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Hepatitis E Diagnostic Tests Market By Test Type, By End User: Global Opportunity Analysis and Industry Forecast, 2021-2031

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    Report

  • 171 Pages
  • October 2022
  • Region: Global
  • Allied Market Research
  • ID: 5725466
The global hepatitis E diagnostic tests market was valued at $61.69 million in 2021, and is projected to reach $93.5 million by 2031, registering a CAGR of 4.2% from 2022 to 2031.

Hepatitis E is a type of viral infection which leads to liver inflammation caused due to hepatitis E virus (HEV). Hepatitis E virus is a positive-sense, single-stranded, non-enveloped, RNA icosahedral virus and is one of the five known human hepatitis virus (A, B, C, D, and E). The transmission of hepatitis E infection occurs through oral or fecal route which is similar to that of hepatitis A. This condition is temporary and can be treated and recovered if diagnosed at an early stage. However, the infection may lead to serious effects in pregnant women and people with weak immune system, which may further lead to death.

Symptoms of hepatitis E infection are asymptomatic in acute cases, however in some cases the patient may suffer from jaundice, fatigue and nausea. It also includes chronic conditions such as fulminant liver failure or liver cirrhosis which are mainly seen in patients with weakened immune systems and who had a solid organ transplant. There is need for early detection and treatment of the infection, which leads to rise in demands for hepatitis E diagnostics kits as the condition may be life threatening in some cases.

According to World Health Organization (WHO), thousands of acute viral hepatitis infections affect children, adolescents and adults every year which may cause mild diseases and even go undetected. However, in some cases, they can cause severe complications and lead to the death of the person.

It also states that in 2019 alone, an estimated 78,000 deaths occurred due to complications of acute hepatitis A to E infections around the globe. This highlights the rise in number of hepatitis infections in population, which further demands for early diagnosis of the condition. This further propels the sale of hepatitis E diagnostic test kits and subsequently the growth of hepatitis E diagnostic tests market.

Furthermore, certain group of population is at high risk of hepatitis E infection, which includes pregnant women, immunosuppressed people, and people with pre-existing liver disease. Pregnant women are majorly at higher risk of getting HEV genotype 1 infection which is associated with fulminant hepatitis and leads to death in women. In addition, women in second or third trimester are at higher risk of acute liver failure, fetal loss and mortality due to hepatitis E. World Health Organization further states that up to 20-25% of pregnant women can die due to hepatitis E in third trimester of pregnancy. Thus, efficient diagnosis and treatment of the condition is necessary to reduce the mortality rate in pregnant women associated with hepatitis E, which propels the growth of hepatitis E diagnostic tests market.

Furthermore, advancements in the field of diagnosis and treatments drive the market. Several advancements have been done by the researchers and manufacturers in healthcare sector which makes the diagnosis and treatment procedure more efficient and accurate. The development of nucleic acid testing kits and enzyme-linked immunosorbent assay (ELISA) kits, which is based on the detection of specific anti-HEV immunoglobulin M (IgM) antibodies to the virus in the blood of a person, offers high quality, efficiency and accuracy in results. For instance, Human Hepatitis E Virus Antibody (IgG) ELISA Kit offered by Cusabio Technology Llc. is used in the detection of HEV IgG antibody in the serum and plasma and is based on qualitative enzyme immunoassay technique.

Such, new and advanced diagnostic tests kits offered by manufacturers increase the demand for the hepatitis E diagnostics tests kits and accelerate the market growth. Furthermore, rise in funds by governments of various countries and non-government organizations to initiate manufacturing units in the healthcare sector are expected to boost the market growth. Moreover, acquisition and partnerships strategies adopted by key market players are boosting factors for the market.

However, hepatitis E diagnostic kits have limited shelf life. Therefore, there is a crucial need to manage the storage of these kits. In addition, these ELISA kits are to be handled with care, as minor changes in the kit may lead to inaccuracies in range, sensitivity, and precision which provides hindrance to the hepatitis E diagnostic tests market growth. On the contrary, rise in the research and development activities by the key market players and increase in healthcare expenditure have further encouraged many key players to enter emerging markets, thus offering lucrative opportunities for the expansion of the hepatitis E diagnostic tests market.

