Pharma

Report: NASH market to increase forty-fold by 2026

A new report by GlobalData has underscored the extreme blockbuster potential of fatty liver disease and non-alcoholic steatohepatitis (NASH), projecting that the current $618 million market will balloon to $25.3 billion by 2026.

graphic design of a liver

A new report by research and consulting firm GlobalData has underscored the extreme blockbuster potential of non-alcoholic steatohepatitis (NASH).

Looking at the seven major markets (7MM) of the U.S., France, Germany, Italy, Spain, the U.K., and Japan, the authors determined that the field would expand at a compound annual growth rate (CAGR) of 45 percent.

That means that during the next 10 years, the field is projected to swell forty-fold from $618 million in 2016 to $25.3 billion in 2026.

Why the sudden gold rush?

NASH is a progression of non-alcoholic fatty liver disease (NAFLD), which affects an estimated 75-100 million Americans — a key area of concern as the U.S. population ages. Approximately five percent (15.9 million) of Americans are currently believed to have NASH, though most are undiagnosed.

Until the final stages of liver cirrhosis, the disease is largely asymptomatic. Add to that the lack of any approved therapies and a difficult diagnostic process (typically involving an invasive liver biopsy) and there are few incentives for patients and providers to take a closer look in 2017.

As president of NGM Bio – a company advancing multiple drug candidates for NASH – Jeff Jonker expects that to change in the coming years.

“We agree with most observers that the population with NASH is growing rapidly, driven by the prevalence and increasing incidence of type 2 diabetes and obesity globally,” Jonkers wrote via email, adding that he was optimistic that some non-invasive diagnostics will soon reach the market.

There’s an urgent need close to home. The report’s authors expect NASH to inflict a disproportionate toll in different nations. The U.S. and Japanese markets are both anticipated to increase at CAGR of close to 50 percent, while the five E.U. countries will expand more conservatively but still around 30 percent.

At the end of 2026, the U.S. will account for around 88 percent of global sales, while the five E.U. countries and Japan will account for approximately 10 percent and 2 percent of sales, respectively. That’s not just due to the local prevalence.

“The higher sales numbers for the US can be attributed to the higher prices of pharmaceuticals and the greater diagnosed prevalence of NASH in the region, as well as the launch of more pipeline agents in this region,” the authors state in an overview of the report.

However, as Jonker noted, the opportunity alone can’t guarantee approvals.

“What the report does highlight well is the challenge in developing treatments for this disease, given that NASH is chronic, asymptomatic and progresses in only a portion of patients,” he said.

GlobalData’s calculations assume that a number of biopharma NASH candidates will be approved in the coming years. Among them, Gilead’s selonsertib, Intercept’s Ocaliva, and Genfit’s elafibranor. Combined, the authors estimate the three drugs will capture just over 70 percent of the market by 2026.

If not these drugs, there are many others that would happily take their place. The development pipeline is positively bursting — almost to a fault. Clinicaltrials.gov lists 155 open studies involving NAFLD/NASH. Combined with the current diagnostic limitations, the competition is putting a strain on clinical trial recruitment. Genfit and Intercept have both disclosed setbacks with their enrollments.

While it’s undoubtedly going to be a tough market to crack, the potential windfall is even greater.

Managing Healthcare Analyst for GlobalData Lakshmi Dharmarajan said via email that she couldn’t comment on whether the forty-fold increase was one of the largest the market research firm had ever predicted.

“That being said, we definitely agree that the NASH market will experience unprecedented growth in the next ten years, due to the launch and use of the pipeline agents,” Dharmarajan wrote.

Photo: eranicle, Getty Images

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