Description
Improved surgical techniques and organ preservation, understanding of immunologic barriers, and the development of newer and more potent immunosuppressives have combined to improve survival of transplant patients and grafts. Rejection remains the major barrier to long-term graft survival in patients, organ transplantation therapy is highly dependent on the success of immunosuppressants to suppress the recipient’s immune responses to the foreign organ.
Most transplant patients require lifelong immunosuppressive therapy to prevent rejection, except when human leukocyte antigen (HLA)-identical transplants are used.
The number of organ transplants performed worldwide is approximately 70,000 annually. As medical science extends the life expectancy of patients with transplanted organs, demand continues to increase for safe, effective immunosuppressants to control transplant rejection.
Kalorama Information’s Organ Transplant Immunosuppressive Markets is focused on immunosuppressants utilized in solid organ transplantation. It provides an in depth look into the trends that have shaped today’s use of transplant immunosuppression regimens, and details the current and future global market. Included in this report:
- Detailed statistics on Transplant Need, Organ Transplant Procedures, Costs, Patient Waiting Lists, and Patient Survival Rates
- Immunosupressive Current Market and Forecasts
- Breakouts of Immunosuppressive Drugs by Drug Type and by Organ Transplanted
- Regional Breakout of Immunosuppressive Sales (US, Europe, Asia/Pacific, Rest of World)
- Market Share of Immunosuppressive Market
- Review of Current Products and New Products in Development
- Profiles of Immunosuppressive Market Competitors
As part of Kalorama Information’s information-gathering process, this report consists of primary research. An exhaustive search of medical and corporate literature was conducted. But interviews with executives in the market were used to build models and test assumptions in this report.
Pharmaceutical marketing directors, executives in the organ transplant market, as well as investors looking at this market are among those who will find this report a useful resource.
Table of Contents
TABLE OF CONTENTS
CHAPTER ONE: EXECUTIVE SUMMARY
Overview
Scope and Methodology
Solid Organ Transplantation
Long-Term Survival
Shortage of Donor Organs
Cost of Transplantation
Organ Transplantation Trends in the U.S.
Organ Waiting List
Organ Transplant Trends in Europe
Immunosuppression in Transplantation
Immunosuppression Therapy
Trends in Use of Immunosuppressants
Trend from Calcineurin Inhibitors to Tacrolimus
Trend From Use of Azathioprine to Mycophenolate Mofetil
Immunosuppressant Market Analysis
Immunosuppressive Market by Drug Classification
Immunosuppressant Sales by Geographical Region
CHAPTER TWO: SOLID ORGAN TRANSPLANTATION
Introduction
History of Organ Transplantation
Progress and Limitations in Solid Organ Replacement
Long-Term Survival
Shortage of Donor Organs
Cost of Transplantation
Evolution of Organ Donation and Procurement
National Transplant Act
Organ Transplant Trends in the U.S.
Organ Waiting List
Organ Transplant Trends in Europe
Number of Organs Transplanted in Europe
Organ Transplantation Procedures
Heart Transplantation
History of Heart Transplantation
Indications/Contraindications for Heart Transplant
Status of Heart Transplantation
Intestine Transplantation
History of Intestine Transplantation
Indications for Intestine Transplantation
Status of Intestine Transplantation
Kidney Transplantation
History of Kidney Transplantation
Indications/Contraindications for Kidney
Transplantation
Status of Kidney Transplantation
Liver Transplantation
History of Liver Transplantation
Indications/Contraindications of Liver Transplantation
Status of Liver Transplantation
Lung Transplantation
History of Lung Transplantation
Indications/Contraindications of Lung Transplantation
Status of Lung Transplantation
Pancreas Transplantatiom
Pancreatic Islet Cell Transplantation
History of Pancreas Transplantation
Indications/Contraindications Pancreas Transplantation
Status of Pancreas Transplantation
The Immune System and Organ Transplantation
Posttransplantation Complications
Organ Rejection
Hyperacute Rejection
Accelerated Rejectiom
Acute Rejection
Chronic Rejection
Infection
Renal Disorders
Cancer
Other Complications
Future Directions in Organ Transplantation
Stem Cells and Tissue Engineering
Xenotransplantation
CHAPTER THREE: TRANSPLANT IMMUNOSUPPRESSIVE THERAPIES
Introduction
The Immune System
Functions of the Immune System
Immunosuppression
Immunosuppression Therapy
Tolerance Induction
History Of The Development Of Transplant Immunosuppressive
Description Of Immunosuppressant Agents
Corticosteroids
Mechanism of Action
