Hepatitis E Diagnostic Tests Market – By Test Type (ELISA HEV IgM Test, ELISA HEV IgG Test, Rapid Diagnostics Test, Polymerase Chain Reaction), Sample Type (Blood, Stool), End-use (Hospitals, Diagnostic Laboratories) – Global Forecast 2024 – 2032

Hepatitis E Diagnostic Tests Market Size

Hepatitis E Diagnostic Tests Market size was valued at around USD 60 million in 2023 and is estimated to grow at 4.3% CAGR from 2024 to 2032. Hepatitis E diagnostic tests are used to detect the presence of the hepatitis E virus (HEV) in the body and to determine whether an individual has been infected. These tests are crucial for diagnosing hepatitis E, an infection that primarily affects the liver and is often transmitted through contaminated water.

The rising incidence of hepatitis E worldwide has heightened the demand for effective diagnostic solutions. Hepatitis E, caused by the hepatitis E virus (HEV), has become more prevalent due to factors such as inadequate sanitation and contaminated water sources, especially in developing regions. For instance, according to the World Health Organization (WHO), approximately 20 million hepatitis E virus infections occur globally each year, resulting in an estimated 3.3 million symptomatic cases of hepatitis E. This increase in incidence has underscored the need for reliable diagnostic tests to manage and control the spread of the virus, thereby driving market growth.
 

Furthermore, advancements in diagnostic technologies have significantly propelled market growth. Innovations in molecular diagnostics, such as polymerase chain reaction (PCR) and enzyme immunoassay have enhanced the accuracy, sensitivity, and speed of hepatitis E detection. These technological improvements facilitate early diagnosis, which is crucial for effective disease management and the prevention of outbreaks. Additionally, advancements in point-of-care testing are making diagnostics more accessible, especially in remote and underserved areas.
 

Hepatitis E Diagnostic Tests Market Trends

• Rising awareness and the adoption of comprehensive screening programs are key factors driving market growth.
   
• Public health campaigns and educational efforts have increased awareness about hepatitis E, motivating individuals to seek testing and diagnosis. Expanded screening programs, particularly in high-risk regions, are improving the ability to detect and manage the disease more effectively. These initiatives not only facilitate early diagnosis but also help track prevalence and control the spread of hepatitis.
   

Hepatitis E Diagnostic Tests Market Analysis

Based on test type, the market is divided into ELISA HEV IgM test, ELISA HEV IgG test, rapid diagnostics test, and polymerase chain reaction (PCR). The ELISA HEV IgM test segment of the market is forecasted to reach USD 44.7 million by 2032 due to its critical role in the early detection and diagnosis of hepatitis E virus (HEV) infections.
 

• This test is highly valued for its ability to identify recent or acute HEV infections by detecting IgM antibodies, which are produced shortly after the onset of infection. As awareness and screening for hepatitis E increase globally, particularly in regions with a higher prevalence of the disease, the demand for accurate and timely diagnostic tools like the ELISA HEV IgM test is expected to rise.
   
• Additionally, advancements in test sensitivity and specificity, coupled with increased funding for public health initiatives aimed at controlling viral hepatitis, are contributing to the anticipated growth in this segment. This trend underscores the growing emphasis on early diagnosis and intervention in managing hepatitis E outbreaks, ultimately accelerating the market's expansion.
   

Based on sample type, the hepatitis E diagnostic tests market is bifurcated into blood and stool. The blood segment accounted for USD 51.1 million in 2023.
 

• Blood-based diagnostic tests, such as serological assays and molecular tests, are highly valued for their ability to identify hepatitis E virus (HEV) antibodies and RNA, providing precise results crucial for the diagnosis and monitoring of the disease.
   
• The popularity of blood tests can be attributed to their capacity to detect the infection at various stages, including acute and chronic phases, which is essential for effective management and treatment.
   
• These tests offer advantages such as higher sensitivity and specificity, enhancing their reliability and making them the preferred choice among healthcare providers. Consequently, the blood-based segment continues to dominate the market, reflecting its pivotal role in the accurate diagnosis of hepatitis E.
   

