Stakeholder Opinions: Kidney Transplantation - Switching to Calcineurin Inhibitor-free Immunosuppression

Published by: Datamonitor

Published: Apr. 7, 2006 - 88 Pages

Table of Contents

About Datamonitor healthcare

About the Respiratory & Infectious Disease team

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

Abstract

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).

• 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

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.

• 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

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