. AND EUROPE, 2003 (%)

LUNGS

TRANSPLANTATION STATISTICS

THE MARKET FOR LUNG TRANSPLANTATION

TABLE 75 U.S. LUNG TRANSPLANTATION MARKET, THROUGH 2013 ($ MILLIONS)

WAITING LISTS

INDICATIONS

TABLE 76 LEADING CAUSES OF CHRONIC LUNG FAILURE IN THE U.S., 2002-2006 (%)

DONATION

IMMUNOSUPPRESSION

TABLE 77 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR LUNG TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLIONS)

Drugs Used for Induction

TABLE 78 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LUNG TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 79 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LUNG TRANSPLANTATION, 2002-2006 (%)

Drugs Used for Maintenance between Discharge and 1-Year Post-Transplant

TABLE 80 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Anti-rejection between Transplant and 1-Year Post-Transplant

TABLE 81 U.S. IMMUNOSUPPRESSION DRUG USE FOR ANTIREJECTION BETWEEN TRANSPLANT AND 1-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 2002-2005 (%)

TABLE 81 (CONTINUED)

REJECTION

TABLE 82 U.S. LUNG TRANSPLANT PATIENT AND GRAFT SURVIVAL RATES* (%)

ALTERNATIVES

HEART-LUNG

THE MARKET FOR HEART-LUNG TRANSPLANTATION

TABLE 83 U.S. HEART-LUNG TRANSPLANT MARKET, THROUGH 2013 ($ MILLIONS)

IMMUNOSUPPRESSION

TABLE 84 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR HEART-LUNG TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLIONS)

Drugs Used for Induction

TABLE 85 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART-LUNG TRANSPLANTATION, 2003-2006 (%).... 122

Drugs Used for Maintenance Prior to Discharge

TABLE 86 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART-LUNG TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance between Discharge and 1-Year Post-Transplant

TABLE 87 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 2002-2005 (%)

Drugs Used for Anti-rejection between Transplant and 1-Year Post-Transplant

TABLE 88 U.S. IMMUNOSUPPRESSION DRUG USE FOR ANTIREJECTION BETWEEN TRANSPLANT AND 1-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 2002-2005 (%)

WAITING LISTS

TABLE 89 U.S. HEART-LUNG WAITING LIST TRENDS, THROUGH 2013

SURVIVAL RATES

TABLE 90 U.S. HEART-LUNG TRANSPLANT PATIENT AND GRAFT SURVIVAL RATES (%)

INTESTINE/SMALL BOWEL

HISTORY

TRANSPLANT TYPES

INDICATIONS

TABLE 91 LEADING INDICATIONS FOR INTESTINE TRANSPLANT: ADULT PATIENTS

TABLE 92 LEADING INDICATIONS FOR INTESTINE TRANSPLANT: PEDIATRIC PATIENTS

U.S. TRANSPLANTATION STATISTICS

TABLE 93 U.S. SMALL BOWEL TRANSPLANTATION TRENDS, THROUGH 2013

THE MARKET FOR INTESTINE TRANSPLANTATION

TABLE 94 U.S. SMALL BOWEL TRANSPLANTATION MARKET, THROUGH 2013 ($ MILLIONS)

COUNTRIES WITH SMALL BOWEL/INTESTINES TRANSPLANT PROGRAMS

TABLE 95 COUNTRIES WITH SMALL BOWEL TRANSPLANT PROGRAMS

IMMUNOSUPPRESSION

TABLE 96 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR HEART-LUNG TRANSPLANT PATIENTS, THROUGH 2013 ($ MILLIONS)

Drugs Used for Induction

TABLE 97 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN INTESTINE TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance Prior to Discharge

TABLE 98 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN INTESTINE TRANSPLANTATION, 2003-2006 (%)

Drugs Used for Maintenance between Discharge and 1-Year Post-Transplant

TABLE 99 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND 1-YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 2002-2005 (%)

