Product Code: GVR-4-68039-911-4
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.
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.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Market Definitions
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased Database
- 1.4.2. GVR's Internal Database
- 1.4.3. Secondary Sources
- 1.4.4. Primary Research
- 1.5. Market Formulation & Validation
- 1.6. Model Details
- 1.6.1. Commodity Flow Analysis
- 1.6.2. Bottom-up Approach
- 1.7. List of Secondary Sources
- 1.8. List of Abbreviations
- 1.9. Objectives
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
Chapter 3. Non-alcoholic Steatohepatitis Clinical Trials Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook.
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Increasing Pharmaceutical R&D Investment
- 3.2.1.2. Rising Diabetic Population & Obesity
- 3.2.1.3. Rising Healthcare Expenditure
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Lack of Awareness
- 3.2.2.2. Barriers to Enrolment
- 3.2.2.3. Lethargic Drug Approval Process
- 3.3. Market Analysis Tools
- 3.3.1. Porter's Five Forces Analysis
- 3.3.2. PESTEL Analysis
- 3.3.3. COVID-19 Impact Analysis
Chapter 4. Non-alcoholic Steatohepatitis Clinical Trials Market: Phase Estimates & Trend Analysis
- 4.1. Segment Dashboard
- 4.2. Global Non-alcoholic steatohepatitis clinical trials Market; Phase Movement Analysis
- 4.3. Global Non-alcoholic Steatohepatitis Clinical Trials Size & Trend Analysis, by Phase, 2018 to 2030 (USD Million)
- 4.4. Phase I
- 4.4.1. Phase I market estimates and forecasts 2018 - 2030 (USD Million)
- 4.5. Phase II
- 4.5.1. Phase II market estimates and forecasts 2018 - 2030 (USD Million)
- 4.6. Phase III
- 4.6.1. Phase III market estimates and forecasts 2018 - 2030 (USD Million)
- 4.7. Phase IV
- 4.7.1. Phase IV market estimates and forecasts 2018 - 2030 (USD Million)
Chapter 5. Non-alcoholic Steatohepatitis Clinical Trials Market: Study Design Estimates & Trend Analysis
- 5.1. Segment Dashboard
- 5.2. Global Non-alcoholic Steatohepatitis Clinical Trials Market; Study Design Movement Analysis
- 5.3. Global Non-alcoholic steatohepatitis clinical trials Size & Trend Analysis, by Study Design, 2018 to 2030 (USD Million)
- 5.4. Interventional Studies
- 5.4.1. Interventional studies market estimates and forecasts 2018 - 2030 (USD Million)
- 5.5. Observational Studies
- 5.5.1. Observational studies market estimates and forecasts 2018 - 2030 (USD Million)
- 5.6. Expanded Access Studies
- 5.6.1. Expanded access studies market estimates and forecasts 2018 - 2030 (USD Million)
Chapter 6. Non-alcoholic Steatohepatitis Clinical Trials Market: Regional Estimates & Trend Analysis
- 6.1. Regional Market Share Analysis, 2024 & 2030
- 6.2. Regional Market Dashboard
- 6.3. North America
- 6.3.1. North America Market Estimates and Forecasts 2018 - 2030 (USD Million)
- 6.3.2. U.S.
- 6.3.2.1. Key country dynamics
- 6.3.2.2. Competitive scenario
- 6.3.2.3. Regulatory framework
- 6.3.2.4. U.S. market estimates and forecasts 2018 - 2030 (USD Million)
- 6.3.3. Canada
- 6.3.3.1. Key country dynamics
- 6.3.3.2. Competitive scenario
- 6.3.3.3. Regulatory framework
- 6.3.3.4. Canada market estimates and forecasts 2018 - 2030 (USD Million)
- 6.3.4. Mexico
- 6.3.4.1. Key country dynamics
- 6.3.4.2. Competitive scenario
- 6.3.4.3. Regulatory framework
- 6.3.4.4. Mexico market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4. Europe
- 6.4.1. Europe Market Estimates and Forecasts 2018 - 2030 (USD Million)
- 6.4.2. UK
- 6.4.2.1. Key country dynamics
- 6.4.2.2. Competitive scenario
- 6.4.2.3. Regulatory framework
- 6.4.2.4. UK market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.3. Germany
- 6.4.3.1. Key country dynamics
- 6.4.3.2. Competitive scenario
- 6.4.3.3. Regulatory framework
- 6.4.3.4. Germany market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.4. France
- 6.4.4.1. Key country dynamics
- 6.4.4.2. Competitive scenario
- 6.4.4.3. Regulatory framework
- 6.4.4.4. France market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.5. Italy
- 6.4.5.1. Key country dynamics
- 6.4.5.2. Competitive scenario
- 6.4.5.3. Regulatory framework
- 6.4.5.4. Italy market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.6. Spain
- 6.4.6.1. Key country dynamics
- 6.4.6.2. Competitive scenario
- 6.4.6.3. Regulatory framework
- 6.4.6.4. Spain market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.7. Denmark
- 6.4.7.1. Key country dynamics
- 6.4.7.2. Competitive scenario
- 6.4.7.3. Regulatory framework
- 6.4.7.4. Denmark market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.8. Sweden
- 6.4.8.1. Key country dynamics
- 6.4.8.2. Competitive scenario
- 6.4.8.3. Regulatory framework
- 6.4.8.4. Sweden market estimates and forecasts 2018 - 2030 (USD Million)
- 6.4.9. Norway
- 6.4.9.1. Key country dynamics
- 6.4.9.2. Competitive scenario
- 6.4.9.3. Regulatory framework
- 6.4.9.4. Norway market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5. Asia Pacific
- 6.5.1. Asia Pacific Market Estimates and Forecasts 2018 - 2030 (USD Million)
- 6.5.2. Japan
- 6.5.2.1. Key country dynamics
- 6.5.2.2. Competitive scenario
- 6.5.2.3. Regulatory framework
- 6.5.2.4. Japan market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5.3. China
- 6.5.3.1. Key country dynamics
- 6.5.3.2. Competitive scenario
- 6.5.3.3. Regulatory framework
- 6.5.3.4. China market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5.4. India
- 6.5.4.1. Key country dynamics
- 6.5.4.2. Competitive scenario
- 6.5.4.3. Regulatory framework
- 6.5.4.4. India market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5.5. Australia
- 6.5.5.1. Key country dynamics
- 6.5.5.2. Competitive scenario
- 6.5.5.3. Regulatory framework
- 6.5.5.4. Australia market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5.6. South Korea
- 6.5.6.1. Key country dynamics
- 6.5.6.2. Competitive scenario
- 6.5.6.3. Regulatory framework
- 6.5.6.4. South Korea market estimates and forecasts 2018 - 2030 (USD Million)
- 6.5.7. Thailand
- 6.5.7.1. Key country dynamics
- 6.5.7.2. Competitive scenario
- 6.5.7.3. Regulatory framework
- 6.5.7.4. Thailand market estimates and forecasts 2018 - 2030 (USD Million)
- 6.6. Latin America
- 6.6.1. Latin America Market Estimates and Forecasts 2018 - 2030 (USD Million)
- 6.6.2. Brazil
- 6.6.2.1. Key country dynamics
- 6.6.2.2. Competitive scenario
- 6.6.2.3. Regulatory framework
- 6.6.2.4. Brazil market estimates and forecasts 2018 - 2030 (USD Million)
- 6.6.3. Argentina
- 6.6.3.1. Key country dynamics
- 6.6.3.2. Competitive scenario
- 6.6.3.3. Regulatory framework
- 6.6.3.4. Argentina market estimates and forecasts 2018 - 2030 (USD Million)
- 6.7. MEA
- 6.7.1. MEA Market Estimates and Forecasts 2018 - 2030 (USD Million)
- 6.7.2. South Africa
- 6.7.2.1. Key country dynamics
- 6.7.2.2. Competitive scenario
- 6.7.2.3. Regulatory framework
- 6.7.2.4. South Africa market estimates and forecasts 2018 - 2030 (USD Million)
- 6.7.3. Saudi Arabia
- 6.7.3.1. Key country dynamics
- 6.7.3.2. Competitive scenario
- 6.7.3.3. Regulatory framework
- 6.7.3.4. Saudi Arabia market estimates and forecasts 2018 - 2030 (USD Million)
- 6.7.4. UAE
- 6.7.4.1. Key country dynamics
- 6.7.4.2. Competitive scenario
- 6.7.4.3. Regulatory framework
- 6.7.4.4. UAE market estimates and forecasts 2018 - 2030 (USD Million)
- 6.7.5. Kuwait
- 6.7.5.1. Key country dynamics
- 6.7.5.2. Competitive scenario
- 6.7.5.3. Regulatory framework
- 6.7.5.4. Kuwait market estimates and forecasts 2018 - 2030 (USD Million)
Chapter 7. Competitive Landscape
- 7.1. Company Categorization
- 7.2. Company Market Position Analysis, 2024
- 7.3. Company Profiles
- 7.3.1. Pfizer Inc.
- 7.3.1.1. Company overview
- 7.3.1.2. Financial performance
- 7.3.1.3. Service benchmarking
- 7.3.1.4. Strategic initiatives
- 7.3.2. Novartis AG
- 7.3.2.1. Company overview
- 7.3.2.2. Financial performance
- 7.3.2.3. Service benchmarking
- 7.3.2.4. Strategic initiatives
- 7.3.3. Icon Plc
- 7.3.3.1. Company overview
- 7.3.3.2. Financial performance
- 7.3.3.3. Service benchmarking
- 7.3.3.4. Strategic initiatives
- 7.3.4. Laboratory Corporation of America
- 7.3.4.1. Company overview
- 7.3.4.2. Financial performance
- 7.3.4.3. Service benchmarking
- 7.3.4.4. Strategic initiatives
- 7.3.5. AbbVie Inc.
- 7.3.5.1. Company overview
- 7.3.5.2. Financial performance
- 7.3.5.3. Service benchmarking
- 7.3.5.4. Strategic initiatives
- 7.3.6. Cadila Healthcare Ltd.
- 7.3.6.1. Company overview
- 7.3.6.2. Financial performance
- 7.3.6.3. Service benchmarking
- 7.3.6.4. Strategic initiatives
- 7.3.7. Takeda Pharmaceuticals
- 7.3.7.1. Company overview
- 7.3.7.2. Financial performance
- 7.3.7.3. Service benchmarking
- 7.3.7.4. Strategic initiatives
- 7.3.8. Eli Lilly and Company
- 7.3.8.1. Company overview
- 7.3.8.2. Financial performance
- 7.3.8.3. Service benchmarking
- 7.3.8.4. Strategic initiatives
- 7.3.9. Novo Nordisk A/S
- 7.3.9.1. Company overview
- 7.3.9.2. Financial performance
- 7.3.9.3. Service benchmarking
- 7.3.9.4. Strategic initiatives
- 7.3.10. Gilead Sciences Inc.
- 7.3.10.1. Company overview
- 7.3.10.2. Financial performance
- 7.3.10.3. Service benchmarking
- 7.3.10.4. Strategic initiatives