Table of Contents
EXECUTIVE SUMMARY
- Scope of the report
- Key findings
BIOSIMILARS OVERVIEW
- Biosimilars forecast analysis
- Seven major markets - biosimilar forecast
- The US - biosimilars forecast
- Japan - biosimilars forecast
- France - biosimilars forecast
- Germany - biosimilars forecast
- Italy - biosimilars forecast
- Spain - biosimilars forecast
- UK - biosimilars forecast
- The case for biosimilars
- Drivers of biosimilar uptake
- Resistors to biosimilar uptake
GENERAL FORECASTING EVENTS AND ASSUMPTIONS
- Key assumptions
- Forecast biosimilar definition
- Forecast rate and magnitude of baseline biosimilar uptake
- Magnitude of biosimilar erosion based on generics volume uptake
- Time to maximal biosimilar erosion of reference product
- Forecast biosimilar pricing assumptions
- Forecast entry of subsequent biosimilars
- Two ‘waves' of biosimilar entry forecast
- Second biosimilar ‘wave' will only erode market share of the first
wave, not the reference brand
- Forecast launches of pipeline biosimilars based on epoetin alpha and
filgrastim development profiles
- Relative unknowns regarding regulatory issues in Japan and the US likely
to delay biosimilar market entry
- Issues impacting biosimilar uptake
- Second generation products will limit uptake
- Device association will drive down biosimilar uptake
- Hospital-retail divide and biosimilar uptake
- Automatic substitution will drive up biosimilar uptake
- Key biosimilars players
- Generics and biosimilar strategies differ depending on company size
- Branded companies poised to enter biosimilars market
BIOSIMILAR EPOETIN ALPHA FORECAST AND ASSUMPTIONS
- Epoetin market overview
- Biosimilar epoetin alpha forecast
- Seven major markets - biosimilar epoetin alpha forecast
- US - biosimilar epoetin alpha forecast
- Japan - biosimilar epoetin alpha forecast
- France - biosimilar epoetin alpha forecast
- Germany - biosimilar epoetin alpha forecast
- Italy - biosimilar epoetin alpha forecast
- Spain - biosimilar epoetin alpha forecast
- UK - biosimilar epoetin alpha forecast
- Biosimilar epoetin alpha assumptions
- Biosimilar epoetin alpha has already launched in Europe and will enter
the US and Japan from 2013
- Second wave of biosimilar epoetin alpha will launch in Europe from 2009,
and in the US and Japan from 2014
- Epoetin is a high margin product
- Biosimilar epoetin alpha market share and speed of uptake
BIOSIMILAR FILGRASTIM FORECAST AND ASSUMPTIONS
- Filgrastim market overview
- Biosimilar filgrastim forecast
- Seven major markets - biosimilar filgrastim forecast
- US - biosimilar filgrastim forecast
- Japan - biosimilar filgrastim forecast
- France - biosimilar filgrastim forecast
- Germany - biosimilar filgrastim forecast
- Italy - biosimilar filgrastim forecast
- Spain - biosimilar filgrastim forecast
- UK - biosimilar filgrastim forecast
- Biosimilar filgrastim assumptions
- Neupogen is off-patent in Europe and Japan, and is set to lose patent
protection in the US during 2013
- Second wave of biosimilar filgrastim to enter market from 2010
- Biosimilar filgrastim is likely to be heavily discounted
- Biosimilar filgrastim market share and speed of uptake
BIOSIMILAR INTERFERON BETA FORECAST AND ASSUMPTIONS
- Interferon beta market overview
- Biosimilar interferon beta forecast
- Seven major markets - biosimilar interferon beta forecast
- US - biosimilar interferon beta 1a forecast
- Japan - biosimilar interferon beta 1a forecast
- France - biosimilar interferon beta 1a forecast
- Germany - biosimilar interferon beta 1a forecast
- Italy - biosimilar interferon beta 1a forecast
- Spain - biosimilar interferon beta 1a forecast
- UK - biosimilar interferon beta 1a forecast
- Biosimilar interferon beta assumptions
- Biosimilar interferon beta 1a anticipated to launch from 2012
- The margin for biosimilar Avonex will be lower than that for epoetin
alpha
- The impact of biosimilar Copaxone, Rebif, and Betaseron will not be
forecast
- Biosimilar interferon beta market share and speed of uptake
BIOSIMILAR INTERFERON ALPHA FORECAST AND ASSUMPTIONS
- Interferon alpha market overview
- Biosimilar interferon alpha forecast
- Seven major markets - biosimilar interferon alpha forecast
- US - biosimilar interferon alpha forecast
- Japan - biosimilar interferon alpha forecast
- France - biosimilar interferon alpha forecast
- Germany - biosimilar interferon alpha forecast
- Italy - biosimilar interferon alpha forecast
- Spain - biosimilar interferon alpha forecast
- UK - biosimilar interferon alpha forecast
- Biosimilar interferon alpha assumptions
- Interferon alpha 2a and 2b forecast to be combined
- Patent protection for Intron-A and Roferon has expired in the seven
major markets, paving the way for biosimilar incursion
- Pricing could be used to incentivize biosimilar uptake
- Biosimilar interferon alpha market share and speed of uptake
BIOSIMILAR HUMAN GROWTH HORMONE FORECAST AND ASSUMPTIONS
