Nonalcoholic Steatohepatitis Biomarkers Market

Non-alcoholic Steatohepatitis Biomarkers Market Size

The global non-alcoholic steatohepatitis biomarkers market size was valued at around USD 1.5 billion in 2024 and is estimated to grow at 25.8% CAGR from 2025 to 2034. Non-alcoholic steatohepatitis (NASH) biomarkers have been defined as biological indicators designed to measure, assess, monitor, or predict the progression of NASH along with its response to therapy. NASH is considered a more advanced form of non-alcoholic fatty liver disease (NAFLD).

The rising number of steatohepatitis cases, particularly NASH, is accelerating the growth of the NASH biomarker market. The National Center for Biotechnology Information (NCBI) estimated that the prevalent cases of NAFLD are set to increase by 21%, from 83.1 million in 2015 to 100.9 million in 2030. Furthermore, the number of people diagnosed with NASH is expected to increase by 63% during the same time frame, going from 16.5 million to 27 million. This increase in the disease burden is in large part due to rising obesity levels, diabetes, and metabolic syndrome, all of which are main drivers of NASH. Chronic NASH is often asymptomatic in the early stage and can silently advance to advanced stages of hepatic fibrosis, cirrhosis or even hepatocellular carcinoma, further emphasizing the need for accurate non-invasive biomarker tests.

Additionally, increased screening for chronic liver diseases is greatly augmenting the expansion of the NASH biomarkers market. Numerous health authorities, both domestically and internationally, such as the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), have recently updated clinical recommendations focusing on the prompt identification of NAFLD and NASH in pivotal demographics such as people suffering from type 2 diabetes and obesity.

According to secondary research, roughly 50 to 70 percent of individuals diagnosed with type 2 diabetes are believed to have latent NAFLD, with a significant percentage advancing to NASH, underlining the need for routine assessments of liver health. Also, programs such as primary care FibroScan screenings and broader insurance reimbursement policies for fibrosis testing are improving preemptive risk assessment and stratification. These approaches are improving the cognitive processes supporting clinical choices and triggering the use of comprehensive multidisciplinary diagnostic systems designed for NASH identification and surveillance.

Non-alcoholic Steatohepatitis Biomarkers Market Trends

• The redefinement of single analyte to multi-analyte and multi-omics including metabolomics, transcriptomics, and proteomics is changing the landscape of biomarker discovery. Companies like Zora Biosciences and SomaLogic are using these technologies to uncover intricate biomarker signatures related to NASH. These technologies provide a more comprehensive understanding of the disease and are increasingly preferred in academic and pharmaceutical research.
  
• Additionally, as pharmaceutical companies focus on developing targeted therapies for NASH, there is an increasing need for companion diagnostics to stratify patients and assess treatment response. For example, GENFIT's NIS4 biomarker panel is being tested as a companion diagnostic in several clinical trials, adding to its functionality beyond simplistic stand-alone diagnostics. Diagnostics and therapeutics are being integrated resulting in strategic partnerships and faster incorporation of biomarkers into clinical development pathways.
  
• Further, as the focus shifts to patient-centered approaches and less clinical burden, the market is seeing non-invasive and minimally invasive sampling techniques gain traction. Investigation of dried blood spots (DBS), micro-sampling, and saliva-based assays for the diagnosis of liver diseases is underway. These techniques could enable the remote monitoring of NASH, improving access and patient compliance through telemedicine, which is expected to reach USD 508.3 billion by 2032, and decentralized frameworks.
  

Trump Administration Tariffs

• Manufacturers in NASH biomarkers industry may face increased costs for some raw materials coming from China such as high-grade reagents, synthetic peptides, and some other assay components. Biochemical imports and diagnostic consumables within the U.S. have had a negative impact on other companies that relied on the Chinese market for polymer substrates, antibody fragments, and reagents used in ELISA and mass spectrometry platforms.
  
• Due to these issues, some manufacturers may shift focus to India, South Korea, and Central Europe as these countries provide strong bio supply ecosystems and compliant manufacturing which makes these regions ideal for cost sensitive production. This is particularly helpful to firms creating multi-analyte biomarker panels and companion diagnostics as needing a large output along with guaranteed quality makes these places advantageous to work with.
  
