OpportunityAnalyzer: Nonalcoholic Steatohepatitis (NASH) - Opportunity Analysis and Forecasts

Monday 24 March 2014, Amsterdam

End of Forecast Surge in Sales for NASH from 2012–2017

GlobalData 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, GlobalData expects sales to grow to about $1.36bn, with a compound annual growth rate (CAGR) of 42.2% across the 6MM. We expect the US to claim the most sales, contributing $1.28bn of global sales and a CAGR of 43.8%.

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.
• We expect the US’ growth will be due in part to the launch of both of these products, while growth in the 5EU will be predominantly driven by GFT505 during the forecast period.

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.