Calcineurine Inhibitor Agents
Cyclosporine
Tacrolimus
mTOR inhibitors
Antiproliferative Agents
Mycophenolate Mofetil
Mycophenolic Acid
Azathioprine
Monoclonal Antibodies
Muromonab-CD3
Basiliximab
Daclizumab
Polyclonal Antibodies
Antithymocyte globulin-equine and Antithymocyte globulin-rabbit
Immunosuppressant Regimens
Designing Immunosuppression Regimens
Induction Therapy
Maintenance Therapy
Organ Rejection Therapy
Hyperacute Rejection
Accelerated Acute Rejection
Acute Rejection
Chronic Rejection
Trends in Immunosuppressive Regimens
Steroid Avoidance/Eliminating Regimens on Increase
Minimizing Calcineurin inhibitor Regimens in Kidney
Transplants
Downside of Transplant Immunusuppressants
Adverse Side Effects
Cost of Transplant Medications
Immunosuppressant Therapies in Research and Development
Current Research and Development
Circumventing the HAMA Reaction
Selective blocker of T-cell Activation
Selective Inhibitor of Janus Kinase
Inhaled Formulation of Cyclosporine
Utilizing Gene Expression Profiles to Measure the
Efficacy of Immunosuppression
CHAPTER FOUR: ORGAN TRANSPLANT IMMUNOSUPPRESSANT MARKET ANALYSIS
Introduction
Development and Expansion Immunosuppressants in Organ Transplants
Trend from Calcineurin Inhibitors to Tacrolimus
Trend From Use of Azathioprine to Mycophenolate Mofetil
Trends in the Use of Immunosuppressives in Specific Organs
Trends in Kidney Transplantation
Maintenance Immunosuppression
Immunosuppression Therapy for Acute Rejection
Trends in Pancreas Transplantation
Maintenance Immunosuppression
Trends in Liver Transplantation
Liver Maintenance Immunosuppression
Immunosuppression Therapy for Rejection
Trends in Intestine Transplantation
Intestine Maintenance Immunosuppression
Antirejection Treatment for Intestine Transplantation
Trends in Lung Transplantation
Lung Maintenance Immunosuppression
Immunosuppression to Treat Acute Lung Rejection
Trends in Heart Transplantation
Immunosuppressant Usage One Year After Transplant
Trends in Heart-Lung Transplantation
Transplant Immunosuppressant Market
Introduction
Market and Forecasts
Immunosuppressive Market by Drug Classification
Immunosuppressant Sales by Geographical Region
Top-Selling Immunosuppressant Brands
Transplant Immunosuppressant Market Share
Strategies to Gain Market Share or Market Entrance
Genzyme Corporation Buys into the Transplant
Immunosuppressant Market
Pharmaceutical Lifecycle Management to Maintain or Gain Market Share
CHAPTER FIVE: COMPANY PROFILES
ASTELLAS PHARMA US, INC.
History and Lines of Business
Immunosuppressive Products
Financial Information
GENZYME CORPORATION
History and Lines of Business
Immunosuppressive Products
Thymoglobulin
Lymphoglobuline
Financial Information
NOVARTIS AG
History and Lines of Business
Immunosuppressive Products
Neoral/Sandimmune
Myfortic
Certican
Simulect
Financial Information
- HOFFMANN-LA ROCHE LTD
History and Lines of Business
Immunosuppressant Products
Financial Information
Wyeth Pharmaceuticals
History and Lines of Business
Immunosuppressive Product
Financial Information
PROFESSIONAL ORGANIZATIONS
COMPANY NAMES AND ADDRESSES
TABLE OF EXHIBITS
- CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Waiting List Candidates (Active and Inactive Combined), in U.S., 2004-2005
- Table 1-2: Current Organ Waiting List, Number of
- Transplant Procedures and Number of Donor Organs Recovered, in U.S., 2007
- Table 1-3: Growth in Number of Transplanted and Recovered Organs, in U.S., 2004-2005
- Table 1-4: Unadjusted One-and Five-Year Patient Survival by Organ, in the U.S.
- Table 1-5: Number of Deceased Donor’s Organs Used for Transplant, by Organ, as Reported by Eurotransplant, from 2002-2006
- Table 1-6: Current Waiting List for Solid Organs, as Reported by Eight European Countries, as of September 2007
- Table 1-7: Chronological Development of Transplant Immunosuppressive Therapies
- Table 1-8: Global Transplant Immunosuppressant Market, 2002-2012
- Figure 1-1: Market Share of Immunosuppressive Categories, 2006
- Figure 1-2: Immunosuppressant Sales by Geographical Region, 2006
- Figure 1-3: Immunosuppressant Market, by Organ Transplanted, 2006 (Kidney, Kidney/Pancreas, Liver, Lung, Heart)
- CHAPTER TWO: SOLID ORGAN TRANSPLANTATION
- Table 2-1: Landmarks in Organ Transplantation in the United States and Canada
- Table 2-2: Estimated US Average First-Year Billed Charges per Transplant, 2005
- Table 2-3: Waiting List Candidates (Active and Inactive Combined), in U.S., 2004-2005
- Table 2-4: Current Organ Waiting List, Number of Transplant Procedures
- Performed and Number of Donor Organs Recovered, in U.S., 2007
- Table 2-5: Growth in Number of Transplanted and Recovered Organs, in U.S., 2004-2005
- Table 2-6: Unadjusted One-and Five-Year Patient Survival by Organ, in U.S.
