The Market for Organ and Tissue Transplantation and Alternatives

INTRODUCTION
STUDY GOAL AND OBJECTIVES
REASONS FOR DOING THE STUDY
CONTRIBUTIONS OF THE STUDY AND FOR WHOM
SCOPE AND FORMAT
METHODOLOGY
INFORMATION SOURCES
AUTHOR'S CREDENTIALS
RELATED BCC PUBLICATIONS
BCC ONLINE SERVICES
DISCLAIMER

SUMMARY
Summary Table:
NUMBER OF PROCEDURES AND VALUE OF U.S. ORGAN AND TISSUE TRANSPLANTATION MARKETS, THROUGH 2010
Summary Figure:
NUMBER OF PROCEDURES AND VALUE OF U.S. ORGAN AND TISSUE TRANSPLANTATION MARKETS, 2005 AND 2010

OVERVIEW
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 2010
KIDNEY
LIVER
HEART
LUNG
INTESTINE
PANCREAS
WAITING LISTS
Waiting Lists Grow Faster than Numbers of Transplantations
Table 2 PATIENTS ON U.S. WAITING LISTS AT THE END OF THE YEARS BY TYPE OF ORGAN TRANSPLANT, 1999-2003
INTERNATIONAL TRENDS
Limited Supply Puts Brakes on Transplantations
Table 3 NUMBERS OF DONATED CADAVERS BY REGION, 1997-2003
TISSUES
AGING BABY BOOMERS DRIVE THE MARKET
Table 4 TISSUE GRAFTING IN THE U.S. BY TISSUE TYPE, THROUGH 2010 (NUMBER OF PROCEDURES)
Figure 1 TISSUE GRAFTING IN THE U.S., 2005 AND 2010 (NUMBER OF PROCEDURES)
CORNEA
BLOOD STEM CELLS
BONE ALLOGRAFTS
HEART VALVES
VASCULAR TISSUE
SKIN AND COLLAGEN
APPLICATIONS
THE TRANSPLANTATION PROCESS
PREPARATION
SURGERY
RECUPERATION
MAINTENANCE
PRODUCTS IN THE TRANSPLANTATION PROCESS
HLA TISSUE TYPING
The World Market for HLA Typing
Table 5 WORLD MARKET FOR HLA TYPING, THROUGH 2010 ($ MILLIONS)
The U.S. Market for HLA Typing
Table 6 U.S. MARKET FOR HLA TYPING, THROUGH 2010 ($ MILLIONS)
Splitting the Market
ORGAN PRESERVATION PRODUCTS
ANTIREJECTION DRUGS
ANTI-INFECTIVES
Table 7 WORLD MARKET FOR ANTI-INFECTIVES USED FOR TRANSPLANT PATIENTS, THROUGH 2010 ($ MILLIONS)
POSTTRANSPLANT MONITORING
Table 8 WORLD MARKET FOR POSTTRANSPLANT MONITORING, THROUGH 2010 ($ MILLIONS)
ALTERNATIVES TO TRANSPLANTATION
GOVERNMENT REGULATION AND PATENTS
EVOLUTION OF TRANSPLANTATION
TISSUE TYPING
IMMUNOSUPPRESSION
PRESERVATION
Improvements in Cold Ischemia Time
Table 9 COLD ISCHEMIA TIMES FOR KIDNEYS, 1998-2002 (HOURS)
GOVERNMENT REIMBURSEMENT OF TRANSPLANTATION COSTS
MECHANICAL ORGANS
GENERAL TRENDS

