Stakeholder Opinions: Kidney Transplantation


Switching to calcineurin inhibitor-free immunosuppression

Pages: 88

Publisher: Datamonitor

Date Published: April 2006

Format: PDF

Price: $3800

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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

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

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