1. What Is the NASH Market?
The NASH Market covers the pharmacological treatments for the nonalcoholic steatohepatitis that progresses through the liver fibrosis stages from the simple steatosis to the NASH-related cirrhosis and the hepatocellular carcinoma. The metabolic liver disease creates the progression in the estimated 115 million people globally. The NASH requires treatment to halt the fibrosis progression. NASH drug development failed repeatedly before the June 2024 FDA approval of the resmetirom for the noncirrhotic NASH with the moderate to advanced fibrosis. The MAESTRO-NASH Phase III trial demonstrated the NASH resolution in 26 percent and the one-stage fibrosis improvement in 24 percent versus the placebo 10 and 14 percent. The NASH market is beginning with the resmetirom approval as the first approved NASH treatment. The thyroid hormone receptor beta agonist mechanism achieves the benefit through the hepatic fat reduction and the anti-inflammatory effect.
2. NASH Market Size & Forecast
3. Emerging Technologies
- Resmetirom Rezdiffra thyroid hormone receptor beta selective agonist MAESTRO-NASH Phase III demonstrated NASH resolution 26 versus 10 percent and one-stage fibrosis improvement 24 versus 14 percent at the 100 mg dose. The trial enrolled the NASH patients with F2 and F3 liver fibrosis. The result represents the first FDA-approved NASH treatment. The March 2024 accelerated approval preceded the June 2024 traditional approval. The two approvals established the first NASH treatment.
- Semaglutide ESSENCE Phase IIb demonstrating 59 percent NASH resolution without worsening fibrosis versus 17 percent placebo in the noncirrhotic NASH patients with the F1 to F3 fibrosis provides the Phase III programme. The ESSENCE-NASH larger trial will confirm the GLP-1 mechanism. The GLP-1 mechanism awaits the Phase III confirmation.
- FXR farnesoid X receptor agonist obeticholic acid REGENERATE Phase III demonstrated the fibrosis improvement in 23 percent versus 12 percent placebo in the NASH patients with F2 and F3 fibrosis. The FDA declined the approval for the incomplete liver safety data. The applicant must address the safety data before resubmission. The resubmission awaits the additional liver safety data.
- Non-invasive NASH biomarker development using the vibration-controlled transient elastography liver stiffness measurement and the multiparametric MRI including the proton density fat fraction MRI-PDFF for the liver fat quantification are being validated. The biomarkers serve as the clinical trial and clinical practice endpoint. The endpoint replaces the biopsy.
Similar technologies are also transforming adjacent markets. Learn more in our Hepatitis C Market.
4. Key Market Opportunity
The primary commercial opportunity in the NASH market comes from resmetirom Rezdiffra commercial expansion as the first approved NASH therapy, where the FDA approval creates a new pharmaceutical category in liver disease and addresses the large NASH/MASH patient population previously without effective therapy. Madrigal Pharmaceuticals capturing Rezdiffra commercial launch represents this paradigm-defining first-mover opportunity. A separate growth lever stems from NASH GLP-1 agonist approval combining weight loss with NASH improvement. As Rezdiffra adoption proceeds and NASH GLP-1 approval advances, the addressable opportunity is expanding from no-therapy NASH treatment toward multi-mechanism NASH pharmacotherapy.
5. Top Companies in the NASH Market
The following organisations hold leading positions in the NASH Market. The full report provides revenue share, SWOT analysis, and competitive benchmarking for each player.
- Madrigal Pharmaceuticals
- Novo Nordisk
- Roche
- GSK
- Eli Lilly
- Inventiva
- Akero Therapeutics
- Sagimet Biosciences
- Boehringer Ingelheim
- Viking Therapeutics
6. Market Segmentation
The NASH Market is analysed across 4 segmentation dimensions. Revenue data, growth rates, and competitive intensity by sub-segment are available in the full report.
| Segmentation | Sub-Segments |
|---|---|
| By Drug Class | THR-Beta AgonistFGF21 AnalogGLP-1 AgonistPPAR AgonistFXR Agonist |
| By Fibrosis Stage | F2F3F4 |
| By Mechanism | MetabolicAnti-Fibrotic |
| By Geography | North AmericaEuropeAsia PacificLatin AmericaMiddle East and Africa |
7. Key Market Trends (2026–2034)
Three major forces are shaping the NASH Market trajectory over the forecast period:
Resmetirom Rezdiffra First FDA-Approved NASH Treatment THR-Beta Selective Agonist 26 Versus 10 Percent NASH Resolution in MAESTRO-NASH Phase III Has Ended the Decade of NASH Drug Development Failures With the First Histological Endpoint-Based NASH Approval.Madrigal Pharmaceuticals's resmetirom demonstrated 25.9% NASH resolution and 14.2% fibrosis improvement versus 9.7% and 9.7% for placebo in MAESTRO-NASH at 52 weeks, earning FDA accelerated approval in March 2024 for the first pharmacotherapy for metabolic dysfunction-associated steatohepatitis with liver fibrosis in adults. The selective hepatic THR-beta agonism mechanism reduces hepatic de novo lipogenesis and mitochondrial fat oxidation without thyroid stimulation adverse effects that non-selective thyroid hormone agonism would produce, explaining the favourable metabolic and lipid effects alongside the histological improvements in liver biopsy. Madrigal's confirmed approval requires demonstration of clinical liver outcomes including progression to cirrhosis, hepatic decompensation, and liver-related death in ongoing MAESTRO-NASH OUTCOMES trial to convert the accelerated approval to full approval.
