Liver Disease Diagnostics Market (2025 - 2033) Size, Share & Trends Analysis Report By Diagnosis Technique (Imaging, Laboratory Tests, Endoscopy, Biopsy), By Disease (NAFLD, NASH, Fibrosis, Cirrhosis), By End Use (Hospitals, Laboratories), By Region, And Segment Forecasts

Liver Disease Diagnostics Market Summary

The global liver disease diagnostics market size was valued at USD 37.85 billion in 2024 and is expected to reach USD 66.40 billion by 2033, growing at a CAGR of 6.39% from 2025 to 2033. This market centers on innovative diagnostic tools that enable early detection and monitoring of liver conditions, supporting improved patient outcomes. 

The growing emphasis on non-invasive testing methods and molecular diagnostics drives demand across clinical settings. These diagnostic solutions find application in identifying liver fibrosis, cirrhosis, hepatitis, and other liver-related disorders. Key contributors to this trend include the intensified efforts by leading companies to develop sensitive and rapid testing methods tailored for specific demographics, such as pregnant women and individuals living with HIV. Additionally, ongoing research and development aimed at creating accurate diagnostic systems is likely to improve timely diagnoses and patient outcomes. The introduction of innovative diagnostic approaches, along with shifts in lifestyle factors like increased alcohol consumption and poor dietary habits, is also projected to influence the liver disease diagnostics market positively.

A notable advancement in this field is the FDA's approval of the Xpert HCV test and GeneXpert Xpress System by Cepheid in June 2024. This authorization marks the first point-of-care hepatitis C RNA test, allowing healthcare providers to diagnose and treat hepatitis C during the same visit. The test provides results in approximately an hour using a fingertip blood sample and can be conducted in various settings, including substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor's offices, emergency departments, and urgent care clinics. This development exemplifies the growing trend toward rapid, accessible, and patient-centered diagnostic solutions in liver disease care.

Advancements in biomarker discovery and molecular diagnostic methods have greatly advanced liver disease diagnostics. The use of next-generation sequencing (NGS) and liquid biopsy techniques offers clinicians more accurate and real-time understanding of liver conditions. These tools enable early detection of disease and personalized treatment approaches, which are vital because many liver disorders often progress without symptoms.

The increasing rate of liver diseases worldwide, caused by factors such as viral hepatitis, alcohol use, and non-alcoholic fatty liver disease (NAFLD), further drives market growth. Greater awareness about liver health and government efforts to improve diagnostic facilities also significantly contribute to broader market adoption. Moreover, the move toward outpatient care and point-of-care testing improves access, allowing for quicker interventions and easing the pressure on healthcare systems.

Overall, innovation in the liver disease diagnostics market is driven by the need for faster, more accurate, and less invasive testing methods. The introduction of rapid point-of-care platforms and advanced molecular techniques has transformed how liver diseases are detected and managed, enabling timely interventions and personalized treatment plans. Additionally, the integration of artificial intelligence is improving data interpretation and predictive capabilities, while portable diagnostic devices are increasing access to testing in underserved areas. These technological advancements collectively contribute to better patient outcomes and are expected to shape the future trajectory of the market.

Market Concentration & Characteristics

The liver cancer diagnostics market is witnessing significant innovation, characterized by the development of advanced imaging techniques, biomarker assays, and minimally invasive testing methods. These innovations enhance early detection and accuracy, improving patient outcomes. Companies are increasingly focusing on integrating artificial intelligence and machine learning to further refine diagnostic processes.

The level of mergers and acquisitions (M&A) in the liver cancer diagnostics market is relatively high, driven by the pursuit of technological advancements and expanded market presence. Companies are actively acquiring smaller firms with innovative diagnostic solutions and technologies to enhance their product portfolios and accelerate research and development efforts. This trend reflects a competitive landscape where collaboration and strategic partnerships are essential for growth and innovation.

