Non-alcoholic Steatohepatitis Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Serum Biomarkers, Hepatic Fibrosis Biomarkers, Apoptosis Biomarkers, Oxidative Stress Biomarkers, Others), By End User (Pharma & CRO Industry, Hospitals, Diagnostic Labs, Academic Research Institutes), By Region and Competition, 2020-2030F

Market Overview

Global 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 with a CAGR of 22.97%. The Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market is witnessing significant momentum due to the rising prevalence of metabolic disorders such as obesity, insulin resistance, and type 2 diabetes, which are primary risk factors for NASH. As the number of patients with non-alcoholic fatty liver disease (NAFLD) progresses toward NASH, the demand for early detection and reliable disease monitoring tools has surged. Traditional liver biopsy, the gold standard for diagnosis, is invasive and poses risks such as bleeding, infection, and sampling error. This has led to an urgent need for non-invasive, accurate, and reproducible biomarkers that can aid in early diagnosis, staging, and monitoring of therapeutic response. Pharmaceutical companies are increasingly relying on these biomarkers for patient stratification and endpoint measurement in clinical trials, which further fuels market growth. According to the Global Liver Institute, more than 115 million people worldwide are estimated to be affected by NASH, highlighting the urgent demand for improved diagnostic technologies.

Technological advancements in genomics, transcriptomics, proteomics, and metabolomics are transforming the landscape of biomarker discovery in NASH. Integration of artificial intelligence and machine learning into data analysis platforms has improved the identification and validation of novel biomarkers. This trend is enabling personalized and precision medicine approaches in NASH management, enhancing treatment outcomes. The growing number of research collaborations between biotech firms, academic institutions, and pharmaceutical companies is accelerating biomarker development and regulatory validation. Multi-parameter panels combining imaging techniques, blood-based markers, and digital health tools are emerging as promising alternatives to liver biopsy, reflecting the market's shift toward comprehensive, patient-friendly diagnostic solutions.

Despite the favorable growth outlook, the market faces several challenges that may limit its progress. One of the key barriers is the lack of universally accepted and validated biomarkers for routine clinical use. The regulatory pathway for biomarker approval is complex and time-consuming, often requiring extensive validation through longitudinal clinical studies. Limited awareness among healthcare professionals and inconsistent reimbursement policies also hinder the adoption of NASH biomarkers in standard clinical practice. Moreover, the biological complexity of NASH and the overlap with other liver conditions make biomarker development particularly challenging. Addressing these hurdles requires continued innovation, robust clinical evidence, and supportive regulatory frameworks to ensure the successful integration of NASH biomarkers into routine diagnostics.

Key Market Drivers

Rising Prevalence of Metabolic Disorders and NASH Progression

The rising prevalence of metabolic disorders such as obesity, insulin resistance, dyslipidemia, hypertension, and type 2 diabetes is fueling expansion of the Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market. In India, a government-backed ICMR‑INDIAB study (2018–2020) reported diabetes prevalence at 11.4%, generalized obesity at 28.6%, abdominal obesity at 39.5%, hypertension at 35.5%, and dyslipidemia at 81.2%.

NFHS‑5 data (2019–2021) showed nearly 40% of adults aged 15–49 were overweight or obese in certain regions, representing a significant increase from previous survey rounds. These chronic metabolic conditions, recognized risk factors for NAFLD progression to NASH, are shifting the global epidemiology toward a larger population at risk. Such population-wide changes are intensifying demand for early detection and ongoing monitoring tools that go beyond the traditional liver biopsy.

NASH often remains asymptomatic until advanced stages like cirrhosis or liver failure, posing a hidden healthcare burden. Biomarkers serve a critical role in this context, offering non-invasive, scalable, and cost-effective solutions for disease screening and staging. They support risk stratification in metabolic disorder clusters and facilitate regular longitudinal monitoring, essential for mitigating progression and tailoring interventions. The increasing adoption of biomarker panels including serum, genetic, imaging, and metabolic markers is further propelling their integration into clinical trials, enabling pharmaceutical sponsors to assess efficacy of emerging NASH therapies more precisely.

