The global hepatitis diagnostic testing market size was valued at USD billion in 2022 and is estimated to grow at a high CAGR in the forecasted period 2022-2029.
Hepatitis is an inflammation of the liver, commonly caused by the hepatitis virus. Heavy alcohol use, some medications, toxins, and certain medical conditions can cause hepatitis. However, hepatitis is often caused due to viral infection. The most common types of viral hepatitis are hepatitis A, hepatitis B, and hepatitis C. The burden of HBV and HCV is disproportionately high in low-income and middle-income countries.
The global hepatitis diagnostic testing market growth is driven by the high burden of hepatitis, increasing blood transfusion and donations, benefits of POC instruments and kits, and awareness initiatives on hepatitis.
The introduction of molecular diagnostics for the diagnosis of hepatitis will drive the market growth
The major shift from conventional technologies to molecular diagnostics has amplified the competence of procedures and has to pull down the dispatch time for results. Molecular diagnostics used in hepatitis testing involve genetic tests to confirm the exact strain of the causative virus. The nucleic acid assays used include HCV RNA and HBV DNA analysis tests. 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. Hence, the availability of such advanced detection techniques is spurring the overall market growth. Furthermore, the high prevalence of hepatitis is also expected to fuel market growth. According to the U.S. Department of Health & Human Services, in 2018, most adults in their 20s and 30s made up 36.5% of newly reported chronic hepatitis C infections and this is expected to increase in the forecast period.
New initiatives taken up by different organizations are expected to be the essential driver to improve the hepatitis viruses market. The promotion of government and non-government organizations in increasing awareness, growing demand for POC diagnostics, and increasing demand for automation and system integration are some of the primary drivers for the growth of the market.
Operational barriers associated with these testing will hamper the market growth
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. This factor will hamper the market growth in the forecast period.
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.
The immunoassays segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)
Immunoassays are bioanalytical methods, in which the quantitation of the analyte depends on the reaction of an antigen and an antibody. Compared to conventional tests, immunoassays have been proven to provide highly accurate results even with very small samples. The versatile applications and ease of diagnosis have made immunoassay quite popular in recent years. Also, with the rising cases of hepatitis, the market is expected to show better growth. According to WHO, in 2019, Hepatitis B prevalence is highest in the WHO Western Pacific region and the WHO African region, where 6.2% and 6.1% of the adult population is infected respectively. Hence, owing to the aforementioned factors, along with rising technological advancements are expected to further drive immunoassays segment growth in the forecast period.
North America region holds the largest market share of the global hepatitis diagnostic testing market
North America dominated the market with the largest revenue. The availability of advanced diagnostic tools and high awareness regarding these products are the key factors driving the growth of the market in the region. The accelerated growth in the Canadian market can be attributed to the initiatives of the government and non-government organizations. For instance, the Public Health Agency of Canada organized World Hepatitis Day in order to increase awareness regarding hepatitis detection. Thereby, leading to a demand surge for hepatitis detection in the country. Thus, these factors are driving the growth of the market in the region.
The hepatitis diagnostic testing market is a moderately competitive presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Abbott Laboratories, Danaher Corporation (Beckman Coulter Inc), BioMerieux SA, Bio-Rad Laboratories Inc, Diasorin S.p.A, F. Hoffmann-La Roche AG, Hologic Inc, MedMira Inc, Qaigen Inc, Siemens Healthineers among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the hepatitis diagnostic testing market globally. For instance, 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.
Abbott Laboratories is a U.S. health care company. The Company operates through four segments: established pharmaceutical products, diagnostic products, nutritional products, and medical devices.
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