SUPPLY MANAGEMENT
REDUCING WASTE AND REJECTION
INCREASING THE HARVEST
Table 10 RECOVERED ORGANS NOT USED BY TYPE, 1998-2003
Table 11 CONSENTED ORGANS NOT RECOVERED BY TYPE, 1998-2003
BETTER HARVESTING
Definition of Brain Death
Papworth Cocktail
Remembering the Ultimate Customer: the Patient on the Waiting List
LESS WASTE
PRESERVATION
Rinse and Preservation Solutions
Table 12 MAJOR ORGAN PRESERVATION SOLUTIONS
Celsior
Collins Solution
Custodiol
Hypothermosol
ViaSpan
The Market for Preservation Solutions
Table 13 NORTH AMERICAN AND WORLD MARKETS FOR ORGAN PRESERVATION SOLUTIONS (EXCEPT PAPWORK COCKTAIL), THROUGH 2010
Organ Preservation Products in Development
Machine Perfusion
Bio-Preserve International
TransMedics, Inc.
Waters Medical Systems
NON-HEART-BEATING DONORS
TESTING
Blood Typing
Tissue Typing
Panel Reactive Antibodies (PRA)
Table 14 TISSUE TYPING TECHNOLOGIES
Advances
Table 15 SELECTED COMPETITORS IN THE HLA TYPING MARKET
Plasmapheresis: Transplantation without Matching Antigens
Posttransplant Testing
Biotronik
Data Sciences
Isis
Reperfusion Injury
FIGHTING REJECTION
Table 16 NUMBER OF PATIENTS IN THE U.S. WHO ARE ON WAITING LISTS BECAUSE OF GRAFT FAILURE (FAILURE OF PREVIOUSLY TRANSPLANTED ORGAN), ALL ORGANS, 1995-2003
Table 17 PERCENT OF U.S. PATIENTS ON WAITING LISTS BY ORGAN WHO PREVIOUSLY HAD A TRANSPLANT, 2000-2003 (%)
Table 18 U.S. ORGAN RECIPIENTS WHO PREVIOUSLY HAD A TRANSPLANT: ALL ORGANS, 1995-2004
Table 19 NUMBERS OF PEOPLE IN THE U.S. LIVING WITH A FUNCTIONING TRANSPLANT BY TYPE, 1998-2003
IMMUNOSUPPRESSIVE DRUG THERAPY
Improvements in Products and Survival Times
Table 20 ANTIREJECTION DRUGS APPROVED IN THE U.S., BY CLASS
Usual Antirejection Drug Protocols
Induction Therapy
Table 21 IMMUNOSUPPRESSANT USE FOR INDUCTION, BY ORGAN (%)
Maintenance Therapy

Table 22 COMMON IMMUNSUPPRESSIVE REGIMENS
Table 23 COMMONLY USED INTRAVENOUS IMMUNOSUPPRESIVE DRUGS
Table 24 IMMUNOSUPPRESSANT DRUG USE AT TRANSPLANT DISCHARGE, BY ORGAN (%)
Table 25 IMMUNOSUPPRESSANT DRUG USE, BY ORGAN, AT END OF FIRST-YEAR POSTTRANSPLANT (%)
Rejection Therapy
Risks Associated with Immunosuppressive Therapy
Annual Cost of Immunosuppressant Drugs
Comparison of Annual Cost of Two Immunosuppressant Drug Regimens during the First Year Following Transplantation
The Market for Immunosuppressant Drug Therapy
Table 26 WORLDWIDE MARKET FOR IMMUNOSUPPRESSION IN SOLID ORGAN TRANSPLANT RECIPIENTS, THROUGH 2010
Table 27 WORLDWIDE SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)
Table 28 U.S. SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)
Table 29 WORLDWIDE SALES OF BRAND NAME IMMUNOSUPPRESSANT DRUGS BY COMPANY: 2004-2010 ($ MILLIONS)
Table 30 PERCENTAGE OF U.S. MARKET BY PRESCRIPTION VOLUME OF ANTIREJECTION DRUGS, 2004 (%)
Products
Antibodies
Table 31 MARKETED ANTIBODY PRODUCTS FOR TREATMENT OF ORGAN TRANSPLANT REJECTION
Monoclonal Antibody Products
Campath/MabCampath
Antithymocyte Globulin
Atgam
Thymoglobulin

The Market for Antibody Products to Treat Organ Transplant Rejection
Table 32 GLOBAL MARKET FOR ANTIBODY PRODUCTS TO TREAT ORGAN TRANSPLANT REJECTION: WORLDWIDE SALES FOR, THROUGH 2010 ($ MILLIONS)
Antibodies in Development for Organ Transplant Rejection
Table 33 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE PREVENTION OF ORGAN TRANSPLANT REJECTION
Antiproliferative Agents
Azathioprine
CellCept
Certican
Myfortic
Calcineurin Inhibitors
Concern About Generics
Leading Cyclosporine Products
Pulminiq: the Newest Entrant to the Market

Prograf
TOR Inhibitors
Immunosuppressive Agents in Development
Table 34 IMMUNOSUPPRESSIVE AGENTS IN PHASE II OR LATER DEVELOPMENT
Generics
HOW THE MEDICARE DRUG DISCOUNT CARD PROGRAM AND THE MEDICARE DRUG BENEFIT WILL AFFECT TRANSPLANT PATIENTS

