Non-alcoholic Steatohepatitis Biomarkers Market to Hit USD 9.1 Billion by 2032 – SNS Insider

The NASH Biomarkers Market Growth is driven by AI-Based Diagnostics, Biomarker Innovations and Non-Invasive Testing Technologies.

Austin, June 12, 2025 (GLOBE NEWSWIRE) -- Non-alcoholic Steatohepatitis Biomarkers Market Size & Growth Analysis:

According to SNS Insider, the Non-alcoholic Steatohepatitis Biomarkers Market was valued at USD 1.14 billion in 2023 and is projected to reach USD 9.1 billion by 2032, growing at a CAGR of 25.9% during the forecast period 2024-2032. The increasing global prevalence of NASH, coupled with the rising adoption of non-invasive diagnostic tools, is significantly driving market growth. Additionally, advancements in biomarker research, propelled by AI-based diagnostic solutions and biomarker assay innovations, are fostering rapid market expansion.

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Market Overview

The increasing burden of NASH, a serious variant of non-alcoholic fatty liver disease (NAFLD), has propelled the need for effective diagnostic solutions. Invasive, costly, and complication-ridden traditional liver biopsies have given way to the increasing dependence on non-invasive biomarker-based diagnostic solutions. The increase in the prevalence of obesity, metabolic syndrome, and diabetes has also been a major driver in fueling the growing patient base of NASH, which has in turn led to increased biomarker demand.

Industry leaders are concentrating on AI-based biomarker assays, proteomic and metabolomic innovation, and strategic partnerships to improve the detection and monitoring of NASH. Pharmaceutical organizations and CROs are leading the charge, using biomarker-driven strategies to enhance clinical trial effectiveness and streamline drug development. With regulatory approval backing innovative biomarker assays and increasing investment in biomarker studies, the market is expected to grow significantly over the forecast period.

Major Players Analysis Listed in this Report are:

• GENFIT (NIS4™, Elafibranor)
• Gilead Sciences (Selonsertib, Cilofexor)
• AstraZeneca (Dapagliflozin, Epanova)
• Novartis AG (Tropifexor, LJN452)
• GE Healthcare (LiverMultiScan, FibroScan)
• Siemens Healthineers (ADVIA Centaur® CP Immunoassay System, Atellica® Solution)
• Bristol-Myers Squibb (Pegbelfermin, BMS-986036)
• Pfizer . (PF-06865571, PF-05221304)
• Akero Therapeutics (Efruxifermin, AKR-001)
• 89bio (Pegozafermin, BIO89-100)

Non-alcoholic Steatohepatitis Biomarkers Market Report Scope

Segment Analysis

By Type

In 2023, the serum biomarkers segment led the market, accounting for 33% of total revenue. Serum biomarkers such as liver enzyme panels and inflammatory markers are much loved because of ease of usage, availability, and high precision of detection for NASH. In addition, demand for non-invasive methods for diagnosis and combination of AI-driven algorithms for detecting biomarkers is also promoting growth in this leading segment.

The apoptosis biomarkers segment is expected to register the highest growth during the forecast period. Apoptosis biomarkers, including cytokeratin-18 (CK-18), are increasingly finding favor as they can offer insights into hepatocyte death and disease progression. Increased use of apoptosis biomarkers in clinical studies and their possible use in patient stratification for therapeutic interventions are some of the most important factors fueling their faster growth.

By End-use

The pharma and CRO industry segment held the highest market share of 39% in 2023. The segment's dominance is due to the growing dependence of pharmaceutical firms on biomarker-based approaches to drug discovery and clinical trials. NASH continues to be a prime area of interest for drug development, with several candidates in late-stage trials. CROs are instrumental in biomarker validation, expediting drug approvals, and increasing the effectiveness of clinical research, further increasing market share.

The diagnostic laboratory segment is also expected to emerge as the growth leader over the next few years. Growing needs for sophisticated diagnostic solutions, and the increased choice for biomarker-based non-invasive tests, are driving growth in diagnostic laboratories focused on identifying NASH. Growing knowledge of the importance of early diagnosis by healthcare professionals and patients will propel this segment further.

Non-alcoholic Steatohepatitis Biomarkers Market Segmentation

By Type

• Serum Biomarkers
• Oxidative Stress Biomarkers
• Hepatic Fibrosis Biomarkers
• Apoptosis Biomarkers
• Others

By End-use

• Pharma & CRO Industry
• Diagnostic Labs
• Hospitals
• Academic Research Institutes

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Regional Analysis

North America dominated the NASH Biomarkers Market in 2023 with 40% of overall market share. The region is influenced by a well-developed healthcare infrastructure, significant research and development expenditure, and high NASH prevalence as a result of obesity and metabolic disorders. The presence of prominent pharmaceutical and diagnostic firms also fuels market growth.

The Asia Pacific region is anticipated to have the highest growth during the forecast period. The increasing NAFLD and NASH burden, rising healthcare investments, and adoption of sophisticated biomarker-based diagnostic solutions are driving regional market growth. Increasing government initiatives and regulatory backing for non-invasive diagnostics further boost the market potential in this region.

Recent Developments

• In September 2024, Siemens Healthineers released a next-generation NASH biomarker assay integrating multiple serum-based markers via AI algorithms to enhance diagnostic accuracy. The assay received FDA clearance for clinical use.
• In January 2025, AstraZeneca and Novo Nordisk collaborated to develop a biomarker platform combining genomic, proteomic, and metabolomic data to advance personalized NASH treatments.

Statistical Insights and Trends Reporting

• The global prevalence of NASH was estimated at 5% to 6% of the adult population in 2023, with North America and Europe exhibiting the highest disease burden.
• North America accounted for 45% of total NASH biomarker-based diagnostic tests conducted, followed by Europe at 30%, with Asia-Pacific witnessing a rapid rise in test adoption.
• The number of biomarker assays performed globally for NASH is projected to grow 4x between 2020 and 2032, driven by increasing non-invasive diagnostic adoption.
• Global research funding for NASH biomarkers exceeded USD 2.5 billion in 2023, with major contributions from biotech firms and academic institutions.
• Government and private healthcare expenditures on NASH diagnostics and treatment surpassed USD 8 billion, reflecting growing investments in disease management.

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Table of Contents – Major Key Points

1. Introduction

2. Executive Summary

3. Research Methodology

4. Market Dynamics Impact Analysis

5. Statistical Insights and Trends Reporting

6. Competitive Landscape

7. Non-alcoholic Steatohepatitis Biomarkers Market by Type

8. Non-alcoholic Steatohepatitis Biomarkers Market by End Use

9. Regional Analysis

10. Company Profiles

11. Use Cases and Best Practices

12. Conclusion

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