Global Hepatitis E Diagnostic Tests Market: Snapshot

The growing incidence of hepatitis E, a liver disease caused by infection due to the virus hepatitis E virus (HEV), is a leading cause of morbidity and mortality worldwide. There is increasing prevalence of hepatitis E in resource-limited region, such as various countries of Asia Pacific. The people of these regions suffer with frequent water contamination and have limited access to sanitation and hygiene, making it imperative for the diagnosis of hepatitis E. These factors have spurred the demand for hepatitis E diagnostic tests, especially among young adults in the age of 15 to 40 years. The growing awareness of the related symptoms of the disease has propelled the growth of the market in various regions.

The global hepatitis E diagnostic tests market is anticipated to rise at a CAGR of 3.80% from 2016 to 2024. The market was valued at US$43.7 mn in 2015 and expected to reach US$60.4 mn by the end of the forecast period.

The global hepatitis E diagnostic tests market is extremely competitive with the leading players adopting a competitive pricing strategy of various diagnostic tests, including the kits used for the primary ELISA HEV IgM tests. 

hepatitis e diagnostic tests market


Hepatitis E Hyper-endemicity in Asian Economies to Ensure Dominance of Asia Pacific Region

On the basis of geography, the global market is segmented into Europe, Asia Pacific, Latin America, North America, and the Middle East and Africa. Of these, Asia Pacific is the leading regional market. The impressive growth of the market is attributed to hepatitis E assuming endemic proportions in various Asian countries, especially resource-poor regions, such as Nepal, Vietnam, Pakistan, Bangladesh, Burma, Kazakhstan, Thailand, and Bhutan. The regional market is poised to attain a share of over 48% by the end of 2024.

Besides, the Middle East and Africa is expected to witness a steady and substantial demand for the hepatitis E diagnostic tests. The growth in the regional market is driven by increasing prevalence of hepatitis E in countries such as Kenya, Uganda, Nigeria, and Morocco attributable to poor hygienic conditions, limited access to safe drinking water, and lack of sanitation. The soaring number of people suffering from Hepatitis E, especially the prevalence of the disease across pregnant women, has made it a public health concern in the region. Consequently, the governments of various countries of Africa are making evidence-based control policies, including the modes of transmission. Timely treatment calls for extensive tests for people who are more prone to infections, especially those using contaminated piped water.  This has spurred the demand for Hepatitis E diagnostic tests fuelling the regional market.

North America and Europe markets are expected to witness only incremental growth over the forecast period.

RT-PCR diagnostic Test Gaining Wide Adoption

Among the different types of diagnostic tests for hepatitis E, the primary tests are ELISA HEV IgM test kits, ELISA HEV IgG test kits, and RT-PCR test kits. The market has witnessed an extensive demand for ELISA HEV IgM test kits. Owing to growing seroprevalence of hepatitis E across the globe, market analysts expect the demand for ELISA HEV IgM diagnostic test kits to soar significantly over the forecast period. The demand for RT-PCR test kits is expected to closely follow that of ELISA HEV IgM test kits in the coming years. The use of RT-PCR diagnostic test among clinicians is propelled by the rapid generation of results and the high sensitivities and specificities of the molecular assay. On the other hand, the ELISA HEV IgG test kits segment is expected to register a modest growth along the forecast period.

Companies vying for a significant share in the global market for hepatitis E diagnostic tests include Beijing Wantai Biological Pharmacy, Primerdesign Ltd., Mikrogen GmBH, MP Biomedicals LLC, Fast-track diagnostics Ltd., Fortress Diagnostics Ltd., F. Hoffmann-La Roche Ltd., Biokit S.A., and Altana Diagnostics GmbH.

Global Hepatitis E Diagnostic Tests Market: Overview 

Hepatitis E is a liver disease that is enterically transmitted and is caused by hepatitis E virus (HEV). It is one of the five known human hepatitis viruses (A, B, C, D, and E). Hepatitis E spreads through fecal-oral transmission due to fecal contamination of drinking water. The other routes of transmission of hepatitis E virus include transfusion of infected blood products, vertical transmission from a pregnant woman to her fetus, and ingestion of undercooked meat or meat products derived from infected animals. Infections with hepatitis E virus are commonly observed in regions with poor sanitation, including the Middle East, Asia, Central America, and Africa. The epidemiology and serology of HEV differs in developing and developed countries. It is considered to be rare in the U.S. and other developed regions. 

Cases of hepatitis E are not clearly distinguishable from other types of viral hepatitis. Hence, diagnosis can be confirmed by testing the presence of RNA and antibodies against HEV. Testing for the presence of IgM and IgG is considered to be indirect tests and testing for the presence of HEV RNA is considered to be direct test. Presence of IgM is the primary test to identify acute infections in patients, which is confirmed by testing for the presence of RNA. Presence of IgG antibodies indicates that the patient has been exposed previously to hepatitis E virus. 

This research is a combination of primary and secondary research, conducted for understanding and arriving at trends, used to forecast the expected revenue of hepatitis E diagnostic kits in the near future. Primary research formed the bulk of our research efforts with information collected from in-depth interviews and discussions with a number of key industry experts and opinion leaders. Secondary research involved study of company websites, annual reports, press releases, investor presentations, analyst presentation and various international and national databases. 

Global Hepatitis E Diagnostic Tests Market: Scope of the Study 

The report provides estimated market size in terms of US$ Mn for each test type, end user, and geography for the period 2014 to 2024, considering the macro and micro environmental factors. The revenue generated from each test type was calculated by considering sero-prevalence rate of hepatitis E, average selling price of the kits, trends in industry, end user trend, and adoption rate across all the geographies. 

The market report comprises an elaborated executive summary, which includes market snapshot that provides information about various segments of the market. It also provides information and data analysis of the market with respect to market segments based on test type, end-user, and geography. The market overview section of the report analyzes market dynamics such as drivers, restraints and opportunities that influences the hepatitis E diagnostic tests market in the current and future scenario. The report also provides value chain analysis of the market that describes the sequence of activities involved from identification of the market need to their final reach to the end users. 

Market share analysis among the market players is analyzed to signify the contribution of these players in the market in terms of percentage share. All these factors will help the market players to decide about the business strategies and plans to strengthen their positions in the global market. Based on geography, the market has been analyzed for major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. The study also covers detailed country analysis contributing majorly in the hepatitis E diagnostic tests market. 

Companies Mentioned in this report 

The report also profiles the major players in the market and provides various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments. Major companies profiled in the hepatitis E diagnostic tests market report are altona Diagnostics GmbH, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Biokit S.A., Dia.Pro - Diagnostic Bioprobes s.r.l, F. Hoffmann-La Roche Ltd., Fast-track diagnostics Ltd., Fortress Diagnostics Limited, Mikrogen GmBH, MP Biomedicals, LLC., and Primerdesign Ltd., among others. 

The Hepatitis E Diagnostic Tests Market has been segmented as follows:

By Test Type

  • ELISA HEV IgM Test kits
  • ELISA HEV IgG Test kits
  • RT-PCR Test kits
  • Others 

By End User

  • Hospitals
  • Research Centers
  • Diagnostic Laboratories
  • Point of Care 

By Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Spain
    • France
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • A.E.
    • South Africa
    • Rest of Middle East and Africa

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Hepatitis E Diagnostic Tests Market

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