Table 35 MEDICARE IMMUNOSUPPRESIVE DRUG COVERAGE OVERVIEW

Table 36 MEDICARE IMMUNOSUPPRESIVE DRUG COVERAGE OVERVIEW (PART II)
EFFECT OF PATENT REFORM EFFORTS TO SHORTEN MONOPOLY TIMES ON TRANSPLANTATION DRUG RESEARCH
TRANSPLANTATION WITHOUT REJECTION
TOLERANCE
Antisense Therapy
Costimulation
Chimerism
Abgenix
Chimeric Therapies
ADDRESSING INFECTION
Table 37 COMMON POSTTRANSPLANT INFECTIONS
Table 38 COMMON POSTTRANSPLANT DRUGS
MONITORING
Table 39 WORLD MARKET FOR TRANSPLANT DRUG AND DISEASE-MONITORING AGENTS, THROUGH 2010 ($ MILLIONS)
THE EFFICIENCY DIVIDEND
TISSUE
FINDING MORE SUPPLY
EXPANDING TRADITIONAL SOURCES: OBTAINING MORE CADAVERS
Spain Sets Donation Standard
Table 40 INTERNATIONAL ORGAN DONOR RATES, 2000 (PER MILLION OF POPULATION)
The Uniform Anatomical Gift Act
Reforms to Boost Donation
Presumed Consent
Table 41 SELECTED COUNTRIES AND TYPE OF CONSENT

First-person Consent
Donor Compensation
Reimbursement for Donor Organs in the U.K.
Tapping New Sources: Expanding Donations to New Nations and Living Donors
Shifting Cadaveric Donation
Table 42 COUNTRIES WITH KIDNEY TRANSPLANT PROGRAMS
Table 43 KIDNEY, LIVER AND HEART TRANSPLANTS BY REGION, 2000

More Competition Splinters the Market
Organ Selling Meets Dammed Up Demand
Marketing Availability
Belgium and Austria
Costa Rica
Cuba
Pakistan
South Africa
Tissues
Effects of Globalization
ORGAN DONATION BREAKTHROUGH COLLABORATIVE
MAJOR U.S. TRANSPLANT CENTERS
Table 44 LEADING U.S. TRANSPLANT PROGRAMS (BY TOTAL NUMBER OF PROCEDURES PERFORMED BETWEEN JANUARY 1, 1988 AND MARCH 1, 2005)
Table 45 LEADING U.S. TRANSPLANT PROGRAMS BY NUMBER OF MULTIORGAN TRANSPLANT PROCEDURES PERFORMED BETWEEN JANUARY 1, 1988 AND MARCH 1, 2005
Living Donors
Table 46 TRENDS IN U.S. LIVING AND CADAVERIC DONATIONS, 2003-2010
TRENDS IN TRANSPLANTATION OF ALL ORGANS
Table 47 U.S. ORGAN TRANSPLANTS, 1998 TO 2004 (NUMBER OF PROCEDURES)
Survival Rates
Table 48 ONE-YEAR AND FIVE-YEAR PATIENT SURVIVAL RATES, BY ORGAN, FOR PATIENTS RECEIVING TRANSPLANTS BETWEEN 1998 AND 2003 (%)
Table 49 ONE-YEAR AND FIVE-YEAR GRAFT SURVIVAL RATES, BY ORGAN FOR TRANSPLANTS PERFORMED BETWEEN 1998 AND 2003 (%)
Kidney Exchanges
Incompatible Kidney Transplant Program
NEW TECHNOLOGIES
ORGANS FROM ANIMALS: XENOTRANSPLANTATION
ORGAN PRIMORDIA
NUCLEAR TRANSFER TO ELIMINATE THE REJECTION GENE
Porcine Endogenous Retrovirus
Competition Thins
Regulatory Issues
Political Problems
ARTIFICIAL ORGANS
REDUCING DEMAND
CELLULAR TRANSPLANTS
ORGANS
KIDNEY
TRANSPLANTATION STATISTICS
Table 50 NUMBER OF KIDNEY TRANSPLANTATIONS BY REGION, THROUGH 2010
THE MARKET FOR KIDNEY TRANSPLANTATION
Table 51 U.S. KIDNEY TRANSPLANT MARKET, THROUGH 2007 ($ MILLIONS)
Figure 2 U.S. KIDNEY TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)
LEADING U.S. KIDNEY TRANSPLANT PROGRAMS
Table 52 TOP FIVE U.S. KIDNEY TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)
TRANSPLANTATION TOO RARE TO BE A SOLUTION
WAITING LIST
Table 53 WAITING LIST TRENDS FOR KIDNEYS BY SELECTED REGION, THROUGH 2010
Shortage is Worse in Japan
CADAVERIC VERSUS LIVING DONATION
Table 54 NUMBER OF U.S. KIDNEY TRANSPLANTATIONS FROM LIVING AND CADAVERIC DONORS, THROUGH 2010
CLOSING THE KIDNEY GAP
INDICATIONS
Table 55 LEADING CAUSES OF KIDNEY FAILURE, 2003
Table 56 LEADING CAUSES OF KIDNEY TRANSPLANTATION, 2004 (%)
OLDER RECIPIENTS
LESS REJECTION
Table 57 GRAFT FAILURE HAZARD RATIO (1993 = 1)
IMMUNOSUPPRESSION
Table 58 IMMUNOSUPPRESSIVE REGIMENS IN A SAMPLE POPULATION OF 113 KIDNEY TRANSPLANT PATIENTS
Drugs Used for Induction
Table 59 U.S IMMUNOSUPPRESSION USE FOR INDUCTION IN KIDNEY TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 60 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN KIDNEY TRANSPLANTATION, 1998-2003 (%)