The market is also experiencing converging trends in preventive health. Expanding public health programs targeting NASH risk populations those with obesity, diabetes, or metabolic syndrome—are advocating for earlier intervention strategies. This has elevated interest in biomarker-based approaches that can detect liver abnormalities long before symptom onset. Biomarkers are now viewed not only as research tools but as foundational elements in value-based care models aimed at reducing long-term healthcare costs from advanced liver disease. As the global incidence of metabolic disorders continues rising, the imperative for accurate, reliable, and non-invasive diagnostic tools becomes more pronounced. Biomarker innovation is now central to this evolving healthcare landscape, offering the potential to transform NASH management and improve patient outcomes.

Growing Investment in Biomarker Research and Development

Growing investment in biomarker research and development is evolving into a dynamic engine for growth in the Global Non‑alcoholic Steatohepatitis (NASH) Biomarkers Market. Pharmaceutical developers, biotech startups, universities, and government agencies are intensifying funding activities aimed at discovering and validating NASH-specific biomarkers. Public institutions such as the FDA, through its Drug Development Tools and Biomarker Qualification Program, have opened grant cycles (e.g., FY 2025 DDT grants) including dedicated support for biomarker analytical and clinical validation that encourage academic-industry partnerships. These grants enable researchers to apply rigorous FDA-aligned standards for assay sensitivity, specificity, and clinical applicability, resulting in richer datasets and a more streamlined regulatory pathway.

Private capital and strategic alliances are also increasing in volume and sophistication. Licensing and merger scenarios now frequently involve biomarker asset portfolios, reflecting investor confidence in biomarkers as crucial facilitators of drug development. Companies are leveraging biomarker-driven companion diagnostics to optimize patient stratification and to improve success rates in late-stage NASH trials. The FDA’s new draft guidance on phase 3 trial design, which positions non-invasive tests as entry screening tools, highlights the growing acceptance of biomarker-based protocols and incentivizes early-stage investment.

Omics research platforms, encompassing genomics, proteomics, metabolomics, and lipidomics are benefiting from high-throughput methods and machine learning, supported by both public and private financing. These investments are accelerating the generation of multi-marker panels with increased disease specificity and sensitivity. The global prevalence of NASH, estimated at around 5.3% in the adult population, means a substantial unmet need for reliable diagnostics. Investment-driven innovation is expanding access to broader patient populations at risk, enabling earlier interventions and more personalized care.

These converging investment streams are not only expanding the NASH biomarker pipeline but helping transition diagnostic strategies from invasive biopsy toward accessible, non-invasive tests. As biomarkers earn formal regulatory recognition used as surrogate or stratification endpoints, this validation is expected to streamline commercialization, improve payer coverage, and drive broader healthcare adoption across the next several years.

Technological Advancements in Omics and AI

Technological advancements in omics sciences and artificial intelligence (AI) are significantly driving growth in the Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market. The integration of genomics, proteomics, transcriptomics, lipidomics, and metabolomics is revolutionizing the way biomarkers are discovered and validated. These omics-based platforms allow researchers to capture a holistic view of the molecular changes associated with NASH, enabling the identification of disease-specific signatures that traditional diagnostic tools often miss. High-throughput sequencing technologies and advanced bioinformatics tools have drastically reduced the time and cost required to analyze large biological datasets, making the biomarker discovery process more efficient and precise. At the same time, AI and machine learning algorithms are transforming raw omics data into clinically meaningful insights. These technologies help uncover complex, non-linear relationships between biological variables and disease progression, offering more accurate predictions of NASH stages and therapeutic responses.

AI-based platforms are also being used to integrate data from multiple sources such as blood tests, imaging modalities, and patient history to develop composite biomarker models with improved sensitivity and specificity. This is especially important in a disease like NASH, which presents heterogeneously and often coexists with other metabolic disorders. Pharmaceutical and diagnostics companies are leveraging these innovations to design personalized diagnostic panels and companion diagnostics that can guide therapeutic decisions. As the field advances, regulatory bodies are also beginning to acknowledge the value of AI-enhanced omics platforms in clinical research and decision-making. These technological improvements are not only accelerating the commercialization of novel biomarker solutions but are also expanding their application from clinical trials to routine diagnostics, making them more accessible to healthcare providers. The convergence of omics and AI is reshaping the NASH biomarker landscape by offering scalable, data-driven, and non-invasive solutions for early detection, patient stratification, and treatment monitoring.