Semaglutide ESSENCE Phase IIb 59 Versus 17 Percent NASH Resolution Providing the Phase III Programme Foundation From the GLP-1 Weight Loss and Metabolic Improvement Mechanism Complements Resmetirom THR-Beta Mechanism for the Obese NASH Patient Benefiting From Both Approaches.Novo Nordisk's semaglutide NASH Phase 2 trial demonstrated 59% NASH resolution without fibrosis worsening versus 17% for placebo at 72 weeks, establishing GLP-1 agonism as effective for NASH histological endpoints through both weight loss and direct hepatic metabolic effects. The ESSENCE Phase 3 confirmatory trial in MASH with fibrosis stage F2-F3 is evaluating liver biopsy outcomes at 72 and 240 weeks that would support a formal NASH indication for semaglutide alongside its existing diabetes and obesity labels. The combination of resmetirom addressing liver fibrosis through THR-beta and semaglutide addressing steatohepatitis through GLP-1-mediated weight and metabolic improvement creates a mechanistic rationale for combination therapy that multiple clinical trials are now testing.
Non-Invasive Liver Stiffness Measurement and MRI-PDFF Validation as NASH Trial and Clinical Practice Endpoints Is Enabling the Biopsy Replacement That Would Remove the Sampling Error, Procedural Risk, and 30 Percent Patient Refusal That Limit Biopsy-Based NASH Diagnosis and Monitoring.Akero Therapeutics's efruxifermin demonstrated 39% of patients achieving a two-stage fibrosis improvement versus 15% for placebo in HARMONY Phase 2b in MASH with bridging fibrosis or compensated cirrhosis, establishing FGF21 analogue as effective in the most advanced fibrosis stages where GLP-1 and THR-beta approaches have shown more limited histological benefit. 89bio's pegozafermin demonstrated 41% fibrosis improvement in ENLIVEN Phase 2b across Stage 2-3 fibrosis, providing independent confirmation of the FGF21 class effect on hepatic fibrogenesis through activation of PPARγ and hepatic stellate cell quiescence. The FGF21 mechanism's anti-fibrotic activity in advanced fibrosis stages where the commercial unmet need and regulatory path for full approval are most clearly defined positions efruxifermin and pegozafermin as the primary non-GLP-1 MASH candidates capable of addressing fibrosis reversal as a primary endpoint.
For related market intelligence, see the Liver Fibrosis Market.
8. Segmental Analysis
By drug class, the thyroid hormone receptor-beta agonist segment dominated the NASH Market in 2025, as Madrigal Pharmaceuticals's Rezdiffra became the first approved therapy for metabolic-dysfunction-associated steatohepatitis with fibrosis, generating effectively all initial category revenue following its landmark accelerated approval.
By mechanism, the incretin and FGF21 segment is projected to register the highest growth rate through 2034, as Novo Nordisk's semaglutide, Akero Therapeutics's efruxifermin, and Roche's pegozafermin advance toward approval and reshape treatment around metabolic and antifibrotic combination strategies for a large undiagnosed population.
9. Regional Analysis
Regional demand patterns across the NASH Market reflect differences in regulation, technological maturity, and capital investment.
Largest Market Share
North America dominated the NASH Market in 2025, accounting for approximately 42% of global revenue, due to US premium pricing for resmetirom Rezdiffra and the launch of the first FDA-approved NASH therapy in the large US NASH patient population. Moreover, Madrigal Pharmaceuticals commercial launch is concentrated in the US. In addition, FGF21 and GLP-1 NASH clinical development are centred in North America. Regional dominance is attributed to this combination of pricing environment and first-mover launch.
Highest CAGR Region
Europe is projected to register the highest CAGR in the NASH Market through 2034, driven by expanding resmetirom access across European healthcare systems and the large NASH/MASH patient population. The region is also witnessing FGF21 and GLP-1 NASH clinical development. Moreover, MASH/NASH screening through transient elastography is expanding. The combination of these demand drivers and patient population positions Europe for sustained growth outperformance through 2034.
