NASH drug market expected to surpass $48B by 2035

The global therapeutic market catering to the widely prevalent liver disease non-alcoholic steatohepatitis (NASH) is projected to reach $48.3B by 2035, international consulting firm Research Nester said in a recent report.

That indicates a compound annual growth rate of 18% between 2023 and 2035, as the NASH treatment landscape generated $5.2B in revenue in 2022, according to the New York-based firm.

Its report came days before Madrigal Pharmaceuticals (NASDAQ:MDGL) received FDA approval for the first U.S.-approved NASH therapy. Branded as Rezdiffra, the oral thyroid hormone receptor (THR) agonist will launch at a list price of $47K in the U.S., where the prevalence of liver diseases, including NASH, is fast rising.

NASH, currently known as metabolic dysfunction-associated steatohepatitis (MASH), is a more advanced form of non-alcoholic fatty liver disease ((NAFLD) and the leading cause of liver transplantation in the U.S.

Madrigal (MDGL) projects that 1.5M Americans have been diagnosed with NASH, with obesity and diabetes among the factors driving the disease's prevalence.

North America is set to generate the lion's share of revenue amid rising expenditures on NASH treatments, according to Research Nester. The heightened awareness of the disease, coupled with rising NAFLD case numbers—about 30% of NAFLD patients are estimated to suffer from NASH—is expected to drive the demand for therapeutic solutions.

However, Europe is anticipated to record the highest CAGR of 18.6% in the NASH treatment market, driven by rising obesity rates in the region.

Meanwhile, in January, healthcare analytics firm IQVIA (IQV) said the global market for NASH treatments can reach more than $100B by 2030. However, the market size can even be $10B, as the industry remains uncertain about how the disease burden can translate into a commercial opportunity due to factors such as barriers to treatment access.

“All innovators tackling NASH face a daunting combination of scientific/clinical, regulatory, and practical barriers,” IQVIA (IQV) said, referring to factors such as low diagnosis rates and the rigorous clinical trial requirements needed for regulatory approvals.

While Rezdiffra has become the first U.S.-approved disease therapy for NASH, Madrigal (MDGL) is unlikely to enjoy the first-mover advantage for too long as the therapeutic landscape gets crowded, given the unmet medical need.

According to IQV, six experimental therapies targeting NASH are currently in late-stage studies. Notable among them is semaglutide, the weight loss therapy developed by Novo Nordisk (NVO) (OTCPK:NONOF). In addition, the Danish drugmaker has a partnership to test the GLP-1 receptor agonist with two experimental drugs from Gilead (GILD) for NASH.

Inventiva (IVA), Galectin Therapeutics (GALT), and Galmed Pharmaceuticals (GLMD) are among the other listed drug developers navigating the NASH space with their late-stage assets.

Companies such as Hepion Pharmaceuticals (HEPA), TERNS Pharmaceuticals (TERN), Sagimet Biosciences (SGMT), Viking Therapeutics (VKTX), and 89bio (ETNB) have already generated positive data for their mid-stage NASH therapies in 2023.

This year, Eli Lilly (NYSE:LLY) has reported positive Phase 2 data for its weight loss therapy tirzepatide in adults with NASH, as did Ionis Pharma (IONS),) whose NASH therapy ION224 reached its main goals in a Phase 2 trial this week.

Other drugmakers, including Pfizer (NYSE:PFE), AstraZeneca (AZN), Gilead (GILD)/ Novo (NVO), and Ascletis Pharma (OTCPK:ASCLF), are awaiting notable Phase 2 readouts for their NASH drugs this year.