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    US Non Alcoholic Steatohepatitis Biomarkers Market

    ID: MRFR/HC/17924-HCR
    100 Pages
    Garvit Vyas
    September 2025

    US Non-Alcoholic Steatohepatitis Biomarkers Market Research Report By Type (Hepatic Fibrosis Biomarkers, Serum Biomarkers, Oxidative Stress Biomarkers, Apoptosis Biomarkers, Others) and By End User (Research Institutes and Academics, Diagnostic Centres, Pharmaceutical Companies and CROs, Hospitals and Clinics, Others) - Forecast to 2035

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    US Non Alcoholic Steatohepatitis Biomarkers Market Infographic
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    US Non Alcoholic Steatohepatitis Biomarkers Market Summary

    The United States Non-Alcoholic Steatohepatitis Biomarkers market is poised for substantial growth over the next decade.

    Key Market Trends & Highlights

    US Non-Alcoholic Steatohepatitis Biomarkers Key Trends and Highlights

    • The market is projected to grow from 43.5 USD Million in 2024 to 560.4 USD Million by 2035.
    • A compound annual growth rate (CAGR) of 26.16% is anticipated from 2025 to 2035.
    • This growth trajectory indicates a robust demand for innovative biomarkers in the management of non-alcoholic steatohepatitis.
    • Growing adoption of advanced diagnostic technologies due to increasing prevalence of metabolic disorders is a major market driver.

    Market Size & Forecast

    2024 Market Size 43.5 (USD Million)
    2035 Market Size 560.4 (USD Million)
    CAGR (2025-2035) 26.16%

    Major Players

    Fujirebio, Prometheus Biosciences, NantKwest, Zymeworks, Gilead Sciences, Thermo Fisher Scientific, Pfizer, Celerion, Quest Diagnostics, Interpace Biosciences, Amgen, Intercept Pharmaceuticals, HepaDx, Roche, AbbVie

    US Non Alcoholic Steatohepatitis Biomarkers Market Trends

    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.

    Market Segment Insights

    Non-Alcoholic Steatohepatitis Biomarkers Market Type Insights

    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, Market Research Future Database and Analyst Review

    Non-Alcoholic Steatohepatitis Biomarkers Market End User Insights

    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.

    Get more detailed insights about US Non Alcoholic Steatohepatitis Biomarkers Market

    Key Players and Competitive Insights

    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.

    Key Companies in the US Non Alcoholic Steatohepatitis Biomarkers Market market include

    Industry Developments

    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.

    Market Segmentation

    Non-Alcoholic Steatohepatitis Biomarkers Market Type Outlook

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

    Non-Alcoholic Steatohepatitis Biomarkers Market End User Outlook

    • Research Institutes and Academics
    • Diagnostic Centres
    • Pharmaceutical Companies and CROs
    • Hospitals and Clinics
    • Others

    Report Scope

    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

    FAQs

    What is the expected market value of the US Non-Alcoholic Steatohepatitis Biomarkers Market in 2024?

    The US Non-Alcoholic Steatohepatitis Biomarkers Market is expected to be valued at 43.5 USD Million in 2024.

    What will be the projected market value in 2035?

    By 2035, the market is expected to reach a valuation of 560.4 USD Million.

    What is the compound annual growth rate (CAGR) of the market from 2025 to 2035?

    The market is anticipated to grow at a CAGR of 26.157% from 2025 to 2035.

    Which type of biomarkers will have the largest market size in 2035?

    Hepatic Fibrosis Biomarkers are expected to dominate the market, with a value of 163.0 USD Million in 2035.

    What market size is projected for Serum Biomarkers in 2035?

    The Serum Biomarkers segment is projected to reach 135.0 USD Million by 2035.

    What are the current leading players in the US Non-Alcoholic Steatohepatitis Biomarkers Market?

    Key players in the market include Fujirebio, Prometheus Biosciences, Gilead Sciences, and Roche.

    What is the value of the Oxidative Stress Biomarkers segment in 2024?

    The Oxidative Stress Biomarkers segment is valued at 9.0 USD Million in 2024.

    What is the market size of the Apoptosis Biomarkers segment by 2035?

    The Apoptosis Biomarkers segment is projected to be worth 70.0 USD Million by 2035.

    How will market demand be driven in the coming years?

    Growing prevalence of Non-Alcoholic Steatohepatitis and advancements in diagnostic technologies will drive market demand.

    What impact do emerging trends have on the US Non-Alcoholic Steatohepatitis Biomarkers Market?

    Emerging trends in personalized medicine and biomarker discovery are expected to create significant opportunities within the market.

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