Global Hepatitis B and C Diagnostics Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In April 2019, Access Bio Inc. partnered with Atomo Diagnostics to create a rapid diagnostic test (RDT) for hepatitis C virus (HCV) screening, aiming to make the test available by the end of the year. This partnership responded to the need for quicker, more accessible testing solutions, especially beneficial in regions with limited healthcare infrastructure.

• In December 2023, the Clinton Health Access Initiative (CHAI) published its third edition of the Hepatitis C Market Intelligence Report. This report provides updates on the supplier landscape for WHO-recommended HCV diagnostics, highlights affordability strategies, and explores harm reduction commodities. This effort aims to improve transparency and accessibility in hepatitis C diagnostics, particularly in high-burden, low- and middle-income countries.

The global hepatitis B and C diagnostics market is experiencing significant growth, driven by several factors. Firstly, increasing awareness about these diseases and their potential complications among healthcare providers and patients is fueling demand for diagnostic tests. With greater understanding of the importance of early detection and treatment, there's a growing emphasis on routine screening, especially in high-risk populations such as intravenous drug users and individuals from regions with high disease prevalence.

Technological advancements in diagnostic techniques are enhancing the accuracy and efficiency of hepatitis B and C testing. Innovations in molecular diagnostics, such as PCR-based assays and nucleic acid amplification tests (NAATs), have greatly improved the sensitivity and specificity of detecting viral genetic material, enabling earlier and more precise diagnosis.

The increasing incidence of hepatitis B and C infections globally is driving the demand for diagnostics. Factors such as unsafe injection practices, inadequate sterilization of medical equipment, and lack of access to screening and vaccination programs contribute to the continued transmission of these viruses. As a result, healthcare systems are under pressure to expand diagnostic capabilities to meet the growing testing needs and to facilitate prompt initiation of treatment to reduce disease burden and prevent further transmission.

The global hepatitis B and C diagnostics market is witnessing robust growth propelled by factors such as heightened awareness, technological advancements, and rising disease incidence. As the healthcare industry continues to prioritize early detection and management of these viral infections, the demand for innovative diagnostic solutions is expected to remain strong, driving further market expansion.

Global Hepatitis B and C Diagnostics Segment Analysis

In this report, the Global Hepatitis B and C Diagnostics Market has been segmented by Procedure, Disease and Geography.

Global Hepatitis B and C Diagnostics Market, Segmentation by Procedure

The Global Hepatitis B and C Diagnostics Market has been segmented by Procedur into Immunodiagnostics, Immunofluorescence, Instruments, Reagents, Hepatitis B and C immunodiagnostics, NAT and Hepatitis B and C NAT.

The global hepatitis B and C diagnostics market is segmented by procedure, catering to the diverse needs of healthcare providers and patients worldwide. One significant segmentation lies in the diagnostic procedures utilized for detecting these infections. These procedures include serology tests, nucleic acid tests (NAT), and imaging tests. Serology tests detect the presence of antibodies or antigens in the blood, aiding in the diagnosis of hepatitis B and C infections. NAT involves the detection of viral genetic material, providing highly sensitive and specific results. Imaging tests, such as ultrasound and MRI, help evaluate liver health and detect any abnormalities caused by hepatitis B or C.

Another crucial segmentation factor is the type of setting where diagnostics are performed. Hepatitis B and C diagnostics can be conducted in various settings, including hospitals, diagnostic laboratories, and point-of-care (POC) settings. Hospitals typically offer comprehensive diagnostic services, including serology tests, NAT, and imaging, making them crucial hubs for diagnosing and managing hepatitis B and C infections. Diagnostic laboratories specialize in conducting a wide range of tests, providing accurate and timely results to healthcare providers. POC settings, such as clinics and community health centers, offer rapid testing options for quick diagnosis and intervention, particularly in resource-limited settings or for remote populations.

The market segmentation extends to the geographical regions where these diagnostics are utilized. The prevalence of hepatitis B and C infections varies across regions, influencing the demand for diagnostic services. High-prevalence regions, such as parts of Asia, Africa, and Eastern Europe, exhibit a greater need for hepatitis B and C diagnostics due to the higher burden of these infections. In contrast, regions with lower prevalence rates may prioritize screening efforts among at-risk populations or focus on managing existing cases through surveillance and treatment programs. Understanding regional variations in disease burden and healthcare infrastructure is essential for tailoring diagnostic strategies and allocating resources effectively to combat hepatitis B and C on a global scale.