Drugs Used for Maintenance Between Discharge and One-year Posttransplant
Table 61 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN KIDNEY TRANSPLANTATION, 1998-2002 (%)
Drugs Used for Maintenance Between Transplant and One-year Posttransplant
Table 62 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN KIDNEY TRANSPLANTATION, 1998-2002 (%)
The Market for Immunosuppressive Therapy for Kidney Transplantation
Table 63 U.S. SALES OF IMMUNOSUPPRESSIVES BY DRUG CATEGORY, THROUGH 2010 ($ MILLIONS)
Table 64 ESTIMATED U.S. MARKET FOR IMMUNOSUPPRESSIVES FOR KIDNEY TRANSPLANT PATIENTS, THROUGH 2010
ADVANCES IN KIDNEY TRANSPLANTATION
ALTERNATIVES
Mechanical
Medical
Animal
Cellular
PANCREAS
TRANSPLANTATION STATISTICS
Table 65 GROWTH OF WHOLE PANCREAS TRANSPLANTATION IN THE U.S. AND EUROPE, THROUGH 2010 (NUMBER OF PROCEDURES)
THE MARKET FOR PANCREAS TRANSPLANTATION
Table 66 U.S. WHOLE PANCREAS TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)
Figure 3 U.S. WHOLE PANCREAS TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)
WAITING LIST
Table 67 U.S. PANCREAS WAITING LIST, THROUGH 2010
LEADING U.S. PANCREAS TRANSPLANT PROGRAMS
Table 68 TOP FIVE U.S. KIDNEY TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)
IMMUNOSUPPRESSION
Drugs Used for Induction
Table 69 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN PANCREAS TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 70 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE AFTER PANCREAS TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance between Discharge and One-year Posttransplant
Table 71 IMMUNOSUPPRESSION DRUG USE IN THE U.S. FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT FOR PANCREAS TRANSPLANTATION, 1998-2002 (%)
Drugs Used for Maintenance Between Transplant and One-year Posttransplant
Table 72 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN PANCREAS TRANSPLANTATION, 1998-2002 (%)

