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Commercial Insight: Solid organ transplantation - The impact of new biologics, generics and reformulations

Published by: Datamonitor

Published: Dec. 18, 2008 - 214 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Infectious Disease and Respiratory (ID&R) pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor insight into the disease market
Related reports
CHAPTER 2 MARKET DEFINITION
Market definition for this report
Countries and regions included in this report
Introduction to the transplantation market
CHAPTER 3 MARKET OVERVIEW
Seven major markets
Current and future market overview
The immunosuppressant market is expected to grow from $4.1 billion in 2007 to $4.4 billion in 2017
Belatacept will take over top-position from Prograf
The US will remain the largest market, but growth in Europe will be higher
Opportunities and threats
Opportunities
Threats
US
Current and future market assessment
Opportunities and threats
Opportunities
Threats
Japan
Current and future market assessment
Threats
Cultural beliefs lead to particularly low organ donation rates
Zenapax is not likely to become available in Japan
Five major European markets
Current and future market assessment
France
Current and future market assessment
Germany
Current and future market assessment
Italy
Current and future market assessment
Spain
Current and future market assessment
UK
Current and future market assessment
Rest of the world snapshot
Rest of the world market assessment
Poor people sell their organs to 'transplant tourists'
Alternative market scenarios
Advagraf is not launched in the US
Certican is not launched in the US
CHAPTER 4 BRAND DYNAMICS
Overview of competitive landscape
Patient acquisition process
Patient care path
Points of influence in the patient care path
Drivers of brand choice
Physicians in the US rely heavily on polyclonal antibodies for induction therapy while those in the five major European markets and Japan prefer monoclonal antibodies
Physicians in the five major European markets and Japan prescribe cyclosporine for maintenance therapy more often than those in the US
US formulary tier status for leading brands
Prograf has most favorable reimbursement status of the maintenance immunosuppressant brands
CellCept has more favorable reimbursement status than Myfortic
Trends in marketing strategies
Promotional spend
Mass media can greatly influence public opinion on organ donation
Prograf (tacrolimus; Astellas)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2017
Launch of generic tacrolimus in the US will erode Prograf's sales over time
Advagraf will not completely protect Astellas's tacrolimus franchise
Other calcineurin inhibitors
Cyclosporine
CellCept (mycophenolate mofetil; Protein Design Labs/Roche)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2017
Generic mycophenolate mofetil expected to have fast uptake
Other antimetabolites
Myfortic (mycophenolate acid/sodium; Novartis)
Bredinin (mizoribine; Asahi Kasei Pharma)
Azathioprine (various)
Rapamune (sirolimus; Wyeth)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2017
Certican is expected to cut Rapamune's US revenues in half if launched successfully
Generic sirolimus not assumed to have major impact in next 10 years
Thymoglobulin (rabbit antithymocyte globulin; Genzyme)
Drug profile
Product positioning
SWOT analysis
Brand forecast to 2017
ATG-Fresenius limits further uptake of Thymoglobulin
Other induction treatments
Monoclonal antibodies
Belatacept (Bristol-Myers Squibb)
Drug profile
Development overview
Product positioning
SWOT analysis
Drug forecast to 2017
Launch date and price of belatacept
Number of de novo transplant patients up to 2017
Number of de novo patients receiving belatacept
LCP-Tacro (tacrolimus; LifeCycle Pharma)
Drug profile
Development overview
Product positioning
SWOT analysis
Drug forecast to 2017
Other forecast pipeline products
Pulminiq (inhaled cyclosporine; APT Pharmaceuticals/Novartis)
Other pipeline products
CHAPTER 5 KEY DEVELOPERS
Strategic overview
Trends in corporate strategy
Several companies redevelop their autoimmune disease portfolio
Small players attempt to enter the market with me-too products
Astellas
Corporate strategy
Immunosuppressant portfolio assessment
Novartis
Corporate strategy
Immunosuppressant portfolio assessment
CHAPTER 6 CASE STUDIES
The transplantation market in Canada
Current immunosuppressant market assessment
Prograf is overtaking cyclosporine as the preferred calcineurin inhibitor
Launch of Myfortic has not had major impact on adjunct market
Thymoglobulin has rapidly become the most popular drug for induction treatment
Pricing and reimbursement in Canada
Product pricing
Drug reimbursement
Opportunities and threats
Opportunities
Threats
BIBLIOGRAPHY
Articles
News and press releases
Websites
Presentations
APPENDIX A - MARKET ASSUMPTIONS
New product launches
Patent expiries
Data definitions, limitations and assumptions
Transplantation-specific sales split
Standard units
Japanese market data
Derivation of sales forecasts and pricing trends
Forecast methodology
APPENDIX B
Contributing experts
