Non-alcoholic Steatohepatitis Biomarkers Market
Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, Share & Trends Analysis by Biomarker Type (Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, Oxidative Stress Biomarkers, and Others), and by End-Users (Hospitals, Diagnostic Laboratories, Academic Research Institute, and Pharmaceutical Companies/CRO), Forecast Period (2026-2035)
Industry Overview
Non-alcoholic steatohepatitis (NASH) biomarkers market was valued at $708 million in 2025 and is projected to reach $ 2,026.50 million by 2035, growing at a CAGR of 11.2% during the forecast Period (2026-2035). The Market focuses on diagnostic and prognostic tools used to detect disease progression, liver inflammation, and fibrosis associated with NASH. Biomarkers are increasingly applied in clinical research, drug development, and non-invasive disease monitoring. Market growth is supported by rising NASH prevalence, limitations of liver biopsy, and increasing clinical trial activity. Advances in serum, genetic, and imaging-based biomarkers continue to improve diagnostic accuracy and clinical decision-making.
Market Dynamics
Rising Prevalence of NASH Driven by Obesity & Metabolic Disorders
One of the most significant drivers of the global NASH biomarkers market is the rapid increase in the prevalence of non-alcoholic fatty liver disease (NAFLD) and its progression to NASH, primarily due to rising rates of obesity, type-2 diabetes, metabolic syndrome, and related lifestyle-linked conditions worldwide. As metabolic disorders become more common, the pool of individuals at risk for liver inflammation and fibrosis grows, creating higher demand for early detection and monitoring tools. Biomarkers are increasingly preferred over invasive procedures like liver biopsy for identifying disease onset, staging progression, and assessing risk, particularly in high-burden regions such as North America, Europe, and Asia-Pacific.
Shift Toward Non-Invasive and Advanced Diagnostic Technologies
A major market catalyst is the transition to non-invasive biomarker-based diagnostics, which offer safer, repeatable, and more patient-friendly alternatives compared with traditional liver biopsies. Technological advancements such as serum biomarkers, imaging-based panels, multi-omics approaches (genomics, proteomics, metabolomics), and AI-driven analytics are enhancing the accuracy, scalability, and clinical utility of NASH detection and progression monitoring. These innovations encourage broader adoption by clinicians and healthcare systems, driving investment into advanced biomarker platforms that can support early intervention and personalized disease management.
Growing Pharmaceutical R&D and Clinical Trial Activity
The expanding pipeline of NASH therapeutics and associated clinical research efforts is another key market driver. Biomarkers play a pivotal role in pharmaceutical R&D by enabling patient stratification, monitoring drug efficacy, and serving as surrogate endpoints in clinical trials for novel NASH therapies. Significant investments from biotech and pharma companies often in collaboration with diagnostic developers and academic institutions are accelerating the discovery, validation, and commercialization of reliable NASH biomarkers. This trend not only fuels market growth but also promotes integration of biomarker assays into drug development frameworks and healthcare protocols.
Market Segmentation
- Based on the biomarker type, the market is segmented into serum biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, oxidative stress biomarkers, and others.
- Based on the end-user, the market is segmented into hospitals, diagnostic laboratories, academic research institute, and pharmaceutical companies/CRO.
Serum Biomarkers Segment to Grow at a Considerable Market Share
Serum Biomarkers are expected to lead the Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market and represent the largest segment across all biomarker and end-user categories. This dominance is primarily driven by their non-invasive nature, wide clinical acceptance, and cost-effectiveness compared to liver biopsy and complex imaging-based assessments. Serum biomarkers, including liver enzymes, inflammatory markers, and composite scoring panels, are routinely used in hospitals, diagnostic laboratories, and clinical research settings for early disease detection, risk stratification, and monitoring disease progression.
Their ease of sample collection, compatibility with standard laboratory infrastructure, and suitability for large-scale screening make them particularly valuable in managing the growing NASH patient population. In addition, serum biomarkers play a critical role in pharmaceutical clinical trials for patient enrollment and therapeutic response evaluation, further strengthening their adoption. Continuous advancements in biomarker validation and panel-based testing are expected to reinforce the leadership of serum biomarkers in the global NASH biomarkers market.
Pharmaceutical Companies/CRO: A Key Segment in Market Growth
Pharmaceutical companies and CRO segment stands out as the key growth driver. This segment currently accounts for the largest share of revenue in the market, largely because pharmaceutical companies and CROs depend heavily on reliable biomarkers for drug discovery, clinical trial execution, patient stratification, and measurement of treatment response. Biomarkers are essential in these settings to efficiently design and interpret NASH clinical trials, satisfy regulatory requirements for surrogate endpoints, and support the development of novel therapies.
As investment in NASH therapeutics continues to rise globally, with multiple drug candidates in advanced stages of development, the demand for validated biomarkers from this end-user category has expanded rapidly. This sustained focus on biomarker-driven research and development not only boosts market revenue but also accelerates technological advancements and commercial validation of new biomarker assays, solidifying pharmaceutical companies/CROs as the pivotal segment shaping market growth.
