Market Size Estimation:

Both top-down and bottom-up approaches were used to estimate and validate the total size of the hepatitis testing market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

# The key players in the industry and market have been identified through extensive secondary research
# The revenues generated from the hepatitis testing business of leading players have been determined through primary and secondary research
# All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources

Projected Growth in Revenue Generation:

The global hepatitis testing market is projected to reach USD 3.6 billion by 2026 from USD 2.8 billion in 2021, at a CAGR of 4.7% during the forecast period.

Data Triangulation:

After arriving at the overall market size from the market size estimation process, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.

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Major Growth Driving Factors:

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.

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.

Recent Developments:

# In 2021, Abbott received FDA Emergency Use Authorization (EUA) for the Alinity m Resp-4-Plex assay.

# In 2021, F.Hoffmann-La Roche Ltd. acquired GenMark Diagnostics (US) which aimed at adding more products to Roche’s molecular diagnostics portfolio and the global distribution of products offered by GenMark Diagnostics.

# In 2021, Bio-Rad Laboratories, Inc. partnered with Seegene, Inc. (South Korea). The partnership aims at collaborative development and the commercialization of infectious disease diagnostic products.

# In 2020, Vela Diagnostics launched an NGS-based test used in the detection of HIV-1, HCV, HBV, and CMV.

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.

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