Report methodology
About Datamonitor
About Datamonitor Healthcare
About the Respiratory and Infectious Disease analysis team
Disclaimer
List of Tables
Table 1: Sales and growth of immunosuppressant drug classes in the seven major markets, 2007-2017
Table 2: Sales forecasts of key immunosuppressant brands in the seven major markets ($m), 2007-2017
Table 3: The different organ donation systems and 2007 deceased donation rate pmp by organ, in the US and five major European markets, 2007
Table 4: Off-label prescription of induction treatments in the US, 2004
Table 5: Off-label prescription of maintenance treatments in the US, 2004
Table 6: Examples of tests/markers available and in development, 2008
Table 7: Number of transplants by organ and country in the seven major markets, 2003-07
Table 8: Summary of opportunities and threats in the immunosuppressant market across the seven major markets, 2008
Table 9: Sales and growth of immunosuppressant drug classes in the US, 2007-2017
Table 10: Sales forecasts of key immunosuppressant brands in the US ($m), 2007-2017
Table 11: Summary of opportunities and threats in the immunosuppressant market in the US, 2008
Table 12: Sales and growth of immunosuppressant drug classes in Japan, 2007-2017
Table 13: Sales forecasts of key immunosuppressant brands in Japan ($m), 2007-2017
Table 14: Size of the monoclonal antibody class in transplantation in Japan, the US and the five major European markets
Table 15: Summary of threats in the immunosuppressant market in Japan, 2008
Table 16: Sales and growth of immunosuppressant drug classes in the five major European markets, 2007-2017
Table 17: Sales forecasts of key immunosuppressant brands in the five major European markets ($m), 2007-2017
Table 18: Sales forecasts of key immunosuppressant brands in France ($m), 2007-2017
Table 19: Sales forecasts of key immunosuppressant brands in Germany ($m), 2007-2017
Table 20: Sales forecasts of key immunosuppressant brands in Italy ($m), 2007-2017
Table 21: Sales forecasts of key immunosuppressant brands in Spain ($m), 2007-2017
Table 22: Sales forecasts of key immunosuppressant brands in the UK ($m), 2007-2017
Table 23: Comparison of the top five therapies ($m) for maintenance immunosuppression in the small and emerging markets, US and five major European countries plus Japan, 2007
Table 24: Leading branded immunosuppressant drug sales in the seven major markets ($m), 2007-2017
Table 25: Key immunosuppressants in late-stage R&D pipeline in the seven major markets, 2008
Table 26: Representative formulary tier status in the US for key immunosuppressants, 2008
Table 27: Marketing strategies employed by US product websites of selected immunosuppressants, 2008
Table 28: Prograf - Drug profile, 2008
Table 29: Impacting factors on the revenues of Prograf in the seven major markets, 2007-2017
Table 30: Dosing of Prograf in adult transplantation patients
Table 31: Calculation of the average price per standard unit (SU) for Prograf and Advagraf in the US
Table 32: CellCept - Drug profile, 2008
Table 33: Impacting factors on the revenues of CellCept in the seven major markets, 2007-2018
Table 34: Rapamune - Drug profile, 2008
Table 35: Impacting factors on the revenues of Rapamune in the seven major markets, 2007-2018
Table 36: Thymoglobulin - Drug profile, 2008
Table 37: Impacting factors on the revenues of Thymoglobulin in the seven major markets, 2007-2018
Table 38: Belatacept - Drug profile, 2008
Table 39: Summary of key late-stage ongoing clinical trials for belatacept, 2008
Table 40: Impacting factors on the revenues of belatacept in the seven major markets, 2010-17
Table 41: Belatacept US patient model, 2007-2017
Table 42: Belatacept 5EU patient model, 2007-2017
Table 43: Belatacept Japan patient model, 2007-2017
Table 44: Calculation of the annual price of Prograf in the US
Table 45: LCP-Tacro - Drug profile, 2008
Table 46: Summary of key late-stage ongoing clinical trials for LCP-Tacro, 2008
Table 47: Impacting factors on the revenues of LCP-Tacro in the seven major markets, 2007-2017
Table 48: Leading companies in the seven major markets immunosuppressant market, 2007-2017
Table 49: Astellas portfolio assessment of immunosuppressants for the transplantation market, 2008
Table 50: Novartis portfolio assessment of immunosuppressants for the transplantation market, 2008
Table 51: Sales and growth of immunosuppressant drug classes in Canada, 2003-07
Table 52: Price per standard unit of key immunosuppressant brands in Canada, the US and the five major European markets, 2007
Table 53: Number of transplants in Canada and the seven major markets, 2003-07
Table 54: Donation rates (pmp), waiting list and number of transplantations per country in the seven major markets and Canada, 2007
Table 55: Datamonitor's launch dates for immunosuppressants in the seven major markets, 2007-2017
Table 56: Patent expiry dates for the approved immunosuppressants in the seven major markets, 2007-2017
Table 57: Sales split between retail and hospital market of key immunosuppressant market in the US, France and Germany, 2007
