The unmet need in non-alcoholic steatohepatitis (NASH) is getting bigger and bigger. In the decade up to 2032, the number of diagnosed cases in seven major markets is forecast to grow by 4.5 million, creating a bigger pie for the drugmakers that ultimately crack the troublesome indication.
It is now almost 10 years since Intercept Pharmaceuticals’ phase 2 NASH data sent investors into a frenzy, driving its share price up more than 500% and marking the start of a period in which the liver disease was one of the hottest indications in biopharma R&D. Money flowed into the space as companies tried to address an unmet medical need that affects millions of people.
Today, a series of clinical and regulatory setbacks have taken some of the heat out of the NASH space but the unmet need is only getting bigger, as GlobalData said in a new report. The market research company estimates the number of people diagnosed with NASH in seven big markets—the U.S., France, Germany, Italy, Spain, the U.K. and Japan—will increase from 22.04 million in 2022 to 26.55 million in 2032.
GlobalData predicts the U.S. will be the biggest market, forecasting that the country will have 10.45 million diagnosed cases in 2032. NASH is growing fastest in Japan and the U.K., which are respectively forecast to have 32% and 71% more diagnosed cases in 2032 than 2022. The U.S. case count is tipped to increase 12%, albeit off a much larger base.
Casey Freimuth, senior epidemiologist at GlobalData, discussed how NASH cases are forecast, explaining in a statement that trends in nonalcoholic fatty liver disease (NAFLD), obesity and type 2 diabetes are leading indicators. Risk factors such as waist circumference, body mass index and triglycerides can help understand the risk of NAFLD and thereby enable longer-term predictions of the NASH burden.
The names of many of the companies attempting to treat NASH patients have changed since the golden age of interest in the indication, with former frontrunner Intercept and Genfit pulling back and a clutch of other players, with assets with different mechanisms, gaining prominence. Madrigal Pharmaceuticals is nearing approval. Akero Therapeutics, Boehringer Ingelheim, Eli Lilly and Pfizer are closing in on data.