Non-alcoholic Steatohepatitis Clinical Trials Market To Reach $4.14 Billion By 2030

Non-alcoholic Steatohepatitis Clinical Trials Market Growth & Trends

The global non-alcoholic steatohepatitis clinical trials market size is expected to reach USD 4.14 billion by 2030, registering a CAGR of 6.26% from 2025 to 2030, according to a new report by Grand View Research, Inc. Rising healthcare expenditure, cases of obesity, and prevalence of non-alcoholic steatohepatitis (NASH) are the factors driving the growth of this market. Due to the COVID-19 pandemic, enrollment in new drug clinical trials for NASH patients was halted, but people shifted to alternate means of data collecting methods, like virtual visits. Non-alcoholic Steatohepatitis is a fatty liver disease that causes scarring and damage to the liver.

NASH has no FDA-approved treatment and can proceed to the point where patients need a liver transplant in extreme situations. NASH, like diabetes, is linked to obesity and a high-sugar diet. Some pharmaceutical companies are testing whether diabetes drugs could help NASH patients. However, the COVID-19 pandemic has thrown a wrench into every element of NASH clinical trials, from patient recruiting to IP administration and safety monitoring to data integrity. As clinical research monitors are not allowed to travel, remote electronic monitoring is a viable alternative to traditional on-site monitoring. Monitors could receive information from research locations by paper mail, e-mail (allowing direct access to electronic medical records), or remote monitoring systems.

In December, the FDA issued guidance urging the pharmaceutical sector to develop and confirm improved biomarkers for the diagnosis and progression of NASH. In many aspects, getting past the biopsy barrier is significant compared to a lack of general awareness of NASH, that’s why it is critical for pharmaceutical companies to invest in innovations (such as a variety of imaging techniques) to alleviate this patient burden, and then persuade the FDA with positive data to accept those advancements as appropriate end-point markers for clinical trials.

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Non-alcoholic Steatohepatitis Clinical Trials Market Report Highlights

• The phase III segment dominated the market, accounting for 54.3% of the total revenue share in 2024. Phase III trials are essential for confirming the efficacy and safety of new therapies before they can be submitted for regulatory approval.

• The interventional studies segment dominated the market in 2024 owing to an increasing focus on evaluating new therapeutic interventions. Moreover, growing research and development studies to test novel drug candidates, including both monotherapies and combination therapies for NASH.

• North America non-alcoholic steatohepatitis clinical trials market dominated and accounted for a 48.9% share in 2024. The growth in the region is attributed to the region’s advanced healthcare system, large patient population, and strong research infrastructure.

• The non-alcoholic steatohepatitis clinical trials market in Asia Pacific is expected to grow at the highest CAGR over the forecast period. The growth can be attributed to the increasing prevalence of metabolic disorders, such as diabetes and obesity.

Non-alcoholic Steatohepatitis Clinical Trials Market Segmentation

Grand View Research has segmented global non-alcoholic steatohepatitis clinical trials market report based on phase, study design, and region:

Non-alcoholic Steatohepatitis Clinical Trials Phase Outlook (Revenue, USD Million, 2018 - 2030)

• Phase I

• Phase II

• Phase III

• Phase IV

Non-alcoholic Steatohepatitis Clinical Trials Study Design Outlook (Revenue, USD Million, 2018 - 2030)

• Interventional Studies

• Observational Studies

• Expanded Access Studies

Non-alcoholic Steatohepatitis Clinical Trials Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Norway

  • Sweden

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Argentina

• MEA

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players of Non-alcoholic Steatohepatitis Clinical Trials Market

• Pfizer Inc.

• Novartis AG

• Icon Plc

• Laboratory Corporation of America

• AbbVie Inc.

• Cadila Healthcare Ltd.

• Shire Plc (Takeda Pharmaceuticals)

• Eli Lilly

• Novo Nordisk

• Gilead Sciences Inc.

• Glaxosmith Kline

• Arrowhead Pharmaceuticals