Global Non-Alcoholic Steatohepatitis (NASH/MASH) Drug Market Size, Share, Trends and Forecasts 2031

Key Findings

• The Non-Alcoholic Steatohepatitis (NASH/MASH) drug market focuses on therapeutic agents designed to treat inflammation, fibrosis, and metabolic dysfunction associated with fatty liver disease.
• The global rise in obesity, type 2 diabetes, and sedentary lifestyles has made NASH/MASH one of the fastest-growing liver diseases worldwide.
• Currently, there is no FDA-approved drug that fully cures NASH, creating significant unmet clinical demand and opportunity for pharmaceutical innovation.
• Advanced therapies in the pipeline, including FXR agonists, PPAR modulators, FGF analogs, and GLP-1 receptor agonists, show promising efficacy in reducing liver fat and fibrosis.
• North America dominates the market due to high disease prevalence, established clinical infrastructure, and robust R&D investment.
• Europe is witnessing growing research activity, while Asia-Pacific exhibits rapid expansion driven by increasing metabolic disorder cases and healthcare modernization.
• Strategic partnerships, acquisitions, and co-development agreements among pharmaceutical firms are accelerating clinical advancement.
• AI-assisted diagnostics and non-invasive imaging biomarkers are transforming early detection and treatment monitoring of NASH.
• Combination therapies addressing multiple metabolic and inflammatory pathways are emerging as the preferred approach to maximize efficacy.
• High clinical trial attrition rates, complex disease pathophysiology, and regulatory challenges continue to impede market growth.

Non-Alcoholic Steatohepatitis (NASH/MASH) Drug Market Size and Forecast

The global NASH/MASH drug market was valued at USD 4.2 billion in 2024 and is projected to reach USD 20.3 billion by 2031, growing at a CAGR of 25.1%. The growth is driven by rising disease prevalence, increased diagnosis rates, and a rapidly expanding late-stage drug pipeline. Market momentum will further intensify following expected regulatory approvals for breakthrough therapies targeting fibrosis and metabolic pathways.

Market Overview

Non-Alcoholic Steatohepatitis (NASH), now reclassified by hepatology associations as Metabolic dysfunction-Associated Steatohepatitis (MASH), is a progressive liver condition characterized by fat accumulation, inflammation, and fibrosis unrelated to alcohol consumption. It is closely linked to obesity, insulin resistance, and dyslipidemia. The market is witnessing a surge in research activity aimed at developing disease-modifying treatments that halt or reverse fibrosis progression. North America remains the largest market, accounting for nearly half of global NASH drug revenues due to high obesity rates and strong diagnostic awareness. Europe and Asia-Pacific are emerging hotspots as healthcare systems prioritize metabolic liver disease management. Biopharmaceutical companies are investing heavily in novel therapeutic targets, non-invasive diagnostics, and AI-enabled trial optimization to address the complex, multifactorial nature of NASH.

Future Outlook

The future of the NASH/MASH drug market will be defined by the approval of first-in-class therapies and the adoption of combination regimens targeting multiple disease mechanisms. FXR and PPAR modulators will likely lead early commercialization, while GLP-1 receptor agonists and FGF analogs will dominate combination therapies for metabolic-fibrotic management. Non-invasive biomarkers, such as MRI-PDFF and circulating fibrosis markers, will become standard endpoints in clinical trials, replacing the need for liver biopsies. Partnerships between pharma and digital health companies will enable precision monitoring and improved adherence. With growing patient awareness and payer interest, the global market is expected to evolve rapidly toward personalized treatment models that integrate lifestyle modification, pharmacotherapy, and digital health support.

Non-Alcoholic Steatohepatitis (NASH/MASH) Drug Market Trends

• Emergence of First FDA-Approved Therapies
  The long-standing gap in approved NASH treatments is being bridged by drugs showing significant efficacy in late-stage trials. Obeticholic acid and resmetirom are leading candidates nearing approval for fibrosis improvement. Their regulatory success is expected to validate the therapeutic approach and boost investor confidence. Approval will open reimbursement pathways and encourage development of next-generation molecules. Early entrants will likely dominate initial adoption due to established clinical trial data. This milestone marks the beginning of the commercial era for NASH/MASH therapies.

• Shift Toward Combination Therapies
  Monotherapy approaches have struggled to achieve meaningful histological improvements across all NASH stages. Pharmaceutical companies are pivoting toward combination regimens that target lipid metabolism, inflammation, and fibrosis simultaneously. FXR agonists are being paired with GLP-1 or PPAR modulators for synergistic effects. These combinations aim to enhance efficacy while minimizing side effects. Clinical outcomes demonstrate improved metabolic control and fibrosis resolution. This trend will drive the next wave of therapeutic approvals and partnerships.