10. Full Report with Exclusive Insights
The complete published market report includes an in-depth analysis of market dynamics, industry trends, competitive landscape, regional outlook, and future growth opportunities. The study provides detailed market sizing and forecasts across key segments and geographies, along with comprehensive insights into drivers, restraints, opportunities, challenges, technological advancements, regulatory landscape, and evolving consumer and industry trends. The report also features company profiles, strategic developments, market share analysis, and actionable recommendations to support informed business decision-making. Additionally, the syndicated report package typically includes forecast datasets, charts and figures, research methodology, and analyst support for strategic interpretation and planning.
Advanced Strategic & Custom Intelligence
In addition to the standard syndicated report package, TrendX Insights can provide the following advanced strategic analyses and customized intelligence solutions for any market:
Standard Report Coverage
- • Competitor Analysis
- • Country Trade Analysis
- • Import & Export Analysis
- • Porter’s Five Forces Analysis
- • SWOT Analysis by Companies
- • TrendX Insights Quadrant Positioning
- • Pricing Analysis
- • Detailed Macro-Economic Indicators Assessment
- • List of Raw Material Suppliers
- • Regulatory Framework Assessment
- • Supply Chain Resilience Mapping
- • Value Chain Analysis
- • Technology adoption trends and innovation tracking
- • Custom company profiling and benchmarking
Exclusive Sections With Additional Cost
- • Agentic AI Readiness Score
- • TAM, SAM, and SOM Analysis
- • AI Act & Privacy Compliance Audit
- • Channel Partner Ecosystem Mapping
- • China + 1 Strategy Analysis
- • Circular Economy Opportunities Assessment
- • Competitor Benchmarking KPI Analysis
- • Country Trade Analysis
- • Country-level opportunity mapping
- • Digital Maturity Matrix
- • Ecosystem Interdependency Mapping
- • ESG & Decarbonization Roadmap
- • Geopolitical Friction Scorecard
- • Geopolitical Risk Assessment
- • Humanoid Workforce Impact Analysis
- • Investment Heatmap
- • List of Distributors and Channel Partners
- • List of Raw Material Suppliers
- • Market Entry Strategy Assessment
- • Mergers & Acquisitions (M&A) Analysis
- • Patent & Intellectual Property (IP) Analysis
- • Pilot Project Analysis
- • Potential High-Growth Region/Country Investment Assessment
- • Product Comparison Analysis
- • Product Revenue Analysis
- • R&D Investment Analysis in Emerging Technologies
- • Raw Material Scarcity Forecast
Note: For highly customized requirements, deeper strategic assessments, company-specific intelligence, or tailored consulting support, please contact TrendX Insights.
Full Report with Exclusive Insights
Available to clients on request
Explore Our Published Reports Library
This page covers market-level data estimates. For comprehensive published research reports including full methodology, primary data, and detailed company profiles, browse the TrendX Insights Published Reports Library.
Visit Published Reports Library ›11. Related Market Reports
Frequently Asked Questions
The NASH Market was valued at USD 952.30 Mn in 2025 and is projected to reach USD 17,285.60 Mn by 2034, growing at a CAGR of 38.0% over the 2026–2034 forecast period.
The NASH Market is projected to grow at a CAGR of 38.0% from 2026 to 2034.
North America dominated the NASH Market in 2025, accounting for approximately 42% of global revenue, due to US premium pricing for resmetirom Rezdiffra and the launch of the first FDA-approved NASH therapy in the large US NASH patient population.
The leading companies in the NASH Market include Madrigal Pharmaceuticals, Novo Nordisk, Roche, GSK, Eli Lilly, Inventiva, Akero Therapeutics, Sagimet Biosciences, Boehringer Ingelheim, Viking Therapeutics.
Resmetirom rezdiffra first fda-approved nash treatment thr-beta selective agonist 26 versus 10 percent nash resolution in maestro-nash phase iii has ended the decade of nash drug development failures with the first histological endpoint-based nash approval.
By drug class, the thyroid hormone receptor-beta agonist segment dominated the NASH Market in 2025, as Madrigal Pharmaceuticals's Rezdiffra became the first approved therapy for metabolic-dysfunction-associated steatohepatitis with fibrosis, generating effectively all initial category revenue following its landmark accelerated approval.
How to Order
Purchasing a TrendX Insights report is straightforward. Our process is designed to be transparent and risk-free for buyers, with a 20% upfront model and full delivery before the balance payment.
This is the price of the syndicated report. Any custom inclusions beyond the Table of Contents will be scoped and priced separately. For the full list of what is covered in the syndicated report, refer to the Table of Contents tab.
A curated, condensed version of this report for students, researchers, and academic institutions. Ideal for thesis work, dissertations, and academic projects. Delivered as PDF to your institutional email.
Valid student ID or institutional email required. For educational and non-commercial use only.