CONTROVERSY
INDICATIONS
Table 73 ESTIMATED ANNUAL PER CAPITA PATIENT COSTS FOR DIABETES IN SELECTED COUNTRIES, 2004
ALTERNATIVES
Medical
Islet Cell Transplantation
Table 74 INTERNATIONAL AND U.S. PANCREAS GRAFT SURVIVAL RATES (%)
A Breakthrough
Juvenile Diabetes Research Foundation
Drawbacks
Cell Encapsulation
AmCyte Biomedical
Islet Technology
Pig-derived Islet Cells
Arbios Systems
Bioartificial Pancreas
Cerco Medical
IMEDD
Cultured Stem Cells
Protection of Islet Cells
Neurochem
COSTS
LIVER
HISTORY
TRANSPLANT STATISTICS
Table 75 GROWTH OF LIVER TRANSPLANTS BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)
THE MARKET FOR LIVER TRANSPLANTATION
Table 76 U.S. LIVER TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)
Figure 4 U.S. LIVER TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)
LEADING U.S. LIVER TRANSPLANT PROGRAMS
Table 77 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)
DONORS
Table 78 U.S. TRENDS IN LIVING DONOR LIVER TRANSPLANTS, 2000-2010
WAITING LIST
Table 79 REGIONAL GROWTH IN LIVER WAITING LISTS, THROUGH 2010
IMMUNOSUPPRESSION
Drugs Used for Induction
Table 80 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LIVER TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 81 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LIVER TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance between Discharge and One-year Posttransplant
Table 82 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 1998-2002 (%)

Drugs Used for Maintenance Between Transplant and One-year Posttransplant
Table 83 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT FOR LIVER TRANSPLANTATION, 1998-2002 (%)
The Market for Immunosuppressive Drugs in Liver Transplantation
Table 84 U.S. MARKET FOR IMMUNOSUPPRESSANT DRUGS FIRST YEAR AFTER LIVER TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)
INDICATIONS
Causes of Cirrhosis
TISSUE TYPING
ORGAN RECOVERY
REJECTION
Table 85 LIVER TRANSPLANT SURVIVAL RATES IN THE U.S. AND EUROPE (%)
ALTERNATIVES
Medical
Artificial Livers
Chemical/ Mechanical and /or Bioartificial Livers
Table 86 INDICATIONS FOR THE BIOARTIFICIAL LIVER

Table 87 BIOARTIFICIAL LIVERS IN DEVELOPMENT
Bioartificial Liver Support System
ELAD
LIVERAID
LiveRX 2000
Modular Extracorporeal Liver Support
Molecular Adsorption Recycling System
Relative Costs
HEART
TRANSPLANTATION STATISTICS
Table 88 DECLINING NUMBERS OF HEART TRANSPLANTATIONS BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)
THE MARKET FOR HEART TRANSPLANTATION
Table 89 U.S. HEART TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)
LEADING U.S. HEART TRANSPLANT PROGRAMS
Table 90 TOP FIVE U.S. HEART TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)
FEWER TRANSPLANTS DUE TO TIGHTER SUPPLY
Cultural Backlash
1995: A Peak Year
SHRINKING WAITING LISTS
Table 91 HEART WAITING LIST TRENDS, THROUGH 2010
IMMUNOSUPPRESSION
Drugs Used for Induction
Table 92 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 93 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Between Discharge and One-year Posttransplant
Table 94 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN HEART TRANSPLANTATION, 1998-2002 (%)

Table 95 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN HEART TRANSPLANTATION, 1998-2002 (%)
The Immunosuppressive Drug Market for Heart Transplantation
Table 96 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER HEART TRANSPLANTATION, FIRST-YEAR AFTER TRANSPLANT, THROUGH 2010
INDICATIONS
Table 97 LEADING CAUSES OF HEART FAILURE, 1999-2003 (%)
TISSUE TYPING
PRESERVATION
ALTERNATIVES
Medical
Angiogenesis Stimulators
Fibroblast Growth Factors

Nicotine
Gene Therapy

Animal
Surgical
Laser Revascularization
Mitral Valve Repair
Cardiac Support Devices
Mechanical
VAD Market
VAD Market
Table 98 U.S. MARKET FOR VADS, THROUGH 2010 ($ MILLIONS)
Table 99 U.S. MARKET FOR VADS USED AS DESTINATION THERAPY, THROUGH 2010 ($ MILLIONS)
DeBakey LVAS
HeartMate
Incor
LionHeart
Novacor
VADs Development in the U.S.
Table 100 LEFT VENTRICULAR ASSIST DEVICES IN DEVELOPMENT
Arrow International
CardiacAssist
Jarvik
MicroMed
Terumo
Thoratec
Ventracor
WorldHeart
Product Comparison
Medicare Changes Give the VAD Market a Boost
The Likelihood of Big Players Entering the Market
Total Artificial Hearts
AbioCor
CardioWest
Other Cardiac Assist Devices in Development
Regeneration Instead of Replacement
Cellular
LUNG
TRANSPLANTATION STATISTICS
Table 101 REGIONAL TRENDS IN LUNG TRANSPLANTATIONS, THROUGH 2010 (NUMBER OF PROCEDURES)
THE MARKET FOR LUNG TRANSPLANTATION
Table 102 U.S. LUNG TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)
Figure 5 U.S. LUNG TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)
LEADING U.S. LUNG TRANSPLANT PROGRAMS
Table 103 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