The hepatitis E diagnostic tests market is segmented on the basis of, test type, end user and region. On the basis of test type, the market is categorized into HEV IgM ELISA Test, HEV IgG ELISA Test, and RT-PCR Test. On the basis of end user, it is segmented into hospitals, diagnostic centers and others (research centers, blood bank, point of care, standalone laboratories). On the basis of region, it is studied across North America, Europe, Asia-Pacific, and LAMEA.

Some of the major companies that operate in the global hepatitis E diagnostic tests market are Altona Diagnostics GmbH, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, Dia. Pro Diagnostic Bioprobes s. r. l, ELITechGroup, PerkinElmer Inc. (Euroimmun Medizinische Labordiagnostika AG), F. Hoffmann-La Roche Ltd., Fortress Diagnostics, Mikrogen Diagnostik, MP Biomedicals, Primerdesign Ltd. and others.

KEY BENEFITS FOR STAKEHOLDERS

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the hepatitis e diagnostic tests market analysis from 2021 to 2031 to identify the prevailing hepatitis e diagnostic tests market opportunities.
  • The market research is offered along with information related to key drivers, restraints, and opportunities.
  • Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
  • In-depth analysis of the hepatitis e diagnostic tests market segmentation assists to determine the prevailing market opportunities.
  • Major countries in each region are mapped according to their revenue contribution to the global market.
  • Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
  • The report includes the analysis of the regional as well as global hepatitis e diagnostic tests market trends, key players, market segments, application areas, and market growth strategies.

Key Market Segments

By Test Type

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

By End User

  • Hospitals
  • Diagnostic Centers
  • Others

By Region

  • North America
  • U. S.
  • Canada
  • Mexico
  • Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • Japan
  • China
  • Australia
  • India
  • South Korea
  • Rest of Asia-Pacific
  • LAMEA
  • Brazil
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA

Key Market Players

  • MP Biomedicals LLP
  • F. Hoffmann-La Roche Ltd.
  • Altona Diagnostics
  • PerkinElmer, Inc
  • Dia. Pro - Diagnostic Bioprobes s. r. l
  • Primerdesign Ltd
  • Mikrogen GmbH
  • Fortress Diagnostics
  • ELITechGroup
  • Beijing Wantai Biolog Pha Ent Co Ltd

Table of Contents

CHAPTER 1: INTRODUCTION
1.1. Report description
1.2. Key market segments
1.3. Key benefits to the stakeholders
1.4. Research Methodology
1.4.1. Secondary research
1.4.2. Primary research
1.4.3. Analyst tools and models

CHAPTER 2: EXECUTIVE SUMMARY
2.1. Key findings of the study
2.2. CXO Perspective

CHAPTER 3: MARKET OVERVIEW
3.1. Market definition and scope
3.2. Key findings
3.2.1. Top investment pockets
3.3. Porter’s five forces analysis
3.4. Market dynamics
3.4.1. Drivers
3.4.2. Restraints
3.4.3. Opportunities
3.5. COVID-19 Impact Analysis on the market

CHAPTER 4: HEPATITIS E DIAGNOSTIC TESTS MARKET, BY TEST TYPE
4.1 Overview
4.1.1 Market size and forecast
4.2. ELISA HEV IgM Test
4.2.1 Key market trends, growth factors and opportunities
4.2.2 Market size and forecast, by region
4.2.3 Market share analysis by country
4.3. ELISA HEV IgG Test
4.3.1 Key market trends, growth factors and opportunities
4.3.2 Market size and forecast, by region
4.3.3 Market share analysis by country
4.4. RT-PCR Test
4.4.1 Key market trends, growth factors and opportunities
4.4.2 Market size and forecast, by region
4.4.3 Market share analysis by country

CHAPTER 5: HEPATITIS E DIAGNOSTIC TESTS MARKET, BY END USER
5.1 Overview
5.1.1 Market size and forecast
5.2. Hospitals
5.2.1 Key market trends, growth factors and opportunities
5.2.2 Market size and forecast, by region
5.2.3 Market share analysis by country
5.3. Diagnostic Centers
5.3.1 Key market trends, growth factors and opportunities
5.3.2 Market size and forecast, by region
5.3.3 Market share analysis by country
5.4. Others
5.4.1 Key market trends, growth factors and opportunities
5.4.2 Market size and forecast, by region
5.4.3 Market share analysis by country