• Advancements in Non-Invasive Diagnostic Technologies
  Traditional liver biopsies are being replaced by non-invasive imaging and blood-based biomarkers. MRI-PDFF, transient elastography (FibroScan), and serum markers like ELF and PRO-C3 are now used for diagnosis and monitoring. These methods improve patient recruitment and reduce clinical trial costs. Integration of AI algorithms enhances diagnostic accuracy and fibrosis grading. The shift toward non-invasive assessment expands the eligible treatment population. Diagnostics innovation supports both clinical research and widespread adoption of approved therapies.

• Integration of Digital Health and AI in Clinical Development
  Artificial intelligence is accelerating drug discovery and clinical trial management. Predictive algorithms identify patient subtypes most responsive to specific mechanisms. Digital platforms track patient adherence, diet, and biomarker evolution. Real-world data analytics support post-marketing surveillance and outcome validation. Integration with wearable devices enables longitudinal monitoring of liver health. These tools shorten development timelines and improve therapeutic precision. AI-enabled innovation is redefining the landscape of metabolic liver disease management.

• Growing Pipeline Diversity and Mechanistic Innovation
  The NASH/MASH pipeline now includes over 150 active candidates targeting diverse biological pathways. Mechanisms such as FXR activation, PPAR modulation, FGF21 analogs, thyroid hormone receptor-beta agonism, and CCR2/CCR5 inhibition dominate R&D efforts. Dual and triple agonists addressing both metabolic and inflammatory components are emerging. This mechanistic diversity improves success rates across disease stages. Investors are increasingly attracted to companies with differentiated modes of action. The expanding therapeutic spectrum enhances long-term market sustainability.

• Increased Strategic Collaborations and Licensing Agreements
  Collaboration is central to overcoming NASH’s high R&D costs and complex pathophysiology. Partnerships between large pharma and biotech firms accelerate candidate progression through clinical phases. Licensing agreements provide access to proprietary molecules, biomarkers, and AI analytics. Joint ventures facilitate regional commercialization and manufacturing scalability. Co-development models reduce trial risk and improve resource efficiency. This collaborative ecosystem supports innovation and market readiness of NASH/MASH drugs globally.

Market Growth Drivers

• Rising Prevalence of Obesity and Type 2 Diabetes
  The global epidemic of metabolic disorders directly contributes to the surge in NASH/MASH cases. Over 25% of the adult population now suffers from NAFLD, with a significant proportion progressing to NASH. Obesity-induced insulin resistance drives hepatic fat accumulation and inflammation. The growing diabetic population amplifies disease incidence across all age groups. Lifestyle shifts and urbanization exacerbate the problem globally. The link between metabolic syndrome and liver disease remains the strongest driver of market expansion.

• Strong Clinical Pipeline and Increasing Late-Stage Trials
  The market is witnessing a surge in Phase II and III candidates from major companies like Madrigal, Intercept, and Novo Nordisk. Each candidate targets unique disease mechanisms with promising results in fibrosis and steatosis reduction. Late-stage trials validate multiple drug classes simultaneously, creating a diversified approval landscape. Successful results are expected to trigger a wave of regulatory filings globally. The robust clinical activity ensures steady progress toward therapeutic commercialization.

• Growing Awareness and Early Diagnosis of Liver Diseases
  Governments and health organizations are promoting awareness campaigns emphasizing early liver disease screening. Primary care providers are increasingly equipped to identify NASH risk factors. Non-invasive diagnostics facilitate earlier patient identification and monitoring. Educational initiatives improve patient adherence to therapy and lifestyle interventions. As awareness spreads, diagnosis rates and treatment eligibility increase significantly. Early detection initiatives strengthen the market base for approved drugs.

• Advancements in Biomarker and Companion Diagnostic Development
  Biomarker innovation is transforming clinical development by enabling stratified trial designs. Validated fibrosis and inflammation markers improve endpoint reliability. Companion diagnostics enhance precision in patient selection and therapy response assessment. Integration of multi-omics platforms deepens disease understanding and personalization. Pharma-diagnostic collaborations are becoming central to regulatory success. These advancements support efficient approval pathways and enhance clinical predictability.

• Increased Investments and Funding in Hepatology R&D
  Global biopharmaceutical investment in liver disease has surged following the success of metabolic drugs. Venture capital firms are prioritizing startups developing novel NASH mechanisms. Governments and research foundations provide grants for translational liver research. Public-private partnerships accelerate clinical trial infrastructure development. Investment confidence has grown with the maturation of the clinical pipeline. Continuous funding ensures a sustainable innovation cycle and future approvals.

• Supportive Regulatory and Market Access Initiatives
  Regulatory bodies have introduced accelerated pathways for NASH therapies addressing unmet needs. Breakthrough and Fast Track designations reduce time to approval for promising candidates. Payers are increasingly open to reimbursement for disease-modifying drugs. Government-backed programs support health system readiness for new liver therapeutics. Harmonization of trial endpoints across regions simplifies global submissions. Policy support provides the foundation for widespread clinical and commercial adoption.

Challenges in the Market

• High Clinical Trial Attrition and Development Costs
  NASH’s multifactorial pathophysiology results in high failure rates during Phase III trials. Endpoint complexity and patient heterogeneity challenge efficacy demonstration. Each trial requires extensive biopsy validation and long monitoring durations. The high cost of failure discourages smaller firms from sustaining late-stage programs. Development costs exceed USD 1 billion for many candidates. Improving predictive models and trial designs remains critical to reducing attrition.

• Absence of Established Regulatory Biomarkers
  Despite progress in non-invasive technologies, no universal biomarkers are yet validated for regulatory endpoints. This inconsistency leads to delays in trial approvals and data interpretation. Agencies demand histological confirmation even with imaging advances. The lack of standardized biomarkers restricts cross-trial comparability. Harmonized global biomarker frameworks are necessary for efficiency. Regulatory uncertainty continues to impede rapid commercialization.

• Limited Patient Awareness and Screening in Developing Regions
  NASH remains underdiagnosed in emerging economies due to low healthcare awareness. Patients often present in advanced disease stages when options are limited. Limited access to non-invasive diagnostic tools further hinders detection. Public health programs for liver screening are still evolving. Physician education gaps delay early intervention opportunities. Expanding awareness campaigns is vital for global treatment penetration.

• Complex Disease Mechanisms and Therapeutic Targeting
  NASH involves intertwined metabolic, inflammatory, and fibrotic pathways, complicating drug development. Single-target drugs often fail to produce holistic improvement across endpoints. Patient variability leads to inconsistent efficacy outcomes. Developing multi-mechanism or combination therapies increases regulatory and safety complexity. Ongoing research is needed to decode molecular interactions driving progression. Understanding disease biology remains a core challenge in therapeutic design.

• Safety and Tolerability Issues in Emerging Drugs
  Many candidates show metabolic benefits but are limited by adverse effects such as pruritus, dyslipidemia, or GI disturbances. Long-term safety data are required due to chronic therapy nature. Managing side effects without compromising efficacy is a delicate balance. Combination regimens may increase safety complexity further. Improved formulations and targeted delivery methods are needed to enhance tolerability. Safety management will remain key to clinical and commercial success.

• Reimbursement and Pricing Challenges
  High therapy costs may limit access, particularly in public healthcare systems. Payers demand robust long-term data before granting reimbursement. Uncertainty over patient population size complicates cost-effectiveness modeling. Tiered pricing and outcome-based reimbursement frameworks are being explored. The economic burden of chronic liver care amplifies payer scrutiny. Addressing affordability will determine global market reach and sustainability.

Non-Alcoholic Steatohepatitis (NASH/MASH) Drug Market Segmentation

By Drug Class

• FXR Agonists

• PPAR Modulators

• FGF21/FGF19 Analogues

• GLP-1 Receptor Agonists

• THR-β Agonists

• CCR2/CCR5 Antagonists

• Others

By Disease Stage

• Early (Steatosis and Inflammation)

• Intermediate (Ballooning and Fibrosis Stage 1–2)

• Advanced (Cirrhosis and End-Stage Liver Disease)

By End User

• Hospitals and Specialty Clinics

• Academic and Research Institutions

• Pharmaceutical and Biotechnology Companies

By Route of Administration

• Oral

• Injectable

By Region

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa

Leading Key Players

• Madrigal Pharmaceuticals, Inc.

• Intercept Pharmaceuticals, Inc.

• Novo Nordisk A/S

• Gilead Sciences, Inc.

• Viking Therapeutics, Inc.

• Genfit SA

• 89bio, Inc.

• Akero Therapeutics, Inc.

• Terns Pharmaceuticals, Inc.

• Enanta Pharmaceuticals, Inc.

Recent Developments

• Madrigal Pharmaceuticals announced FDA acceptance of its New Drug Application for Resmetirom, a THR-β agonist showing significant fibrosis reduction in Phase III trials.

• Intercept Pharmaceuticals resumed global development of Obeticholic acid after demonstrating improved efficacy in liver histology endpoints.

• Novo Nordisk expanded trials investigating semaglutide for dual benefits in diabetes and NASH management.

• Akero Therapeutics reported positive Phase IIb results for efruxifermin, an FGF21 analog that achieved high rates of fibrosis improvement.

• Gilead Sciences entered a collaboration with 89bio to co-develop combination regimens targeting metabolic and inflammatory NASH pathways.

This Market Report Will Answer the Following Questions

• What is the projected market growth trajectory for NASH/MASH drugs through 2031?

• Which drug classes and mechanisms are leading the therapeutic pipeline?

• How will the first FDA approvals shape the competitive landscape?

• What are the key technological and diagnostic innovations driving market progress?

• How are combination therapies transforming the treatment paradigm?

• What regulatory and reimbursement challenges affect commercialization?

• Which regions offer the highest growth opportunities for NASH therapies?

• How are AI and non-invasive diagnostics influencing clinical trial efficiency?

• What strategic collaborations are driving innovation in hepatology R&D?

• Which companies are best positioned to lead the next generation of NASH/MASH drug development?