臓器移植の免疫抑制剤市場

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

• 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)