Global Hepatitis Diagnostic Test Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In July 2022, Roche announced the launch of Elecsys HCV Duo immunoassay for the hepatitis C diagnostic test. Elecsys HCV Duo immunoassay is intended to determine hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. The launch of this innovative dual antigen and antibody diagnostic test has helped the company to enhance their product portfolio and increase their business revenue.

• In February 2019, Abbott announced that they had received CE Mark approval for Determine HBsAg 2, a rapid diagnostic test for the detection of hepatitis B surface antigen. This test is an in-vitro, visually read, qualitative immunoassay for the detection of HBsAg in serum, plasma or whole blood and provides rapid and accurate results with analytical sensitivity. This regulatory approval helped the company to enhance their geographical presence and increase their customer base.

The Global Hepatitis Diagnostic Test Market has been segmented by diagnostic tests, technology, and end-use, each addressing specific aspects of the diagnosis and management of hepatitis infections. By diagnostic tests, the market includes blood tests, imaging tests, and liver biopsy. Blood tests are commonly used for diagnosing hepatitis, with liver function tests, immunoassays, and nucleic acid tests playing a key role. Liver function tests measure liver enzymes and other markers to assess liver damage, while immunoassays detect specific antibodies or antigens related to hepatitis viruses. Nucleic acid tests, such as PCR, are used to detect viral genetic material, enabling more accurate diagnosis and viral load measurement. Imaging tests, including ultrasound and elastography, provide visual insights into liver conditions, aiding in the detection of liver fibrosis or cirrhosis. Liver biopsy remains a gold standard for assessing the extent of liver damage, though it is less commonly performed due to its invasive nature.

By technology, the market includes various diagnostic approaches such as Enzyme-linked Immunosorbent Assay (ELISA), Rapid Diagnostic Tests (RDT), Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), and others. ELISA is widely used for detecting hepatitis antibodies and antigens, offering high sensitivity and specificity. RDTs are gaining popularity for their speed and ease of use, making them suitable for point-of-care settings, especially in regions with limited healthcare infrastructure. PCR is the gold standard for detecting and quantifying the hepatitis virus, providing critical information on viral load and genotype. INAAT is an emerging technology that offers rapid and sensitive detection of hepatitis viruses, presenting a potential alternative to PCR with advantages in terms of portability and faster results. Other technologies, such as lateral flow assays and fluorescent immunoassays, are also expanding the diagnostic capabilities in the market.

By end-use, the market is segmented into hospitals & diagnostic labs, blood banks, and others. Hospitals and diagnostic labs are the primary settings for hepatitis diagnostic tests, as they have the necessary infrastructure, skilled professionals, and equipment to conduct comprehensive testing. Blood banks play a crucial role in screening for hepatitis infections, ensuring blood safety for transfusions, particularly in regions where hepatitis prevalence is high. The "Others" category includes private clinics, research labs, and home testing kits, providing more options for testing outside traditional healthcare settings. This segmentation highlights the diverse landscape of the hepatitis diagnostic test market, catering to a wide range of testing needs across various healthcare environments.

Global Hepatitis Diagnostic Test Segment Analysis

In this report, the Global Hepatitis Diagnostic Test Market has been segmented by Diagnostic Tests, Technology, End-Use and Geography.

Global Hepatitis Diagnostic Test Market, Segmentation by Diagnostic Tests

The Global Hepatitis Diagnostic Test Market has been segmented by Diagnostic Tests into Blood tests, Imaging Tests and Liver Biopsy.

Global hepatitis diagnostic segmentation by diagnostic tests encompasses a range of methodologies aimed at identifying and characterizing hepatitis infections. One prevalent diagnostic test is serology, which involves detecting antibodies or antigens present in the blood. Serological tests, including enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests (RDTs), are crucial for screening individuals for hepatitis A, B, C, and E viruses. These tests enable healthcare providers to identify past exposure to the virus, current infection status, and immune response, thereby informing treatment decisions and public health interventions.

Molecular diagnostic tests play a pivotal role in hepatitis diagnosis by detecting viral nucleic acids in patient samples. Polymerase chain reaction (PCR) assays, nucleic acid amplification tests (NAATs), and next-generation sequencing (NGS) techniques are commonly used to detect and quantify hepatitis virus RNA or DNA. These tests offer high sensitivity and specificity, allowing for early detection of viral infections and monitoring of treatment efficacy. Additionally, molecular diagnostics enable the identification of viral genotypes and mutations, which inform therapeutic strategies and help mitigate the risk of antiviral resistance.

liver function tests (LFTs) are instrumental in assessing hepatic health and identifying liver damage associated with hepatitis infections. LFTs measure various enzymes, proteins, and substances in the blood, providing insights into liver function and integrity. Key parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and albumin levels. Abnormal LFT results may indicate liver inflammation, hepatocellular injury, or impaired synthetic function, prompting further evaluation and management. By incorporating serological, molecular, and biochemical assays, the diagnostic landscape for hepatitis encompasses a comprehensive approach to disease detection, characterization, and monitoring, facilitating timely interventions and improved patient outcomes.

