Biosimilars Series: Forecast Analysis

Publication Date	June 2009
Publisher	Datamonitor
Product Type	Report
Pages	151
ISBN Number	not applicable
Product Code	DAT13073

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Summary

The high cost and utilization of biologic drugs, coupled to the growing need to curb pharmaceutical expenditure, provides considerable momentum to the emerging biosimilars market. With a biosimilar approval pathway in place in Europe and Japan, and imminently in the US, Datamonitor expects payer pressure to drive biosimilar uptake, particularly in Germany, the US, and the UK.

Scope

Molecule specific forecasts for biosimilar epoetin alpha, filgrastim, interferon beta, interferon alpha, human growth hormone, and insulin-glargine.
Molecule specific forecasts for France, Germany, Italy, Spain, the US, and Japan through 2019.
An overview of the emerging biosimilars market, including a regulatory update.
An outline of the key issues which will impact on biosimilars uptake going forward.

Highlights

As the first to introduce guidelines for biosimilar drug approval, Europe has emerged as the testing ground for biosimilar drugs, with biosimilars for three biologics having entered the market to date human growth hormone, epoetin alpha, and filgrastim.

The size of the US market, combined with the voracious generic erosion that characterize it, make it an attractive prospect for would-be biosimilars makers, and as such, it represents the real prize, contingent on the creation of a biosimilars approval pathway.

Although guidance for biosimilar approval was issued in Japan in 2009, this market is unlikely to experience significant biosimilar incursion through the forecast period, contributing at most 1% to total seven major market volume sales in 2019.

Reasons to Purchase

Learn how biosimilar uptake for six biologic drugs is anticipated to change through 2019, in France, Germany, Italy, Spain, the UK, the US, and Japan.
Understand how the seven major markets compare in terms of speed and extent of biosimilars uptake.
Identify the key molecule and market specific drivers and resistors to biosimilar uptake.

Content

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report
Key findings

CHAPTER 2 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
The number and use of biologics on the market is set to grow, expanding the potential biosimilars market
The high cost of biologics will drive payers to look to biosimilars for cost-savings
Japan has introduced a biosimilars approval pathway
Resistors to biosimilar uptake
Absence of a biosimilars approval pathway in the US
Demonstrating comparability to the branded reference drug
Rebates and service agreements will present a barrier to biosimilars uptake

CHAPTER 3 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
Biosimilar clinical development timelines
Negotiating the biosimilar regulatory landscape
Relative unknowns regarding regulatory issues in Japan and the US likely to delay biosimilar market entry
Biosimilars approval time in Japan likely to be the rate-limiting step
Market exclusivity in the US a contentious issue
Medicare billing in the US will affect uptake
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
Merck & Co. set to enter the biosimilars market in 2012
AstraZeneca and Eli Lilly commit to entering the biosimilars market
Daiichi-Sankyo in position to enter biosimilar market
Sanofi-Aventis and Pfizer eye up Wockhardt
GlaxoSmithKline and Johnson & Johnson say no to biosimilars

CHAPTER 4 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
Molecule-specific factors for epoetin alpha have a net neutral effect on biosimilar uptake
Cost could be a considerable driver of biosimilar uptake in Germany, Spain and the UK
Aranesp will limit biosimilar epoetin alpha uptake
Hospital sales will slow biosimilar uptake
Market-specific characteristics will contribute to rate of uptake

CHAPTER 5 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
Molecule-specific factors will drive biosimilar filgrastim uptake
Neulasta will limit biosimilar filgrastim uptake
Hospital sales will slow biosimilar uptake
Market-specific characteristics will contribute to rate of uptake

CHAPTER 6 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
Majority of biosimilar uptake will be derived from treatment-na??ve patients and switching from non-responders
Hospital sales may include home deliveries
The multiple sclerosis market is highly cost-sensitive

CHAPTER 7 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
Molecule safety concerns may resist uptake
Device association will impact on uptake
Pegylated interferon alpha drives down the value of the biosimilar market
Retail dominance benefits biosimilar uptake
Smaller lesser known manufacturers will slow uptake

CHAPTER 8 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
Human growth hormone has a good safety profile
Uptake will largely be restricted to treatment-na??ve population
Retail dominance will drive uptake
Formulation and device will be key to biosimilar success
Value-adds are important in the biosimilar human growth hormone market