CHAPTER 6: HEPATITIS E DIAGNOSTIC TESTS MARKET, BY REGION
6.1 Overview
6.1.1 Market size and forecast
6.2 North America
6.2.1 Key trends and opportunities
6.2.2 North America Market size and forecast, by Test Type
6.2.3 North America Market size and forecast, by End User
6.2.4 North America Market size and forecast, by country
6.2.4.1 U. S.
6.2.4.1.1 Key market trends, growth factors and opportunities
6.2.4.1.2 Market size and forecast, by Test Type
6.2.4.1.3 Market size and forecast, by End User
6.2.4.2 Canada
6.2.4.2.1 Key market trends, growth factors and opportunities
6.2.4.2.2 Market size and forecast, by Test Type
6.2.4.2.3 Market size and forecast, by End User
6.2.4.3 Mexico
6.2.4.3.1 Key market trends, growth factors and opportunities
6.2.4.3.2 Market size and forecast, by Test Type
6.2.4.3.3 Market size and forecast, by End User
6.3 Europe
6.3.1 Key trends and opportunities
6.3.2 Europe Market size and forecast, by Test Type
6.3.3 Europe Market size and forecast, by End User
6.3.4 Europe Market size and forecast, by country
6.3.4.1 Germany
6.3.4.1.1 Key market trends, growth factors and opportunities
6.3.4.1.2 Market size and forecast, by Test Type
6.3.4.1.3 Market size and forecast, by End User
6.3.4.2 France
6.3.4.2.1 Key market trends, growth factors and opportunities
6.3.4.2.2 Market size and forecast, by Test Type
6.3.4.2.3 Market size and forecast, by End User
6.3.4.3 UK
6.3.4.3.1 Key market trends, growth factors and opportunities
6.3.4.3.2 Market size and forecast, by Test Type
6.3.4.3.3 Market size and forecast, by End User
6.3.4.4 Italy
6.3.4.4.1 Key market trends, growth factors and opportunities
6.3.4.4.2 Market size and forecast, by Test Type
6.3.4.4.3 Market size and forecast, by End User
6.3.4.5 Spain
6.3.4.5.1 Key market trends, growth factors and opportunities
6.3.4.5.2 Market size and forecast, by Test Type
6.3.4.5.3 Market size and forecast, by End User
6.3.4.6 Rest of Europe
6.3.4.6.1 Key market trends, growth factors and opportunities
6.3.4.6.2 Market size and forecast, by Test Type
6.3.4.6.3 Market size and forecast, by End User
6.4 Asia-Pacific
6.4.1 Key trends and opportunities
6.4.2 Asia-Pacific Market size and forecast, by Test Type
6.4.3 Asia-Pacific Market size and forecast, by End User
6.4.4 Asia-Pacific Market size and forecast, by country
6.4.4.1 Japan
6.4.4.1.1 Key market trends, growth factors and opportunities
6.4.4.1.2 Market size and forecast, by Test Type
6.4.4.1.3 Market size and forecast, by End User
6.4.4.2 China
6.4.4.2.1 Key market trends, growth factors and opportunities
6.4.4.2.2 Market size and forecast, by Test Type
6.4.4.2.3 Market size and forecast, by End User
6.4.4.3 Australia
6.4.4.3.1 Key market trends, growth factors and opportunities
6.4.4.3.2 Market size and forecast, by Test Type
6.4.4.3.3 Market size and forecast, by End User
6.4.4.4 India
6.4.4.4.1 Key market trends, growth factors and opportunities
6.4.4.4.2 Market size and forecast, by Test Type
6.4.4.4.3 Market size and forecast, by End User
6.4.4.5 South Korea
6.4.4.5.1 Key market trends, growth factors and opportunities
6.4.4.5.2 Market size and forecast, by Test Type
6.4.4.5.3 Market size and forecast, by End User
6.4.4.6 Rest of Asia-Pacific
6.4.4.6.1 Key market trends, growth factors and opportunities
6.4.4.6.2 Market size and forecast, by Test Type
6.4.4.6.3 Market size and forecast, by End User
6.5 LAMEA
6.5.1 Key trends and opportunities
6.5.2 LAMEA Market size and forecast, by Test Type
6.5.3 LAMEA Market size and forecast, by End User
6.5.4 LAMEA Market size and forecast, by country
6.5.4.1 Brazil
6.5.4.1.1 Key market trends, growth factors and opportunities
6.5.4.1.2 Market size and forecast, by Test Type
6.5.4.1.3 Market size and forecast, by End User
6.5.4.2 Saudi Arabia
6.5.4.2.1 Key market trends, growth factors and opportunities
6.5.4.2.2 Market size and forecast, by Test Type
6.5.4.2.3 Market size and forecast, by End User
6.5.4.3 South Africa
6.5.4.3.1 Key market trends, growth factors and opportunities
6.5.4.3.2 Market size and forecast, by Test Type
6.5.4.3.3 Market size and forecast, by End User
6.5.4.4 Rest of LAMEA
6.5.4.4.1 Key market trends, growth factors and opportunities
6.5.4.4.2 Market size and forecast, by Test Type
6.5.4.4.3 Market size and forecast, by End User