IMMUNOSUPPRESSION
Drugs Used for Induction
Table 104 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN LUNG TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 105 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN LUNG TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance between Discharge and One-year Posttransplant
Table 106 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 1998-2002 (%)

Drugs Used for Maintenance between Transplant and One-year Posttransplant
Table 107 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN LUNG TRANSPLANTATION, 1998-2002 (%)
The Market for Immunosuppressive Drugs Used in Lung Transplantation
Table 108 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER LUNG TRANSPLANTATION, FIRST YEAR AFTER TRANSPLANT, THROUGH 2010 ($ MILLIONS)
DONATION
Table 109 RECOVERED LUNGS NOT USED IN THE U.S., 1998-2003
Hormonal Resuscitation
WAITING LISTS
Table 110 LUNG WAITING LIST TRENDS, THROUGH 2010
REJECTION
Table 111 INTERNATIONAL AND U.S. LUNG TRANSPLANT AND GRAFT SURVIVAL RATES* (%)
INDICATIONS
Table 112 LEADING CAUSES OF CHRONIC LUNG FAILURE, 1998-2002 (%)
PRESERVATION
Celsior
Prolactin
ALTERNATIVES
Medical
Surgical
Cellular
HEART-LUNG
TRANSPLANTATION STATISTICS
Table 113 TRENDS IN HEART-LUNG TRANSPLANTATION BY REGION, THROUGH 2010 (NUMBER OF PROCEDURES)
THE MARKET FOR HEART-LUNG TRANSPLANTATION
Table 114 U.S. HEART-LUNG TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)
Figure 6 U.S. HEART-LUNG TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)
THE LEADING U.S. HEART-LUNG TRANSPLANT PROGRAMS
Table 115 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)
WAITING LIST
Table 116 HEART-LUNG WAITING LIST TRENDS, THROUGH 2010
SURVIVAL RATES
Table 117 INTERNATIONAL HEART AND HEART-LUNG TRANSPLANT PATIENT SURVIVAL RATES (%)
IMMUNOSUPPRESSION
Drugs Used for Induction
Table 118 U.S. IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN HEART-LUNG TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 119 U.S IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN HEART-LUNG TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Between Discharge and One-year Posttransplant
Table 120 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 1998-2002 (%)
Table 121 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE-YEAR POSTTRANSPLANT IN HEART-LUNG TRANSPLANTATION, 1998-2002 (%)
INTESTINE
HISTORY
TRANSPLANTATION STATISTICS
Table 122 INTERNATIONAL AND U.S. INTESTINE TRANSPLANT SURVIVAL RATES (%)
Table 123 U.S. SMALL BOWEL TRANSPLANTATION TRENDS, THROUGH 2010
THE MARKET FOR INTESTINE TRANSPLANTATION
Table 124 U.S. SMALL BOWEL TRANSPLANTATION MARKET, THROUGH 2010 ($ MILLIONS)
Figure 7 U.S. SMALL BOWEL TRANSPLANTATION MARKET, 2005 AND 2010 ($ MILLIONS)
LEADING U.S. INTESTINE TRANSPLANT PROGRAMS
Table 125 TOP FIVE U.S. LIVER TRANSPLANT PROGRAMS (BY TOTAL PROCEDURES PERFORMED FROM JANUARY 1, 1988 TO MARCH 1, 2005)

