Hepatic Fibrosis Biomarkers Market By Diagnostic Technique (Imaging Techniques {Magnetic Resonance Elastography, Ultrasound-based Elastography, CT-based Techniques}, Serum-based Tests {Direct Biomarkers, Indirect Biomarkers}, Molecular Diagnostics), By Application (Diagnostic Testing, Prognostic Testing, Drug Discovery & Development, Clinical Trials Monitoring, Personalized Medicine), By Biomarker Type (Serum Biomarkers, Imaging Biomarkers, Genetic Biomarkers, Proteomic Biomarkers, Metabolomic Biomarkers), By Biomarker Origin (Extracellular Matrix Biomarkers, Inflammatory Biomarkers, Genetic & Epigenetic Biomarkers), and By End User (Hospitals & Clinics, Diagnostic Laboratories, Research Institutes, Pharmaceutical & Biotechnology Companies, Academic Centers), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

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What trends will shape Hepatic Fibrosis Biomarkers Market in the coming years?

The Hepatic Fibrosis Biomarkers Market accounted for USD 427.43 Million in 2024 and USD 509.58 Million in 2025 is expected to reach USD 2956.01 Million by 2035, growing at a CAGR of around 19.22% between 2025 and 2035. The hepatic fibrosis biomarkers market is understood as the industry leading to the development, manufacture, and sale of the biomarkers used to diagnose and measure the presence of liver fibrosis. Hepatic fibrosis is commonly a result of persistent liver diseases, including hepatitis or fatty non-alcoholic liver disease (NAFLD). Blood-based biomarkers, as a non-invasive alternative to liver biopsy, are effective in early diagnosis, staging of the disease, and monitoring of treatment. This market is composed of serum-driven and imaging-based biomarkers, and the increasing incidence of liver disease and the enhanced demand for early diagnosis tools drive this market. The important players in this field are pharmaceutical companies, diagnostic labs, and research institutions.

What do industry experts say about the Hepatic Fibrosis Biomarkers market trends?

“Non-invasive hepatic fibrosis biomarkers are transforming liver disease management by reducing the need for liver biopsies. They allow for earlier detection, disease staging, and monitoring of treatment response.”

• Dr. Rohit Loomba, MD, MHSc – Director, NAFLD Research Center, University of California, San Diego

“Biomarker-driven approaches in hepatic fibrosis are critical for precision medicine. Combining serum biomarkers with imaging techniques is improving diagnostic accuracy and enabling better clinical trial designs.”

• Dr. Arun Sanyal, MD – Professor of Medicine, Virginia Commonwealth University

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the Hepatic Fibrosis Biomarkers market?

How does increasing prevalence of liver diseases influence biomarker development?

The increased incidence of liver disease types such as chronic hepatitis B and C, non-alcoholic fatty liver disease (NAFLD), and alcoholic liver disease has amplified the requirement for refined biomarkers to identify hepatic fibrosis at an early stage. Practically more than 300 million people all over the world are already infected with chronic hepatitis, and millions of others are exposed to the high risks of liver fibrosis and cirrhosis.

In the United States, an estimate by the Centers for Disease Control and Prevention (CDC) has indicated that 4.5 million people are living with chronic hepatitis C, thus a large burden on the community. As liver fibrosis is usually not initially symptomatic, reliable non-invasive biomarkers are needed to help in early diagnosis and monitoring of liver-fibrotic therapies.

With the increase in liver diseases associated with lifestyle choices and infections, there is pressure in the research and healthcare fields that seems to be demanding sensitive, specific, and cost-effective biomarkers. These instruments decrease invasive biopsies and enhance results with personalised therapy. Accordingly, the increasing burden of liver disease is a central growth catalyst that is driving hepatic fibrosis biomarker innovation and market development.

Is growing research funding accelerating advancements in fibrosis biomarker technologies?

A growing number of government and academic researchers are increasing funding for hepatic fibrosis biomarker technologies. Funded agencies such as the U.S. National Institutes of Health (NIH) have stepped up investments in research on liver disease by financing large-scale studies and biobanking initiatives. For instance, the NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports research networks investigating nonalcoholic fatty liver disease (NAFLD) and fibrosis, which have allowed thousands of patient samples to be collected to discover novel biomarkers. Within the non-invasive biomarkers, genomics and proteomics have provided promising touchstones because of such initiatives by the NIH.

Government funding is also provided through grants such as Small Business Innovation Research (SBIR) to be used to develop advanced imaging agents and tools to detect early fibrosis. Such investments will establish a pathway to use biomarker development to improve patient outcomes, e.g., by diagnosing hepatic fibrosis earlier and more accurately.

Do high diagnostic costs limit accessibility for widespread patient use?