Drugs Used for Anti-rejection between Transplant and 1-Year Post-Transplant

TABLE 100 U.S. IMMUNOSUPPRESSION DRUG USE FOR ANTIREJECTION BETWEEN TRANSPLANT AND 1-YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 2002-2005 (%)

TABLE 100 (CONTINUED)

INFECTION PROPHYLAXIS

ALTERNATIVES

CHAPTER 8: TISSUE TRANSPLANTATION

OVERVIEW

FEWER DONATIONS DUE TO PUBLIC MISTRUST

Compensation

Cosmetic Tissue Usage

CORNEA

HISTORY

GLOBAL ESTIMATES OF VISUAL IMPAIRMENT

CORNEAL TRANSPLANTS IN THE U.S.

TABLE 101 U.S. CORNEAL TRANSPLANT MARKET, THROUGH 2013

Waiting Lists

Waiting Lists: Other Countries

Tissue Testing

Preservation

Cryopreservation

Immunosuppression

ALTERNATIVES

BLOOD STEM CELLS

HISTORY

First Successful Transplant

Donor Registry Established

INDICATIONS

Cord Blood

Cord Blood Banking

PROCEDURE VOLUMES

TABLE 102 PROJECTED U.S. HEMATOPOIETIC STEM CELL TRANSPLANT PROCEDURES, THROUGH 2013

Autologous Versus Allogeneic

DONORS

TABLE 103 BMDW MEMBER HOME COUNTRIES

Blood Collection in the U.S.

TABLE 104 NUMBER OF BONE MARROW DONORS, BY COUNTRY

WAITING LISTS

REJECTION

IMMUNOSUPPRESSION

Enzo Biochem

MARKET FOR IMMUNOSUPPRESSANTS IN BLOOD STEM CELL TRANSPLANTS

TABLE 105 U.S. MARKET FOR IMMUNOSUPPRESSIVE DRUG THERAPY FOLLOWING HEMATOPOIETIC TRANSPLANTATION, THROUGH 2013 ($ MILLIONS)

CORD BLOOD

Increasing the Number of Cord Blood Cells

BONE GRAFT TRANSPLANTATION

HISTORY

GLOBAL BONE GRAFT MARKET

PROCEDURES

TABLE 106 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2013

FIGURE 7 U.S. BONE GRAFT PROCEDURES, 2007-2013 ($ MILLIONS)

Spinal Fusion

Joint Replacement

INDICATIONS

ORTHOPEDIC IMPLANT MARKET

TABLE 107 U.S. AND WORLDWIDE ORTHOPEDIC IMPLANT MARKET GROWTH, THROUGH 2013 ($ MILLIONS)

TABLE 108 U.S. ORTHOPEDIC IMPLANT MARKET BY NUMBER AND TYPE OF PROCEDURE, THROUGH 2013

AUTOGRAFTS

Autografts (Continued)

TABLE 109 U.S. AND WORLD VALUES OF THE BONE GRAFTING MARKET, THROUGH 2013 ($ MILLIONS)

ALLOGRAFTS

Allografts (Continued)

Risks Associated with Allografts

Products

Base Tissue

Demineralized Bone Matrix Products

Machined Implants

THE ORTHOBIOLOGICS MARKET

TABLE 110 GLOBAL ORTHOBIOGICS MARKET, BY PRODUCT, THROUGH 2013 ($ MILLIONS)

The Market for Allografted Tissue

TABLE 111 U.S. SALES OF BONE ALLOGRAFTS BY TYPE, THROUGH 2013 ($ MILLIONS)

FIGURE 8 BONE ALLOGRAFT MARKET, THROUGH 2013 ($ MILLIONS)

BONE GRAFT SUBSTITUTES

TABLE 112 COMPARISON OF BONE GRAFT MATERIALS

TABLE 113 SUBSTITUTE BONE GRAFT

FACTOR-BASED BONE GRAFT SUBSTITUTES

Factor-Based Bone Graft … (Continued)

Bone Morphogenic Proteins (BMPs)