Global Hepatitis B and C Diagnostics Market, Segmentation by Disease

The Global Hepatitis B and C Diagnostics Market has been segmented by Disease into Hepatitis B, Hepatitis B diagnostics, Hepatitis C and Hepatitis C diagnostics.

Hepatitis B remains a significant public health concern worldwide, with over 250 million people estimated to be chronically infected. The diagnostics market for hepatitis B encompasses a range of tests including serologic tests, nucleic acid tests (NAT), and point-of-care tests (POCT). Serologic tests detect viral antigens or antibodies in blood, while NAT can directly detect viral DNA or RNA. POCT offers rapid results and is particularly useful in resource-limited settings.

Hepatitis C, characterized by a high rate of chronic infection, affects approximately 71 million people globally. The diagnostics market for hepatitis C has evolved significantly with the advent of direct-acting antivirals (DAAs) that have transformed treatment outcomes. Diagnostic tests include antibody tests to detect past exposure, RNA tests to confirm active infection, and genotype testing to guide treatment decisions. The emphasis is on early detection to prevent complications like cirrhosis and hepatocellular carcinoma.

In both disease segments, technological advancements such as next-generation sequencing (NGS) and the development of biomarker-based assays are driving innovation. These advancements are crucial for improving accuracy, sensitivity, and cost-effectiveness, thereby facilitating better disease management and treatment outcomes. The market is also witnessing increased demand for rapid, accurate, and affordable diagnostics, especially in regions with high disease prevalence but limited healthcare infrastructure.

Global Hepatitis B and C Diagnostics Market, Segmentation by Geography

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

Global Hepatitis B and C Diagnostics Market Share (%), by Geographical Region, 2024

The global hepatitis B and C diagnostics market exhibits varying dynamics across different geographical regions. In North America, the market is primarily driven by the presence of advanced healthcare infrastructure, high awareness levels among the population, and favorable government initiatives for the prevention and control of hepatitis. Additionally, the region benefits from the presence of key market players and ongoing research and development activities aimed at improving diagnostic techniques and treatment options. However, challenges such as stringent regulatory requirements and high healthcare costs could potentially hinder market growth in this region.

In Europe, the hepatitis B and C diagnostics market is characterized by a growing prevalence of these diseases, particularly among high-risk populations such as injecting drug users and individuals with a history of blood transfusions. As a result, there is an increasing demand for effective diagnostic tools to facilitate early detection and management of hepatitis infections. Moreover, government-supported screening programs and initiatives aimed at raising awareness about hepatitis contribute to market growth in this region. However, budget constraints faced by healthcare systems in some European countries may limit the adoption of advanced diagnostic technologies.

In the Asia Pacific region, the hepatitis B and C diagnostics market is driven by factors such as a large patient pool, increasing healthcare expenditure, and rising awareness about the importance of disease screening and prevention. Countries like China and India are witnessing significant market growth due to improving healthcare infrastructure, expanding access to diagnostic services, and initiatives aimed at controlling the spread of hepatitis infections. Furthermore, collaborations between international organizations, governments, and healthcare providers are facilitating the development and implementation of cost-effective diagnostic solutions tailored to the needs of the local population. Despite these opportunities, challenges such as limited access to healthcare in rural areas and disparities in healthcare quality across different socioeconomic segments remain significant concerns for market stakeholders in the Asia Pacific region.

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

Drivers, Restraints and Opportunity Analysis

Key players in Global Hepatitis B and C Diagnostics Market include:

• Abbott Laboratories
• Bio-Rad Laboratories Inc.
• bioMérieux SA
• DAAN Gene Co. Ltd.
• DiaSorin SpA
• Enzo Biochem Inc.
• F. Hoffmann-La Roche Ltd.
• Grifols SA
• Hologic Inc.
• MedMira Inc.
• OraSure Technologies Inc.
• Perkin Elmer Inc.
• QIAGEN NV
• QuidelOrtho Corp.
• Randox Laboratories Ltd.
• Siemens AG
• Sysmex Corp.
• Xiamen Innovax Biotech Co. Ltd.

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