Hepatitis B Diagnostic Test Market Volume Analysis, size, share and Key Trends -2026

Hepatitis B is an infectious disease associated with the inflammation of the liver. Hepatitis B infection is caused due to the Hepatitis B virus (HBV) transmitted from one person to other through infectious blood, semen and other body fluids. Hepatitis B infection can be acute and it may develop into chronic infection if not diagnosed and treated at an early stage. Chronically infected Hepatitis B patients eventually develop liver cirrhosis, hepatocellular carcinoma (liver cancer), fulminant hepatitis B (autoimmune disorder) or suffer from liver failure requiring liver transplant and can even result in death. In 2014, out of the 360 Mn people infected with hepatitis B worldwide, around 1 Mn people died of the disease or other complications associated with it. However, there is a significant decrease in incidence of hepatitis B after introduction of hepatitis B vaccine. Diagnosis of HBV is achieved by performing several tests for serological markers of HBV such as HBsAg, anti-HBs antibodies, HBeAg, anti-HBe antibodies and anti-HBV core antibodies. Currently, nucleic acid testing for HBV DNA is used to detect the hepatitis B viral load. The diagnosis of hepatitis B involves collection of blood samples followed by the detection of viral antigens and antibodies in either serum or plasma.

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Hepatitis B Diagnostic Test Market: Drivers and Restraints

In vitro diagnostics is the vital market for the hepatitis B diagnostic test as the serological markers from blood are tested outside the body in the laboratory. Increasing prevalence and incidence of hepatitis B worldwide and multitude of available tests are the major drivers for the increasing growth of global hepatitis B diagnostic test market. Increasing public awareness and understanding of viral hepatitis, promotion of wider access to monitoring and screening procedures by several countries as a part of national program and introduction of evidence based policies are anticipated to aid the growth of global hepatitis B diagnostic tests market. However, complexity of clinical management and lack of coordination between clinicians and laboratory personnel to decide choice of assay employing appropriate hepatitis B diagnostic test will remain some of the major restraints for the global hepatitis B diagnostic test market.

Hepatitis B Diagnostic Test Market: Segmentation

The global hepatitis B diagnostic tests market is classified on the basis of test type, technique end use and geography.

Based on test type, the global hepatitis B diagnostic test market is segmented into the following:

Hepatitis B surface antigen test (HBsAg)

Anti-hepatitis B surface antibody test

Hepatitis B core antigen test (HBcAb)

Anti-hepatitis B core antibody test

HBV DNA test

Others

Based on techniques, the global hepatitis B diagnostic test market is segmented into the following:

PCR

Radioimmunoassay (RIA)

Enzyme-linked immunosorbent assay (ELISA)

Others

Based on end use type, the global hepatitis B diagnostic test market is segmented into the following:

Hospitals

Diagnostic centers

Clinics

Hepatitis B Diagnostic Test Market: Overview

More than 13 immunoassays are available for the diagnosis of hepatitis B at an early stage. They can also be used to distinguish acute and chronic hepatitis B infections. Global market for HBsAg test is expected to drive the greater revenue generation as it the preliminary test for the detection of HBV in the blood of infected person and also the test is ordered for many of the blood donors prior to blood donation.

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Hepatitis B Diagnostic Test Market: Regional Overview

Geographically, the global hepatitis B diagnostic tests market is classified into regions namely, North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America is expected to be the key region in global hepatitis diagnostic tests market followed by Asia-Pacific and Europe. Availability of good reimbursement policies for diagnostic tests in many of the high income countries in Europe is expected to keep up the market for hepatitis B diagnostic testsin nearest future.

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