CHAPTER 9 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
Insulin-glargine is one of the simplest biologics
The need to adjust dosing presents a resistor to biosimilar substitution
Retail dominance will drive uptake
Brand loyalty on the part of physicians, and the need for value-adds will slow uptake
Biosimilars must enter the market with a strong device

BIBLIOGRAPHY

Publications and online articles
Conference literature
Datamonitor resources

APPENDIX

Table 1: Development and marketing of epoetin in the US and Europe, 2009
Table 2: Epoetin biosimilars with EMEA Marketing Authorization, 2009
Table 3: Epoetin alpha biosimilar pipeline, 2009
Table 4: Volume market split between short- and long-acting epoetin in the seven major markets, 2008
Table 5: Hospital-retail divide for branded epoetin alpha volume sales in the seven major markets, 2008
Table 6: Granulocyte colony stimulating factor (GCSF) biosimilars with European market authorization, 2008
Table 7: Filgrastim biosimilar pipeline, 2009
Table 8: Volume market split between short- and long-acting granulocyte colony stimulating factor (GCSF) in the seven major markets, 2005-08
Table 9: Hospital-retail divide for branded filgrastim volume sales in the seven major markets, 2008
Table 10: Market leading treatments for multiple sclerosis, 2009
Table 11: Biosimilar interferon beta pipeline, 2009
Table 12: Dominance of Avonex device use across the seven major markets, 2008
Table 13: Hospital-retail divide for branded interferon beta volume sales in the seven major markets, 2008
Table 14: Biosimilar interferon alpha pipeline, 2009
Table 15: Market split between short- and long-acting interferon alpha in the seven major markets, 2008
Table 16: Hospital-retail divide for interferon alpha volume sales in the seven major markets, 2008
Table 17: Omnitrope uptake in the seven major markets, 2008
Table 18: Hospital-retail divide for human growth hormone volume sales in the seven major markets, 2008
Table 19: Insulin analog market, 2009
Table 20: Hospital-retail divide for branded insulin-glargine volume sales in the seven major markets, 2008
Table 21: Market split for type of device associated with insulin-glargine in the seven major markets, 2008
Table 22: Currency exchange rates, 2008
Figure 1: Biosimilars market by country in the seven major markets, 2008-2019
Figure 2: Biosimilars market by market in the seven major markets, 2008-2019
Figure 3: The US biosimilars market, 2008-2019
Figure 4: Japan biosimilars market, 2008-2019
Figure 5: France biosimilars market, 2008-2019
Figure 6: Germany biosimilars market, 2008-2019
Figure 7: Italy biosimilars market, 2008-2019
Figure 8: Spain biosimilars market, 2008-2019
Figure 9: The UK biosimilars market, 2008-2019
Figure 10: The potential biosimilars market through 2015
Figure 11: Change in US Medicare drug price, 2004-07
Figure 12: The spectrum of biologic complexity
Figure 13: Market share dynamics for biosimilar Epogen in Germany, 2008
Figure 14: Biosimilars development timeline
Figure 15: Approval pathway for the first wave of biosimilars in Europe
Figure 16: US biosimilars pathway bills to date, 2009
Figure 17: The hospital versus retail divide for biosimilars, 2009
Figure 18: Biosimilar epoetin alpha volume uptake in Germany, Q4 2008
Figure 19: Epoetin drug sales in the seven major markets, 2008
Figure 20: Epoetin alpha biosimilar forecast in the seven major markets, 2008-2019
Figure 21: Epoetin alpha biosimilar and branded forecast, US, 2008-2019
Figure 22: Epoetin alpha biosimilar and branded forecast, Japan, 2008-2019
Figure 23: Epoetin alpha biosimilar and branded forecast, France, 2008-2019
Figure 24: Epoetin alpha biosimilar and branded forecast, Germany, 2008-2019
Figure 25: Epoetin alpha biosimilar and branded forecast, Italy, 2008-2019
Figure 26: Epoetin alpha biosimilar and branded forecast, Spain, 2008-2019
Figure 27: Epoetin alpha biosimilar and branded forecast, UK, 2008-2019
Figure 28: Molecule- and market-specific factors affecting biosimilar epoetin alpha uptake in the seven major markets, 2009
Figure 29: Granulocyte colony stimulating factor (GCSF) uptake in the seven major markets, 2008
Figure 30: Filgrastim biosimilar forecast in the seven major markets, 2008-2019
Figure 31: Filgrastim biosimilar and branded forecast, US, 2008-2019
Figure 32: Filgrastim biosimilar and branded forecast, Japan, 2008-2019
Figure 33: Filgrastim biosimilar and branded forecast, France, 2008-2019
Figure 34: Filgrastim biosimilar and branded forecast, Germany, 2008-2019
Figure 35: Filgrastim biosimilar and branded forecast, Italy, 2008-2019
Figure 36: Filgrastim biosimilar and branded forecast, Spain, 2008-2019
Figure 37: Filgrastim biosimilar and branded forecast, UK, 2008-2019
Figure 38: Molecule- and market-specific factors affecting biosimilar filgrastim uptake in the seven major markets, 2009
Figure 39: Uptake of the leading multiple sclerosis drugs in the seven major markets, 2008
Figure 40: Interferon beta biosimilar forecast in the seven major markets, 2008-2019
Figure 41: Interferon beta 1a biosimilar and branded forecast, US, 2008-2019
Figure 42: Interferon beta 1a biosimilar and branded forecast, Japan, 2008-2019
Figure 43: Interferon beta 1a biosimilar and branded forecast, France, 2008-2019
Figure 44: Interferon beta 1a biosimilar and branded forecast, Germany, 2008-2019
Figure 45: Interferon beta 1a biosimilar and branded forecast, Italy, 2008-2019
Figure 46: Interferon beta 1a biosimilar and branded forecast, Spain, 2008-2019
Figure 47: Interferon beta 1a biosimilar and branded forecast, UK, 2008-2019
Figure 48: Molecule- and market-specific factors affecting biosimilar interferon beta uptake in the seven major markets, 2009
Figure 49: Variation in multiple sclerosis treatment across the seven major markets, 2006
Figure 50: Interferon alpha drug sales across the seven major markets, 2008
Figure 51: Interferon alpha biosimilar forecast in the seven major markets, 2008-2019
Figure 52: Interferon alpha biosimilar and branded forecast, US, 2008-2019
Figure 53: Interferon alpha biosimilar and branded forecast, Japan, 2008-2019
Figure 54: Interferon alpha biosimilar and branded forecast, France, 2008-2019
Figure 55: Interferon alpha biosimilar and branded forecast, Germany, 2008-2019
Figure 56: Interferon alpha biosimilar and branded forecast, Italy, 2008-2019
Figure 57: Interferon alpha biosimilar and branded forecast, Spain, 2008-2019
Figure 58: Interferon alpha biosimilar and branded forecast, UK, 2008-2019
Figure 59: Molecule- and market-specific factors affecting biosimilar interferon alpha uptake, 2009
Figure 60: Device dominance in interferon alpha therapy across the seven major markets, 2008
Figure 61: Human growth hormone market in the seven major markets, 2008
Figure 62: Human growth hormone forecast in the seven major markets, 2008-2019
Figure 63: Human growth hormone biosimilar and branded forecast, US, 2008-2019
Figure 64: Human growth hormone biosimilar and branded forecast, Japan, 2008-2019
Figure 65: Human growth hormone biosimilar and branded forecast, France, 2008-2019
Figure 66: Human growth hormone biosimilar and branded forecast, Germany, 2008-2019
Figure 67: Human growth hormone biosimilar and branded forecast, Italy, 2008-2019
Figure 68: Human growth hormone biosimilar and branded forecast, Spain, 2008-2019
Figure 69: Human growth hormone biosimilar and branded forecast, UK, 2008-2019
Figure 70: Molecule- and market-specific factors affecting biosimilar human growth hormone uptake, 2009
Figure 71: Standard and modern insulin sales across the seven major markets, 2005-08
Figure 72: Insulin analog sales in the seven major markets, 2008
Figure 73: Insulin-glargine forecast in the seven major markets, 2008-2019
Figure 74: Insulin-glargine biosimilar and branded forecast, US, 2008-2019
Figure 75: Insulin-glargine biosimilar and branded forecast, Japan, 2008-2019
Figure 76: Insulin-glargine biosimilar and branded forecast, France, 2008-2019
Figure 77: Insulin-glargine biosimilar and branded forecast, Germany, 2008-2019
Figure 78: Insulin-glargine biosimilar and branded forecast, Italy, 2008-2019
Figure 79: Insulin-glargine biosimilar and branded forecast, Spain, 2008-2019
Figure 80: Insulin-glargine biosimilar and branded forecast, UK, 2008-2019
Figure 81: Molecule- and market-specific factors affecting biosimilar insulin-glargine uptake, 2009
Figure 82: IMS