Costs associated with diagnostic procedures may be a substantial impediment to the adoption of hepatic fibrosis biomarkers, creating a problem with accessibility, particularly in low- and, to a degree, middle-income groups. Diagnostic tests such as FibroScan and state-of-the-art panels of biomarkers may be cost-prohibitive and, hence, unavailable to large numbers of patients who need frequent follow-ups.

The high out-of-pocket expenditure in low-resource countries often leads to a late diagnosis and therapies, according to statistics published by the World Health Organisation (WHO). Moreover, the National Institutes of Health (NIH) highlights that the economic costs of specialised tests limit such tests to centralised medical facilities in an urban environment, underserving the rural population.

In countries like the United States and India, the government initiates programmes that will help in subsidising diagnostic services by increasing the country's population's access to diagnostic services. There must be further cost-cutting or insurance cover expansion to ensure that many patients can access these important hepatic fibrosis diagnostic tools without challenges, which will facilitate early hepatic fibrosis diagnosis and management.

Will artificial intelligence enhance accuracy of biomarker-based fibrosis detection?

AI has great potential to increase the accuracy of detecting hepatic fibrosis based on biomarkers. AI-powered algorithms are able to interpret even more complex blood biomarkers and imaging data more accurately as compared to traditional procedures, lowering diagnostic mistakes and inconsistency among healthcare experts.

According to the studies published on the National Institutes of Health (NIH), the machine learning models often have sensitivity and specificity of more than 90% in predicting fibrosis levels. AI in combination with non-invasive imaging (such as elastography) has shown an AUC of over 0.95, which is a remarkable difference between respective levels of fibrosis. These developments can help minimise the use of invasive liver biopsies because they can be used to determine a real-time assessment of the liver.

Moreover, AI can be adjusted to continuously learn and become better at its task due to the appearance of more patient data, thus ultimately improving diagnostic performance. As a promising direction of government-funded research, AI involvement in the task of fibre detection using biomarkers will transform the landscape of fibrosis detection and patient outcomes.

Can emerging markets increase demand for affordable diagnostic biomarker kits?

Emerging markets pose a great potential in enhancing demand for affordable diagnostic biomarker kits in hepatic fibrosis due to the high incidence of liver diseases, including hepatitis B, hepatitis C, and non-alcoholic fatty liver disease (NAFLD). WHO estimates that around 296 million individuals around the world carry chronic hepatitis B, a lot of whom are in low- and middle-income countries. Such areas do not have access to expensive imaging technologies, such as elastography, and inexpensive non-invasive biomarker kits would be critical in making early diagnoses. Research conducted by the CDC reports that such tests as the AST-to-platelet ratio index (APRI) have potential in areas with few resources.

NAFLD is estimated to have a prevalence of approximately 25% of the worldwide population, and it is on the rise in nations such as India and China, which accelerates the necessity of affordable diagnostics. The factors fuelling the growth in the hepatic fibrosis biomarker kits market are governments of these regions and healthcare facilities putting emphasis on cost-effective testing so as to enhance disease management, which has made emerging markets major drivers of growth in this area.

What are the key market segments in the Hepatic Fibrosis Biomarkers industry?

Based on the Diagnostic Technique, the Hepatic Fibrosis Biomarkers Market is classified into Imaging Techniques, Serum-based Tests, and Molecular Diagnostics. Molecular diagnostics is the largest category in the hepatic fibrosis biomarkers market. This is because it is highly sensitive and specific in the identification of early-stage fibrosis with genetic and proteomic markers, which is hypothetically adept in plotting the disease and forecasting which is effectively progression with traditional imaging or serum testing. Personalised treatment. With an increasing volume of clinical and research work demanding molecular tests, large-scale personalised treatment is likely. The steadily growing popularity of non-invasive and very accurate molecular appliances also continues to enlarge this group greatly.

Based on the application, the Hepatic Fibrosis Biomarkers Market is classified into Diagnostic Testing, Prognostic Testing, Drug Discovery & Development, Clinical Trials Monitoring, and Personalized Medicine. Diagnostic testing is carrying the largest and most dominant position in terms of the hepatic fibrosis biomarkers market. This is because timely and precise diagnosis of hepatic fibrosis is of utmost importance in terms of managing the disease and the subsequent progression to liver cancer or cirrhosis. The availability of biomarkers to be used in diagnostic testing enables non-invasive, time-saving, and accurate determination of liver fibrosis, obviating the need to perform invasive liver biopsies. It is the most widely used application in clinical practice and in deciding treatment strategies, and thus holds the major market potential.

Which regions are leading the Hepatic Fibrosis Biomarkers market, and why?

