The Zhitong Finance App learned that the international consulting firm Research Nester said that by 2035, the global non-alcoholic steatohepatitis (NASH) treatment market is expected to reach 48.3 billion US dollars.

According to the agency, this means that between 2023 and 2035, the NASH treatment sector will have a compound annual growth rate of 18%, and the NASH treatment sector's revenue will reach 5.2 billion US dollars in 2022.

A few days after the report was released, Madrigal Pharmaceuticals (MDGL.US) received the first NASH treatment approved by the US FDA. This oral thyroid hormone receptor (THR) agonist, called Rezdiffra, will be marketed in the US at a price of 47,000 US dollars, where the prevalence of liver diseases, including NASH, is rapidly rising.

NASH, currently known as metabolic dysfunction-related fatty hepatosis (MASH), is a more advanced non-alcoholic fatty liver disease (NAFLD) and the main cause of liver transplantation in the US

Madrigal Pharmaceuticals expects 1.5 million Americans to be diagnosed with NASH, and obesity and diabetes are factors contributing to the spread of the disease.

As NASH treatment spending continues to rise, North America will generate the largest share of revenue, according to Research Nester. Increased awareness of the disease, combined with an increase in the number of NAFLD cases (an estimated 30% of NAFLD patients have NASH), is expected to drive demand for treatment options.

However, driven by rising obesity rates in the region, the European NASH treatment market is expected to have the highest compound annual growth rate of 18.6%.

Meanwhile, in January of this year, healthcare analytics company IQVIA (IQV.US) said that by 2030, the global market for NASH treatment will exceed 100 billion US dollars. However, due to factors such as treatment barriers, the industry is still uncertain about how the burden of disease can be transformed into a business opportunity.

“All innovators solving NASH face a difficult combination of science/clinical, regulatory, and practical barriers,” said IQVIA. IQV refers to factors such as low diagnosis rates and strict clinical trial requirements required for regulatory approval.

RezDiffra has become the first drug approved in the US to treat NASH, and Madrigal is unlikely to enjoy a first-mover advantage for a long time as the treatment field becomes crowded and medical needs are unmet.

According to IQV, six experimental treatments for NASH are currently in late stages of research. Notable among them is semaglutide, a weight loss therapy developed by Novo Nordisk (NVO.US). Additionally, the Danish pharmaceutical company collaborated with Gilead (GILD.US)'s two experimental NASH drugs to test GLP-1 receptor agonists.

Inventiva (IVA.US), Galectin Therapeutics (GALT.US), and Galmed Pharmaceuticals (GLMD.US) are other marketed drug developers that have used their late-stage assets to enter the NASH field.

Companies such as Hepion Pharmaceuticals (HEPA.US), TERNS Pharmaceuticals (TERN.US), Sagimet Biosciences (SGMT.US), Viking Therapeutics (VKTX.US), and 89bio (ETNB.US) have obtained positive data on NASH treatment in mid-2023.

This year, Lily.US (LLY.US) reported phase 2 trial data for adult NASH patients with its weight loss therapy tirzepatide, and Ionis Pharma (IONS.US) also reported phase 2 trial data for this treatment. ION224 achieved the main goals in this week's phase 2 trial.

Other pharmaceutical companies, including PFE.US (PFE.US), AstraZeneca (AZN.US), Gilead/Novo Nordisk, and Ascletis Pharma, are awaiting significant Phase 2 data for NASH drugs this year.