Regional Outlook
The global non-alcoholic steatohepatitis (NASH) biomarkers market is further divided by geography, including North America (the US and Canada), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), and the Rest of the World (the Middle East & Africa, and Latin America).
North America Region to Hold a Substantial Growth Rate
In North America, the US dominates the market and contributes the largest share of global revenue. North America accounted for over 50% of the total NASH biomarkers market in 2024, driven by a combination of high prevalence of metabolic disorders such as obesity and type 2 diabetes, well-established healthcare infrastructure, and strong research & development activities focused on non-invasive diagnostic solutions.
The presence of major pharmaceutical companies, advanced diagnostic laboratories, and supportive regulatory frameworks, especially by agencies like the US FDA for biomarker integration in clinical trials, further strengthens North America’s leadership position. Clinical adoption of innovative biomarker tests is higher in the region, supported by favorable reimbursement policies and robust healthcare spending, which encourages early disease detection and monitoring. On the other hand, regions such as Europe and Asia Pacific are growing rapidly but still trail North America in terms of overall market share. Europe’s growth is underpinned by rising awareness and healthcare initiatives, whereas Asia Pacific is expanding due to increasing disease burden and healthcare investments, yet overall remains smaller in market size compared to North America.
Market Players Outlook
The major companies operating in the global non-alcoholic steatohepatitis (NASH) biomarkers market include Biopredictive, GENFIT SA, Labcorp (Laboratory Corporation of America Holdings), Siemens Healthineers AG, Quest Diagnostics Inc., among others. Market players are leveraging partnerships, collaborations, mergers, and acquisitions to expand their businesses and develop innovative products to maintain their market positioning.
Recent Development
- In December 2025, the US FDA qualified the AIM-MASH AI Assist tool as the first AI-powered pathology biomarker under its Drug Development Tool (DDT) program, supporting NASH disease activity assessment in clinical trials
- In January 2025, AstraZeneca and Novo Nordisk formed a collaboration to build a biomarker platform combining genomic, proteomic, and metabolomic data for personalized NASH diagnostics and treatments.
- In September 2024, Siemens Healthineers launched a next-generation NASH biomarker assay using AI to improve diagnostic accuracy, receiving regulatory clearance for clinical use.
The Report Covers
- Market value data analysis for 2025 and forecast to 2035.
- Annualized market revenues ($ million) for each market segment.
- Country-wise analysis of major geographical regions.
- Key companies operating in the global non-alcoholic steatohepatitis (NASH) biomarkers market. Based on the availability of data, information related to new products and relevant news is also available in the report.
- Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
- Analysis of market-entry and market expansion strategies.
- Competitive strategies by identifying ‘who-stands-where’ in the market.
- Report Summary
- Current Industry Analysis and Growth Potential Outlook
- Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis – Biomarker Biomarker Type | End-Users ($ Million)
- Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Performance of Top Countries
- Research Methodology
- Primary Research Approach
- Secondary Research Approach
- Market Snapshot
- Market Overview and Insights
- Scope of the Study
- Analyst Insight & Current Market Trends
- Key Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Trends
- Market Recommendations
- Porter's Five Forces Analysis for the Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market
- Competitive Rivalry
- Threat of New Entrants
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Market Determinants
- Market Drivers
- Drivers For Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market: Impact Analysis
- Market Pain Points and Challenges
- Restraints For Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market: Impact Analysis
- Market Opportunities
- Opportunities For Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market: Impact Analysis
- Market Drivers
- Competitive Landscape
- Competitive Dashboard – Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Revenue and Share by Manufacturers
- Non-Alcoholic Steatohepatitis (NASH) Biomarkers Product Comparison Analysis
- Top Market Player Ranking Matrix
- Key Company Analysis
- Biopredictive
- Overview
- Product Portfolio
- Financial Analysis
- SWOT Analysis
- Business Strategy
- GENFIT SA
- Overview
- Product Portfolio
- Financial Analysis
- SWOT Analysis
- Business Strategy
- Labcorp (Laboratory Corporation of America Holdings)
- Overview
- Product Portfolio
- Financial Analysis
- SWOT Analysis
- Business Strategy
- Siemens Healthineers AG
- Overview
- Product Portfolio
- Financial Analysis
- SWOT Analysis
- Business Strategy
- Quest Diagnostics Inc.
