San Francisco, 06 March 2030: The Report Non-alcoholic Steatohepatitis Treatment Market Size, Share & Trends Analysis Report By Drug (Vitamin E & Pioglitazone, Resmetirom), By Disease Stage, By Distribution Channel, By Region, And Segment Forecasts, 2030 - 2030
The global non-alcoholic steatohepatitis treatment market size is expected to reach USD 33.80 billion by 2030, registering a CAGR of 28.1% from 2030 to 2030, according to a new report by Grand View Research, Inc. The non-alcoholic steatohepatitis (NASH) treatment market is primarily driven by the launch of drugs such as Novo Nordisk's Ozempic, Intercept's Ocaliva, and Inventiva's lanifibranor, among others.
The NASH treatment market has major unmet needs owing to factors such as the unavailability of approved drugs, high disease burden, and complex diagnostic procedures. Currently, the market is dominated by off-label drugs such as Pioglitazone and Vitamin E. These are widely prescribed drugs in this space globally. However, to address the unmet opportunity, key market players are heavily investing in R&D activities to develop novel therapeutics for NASH treatment. Currently, there are more than 50 pipeline candidates.
Some of the late-stage pipeline candidates expected to launch during the forecast period include Inventiva Pharma's Lanifibranor, Intercept Pharmaceuticals' Obeticholic acid, Galmed Pharmaceuticals Ltd.'s Aramchol, Novo Nordisk A/S's Semaglutide, and Madrigal Pharmaceuticals, Inc.'s Resmetirom. Among these, Intercept Pharmaceuticals's Obeticholic Acid (OCA), and Madrigal Pharmaceuticals, Inc.'s Resmetirom, are the most looked upon drugs and are expected to enter comparatively earlier than other pipeline candidates.
Research studies reveal that non-alcoholic steatohepatitis is strongly associated with obesity and diabetes. Research studies show that around 80% of NASH patients are obese. In countries such as the U.S., the obesity prevalence is as high as 42%, according to the latest 2021 statistics by CDC. In addition, countries such as the U.S. and Japan account for the highest prevalence of non-alcoholic steatohepatitis globally, and these countries also have a high burden of obesity and diabetes. All such factors will fuel the NASH treatment market throughout the forecast period.
Strategic initiatives by pharma giants and supportive regulatory authority policies such as fast track designation are further expected to accelerate the market growth. In May 2022, Pfizer, Inc.'s Ervogastat/Clesacostat Combination therapy received fast track designation. This is one of the potential drug combinations for the treatment of non-alcoholic steatohepatitis. Such drug designation boosts the clinical trial process for drugs.
Liver biopsy is the gold standard for the diagnosis of non-alcoholic steatohepatitis. The invasive nature of this diagnostics test limits its usage to only symptomatic cases, and as a result, the global average diagnostic rate for NASH is around 20%. The unavailability of biomarkers-based non-invasive tests for the diagnosis of non-alcoholic steatohepatitis is expected to impede the market growth.
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Non-alcoholic fatty liver disease (NAFLD) stands as the leading chronic liver disease in the United States, affecting about one-quarter of the adult population. While most individuals with NAFLD experience liver fat buildup without accompanying inflammation, around 20% of these cases progress to non-alcoholic steatohepatitis, a form that involves liver inflammation and poses a risk for severe liver damage. Globally, more than 115 million adults are estimated to suffer from NASH, according to Pfizer Inc. This condition primarily affects individuals with obesity or Type 2 diabetes. Thus, rising cases of type 2 diabetes are also expected to increase cases of non-alcoholic steatohepatitis over the forecast period.
In 2023, the American Diabetes Association (ADA) stated that individuals with type 2 diabetes mellitus (T2DM) are more likely than the general population to develop non-alcoholic fatty liver disease (NAFLD), placing them at an elevated risk of progressing to non-alcoholic steatohepatitis (NASH) and atrial fibrillation (AF). However, the exact prevalence of NASH and AF among T2DM patients is not yet well established. This association between T2DM and increased risks for NAFLD, and subsequently non-alcoholic steatohepatitis, underscores the growing demand for effective treatment options within the NASH treatment market. Given the worldwide prevalence of T2DM, this overlap of conditions may substantially increase the number of patients needing targeted treatments for both T2DM and NASH.
In Europe, deaths attributed to non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis are particularly high in Ireland, Hungary, Luxembourg, and the United Kingdom. According to the European Association for the Study of the Liver (EASL), the prevalence of NASH across Europe is estimated to reach as high as 5%. The high prevalence and mortality rates of NAFLD and NASH in certain European countries may drive demand for therapeutic development and implementation, including early diagnostic tools and preventive measures over the forecast period.