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Hepatitis Testing Research Industry Aiming for Major Tech Revolutions in Near Future

Overview of This Study:

This study involved four major activities in estimating the current size of the hepatitis testing market. Exhaustive secondary research was carried out to collect information on the market, its peer markets, and its parent market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.

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.

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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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.

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.

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.

Expected Monetary Gains in the Forecast Period:

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.

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Geographical Growth Dynamics:

North America was the largest regional market for the 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.

However, the Asia Pacific market is estimated to grow at the highest CAGR during the forecast period. High burden of hepatitis infections, rising disposable income levels, improving healthcare infrastructure and increasing awareness of hepatitis testing are the major factors driving the growth of the hepatitis testing market in the Asia Pacific.


on August 16 at 6:09

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