Regulations significantly impact the liver cancer diagnostics market by ensuring the safety, efficacy, and quality of diagnostic products. Stringent regulatory requirements can enhance patient trust and drive market growth by encouraging the development of innovative technologies. However, these regulations can also lead to longer approval timelines and increased costs for companies, potentially slowing down the introduction of new diagnostic tools. Additionally, adherence to evolving regulations fosters collaboration between manufacturers and regulatory bodies, promoting the advancement of standardized testing protocols and improved diagnostic accuracy.

Companies are focusing on developing a wider range of tests, including advanced imaging technologies, biomarker assays, and liquid biopsies, to enhance early detection and monitoring. This expansion often includes partnerships with research institutions and healthcare providers to validate new products and integrate them into clinical practice. Additionally, firms are exploring innovations in point-of-care testing to improve accessibility and convenience for patients, thereby broadening their market reach and addressing diverse healthcare needs.

Regional expansion in the liver cancer diagnostics market is characterized by companies targeting emerging markets and underserved regions with high incidences of liver disease. As awareness of liver health increases and healthcare infrastructure improves, firms are strategically entering these markets through partnerships, local manufacturing, and tailored marketing strategies. Additionally, regulatory bodies in various regions are increasingly supportive of innovative diagnostic solutions, further encouraging market entry. This expansion not only aims to increase market share but also seeks to improve patient access to essential diagnostic tools, ultimately enhancing early detection and treatment outcomes globally.

Diagnosis Technique Insights

The imaging segment led the global market with a 30.62% share in 2024. Imaging dominates the liver disease diagnostics market because of its non-invasive nature and ability to provide detailed views of liver anatomy and pathology. Techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) enable clinicians to detect liver tumors, evaluate liver damage, and monitor disease progression effectively. These methods offer high sensitivity and specificity, which are essential for accurate diagnosis. Additionally, advances in imaging technologies, like elastography and contrast-enhanced imaging, have improved assessments of liver stiffness and blood flow, boosting diagnostic capabilities. The increasing prevalence of liver diseases, including hepatitis and liver cancer, further accelerates the demand for reliable imaging methods.

Biopsy is expected to grow at a steady CAGR of 6.48% over the forecast period. Biopsy plays a crucial role in diagnosing liver diseases by providing definitive tissue samples for histopathological examination. This procedure allows healthcare professionals to assess the nature and extent of liver damage, identify specific conditions such as hepatitis, cirrhosis, or liver cancer, and determine the underlying causes of liver dysfunction. There are several types of liver biopsies, including percutaneous, trans jugular, and laparoscopic approaches, each suited to different clinical scenarios. By analyzing the cellular composition and architecture of liver tissue, pathologists can identify inflammation, fibrosis, and tumor characteristics, which are essential for developing targeted treatment plans. Biopsies also help in assessing the severity of disease and monitoring response to therapies, enabling personalized patient management. While less commonly performed due to the availability of non-invasive alternatives, biopsies remain a vital tool in certain cases where a precise diagnosis is necessary for effective treatment decisions.

Disease Insights

The NAFLD segment led the market in 2024. Non-alcoholic fatty liver disease (NAFLD) dominates the liver disease diagnostics market because of its increasing prevalence, which aligns with global trends in obesity, diabetes, and metabolic syndrome. As a complex condition, NAFLD ranges from simple fatty liver to more severe forms like non-alcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver cancer. Growing awareness of NAFLD among healthcare providers and patients has boosted demand for effective diagnostic tools. Non-invasive methods such as imaging techniques and biomarker tests have become more popular, enabling early detection without the need for liver biopsies. This is especially important since many individuals with NAFLD show no symptoms until advanced stages, underscoring the importance of regular screening. Additionally, regulatory agencies are highlighting NAFLD in their guidelines, promoting the development of targeted therapies and diagnostics. Consequently, NAFLD's increasing recognition as a major public health concern has cemented its lead position in the liver disease diagnostics market.