- Overview
- Product Portfolio
- Financial Analysis
- SWOT Analysis
- Business Strategy
- Top Winning Strategies by Market Players
- Merger and Acquisition
- Product Launch
- Partnership And Collaboration
- Biopredictive
- Key Company Analysis
- Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis by Biomarker Biomarker Type ($ Million)
- Serum Biomarkers
- Hepatic Fibrosis Biomarkers
- Apoptosis Biomarkers
- Oxidative Stress Biomarkers
- Others (Carbon Isotope Markers and miRNA Biomarkers)
- Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis by End-User ($ Million)
- Hospitals
- Diagnostic Laboratories
- Academic Research Institute
- Pharmaceutical Companies/CRO
- Regional Analysis
- North American Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis – Biomarker Biomarker Type | End-Users | Country ($ Million)
- Macroeconomic Factors for North America
- United States
- Canada
- European Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis – Biomarker Biomarker Type | End-Users | Country ($ Million)
- Macroeconomic Factors for Europe
- UK
- Germany
- Italy
- Spain
- France
- Russia
- Rest of Europe
- Asia-Pacific Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis – Biomarker Biomarker Type | End-Users | Country ($ Million)
- Macroeconomic Factors for Asia-Pacific
- China
- Japan
- South Korea
- India
- Australia & New Zealand
- ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
- Rest of Asia-Pacific
- Rest of the World Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Sales Analysis – Biomarker Biomarker Type | End-Users | Country ($ Million)
- Macroeconomic Factors for the Rest of the World
- Latin America
- Middle East and Africa
- Company Profiles
- Allergan PLC (AbbVie Inc.)
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- AstraZeneca PLC
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- BioPredictive (FibroTest)
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Bristol-Myers Squibb Co.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Echosens SA (FibroScan technology)
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Exalenz Bioscience Ltd.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Genfit SA (Innovator of NIS4 technology)
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Gilead Sciences, Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Intercept Pharmaceuticals, Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Labcorp (Laboratory Corporation of America Holdings)
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Madrigal Pharmaceuticals, Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- NGM Biopharmaceuticals, Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Novartis AG
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Novo Nordisk A/S
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- OWL Metabolomics
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Perspectum Ltd.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Pfizer Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Prometheus Laboratories Inc.
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Quest Diagnostics
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Siemens Healthineers AG
- Quick Facts
- Company Overview
- Product Portfolio
- Business Strategies
- Allergan PLC (AbbVie Inc.)
1. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Biomarker Type, 2025–2035 ($ Million)
2. Global Serum Biomarkers Market Research And Analysis By Region, 2025–2035 ($ Million)
3. Global Hepatic Fibrosis Biomarkers Market Research And Analysis By Region, 2025–2035 ($ Million)
4. Global Apoptosis Biomarkers Market Research And Analysis By Region, 2025–2035 ($ Million)
5. Global Oxidative Stress Biomarkers Market Research And Analysis By Region, 2025–2035 ($ Million)
6. Global Other Biomarker Type Market Research And Analysis By Region, 2025–2035 ($ Million)
7. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by End-User, 2025–2035 ($ Million)
8. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers For Hospitals Market Research And Analysis By Region, 2025–2035 ($ Million)
9. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers For Diagnostic Laboratories Market Research And Analysis By Region, 2025–2035 ($ Million)
10. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers For Academic Research Institute Market Research And Analysis By Region, 2025–2035 ($ Million)
11. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers For Pharmaceutical Companies/CRO Market Research And Analysis By Region, 2025–2035 ($ Million)
12. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Region, 2025–2035 ($ Million)
13. North American Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Biomarker Type, 2025–2035 ($ Million)
14. North American Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by End-User, 2025–2035 ($ Million)
15. European Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Biomarker Type, 2025–2035 ($ Million)
16. European Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by End-User, 2025–2035 ($ Million)
17. Asia-Pacific Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Biomarker Type, 2025–2035 ($ Million)
18. Asia-Pacific Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by End-User, 2025–2035 ($ Million)
19. Rest of the World Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Region, 2025–2035 ($ Million)
20. Rest of the World Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by Biomarker Type, 2025–2035 ($ Million)
21. Rest of the World Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Research and Analysis by End-User, 2025–2035 ($ Million)
1. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share By Biomarker Type, 2025 Vs 2035 (%)
2. Global Serum Biomarkers Market Share By Region, 2025 Vs 2035 (%)
3. Global Hepatic Fibrosis Biomarkers Market Share By Region, 2025 Vs 2035 (%)
4. Global Apoptosis Biomarkers Market Share By Region, 2025 Vs 2035 (%)
5. Global Oxidative Stress Biomarkers Market Share By Region, 2025 Vs 2035 (%)
6. Global Other Biomarker Type Market Share By Region, 2025 Vs 2035 (%)
7. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share By End-User, 2025 Vs 2035 (%)
8. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share For Hospitals By Region, 2025 Vs 2035 (%)
9. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share For Diagnostic Laboratories By Region, 2025 Vs 2035 (%)
10. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share For Academic Research Institute By Region, 2025 Vs 2035 (%)
11. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share For Pharmaceutical Companies/CRO By Region, 2025 Vs 2035 (%)
12. Global Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Share By Region, 2025 Vs 2035 (%)
13. US Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
14. Canada Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
15. UK Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
16. France Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
17. Germany Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
18. Italy Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
19. Spain Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
20. Russia Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
21. Rest of Europe Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
22. India Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
23. China Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
24. Japan Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
25. South Korea Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
26. Australia and New Zealand Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
27. ASEAN Economies Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
28. Rest of Asia-Pacific Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
29. Latin America Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
30. Middle East and Africa Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Size, 2025–2035 ($ Million)
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