Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market Overview
Non-alcoholic steatohepatitis (NASH) biomarkers are diagnostic and prognostic tools used to detect, monitor, and evaluate the progression of NASH, a severe form of non-alcoholic fatty liver disease (NAFLD). They offer a less invasive alternative to liver biopsies, providing critical support in clinical research, drug development, and patient management. Given the global rise in obesity, diabetes, and metabolic disorders, reliable biomarkers are becoming central to advancing early detection and personalized treatment approaches.
Market Size & Projected Growth
According to Straits Research, the global NASH biomarkers market size was valued at USD 1.43 billion in 2024 and is projected to expand from USD 1.75 billion in 2025 to USD 11.17 billion by 2033, growing at a CAGR of 22.8% (2025–2033).
Descriptive Analysis of Growth Drivers
- Rising prevalence of lifestyle-related diseases: The global surge in obesity, type 2 diabetes, and metabolic syndrome is fueling NASH cases, driving biomarker demand.
- Need for non-invasive diagnostics: Biomarkers are increasingly preferred over invasive liver biopsies, supporting safer, faster, and more cost-efficient diagnostics.
- Pharma & clinical trial expansion: Growing NASH drug development pipelines are accelerating biomarker adoption for patient selection and therapeutic monitoring.
- Healthcare investment in liver disease management: Rising awareness, government initiatives, and investments in advanced diagnostic tools strengthen market growth.
Key Competitors
- Genfit
- Prometheus Laboratories
- Siemens Medical Solutions USA Inc.
- BioPredictive
- Quest Diagnostics
- AstraZeneca
- Exalenz Bioscience Ltd
- Laboratory Corporation of America Holdings
- Pfizer Inc.
- Bristol-Myers Squibb Company
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Market Segmentation
By Type
- Serum Biomarkers
- Hepatic Fibrosis Biomarkers
- Apoptosis Biomarkers
- Oxidative Stress Biomarkers
- Others
By End-Use
- Pharma and CRO Industry
- Hospitals
- Diagnostic Labs
- Academic Research Institutes
Emerging Trends & Innovations
- Expansion of multi-biomarker panels to improve diagnostic accuracy.
- Integration of AI and machine learning in biomarker-based diagnostics for predictive modeling.
- Rising collaborations between pharma companies and diagnostic firms to accelerate companion diagnostics.
- Growth in liquid biopsy techniques as a minimally invasive approach for disease staging and monitoring.
Regional Insights & Market Share
- North America: Leads due to high NASH prevalence, advanced healthcare infrastructure, and strong presence of diagnostics companies.
- Europe: Significant growth supported by robust clinical research and rising government funding for liver disease management.
- Asia-Pacific: Expected to be the fastest-growing region, driven by increasing obesity rates, large patient pools, and expanding diagnostic labs.
- Latin America & Middle East/Africa: Gradual adoption due to improving healthcare access and growing demand for cost-effective diagnostics.
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Industry Challenges/Restraints
- High costs associated with advanced biomarker tests.
- Limited awareness among physicians and patients in developing regions.
- Regulatory complexities surrounding biomarker validation and clinical adoption.
- Competition from traditional diagnostic procedures in low-resource settings.
Future Outlook & Strategic Directions
The NASH biomarkers market is poised for rapid expansion as healthcare systems emphasize early detection, personalized medicine, and drug development acceleration. Strategic collaborations between pharmaceutical companies and diagnostic providers will be critical to enhancing accessibility and innovation. Adoption of AI-powered biomarker platforms and cost-optimized testing solutions will likely define the next growth phase.
About Straits Research
Straits Research delivers industry-leading analysis and intelligence across multiple sectors, empowering businesses, investors, and strategists with the data they need to make informed decisions. Our team of analysts combines rigorous research methodologies with deep market understanding to provide actionable insights and forecasts.
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