Table 58: Sales split between retail and hospital market of key immunosuppressant market in Italy, Spain and the UK, 2007
List of Figures
Figure 1: Schematic overview of the use of immunosuppressants in transplantation
Figure 2: Indexed total immunosuppressant drug sales by class in the seven major markets, 2003-2017
Figure 3: Top five immunosuppressant brands in the seven major markets, 2007 and 2017
Figure 4: Sales performance of the seven major markets immunosuppressant market by country, 2003-2017
Figure 5: Principles of the Spanish model of organ donor recruitment
Figure 6: Branded and generic cyclosporine market split in the US, Japan and 5EU, 2007
Figure 7: Prescription of immunosuppressants in the US, 2004
Figure 8: Projected half-lives versus actual half-lives in deceased donor transplants: 1988-1995 (including re-transplant recipients)
Figure 9: Indexed total immunosuppressant drug sales by class in the US, 2003-2017
Figure 10: Waiting list on December 31, 2007, versus number of transplantations in 2007, by country
Figure 11: Overview of events related to Certican (everolimus) in the US, Europe and Japan
Figure 12: Overview of events related to Advagraf (tacrolimus) in the US, Europe and Japan
Figure 13: Indexed total immunosuppressant drug sales by class in Japan, 2003-2017
Figure 14: Indexed total immunosuppressant drug sales by class in the five major European markets, 2003-2017
Figure 15: Indexed total immunosuppressant drug sales by country in the five major European markets, 2003-2017
Figure 16: Indexed total immunosuppressant drug sales by class in France, 2003-2017
Figure 17: Indexed total immunosuppressant drug sales by class in Germany, 2003-2017
Figure 18: Indexed total immunosuppressant drug sales by class in Italy, 2003-2017
Figure 19: Indexed total immunosuppressant drug sales by class in Spain, 2003-2017
Figure 20: Indexed total immunosuppressant drug sales by class in the UK, 2003-2017
Figure 21: Seven major markets versus rest of the world sales split for the maintenance immunosuppressant market, 2003 and 2007
Figure 22: Indexed annual sales of the maintenance immunosuppressant market in small and emerging markets, 2003-07
Figure 23: Main forecast versus alternative forecast for the launch of Advagraf in the US
Figure 24: Main forecast versus alternative forecast for the launch of Certican in the US
Figure 25: Solid organ transplant patient care path
Figure 26: Market share ($m) of the products used for induction treatment in the US, five major European countries and Japan, 2007
Figure 27: Market share ($m) of the products used for maintenance treatment in the US, five major European countries and Japan, 2007
Figure 28: Promotional spend for key brands in the US, 2007
Figure 29: Retail sales split of Prograf in the seven major markets, 2007
Figure 30: Prograf SWOT analysis, 2008
Figure 31: Sales of Prograf, Advagraf and generic tacrolimus in the seven major markets, 2007-2017
Figure 32: Market share of Neoral/Sandimmun and generic cyclosporine in the US, 2001-07 (1999-2001 assumed)
Figure 33: Market share of Prograf and Advagraf in Spain, Q1 2007- Q4 2009
Figure 34: Calculation of price difference per standard unit (SU) in the US between Prograf and Advagraf
Figure 35: Sales of Neoral/Sandimmun and generic cyclosporine in the seven major markets, 2007-2017
Figure 36: Retail sales split of CellCept in the seven major markets, 2007
Figure 37: CellCept SWOT analysis, 2008
Figure 38: Sales of CellCept and generic mycophenolate mofetil in the seven major markets, 2007-2017
Figure 39: Sales of azathioprine, Myfortic and Bredinin in the seven major markets, 2007-2017
Figure 40: Retail sales split of Rapamune in the seven major markets, 2007
Figure 41: Rapamune SWOT analysis, 2008
Figure 42: Sales of Rapamune, Certican and generic sirolimus in the seven major markets, 2007-2017
Figure 43: Market share of Rapamune and Certican in Germany, Q1 2004-Q2 2008
Figure 44: Thymoglobulin SWOT analysis, 2008
Figure 45: Sales of Rapamune, Thymoglobulin, ATGAM and ATG-Fresenius in the seven major markets, 2007-2017
Figure 46: Market share of Neoral/Sandimmun, Gengraf and other generic cyclosporine in the US, 2001-07
Figure 47: Sales of Rapamune, Simulect, Zenapax and Orthoclone Okt-3 in the seven major markets, 2007-2017
Figure 48: Clinical trial design of belatacept's key Phase II trial
Figure 49: Belatacept SWOT analysis, 2008
Figure 50: Sales of belatacept, tacrolimus and cyclosporine in the seven major markets, 2007-2017
Figure 51: LCP-Tacro SWOT analysis, 2008
Figure 52: Sales of LCP-Tacro, Astellas's tacrolimus franchise and generic tacrolimus in the seven major markets, 2007-2017
Figure 53: Indexed total immunosuppressant drug sales by class in Canada, 2003-07
Figure 54: Indexed total sales for key immunosuppressants in Canada, 2003-07
Figure 55: Sales of Prograf and cyclosporine in Canada, 2003-07
Figure 56: Sales of CellCept, azathioprine and Myfortic in Canada, 2003-07
Figure 57: Sales of induction treatments in Canada, 2003-07
Figure 58: Average delay between first launch in the world and launch in each country for drugs launched between 1999 and 2003

