Organ Transplant Immunosuppressive Markets

Table of Contents

• 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

• 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

• 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

• 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

• 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
• F. 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 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)

• 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

• 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

• 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)