InductOs

INFUSE Bone Graft

OP-1 Implant

PREVENTING INFECTION

PRESERVATION

COMPETITION

VASCULAR TRANSPLANTATION

HISTORY

INDICATIONS

PROCEDURES

DONORS

HEART VALVES

HEART VALVE ALLOGRAFT MARKET

TABLE 114 U.S. HEART VALVE TRANSPLANT MARKET, THROUGH 2013 ($ MILLIONS)

TISSUE TESTING

SYNTHETICS

XENOGRAFTS

ADVANCES

Symetis

Edwards Life Sciences

BETTER MONITORING

TISSUE VALVES GAIN POPULARITY

MAJOR COMPETITORS

VASCULAR GRAFTS

Indications

Waiting List

Products

ALTERNATIVES TO VASCULAR TRANSPLANTATION

SKIN TRANSPLANTATION

TABLE 115 U.S. MARKET FOR HUMAN SKIN-BASED PRODUCTS, THROUGH 2013

HISTORY

MARKET POTENTIAL

INDICATIONS

Burns

Other Injuries

Cosmetic Surgery

Wounds

Venous Ulcers

TABLE 116 ESTIMATED INCIDENCE OF VENOUS ULCERS IN THE U.S. OVER-64 POPULATION, THROUGH 2013

Diabetic Ulcers

TABLE 117 ESTIMATED U.S. INCIDENCE OF DIABETIC FOOT ULCERS, THROUGH 2013 (MILLIONS)

Pressure Ulcers

Urinary Incontinence and Other Uses

Collagen Meniscus Implant

REJECTION

TISSUE TESTING

PRESERVATION

CELLULAR TRANSPLANTATION

HISTORY

INDICATIONS

TYPES OF CELLS

DONORS

REJECTION

GOVERNMENT REGULATIONS

ALTERNATIVES

CHAPTER 9: ALTERNATIVES TO DONOR TRANSPLANTATION

ALTERNATIVES TO CORNEAL TRANSPLANTATION

SURGICAL

ARTIFICIAL CORNEAS

RETINAL TRANSPLANTS

CELLULAR TRANSPLANTS

ELECTRONIC IMPLANTS

ALTERNATIVES TO INTESTINAL TRANSPLANTATION

MEDICAL

CELLULAR

ALTERNATIVES TO PANCREAS TRANSPLANTATION

MEDICAL

Islet Cell Transplantation

Islet Cell Transplantation (Continued)

Drawbacks

Cell Encapsulation

ReNeuron

Bioartificial Pancreas

Cerco Medical

Cultured Stem Cells

Diminished Need for Transplantation in the Future

COSTS

ALTERNATIVES TO HEART TRANSPLANTATION

MEDICAL

Fibroblast Growth Factors

CardioVascular BioTherapeutic, Inc

Endovasc, Ltd

Gene Therapy

Naked Plasmid DNA Transfer

Adenoviral Vectors

XENOTRANSPLANTATION

SURGICAL

Laser Revascularization

Mitral Valve Repair

CARDIAC SUPPORT DEVICES

Passive Support Systems

MECHANICAL

REGENERATION INSTEAD OF REPLACEMENT

Biophan

MECHANICAL ORGANS

VAD Market

VAD costs

TABLE 118 GLOBAL MARKET FOR VADS, THROUGH 2013 ($ MILLIONS)

TABLE 119 U.S. MARKET FOR VADS USED AS DESTINATION THERAPY, THROUGH 2013 ($ MILLIONS)

DeBakey LVAS

HeartMate

Incor LVAD, Excor VAD

Novacor

VAD DEVELOPMENT IN THE U.S.

