Pharmaceutical Key Trends 2011 – Biosimilar Market Overview

Introduction

In 2009, the combined biosimilars market size for the US and five major European markets was $150m. With more than 30 branded biologics with sales of $51bn set to lose patent exclusivity between 2011 and 2015, Datamonitor forecasts that the global biosimilar market will grow from $243m in 2010 to $3.7bn in 2015.

Features and benefits

* Overview of the biosimilar market, with biosimilar definitions in the US, EU and Japan, plus historical and forecast biosimilar sales out to 2015.
* Insight into the key drivers and resistors to biosimilar uptake in the developed and emerging markets.
* Assesses key factors determining successful biosimilar market access, and examines the major biosimilar players and the strategies they implement.
* Analyses biosimilar uptake in the five main European markets and provides insight into the future opportunities for biosimilar players.

Highlights

Due to their complexity, cost, and development risks, biosimilar production and commercialization in developed markets is concentrated among only a handful of pharma companies, all of which are established generics players.
Despite the introduction of approval pathways in the US, EU, and Japan, the growing use of biologics, and the need for more cost-effective treatments, all of which help drive biosimilar uptake, there remain a large number of barriers to uptake.
There are relatively few factors which limit the growth of the biosimilar industry in the developing markets, although the introduction of biosimilar pathways will restrict market access to many domestic biosimilar players, while low purchasing power and a high proportion of out-of-pocket expenditure, coupled with brand loyalty, limit access.

Your key questions answered

* Evaluate the evolving regulatory environment in the US, EU and Japan, and how this impacts biosimilar market access and uptake.
* Gain insight into the deal types among branded, generic and biosimilars players to either enter or bolster their position in the biosimilars market.
* Identify which branded biologics are facing patent expiry and provide significant opportunities for biosimilar developers.
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Executive Summary
Introduction
Strategic scoping and focus
Key findings
Related reports
Upcoming related reports
2. GLOBAL BIOSIMILAR MARKET SIZE
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Biosimilar definitions
Biosimilar sales in 2009
Biologic sales exposed to potential biosimilar competition during 2011–15
Forecast biosimilar sales, 2010–15
Profitability of biosimilars versus branded biologics and generics
3. DRIVERS AND RESISTORS TO BIOSIMILAR UPTAKE
Drivers and resistors to biosimilar uptake in the developed markets
Drivers of biosimilar uptake in developed markets
Neutral factors impacting biosimilar uptake in developed markets
Resistors to biosimilar uptake in developed markets
Drivers and resistors to biosimilar uptake in Brazil, Russia, India, and China
Drivers of biosimilar uptake in emerging markets
Resistors impacting biosimilar uptake in emerging markets
4. BIOSIMILAR MARKET ACCESS
Key factors in determining the success of biosimilar market access
Biosimilar development timeline
Biosimilar development costs
Pros and cons of developing and manufacturing biosimilars in developing markets
Biosimilar approval pathways
Biosimilar producers face a challenging patent environment
Biosimilar pricing in developed markets
Partnerships help drive growth of the biosimilars industry
5. KEY BIOSIMILAR PLAYERS
Key biosimilar players in the developed and emerging markets
Key biosimilar players in the developed markets
Key players in the emerging markets
6. BIOSIMILARS BY GEOGRAPHIC MARKET
Biosimilar launches
US biosimilars market
Biosimilars in the five major EU markets
Japanese biosimilars market
Australian biosimilars market
BRIC biosimilars market
7. BIOSIMILAR UPTAKE
Uptake of biosimilar somatropin, filgrastim and epoetin
Biosimilar somatropin
Biosimilar filgrastim
Biosimilar epoetin
8. OPPORTUNITIES FOR THE BIOSIMILAR INDUSTRY
Branded biologic patent expiries present opportunities for the biosimilar industry
Biologic patent expiries in the US
Biologic patent expiries in the five major EU markets
Biologic patent expiries in Japan
Biosimilars in development internationally
Biosimilar MAbs and second-generation biosimilars offer the greatest commercial potential
9. BIBLIOGRAPHY
Publications and online articles
APPENDIX
Exchange rates used in this report
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