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Key Market Challenges

Lack of Standardization and Clinical Validation

One of the most significant challenges hindering the growth of the Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market is the lack of standardization and clinical validation across different biomarker platforms. While numerous biomarkers ranging from blood-based molecules to imaging indicators have shown promise in detecting or monitoring NASH, very few have been universally accepted or incorporated into clinical practice. The heterogeneity in patient profiles, disease stages, and diagnostic methodologies results in inconsistent findings that limit the reliability of these biomarkers in real-world settings. This variation also creates difficulty for clinicians when interpreting results, often leading to underutilization or reliance on invasive methods like liver biopsy.

The absence of a standardized framework for evaluating the performance of NASH biomarkers poses a major barrier to regulatory approval and clinical adoption. Regulatory bodies such as the FDA and EMA require robust evidence demonstrating the biomarker’s accuracy, reproducibility, and correlation with disease progression or treatment response. Meeting these criteria often demands extensive longitudinal studies and multi-cohort validation, which are both time-consuming and costly. Without consistent standards or guidelines, companies and research institutions face uncertainty in designing trials that meet approval requirements, delaying the path to market.

Another key issue is the lack of consensus among researchers and clinicians regarding which biomarkers should be prioritized for validation. With various academic institutions and companies developing their own proprietary assays or panels, the field remains fragmented. This fragmentation not only leads to duplication of efforts but also restricts data harmonization and comparative studies. As a result, many promising biomarkers fail to progress beyond the research phase. Addressing this challenge will require coordinated efforts to establish global guidelines, facilitate cross-study collaboration, and incentivize the validation of biomarker candidates through clinical consortia or public-private partnerships.

Regulatory Complexity and Slow Approval Processes

One of the most significant challenges facing the Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market is the complexity of the regulatory landscape. Biomarkers intended for clinical use must undergo a stringent approval process to meet the safety, accuracy, and clinical relevance standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These agencies require robust scientific evidence demonstrating a biomarker’s analytical validity, clinical validity, and utility before granting regulatory approval. For NASH biomarkers, this is particularly challenging due to the multifactorial nature of the disease and the absence of universally accepted diagnostic benchmarks outside of liver biopsy.

The validation process for NASH biomarkers often requires longitudinal clinical studies that track patients over several years to confirm the predictive power of the biomarker for disease progression or treatment response. This demand for long-term data significantly increases development costs and delays the timeline for market entry. Even when promising results emerge in early trials, translating those findings into a clinically accepted tool requires navigating an extended and resource-intensive regulatory pathway.

There is also a lack of harmonized global regulatory guidelines specific to NASH biomarkers. Different countries and regions may have varying standards for evidence requirements, trial designs, and clinical endpoints, complicating the efforts of companies aiming for global commercialization. Inconsistent frameworks discourage smaller diagnostic companies from pursuing market access in multiple jurisdictions, limiting the availability of novel biomarker solutions.

Regulatory uncertainty creates hesitation among investors and slows the pace of innovation. Without clear guidance and expedited pathways for biomarker approvals, diagnostic developers face significant barriers in bringing clinically valuable tools to healthcare providers and patients. This delay not only restricts commercial growth but also hampers the adoption of non-invasive, early-stage diagnostics that could significantly improve NASH patient outcomes.

Key Market Trends

Emergence of Multi-Omics-Based Biomarker Discovery

The emergence of multi-omics-based biomarker discovery is transforming the Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market by offering a comprehensive view of the molecular mechanisms underlying disease progression. Traditional diagnostic methods often rely on single biomarker indicators, which can lack sensitivity or specificity in complex conditions like NASH. Multi-omics approaches integrate data from genomics, proteomics, metabolomics, transcriptomics, and lipidomics to capture a more accurate and holistic profile of the disease. This layered understanding allows researchers to pinpoint molecular signatures that reflect different stages and phenotypes of NASH, enabling earlier detection and more precise disease classification.

Multi-omics platforms are becoming essential in biomarker research due to their ability to reveal novel pathways and biomarkers that would otherwise go undetected using single-domain methods. For example, metabolomic and lipidomic analyses can identify metabolic disturbances associated with liver inflammation and fibrosis, while transcriptomic profiling can highlight changes in gene expression linked to hepatocellular stress. The integration of these diverse datasets enhances the robustness of biomarker panels, allowing for better differentiation between simple steatosis, early-stage NASH, and advanced fibrosis.

