ReportsnReports adds new market research report on Biosimilars market that says the US continues to disappoint and Europe forges ahead, globally.

Dallas, TX -- (SBWire) -- 01/30/2012 --Examining the market for companies : The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow and critical issues driving the market dynamic include:

Industry investment: a sign of confidence?
This report provides a detailed analysis of 50 companies active in the biosimilars field, many of which have declared their interest in 2011.

The move may reflect a growing confidence that as regulatory provision for biosimilars increases, and as the pipeline of prospective products matures, then the prospect of actually being able to launch products grows more realistic.

The US continues to disappoint; Europe forges ahead
Despite President Obama's health reform bill being passed in 2010, very little has happened. And the FDA's cautious approach suggests little will happen in the immediate future. The much anticipated Guidance, expected in 2011 has failed to appear, and in May 2011 FDA published details for User Fees - a scheme that will not come into effect (assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.

Developing markets may offer a profitable alternative
Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.

This report provides a comprehensive insight to the market environment, current and future products and the companies involved.

- A complete examination of the regulatory situation in the US, Europe and emerging markets
- Detailed assessment of current biosimilar products and developers with market share by product

EPO
G-CSF
HGH
Human Insulin
Interferon (alfa & beta)

- Identification and analysis of likely second wave of advanced biologics to come to the market


Adalimumab
Etanercept
Infliximab
Rituximab
Trastuzumab

- A review of operational issues that will affect the adoption of biosimilars including pricing/reimbursement, clinician attitudes and patient acceptance

- The position, activity, products, pipeline and plans of 50 leading players in the field

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