- Human growth hormone market overview
- Biosimilar human growth hormone forecast
- Seven major markets - biosimilar human growth hormone forecast
- US - biosimilar human growth hormone forecast
- Japan - biosimilar human growth hormone forecast
- France - biosimilar human growth hormone forecast
- Germany - biosimilar human growth hormone forecast
- Italy - biosimilar human growth hormone forecast
- Spain - biosimilar human growth hormone forecast
- UK - biosimilar human growth hormone forecast
- Biosimilar human growth hormone assumptions
- One biosimilar human growth hormone product has launched in the EU and US
- Biosimilar growth hormone launched at a 40% discount
- Biosimilar human growth hormone market share and speed of uptake
BIOSIMILAR INSULIN FORECAST AND ASSUMPTIONS
- Insulin market overview
- Standard human insulin market presents a poor commercial prospect for
biosimilars
- Modern insulin analogs offer greater commercial potential for biosimilar
incursion
- Lantus is the most lucrative biosimilar target
- Biosimilar insulin-glargine forecast
- Seven major market - biosimilar insulin-glargine forecast
- US - biosimilar insulin-glargine forecast
- Japan - biosimilar insulin-glargine forecast
- France - biosimilar insulin-glargine forecast
- Germany - biosimilar insulin-glargine forecast
- Italy - biosimilar insulin-glargine forecast
- Spain - biosimilar insulin-glargine forecast
- UK - biosimilar insulin-glargine forecast
- Biosimilar insulin-glargine assumptions
- Biosimilar insulin-glargine will enter the seven major markets in 2014
- Biosimilar insulin-glargine will erode market share only from Lantus
- Second wave of biosimilar insulin-glargine will enter the following year
- Insulin-glargine likely to launch at moderate discount
- Biosimilar insulin-glargine market share and speed of uptake
BIBLIOGRAPHY
- Publications and online articles
- Conference literature
- Datamonitor resources
TABLES
- Table: Development and marketing of epoetin in the US and Europe, 2009
- Table: Epoetin biosimilars with EMEA Marketing Authorization, 2009
- Table: Epoetin alpha biosimilar pipeline, 2009
- Table: Volume market split between short - and long-acting epoetin in the
seven major markets, 2008
- Table: Hospital-retail divide for branded epoetin alpha volume sales in
the seven major markets, 2008
- Table: Granulocyte colony stimulating factor (GCSF) biosimilars with
European market authorization, 2008
- Table: Filgrastim biosimilar pipeline, 2009
- Table: Volume market split between short - and long-acting granulocyte
colony stimulating factor (GCSF) in the seven major markets, 2005 - 08
- Table: Hospital-retail divide for branded filgrastim volume sales in the
seven major markets, 2008
- Table: Market leading treatments for multiple sclerosis, 2009
- Table: Biosimilar interferon beta pipeline, 2009
- Table: Dominance of Avonex device use across the seven major markets, 2008
- Table: Hospital-retail divide for branded interferon beta volume sales in
the seven major markets, 2008
- Table: Biosimilar interferon alpha pipeline, 2009
- Table: Market split between short - and long-acting interferon alpha in
the seven major markets, 2008
- Table: Hospital-retail divide for interferon alpha volume sales in the
seven major markets, 2008
- Table: Omnitrope uptake in the seven major markets, 2008
- Table: Hospital-retail divide for human growth hormone volume sales in the
seven major markets, 2008
- Table: Insulin analog market, 2009
- Table: Hospital-retail divide for branded insulin-glargine volume sales in
the seven major markets, 2008
- Table: Market split for type of device associated with insulin-glargine in
the seven major markets, 2008
- Table: Currency exchange rates, 2008
FIGURES
- Figure: Biosimilars market by country in the seven major markets, 2008 -
2019
- Figure: Biosimilars market by market in the seven major markets, 2008 -
2019
- Figure: The US biosimilars market, 2008 - 2019
- Figure: Japan biosimilars market, 2008 - 2019
- Figure: France biosimilars market, 2008 - 2019
- Figure: Germany biosimilars market, 2008 - 2019
- Figure: Italy biosimilars market, 2008 - 2019
- Figure: Spain biosimilars market, 2008 - 2019
- Figure: The UK biosimilars market, 2008 - 2019
- Figure: The potential biosimilars market through 2015
- Figure: Change in US Medicare drug price, 2004 - 07
- Figure: The spectrum of biologic complexity
- Figure: Market share dynamics for biosimilar Epogen in Germany, 2008
- Figure: Biosimilars development timeline
- Figure: Approval pathway for the first wave of biosimilars in Europe
- Figure: US biosimilars pathway bills to date, 2009
- Figure: The hospital versus retail divide for biosimilars, 2009
- Figure: Biosimilar epoetin alpha volume uptake in Germany, Q4 2008
- Figure: Epoetin drug sales in the seven major markets, 2008
- Figure: Epoetin alpha biosimilar forecast in the seven major markets, 2008
- 2019