This trend is also gaining momentum because of its strong alignment with the push for personalized medicine. Multi-omics data enables the development of tailored diagnostic tools that match individual patient profiles, helping clinicians predict disease progression and monitor therapeutic responses more accurately. As pharmaceutical companies seek reliable biomarkers to guide clinical trial design and patient stratification, multi-omics technologies are becoming indispensable. Their application is expected to accelerate the development of companion diagnostics and improve the efficiency of drug development pipelines.

The growing adoption of bioinformatics tools and machine learning algorithms to interpret complex multi-omics datasets is further strengthening this trend. By uncovering intricate biological interactions, multi-omics biomarker discovery is setting a new standard for precision diagnostics in NASH care.

Growing Use of Artificial Intelligence and Machine Learning

The Global Non-alcoholic Steatohepatitis (NASH) Biomarkers Market is experiencing a transformative shift with the integration of artificial intelligence (AI) and machine learning (ML) technologies into biomarker discovery, validation, and clinical application. The complexity of NASH, which involves a combination of metabolic, inflammatory, and fibrotic processes, generates a wide array of biological data. Traditional analytical methods often fall short in managing such multidimensional datasets. AI and ML offer powerful computational capabilities that enable the identification of hidden patterns, correlations, and predictive signatures from large-scale genomic, proteomic, and metabolomic datasets, enhancing the efficiency and accuracy of biomarker research.

AI algorithms are being deployed to analyze real-world data from clinical trials, electronic health records, and imaging platforms to extract meaningful insights into disease progression and therapeutic response. These models can classify patients based on disease severity, risk of progression, and likely treatment outcomes, which supports the development of personalized NASH management strategies. Machine learning is also helping researchers develop multi-biomarker diagnostic panels by selecting the most informative combinations of markers to improve diagnostic precision over single-marker approaches.

Integration of AI is further streamlining the drug development process in NASH by enabling virtual screening of biomarker candidates and optimizing patient recruitment in clinical trials. AI-powered platforms can predict which patients are most suitable for specific therapeutic interventions, thus enhancing trial success rates and reducing costs. Regulatory agencies and pharmaceutical companies are recognizing the value of AI-enhanced biomarkers for use as surrogate endpoints in NASH trials. As digital health technologies evolve, AI-enabled biomarker platforms are expected to be embedded in clinical workflows, providing real-time, actionable insights to clinicians. This trend is driving a paradigm shift in the NASH biomarker landscape toward data-driven diagnostics and precision medicine.

Segmental Insights

Type Insights

Based on the Type, Serum Biomarkers emerged as the dominant segment in the Global Non-alcoholic Steatohepatitis Biomarkers Market in 2024. This is due to their non-invasive nature, accessibility, and clinical utility. Serum-based tests offer a convenient and cost-effective alternative to liver biopsies, which are invasive, risky, and not feasible for repeated monitoring. As NASH often progresses silently, routine blood sampling allows for early detection and ongoing assessment of disease severity, which is critical for timely intervention. Key serum biomarkers such as ALT (alanine aminotransferase), AST (aspartate aminotransferase), cytokeratin-18 fragments, and inflammatory markers like TNF-α and IL-6 are widely studied and used in clinical research and practice. These markers help evaluate liver inflammation, hepatocyte apoptosis, and fibrosis, offering a comprehensive view of disease progression. Growing demand for such non-invasive diagnostic solutions among healthcare providers and patients has significantly driven the adoption of serum biomarkers.

End User Insights

Based on the End User, Pharma & CRO Industry emerged as the dominant segment in the Global Non-alcoholic Steatohepatitis Biomarkers Market in 2024. This dominance is due to its pivotal role in drug development and clinical research. With no approved pharmacological treatment for NASH as of now, pharmaceutical companies are heavily investing in the development of novel therapeutics. Biomarkers play a critical role in identifying suitable patient populations, monitoring therapeutic response, and serving as surrogate endpoints in clinical trials, making them essential tools for pharma and CRO operations. CROs, in particular, are increasingly relied upon for their expertise in biomarker discovery, validation, and data analytics, enabling faster and more cost-efficient clinical development processes. These organizations are integrating advanced biomarker platforms and collaborating with diagnostic developers to optimize trial design and improve patient stratification. The adoption of biomarker-driven strategies helps reduce trial failures, lower costs, and enhance regulatory acceptance.

