Non-alcoholic Steatohepatitis Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

The Non-alcoholic Steatohepatitis Biomarkers Market was valued at USD 1.81 Billion in 2024, and is expected to reach USD 6.27 Billion by 2030, rising at a CAGR of 22.97%. Rising global prevalence of metabolic disorders - including obesity, insulin resistance, and type 2 diabetes - continues to accelerate the demand for non-invasive and reliable diagnostic tools for NASH. As non-alcoholic fatty liver disease (NAFLD) advances toward NASH in many patients, the limitations of liver biopsy, such as invasiveness and sampling variability, have driven interest in biomarker-based diagnostics. These biomarkers enable early detection, disease staging, and therapeutic monitoring.

With over 115 million people estimated to be affected by NASH globally, there is an urgent need for scalable diagnostic alternatives. The pharmaceutical industry is leveraging biomarkers for patient stratification and efficacy tracking in clinical trials. Technological advancements in multi-omics platforms - such as proteomics, metabolomics, and transcriptomics - along with AI-driven analytics, are transforming biomarker development and enabling precision medicine. This market is further supported by cross-sector collaborations that focus on integrated diagnostic solutions, combining imaging, blood-based markers, and digital platforms.

Key Market Drivers

Rising Prevalence of Metabolic Disorders and NASH Progression

The growing incidence of metabolic conditions such as obesity, insulin resistance, dyslipidemia, hypertension, and type 2 diabetes is significantly boosting the Global NASH Biomarkers Market. Data from the ICMR INDIAB study and NFHS 5 reveal concerning rates of obesity and diabetes, particularly among younger adults, further expanding the at-risk population. As NAFLD progresses silently to NASH, non-invasive biomarker-based diagnostics are gaining traction for early identification and risk assessment.

Unlike liver biopsies, biomarkers offer repeatable, safer, and scalable alternatives for detecting liver inflammation and fibrosis. These tools are becoming essential in both clinical care and clinical research, where they enable real-time disease monitoring, guide therapy adjustments, and improve clinical trial design by supporting patient selection and endpoint analysis. The increasing use of multi-biomarker panels - spanning serum, genetic, and imaging data - is enabling more precise diagnosis and advancing the clinical utility of NASH biomarkers in both preventive and therapeutic strategies.

Key Market Challenges

Lack of Standardization and Clinical Validation

A major constraint for the NASH biomarker market is the lack of standardization and widespread clinical validation. Despite a growing pool of potential biomarkers, few have achieved regulatory approval or consistent use in clinical practice due to variability in study outcomes, assay formats, and patient heterogeneity. This inconsistency makes it difficult for physicians to rely on biomarker data as definitive diagnostic or prognostic tools, reinforcing dependence on liver biopsy.

Furthermore, regulatory agencies demand high standards of accuracy, reproducibility, and clinical correlation, which are challenging to meet without robust, multi-phase clinical validation. Fragmentation across research efforts - where academic institutions and companies pursue proprietary solutions - further hinders the development of universal standards and complicates comparative evaluation. This lack of harmonization delays market entry and restricts biomarker adoption, requiring coordinated global frameworks and collaborative initiatives to ensure consistency, validation, and data interoperability across platforms and studies.

Key Market Trends

Emergence of Multi-Omics-Based Biomarker Discovery

The growing adoption of multi-omics approaches is reshaping the NASH biomarker landscape by offering a comprehensive understanding of disease mechanisms. Unlike traditional methods that rely on single markers, multi-omics strategies integrate genomic, proteomic, metabolomic, lipidomic, and transcriptomic data to identify complex biomarker signatures. These approaches allow for more accurate differentiation between NAFLD, early-stage NASH, and advanced fibrosis.

Metabolomics and lipidomics, in particular, uncover liver-specific metabolic dysfunctions, while transcriptomic profiling helps detect gene expression patterns linked to hepatic inflammation and stress. As these datasets are processed using AI and machine learning, researchers can generate robust biomarker panels tailored to disease subtypes and progression stages. This trend supports personalized diagnostics, better disease stratification, and targeted therapy monitoring, making multi-omics tools essential in advancing non-invasive, high-precision NASH diagnostics.

Key Market Players

• GENFIT SA
• Prometheus Laboratories Inc.
• Siemens Healthineers AG
• BioPredictive S.A.S.
• Quest Diagnostics Incorporated
• AstraZeneca PLC
• Exalenz Bioscience Ltd. (Meridian Bioscience, Inc.)
• Laboratory Corporation of America Holdings
• Pfizer Inc.
• Bristol-Myers Squibb Company

Report Scope

In this report, the Global Non-alcoholic Steatohepatitis Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Non-alcoholic Steatohepatitis Biomarkers Market, By Type:

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

Non-alcoholic Steatohepatitis Biomarkers Market, By End User:

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

Non-alcoholic Steatohepatitis Biomarkers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia-Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-alcoholic Steatohepatitis Biomarkers Market.

Available Customizations

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.