NASH is poised to emerge as the most lucrative segment of the liver disease diagnostics market and is expected to grow at a CAGR of 7.19% over the forecast period. NASH is increasingly recognized as a severe liver condition that can lead to cirrhosis and liver cancer, driving a higher demand for accurate diagnostic tools and treatments. As the prevalence of obesity and metabolic syndrome rises globally, the number of individuals affected by NASH is expected to grow, further fueling market potential.

End Use Insights

The hospitals segment had the largest revenue share in 2024 mainly because most patients rely on hospitals equipped with advanced diagnostic testing devices. Hospitals are crucial for delivering high-quality patient care and enabling early detection and diagnosis, which drives the growth of the liver disease diagnostics market. Additionally, ongoing improvements in healthcare infrastructure are expected to further enhance hospital capabilities and services. This segment is also projected to be the most profitable of all.

The laboratories segment is experiencing rapid growth in the liver disease diagnostics market. This increase is mainly driven by the rising demand for specialized and high-volume testing, including serological panels, molecular assays, and biomarker-based fibrosis screening, which are often outsourced to centralized labs. Key factors supporting this growth include the expansion of diagnostic facilities-especially in emerging economies-improved access, and more affordable testing options. Labs are also gaining from technological improvements like automated analyzers, immunoassays, digital pathology, and AI-assisted diagnostics, all of which enhance accuracy, throughput, and workflow efficiency.

Regional Insights

North America liver disease diagnostics market dominated the overall global market and accounted for the 43.46% share in 2024, driven by the rising prevalence of liver diseases, such as non-alcoholic fatty liver disease (NAFLD) and hepatitis, is driving demand for effective diagnostic tools. As awareness of these conditions increases, more patients seek medical attention, prompting healthcare providers to invest in advanced diagnostic technologies. Secondly, significant advancements in diagnostic methods, including non-invasive imaging techniques and biomarker assays, are enhancing early detection and patient outcomes. These innovations are increasingly being adopted by hospitals and clinics across the region. 

Additionally, strong regulatory support and initiatives aimed at improving liver disease awareness contribute to market growth. The presence of major pharmaceutical and biotech companies in North America fosters a competitive environment, driving research and development of new diagnostic solutions. Lastly, the integration of healthcare systems and electronic health records facilitates better monitoring and management of liver diseases, further supporting market expansion.

U.S. Liver Disease Diagnostics Market Trends

The U.S. liver disease diagnostics market accounted for a significant portion of the North American market in 2024. Rapid advancements in non-invasive diagnostic techniques, such as elastography and novel biomarker tests, have simplified the detection of liver diseases by reducing the reliance on invasive procedures. These innovations support earlier diagnosis and contribute to improved patient outcomes, driving widespread adoption among healthcare providers.

A recent milestone in this space is the FDA’s granting of Breakthrough Device Designation to the EvoLiver test in April 2025. Developed by Mursla Bio, EvoLiver is a blood-based assay designed to detect early-stage hepatocellular carcinoma (HCC) in patients with high-risk cirrhosis. In the MEV01 clinical trial, the test demonstrated 86% sensitivity and 88% specificity, outperforming traditional diagnostic methods such as ultrasound and alpha-fetoprotein testing. This recognition highlights the growing focus on non-invasive, precise diagnostic solutions within the U.S. liver disease diagnostics market.

Europe Liver Disease Diagnostics Market Trends

The Europe liver disease diagnostics market is experiencing significant growth. Strong regulatory frameworks and initiatives aimed at improving public health awareness around liver diseases support market growth. The presence of leading research institutions and healthcare companies in Europe fosters a collaborative environment for developing new diagnostic methods. Lastly, the emphasis on preventive healthcare and routine screenings further boosts the demand for liver disease diagnostics across the region.

The UK liver disease diagnostics market is experiencing significant growth due to healthcare improvements and technological developments. A strong presence of research institutions and biotechnology firms in the UK fosters innovation and collaboration, paving the way for the development of new diagnostic tools tailored to meet the needs of patients with liver diseases

The Germany liver disease diagnostics market is experiencing significant growth, driven by Germany's robust healthcare system, characterized by comprehensive insurance coverage and access to high-quality medical care, supports the adoption of advanced diagnostic technologies. Regulatory bodies in Germany also encourage the development and integration of new diagnostic solutions, further promoting market growth.

