Table of Contents
EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
MARKET DEFINITION
- Market definition for this report
- Countries and regions included in this report
- Introduction to the transplantation market
MARKET OVERVIEW
- Seven major markets
- Current and future market overview
- Opportunities and threats
- US
- Current and future market assessment
- Opportunities and threats
- Japan
- Current and future market assessment
- Threats
- Five major European markets
- Current and future market assessment
- France
- Current and future market assessment
- GermanyCurrent 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
- Alternative market scenarios
- Advagraf is not launched in the US
- Certican is not launched in the US
BRAND DYNAMICS
- Overview of competitive landscape
- Patient acquisition process
- 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
- Other calcineurin inhibitors
- CellCept (mycophenolate mofetil; Protein Design Labs/Roche)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Other antimetabolites
- Rapamune (sirolimus; Wyeth)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Thymoglobulin (rabbit antithymocyte globulin; Genzyme)
- Drug profile
- Product positioning
- SWOT analysis
- Brand forecast to 2017
- Other induction treatments
- Belatacept (Bristol-Myers Squibb)
- Drug profile
- Development overview
- Product positioning
- SWOT analysis
- Drug forecast to 2017
- 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
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
CASE STUDIES
- The transplantation market in Canada
- Current immunosuppressant market assessment
- Pricing and reimbursement in Canada
- Opportunities and 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
TABLES
- Table: Sa les and growth of immunosuppressant drug classes in the seven
major markets, 2007 - 2017
- Table: Sales forecasts of key immunosuppressant brands in the seven major
markets ($m), 2007 - 2017
- Table: The different organ donation systems and 2007 deceased donation
rate pmp by organ, in the US and five major European markets, 2007
- Table: Off-label prescription of induction treatments in the US, 2004
- Table: Off-label prescription of maintenance treatments in the US, 2004
- Table: Examples of tests/markers available and in development, 2008
- Table: Number of transplants by organ and country in the seven major
markets, 2003 - 07
- Table: Summary of opportunities and threats in the immunosuppressant
market across the seven major markets, 2008
- Table: S ales and growth of immunosuppressant drug classes in the US, 2007
- 2017
- Table: Sales forecasts of key immunosuppressant brands in the US ($m),
2007 - 2017
- Table: Summary of opportunities and threats in the immunosuppressant
market in the US, 2008
- Table: S ales and growth of immunosuppressant drug classes in Japan, 2007
- 2017
- Table: Sales forecasts of key immunosuppressant brands in Japan ($m), 2007
- 2017
- Table: Size of the monoclonal antibody class in transplantation in Japan,
the US and the five major European markets
- Table: Summary of threats in the immunosuppressant market in Japan, 2008
- Table: S ales and growth of immunosuppressant drug classes in the five
major European markets, 2007 - 2017
- Table: Sales forecasts of key immunosuppressant brands in the five major
European markets ($m), 2007 - 2017
- Table: Sales forecasts of key immunosuppressant brands in France ($m),
2007 - 2017
- Table: Sales forecasts of key immunosuppressant brands in Germany ($m),
2007 - 2017
- Table: Sales forecasts of key immunosuppressant brands in Italy ($m), 2007
- 2017
- Table: Sales forecasts of key immunosuppressant brands in Spain ($m), 2007
- 2017
- Table: Sales forecasts of key immunosuppressant brands in the UK ($m),
2007 - 2017
- Table: Comparison of the top five therapies ($m) for maintenance
immunosuppression in the small and emerging markets, US and five major
European countries plus Japan, 2007