Abstract

Introduction

The transplant immunosuppressant market has seen considerable growth in recent years, but this is expected to slow down. Two factors combine to cause a decline in the market from 2011, the limited availability of donor organs and patent expiries of several key products. Neither the shift to once-daily formulations nor the launch of novel biologic therapies will prevent the contraction. Scope
  • Forecasts for immunosuppressants used in solid organ transplantation and significant pipeline drugs (to 2017 in report and to 2018 in excel tool)


  • Market overview by geographical area, including a rest of the world snapshot and a case study on the Canadian transplant market


  • Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates


  • An overview of key companies active in the transplant market and their strategies
Highlights

Datamonitor expects immunosuppressant sales in the seven major markets to grow to about $4.7 billion annually by 2011, after which the market is forecast to slowly decline to $4.4 billion by 2017 due to key products' patent expiries. The immunosuppressant market overall will be held back by the limited availability of organs.

Bristol-Myers Squibb's once-monthly monoclonal belatacept is expected to be the top-selling single brand in the seven major markets in 2017. However, the combined sales of Astellas's tacrolimus franchise (Prograf and once-daily Advagraf) will dominate the immunosuppressant market over the next ten years.

The toxicity associated with calcineurin inhibitors will lead to more emphasis on immunosuppressive regimens that permit reduction or avoidance of products from this class while maintaining adequate immunosuppression and graft survival. This leads to a fertile environment for novel immunomodulatory approaches. Reasons to Purchase
  • Identify key opportunities and threats that will impact the use and uptake of new and existing products


  • Quantify the future size and scope of the transplant immunosuppressant market and predict the performance of key compounds


  • Understand and capitalize on clinical unmet needs in the market through both lifecycle management of marketed drugs and new product development
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