CHAPTER 7: COMPETITIVE LANDSCAPE
7.1. Introduction
7.2. Top winning strategies
7.3. Product Mapping of Top 10 Players
7.4. Competitive Dashboard
7.5. Competitive Heatmap
7.6. Top player positioning, 2021

CHAPTER 8: COMPANY PROFILES
8.1 MP Biomedicals LLP
8.1.1 Company overview
8.1.2 Key Executives
8.1.3 Company snapshot
8.1.4 Operating business segments
8.1.5 Product portfolio
8.1.6 Business performance
8.1.7 Key strategic moves and developments
8.2 F. Hoffmann-La Roche Ltd.
8.2.1 Company overview
8.2.2 Key Executives
8.2.3 Company snapshot
8.2.4 Operating business segments
8.2.5 Product portfolio
8.2.6 Business performance
8.2.7 Key strategic moves and developments
8.3 Altona Diagnostics
8.3.1 Company overview
8.3.2 Key Executives
8.3.3 Company snapshot
8.3.4 Operating business segments
8.3.5 Product portfolio
8.3.6 Business performance
8.3.7 Key strategic moves and developments
8.4 PerkinElmer, Inc
8.4.1 Company overview
8.4.2 Key Executives
8.4.3 Company snapshot
8.4.4 Operating business segments
8.4.5 Product portfolio
8.4.6 Business performance
8.4.7 Key strategic moves and developments
8.5 Dia. Pro - Diagnostic Bioprobes s. r. l
8.5.1 Company overview
8.5.2 Key Executives
8.5.3 Company snapshot
8.5.4 Operating business segments
8.5.5 Product portfolio
8.5.6 Business performance
8.5.7 Key strategic moves and developments
8.6 Primerdesign Ltd
8.6.1 Company overview
8.6.2 Key Executives
8.6.3 Company snapshot
8.6.4 Operating business segments
8.6.5 Product portfolio
8.6.6 Business performance
8.6.7 Key strategic moves and developments
8.7 Mikrogen GmbH
8.7.1 Company overview
8.7.2 Key Executives
8.7.3 Company snapshot
8.7.4 Operating business segments
8.7.5 Product portfolio
8.7.6 Business performance
8.7.7 Key strategic moves and developments
8.8 Fortress Diagnostics
8.8.1 Company overview
8.8.2 Key Executives
8.8.3 Company snapshot
8.8.4 Operating business segments
8.8.5 Product portfolio
8.8.6 Business performance
8.8.7 Key strategic moves and developments
8.9 ELITechGroup
8.9.1 Company overview
8.9.2 Key Executives
8.9.3 Company snapshot
8.9.4 Operating business segments
8.9.5 Product portfolio
8.9.6 Business performance
8.9.7 Key strategic moves and developments
8.10 Beijing Wantai Biolog Pha Ent Co Ltd
8.10.1 Company overview
8.10.2 Key Executives
8.10.3 Company snapshot
8.10.4 Operating business segments
8.10.5 Product portfolio
8.10.6 Business performance
8.10.7 Key strategic moves and developments

Executive Summary

According to this report, titled, 'Hepatitis E Diagnostic Tests Market,' the hepatitis e diagnostic tests market size was valued at $61.69 million in 2021, and is estimated to reach $93.5 million by 2031, growing at a CAGR of 4.2% from 2022 to 2031.

