The global non-alcoholic steatohepatitis treatment market size was valued at USD 1.04 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 39.2% from 2022 to 2030. The non-alcoholic steatohepatitis (NASH) treatment market is witnessing growth due impending launch of drugs like Intercept's Ocaliva, Inventiva's lanifibranor, and Novo Nordisk's Ozempic, among others. Some other driving factors include the rising burden of obesity and diabetes, as these are considered prominent co-morbidities associated with NASH.
Throughout the forecast period, slow reimbursement rates, cumbersome diagnostic procedures, and high therapy costs will likely impede the uptake of pipeline drugs. Non-alcoholic steatohepatitis (NASH) is becoming a global concern and is the most severe form of non-alcoholic fatty liver disease (NAFLD). In a meta-analysis of several studies, in 2020, the global prevalence of non-alcoholic steatohepatitis was around 2.79%, and in the U.S., the prevalence rate was approximately 12%.
Additionally, the rising burden of diabetes and obesity further contributes to the rising NASH prevalence during the forecast period. For instance, research studies show a strong association between non-alcoholic steatohepatitis with obesity and diabetes; about 80% of all individuals with NASH are obese, and around 35% have diabetes. According to the Trust for America's Health, in 2020, the prevalence of obesity in U.S. adults was estimated to reach 42%, and according to the WHO, globally, the prevalence of diabetes was approximately 537 million in 2021; one in 10 adults had diabetes.
Currently, pharmacological options for non-alcoholic steatohepatitis have been limited to vitamin E and the off-label use of pioglitazone, as there are no approved drugs on the market for NASH treatment. This creates remunerative opportunities and fierce competition among companies to bring the first treatment to the market. As a result, key players such as Novo Nordisk A/S, Intercept Pharmaceuticals, Madrigal Pharmaceuticals, Inc., Gilead Sciences, Galmed Pharmaceuticals, and many more are currently developing novel drug therapies to target non-alcoholic steatohepatitis.
However, poor diagnostic rates, slow reimbursement, and high cost of therapy are very likely to slow down the market growth during the forecast period. There are fewer cumbersome options available for NASH diagnosis, such as liver biopsy, which is a painful, costly, and invasive method that creates patient hindrance. Owing to such factors, the non-alcoholic steatohepatitis global average diagnosis rate lies at only around 20%. This also affects the treatment rate negatively.
Intercept Pharmaceuticals' Obeticholic Acid (OCA) and Madrigal Pharmaceuticals, Inc.'s Resmetirom are under phase III clinical trials and are the most looked upon drugs and are anticipated to enter the NASH treatment market early, as compared to other drugs in the pipeline. The NASH clinical trial space saw a setback due to the COVID-19 pandemic. Amid the pandemic, major players in this space reported delays in the clinical trial procedures owing to several restrictions imposed by the government and regulatory authorities.
Vitamin E and pioglitazone segment completely dominated the market with a share of 100% in 2021. The domination of off-label therapies can be attributed to the unavailability of approved therapeutic options in the market. Off-label treatments like Vitamin E are the most commonly prescribed therapeutics for non-alcoholic steatohepatitis.
However, Vitamin E is not recommended for diabetic patients due to the medical complications associated with it. In contrast, Pioglitazone is administered to NASH patients with type 2 diabetes. Some other off-label drugs include statins, which are prescribed to NASH patients with a risk of cardiovascular disease.
The NASH market is highly engaged in robust R&D activities; various potential pathways are in R&D for NASH treatments, including lipogenesis inhibitors, medications targeting the farnesoid X receptor axis, ASK1 inhibitors, and many more. Some prominent drugs anticipated to be launched during the forecast period include Intercept Pharmaceuticals' Obeticholic acid, Inventiva Pharma's Lanifibranor, Novo Nordisk A/S's Semaglutide, Galmed Pharmaceuticals Ltd's Aramchol, and Madrigal Pharmaceuticals, Inc.'s Resmetirom.