- Table: Leading branded immunosuppressant drug sales in the seven major
markets ($m), 2007 - 2017
- Table: Key immunosuppressants in late-stage R&D pipeline in the seven
major markets , 2008
- Table: Representative formulary tier status in the US for key
immunosuppressants, 2008
- Table: Marketing strategies employed by US product websites of selected
immunosuppressants, 2008
- Table: Prograf - Drug profile, 2008
- Table: Impacting factors on the revenues of Prograf in the seven major
markets, 2007 - 2017
- Table: Dosing of Prograf in adult transplantation patients
- Table: Calculation of the average price per standard unit (SU) for Prograf
and Advagraf in the US
- Table: CellCept - Drug profile, 2008
- Table: Impacting factors on the revenues of CellCept in the seven major
markets, 2007 - 2018
- Table: Rapamune - Drug profile, 2008
- Table: Impacting factors on the revenues of Rapamune in the seven major
markets, 2007 - 2018
- Table: Thymoglobulin - Drug profile, 2008
- Table: Impacting factors on the revenues of Thymoglobulin in the seven
major markets, 2007 - 2018
- Table: Belatacept - Drug profile, 2008
- Table: Summary of key late-stage ongoing clinical trials for belatacept,
2008
- Table: Impacting factors on the revenues of belatacept in the seven major
markets, 2010 - 17
- Table: Belatacept US patient model, 2007 - 2017
- Table: Belatacept 5EU patient model, 2007 - 2017
- Table: Belatacept Japan patient model, 2007 - 2017
- Table: Calculation of the annual price of Prograf in the US
- Table: LCP-Tacro - Drug profile, 2008
- Table: Summary of key late-stage ongoing clinical trials for LCP-Tacro,
2008
- Table: Impacting factors on the revenues of LCP-Tacro in the seven major
markets, 2007 - 2017
- Table: Leading companies in the seven major markets immunosuppressant
market, 2007 - 2017
- Table: Astellas portfolio assessment of immunosuppressants for the
transplantation market, 2008
- Table: Novartis portfolio assessment of immunosuppressants for the
transplantation market, 2008
- Table: S ales and growth of immunosuppressant drug classes in Canada, 2003
- 07
- Table: Price per standard unit of key immunosuppressant brands in Canada,
the US and the five major European markets, 2007
- Table: Number of transplants in Canada and the seven major markets, 2003 -
07
- Table: Donation rates (pmp), waiting list and number of transplantations
per country in the seven major markets and Canada, 2007
- Table: Datamonitor' s launch dates for immunosuppressants in the seven
major markets, 2007 - 2017
- Table: Patent expiry dates for the approved immunosuppressants in the
seven major markets, 2007 - 2017
- Table: Sales split between retail and hospital market of key
immunosuppressant market in the US, France and Germany, 2007
- Table: Sales split between retail and hospital market of key
immunosuppressant market in Italy, Spain and the UK, 2007
FIGURES
- Figure: Schematic overview of the use of immunosuppressants in
transplantation
- Figure: Indexed total immunosuppressant drug sales by class in the seven
major markets, 2003 - 2017
- Figure: Top five immunosuppressant brands in the seven major markets, 2007
and 2017
- Figure: Sales performance of the seven major markets immunosuppressant
market by country, 2003 - 2017
- Figure: Principles of the Spanish model of organ donor recruitment
- Figure: Branded and generic cyclosporine market split in the US, Japan and
5EU, 2007
- Figure: Prescription of immunosuppressants in the US, 2004
- Figure: Projected half-lives versus actual half-lives in deceased donor
transplants: 1988 - 1995 (including re-transplant recipients)
- Figure: Indexed total immunosuppressant drug sales by class in the US,
2003 - 2017
- Figure: Waiting list on December 31, 2007, versus number of
transplantations in 2007, by country
- Figure: Overview of events related to Certican (everolimus) in the US,
Europe and Japan
- Figure: Overview of events related to Advagraf (tacrolimus) in the US,
Europe and Japan
