Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment

This report provides a comprehensive examination of the clinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. It identifies the major drivers and barriers to conducting clinical trials in emerging regions and profiles key issues for consideration when selecting a trial site.

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Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

This report explores the potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech and diagnostic industries. It also reviews 28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to result in commercial products in the near future.

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Negotiating the Emerging Biosimilars Landscape: Key developments in the regulatory environment

As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011.

The Top 10 Biosimilar Players: Positioning, performance and SWOT analyses

Biologics continue to outperform the global pharma market, driven by premium priced therapies for conditions that cannot be managed by conventional drugs. The rapid penetration of novel biologics and the gradual expiry of their patents will create significant market opportunities for biosimilars developers through to 2016.

New Approaches to Pharma R&D: Evolving strategies to rejuvenate R&D efficiency

With industry consolidation, the economic downturn, and an increasing threat from generics, pharma companies are coming under greater pressure to fill their pipelines with innovative drugs. However, despite the costs and risks involved in drug development, the pharma industry is finding new ways to streamline the R&D process in an effort to increase efficiency and output.

Generic Benchmarking: Brand Erosion at Patent Expiry

Not only is Pharma facing a continued slow down in sales growth in the seven major markets, but erosion of branded drugs by generics follow patent expiry is increasing, driven by evolving payer initiatives to incentivize generic use.

Forecast Analysis

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.

Maximizing opportunities towards achieving clinical success

For the last few years the biggest pharma companies have started to bring new technologies for drug safety prediction into the discovery phases of research. This report will describe these technologies, their place in the drug discovery and development paradigm and their value for improving drug safety.