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Regional Insights

North America emerged as the dominant region in the Global Non-alcoholic Steatohepatitis Biomarkers Market in 2024. This is driven by a combination of high disease prevalence, advanced healthcare infrastructure, and strong research and development activity. The region has witnessed a significant rise in obesity, type 2 diabetes, and metabolic syndrome key risk factors contributing to the growing incidence of NASH. The United States, in particular, accounts for a large portion of the global NASH burden, prompting increased demand for accurate and non-invasive diagnostic solutions. The presence of major pharmaceutical companies, diagnostic developers, and contract research organizations in North America has also contributed to the market’s expansion. These entities are actively engaged in biomarker discovery, validation, and integration into clinical trials for NASH drug development. Regulatory bodies like the U.S. FDA are supportive of biomarker-driven approaches, especially as surrogate endpoints in NASH therapeutic trials, further encouraging innovation and market adoption.

Asia-Pacific emerged as the fastest growing region in the Global Non-alcoholic Steatohepatitis Biomarkers Market during the forecast period. This is driven by significant shifts in lifestyle, urbanization, and dietary habits. As countries in the region experience rapid economic development, there is a parallel rise in sedentary behavior, unhealthy eating patterns, and obesity rates. These changes have led to a surge in metabolic diseases, including type 2 diabetes and NAFLD, which are major precursors to NASH. The increasing burden of liver-related disorders is pushing healthcare systems across Asia-Pacific to invest in early diagnostic solutions, with non-invasive biomarker-based tests gaining considerable traction. Countries like China, India, and South Korea are witnessing a rising demand for cost-effective, scalable diagnostic tools, especially in urban centers where lifestyle-related diseases are more prevalent. Biomarkers are being increasingly adopted in screening programs to facilitate early detection and reduce dependence on invasive liver biopsy procedures, which are often limited in availability across the region.

Recent Developments

• In July 2024, SomaLogic Inc., a prominent player in the field of protein biomarker discovery and clinical diagnostics, announced the launch of a new panel of biomarkers designed to advance the diagnosis and understanding of Non-alcoholic Steatohepatitis (NASH). The company’s latest development includes novel biomarkers offering deeper mechanistic and clinical insights into Acetyl-CoA Carboxylase (ACC), a key enzyme involved in fatty acid metabolism and a critical target in NASH pathogenesis.
• In February 2024, Gilead Sciences Inc., a global biopharmaceutical leader, entered into a definitive agreement to acquire CymaBay Therapeutics Inc. in a transaction valued at USD 4.3 billion. This acquisition is a strategic move to strengthen Gilead’s liver disease treatment pipeline. As part of the deal, Gilead gained access to Seladelpar, a selective PPARδ agonist currently in late-stage development for the treatment of Primary Biliary Cholangitis (PBC).
• In January 2024, Boston Pharmaceuticals announced positive Phase 2 data for BOS-580, its investigational long-acting FGF21 analogue for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH/NASH). The results, presented at NASH-TAG 2024, demonstrated low immunogenicity and favorable clinical outcomes, highlighting BOS-580’s potential to offer sustained efficacy with reduced risk of anti-drug antibody development—an advantage over other FGF21 candidates in the pipeline.
• In November 2023, Boston Pharmaceuticals presented positive clinical data for BOS-580, its investigational long-acting FGF21 analog, at The Liver Meeting hosted by the AASLD. The results support once-monthly subcutaneous dosing and show promising effects in reducing liver fat, inflammation, and fibrosis markers in NASH patients, particularly those with or at risk for type 2 diabetes.

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:

o   Serum Biomarkers

o   Hepatic Fibrosis Biomarkers

o   Apoptosis Biomarkers

o   Oxidative Stress Biomarkers

o   Others

• Non-alcoholic Steatohepatitis Biomarkers Market, By End User:

o   Pharma & CRO Industry

o   Hospitals

o   Diagnostic Labs

o   Academic Research Institutes

• Non-alcoholic Steatohepatitis Biomarkers Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   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.

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Global Non-alcoholic Steatohepatitis Biomarkers Market report with the given market data, TechSci Research 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).

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