- Figure: Epoetin alpha biosimilar and branded forecast, US, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, Japan, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, France, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, Germany, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, Italy, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, Spain, 2008 - 2019
- Figure: Epoetin alpha biosimilar and branded forecast, UK, 2008 - 2019
- Figure: Molecule - and market-specific factors affecting biosimilar
epoetin alpha uptake in the seven major markets, 2009
- Figure: Granulocyte colony stimulating factor (GCSF) uptake in the seven
major markets, 2008
- Figure: Filgrastim biosimilar forecast in the seven major markets, 2008 -
2019
- Figure: Filgrastim biosimilar and branded forecast, US, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, Japan, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, France, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, Germany, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, Italy, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, Spain, 2008 - 2019
- Figure: Filgrastim biosimilar and branded forecast, UK, 2008 - 2019
- Figure: Molecule - and market-specific factors affecting biosimilar
filgrastim uptake in the seven major markets, 2009
- Figure: Uptake of the leading multiple sclerosis drugs in the seven major
markets, 2008
- Figure: Interferon beta biosimilar forecast in the seven major markets,
2008 - 2019
- Figure: Interferon beta 1a biosimilar and branded forecast, US, 2008 - 2019
- Figure: Interferon beta 1a biosimilar and branded forecast, Japan, 2008 -
2019
- Figure: Interferon beta 1a biosimilar and branded forecast, France, 2008 -
2019
- Figure: Interferon beta 1a biosimilar and branded forecast, Germany, 2008
- 2019
- Figure: Interferon beta 1a biosimilar and branded forecast, Italy, 2008 -
2019
- Figure: Interferon beta 1a biosimilar and branded forecast, Spain, 2008 -
2019
- Figure: Interferon beta 1a biosimilar and branded forecast, UK, 2008 - 2019
- Figure: Molecule - and market-specific factors affecting biosimilar
interferon beta uptake in the seven major markets, 2009
- Figure: Variation in multiple sclerosis treatment across the seven major
markets, 2006
- Figure: Interferon alpha drug sales across the seven major markets, 2008
- Figure: Interferon alpha biosimilar forecast in the seven major markets,
2008 - 2019
- Figure: Interferon alpha biosimilar and branded forecast, US, 2008 - 2019
- Figure: Interferon alpha biosimilar and branded forecast, Japan, 2008 -
2019
- Figure: Interferon alpha biosimilar and branded forecast, France, 2008 -
2019
- Figure: Interferon alpha biosimilar and branded forecast, Germany, 2008 -
2019
- Figure: Interferon alpha biosimilar and branded forecast, Italy, 2008 -
2019
- Figure: Interferon alpha biosimilar and branded forecast, Spain, 2008 -
2019
- Figure: Interferon alpha biosimilar and branded forecast, UK, 2008 - 2019
- Figure: Molecule - and market-specific factors affecting biosimilar
interferon alpha uptake, 2009
- Figure: Device dominance in interferon alpha therapy across the seven
major markets, 2008
- Figure: Human growth hormone market in the seven major markets, 2008
- Figure: Human growth hormone forecast in the seven major markets, 2008 -
2019
- Figure: Human growth hormone biosimilar and branded forecast, US, 2008 -
2019
- Figure: Human growth hormone biosimilar and branded forecast, Japan, 2008
- 2019
- Figure: Human growth hormone biosimilar and branded forecast, France, 2008
- 2019
- Figure: Human growth hormone biosimilar and branded forecast, Germany,
2008 - 2019
- Figure: Human growth hormone biosimilar and branded forecast, Italy, 2008
- 2019
- Figure: Human growth hormone biosimilar and branded forecast, Spain, 2008
- 2019
- Figure: Human growth hormone biosimilar and branded forecast, UK, 2008 -
2019
- Figure: Molecule - and market-specific factors affecting biosimilar human
growth hormone uptake, 2009
- Figure: Standard and modern insulin sales across the seven major markets,
2005 - 08
- Figure: Insulin analog sales in the seven major markets, 2008
- Figure: Insulin-glargine forecast in the seven major markets, 2008 - 2019
- Figure: Insulin-glargine biosimilar and branded forecast, US, 2008 - 2019
- Figure: Insulin-glargine biosimilar and branded forecast, Japan, 2008 -
2019
- Figure: Insulin-glargine biosimilar and branded forecast, France, 2008 -
2019
- Figure: Insulin-glargine biosimilar and branded forecast, Germany, 2008 -
2019
- Figure: Insulin-glargine biosimilar and branded forecast, Italy, 2008 -
2019
- Figure: Insulin-glargine biosimilar and branded forecast, Spain, 2008 -
2019
- Figure: Insulin-glargine biosimilar and branded forecast, UK, 2008 - 2019
- Figure: Molecule - and market-specific factors affecting biosimilar
insulin-glargine uptake, 2009
- Figure: IMS
|
Related Report
|
View Cart