The retail and specialty pharmacies segment is anticipated to expand at a substantial CAGR of 39.4% during the forecast period. As NASH is a chronic disease, it takes a long period of support of medications, which favors retail pharmacies' growth. Most medication consumption, including off-label, is anticipated in homecare settings associated with retail pharmacies. All these factors are expected to propel the market growth during the assessment period.
The others segment is expected to progress at the highest CAGR of 42.0% during the forecast period. Other end-use segments include online pharmacy; this platform encourages ease of buying for customers. The trend of online purchasing is growing due to the platform's comfort, flexibility, and convenience, thus generating high revenues and driving the segment.
In 2021, North America accounted for the largest market share of 79.62%. This can be attributed to the high disease burden, increased healthcare expenditure, rise in patient awareness, and presence of major players in the region. In addition, the U.S. accounted for the highest prevalence of cases for NASH, followed by Japan.
Spain was the least affected among the European countries, and Germany had the highest NASH prevalence. In addition, the Asia Pacific region is expected to witness substantial growth during the forecast period. This is more likely due to high NASH prevalent countries such as Japan.
The global non-alcoholic steatohepatitis treatment market is expected to witness intense competition during the forecast period, led by companies such as Novo Nordisk A/S and Gilead Sciences Inc. Key players are trying to gain market share through collaborations and other strategic initiatives. For instance, in April 2019, Gilead Sciences Inc. entered into a strategic partnership with insitro for the development of new therapies for non-alcoholic steatohepatitis. Under this collaboration, Gilead Sciences Inc. utilizes insitro's proprietary platform for drug development. Some of the key players in the global non-alcoholic steatohepatitis treatment market include:
Galectin Therapeutics Inc.
NGM Biopharmaceuticals Inc.
Novo Nordisk A/S
Bristol Myers Squibb
Gilead Sciences Inc.
Market size value in 2022
USD 1.13 billion
Revenue forecast in 2030
USD 15.95 billion
CAGR of 39.2% from 2022 to 2030
Base year for estimation
2018 - 2020
2022 - 2030
Revenue in USD billion and CAGR from 2022 to 2030
Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Drug type, end-use, region
North America; Europe; Asia Pacific; Latin America; MEA
U.S.; Canada; Germany; U.K.; France; Italy; Spain; China; Japan; India; Australia; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE
Key companies profiled
Intercept Pharmaceuticals; Galmed Pharmaceuticals; Inventiva Pharma; AbbVie Inc.; Galectin Therapeutics Inc.; Madrigal Pharmaceuticals; NGM Biopharmaceuticals Inc.; Novo Nordisk A/S; Bristol Myers Squibb; Gilead Sciences Inc.
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This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global non-alcoholic steatohepatitis treatment market report on the basis of drug type, end-use, and region:
Drug Type Outlook (Revenue, USD Million, 2018 - 2030)
Vitamin E and Pioglitazone
Obeticholic Acid (OCA)
End-use Outlook (Revenue, USD Million, 2018 - 2030)
Retail & Specialty Pharmacies
Regional Outlook (Revenue, USD Million, 2018 - 2030)
Middle East and Africa
b. The global non-alcoholic steatohepatitis treatment market size was estimated at USD 1.04 billion in 2021 and is expected to reach USD 1.13 billion in 2022.
b. The global non-alcoholic steatohepatitis treatment market is expected to grow at a compound annual growth rate of 39.02% from 2022 to 2030 to reach USD 15.95 billion by 2030.
b. Based on drug type, the Vitamin E and Pioglitazone (Off-label) segment dominated the NASH treatment market in 2021. This can be attributed to the unavailability of approved drugs in the market.
b. Some key players operating in the NASH treatment market include Intercept Pharmaceuticals; Galmed Pharmaceuticals; Inventiva Pharma; AbbVie Inc.; Galectin Therapeutics Inc.; Madrigal Pharmaceuticals; NGM Biopharmaceuticals Inc.; Novo Nordisk A/S; Bristol Myers Squibb
b. Key factors driving the non-alcoholic steatohepatitis treatment market growth include the launch of new drugs such as Novo Nordisk's Ozempic, Intercept's Ocaliva, and Inventiva's lanifibranor. In addition, the high prevalence of obesity and diabetes is another impact-rendering driver for the market.
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