• In near term, with targeted NASH diagnostics, users could face access delays or increased pricing due to commoditization. Increased emphasis is being placed on U.S. and EU regional partnerships focused on increasing supply stability along with supporting turnaround times to mitigate procurement risks.
  

Non-alcoholic Steatohepatitis Biomarkers Market Analysis

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Based on type, the market is segmented into serum biomarkers, hepatic fibrosis biomarkers, apoptosis biomarkers, oxidative stress biomarkers, and other types. The global market was valued at USD 1.5 billion in 2024. The serum biomarkers segment dominated the market with the largest revenue share of 32.8% in 2024.

• This dominance is chiefly driven by their non-invasive nature, easy sampling, and its use in disease diagnosis, prognosis, and therapy monitoring. The serum biomarkers - ALT (alanine aminotransferase), AST (aspartate aminotransferase), and cytokeratin-18 (CK-18) have been shown to assess hepatocellular injury and apoptotic changes over time resulting in hepatocyte death in the liver.
  
• Patient population with advanced fibrosis or NASH at risk is further stratified by serum analytes in proprietary panel - GENFIT’s NIS4 and ELF tests by Siemens Healthineers. These are increasingly being adopted in clinical and drug development settings because of their quantifiable, reproducible, and reliable results. Because serum biomarkers have the potential to replace or reduce the reliance on liver biopsies in NASH, they are foundational to the diagnostic and monitoring strategies for the disease.

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Based on end use, the non-alcoholic steatohepatitis biomarkers market is segmented into pharma and CRO industry, hospitals, diagnostic labs, and academic research institutes. Pharma and CRO industry segment dominated the market with the largest revenue share of USD 42.2% in 2024.

• This leadership has been attributed to a focus on biomarker-driven drug development and patient stratification in NASH in clinical trials. With aggressive investment in research and development, pharmaceutical companies have a strong need for reliable biomarkers to measure disease and treatment response.
  
• Further, contract research organizations (CROs) are also playing an important role in supporting biomarker validation and regulatory submissions by extending specialized analytical services. This suggests their critical function in bridging diagnostics and therapeutics, thereby supporting the broader objective of precision medicine in liver disease management, fostering the growth of this segment in NASH biomarker market.

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North America: The U.S. non-alcoholic steatohepatitis biomarkers market is projected to grow significantly, from USD 308.8 million in 2024 to USD 2.9 billion by 2034.

• The country dominated the region due to strong market innovations, high prevalence of diseases, and a well-developed healthcare system. The prevalence of nonalcoholic fatty liver disease (NAFLD) is currently estimated at 38% in the U.S. which represents a 50% growth in the last 3 decades, as reported by National Institutes of Health. This is mainly due to the increase in obesity levels, diabetes, and a higher sedentary lifestyle in the country.
  
• Moreover, the advancing older demographic is also increasing demand for diagnosis. According to the U.S. Census Bureau, the number of persons aged sixty-five years and older will increase from fifty-eight million in 2022 to eighty-two million by 2050, which is a 47% increase. This demographic shift suggests the need for cost-effective, rapid, and non-invasive screening and monitoring tools based on biomarkers that are crucial to address the challenges associated with timely NASH complication management.
  

Europe: The non-alcoholic steatohepatitis biomarkers market in UK is expected to experience significant and promising growth from 2025 to 2034.

• The UK has seen a surge in its aging population. According to the Office for National Statistics (ONS), it is projected that in 2050 1 in 4 people in the country will be aged 65 or over.
  
• With this increase in population, the country is witnessing an increasing burden of chronic conditions, such as type 2 diabetes, which is a significant factor responsible for the growth of this market in the UK.
  
• According to the statistics by Diabetes UK, currently over 5.8 million diabetes patients reside in the country. Approximately 1.3 million such people are estimated to be undiagnosed with type 2 diabetes, further fostering the market.
  

Asia Pacific: Japan non-alcoholic steatohepatitis biomarkers market is anticipated to witness lucrative growth between 2025 – 2034.

• Japan has one of the largest aging populations in the world which is a major factor driving demand for non-alcoholic steatohepatitis biomarkers. According to Statista, 36.35 million people (29% of the population) were aged 65 or older, as of November 2023.
  
• Older people are more prone to diabetes and various other diseases thus further fostering the expansion of this market in Japan.
  

Middle East and Africa: The non-alcoholic steatohepatitis biomarkers market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.

• In Saudi Arabia, the NASH biomarker market is growing due to an increase in the metabolic disorder epidemics such as obesity and type 2 diabetes.
  
• For example, as of 2021, Statista reported that 40.4% of the adult population in the country was obese, forecasting an increase to 42.9% by 2026. Obesity is one of the leading risk factors for NAFLD and its progressive form, NASH.
  
• Furthermore, the Saudi Diabetes Federation published a report claiming there were 4.3 million adult diabetes patients in the year 2021 showcasing a growing at-risk population, thus increasing the need for early NASH detection through biomarker-based tests.
  

Non-alcoholic Steatohepatitis Biomarkers Market Share

The market for NASH biomarkers is moderately fragmented, as it includes a mix of specialized biomarker companies and in-vitro diagnostics (IVD) corporations. The top four players, GENFIT, Nordic Bioscience, Siemens Healthineers, and Labcorp, are active in the market and are dominant contributors along with their technologies and alliances. These firms account for approximately 40% of the market share.

The NASH biomarker market is expanding faster than before due to an increase in non-invasive diagnostics with pharmaceutical companies sponsoring targeted therapies. There is also a shift towards the use of integrated AI analytics and multiplexed testing, which is redefining the biomarker space, especially for NASH stratification and therapeutic monitoring.

Non-alcoholic Steatohepatitis Biomarkers Market Companies

Some of the eminent market participants operating in the non-alcoholic steatohepatitis biomarkers industry include:

• BioPredictive
• GENFIT
• Glycotest
• Labcorp
• Nordic Bioscience
• Prometheus Laboratories
• Quest Diagnostics
• Siemens Healthineers
• SomaLogic
• Zora Biosciences

• Siemens uses its know-how in the automation of clinical chemistry and diagnostics of chronic diseases to deploy solutions for testing fibrosis on a global scale. The company provides ELF Test, a biomarker panel used for liver fibrosis assessment that is validated and approved by regulatory bodies and thus, extensively used in NASH clinical trials and patient monitoring.
  
• Nordic bioscience has developed ECM (extracellular matrix) turnover biomarkers PRO-C3 and C3M, which are validated for use in monitoring liver fibrosis and NASH. The company specializes in developing and manufacturing ECM biomarkers based on proprietary technologies. Their ECM proteolytic biomarker assays are co-developed with analytical platforms of high performance and are backed with multicenter clinical trials in Europe and North America.
  

Non-alcoholic Steatohepatitis Biomarkers Industry News:

• In August 2021, Siemens Healthineers disclosed that the Enhanced Liver Fibrosis (ELF) Test received marketing authorization from U.S. FDA utilizing the De Novo classification pathway. With the ADVIA Centaur XP Immunoassay System, the ELF Test provides a quantitative fibrosis risk score derived from complex algorithms proprietary to Siemens Healthineers. The test assists the clinicians in estimating the possibility of progression to cirrhosis and other liver-related complications in patients with advanced fibrosis (F3 or F4) due to NASH. This achievement was a significant breakthrough in the non-invasive management of liver disease, because it provides blood tests-based biomarkers for evaluating liver fibrosis risk in NASH patients.
  
• In September 2020, GENFIT entered into a five-year exclusive licensing agreement with LabCorp for the commercialization of its NIS4 technology, a blood-based molecular diagnostic platform designed to identify patients with non-alcoholic steatohepatitis (NASH) at risk for disease progression. Under this agreement, LabCorp would be developing and distributing NIS4 powered diagnostic tests in the U.S. as well a as Canada, greatly improving access to non-invasive testing for healthcare providers. The collaboration sought to improve non-alcoholic steatohepatitis detection and clinical management by providing a validated and scalable biomarker-driven strategy.
  

The non-alcoholic steatohepatitis biomarkers market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Type

• Serum biomarkers
• Hepatic fibrosis biomarkers
• Apoptosis biomarkers
• Oxidative stress biomarkers
• Other types

Market, By End Use

• Pharma and CRO industry
• Hospitals
• Diagnostic labs
• Academic research institutes

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands 
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea 
• Latin America
  • Brazil
  • Mexico
  • Argentina 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE