Global Hepatitis E Diagnostic Tests Market - 2022-2029

Market Overview

Hepatitis E Diagnostic Tests Market size was valued US$ YY million in 2021 and is estimated to reach US$ YY million by 2029, growing at a CAGR of 4.5 % during the forecast period (2022-2029).

The hepatitis E virus causes the enteric liver disease known as hepatitis E. (HEV). It belongs to the group of five known human hepatitis viruses (A, B, C, D, and E). Due to the feces in the water being a source of contamination, it is spread by fecal-oral contact. Hepatitis E cannot currently be diagnosed using an officially recognized test. Doctors rely on testing to identify the antibodies that fight the virus to diagnose hepatitis E correctly. It often relies on finding specific anti-HEV immunoglobulin M (IgM) antibodies to the virus in a person's blood; this is usually sufficient in regions where the disease is prevalent. For field use, rapid testing is available.

Market Dynamics

The development of a Novel Recombinant Protein-based Diagnostic Kit for Hepatitis E is expected to drive market growth.

Biotech Consortium India Limited has developed a technology that is a sensitive test for detecting HEV infection compared to other commercial assay kits. The technology is based on using Swine HEV's Open Reading Frame-2 for the development of Hepatitis E testing kits. The gene sequence underwent a 2-percent alteration in the current technology, leading to increased HEV protein production for better protein identification in the patient's sera sample and increased diagnostic kit effectiveness. This is a technology platform that can be used to create vaccines. Moreover, the technology benefits by detecting genotypes 1& 4 and has higher sensitivity. Thus, from the above statements, the market is expected to drive in the forecast period.

Restraint:

Lack of awareness among the population, high cost of diagnostic procedures and inadequate reimbursement regulations are some factors the market is expected to hamper in the forecast period.

Global Hepatitis E Diagnostic Tests Market - Industry Analysis

The hepatitis E diagnostic tests market provides in-depth analysis of the market based on various industry factors such as porter's five forces, reimbursement scenario, pricing analysis, supply chain etc.

COVID-19 Impact Analysis

The COVID-19 pandemic has moderately impacted healthcare systems and the market. The COVID-19 pandemic has disrupted healthcare systems, making it more difficult to provide basic clinical care, hepatitis E virus antibody testing, and treatment. As a result, increased morbidity and mortality rates may result from those who had undiagnosed hepatitis E virus during the pandemic subsequently being found to have the disease in more advanced stages. Moreover, as part of the original COVID-19 pandemic mitigation initiatives, the CDC published guidelines on deferring routine clinical visits and delaying non-essential operations. By this advice, patients should avoid making unnecessary in-person visits and communicate with their healthcare practitioner via telemedicine, patient portals, phone, and email.

Additionally, the pandemic interrupts the supply chain and process. Many companies will vary to other geographic regions to ensure that products remain available and protect their supply chain. Thus, from the above statements, the market got affected, and it is expected to gain traction quickly with the resumption of the economic activities.

Segment Analysis

ELISA HEV IgM Test kits segment is expected to hold the largest market share in hepatitis E diagnostic tests market

The ELISA HEV IgM test kits segment is expected to dominate in 2021. HEV infection typically takes 2 to 6 weeks to develop. HEV RNA and anti-HEV IgM antibodies can be found at the time of diagnosis, followed by anti-HEV IgG antibodies. Positive anti-HEV IgM antibody results in serum can significantly indicate acute HEV infection. Anti-HEV IgM antibodies typically only remain positive for a few months (about 3-4 mo), although occasionally they do. The precise length of this response is still unknown. However, the anti-HEV IgG antibody is comparatively long-lasting.

Additionally, the avidity of the anti-HEV IgG antibody increases over time. Therefore, the demand for the ELISA HEV IgM Test kits increases. It is because it is a third-generation Enzyme ImmunoAssay (ELISA) for qualitatively determining IgG antibodies to Hepatitis E Virus in human plasma and sera. The kit is intended for the follow-up of HEV-infected patients. Thus, from the above statements, the market segment is expected to hold the largest market share in the forecast period.

Geographical Analysis

Asia Pacific region holds the largest market share in the global hepatitis E diagnostic tests market

In 2021, Asia Pacific accounted for the highest revenue share. The increasing prevalence of Hepatitis E cases, rising geriatric population, increasing consumption of pork, rise in adoption of Hepatitis E tests and product launches by the market players in the region are some factors the market is expected to boost in the forecast period. For instance, according to the National Center for Biotechnology Information, nearly 60% of blood donors in India have circulating anti-HEV IgG antibodies, indicating prior exposure to the virus, indicating that HEV infection and illness are extremely endemic country. The seroprevalence rates differ by age, with older people having greater rates. 5 Hepatitis E causes almost half of all instances of acute hepatitis and a comparable percentage of cases of acute liver failure (ALF).

Moreover, the middle and northern regions of India are where most of the country's pigs are found. Assam had more than two million people in 2019. Since swine is thought to be the main carrier of HEV, the largest pork intake suggests that the disease is spread through zoonotic agents. Thus, it has increased the demand for hepatitis E diagnostic tests, due to which the Asia Pacific is expected to hold the largest market share in the forecast period.

Competitive Landscape

Major key players in the hepatitis E diagnostic tests market are Diagnostic Automation / Cortez Diagnostics, Inc., EUROIMMUN Medizinische Labordiagnostika AG, Dia.Pro - Diagnostic Bioprobes s.r.l , Biokit S.A., altona Diagnostics GmbH, ORGENTEC Diagnostika, Fortress Diagnostics, Mikrogen GmBH, Primerdesign Ltd, F. Hoffmann-La Roche Ltd.

altona Diagnostics GmbH:

Overview:

altona Diagnostics is a privately held medical diagnostic company headquartered in Hamburg-Altona, Germany. The business creates and produces in-vitro diagnostic tests for the DNA-based identification of pathogens like viruses, bacteria, and parasites. The company has over 20 years of experience in the molecular diagnostics industry and has received the ISO 13485 certification. Through subsidiaries and more than 40 distribution partners, altona Diagnostics provides its certified products to private and clinical laboratories worldwide. Additionally, altona Diagnostics' diagnostic tests are offered as ready-to-use kits based on real-time PCR technology. Over 50 CE-marked kits compatible with open real-time PCR platforms are available in the company's product line. Further, altona Diagnostics provides an automated workflow system that includes apparatus, specialized software, and chemistry for nucleic acid extraction.

Product Portfolio:

RealStar HEV RT-PCR Kit 2.0: The RealStar HEV RT-PCR Kit 2.0 is an in vitro diagnostic test, based on real-time PCR technology, for detecting and quantifying hepatitis E virus (HEV) specific RNA.

The global hepatitis E diagnostic tests market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.