Home > Healthcare > Medical Devices > Diagnostic Devices > Hepatitis Diagnostic Tests Market

Hepatitis Diagnostic Tests Market - By Product (Instruments, Reagents & Kits), By Technology (Enzyme-Linked Immunosorbent Assay, Rapid diagnostic tests, Polymerase Chain Reaction), By Test Type (Blood Test, Imaging Test), By End-use & Forecast, 2023 – 2032

  • Report ID: GMI5626
  • Published Date: May 2023
  • Report Format: PDF

Hepatitis Diagnostic Tests Market Size

Hepatitis Diagnostic Tests Market size was valued at around USD 3.4 billion in 2022 and is projected to witness over 5.8% CAGR from 2023 to 2032. Increasing prevalence of hepatitis is expected to augment the market growth.

Hepatitis Diagnostic Tests Market

To understand key trends  
Download Free Sample

Rising awareness regarding availability of several diagnostic tests for hepatitis screening has surged the market progress. Technological advancements pertaining to these diagnostic tests have fuelled the screening of blood sample, thereby resulting in better diagnosis and treatment. Availability of advanced detection techniques such as molecular diagnostics, nucleic acid assays, rapid diagnostic tests (RDTs) etc. is spurring the overall market revenue.

Hepatitis diagnostic tests are medical tests intended to detect the presence of hepatitis viruses and evaluate the extent of inflammation or damage of the liver caused by the virus. These tests detect antibodies or antigens associated with different types of hepatitis and measure various enzymes and proteins produced by the liver.

Limited access to reliable and low-cost hepatitis diagnostic tests is a major public health concern. Moreover, this limited access is a major constraint particularly in resource-limited healthcare facilities. Hepatitis is a major cause of liver disease and can have serious long-term health consequences if left untreated. However, the cost of diagnostic tests, particularly for hepatitis B and C, can be excessively high and testing may not be available for patients in developing countries. Growing concern pertaining to the rising costs of these test is further compounded by the increasing demand for hepatitis screening in blood, thereby requiring these kits and devices for diagnosis.

Impact of COVID-19 Pandemic

The onset of the COVID-19 pandemic was an unprecedented event impacting the public health and led to an incremental surge in the number of hospitalizations. The coronavirus outbreak proliferated the disease burden and hampered several global businesses including the healthcare sector, during 2020 & initial phase of 2021. This has resulted in delay or postponing several medical and diagnostics procedures. The COVID-19 pandemic had a negative impact on the market, as it impacted several factors such as blood donation and other healthcare services catering to the screening of samples with hepatitis virus.

Hepatitis Diagnostic Tests Market Trends

Rising number of patients suffering is one of the major health concerns in several countries worldwide. Hepatitis is a viral infection that can cause liver inflammation and, if left untreated, can lead to cirrhosis, liver failure, and liver cancer. Hepatitis is a major cause of liver disease and can have serious long-term health consequences. Some of the major factors influencing the upsurge in patient volume include lack of awareness regarding the disease and treatment options coupled with limited access to testing and diagnosis. However, increasing initiatives by government authorities for hepatitis awareness and disease screening associated with providing cost effective diagnostic tests by market players is projected to augment the product adoption.

Hepatitis Diagnostic Tests Market Analysis

 Hepatitis Diagnostic Tests Market Size, By Product

To understand key market trends  
Download Free Sample

Based on product, the hepatitis diagnostic tests market is segmented as reagents & kits and instruments. The reagents & kits held a majority market value of USD 2.3 billion in 2022. This high business share is owing to several benefits offered by reagents & kits in precise and accurate screening of hepatitis disease. Reagents and kits are designed for highly specific and sensitive screening of hepatitis B and C virus and can accurately detect the low level of components in a sample particularly during the early stages of infection. These products can provide faster results that allows for prompt diagnosis and treatment, thereby preventing disease progression.

Additionally, raising number of blood donations has resulted in demand for faster clinical outcomes and these reagents and kits are designed to perform high volume diagnostic test and are ideal for large-scale screening programs. Therefore, due to several benefits offered by reagents & kits is expected to propel the market development.

Based on technology the hepatitis diagnostic tests market is segmented as enzyme-linked immunosorbent assay (ELISA), rapid diagnostic tests (RDTs), polymerase chain reaction (PCR), isothermal nucleic acid amplification test (INAAT) and others. The enzyme-linked immunosorbent assay held a dominant market share in 2022 and is anticipated to grow at a lucrative pace by 2032.

Enzyme-linked immunosorbent assay (ELISA) is intended for the diagnostic test for hepatitis, particularly for hepatitis B and C. This technology uses antibodies to detect the presence of viral antigens or antibodies in a patient's blood or serum. ELISA is a highly sensitive and specific test for the detection of hepatitis virus infections. It can be used for both screening and confirmatory testing to provide a comprehensive diagnostic evaluation. Therefore, owing to several advantages offered by ELISA is estimated to increase the product acceptance rate in several countries worldwide.

 Global Hepatitis Diagnostic Tests Market Revenue Share By Test Type, (2022)

To understand key market trends  
Download Free Sample

Based on test type the hepatitis diagnostic tests market is segmented as blood tests, imaging test and liver biopsy. Blood tests is further segmented as liver function tests, immunoassays and nucleic acid tests. The blood tests segment held a major revenue share with over 45% in 2022. This majority market share is driven by several clinical benefits offered by blood tests in the diagnosis and treatment of hepatitis, thereby preventing chronic ailments. Blood tests can detect the presence of symptomatic hepatitis virus and accurately differentiate between different types of hepatitis viruses.

Additionally, tests help to identify infected individuals and measure the effectiveness of antiviral therapy and track disease progression over time. Therefore, blood tests for hepatitis screening are an essential tool for the early detection and diagnosis of hepatitis virus infections. They are highly accurate, non-invasive, and can be used for monitoring treatment and preventing transmission. Thus, the high-quality blood tests and growing number of blood donations are anticipated to expedite the business growth.

Based on end-use the hepatitis diagnostic tests market is segmented as hospitals, diagnostic laboratories, and others. Hospitals segment held 35% business share in 2022 and is projected to grow at a rapid pace by 2032. This is attributable to the increased usage of hepatitis diagnostic tests in hospital settings, that is foreseen to increase patients' choice for hospitals by providing better results. Growing admissions with target disorders comprising chronic diseases and surging disease screening initiatives coupled with the accessibility of highly skilled healthcare professionals are some other attributes that are propelling the industry landscape.

Additionally, the high chronic disease incidence in developed countries with robust healthcare infrastructure is projected to positively impact segment expansion. Surging hepatitis B and C cases, liver cirrhosis and other disorder prevalence will significantly propel the diagnostic test rate at hospitals. Thus, accessibility to better treatment & diagnosis coupled with the rising prevalence of hepatitis and associated conditions is estimated to boost patient visits to hospitals.

U.S. Hepatitis Diagnostic Tests Market Size

To understand regional trends  Download Free Sample

North American hepatitis diagnostic tests market crossed USD 1.4 billion in 2022. This majority market share is attributable to several factors such as the growing prevalence of hepatitis and related chronic diseases, rising healthcare expenditure along with growing product adoption across the country. The adoption of cutting-edge technologies is facilitated by the involvement of major stakeholders, that helps in the region's industrial development. The high prevalence of hepatitis C and the rising hospital admission in the region emphasize the growing need for blood transfusion in related procedures.

Furthermore, approximately 17,000 new Hepatitis C cases are estimated to witness each year in the U.S. Moreover, the availability of advanced technologies that enhance the quality of hepatitis diagnostic tests foster the development of the regional market.

Hepatitis Diagnostic Tests Market Share

Some of the major industry players operating in the hepatitis diagnostic tests market are

  • Abbott Laboratories
  • Analytik Jena
  • Autobio Diagnostics
  • Bio-Mérieux
  • Danher Corporation
  • DiaSorin
  • Grifols SA
  • Hologic Inc.
  • MedMira Inc
  • Ortho-Clinical Diagnostics
  • Qualpro Diagnostics
  • Roche Molecular Diagnostics
  • Siemens Healthcare
  • Sysmex Corporation

These players focus on strategic partnerships, new product launch & commercialization for market expansion.

Hepatitis Diagnostic Tests Industry News:

  • 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.

 Hepatitis diagnostic tests market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million & Units from 2018 to 2032, for the following segments:

Click here to Buy Section of this Report

By Product, 2018 - 2032 (USD Million & Units)

  • Instruments
  • Reagents & Kits

By Technology, 2018 - 2032 (USD Million)

  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Rapid diagnostic tests (RDTs)
  • Polymerase Chain Reaction (PCR)
  • Isothermal Nucleic Acid Amplification Test (INAAT)
  • Others

By Test Type, 2018 - 2032 (USD Million)

  • Blood Tests
    • Liver Function Tests
    • Immunoassays
    • Nucleic Acid Tests
  • Imaging Test
  • Liver Biopsy

By End-use, 2018 - 2032 (USD Million)

  • Hospitals
  • Diagnostic Laboratories
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Poland
    • Belgium
    • The Netherland
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Indonesia
    • Philippines
    • Malaysia
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Chile
    • Colombia
    • Peru
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Israel
    • Turkey
    • Egypt


Authors: Mariam Faizullabhoy

Frequently Asked Questions (FAQ) :

Global market for hepatitis diagnostic tests was around USD 3.4 billion in 2022 and will record a 5.8% CAGR between 2023 to 2032.

Reagents & kits was USD 2.3 billion in 2022 owing to benefits offered by kits and reagents in precise & accurate screening of hepatitis disease.

Abbott Laboratories, Autobio Diagnostics, Analytik Jena, DiaSorin, Grifols SA, Danher Corporation, Roche Molecular Diagnostics, Hologic Inc., MedMira Inc, and Ortho-Clinical Diagnostics are the top companies in the global market.

North America hepatitis diagnostic tests market size was about USD 1.4 billion in 2022 and is anticipated to expand due to growing prevalence of hepatitis and related chronic diseases across the region.

Hepatitis Diagnostic Tests Market Scope

Buy Now

Access to only 1 person; cannot be shared; cannot be printed
Access for 2 to 5 users only within same department of one company
Access to a company wide audience; includes subsidiary companies or other companies within a group of companies

Premium Report Details

  • Base Year: 2022
  • Companies covered: 14
  • Tables & Figures: 520
  • Countries covered: 30
  • Pages: 185
 Download Free Sample