Market Report Source

Overview

Introduction
In 2005, over 50.000 solid organ transplants were conducted in the seven major markets. In order to prevent the patient’s immune system from rejecting the transplanted organ, immunosuppression therapy is required for the lifetime of the graft with a base maintenance drug (either Calcineurin- or mTOR inhibitors) and adjunctive therapies (antimetabolites, steroids).

Scope
The report focuses on current and future therapies used for immunosuppression in solid organ transplantation, with sales and volume forecasts to 2015
Assessment of current and future dynamics, opportunities and threats for immunosuppressants across the seven major markets
Overview of organ supply, national donation rates, waiting lists and forecasts of the number of transplants and maintenance population to 2015
Assessment of key factors affecting prescription choice, including analysis of regional differences

Highlights
The transplantation market poses unusual challenges to pharmaceutical companies, the most significant one being a lack of donor organs: the waiting list for transplants will continue to grow faster than the number of available organs. Another challenge is the static nature of the market: maintenance regimens of stable patients rarely get changed.

The market for immusuppresssants used in transplantation is set to grow to $4.3 billion by 2015s. Despite changing protocols, the leading drug class by value should continue to be calcineurin inhibitors with a 37% market share, followed by mTOR inhibitors.

mTOR inhibitors are expected to be the fastest growing class, driven by Wyeth’s Rapamune. Datamonitor foresees the drug to gain a greater role as a primary immunsuppressant despite current tolerability issues. Bristol Myers Squibb’s injectable fusion protein belatacept may offer another alternative to calcineurin inhibitors

Reasons to Purchase
Identify and understand the dynamics in immunosuppressive protocols as reflected in opinion leaders’ thoughts
Quantify the future immunosuppressant market size by volume and value for each of the seven major markets
Quantify the future market size based on transplant types, numbers and the maintenance population

Table of Contents

About Datamonitor Healthcare

About the Respiratory and Infectious Disease team

CHAPTER 1 EXECUTIVE SUMMARY

Scope

Datamonitor insight into the disease market

CHAPTER 2 MARKET OVERVIEW

Transplantation market valued at $3.3 billion

History of immunosuppression therapy

CHAPTER 3 MARKET ENVIRONMENT

Modest growth in the number of transplants

Uptake of novel maintenance therapies limited to de novo transplants

Low percentage of patients continue original regimens

The cost of non-adherence

Impact of pricing controls

CHAPTER 4 FORECAST ANALYSIS

Calcineurin inhibitors

No difference in long-term efficacy between Neoral and Prograf

Limited generic erosion of Prograf sales

Primary use of once-daily Prograf reformulation in de novo transplants

Slow uptake of generic cyclosporine maintains Neoral’s sales

mTOR inhibitors

Rapamune use expands in US

Certican US launch in early 2008

Adjunctive therapy

CellCept to remain dominant until patent expiry

Myfortic not sufficiently differentiated from CellCept

FK-778 demonstrates antiviral activity against polyoma virus

Induction therapy

Belatacept holds promise as alternative to calcineurin inhibitors

CHAPTER 5 SALES FORECASTS

Global forecasts

US forecasts

Japan forecasts

France forecasts

Germany forecasts

Italy forecasts

Spain forecasts

UK forecasts

CHAPTER 6 APPENDIX

Market definition

Forecasting assumptions and estimates

References

About Datamonitor

Disclaimer

List of Tables

Table 1: Global brand performance ($m), 2005-15

Table 2: Percentage of retail sales of tacrolimus, MMF, and cyclosporine in transplantation (%)

Table 3: Number of transplants by organ, seven major markets, 2000-05

Table 4: Transplants by organ, by country, 2005-15

Table 5: Continuation of original immunosuppressive discharge regimen in kidney patients transplanted in 2002, US

Table 6: Prograf generic erosion and pricing assumptions (%)

Table 7: Relative pricing of reformulations launched in the US

Table 8: Belatacept patient model

Table 9: Forecast sales, Global, 2005-15 ($m)

Table 10: Forecast sales, US, 2005-15 ($m)

Table 11: Forecast sales, Japan, 2005-15 ($m)

Table 12: Forecast sales, France, 2005-15 ($m)

Table 13: Forecast sales, Germany, 2005-15 ($m)

Table 14: Forecast sales, Italy, 2005-15 ($m)

Table 15: Forecast sales, Spain, 2005-15 ($m)

Table 16: Forecast sales, UK, 2005-15 ($m)

Table 17: Percentage of retail sales of tacrolimus, MMF, and cyclosporine in transplantation

List of Figures

Figure 1: Global sales performance by class ($m), 2005-15

Figure 2: Global brand performance ($m), 2005-15

Figure 3: Use of CellCept and Prograf, % kidney transplant patients prior to discharge, 1995 to 2004, US

Figure 4: Neoral and generic cyclosporine volume, 2001-2005, US

Figure 5: Continuation of original immunosuppressive discharge regimen in kidney patients transplanted in 2002, US

Figure 6: Generic erosion of Prograf and Neoral, US

Figure 7: Prograf and modified-release tacrolimus (FK-506MR4) sales ($m), 2005-15, global 45