Dallas, TX (PRWEB) March 22, 2014 -- OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update report estimates the 2012 off-label sales for nonalcoholic steatohepatitis (NASH) to be approximately $233m across the US and five major European markets of France, Germany, Italy, Spain, and the UK. By forecast end in 2017, this research expects sales to grow to about $1.36bn, with a compound annual growth rate (CAGR) of 42.2% across the 6MM. The US is set to claim the most sales, contributing $1.28bn of global sales and a CAGR of 43.8% as per the report available at http://www.reportsnreports.com/reports/277079-opportunityanalyzer-nonalcoholic-steatohepatitis-nash-opportunity-analysis-and-forecasts-to-2017-event-driven-update.html .
Major drivers of growth in the NASH market are attributed to two factors:
The growing rate of obesity and diabetes globally.
The launch of Genfit’s GFT505 and Intercept/DSP’s obeticholic acid (OCA) in 2017. In OCA’s favor, its Phase II/IIb trial was stopped early in January 2014, after a planned interim analysis showed that the primary endpoint of the study had been met. While for GFT505, Genfit is aligning itself to register GFT505 among the first approved therapies for NASH and the company received Fast Track designation for the GFT505 NASH program on February 14, 2014.
Major barriers to the growth of the NASH market are attributed to:
• Slow development of therapies specific for NASH.
• Unclear understanding of the pathophysiology of NASH.
• Inefficient diagnostic tools for NASH that may lead to delayed diagnosis of NASH.
Emerging Market Players Employing Strategies to Improve Diagnostics and Trial Designs
The NASH market is virtually vacant aside from off-label therapies that do not provide a “one size fits all” approach. The potential for market leaders to emerge is wide open to all contenders. We expect Gilead and Novo Nordisk to gain market entry after the end of the forecast period in 2017; however, with their market knowledge, their products simtuzumab and liraglutide should do well commercially.
As for newcomers Genfit and Intercept/DSP, fame will be claimed since their products will likely launch at the end of the forecast in Q4 2017, thus giving them an early foothold in the NASH market space.
Since there is no cure or one specific therapy currently available for NASH, R&D strategies in this market space are complicated. Complications range from unraveling the pathophysiology of NASH, to designing diagnostic tools for more accurate diagnosis and staging, to the design of clinical trials. As our expert leaders have agreed, NASH needs an approved therapy that is cost-effective and touts a desirable efficacy and safety profile.
Analyze Vast Unmet Needs in the NASH Market by ordering the report OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update at http://www.reportsnreports.com/Purchase.aspx?name=277079:
The level of unmet needs for NASH, including both environmental and clinical, is high and includes patient awareness, physician education, and approved therapies specific to NASH. These issues compound the reasons why the NASH market space is very sparse. A series of unknowns exist for the disease, due to its heterogeneous nature, and its slow progression poses problems for drug development. Vitamin E, the current gold-standard therapy, dominates what little drug therapy NASH market there is. We expect both Genfit’s small molecule GFT505 and Intercept Pharmaceuticals/DSP’s small molecule OCA to claim patient share in all subpopulations of NASH.
These products will likely solve the top unmet need – the dire need for an approved therapy for NASH.
Opportunities Will Remain for Tools that Provide Accurate Diagnosis
There is a major opportunity for new entrants to design better biomarkers than the current liver enzymes: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) as non-invasive surrogates for Nonalcoholic Fatty Liver Disease (NAFLD). Testing may also include cytokeratin-18 (CK18), which may provide clues to hepatocyte cell death. In addition, markers that can assess liver stages are needed, since CK18 is also elevated in other liver conditions.
Currently, NASH patients may be diagnosed by chance during routine serological examination, or via invasive liver biopsy. Most NASH patients will be in the mid/late stage of the disease once diagnosed. A more accurate diagnostic tool for determining the extent of fibrosis in NASH patients will also be paramount. That said, we expect these opportunities to remain unmet during the five-year forecast period from 2012–2017.
Comprehensive Table of Contents and more is available at - OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts to 2017 - Event-Driven Update.
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