Nonalcoholic Steatohepatitis (NASH) Therapeutics - Pipeline Assessment and Market Forecasts to 2018

London, United Kingdom (PressExposure) August 04, 2011 -- GlobalData estimates that the global Nonalcoholic Steatohepatitis (NASH) therapeutics market was valued at $615m in 2010, and is forecast to grow at a Compound Annual Growth Rate (CAGR) of 15.9%

over the next eight years, to reach $2,008m by 2018. This steady growth is primarily attributed to the increasing prevalence of NASH due to an increase in the prevalence of co-morbid conditions such as diabetes, obesity and hyperlipidemia, as well as increasing awareness among patients and physicians, which will lead to an increase in the diagnosed and treated patient pool. Off-label usage of antioxidants,

anti-diabetes drugs, anti-obesity drugs and antihyperlipidemics is likely to continue as no specific therapies are likely to get approval through the forecast period up to 2018

GlobalData's research indicates that the current competition in the NASH market is weak. The market

lacks any therapies approved by the FDA (Food and Drug Administration) or the EMEA (European Medicines Agency) for the treatment of NASH. This is mainly due to the poor understanding of the pathophysiology of NASH and the non-specific symptoms of the disease, which hinder the diagnosis at an early stage. The most effective mode of treatment is lifestyle changes and a modified diet regime with regular exercise. Generally, off-label drugs such as anti-diabetes drugs, anti-hyperlipidemics, antioxidants, and anti-obesity drugs are used for the management of NASH.

GlobalData identified that the pipeline for NASH is weak. Clinical research activity in the NASH pipeline is

mainly focused in Phase II. The late stage pipeline for NASH is weak, with no molecules in development

with novel mechanisms of action. Phase II has a few novel molecules, such as Raptor's DR Cysteamine,

Gilead Science's GS 9450, Enzo Biochem's EGS21 and NasVax's anti-CD3 monoclonal antibody, which have shown promising results. However, there seems to be only a limited possibility that these molecules could be approved for the treatment of NASH by 2018.

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The NASH market has significant unmet need because the current market has no specific approved products to treat the condition. When considering the pipeline, Phase II trial of ASP9831 was discontinued by Astellas Pharma Inc. as ASP9831 was not able to achieve expected effects on liver tests. Similarly, Olesoxime (TRO19622), a Phase II product, whose development was halted by Trophos SA due to high variability in the pre-treatment values for the primary endpoint. This implies that limited knowledge of the pathology of the disease has increased challenges in drug development for NASH treatment.

Due to concerns related to the safety and efficacy, the off-label drugs currently in the market do not serve the huge unmet need that exists. Thus, NASH continues to present opportunities for novel pipeline


GlobalData, the industry analysis specialist, has released its new report, "Nonalcoholic Steatohepatitis

(NASH) Therapeutics - Pipeline Assessment and Market Forecasts to 2018". The report is an essential source of information and analysis on the global NASH market. The report identifies the key trends shaping and driving the global NASH market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of

the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global NASH sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of

industry experts.

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Press Release Submitted On: August 04, 2011 at 4:52 am
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