Visiongain has published a new report entitled Liver Fibrosis & NASH/MASH Drugs Market Report 2025-2035: Forecasts by Disease Drug Types (Antivirals, Alcoholic Liver Disease, Autoimmune Disease, Anti-Oxidant Modulators, Drug Induced Liver Injury, by Drugs (Vitamin E & Pioglitazone, Rezdiffra, Semaglutide, Tirzepatide, Pemvidutide, Lanifibranor, Belapectin, Efruxifermin, Pegozafermin, Denifanstat, Combination Therapies), by End-Users (Hospital Pharmacies, Speciality Pharmacies, Other), by Clinical Pipeline (Phase III, Phase II, New Entrants, Combination Therapies, Repurposing Drugs) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.

The liver fibrosis & NASH/MASH drugs market is estimated at US$18.3 billion in 2025 and is projected to grow at a CAGR of 10.0% during the forecast period 2025-2035.

Rise in Prevalence of Liver Diseases

There has been a significant rise in liver diseases, including Hepatitis B, Hepatitis C, and fatty liver diseases such as alcoholic fatty liver disease and non-alcoholic fatty liver disease, now referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). According to the National Library of Medicine (NLM), liver cirrhosis is the 11th leading cause of death globally. While viral hepatitis has historically been the primary cause of chronic liver diseases, effective preventive measures, such as vaccination drives, have significantly reduced the mortality rate over the past 30 years.

Obesity and alcohol consumption have emerged as major contributing factors to chronic liver diseases. In 2021, the global prevalence of chronic liver diseases was estimated to be 1.5 billion, according to the NLM. Among these, non-alcoholic fatty liver disease had the highest prevalence at 59%, followed by Hepatitis B infection at 29%, Hepatitis C infection at 9%, and alcoholic liver disease at 2%. Other rare liver diseases, including primary biliary cholangitis, autoimmune hepatitis, alpha-1 antitrypsin deficiency, and Wilson’s disease, collectively accounted for 1% of global liver disease prevalence.

How will this Report Benefit you?

Visiongain’s 245-page report provides 112 tables, 138 charts, and graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the Liver fibrosis & NASH/MASH drugs market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Liver fibrosis & NASH/MASH drugs. Get financial analysis of the overall market and different segments including drug types, NASH drugs by brands, pipeline analysis and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing Liver fibrosis & NASH/MASH drugs market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Advancing Non-Invasive Diagnostics for Liver Fibrosis Detection

The healthcare industry is increasingly adopting non-invasive diagnostic tests (NITs) to leverage advancements in research. NITs for liver fibrosis primarily fall into two categories: blood-based diagnostic markers and diagnostic imaging technologies. Circulatory blood biomarkers can assess inflammation, cell death, oxidative stress, and cellular changes through blood tests. Meanwhile, emerging imaging diagnostic techniques, such as magnetic resonance-based elastography, utilize advanced ultrasound technology to enhance liver fibrosis detection.

Although NITs are still in their early stages, several organizational initiatives are promoting their adoption. For instance, the European Innovative Medicines Initiative 2 has launched the LITMUS project (Liver Investigation: Testing Marker Utility in Steatohepatitis), which brings together clinicians, academia, and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to develop and validate early-stage biomarkers for NASH and liver fibrosis. Similarly, the U.S. FDA, in collaboration with the National Institutes of Health (NIH), has established a public-private partnership called NIMBLE (Non-Invasive Biomarkers of Metabolic Liver Diseases). This initiative aims to support, validate, and measure biomarker use in both clinical trials and medical practice.

Public and private sector participation is driving the growth of NITs. In 2023, LITMUS and NIMBLE collaborated to introduce a standardized set of liver biomarkers for “diagnostic enrichment,” providing a framework for liver fibrosis diagnosis. Key circulatory biomarkers include ELF (Enhanced Liver Fibrosis), FIB-4 (Fibrosis-4), NIS-4, NAFLD Fibrosis Score, PRO-C3 (Pro-peptide type 3 collagen), and OWLiver. Imaging diagnostic markers include MRI-PDFF (MRI-derived proton density fat fraction), MRE (Magnetic Resonance Elastography), VCTE (Vibration-Controlled Transient Elastography) stiffness measurement, VCTE CAP (Controlled Attenuation Parameter), and the FAST score (FibroScan-AST).

AI-driven Preclinical Models and Digital Pathology Accelerate MASH Drug Development

The rise in the prevalence of metabolic dysfunction-associated liver disease (MASH), coupled with the availability of only one commercially approved drug for its treatment, has increased awareness among both the medical community and patients. Clinical trial failures have often been attributed to the lack of human-relevant translational preclinical models that could facilitate effective predictive analysis of liver drug trials. Currently available preclinical models fail to accurately replicate complex liver mechanisms, including metabolism, nutrition, and the process of liver fibrosis.