Hepatitis E diagnostic test market mainly involves the sales and distribution of hepatitis E diagnostic tests kits by the key market players. Hepatitis E is the infection caused by hepatitis E virus (hepevirus), which is an inflammation caused to the liver. This infection includes symptoms such nausea and jaundice which further leads to acute hepatitis in normal people and chronic hepatitis in immunosuppressed people. Furthermore, if chronic hepatitis remains undiagnosed and untreated it may lead to severe conditions such as cirrhosis and liver cancer.

World Health Organization states that around 30% (15-45%) of infected people clear the infection within 6 months of occurrence without any treatment. The remaining 70% of people may develop chronic infection, having the risk of cirrhosis ranging from 15% to 30% within 20 years. Thus, the need for early diagnosis and treatment of the condition is necessary, which further rises the demand for hepatitis E diagnostic test kits, and propels the hepatitis E diagnostic tests market growth.In addition, factors that drive the growth of the global hepatitis E diagnostic tests market trends include high prevalence of hepatitis E cases, rise in awareness about risk factors associated with hepatitis E if remained untreated, advancements in the field of diagnosis and treatment, and rise in investments by the public and private players in the R&D activities in this field.Moreover, the new product launches and product approvals by the public and private players is anticipated to provide a lucrative opportunity for the market. For instance, in August 2022, Roche announced the launch of a digital PCR system, which is a powerful new diagnostics platform in the fight against cancer and other infectious diseases. The new system has the potential to find and quantify rare and hard to detect mutations allowing for early diagnosis of severe hepatitis infections.

In addition, the government and non-government organizations in the developed as well as developing countries focus on creating awareness among the population about hepatitis diseases and related risk factors. Various campaigns and drives are arranged by different organizations which further creates awareness among the population about the causes and symptoms about the infection. It is necessary to create awareness among people about the safety of drinking water, and various methods to stop this spread of infection from drinking water, as hepatitis infection is caused due to drinking water contaminated by feces. In addition, the government have also taken initiatives to spread knowledge and information about the advanced diagnostic techniques which will help in early detection and treatment of the infection and avoid any serious conditions associated with it. This, further expand the market of hepatitis E diagnostic tests.

The hepatitis E diagnostic tests industry is segmented on the basis of test type, end user, and region. On the basis of test type, the market is segmented into HEV IgM ELISA Test, HEV IgG ELISA Test, and RT-PCR test. The HEV IgM ELISA Test segment dominated the market in 2021, and this trend is expected to continue during the forecast period, owing to the rise in advancements in this segment which offers accurate and immediate results in diagnosis of infectious diseases.On the basis of end user, the market is categorized into hospitals, diagnostic centers and others (research centers, blood bank, point of care, standalone laboratories). In 2021, the diagnostic centers segment held the largest Hepatitis E Diagnostic tests market share of the global hepatitis E diagnostic tests market, and is expected to grow at the highest CAGR during the forecast period. Increase in patient visits to the diagnostic centers after the COVID-19 pandemic as they offer the precise testing and thus assist the healthcare provider to decide the treatment regime.

Asia-Pacific acquired the major share of the hepatitis E diagnostic tests market in 2021, is expected to register highest CAGR from 2022 to 2031, owing to the rapid changes in the environmental conditions and associated viral and bacterial infections which leads to severe viral endemics in this region.

Key findings of the study

By test type, the HEV IgM ELISA Test segment was the highest contributor to the market in 2021.

By end user, the diagnostic centers segment held the highest position in terms of revenue in 2021, and are expected to grow at the highest CAGR during the forecast period
Region wise, Asia-Pacific garnered the largest revenue share in 2021, and is anticipated to grow at the highest CAGR during the forecast period.

Companies Mentioned

  • Mp Biomedicals Llp
  • F. Hoffmann-La Roche Ltd.
  • Altona Diagnostics
  • Perkinelmer, Inc.
  • Dia.Pro - Diagnostic Bioprobes S.R.L
  • Primerdesign Ltd.
  • Mikrogen GmbH
  • Fortress Diagnostics
  • Elitechgroup
  • Beijing Wantai Biolog Pha Ent Co Ltd

Methodology

The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.

They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.

They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:

  • Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
  • Scientific and technical writings for product information and related preemptions
  • Regional government and statistical databases for macro analysis
  • Authentic news articles and other related releases for market evaluation
  • Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast

Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.

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