- Figure: Indexed total immunosuppressant drug sales by class in Japan, 2003
- 2017
- Figure: Indexed total immunosuppressant drug sales by class in the five
major European markets, 2003 - 2017
- Figure: Indexed total immunosuppressant drug sales by country in the five
major European markets, 2003 - 2017
- Figure: Indexed total immunosuppressant drug sales by class in France,
2003 - 2017
- Figure: Indexed total immunosuppressant drug sales by class in Germany,
2003 - 2017
- Figure: Indexed total immunosuppressant drug sales by class in Italy, 2003
- 2017
- Figure: Indexed total immunosuppressant drug sales by class in Spain, 2003
- 2017
- Figure: Indexed total immunosuppressant drug sales by class in the UK,
2003 - 2017
- Figure: Seven major markets versus rest of the world sales split for the
maintenance immunosuppressant market, 2003 and 2007
- Figure: Indexed annual sales of the maintenance immunosuppressant market
in small and emerging markets, 2003 - 07
- Figure: Main forecast versus alternative forecast for the launch of
Advagraf in the US
- Figure: Main forecast versus alternative forecast for the launch of
Certican in the US
- Figure: Solid organ transplant patient care path
- Figure: Market share ($m) of the products used for induction treatment in
the US, five major European countries and Japan, 2007
- Figure: Market share ($m) of the products used for maintenance treatment
in the US, five major European countries and Japan, 2007
- Figure: Promotional spend for key brands in the US, 2007
- Figure: Retail sales split of Prograf in the seven major markets, 2007
- Figure: Prograf SWOT analysis, 2008
- Figure: Sales of Prograf, Advagraf and generic tacrolimus in the seven
major markets, 2007 - 2017
- Figure: Market share of Neoral/Sandimmun and generic cyclosporine in the
US, 2001 - 07 (1999 - 2001 assumed)
- Figure: Market share of Prograf and Advagraf in Spain, Q1 2007 - Q4 2009
- Figure: Calculation of price difference per standard unit (SU) in the US
between Prograf and Advagraf
- Figure: Sales of Neoral/Sandimmun and generic cyclosporine in the seven
major markets, 2007 - 2017
- Figure: Retail sales split of CellCept in the seven major markets, 2007
- Figure: CellCept SWOT analysis, 2008
- Figure: Sales of CellCept and generic mycophenolate mofetil in the seven
major markets, 2007 - 2017
- Figure: Sales of azathioprine, Myfortic and Bredinin in the seven major
markets, 2007 - 2017
- Figure: Retail sales split of Rapamune in the seven major markets, 2007
- Figure: Rapamune SWOT analysis, 2008
- Figure: Sales of Rapamune, Certican and generic sirolimus in the seven
major markets, 2007 - 2017
- Figure: Market share of Rapamune and Certican in Germany, Q1 2004 - Q2 2008
- Figure: Thymoglobulin SWOT analysis, 2008
- Figure: Sales of Rapamune, Thymoglobulin, ATGAM and ATG-Fresenius in the
seven major markets, 2007 - 2017
- Figure: Market share of Neoral/Sandimmun, Gengraf and other generic
cyclosporine in the US, 2001 - 07
- Figure: Sales of Rapamune, Simulect, Zenapax and Orthoclone Okt-3 in the
seven major markets, 2007 - 2017
- Figure: Clinical trial design of belatacept' s key Phase II trial
- Figure: Belatacept SWOT analysis, 2008
- Figure: Sales of belatacept, tacrolimus and cyclosporine in the seven
major markets, 2007 - 2017
- Figure: LCP-Tacro SWOT analysis, 2008
- Figure: Sales of LCP-Tacro, Astellas' s tacrolimus franchise and generic
tacrolimus in the seven major markets, 2007 - 2017
- Figure: Indexed total immunosuppressant drug sales by class in Canada,
2003 - 07
- Figure: Indexed total sales for key immunosuppressants in Canada, 2003 - 07
- Figure: Sales of Prograf and cyclosporine in Canada, 2003 - 07
- Figure: Sales of CellCept, azathioprine and Myfortic in Canada, 2003 - 07
- Figure: Sales of induction treatments in Canada, 2003 - 07
- Figure: Average delay between first launch in the world and launch in each
country for drugs launched between 1999 and 2003
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