COUNTRIES WITH SMALL BOWEL TRANSPLANT PROGRAMS
Table 126 COUNTRIES WITH SMALL BOWEL TRANSPLANT PROGRAMS
LACK OF SURGICAL SUCCESS
TRANSPLANT TYPES
INDICATIONS
Table 127 LEADING INIDICATIONS FOR INTESTINE TRANSPLANT: ADULT PATIENTS, 2003 (%)
Table 128 LEADING INDICATIONS FOR INTESTINE TRANSPLANT: PEDIATRIC PATIENTS, 2003 (%)
IMMUNOSUPPRESSION
Drugs Used for Induction
Table 129 U.S IMMUNOSUPPRESSION DRUG USE FOR INDUCTION IN INTESTINE TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Prior to Discharge
Table 130 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE PRIOR TO DISCHARGE IN INTESTINE TRANSPLANTATION, 1998-2003 (%)
Drugs Used for Maintenance Between Discharge and One-year Posttransplant
Table 131 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN DISCHARGE AND ONE-YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 1998-2002 (%)
Drugs Used for Maintenance Between Transplant and One Year Posttransplant
Table 132 U.S. IMMUNOSUPPRESSION DRUG USE FOR MAINTENANCE BETWEEN TRANSPLANT AND ONE YEAR POSTTRANSPLANT IN INTESTINE TRANSPLANTATION, 1998-2002 (%)
The Market for Immunosuppressive Drugs Used in Intestine Transplantation
Table 133 U.S. MARKET FOR ANTIREJECTION DRUGS AFTER SMALL BOWEL TRANSPLANTATION, FIRST YEAR AFTER TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)
INFECTION PROPHYLAXIS
ALTERNATIVES
Medical
Mechanical
Cellular

TISSUES
OVERVIEW
MANDATORY REFERRALS
PUBLIC CYNICISM
DONOR COMPENSATION
CORNEA
Table 134 CORNEAL TRANSPLANTS IN SELECTED COUNTRIES, 1999-2003
Table 135 CORNEAL TRANSPLANTS AND U.S. MARKET, THROUGH 2010
Figure 8 U.S. CORNEAL TRANSPLANT MARKET, 2005 AND 2010 ($ MILLIONS)
Donors
Table 136 NUMBER OF U.S. CORNEA DONORS, 1999-2004
Waiting Lists
U.S.
Other Countries
Indications
Tissue Testing
Preservation
Cryopreservation
Immunosuppression
Alternatives
Surgical
Artificial Corneas
RETINAL DEGENERATION
Cellular Transplants
Gene Therapy
Electronic Implants
BLOOD STEM CELLS
HISTORY
First Successful Transplant
Donor Registry Established
Cord Blood
Cord Blood Banking
PROCEDURE VOLUMES
Table 137 ESTIMATED U.S. BONE MARROW TRANSPLANTS, 1998-2004
Table 138 PROJECTED U.S. BONE MARROW TRANSPLANT PROCEDURES, THROUGH 2010
Autologous Passes Allogeneic
Less Bone Marrow
DONORS
Table 139 BMDW MEMBER HOME COUNTRIES
Potential for HLA Testing
Table 140 NUMBERS OF BONE MARROW DONORS PER 10,000 INHABITANTS

WAITING LISTS
REJECTION
Table 141 U.S. MARKET FOR IMMUNOSUPPRESSIVE DRUG THERAPY FOLLOWING BONE MARROW TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)
Table 142 U.S. MARKET FOR IMMUNOSUPPRESSIVE DRUG THERAPY FOLLOWING BLOOD STEM CELL TRANSPLANTATION, THROUGH 2010 ($ MILLIONS)
INDICATIONS
IMMUNOSUPPRESSION
Abgenix
University of Pennsylvania
ALTERNATIVES
Expanding Cord Blood
Replicell
BONE
HISTORY
PROCEDURES
Table 143 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2010
Table 144 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2010
MARKET TOTALS
Table 145 U.S. AND WORLDWIDE ORTHOPEDIC IMPLANT MARKET GROWTH, THROUGH 2010 ($ BILLIONS)
Figure 9 U.S. AND WORLDWIDE IMPLANT MARKET GROWTH, 2005 AND 2010 ($ BILLIONS)
AUTOGRAFTS
ALLOGRAFTS

Risks Associated with Allografts
Products
Base Tissue
Demineralized Bone Matrix Products
Machined Implants
The Market for Allografted Tissue
Table 146 U.S. AND WORLD VALUES OF THE BONE ALLOGRAFT MARKET, THROUGH 2010 ($ MILLIONS)
Figure 10 VALUE OF THE U.S. AND WORLD BONE ALLOGRAFT MARKET, 2005 AND 2010 ($ MILLIONS)
Table 147 U.S. SALES OF BONE ALLOGRAFTS BY TYPE, THROUGH 2010 ($ MILLIONS)
Figure 11 U.S. SALES OF BONE ALLOGRAFTS BY TYPE, 2005 AND 2010 ($ MILLIONS)
BONE GRAFT SUBSTITUTES
Table 148 COMPARISON OF BONE GRAFT MATERIALS
Table 149 SUBSTITUTE BONE GRAFT TYPES
FACTOR-BASED BONE GRAFT SUBSTITUTES

