Hepatitis Diagnostic Tests Market Report 2025

This report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.

The hepatitis diagnostic tests market size has grown strongly in recent years. It will grow from $4.64 billion in 2024 to $4.95 billion in 2025 at a compound annual growth rate (CAGR) of 6.5%. The growth in the historic period can be attributed to globalization of healthcare, government initiatives, high disease burden, increased blood safety measures, public health campaigns.

The hepatitis diagnostic tests market size is expected to see strong growth in the next few years. It will grow to $6.24 billion in 2029 at a compound annual growth rate (CAGR) of 6%. The growth in the forecast period can be attributed to global health security concerns, population growth and urbanization, tailored testing strategies, emphasis on elimination programs, increasing healthcare spending. Major trends in the forecast period include advancements in testing technologies, multiplex testing for different hepatitis viruses, integration of molecular diagnostics, digital health solutions, strategic collaborations and partnerships.

The increasing number of blood transfusions and donations is expected to drive growth in the hepatitis diagnostic test market. Blood transfusions and donations are connected processes in which individuals voluntarily provide blood, which is then collected, tested, and administered to patients in need of additional blood components due to medical conditions, surgeries, accidents, or illnesses. Hepatitis diagnostic tests are essential for thoroughly screening blood before donation or transfusion, ensuring patient safety. For instance, in August 2023, the Royal College of Pathologists, a UK-based organization, reported that blood transfusion is the most commonly performed procedure for hospitalized patients, with nearly 2 million blood components issued and transfused annually in England, costing over £300 million ($390.69 million). Thus, the growing number of blood transfusions and donations supports the expansion of the hepatitis diagnostic test market.

The surge in hepatitis cases globally is another key factor propelling the growth of the hepatitis diagnostic tests market. Hepatitis, characterized by liver inflammation, poses significant health risks and can lead to various symptoms and complications. Accurate diagnostic tests for hepatitis are crucial in identifying and confirming the presence of hepatitis infections, enabling timely interventions and effective disease management. For instance, according to the Hepatitis B Foundation in 2023, an estimated 1.5 million people contract hepatitis infections annually, highlighting the persistent challenge posed by these diseases. The growing incidence of hepatitis underlines the critical importance of reliable diagnostic tests in early detection and management, thereby fueling the demand for hepatitis diagnostic tests in the market.

Dominant players in the hepatitis diagnostic test market are concentrating on innovating automated immunoassays, exemplified by the Elecsys HCV Duo, to enhance customer service reliability. Automated immunoassays represent laboratory techniques utilizing automated systems and specialized instruments to conduct various phases of the immunoassay process, encompassing sample handling, reagent mixing, incubation, detection, and result calculation. For instance, in July 2023, Roche Diagnostics India, a biotechnology research company based in India, introduced Elecsys HCV Duo. This advanced solution represents India's maiden fully automated immunoassay available commercially, facilitating the simultaneous and independent evaluation of hepatitis C virus (HCV) antigen and antibody levels from a single human plasma or serum sample. Moreover, this approach streamlines the diagnostic procedure, enabling single-specimen testing and potentially reducing the number of necessary follow-up visits, consequently alleviating the burden on healthcare systems.

In October 2024, The Bank of Nova Scotia, a Canada-based company, acquired Bio-Rad Laboratories Inc. for an undisclosed amount. This acquisition allows The Bank of Nova Scotia to diversify its portfolio by integrating Bio-Rad Laboratories’ expertise in hepatitis diagnostic testing. Bio-Rad Laboratories Inc., a U.S.-based company, is known for its products and services in diagnostic testing for hepatitis.

Major companies operating in the hepatitis diagnostic tests market report are Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Roche Diagnostics, Quest Diagnostics Incorporated, Grifols S.A, Hologic Inc., BioMérieux SA, Beckman Coulter Inc., Bio-Rad Laboratories Inc., SD Biosensor Co. Ltd., QIAGEN N.V., DiaSorin S.p.A., Randox Laboratories Ltd., Luminex Corporation, Fujirebio Diagnostics Inc., Trivitron Healthcare Private Limited, Trinity Biotech PLC, MP Biomedicals LLC, R-Biopharm AG, Creative Diagnostics, InBios International Inc., Dia.Pro Diagnostic Bioprobes srl, DIALAB GmbH.

North America was the largest region in the hepatitis diagnostic tests market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the hepatitis diagnostic tests market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the hepatitis diagnostic tests market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The hepatitis diagnostic test market consists of revenues earned by entities by providing diagnostic services such as liver ultrasound, computerized tomography (CT) scans, and antibody tests. The market value includes the value of related goods sold by the service provider or included within the service offering. The hepatitis diagnostic test market also includes sales of laboratory equipment, reagents, and assay components that are used in providing hepatitis diagnostic test services. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Hepatitis diagnostic tests are medical procedures and laboratory analyses designed to identify and diagnose infections caused by hepatitis viruses, including hepatitis A, B, C, D, and E. These tests are essential for detecting the presence of hepatitis viruses or specific antibodies in a patient's blood or other bodily fluids. The primary goal is to confirm the infection, determine its type, assess severity, and monitor its progression.

The main categories of hepatitis diagnostic tests include blood tests, imaging tests, and liver biopsy. Blood tests involve examining blood samples to assess various constituents such as blood cells, proteins, enzymes, hormones, antibodies, and other chemicals. Various technologies are utilized in these tests, including enzyme-linked immunosorbent assay (ELISA), rapid diagnostic tests, polymerase chain reaction (PCR), isothermal nucleic acid amplification tests, and others. These diagnostic tools find applications in diverse healthcare settings such as hospitals, diagnostic laboratories, blood banks, and other medical facilities.

The hepatitis diagnostic tests market research report is one of a series of new reports that provides hepatitis diagnostic tests market statistics, including hepatitis diagnostic tests industry global market size, regional shares, competitors with a hepatitis diagnostic tests market share, detailed hepatitis diagnostic tests market segments, market trends, and opportunities, and any further data you may need to thrive in the hepatitis diagnostic test industry. This hepatitis diagnostic tests market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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