腎臓移植：カルシニューリン阻害剤を用いない免疫抑制療法への移行

Abstract

Overview

Introduction

In 2005, around 30,000 renal transplants were conducted in the seven major markets. In order to prevent the patient's immune system from rejecting the transplanted organ, daily immunosuppression therapy is a necessity for the lifetime of the graft with a base maintenance drug (cyclosporine, tacrolimus, sirolimus) combined with adjunctive therapies (azathioprine, mycophenolate mofetil, steroids).

Scope

• Historical and recent trends in immunosuppressive therapy including current clinical practice and clinical advantages and side effects of treatments
• Organ supply, national donation rates, waiting lists and forecasts of the number of transplants and maintenance populations to 2015
• Primary diagnosis, graft survival rates, reasons for late graft failure and risk factors associated with acute rejection
• Future market outlook including calcineurin inhibitor avoidance/withdrawal strategies

Report Highlights

30,000 renal transplants were performed in 2005, increasing to 43,000 by 2015 (CAGR, 2005-15, 4%), although the "organ gap" may widen further as increasing morbidity, such as diabetes mellitus, drives demand. The number of patients with functioning kidney transplants will double to 428,000 by 2015, creating a large group of patients with unique and complex long-term medical care needs directly attributable to adverse effects of immunosuppressive drugs, including nephrotoxicity, diabetes, hypertension, hyperlipidemia and vulnerability to infection. Although prevention of acute rejection remains a primary treatment goal, agents that do not impair long-term renal function are required. While results from sirolimus based calcineurin-inhibitor withdrawal regimens are inconclusive more promising results are emerging from use in the calcineurin-inhibitor avoidance or switching setting.

Reasons to Purchase

• Identify changing trends in immunosuppressive protocols
• Understand the most common treatment protocols in renal transplantation by patient type
• Quantify the future market size based on the number of transplants and renal maintenance populations

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