Nonalcoholic Steatohepatitis (NASH) Therapeutics – Pipeline Assessment and Market Forecasts to 2018 by rgunnam


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

The NASH Therapeutics Market is forecast to Show Marginal Growth until 2018

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

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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