The North American hepatic fibrosis biomarkers market is dominant, as a combination of advanced health infrastructure, prevalence of liver diseases, and substantial investment in research and development leads to the market. The region is widely represented by the key pharmaceutical and biotechnology companies developing non-invasive diagnostic technologies on the basis of biomarkers. Further, increasing awareness of early detection of diseases and the positive reimbursement policy have stimulated the usage of these biomarkers.

The United States dominates the leadership in the market share, especially as it has a high prevalence of diseases such as non-alcoholic fatty liver disease (NAFLD) and hepatitis C. There is strong government support and a well-established clinical trials network. Cooperation with universities and companies is on the rise, leading to ongoing innovation and product development in this field.

The Asia Pacific Hepatic Fibrosis Biomarkers Market is growing due to an increase in the prevalence of liver diseases in the region, primarily hepatitis B and C, and a rising intake of alcohol in countries like China and India. There is also an emerging burden of non-alcoholic fatty liver disease (NAFLD) in the region brought about by changing lifestyles, obesity, and diabetes.

The rise of rapidly increasing costs of healthcare and the desire made by the governments and healthcare systems to move towards early diagnosis and preventative care is fuelling the demand for non-invasive diagnostic solutions like biomarkers. Jointly, innovations in biotechnology, growing research efforts, and liver disease research funding are driving the pace of biomarker development.

The availability of a huge patient load, the expansion of the healthcare infrastructure, and the development of awareness regarding the health of the liver further establish the Asia Pacific as a market with high growth prospects. In addition, the partnership between international and domestic pharmaceutical organisations is stimulating technological outgrowth and market penetration. The simultaneous increase in income levels and the easier availability of high-tech diagnostic services are contributing to the market penetration in this region.

What does the competitive landscape of the Hepatic Fibrosis Biomarkers market look like?

The hepatic fibrosis biomarker market becomes highly competitive as it results in the development of more and more companies concentrated on the creation of non-invasive and reliable diagnostic tools for liver fibrosis. Vendors, including Siemens Healthineers, Genfit, BioPredictive, and Quest Diagnostics, have been the most innovative by extending their use of advanced technologies with AI and multi-omics-based approaches to increase diagnostic accuracy.

Other pharma companies such as AstraZeneca and Gilead Sciences are also investing heavily in research biomarkers to develop drugs to treat liver diseases such as NASH. Recently, biotech firms and diagnostic firms have joined efforts in bringing about composite panels of biomarkers to stage fibrosis without liver biopsy. Development of the market further relies on the increased awareness in regard to chronic liver diseases and the clinical necessity of early detection, which makes it necessary to distinguish through technology and clinical validation to achieve success.

Hepatic Fibrosis Biomarkers Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the Hepatic Fibrosis Biomarkers industry?

• In August 2025, HistoIndex launched FibroSIGHT™ Plus. This new AI-based Lab Developed Test improved automation and precision for measuring liver fibrosis. It gave pathologists a more reliable and consistent tool to manage fibrotic liver disease in the U.S.
• In April 2025, Inventiva published a study in Clinical Gastroenterology and Hepatology. The study introduced novel biomarker panels called E1, E2, and E3 scores, which combined indicators like adiponectin, ferritin, cytokeratin 18 fragments, hyaluronic acid, and liver enzymes. These scores showed high accuracy (AUROC ~0.81) in predicting histological responses in MASH patients treated with lanifibranor.

Report Coverage:

By Diagnostic Technique

• Imaging Techniques
  • Magnetic Resonance Elastography
  • Ultrasound-based Elastography
  • CT-based Techniques
• Serum-based Tests
  • Direct Biomarkers
  • Indirect Biomarkers
• Molecular Diagnostics

By Application

• Diagnostic Testing
• Prognostic Testing
• Drug Discovery & Development
• Clinical Trials Monitoring
• Personalized Medicine

By Biomarker Type

• Serum Biomarkers
• Imaging Biomarkers
• Genetic Biomarkers
• Proteomic Biomarkers
• Metabolomic Biomarkers

By Biomarker Origin

• Extracellular Matrix Biomarkers
• Inflammatory Biomarkers
• Genetic & Epigenetic Biomarkers

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes
• Pharmaceutical & Biotechnology Companies
• Academic Centers

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Genfit SA
• BioPredictive S.A.S.
• Nordic Bioscience
• Siemens Healthineers AG
• Labcorp
• Quest Diagnostics Incorporated
• Prometheus Laboratories Inc.
• AstraZeneca plc
• Bristol‑Myers Squibb Company
• Pfizer Inc.
• Novartis AG
• Gilead Sciences, Inc.
• Meridian Bioscience
• NGM Biopharmaceuticals, Inc.
• Perspectum Diagnostics Ltd.

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