Non-alcoholic Steatohepatitis Clinical Trials

Global Non-alcoholic Steatohepatitis Clinical Trials Market to Reach US$4.3 Billion by 2030

The global market for Non-alcoholic Steatohepatitis Clinical Trials estimated at US$3.2 Billion in the year 2024, is expected to reach US$4.3 Billion by 2030, growing at a CAGR of 5.5% over the analysis period 2024-2030. Phase I, one of the segments analyzed in the report, is expected to record a 6.8% CAGR and reach US$2.0 Billion by the end of the analysis period. Growth in the Phase II segment is estimated at 3.9% CAGR over the analysis period.

The U.S. Market is Estimated at US$828.8 Million While China is Forecast to Grow at 5.3% CAGR

The Non-alcoholic Steatohepatitis Clinical Trials market in the U.S. is estimated at US$828.8 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$697.8 Million by the year 2030 trailing a CAGR of 5.3% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 5.3% and 4.6% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.3% CAGR.

Global Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Market – Key Trends & Drivers Summarized

Why Is the Demand for NASH Clinical Trials Growing Rapidly?

The rising global burden of non-alcoholic steatohepatitis (NASH) has fueled the demand for clinical trials aimed at developing effective therapeutic interventions for this complex liver disease. Unlike other metabolic disorders, NASH currently has no FDA-approved treatments, making clinical research essential for identifying potential drug candidates that can prevent liver fibrosis and disease progression. Pharmaceutical and biotechnology companies are investing heavily in NASH drug development, with multiple compounds in Phase II and III clinical trials targeting different disease pathways, including inflammation, fibrosis, and lipid metabolism. The need for diverse patient populations in trials is also increasing, as researchers seek to understand how genetic, lifestyle, and metabolic factors influence disease progression and treatment response. Additionally, regulatory agencies are providing fast-track designations and priority reviews for promising NASH therapies, encouraging investment in large-scale clinical trials. As the healthcare industry prioritizes metabolic liver disease research, the NASH clinical trials market is experiencing significant expansion, paving the way for the next generation of liver therapeutics.

What Challenges Are Impacting the Progress of NASH Clinical Trials?

Despite increased investment in NASH research, clinical trials face several hurdles that affect drug development timelines and success rates. One of the most significant challenges is patient recruitment and retention, as NASH is often asymptomatic in its early stages, leading to difficulties in identifying eligible trial participants. The reliance on liver biopsy as a primary endpoint for assessing treatment efficacy also poses a challenge, as it limits patient willingness to participate in invasive procedures. Additionally, the heterogeneity of NASH pathophysiology complicates drug development, as different mechanisms contribute to disease progression in various patient subgroups. Regulatory uncertainties and varying approval criteria across global markets further slow down trial progression, requiring companies to navigate complex compliance frameworks. Moreover, the high failure rate of NASH drug candidates in late-stage trials has raised concerns about the commercial viability of potential treatments. Addressing these challenges will require improved trial designs, better non-invasive biomarkers, and greater collaboration between stakeholders to accelerate drug discovery efforts.

How Are Innovations and Emerging Therapies Shaping the Future of NASH Clinical Trials?

Advancements in drug development and clinical trial methodologies are transforming NASH research, increasing the likelihood of successful therapeutic breakthroughs. Precision medicine approaches are enabling patient stratification based on genetic and metabolic profiles, allowing researchers to tailor treatments to specific disease subtypes. The use of AI-powered clinical trial management systems is improving patient recruitment, reducing dropout rates, and optimizing trial efficiency. Non-invasive imaging techniques, such as multiparametric MRI and transient elastography, are being integrated into trials to assess liver health without requiring biopsies, improving patient compliance. Additionally, combination therapies targeting multiple disease pathways simultaneously are showing promise in addressing the complexity of NASH progression. The emergence of novel drug classes, including FXR agonists, PPAR agonists, and anti-fibrotic agents, is further diversifying the therapeutic landscape, increasing the chances of successful treatment approvals. As these innovations continue to evolve, they are reshaping the NASH clinical trials market, accelerating the development of effective and accessible liver disease treatments.

What Is Driving the Growth of the NASH Clinical Trials Market?

The growth in the NASH clinical trials market is driven by several factors, including the urgent need for FDA-approved treatments, increasing prevalence of metabolic liver diseases, and advancements in non-invasive diagnostic tools. The expansion of pharmaceutical investments in metabolic disorder therapeutics is fueling trial activity, with multiple biopharma companies competing to bring the first approved NASH drug to market. The growing adoption of digital health platforms and AI-driven patient monitoring solutions is improving trial efficiency, reducing costs, and enhancing data collection accuracy. Additionally, regulatory incentives such as orphan drug designations, fast-track approvals, and breakthrough therapy designations are encouraging drug developers to invest in high-risk, high-reward NASH research. The increasing role of real-world evidence (RWE) in trial designs is further shaping market dynamics, providing valuable insights into long-term treatment outcomes. As clinical research continues to evolve, the NASH clinical trials market is expected to witness rapid growth, driving progress toward effective and scalable treatments for this widespread liver disease.

SCOPE OF STUDY:

The report analyzes the Non-alcoholic Steatohepatitis Clinical Trials market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Phase (Phase I, Phase II, Phase III, Phase IV); Study (Interventional Studies, Observational Studies, Expanded Access Studies)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 42 Featured) -

• 89bio, Inc.
• Akero Therapeutics, Inc.
• Alimentiv Inc.
• Allergan plc
• Boehringer Ingelheim
• Cadila Healthcare Limited
• FOMAT Medical Research
• Gilead Sciences, Inc.
• ICON plc
• Intercept Pharmaceuticals, Inc.
• Laboratory Corporation of America Holdings (LabCorp)
• Madrigal Pharmaceuticals, Inc.
• NGM Biopharmaceuticals, Inc.
• Novartis AG
• Novo Nordisk A/S
• Pfizer Inc.
• Poxel SA
• ProSciento, Inc.
• Viking Therapeutics, Inc.
• Zealand Pharma A/S

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

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APRIL 2025: NEGOTIATION PHASE

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