TABLE 120 LEFT VENTRICULAR ASSIST DEVICES IN DEVELOPMENT

Arrow International

CardiacAssist

Jarvik

Ventracor

TOTAL ARTIFICIAL HEARTS

AbioMed

CardioWest

OTHER CARDIAC ASSIST DEVICES IN DEVELOPMENT

CELLULAR THERAPY

Bioheart

ALTERNATIVES TO LIVER TRANSPLANTATION

MEDICAL

Vertex Pharmaceuticals

ARTIFICIAL LIVERS

CHEMICAL/MECHANICAL AND/OR BIOARTIFICIAL LIVERS

TABLE 121 INDICATIONS FOR THE BIOARTIFICIAL LIVER

Chemical/Mechanical…(Continued)

TABLE 122 BIOARTIFICIAL LIVERS IN DEVELOPMENT

Bioartificial Liver Support System

ELAD

Modular Extracorporeal Liver Support (MELS)

Molecular Adsorption Recycling System (MARS)

RELATIVE COSTS

ALTERNATIVES TO LUNG TRANSPLANTATION

MEDICAL

SURGICAL

ALTERNATIVES TO BONE GRAFTS

MEDICAL

SYNTHETIC MATERIALS

Orthovita

Spine Wave

ReGen Biologics

ALTERNATIVES TO VASCULAR TRANSPLANTATION

ANIMAL

Stentless Valves

Calcification

SURGICAL

Angioplasty and Stents

MEDICAL

MECHANICAL/SYNTHETIC

ALTERNATIVES TO VASCULAR TRANSPLANTATION

TISSUE ENGINEERING OF VASCULAR GRAFTS

GENE THERAPY

ALTERNATIVES TO SKIN TRANSPLANTATION

ANIMAL-BASED PRODUCTS

Biobrane

OaSIS

GROWTH FACTORS

ARTIFICIAL SKIN/SKIN REPLACEMENT PRODUCTS

AlloDerm

Apligraf

Cymetra

Dermagraft

Epicel

Integra Products

OrCel

TransCyte

MANUFACTURERS OF ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS

TABLE 123 MANUFACTURERS OF ARTIFICIAL SKIN AND SKIN REPLACMENT PRODUCTS

THE MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS

TABLE 124 ESTIMATED WORLDWIDE MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2013 ($ MILLIONS)

TABLE 125 ESTIMATED U.S. MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2013 ($ MILLIONS)

PRODUCTS IN DEVELOPMENT

Altex Plus, Ltd.

Cytomedix

Geron

OTHER RESEARCH

REGULATION

CHAPTER 10: COMPANY PROFILES

ABIOMED, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ARBIOS SYSTEMS, INC

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ARROW INTERNATIONAL

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ASTELLAS PHARMA, INC

BUSINESS OVERVIEW

FINANCIAL INFORMATION

CRYOLIFE, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

DEPUY ORTHOPEDICS

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

EDWARDS LIFESCIENCES

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

EXACTECH

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

FORTICELL BIOSCIENCE

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

FRESENIUS MEDICAL CARE AG & CO. KGAA

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

GENZYME

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

HEMOCLEANSE, INC

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

JOHNSON & JOHNSON

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

KIADIS PHARMA

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

KINETIC CONCEPTS, INC (KCI)

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

LIFEBLOOD MEDICAL, INC

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

LIFECELL CORP. (SEE KINETIC CONCEPTS, INC)

LIFECYCLE PHARMA A/S

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

LIVING CELL TECHNOLOGIES, LTD

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

MEDTRONIC, INC.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

NOVARTIS AG

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ON-X LIFE TECHNOLGIES, INC

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

ORGANOGENESIS, INC.

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

OSTEOTECH

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

PDL BIOPHARMA

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

ROCHE PHARMACEUTICALS

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

SORIN GROUP, S.P.A

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

ST. JUDE MEDICAL

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

STRYKER CORPORATION

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

SYNCARDIA SYSTEMS, INC

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

SYTHES (US)

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

TRANSMEDICS, INC

BUSINESS OVERVIEW

FINANCIALS

PRODUCTS

THORATEC CORP.

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

VENTRACOR

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

VIROPHARMA, INC

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

WORLD HEART CORP

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

WYETH

BUSINESS OVERVIEW

FINANCIAL INFORMATION

PRODUCTS

LIST OF TABLES

SUMMARY TABLE U.S. MARKET FOR SOLID ORGAN AND TISSUE TRANSPLANTATION, THROUGH 2013 ($ MILLIONS)