Hepatitis Testing/Diagnosis Market by Disease Type (Hepatitis B, Hepatitis C, Other Hepatitis), Technology (ELISA, RDT, PCR, INAAT), End User (Hospitals, Diagnostic Laboratories, Blood Banks)- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

The global Hepatitis Testing/Diagnosis market size was estimated at USD 2.9 billion in 2022 and is expected to surpass around USD 8.6 billion by 2030 and poised to grow at a compound annual growth rate (CAGR) of 11.7% during the forecast period 2022 to 2030.

The growth of the global hepatitis testing market is being driven by factors such as the high burden of hepatitis, increasing blood transfusion and donations, benefits of POC instruments and kits, and awareness initiatives on hepatitis. High cost of nucleic acid tests, lack of mandates for nucleic acid tests in developing countries and unfavorable reimbursement scenarios are expected to restrain hepatitis market growth. Emerging markets, rising technological advancements in molecular diagnostics, and growth in the biotechnology and biopharmaceutical industries are expected to offer strong growth opportunities for players in the market. In contrast, changing regulatory landscape, opertationsla barriers and shortage of skilled professionals may challenge market growth to a certain extent. The hepatitis testing market is segmented based on disease type, technology, end user, and region.

Report Scope of the Hepatitis Testing/Diagnosis Market

COVID-19 Impact on the Hepatitis Testing Market

The COVID-19 outbreak had a negative impact on the hepatitis testing market due to decreasing patient visits to hospitals. The pandemic has put significant strain on healthcare systems. Healthcare institutes and providers were instructed to stop performing elective surgical procedures and medical examinations to slow the spread of the disease and conserve healthcare resources for COVID-19 patients. As a result, many hepatitis testing clinical laboratories experienced a rapid decline in testing volume.

According to the American Journal of Preventive Medicine, a significant decline was observed in hepatitis C testing across the US. The results from the research article—Decreases in Hepatitis C Testing and Treatment During the COVID-19 Pandemic—indicated antibody tests for HCV declined by 59% in April 2020 and rebounded to a 6% decline in July 2020. In comparison, HCV RNA-positive tests declined by 62% in March 2020 and 39% in July 2020.

Global Hepatitis Testing Market Dynamics

DRIVER: High burden of hepatitis

Hepatitis is a major public health concern with a high prevalence rate worldwide, despite significant improvements in treatment options, vaccination coverage, and public awareness. Of all the hepatitis types, B and C are the most prevalent and contribute toward higher mortality rates. In 2019, an estimated 296 million and 58 million people were living with chronic HBV and chronic HCV infection, respectively. In underdeveloped countries, the prevalence of hepatitis is high as compared to developed countries

RESTRAINT: Lack of mandates for nucleic acid tests in developing countries

In developing and low-resource countries, NAT is not mandatory due to the expensive nature of this test and the requirement of skilled personnel. In India, by 2016, only 58 out of a total of 2,550 (~2%) blood banks performed NAT for hepatitis diagnosis. In many developing countries such as India and China, ELISA is the only mandatory test, which acts as a major inhibitor for the adoption of NAT. In India, blood screening involves serological testing for hepatitis surface antigens; however, there are no mandates for using NAT. As a result, there is a lack of clarity about results among people undergoing hepatitis diagnostic tests, which acts as a restraint for market growth.

OPPORTUNITY: Growth in biotechnology and biopharmaceutical industries

The demand for immunoassay instruments and consumables is high in the biotechnology and biopharmaceutical industries. As a result, the growth of these industries is expected to support the growth of the hepatitis testing market during the forecast period. In these industries, the growth of the end-user base has compelled many companies to launch new products and invest in developing advanced products. This is considered a positive indicator for market growth as immunoassays are applied at many stages— from product development and manufacturing to quality control—in production.

CHALLENGE: Operational barriers

Clinical laboratories across major markets are still evolving; technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also needs to be reconfigured to meet the requirements of conducting specific molecular diagnostic tests used for pathogen detection as a means of avoiding cross-contamination and ensuring efficient time management. This results in considerable cost escalation to maintain and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type. Furthermore, due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, the shortage of skilled and technically knowledgeable laboratory technicians to operate advanced hepatitis testing products has hindered their overall adoption, particularly in emerging markets.

Hepatitis B segment dominated the Hepatitis testing market in 2020.

Based on disease type, the hepatitis testing market is segmented into hepatitis B, hepatitis C, and other hepatitis diseases (hepatitis A, D, and E). The hepatitis B segment accounted for the largest share of the hepatitis testing market in 2020. Factors such as the rising prevalence of hepatitis B, availability of a large number of hepatitis B diagnostic tests, and the increasing adoption of nucleic acid tests for HBV diagnosis are driving the growth of this market segment.

The ELISA segment to witness the highest market share during the forecast period.

Based on technology, the hepatitis testing market is segmented into enzyme-linked immunosorbent assay (ELISA), rapid diagnostic tests, polymerase chain reaction (PCR), isothermal nucleic acid amplification technology (INAAT), and other technologies (such as sequencing, mass spectrometry, and western blotting). The ELISA segment accounted for the largest share of the hepatitis testing market in 2020. The large share of this segment can primarily be attributed to the wide acceptance of this test in clinical practices to diagnose hepatitis.

North America was the largest regional market for hepatitis testing market in 2020.

The global hepatitis testing market is segmented into North America (the US and Canada), Europe (Germany, the UK, and the Rest of Europe), Asia Pacific, and Rest of the World. In 2020, North America dominates the global market, and this trend is expected to continue during the forecast period. The large share and high growth of this region can be attributed to the rising prevalence of hepatitis and increased research and clinical trials for hepatitis testing in the US.

Some of the prominent players in the Hepatitis Testing/Diagnosis Market include: F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), Siemens Healthineers AG (Germany), Bio-Rad Laboratories, Inc. (US), Danaher Corporation (US), QIAGEN (Netherlands), bioMérieux SA (France), DiaSorin S.P.A. (Italy), Ortho Clinical Diagnostics (US), MedMira Inc. (Canada), Fujirebio US, Inc. (Japan), Grifols, S.A. (Spain), Orasure Technologies (US), GenMark Diagnostics Inc. (US), Vela Diagnostics (Singapore), Epitope Diagnostics (US), Trivitron Healthcare (India), Meril Life Sciences Pvt. Ltd. (India), geneOmbio Technologies Pvt. Ltd. (India), and Molbio Diagnostics Pvt. Ltd. (India).

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Hepatitis Testing/Diagnosis market

By Disease Type

• Hepatitis B (HBV)
• Hepatitis C (HCV)
• Other Hepatitis Diseases

By Technology

• Enzyme-linked Immunosorbent Assay (ELISA)
• Rapid Diagnostic Tests (RDT)
• Polymerase Chain Reaction (PCR)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Other Technologies

By End User

• Hospital & Diagnostic Laboratries
• Blood Banks
• Other End Users

By Geography

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
• Rest of Middle East & Africa

Key Points Covered in Hepatitis Testing/Diagnosis Market Study:

• Growth of Hepatitis Testing/Diagnosis in 2022
• Market Estimates and Forecasts (2017-2030)
•  Brand Share and Market Share Analysis
•  Key Drivers and Restraints Shaping Market Growth
•  Segment-wise, Country-wise, and Region-wise Analysis
•  Competition Mapping and Benchmarking
•  Recommendation on Key Winning Strategies
•  COVID-19 Impact on Demand for Hepatitis Testing/Diagnosis and How to Navigate
•  Key Product Innovations and Regulatory Climate
•  Hepatitis Testing/Diagnosis Consumption Analysis
•  Hepatitis Testing/Diagnosis Production Analysis
•  Hepatitis Testing/Diagnosis and Management