- Table 2-7: Unadjusted One-and Five-Year Graft Survival by Organ, in U.S.
- Table 2-8: Number of Deceased Donor’s Organs Used for Transplant, by Organ, as Reported by Eurotransplant, from 2002-2006
- Table 2-9: Number of Deceased Donor’s Organs Used for Transplant, by Organ and Country, as Reported by Eurotransplant, 2002-2006
- Table 2-10: Summary of Donor and Transplant Activity in the United Kingdom and the Republic of Ireland for 2005-2006
- Table 2-11: Current Waiting List for Solid Organs, as Reported by Eight European Countries, as of September 2007
- Table 2-12: Types of Transplant Rejection, by Organ
- CHAPTER THREE: TRANSPLANT IMMUNOSUPPRESSIVE THERAPIES
- Table 3-1: Chronological Development of Transplant Immunosuppressive Therapies
- Table 3-2: Most Commonly Prescribed Transplant Immunosuppressant Agents
- Table 3-3: Steroid Avoidance Rate at Discharge, 1996 to 2005 Recipients of Deceased Donor Kidneys
- Table 3-4: Steroid Avoidance Rate at Discharge, 1996-2005 Recipients of Deceased Donor Livers
- Table 3-5: Steroid Avoidance Rate at Discharge, 1996 to 2005 Recipients of Heart Transplants
- Table 3-7: Estimated Monthly Cost of Immunuosuppressant Drugs
- CHAPTER FOUR: MARKET ANALYSIS
- Figure 4-1: Comparative Calcineurin Inhibitor Use for Immunosuppressive Prior to Discharge, by Organ, 2003
- Figure 4-2: Comparative Use of Maintenance Antimetabolite and Sirolimus Immunosuppression Prior to Discharge, by Organ, 2003
- Figure 4-3: Immunosuppression Agents Used for Induction in Kidney Transplantation, 1996-2005
- Table 4-1: Immunosuppression Use for Kidney Transplant Maintenance Prior to Discharge, 1996 to 2005
- Table 4-2: Decrease in Acute Rejection Incidence Within a Year of Kidney Transplant, 1996-2003
- Table 4-3: Immunosuppression Use for PTA Maintenance Prior to Discharge, 1996 to 2005
- Table 4-4: Immunuosuppression Use: Liver Antirejection Treatment from Transplant to One Year Posttransplant, 1994-2003
- Table 4-5: Immunosupression Use for Maintenance Prior to Discharge for Intestine Transplants, 1995-2004
- Table 4-6: Immunosuppression Use for Induction in Lung Transplantation, 1996-2005
- Table 4-7: Immunosuppression Use of Maintenance Prior to Discharge for Lung Transplant Recipients, 1996-2005
- Table 4-8: Immunosuppression Use for Antirejection of Lung Transplant up to One Year Following Transplantation, 1995-2004
- Table 4-9: Immunosuppression Use for Induction for Recipients of Heart Transplants, 1996-2005
- Table 4-10: Immunosuppression Usage Rates from Discharge to One Year Post-Transplantation for Heart Recipients, 1994 & 1995
- Table 4-11: Immunusuppression use for Induction in Heart-Lung Transplantations, 1996-2005
- Table 4-12: Most Commonly Used Immunosuppressants, by Organ (Kidney, Kidney/Pancreas, Lung, Heart, Liver)
- Table 4-13: Global Transplant Immunosuppressant Market, 2002-2012
- Figure 4-5: Market Share of Immunosuppressive Categories, 2006 (Calcineurin Inhibitors, Corticosteroids, Polyclonal Antibodies, Monoclonal Antibodies, TOR Inhibitors, Antiproliferative Agents)
- Figure 4-6: Immunosuppressant Sales by Geographical Region, 2006
- Figure 4-7: Value of Immunosuppressant Market, by Transplanted Organ, 2006 (Kidney, Kidney/Pancreas, Lung, Heart, Liver)
- Figure 4-8: Immunosuppressant Market, by Transplanted Organ, by Percent (Kidney, Kidney/Pancreas, Lung, Heart, Liver)
- Figure 4-9: Top-Selling Transplant Immunosuppressants, by Brand Name, 2006
- Table 4-14: Transplant Immunosuppressant Market Share, by Manufacturer, 2006 ($billions)