Based on end-use, the hepatitis E diagnostic tests market is bifurcated into hospitals, diagnostic laboratories, blood banks, and other end-users. The hospitals segment accounted for USD 25.7 million in 2023.
 

• Hospitals are primary centers for comprehensive healthcare delivery, including the diagnosis and management of infectious diseases such as hepatitis E. They possess the necessary infrastructure, including advanced diagnostic equipment and trained medical professionals, which facilitates timely and accurate testing.
   
• Additionally, hospitals often serve as central hubs for patient care, where initial screenings and confirmatory tests are performed, thereby driving substantial revenue in this segment.
   
• The integration of hepatitis E diagnostic tests into routine hospital procedures, along with continuous advancements in diagnostic technology, further supports the growth and importance of this market segment.
   

The growth of the hepatitis E diagnostic tests market in the U.S., projected to reach USD 34.2 million by 2032.
 

• In the U.S., the market is being significantly boosted by advances in diagnostic technologies and the rise of point-of-care testing.
   
• Innovations such as molecular diagnostics and advanced assays are enhancing the accuracy and speed of hepatitis E detection, while the growing availability of rapid and point-of-care tests is making these diagnostics more accessible in clinical settings. This technological progress is expected to drive substantial market growth by improving diagnostic capabilities and facilitating quicker, more efficient testing.
   

The hepatitis E diagnostic tests market in UK is expected to experience significant and promising growth from 2024 to 2032.
 

• The UK government is investing in research and development to advance diagnostic technologies and improve disease detection methods. This funding supports the development of more accurate and efficient diagnostic tests such as hepatitis E diagnostic tests, contributing to market growth.
   

Japan hepatitis E diagnostic tests market is anticipated to witness lucrative growth between 2024 – 2032.
 

• Rising awareness about hepatitis E among healthcare professionals and the public in Japan is contributing to more frequent and early diagnosis. Awareness campaigns and educational programs play a crucial role in improving disease detection and driving demand for diagnostic tests.
   

The hepatitis E diagnostic tests market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.
 

• The Saudi government’s investment in healthcare infrastructure, including the expansion of diagnostic laboratories and medical facilities, supports the growth of the market. These investments ensure that advanced diagnostic technologies are available to meet the growing demand.
   

Hepatitis E Diagnostic Tests Market Share

The market is highly competitive, with a mix of major global players and numerous smaller to medium-sized companies. Leading firms prioritize innovation by making significant investments in research and development to enhance product performance and comply with evolving regulatory standards. Strategic partnerships, acquisitions, and mergers play a crucial role in strengthening market positions and expanding global presence.
 

Hepatitis E Diagnostic Tests Market Companies

Some of the eminent market participants operating in the hepatitis E diagnostic tests industry include:

• altona Diagnostics GmbH
• CTK Biotech, Inc.
• Dia.Pro Diagnostic Bioprobes s.r.l
• DiaSorin S.p.A.
• ELITechGroup (Bruker company)
• F. Hoffmann-La Roche Ltd
• Fortress Diagnostics
• Genscript Biotech Corporation
• Guangzhou Wondfo Biotech Co., Ltd.
• Medsource Ozone Biomedicals Pvt. Ltd.
• MIKROGEN GmbH
• MP Biomedicals
• Primer Design
• Wantai BioPharm
   

Hepatitis E Diagnostic Tests Industry News:

• In November 2023, Roche introduced the automated Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections in CE mark-accepting countries, including those in the European Union. This launch expanded Roche's diagnostic portfolio for HEV and provided the company with a competitive advantage in the market.
   

The hepatitis E diagnostic tests market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Test Type

• ELISA HEV IgM test
• ELISA HEV IgG test
• Rapid diagnostics test
• Polymerase chain reaction (PCR)

Market, By Sample Type

• Blood
• Stool

Market, By End-use

• Hospitals
• Diagnostic laboratories
• Blood banks
• Other end-users

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America 
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa