Major Growth Influencing 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.
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.
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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.
# 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.
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.
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.
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Projected Surge in Revenue:
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.
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.