Asia Pacific Liver Disease Diagnostics Market Trends

The Asia Pacific liver disease diagnostics market is experiencing the fastest growth, driven by increasing prevalence of liver diseases, particularly hepatitis B and C, as well as non-alcoholic fatty liver disease (NAFLD), is driving demand for effective diagnostic solutions. Rapid urbanization and lifestyle changes in countries like China and India have contributed to a rise in liver-related health issues.

The Japan liver disease diagnostics market is experiencing growth. The high prevalence of liver diseases, particularly hepatitis B and C, as well as non-alcoholic fatty liver disease (NAFLD), is driving demand for effective diagnostic tools. Japan has a well-established healthcare system that emphasizes early detection and management of liver conditions, encouraging patients to seek diagnostic testing.

The China liver disease diagnostics market is growing, driven by a collaboration between local research institutions and international biotech companies is fostering innovation, resulting in the development of new and effective diagnostic solutions tailored to meet the specific needs of the Chinese population.

Latin America Liver Disease Diagnostics Market Trends

The Latin America Liver Disease Diagnostics market is experiencing significant growth, due to advancements in medical technology, particularly non-invasive diagnostic methods, are improving access to accurate liver disease detection. Techniques such as elastography and innovative biomarker assays are gaining traction, making early diagnosis more achievable and reducing reliance on invasive procedures.

Middle East and Africa Liver Disease Diagnostics Market Trends

The MEA liver disease diagnostics market is expanding. Government initiatives focused on public health awareness and improving healthcare infrastructure are supporting market growth. Collaborations between local and international health organizations are fostering the development of new diagnostic tools tailored to regional needs.

The Saudi Arabia liver disease diagnostics market is characterized by rapid innovation, growing competition, and a dynamic regulatory environment. The Saudi Arabian government is investing heavily in healthcare as part of its Vision 2030 initiative, further encouraging the adoption of advanced diagnostic tools.

Key Liver Disease Diagnostics Company Insights

Key players in the liver disease diagnostics market are prioritizing new product development and obtaining regulatory approvals to broaden their product portfolios. In parallel, companies are engaging in strategic initiatives such as partnerships, collaborations, mergers, and acquisitions to reinforce their market positions. These actions focus on expanding technological capabilities, extending geographic coverage, and facilitating wider access to rapid and accurate diagnostic solutions across varied healthcare environments.

Recent Developments

• In May 2025, Roche launched the Elecsys PRO-C3 test, a biomarker assay designed to assess liver fibrosis severity rapidly, providing results within 18 minutes to support timely clinical decision-making in liver disease management.

• In July 2025, LuminoDx announced its participation at the World Transplant Congress, where it will present and exhibit its proprietary liquid biopsy technology designed for non-invasive monitoring of liver transplant recipients. This development reflects increasing focus on advanced diagnostic solutions to improve post-transplant care and management in the liver disease diagnostics market.

• In August 2024, Lumos Diagnostics announced that they will be expanding the current deal Burnet Diagnostics Initiative to develop a point of care test to monitor liver function.

Liver Disease Diagnostics Market Report Scope

Global Liver Disease Diagnostics Market Report Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For the purpose of this report, Grand View Research has segmented the global liver disease diagnostics market on the basis of diagnosis technique, disease, end use and region:

• Diagnosis Technique Outlook (Revenue, USD Million, 2021 - 2033)

  • Laboratory Tests

  • Imaging

  • Endoscopy

  • Biopsy

  • Others

• Disease Outlook (Revenue, USD Million, 2021 - 2033)

  • NAFLD

  • NASH

  • Fibrosis

  • Cirrhosis

  • HCC

  • Others

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Hospitals

  • Laboratories

  • Others

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait