E형 간염 진단 테스트 시장 : 기회, 성장 동인, 산업 동향 분석 및 예측(2024-2032년)

The Global Hepatitis E Diagnostic Tests Market was valued at approximately USD 60 million in 2023. Projections indicate a growth rate of 4.3% CAGR from 2024 to 2032. The global surge in hepatitis E cases has increased the demand for efficient diagnostic solutions. The hepatitis E virus (HEV) is the culprit behind hepatitis E, with its prevalence rising due to poor sanitation and tainted water sources, notably in developing areas. The World Health Organization (WHO) reports that around 20 million global infections of the hepatitis E virus occur annually, leading to roughly 3.3 million symptomatic cases. This rising incidence highlights the urgent need for dependable diagnostic tests, driving market expansion.

Heightened awareness and comprehensive screening programs are pivotal in driving market growth. Public health initiatives and educational campaigns have shed light on hepatitis E, encouraging more individuals to pursue testing. Enhanced screening initiatives, especially in high-risk regions, bolster the detection and management of the disease. These efforts promote early diagnosis and help monitor prevalence and curb the spread of hepatitis.

The Hepatitis E Diagnostic Tests Market is grouped based on test type, sample test, end-use, and region.

The market is segmented by test type into ELISA HEV IgM test, ELISA HEV IgG test, rapid diagnostics test, and polymerase chain reaction (PCR). The ELISA HEV IgM test segment will reach USD 44.7 million by 2032. The test is significant because it identifies recent HEV infections by detecting IgM antibodies, which appear shortly after infection onset. As global awareness and screening for hepatitis E increase, especially in high-prevalence regions, the demand for timely diagnostic tools like the ELISA HEV IgM test will rise. Additionally, advancements in test sensitivity and specificity, along with increased public health funding for viral hepatitis control, contribute to this segment's growth. This trend underscores the importance of early diagnosis and intervention in managing hepatitis E outbreaks, driving market expansion.

Based on sample type, the hepatitis E diagnostic tests market is divided into blood and stool. In 2023, the blood segment generated USD 51.1 million. Blood-based diagnostics, including serological assays and molecular tests, are highly valued for their ability to detect HEV antibodies and RNA. This precision is crucial for diagnosing and monitoring the disease. Their popularity stems from their ability to detect infections in both acute and chronic stages, which is essential for effective management. With advantages like higher sensitivity and specificity, blood tests are considered reliable, making them the preferred choice among healthcare professionals. Consequently, the blood-based segment continues to dominate the market, reflecting its central role in accurately diagnosing hepatitis E.

In the U.S., the hepatitis E diagnostic tests market is projected to reach USD 34.2 million by 2032. Key drivers include technological advancements in diagnostics 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. At the same time, 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.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising hepatitis E incidence
    • 3.2.1.2 Advancement in diagnostic technologies
    • 3.2.1.3 Rising awareness and screening programs
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Limited availability in developing regions
    • 3.2.2.2 Stringent regulatory scenario
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technology landscape
  • 3.5.1 Core technologies
  • 3.5.2 Adjacent technologies
• 3.6 Future market trends
• 3.7 Gap analysis
• 3.8 Porter's analysis
• 3.9 PESTLE analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 ELISA HEV IgM test
• 5.3 ELISA HEV IgG test
• 5.4 Rapid diagnostics test
• 5.5 Polymerase chain reaction (PCR)

Chapter 6 Market Estimates and Forecast, By Sample Type, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Blood
• 6.3 Stool

Chapter 7 Market Estimates and Forecast, By End-use, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Hospitals
• 7.3 Diagnostic laboratories
• 7.4 Blood banks
• 7.5 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
  • 8.3.7 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 altona Diagnostics GmbH
• 9.2 CTK Biotech, Inc.
• 9.3 Dia.Pro Diagnostic Bioprobes s.r.l
• 9.4 DiaSorin S.p.A.
• 9.5 ELITechGroup ( Bruker company)
• 9.6 F. Hoffmann-La Roche Ltd
• 9.7 Fortress Diagnostics
• 9.8 Genscript Biotech Corporation
• 9.9 Guangzhou Wondfo Biotech Co., Ltd.
• 9.10 Medsource Ozone Biomedicals Pvt. Ltd.
• 9.11 MIKROGEN GmbH
• 9.12 MP Biomedicals
• 9.13 Primer Design
• 9.14 Wantai BioPharm