Bone Morphogenic Proteins (BMPs)
InductOs
INFUSE® Bone Graft

Ne-Osteo
OP-1 Implant®
Skelite®
THE MARKET FOR BONE GRAFT PRODUCTS
Table 150 WORLDWIDE MARKET FOR BONE GRAFT PRODUCTS, THROUGH 2010 ($ MILLIONS)
INDICATIONS
TISSUE TESTING
Preventing Infection
PRESERVATION
COMPETITION
ALTERNATIVES
Animal Bone Grafts
Medical
Synthetic Materials
Orthovita
Spine Wave
Meniscus Allografts
Collagen Meniscus Implant
REPLACEMENT HEART VALVES, ARTERIES AND OTHER VESSELS
HISTORY
INDICATIONS
PROCEDURES
Table 151 NUMBER OF U.S. HEART VALVE TRANSPLANTS AND BYPASS OPERATIONS, 1998-2004
DONORS
Valves from Morgues
HEART VALVE ALLOGRAFT MARKET
Table 152 U.S. AND WORLD HEART VALVE TRANSPLANT MARKET, THROUGH 2010 ($ MILLIONS)
TISSUE TESTING
PRESERVATION AND PROCESSING
Synthetics
Xenografts
Defects and Regulation
ADVANCES
ALTERNATIVES
Animal
Stentless Valves
Calcification
Surgical
Coronary Bypass Grafts
Medical
Heart Valve and Vascular Disease
Mechanical/Synthetic
Improving Blood Flow
Better Maintenance
Tissue Valves Gain Popularity
Major Competitors
VASCULAR GRAFTS
Waiting List
Indications
Advances
Products
Tissue Engineering of Vascular Grafts
Alternatives
Gene Therapy

SKIN
Table 153 U.S. MARKET FOR HUMAN SKIN-BASED PRODUCTS, THROUGH 2010
HISTORY
INDICATIONS
Burns
Wounds
Venous Ulcers
Table 154 ESTIMATED INCIDENCE OF VENOUS ULCERS IN THE U.S. OVER-64 POPULATION, THROUGH 2010
Diabetic Ulcers
Table 155 ESTIMATED U.S. INCIDENCE OF DIABETIC FOOT ULCERS, THROUGH 2010
Pressure Ulcers
Urinary Incontinence and Other Uses
Table 156 U.S. TENDON, CARTILAGE AND MUSCLE GRAFTS, 1998-2004
REJECTION
TISSUE TESTING
PRESERVATION
Alternatives
Animal-based Products
Biobrane
OaSIS
Medical
Artificial Skin/Skin Replacement Products
AlloDerm
Apligraf
Cymetra
Dermagraft
Epicel
Integra Products
OrCel
TransCyte
Manufacturers of Artificial Skin and Skin Replacement Products
Table 157 MANUFACTURERS OF ARTIFICIAL SKIN AND SKIN REPLACMENT PRODUCTS
The Market for Artificial Skin and Skin Replacment Products
Table 158 ESTIMATED WORLDWIDE MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2010 ($ MILLIONS)
Table 159 ESTIMATED U.S. MARKET FOR ARTIFICIAL SKIN AND SKIN REPLACEMENT PRODUCTS, THROUGH 2010 ($ MILLIONS)
Products in Development
Other Research
REGULATION
CELLULAR TRANSPLANTATION
HISTORY
FOUR TYPES OF CELLS OFFER POTENTIAL
NUMBERS
DONORS
REJECTION
INDICATIONS
PATENTS
New Rule Requires Demonstrating Specific and Substantial Utility
ALTERNATIVES

COMPANY PROFILES
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FINANCIAL INFORMATION
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WEB SITE: WWW.GENZYME.COM
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FINANCIAL INFORMATION
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FINANCIAL INFORMATION
PRODUCTS
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CORPORATE STRATEGY
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BUSINESS OVERVIEW
FINANCIAL INFORMATION
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BUSINESS OVERVIEW
FINANCIAL INFORMATION
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WORLDHEART CORP.
BUSINESS OVERVIEW
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WYETH
BUSINESS OVERVIEW
FINANCIAL INFORMATION
PRODUCTS