Non-alcoholic Steatohepatitis Treatment Market Report, 2030 (2024)

Report Overview

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 reimbursem*nt 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 reimbursem*nt, 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.

Drug Type Insights

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.

End-Use Insights

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.

Regional Insights

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.

Key Companies & Market Share Insights

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:

• Intercept Pharmaceuticals

• Galmed Pharmaceuticals

• Inventiva Pharma

• AbbVie Inc.

• Galectin Therapeutics Inc.

• Madrigal Pharmaceuticals

• NGM Biopharmaceuticals Inc.

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• Novo Nordisk A/S

• Bristol Myers Squibb

• Gilead Sciences Inc.

Non-Alcoholic Steatohepatitis Treatment Market Report Scope

Global Non-Alcoholic Steatohepatitis Treatment Market Segmentation

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)

  • Lanifibranor

  • Semaglutide

  • Resmetirom

  • Aramchol

  • Cenicriviroc

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital Pharmacies

  • Retail & Specialty Pharmacies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

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    • UK

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE