As per MRFR analysis, the US Non-Alcoholic Steatohepatitis Biomarkers Market Size was estimated at 33.6 (USD Million) in 2023. The US Non-Alcoholic Steatohepatitis Biomarkers Market Industry is expected to grow from 43.5(USD Million) in 2024 to 560.4 (USD Million) by 2035. The US Non-Alcoholic Steatohepatitis Biomarkers Market CAGR (growth rate) is expected to be around 26.157% during the forecast period (2025 - 2035).
The US Non-Alcoholic Steatohepatitis (NASH) Biomarkers Market is experiencing significant momentum, driven primarily by the rising prevalence of obesity and metabolic syndrome among the population. As more individuals in the United States face health challenges related to these conditions, there is an increased focus on early detection and management of NASH, fostering demand for reliable biomarkers.
The growing awareness of liver diseases, supported by public health initiatives, is also propelling growth in the market. Regulatory bodies, such as the FDA, are pushing for more rigorous testing and validation of biomarkers, which encourages research and development in this area.
In recent times, advancements in technology have facilitated the discovery of novel biomarkers that are more effective in diagnosing and monitoring NASH. This trend is appealing to researchers and healthcare providers, as it offers improved patient outcomes through personalized treatment plans. Additionally, increased funding for research institutions and biopharmaceutical companies in the US has opened new opportunities for innovation in NASH diagnostics. Data sharing initiatives among research communities are further streamlining the development process, leading to faster translations of laboratory findings into clinical applications.
Moreover, the demographic shift towards an aging population in the US is expected to increase the burden of chronic liver diseases, including NASH. This presents opportunities for servicing an evolving market that is adapting to meet the specific needs of older adults. Collaborative efforts among stakeholders, such as pharmaceutical companies and healthcare organizations, aim to enhance awareness, support screening programs, and improve the overall understanding of NASH, paving the way for future growth in the biomarkers sector.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The increasing number of individuals diagnosed with Non-Alcoholic Steatohepatitis in the United States significantly fuels growth in the US Non-Alcoholic Steatohepatitis Biomarkers Market Industry. According to the Centers for Disease Control and Prevention (CDC), approximately 30% of American adults are estimated to have non-alcoholic fatty liver disease (NAFLD), of which a substantial percentage progresses to NASH. This translates to millions of individuals at risk for advanced liver disease, necessitating effective biomarker development for early detection and diagnosis.
As awareness and diagnosis of NASH continue to grow, companies like Genfit and Intercept Pharmaceuticals are actively investing in Research and Development of novel biomarkers, paving the way for advancement in patient care and driving market growth. Moreover, initiatives such as the Healthy People 2030 set by the U.S. Department of Health and Human Services aim to reduce the health consequences of NAFLD and NASH, generating further research and innovation in this field.
The surge in investment in Research and Development for Non-Alcoholic Steatohepatitis biomarkers is a critical driver for the US Non-Alcoholic Steatohepatitis Biomarkers Market Industry. The National Institutes of Health (NIH) allocated over USD 2.5 billion to liver disease research in recent years, reflecting a significant commitment to understanding the complexities of NASH and related biomarkers. This financial backing not only enables researchers and companies to develop cutting-edge diagnostic tools but also encourages collaborations between academic institutions and businesses.
As more entities, such as the American Liver Foundation, advocate for advancements in NASH treatment, the demand for effective biomarkers capable of early diagnosis and intervention is poised to rise, ensuring continuous market growth over the coming years.
As the public becomes increasingly aware of liver diseases, particularly Non-Alcoholic Steatohepatitis, the US Non-Alcoholic Steatohepatitis Biomarkers Market Industry is expected to experience significant growth. Campaigns led by organizations such as the American Association for the Study of Liver Diseases (AASLD) have played a crucial role in educating the public about the importance of liver health. A survey conducted by the organization revealed that 70% of respondents felt they lacked sufficient knowledge about liver diseases.
This heightened awareness has fostered an environment where more individuals are seeking screening and diagnosis, leading to a surge in the demand for biomarkers tailored for early identification and management of NASH, thus positively influencing market expansion.
The rapid advancement of technology has revolutionized the diagnostic landscape in the US Non-Alcoholic Steatohepatitis Biomarkers Market Industry. Innovations in genomics, proteomics, and metabolomics are facilitating the development of highly sensitive and specific biomarkers. The U.S. Food and Drug Administration (FDA) has increasingly been approving new diagnostic tests, reflecting confidence in technological progress and its potential to improve patient outcomes.
For example, the recent approval of non-invasive biomarkers like the FibroScan by Echosens has dramatically changed how NASH is diagnosed and monitored, eliminating the need for invasive liver biopsies. As these technologies become more accessible and integrated into clinical practice, they are expected to enhance the early detection and treatment of NASH, thereby driving market demand forward.
The US Non-Alcoholic Steatohepatitis Biomarkers Market experiences significant growth propelled by Type segmentation, which includes various biomarkers that are crucial for the diagnosis and monitoring of this liver condition. Hepatic Fibrosis Biomarkers play a vital role in assessing the severity of liver damage, with growing emphasis on their predictive capabilities for disease progression. These biomarkers are increasingly integrated into standard clinical practices to improve patient outcomes, making them a prominent feature of the market landscape.
Serum Biomarkers provide essential insights into liver inflammation and damage, serving as non-invasive tools that enhance diagnostic accuracy and facilitate patient management. The importance of these biomarkers is underscored by the rising incidences of obesity and metabolic disorders in the US, which are closely related to the prevalence of Non-Alcoholic Steatohepatitis. Oxidative Stress Biomarkers are also gaining traction in market discussions, as their analysis reveals critical information about cellular damage and the underlying mechanisms of disease progression. As research expands, these biomarkers present an opportunity for novel therapeutic approaches.
Furthermore, Apoptosis Biomarkers contribute significantly to understanding the pathological processes of Non-Alcoholic Steatohepatitis. Their significance lies in the ability to elucidate cellular death mechanisms, which are integral to developing effective treatments. The other categories encompass a diverse range of biomarkers that may yield important insights into the complex interactions of metabolic pathways associated with liver health. Overall, the Type classification within the US Non-Alcoholic Steatohepatitis Biomarkers Market underscores the complexity of diagnosing and managing this condition.
The steady rise in awareness and diagnostic requirements among healthcare professionals drives demand for advanced biomarker applications, ultimately positioning the market for an upward trajectory as health concerns linked to liver diseases continue to escalate in the US population. Each type of biomarker addresses unique aspects of disease pathology, contributing to a comprehensive approach in the monitoring and treatment strategies for Non-Alcoholic Steatohepatitis.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
The US Non-Alcoholic Steatohepatitis Biomarkers Market is characterized by a diverse range of End Users, each playing a pivotal role in driving market growth and innovation. Research Institutes and Academics contribute significantly to the development of novel biomarkers, facilitating improvements in diagnosis and treatment of Non-Alcoholic Steatohepatitis. Diagnostic Centres hold a critical position in enabling early detection and monitoring of the disease, directly impacting patient outcomes.
Pharmaceutical Companies and Contract Research Organizations (CROs) are instrumental in advancing research and development, focusing on biomarkers critical to drug discovery and therapeutic strategies.
Hospitals and Clinics serve as essential frontline institutions for patient care, integrating biomarkers into routine clinical practice to enhance disease management. Other categories encompass a broad array of service providers and emerging players who support the overall ecosystem. This dynamic segmentation structure indicates that each End User not only fulfills a distinct function within the US Non-Alcoholic Steatohepatitis Biomarkers Market but also highlights the collaborative nature of the market landscape, essential for tackling the challenges posed by this growing health concern.
The US Non-Alcoholic Steatohepatitis Biomarkers Market is witnessing robust growth due to the increasing prevalence of liver diseases and the rising awareness among healthcare professionals regarding the significance of early diagnosis and effective management of non-alcoholic steatohepatitis (NASH). The competitive landscape in this market is dynamic, with several key players striving to develop innovative biomarker tests that can assist in the timely identification of NASH in patients.
The focus on research and development is significant, with companies investing heavily in clinical trials and partnerships to enhance the diagnostic capabilities and treatment options available. Additionally, as government support and funding for liver disease research are increasing, more stakeholders are entering the market, raising the competition substantially.
Fujirebio has established a solid presence in the US Non-Alcoholic Steatohepatitis Biomarkers Market through its commitment to pioneering diagnostics in the field of liver diseases. The company's strengths lie in its extensive portfolio of innovative biomarker tests and its strong relationships with healthcare providers, enabling it to reach a wide audience. Fujirebio's deep expertise in biomarker discovery and development, coupled with robust research capabilities, allows it to stay at the forefront of advancements in NASH diagnostics.
The company's dedication to improving patient outcomes and enhancing the accuracy of NASH diagnosis demonstrates its leadership position within the market. Furthermore, Fujirebio's strategic collaborations with research institutions and healthcare organizations in the US foster innovation and facilitate the introduction of new products catering specifically to the healthcare needs associated with non-alcoholic fatty liver disease.
Prometheus Biosciences is a notable player in the US Non-Alcoholic Steatohepatitis Biomarkers Market, recognized for its focus on advancing precision medicine for liver diseases. The company offers a range of key products and services that target biomarkers related to NASH, positioning itself as a pivotal entity in biomarker development and application. Its market presence is further fortified by its proactive approach to research and product development, enhancing its portfolio with innovative solutions that align with the emerging demands of healthcare providers.
Prometheus Biosciences has made strategic moves through mergers and acquisitions that bolster its capabilities and market reach. The emphasis on developing cutting-edge diagnostic tests and fostering relationships with medical professionals underscores its strength in addressing the clinical scenarios posed by NASH. Moreover, Prometheus's aim to facilitate comprehensive treatment options for patients creates a competitive advantage, as it aligns with the growing trend of personalized medicine in the US healthcare landscape.
Recent developments in the US Non-Alcoholic Steatohepatitis Biomarkers Market indicate a dynamic growth trajectory, fueled by increased research and heightened awareness of the condition. Companies like Gilead Sciences and AbbVie have been actively expanding their product pipelines to address the NASH epidemic, with promising therapies undergoing extensive clinical trials. Notably, in April 2023, Thermo Fisher Scientific announced a strategic partnership with Interpace Biosciences to enhance biomarker research capabilities, demonstrating a focus on collaboration within the industry.
Additionally, in January 2023, Roche's acquisition of a diagnostics firm specializing in liver disease biomarkers underscored a trend toward consolidation as companies aim to solidify their positions. The market valuation for Non-Alcoholic Steatohepatitis biomarkers has seen significant growth, driven by innovations and advancing technologies, particularly in non-invasive testing methods. Moreover, the US market's landscape has evolved with increased regulatory support and funding for Research and Development of NASH therapies, attracting investments and partnerships.
Over the past two to three years, the sector has benefited from heightened FDA engagement and a renewed commitment to addressing the growing prevalence of NASH, particularly among the rising demographic of obese patients in the US.
| Report Attribute/Metric Source: | Details |
| MARKET SIZE 2018 | 33.6(USD Million) |
| MARKET SIZE 2024 | 43.5(USD Million) |
| MARKET SIZE 2035 | 560.4(USD Million) |
| COMPOUND ANNUAL GROWTH RATE (CAGR) | 26.157% (2025 - 2035) |
| REPORT COVERAGE | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| BASE YEAR | 2024 |
| MARKET FORECAST PERIOD | 2025 - 2035 |
| HISTORICAL DATA | 2019 - 2024 |
| MARKET FORECAST UNITS | USD Million |
| KEY COMPANIES PROFILED | Fujirebio, Prometheus Biosciences, NantKwest, Zymeworks, Gilead Sciences, Thermo Fisher Scientific, Pfizer, Celerion, Quest Diagnostics, Interpace Biosciences, Amgen, Intercept Pharmaceuticals, HepaDx, Roche, AbbVie |
| SEGMENTS COVERED | Type, End User |
| KEY MARKET OPPORTUNITIES | Increased demand for early diagnosis, Advancements in biomarker research, Rise in obesity-related liver diseases, Growing investment in healthcare technologies, Strong pipeline of therapeutic agents |
| KEY MARKET DYNAMICS | Rising prevalence of NASH, Increasing healthcare expenditure, Advances in biomarker research, Growing patient awareness, Regulatory support for diagnostics |
| COUNTRIES COVERED | US |
Frequently Asked Questions (FAQ) :
The US Non-Alcoholic Steatohepatitis Biomarkers Market is expected to be valued at 43.5 USD Million in 2024.
By 2035, the market is expected to reach a valuation of 560.4 USD Million.
The market is anticipated to grow at a CAGR of 26.157% from 2025 to 2035.
Hepatic Fibrosis Biomarkers are expected to dominate the market, with a value of 163.0 USD Million in 2035.
The Serum Biomarkers segment is projected to reach 135.0 USD Million by 2035.
Key players in the market include Fujirebio, Prometheus Biosciences, Gilead Sciences, and Roche.
The Oxidative Stress Biomarkers segment is valued at 9.0 USD Million in 2024.
The Apoptosis Biomarkers segment is projected to be worth 70.0 USD Million by 2035.
Growing prevalence of Non-Alcoholic Steatohepatitis and advancements in diagnostic technologies will drive market demand.
Emerging trends in personalized medicine and biomarker discovery are expected to create significant opportunities within the market.
Leading companies partner with us for data-driven Insights.
Kindly complete the form below to receive a free sample of this Report
Analyst Explore the profile of garvit vyas, one of our esteemed authors at market research future, and access their expert research contributions in the field of market research and industry analysis
Get in Touch
© 2025 Market Research Future ® (Part of WantStats Reasearch And Media Pvt. Ltd.)