The European Medicines Agency (EMA) advocates for the principles of replacement, reduction, and refinement in animal testing and promotes the implementation of organoid models. Meanwhile, the U.S. FDA has modernized its research through the FDA Modernization Act 2.0, which supports translational and cutting-edge technologies such as organ-on-a-chip and advanced artificial intelligence (AI) for preclinical drug safety assessments. Companies are now exploring tissue fibrosis by analyzing collagen deposition and degradation through histological studies.

For instance, PharmaNest’s “FibroNest” enables automated quantification of the histological phenotype of fibrosis and associated NASH activity using high-resolution, fully translational AI-driven digital pathology image analysis. Similarly, inSphero has developed its flagship platform, “3D Insights,” which facilitates the understanding of human liver microtissues and aids in early drug safety assessments by simulating liver pathology with predictive AI analysis capable of evaluating liver injury for clinical trial purposes.

The growing adoption of AI and advanced digital pathology technologies for clinical trials is expected to drive industry growth. Strategic partnerships between major industry players and AI-driven platform companies are poised to transform the MASH drug development landscape. For example, in April 2024, Cellarity partnered with Novo Nordisk, leveraging AI-enabled models to study cellular-level functions of hepatic cells and assist Novo Nordisk in identifying drug candidates. Under this collaboration, Novo Nordisk agreed to cover R&D expenses and provide up to $532 million for drug development and commercialization, along with royalty payments on annual net sales of the licensed product, which will also be shared with Flagship Pioneering Medicines, the co-founding company of Cellarity.

Where are the Market Opportunities?

Diagnostic & Biopharma Partnerships

The liver fibrosis and NASH drugs market is currently witnessing numerous collaborative agreements between biopharmaceutical and diagnostic companies. These partnerships are expected to accelerate the commercial launch of liver treatment drugs. The growing emphasis on non-invasive diagnostic test solutions, including both blood and imaging biomarkers, is reducing the reliance on liver biopsies, which were previously essential for assessing disease progression during clinical trials.

Additionally, such collaborations enhance physician awareness, facilitating early diagnosis and timely intervention. In 2023, the FDA convened clinical trial experts to address knowledge gaps in non-invasive testing for NASH. During this workshop, the FDA urged industry players to incorporate biomarkers for diagnosing and monitoring treatment response in non-cirrhotic NASH clinical trials. It also emphasized the adoption of surrogate biomarkers as endpoints for evaluating the safety and efficacy of clinical trials. These surrogate endpoints play a crucial role in studying long-term clinical outcomes, as they provide early indications of treatment effectiveness.

Several companies have already formed strategic alliances to address this unmet need in the NASH industry. For instance, in 2022, Novo Nordisk partnered with Echosens, a company specializing in advanced liver diagnostic solutions. Through this collaboration, both companies aim to support clinical validation and raise awareness among patients about the importance of early NASH/MASH diagnosis using available diagnostic tools. Novo Nordisk and Echosens share a common goal of improving the diagnostic rate of MASH patients by the end of 2025.

Competitive Landscape

The major players operating in the Liver Fibrosis & NASH/MASH drugs market are List of Companies Profiled in the Report Madrigal Pharmaceuticals, Novo Nordisk, Eli Lilly, Gilead Sciences Inc., Galectin Therapeutics, Galmed Pharmaceuticals, Akero Therapeutics, AstraZeneca, Altimmune and Boehringer Ingelheim  These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Recent Developments

• On 4^th January 2024, Novo Nordisk entered into partnership with Cellarity to find novel treatment approach for Metabolic Steatohepatitis (MASH) using its innovative platform. Under this agreement Novo Nordisk will leverage Cellarity’s unique platform that will use AI models and gain insights at cellular level functioning of liver tissue enabling the understand the novel cell functioning leading to MASH disease progress.

• On 3^rd January 2024, Boehringer Ingelheim inked a partnership deal with Suzhou Ribo Life Sciences (Chinese biotech firm) and Ribocure Pharmaceuticals (Sweden Biotech firm). Both these biotech firms have their expertise in small interfering RNA (isRNA). RiboCure’s RIBO-GalSTAR platform helps to target the RNAi drugs ( a drug delivery platform) that are responsible for MASH causing genes by silencing the mRNA. Boehringer Ingelheim intends to use this expertise to create therapeutic treatment for NASH/MASH.

Notes for Editors

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