Report

The Global Hepatitis Diagnostic Test Market size is estimated at USD 4.73 billion in 2025, and is expected to reach USD 6.24 billion by 2030, at a CAGR of 5.67% during the forecast period (2025-2030).

The impact of COVID-19 in its initial phase was adverse owing to cancellations of diagnostic procedures worldwide. For instance, a research article published in the Journal of Hepatology in July 2022 stated that the COVID-19 pandemic hampered HBV and HCV overall services. The survey was conducted across 32 European and 12 non-European centers dealing with hepatitis B and C services. Chronic HBV consultations decreased by 30%, new referrals by 39%, HBsAg testing was reduced by 35%, and HBV DNA testing was reduced by 29%. HCV during the same time, the overall reductions were 41% for consultations, 49% for new referrals, 12% for HCV RNA detection, and 52% for new HCV antiviral treatments. However, the market gained traction as treatment, diagnostic procedures, and awareness campaigns resumed in the latter phase of the pandemic. For instance, in 2021, World Hepatitis Day was celebrated with the theme "Hepatitis Can'tWait," wherein the event emphasized the need for all countries to work together to eliminate viral hepatitis by 2030. This worldwide initiative by the WHO is anticipated to propel the hepatitis diagnostic test, which is ultimately projected to boost market growth during the forecast period.

The significant factors for the growth of the market include the growing burden of hepatitis, the introduction of molecular diagnostics for the diagnosis of hepatitis, and increasing awareness regarding the disease. For instance, according to the WHO's June 2022 report, an estimated 58 million people suffer from chronic hepatitis C virus infection worldwide, with about 1.5 million new cases occurring annually. There are an estimated 3.2 million adolescents and children with chronic hepatitis C infection. Such a high burden of the disease is anticipated to boost the market's growth. Moreover, awareness campaigns are conducted worldwide to educate people about the treatment and diagnosis of hepatitis. For instance, every year, the World Health Organization organizes a campaign named "World Hepatitis Day" to raise awareness and understanding of viral hepatitis. The WHO is focusing on the theme "Bringing hepatitis care closer to you" for World Hepatitis Day 2022 and has appealed for simplified service delivery of viral hepatitis services to bring care closer to communities. As early diagnosis helps improve the treatment of the disease, these awareness initiatives are projected to boost the demand for hepatitis diagnostics worldwide and augment the market's growth.

Additionally, the advancements in technology and increasing product approvals, along with partnerships and acquisitions by key players, are aiding the market's growth. For instance, in October 2021, Transasia Bio-Medicals, a diagnostic company based in India, launched a high-sensitivity ErbaLisa HCV Gen 4 Ag+Ab testing kit for the hepatitis C virus in India. Based on the latest method, the testing kit is one of India's first indigenously developed 4th generation ELISA kits and has been evaluated by the National Institute of Biologicals (NIB). Such technological advancements are predicted to boost the hepatitis diagnostic test demand and enhance market growth further.

Therefore, owing to the aforementioned factors, the studied market is anticipated to witness growth over the forecast period. However, restricted facilities or services for hepatitis testing and limited access to reliable and low-cost HBV and HCV diagnostics are likely to impede the market's growth.

Hepatitis Diagnostic Test Market Trends

Immunoassay Segment is Expected to Witness Growth Over the Forecast Period.

Immunoassays are bioanalytical methods in which the quantitation of the analyte depends on the reaction of an antigen with an antibody. Compared to conventional tests, immunoassays have been proven to provide highly accurate results, even with microscopic samples. The versatile applications and ease of diagnosis have made immunoassays quite popular in recent years. The Pan American Health Organization organized World Hepatitis Day on July 28th, 2022. The key message of the event was to eradicate hepatitis by 2030. The event highlighted the need to reduce new infections of hepatitis B and C by 40% by 2025. To eliminate hepatitis and meet the WHO's new interim targets by 2025, at least 60% of people living with hepatitis B and C should be diagnosed. This emphasizes the increasing need for immunoassay to diagnose different types of hepatitis, which is ultimately projected to augment the segment's growth during the forecast period.

In addition, the growing product launches, partnerships, and acquisitions by the key market players are leading to increased segment growth. For instance, in May 2022, Abbott launched the HBsAg next qualitative solution in India to improve the identification of the Hepatitis B virus (HBV). This extremely sensitive chemiluminescent microparticle immunoassay (CMIA) helps in the early and enhanced detection of HBV in human serum, plasma samples, and population screening. Such launches are projected to boost the segment's growth.

Thus, the aforementioned factors are anticipated to boost the market's growth over the forecast period.

North America is Expected to Dominate The Hepatitis Diagnostic Test Market Over the Forecast Period

North America is expected to dominate the market owing to advanced diagnostic tools, high awareness regarding the disease and diagnostic devices, the strong presence of industry players in the region, better healthcare infrastructure, and higher awareness among healthcare industry stakeholders about available technologies in the region. For instance, between April and September 2022, the Public Health Agency of Canada investigated 28 cases of severe acute hepatitis in children in Canada that met the national case definition. Thus, an increase in hepatitis cases is expected to increase its diagnostic testing, eventually driving the market growth in the region.

Additionally, the increasing product launches, partnerships, acquisitions, and government initiatives, particularly in the United States, bolsters the market's growth. For instance, in January 2021, Gilead Sciences, Inc. and Vir Biotechnology, Inc. formed a clinical collaboration to test novel therapeutic combination approaches to develop a functional cure for chronic hepatitis B virus (HBV). Such collaborations are projected to expedite the growth of the hepatitis diagnostic test market in the region.

Therefore, owing to the factors mentioned above, the growth of the studied market is anticipated to boost in the North American region.

Hepatitis Diagnostic Test Industry Overview

The hepatitis diagnostic test market is slightly fragmented in nature due to the presence of a few companies operating globally as well as regionally. The competitive landscape includes an analysis of a few international as well as local companies that hold the market share and are well known. Key market players include Abbott Laboratories, Danaher Corporation, BioMerieux SA, Bio-Rad Laboratories Inc, Diasorin S.p.A, F. Hoffmann-La Roche AG, Hologic Inc, MedMira Inc, Qaigen Inc, Grifols SA, Sysmex Corporation, and Siemens Healthineers.

Additional Benefits:

- The market estimate (ME) sheet in Excel format
- 3 months of analyst support