Biosimilars Series: Forecast Analysis : Market Research Report

Biosimilars Series: Forecast Analysis

Published by: Datamonitor

Published: Jun. 11, 2009 - 151 Pages

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
List of Tables: 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
List of Figures: 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

Abstract

Introduction

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.

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Biosimilars Series: Forecast Analysis

Table of Contents

Abstract