Nonalcohol?ic Steatohepa?titis Market to Grow Substantia?lly by 2017

The growing global rate of obesity and diabetes will significantly boost the nonalcoholic steatohepatitis (NASH) market from $233 million in 2012 to $863 million by 2017, at a Compound Annual Growth Rate (CAGR) of 30%, forecasts research and consulting firm GlobalData.

According to the company’s latest report*, the US will have the largest share of the market, contributing $827 million towards global sales, followed by the five major European markets — France, Germany, Italy, Spain and the UK. Currently, there are 29.3 million prevalent cases of NASH across these six major markets.

In addition to obesity and diabetes, another factor that will contribute to the sales growth is the launch of Intercept Pharmaceuticals/Dainippon Sumitomo Pharma’s obeticholic acid in the US and of Genfit’s GFT505 in the US and Europe in Q4 2017, giving them an early foothold in the NASH market space.

Besides these two product launches, GlobalData believes there are two more therapies with the potential to revolutionize the treatment paradigm for NASH in the near future: Gilead’s simtuzumab and Novo Nordisk’s liraglutide (Victoza).

These four novel, potentially first-in-class therapies, which are anti-fibrotic and anti-diabetic, will target subpopulations — obese, diabetic, and healthy donors — within NASH.

Still, there are no approved therapies for the treatment of NASH and there are few therapies in the pipeline that are specific to the condition that appear to be nearing approval over the next 5 years.

Dina Rufo, MS, GlobalData's Analyst covering Immunology, says: “As there is neither cure, nor one specific therapy currently available for NASH, R&D strategies in this market space are complicated. Challenges range from unraveling the pathophysiology of NASH and designing diagnostic tools for more accurate diagnosis and staging, to the design of clinical trials.

“Furthermore, the level of unmet needs for NASH, including both environmental and clinical, is high and requires patient awareness and physician education. 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.”

However, there have been attempts at designing new tools, such as an obesity-related NASH diagnostic and cell apoptosis assessment, to allow for better understanding of drug efficacy.

*Opportunity Analyzer: Nonalcoholic Steatohepatitis (NASH) — Opportunity Analysis and Forecasts to 2017