Global Hepatitis Diagnostic Test Market, Segmentation by Technology

The Global Hepatitis Diagnostic Test Market has been segmented by Technology into Enzyme-linked Immunosorbent Assay (ELISA), Rapid Diagnostic Test, Polymerase Chain Reaction (PCR), Isothermal Nucleic Acid Amplification Technology (INAAT), and Others.

ELISA is widely used for detecting specific antibodies or antigens related to hepatitis viruses, offering high sensitivity and specificity. It is commonly used in diagnostic labs and hospitals for initial screening and confirmation of infection, especially for hepatitis B and C. RDTs, on the other hand, provide rapid results and are increasingly being adopted for point-of-care testing, particularly in resource-limited settings. Their simplicity and speed make them ideal for remote or rural areas where immediate results are needed.

PCR remains the gold standard in hepatitis diagnosis, particularly for detecting the presence of viral RNA or DNA in the blood. PCR provides accurate quantification of the virus, helping to determine viral load and monitor disease progression. This technology is crucial for assessing the effectiveness of antiviral treatment and determining the most appropriate therapeutic strategies. Isothermal Nucleic Acid Amplification Technology (INAAT) is an emerging technique that offers rapid and portable testing, often providing results faster than traditional PCR. INAAT is particularly beneficial in field settings and point-of-care testing, as it does not require complex laboratory equipment. Other technologies, such as lateral flow assays and fluorescent immunoassays, are also being developed to improve diagnostic speed and portability, further broadening the range of options for hepatitis testing. Together, these technologies enhance the market's ability to provide accurate, timely, and accessible hepatitis diagnostics across diverse healthcare settings.

Global Hepatitis Diagnostic Test Market, Segmentation by End-Use

The Global Hepatitis Diagnostic Test Market has been segmented by End-Use into Hospitals & Diagnostic Labs, Blood Banks, and Others.

Hospitals and diagnostic labs are the primary end-users, as they are equipped with advanced technologies and infrastructure to conduct a wide range of diagnostic tests. These settings typically offer comprehensive testing, including blood tests, imaging, and liver biopsy, providing a thorough evaluation of liver health and hepatitis infection. Hospitals, with their access to specialized healthcare professionals, are essential for diagnosing complex or severe hepatitis cases and managing patients with advanced liver disease.

Blood banks are another significant end-user in the hepatitis diagnostic test market. Given the critical importance of ensuring the safety of donated blood, blood banks regularly conduct screening for hepatitis infections to prevent the transmission of the virus through blood transfusions. With hepatitis B and C being major concerns in blood safety, blood banks utilize diagnostic tests such as nucleic acid testing (NAT) and enzyme-linked immunosorbent assays (ELISA) to detect viral presence and protect recipients from infection.

The Others category includes settings like private clinics, home healthcare services, and research laboratories. These establishments play a vital role in the diagnosis and monitoring of hepatitis in outpatient care or non-hospitalized patients. In private clinics, rapid diagnostic tests and basic blood tests are often used for quick screening, while research labs contribute to the development of new diagnostic techniques and therapies. This segmentation reflects the diverse applications of hepatitis diagnostic tests across different healthcare environments, ensuring that hepatitis is detected and managed effectively across a wide range of patient populations.

Global Hepatitis Diagnostic Test Market, Segmentation by Geography

In this report, the Global Hepatitis Diagnostic Test Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Hepatitis Diagnostic Test Market Share (%), by Geographical Region, 2024

The global hepatitis diagnostic market varies significantly across different geographical regions due to factors such as prevalence of hepatitis, healthcare infrastructure, and access to diagnostic technologies. In regions like Asia-Pacific and Africa, where hepatitis infections are more prevalent, there is a growing demand for hepatitis diagnostic tests. This demand is driven by efforts to control and manage hepatitis infections through early detection and treatment. However, challenges such as limited access to healthcare services and resources can affect the adoption of advanced diagnostic technologies in these regions, leading to a mix of traditional and modern diagnostic methods being used.

Developed regions like North America and Europe have well-established healthcare systems and higher healthcare spending, which contribute to greater adoption of advanced hepatitis diagnostic technologies. These regions often have comprehensive screening programs and guidelines for hepatitis testing, leading to earlier detection and better management of hepatitis infections. Additionally, the presence of leading diagnostic companies and research institutions in these regions fosters continuous innovation in hepatitis diagnostics, resulting in a wider range of sophisticated tests and technologies available to healthcare providers.

The regulatory landscape plays a crucial role in shaping the hepatitis diagnostic market across different regions. Stringent regulatory requirements in developed countries ensure the quality and accuracy of diagnostic tests, driving the development and adoption of new technologies. In contrast, regulatory challenges in developing regions may hinder the introduction of novel diagnostic products and limit market growth. Efforts to harmonize regulatory standards globally and improve access to essential diagnostic tools are essential for addressing the burden of hepatitis infections worldwide and promoting equitable healthcare outcomes across different geographical regions.

This report provides an in depth analysis of various factors that impact the dynamics of Global Hepatitis Diagnostic Test Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Key players in Global Hepatitis Diagnostic Test Market include:

• Siemens Healthineers
• F. Hoffmann La-Roche
• Abbott Laboratories
• DiaSorin S.p.A
• bioMeriuex
• MedMira
• Hologic Inc.
• Danaher Corporation
• Bio-Rad Laboratories.

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis