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Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

2046.9

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Market

Healthcare and Medical

Report Type

Market Research

Country

Global

Published

10 July 2012

Number of Pages

141

Report Delivery

Email

Delivery Lead Time

1-3 hours, 24 hour max

Publisher

GBI Research

File Format

PDF

Global biologics market to hit $7.5 billion by 2018

New guidelines laid out by the US Food and Drug Administration (FDA) lack clarity and specificity, meaning that a wealth of biosimilars are currently restricted from the worlds biggest pharmaceutical market. Ambiguity within the healthcare authoritys approval pathway procedure suggests decisions will be made on a case-by-case basis, hindering the flow of biosimilars into the US market.

As biosimilars require high investments and long periods of development compared to generics, companies need to know in advance what US regulators will require when they submit their applications for the approval of a new product.

GBI Research expects the first biosimilar to be approved in the US by the end of this year, followed by products by Sandoz and Hospira in early 2013. Once these medications have broken through, and a clearer approval pathway is established, an abundance of biosimilars is expected to follow and take advantage of the highly lucrative US pharmaceutical market.

Europe has already approved 14 biosimilars – the highest of any region – with a range of products belonging to the erythropoietin (EPO) and granulocyte colony stimulating factors (G-CSF) and human growth hormones (HGH) groups. Japan launched its first biosimilar in October 2009.

The reduction of healthcare expenditure is at the top of the agenda for national healthcare authorities around the globe, and as biologics are among the highest priced therapies in the world, establishing governing regulations is a key focus.

GBI Research predicts that the value of the worldwide biologics market will rocket from $450m in 2011 to $7.5 billion in 2018, climbing at a highly impressive Compound Annual Growth Rate (CAGR) of 49.6%. This staggering jump is attributed to the entrance of the US into the global biologics market.

Report Scope

- Data and analysis on the biosimilar market in the leading geographies of the world – the US, the UK, Germany, France, Italy, Spain, and Japan.
- Market forecast for global biosimilar market from 2011 to 2018, by geography as well as product category.
- Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
- The regulatory environment for biosimilars in the US, the EU and in Japan.
- Analysis of competitive environment in the industry and profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddys, Biocon, Intas, Celltrion and 3S Bio.
- Key M&A activities and Licensing Agreements that took place between 2009 up until February 2012 in the global biosimilar market.

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Select License Type

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Electronic License

An electronic version (mostly PDF, but can be Excel or PPT), which is either available for immediate download or will be sent via email by the Publisher of the report. The licencing for an electronic version is for use by the purchaser ONLY.

Site License

Site License

An electronic version (mostly PDF, but can be Excel or PPT). Where the report(s) is intended for use by more than one individual, across for example, a site, an office, or a division or country.

Corporate License

Corporate License

An electronic version (mostly PDF, but can be Excel or PPT). Where the report(s) is/are intended for use by an organisation in its entirety. For example, if reports are put on an Intranet or if they are distributed or used by more than one office, division, or country operation, then a Corporate Licence is required.

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