Stakeholder Opinions: Kidney Transplantation - Switching to calcineurin inhibitor-free immunosuppression

Table of Contents

• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope
  • Datamonitor market insight
• CHAPTER 2 MARKET ENVIRONMENT
  • History of immunosuppression therapy
  • Organ transplantation timeline
  • Trends in immunosuppressive therapy
    • Prograf replaces Neoral in the US
    • CellCept is the most widely employed adjuctive agent
    • New drug regimens attempt calcineurin-inhibitor minimization
    • Genzyme's Thymoglobulin is the leading induction therapy
• CHAPTER 3 ORGAN SUPPLY AND DEMAND
  • Supply: where do donated organs come from?
    • Concept of "brain death" vital to wider clinical application of transplantation
    • Non-heart-beating donors important means to expand organ pool
    • Kidneys are the most frequently-donated living-donor organs
  • Demand : waiting lists outpace supply
    • The "organ gap" is most acute in the US
  • Closing the organ gap: current utilization of donor supply is low
    • Maximizing cadaveric donation rates is a priority
    • Living-donor rates will take 15 years to match US
    • Number of transplants to grow modestly by 2015
• CHAPTER 4 KIDNEY TRANSPLANTATION
  • Diabetes and hypertensive nephrosclerosis are common primary diagnoses
  • One-year graft-survival rates now exceed 90% in most patients
    • Recipients of ECD and NHBD organs are at increased risk of delayed graft function
    • Adolescents have poor graft-survival rates
    • Reasons for inferior outcomes in African-Americans are poorly understood
  • Kidney maintenance population to double by 2015
  • Chronic rejection is the leading cause of late graft failure
  • Cardiovascular disease, infection and malignancies are the most important post-transplant complications
    • Tacrolimus has a reduced coronary artery disease risk compared to cyclosporine
    • Post-transplant infections: BK virus allograft nephropathy is a major cause of renal graft dysfunction
    • Risk of post-transplant malignancies is not influenced by choice of calcineurin inhibitors
• CHAPTER 5 OPTIMIZING IMMUNOSUPPRESSION
  • Current clinical practice: Tacrolimus/MMF is the gold-standard in the US
  • Clinical advantages and side effects of CNI treatments
  • CNI-avoidance/withdrawal strategies evolve
  • Broad risk stratification determines optimal protocol
    • US transplant population size by risk factor
  • The future market in immunosuppressive drugs
• CHAPTER 6 APPENDIX
  • Sources for number of transplants, donors and waiting lists
  • Websources
  • References
  • About Datamonitor
  • Disclaimer
  • List of Tables
    • Table 1: Immunosuppressant drugs
    • Table 2: Transplantation drugs: sales (in $m), 2002-05, worldwide and US
    • Table 3: Maintenance therapy (% of patients) at discharge, by transplant type, US, 2004
    • Table 4: Induction therapy (% patients), by transplant type, US, 2004
    • Table 5: Cadaveric donors, US and the UK, 2000-05
    • Table 6: Annual number of donors by type (cadaveric and living), by market, 2000-05
    • Table 7: Factors influencing cadaveric donation rates, by country, 2005
    • Table 8: Number of transplants by organ, seven major markets, 2000-05
    • Table 9: Transplant waiting list, by organ, seven major markets, 2005
    • Table 10: Average number of transplants* per cadaveric donor, by market, 2000-05
    • Table 11: Utilization of donor supply, by market
    • Table 12: Transplants by organ, by country, 2005-15
    • Table 13: Primary diagnosis for adult kidney transplantation, by race, US, 2005
    • Table 14: Patients with functioning kidney transplants, by age, 2005-15, global market
    • Table 15: Continuation of original immunosuppressive discharge regimen in kidney patients transplanted in 2001, US
  • List of Figures
    • Figure 1: Development of immunosuppressive regimes, 1960-2006
    • Figure 2: Organ transplantation timeline
    • Figure 3: Transplantation drugs: worldwide sales (in $m), 2005
    • Figure 4: Evolution in therapeutic protocols
    • Figure 5: Donor supply by type, US, 2005
    • Figure 6: Number of donors by type (cadaveric and living), seven major markets, 2000-05
    • Figure 7: Cadaveric and living donation rates, seven major markets, 2005
    • Figure 8: Number of transplants and waiting list, by organ, seven major markets, 2005
    • Figure 9: Waiting list per million of population, kidney and liver transplants, seven major markets, 2005
    • Figure 10: Utilization of donor supply, by market
    • Figure 11: Cadaveric donation rates, six major markets, 2000-15
    • Figure 12: Living-donor kidney transplants, US, 1995-2015
    • Figure 13: Living donor rates, seven major markets, 2000-15
    • Figure 14: Transplants by organ, seven major markets, 2005-15
    • Figure 15: Top three primary diagnoses for kidney transplantation, 1995-2005, US
    • Figure 16: Time progression of diabetic nephropathy in type 2 diabetes patients (millions), seven major markets
    • Figure 17: Trends in one-year and five-year graft-survival rates, US
    • Figure 18: Kidney maintenance pool and new transplants, 2005-15, global markets
    • Figure 19: Causes of chronic allograft nephropathy
    • Figure 20: Cause of death with functioning kidney transplant
    • Figure 21: Timeline for post-transplant infections
    • Figure 22: Maintenance immunosuppression use prior to discharge, % kidney transplant patients, US, 1995 to 2004
    • Figure 23: Use of induction immunosuppressants, % kidney transplant patients, US, 1995 to 2004
    • Figure 24: Calcineurin inhibitor use by volume, 2005, by market
    • Figure 25: Comparison of Prograf and Neoral
    • Figure 26: Sirolimus use for maintenance prior to discharge and at one year post-transplant, US, 1995-2003
    • Figure 27: A two-stage immunosuppressive protocol