Serological Testing / Diagnostic Market - Forecast(2021 - 2026)

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Serological Testing Market Overview

Serological Testing Market size is forecast to reach $4.8 billion by 2025, growing at a CAGR of 8.73% during the forecast period 2020-2025. Serological test is a type of medical testing that works on blood samples by testing the presence of antibodies against viruses. The blood of a person who has been exposed should be full of antibodies against the virus. Serology testing demand has increased in order to better quantify the number of cases of COVID-19, including those that is set to recovered or not have the symptoms. Growing concerns for testing of COVID-19 and increasing technological advancements of serological testing are major factors driving the growth of the market. Rising need for prevention of COVID-19 global pandemic and rising cases of diseases like hepatitis, tuberculosis, and AIDS across the world is set to further enhance the Serological Testing Market demand during the forecast period 2020-2025. 

Key Takeaways

  • Europe region dominates the Serological Testing Market in 2019 owing to the need of a robust method of testing COVID-19 virus, following an alarming rate of COVID-19 affected and deaths in the European countries of Italy and UK. Increasing investments in healthcare by key market players has further helped in market demand of Serological Testing. The Serological Testing Market scope for different regions will be provided in the final report.
  • Growing cases of COVID-19, HIV, Hepatitis C and other infectious diseases, rising investments by key players for better technological development of serological testing and growing financial cooperation by various state funds have helped in significant growth of Serological Testing Market. Well-established health care infrastructure and rising geriatric population is estimated to drive industry growth during the forecast period 2020-2025.
  • Detailed analysis on the Strength, Weakness and opportunities of the prominent players operating in the market will be provided in the Serological Testing Market report.
  • Increasing costs of manufacturing and availing serological tests and invention of better testing methods are anticipated to hamper the market growth of the Serological Testing Industry.

Test Type - Segment Analysis

Primary Testing held the largest share in the test type segment of Serological Testing Market in 2019 and is estimated to grow at a CAGR of 6.81% during the forecast period 2020-2025. Primary testing is of three types. They are enzyme linked immunosorbent assay (ELISA), immunofluorescent antibody technique (IFAT), and radio immunoassay (RIA). Growing demand for diagnosis of HIV infection and pregnancy tests has driven the growth of ELISA test kits. However, demand of IFAT tests are driven by rising prevalence of chronic diseases, and quality and error-free results drive the demand of RIA tests. Secondary serological testing held the second largest share in the market, owing to rising incidences of rheumatoid arthritis, autoimmune disorder, and Hepatitis B infections. Agglutination tests, complement fixation tests (CFT), precipitation tests come under secondary testing. It is estimated that Primary Testing is set to continue to be the fastest growing segment and is poised to register the highest CAGR during the forecast period 2020-2025, owing to more incidences of chronic and infectious diseases and launch of novel immunoassay products by key market players.

Application - Segment Analysis

Hepatitis hold the major share in the application segment of Serological Testing Market in 2019. Diagnosis of hepatitis B virus (HBV) infection is established through serological testing. The diagnostic panel for hepatitis B serology allows determination of susceptibility, active infection, or immunity through vaccination or past infection. About 35% of children infected between the ages of 1 and 5 years develop chronic hepatitis B. By contrast, about 95% of adults recover completely and do not become chronically infected. Fatality rates drive the attention of healthcare sector and also state funded programs. Coronavirus (COVID-19) held the second largest share in the year 2019, owing to an immediate requirement of a robust testing which accurately diagnoses the virus. Companies like Cellex Inc., ChemBio, VITROS Immunodiagnostic Products and MayoClinic have already got their testing kits approved for diagnostic purposes. Human Immunodeficiency Virus (HIV) is forecasted to grow at the fastest rate with the highest CAGR during the forecast period 2020-2025, owing to more favorable performance characteristics with the best diagnostic tests in most cases.

Geography - Segment Analysis

Europe dominates the Serological Testing Market in 2019 with a market share of more than 41.8%, followed by North America. The immediate need of appropriate testing of COVID-19 virus has driven the growth of Serology Testing market in this region. With death toll of 21,000 in Italy and 12,000 in U.K. owing to the outbreak of the global pandemic, there is a huge demand of prevention and testing of the virus. Increasing healthcare expenditure and growing healthcare awareness has also fuelled the market growth. North America held the second largest share in 2019, owing to demand for better testing methods, robust healthcare methods and growing prevalence of chronic diseases among old age people.
However, Asia-Pacific is estimated to grow at a higher CAGR during the forecast period 2020-2025. This is owing to growth of infectious diseases in developing countries such as India and China, growing health awareness among the masses, and increase in disposable income in the region.

Drivers – Serological Testing Market


  • Growing cases of global pandemic COVID-19 and other infectious diseases

The World Health Organization (WHO) considered Europe the active center of the 2019–20 coronavirus pandemic. Cases by country across Europe had doubled over periods of typically 3 to 4 days, with some countries (mostly those at earlier stages of detection) showing doubling every 2 days. As such, it is very important to stop the virus from becoming a community-level outbreak. Amidst lockdowns and economical unrest, the only way to fight the virus is testing. Serological Testing offers the most accurate way of testing the virus. Hepatitis B and HIV testing is also becoming more easy with the help of serological tests. Growing prevalence of viral infections, increasing investments by key market players, state funds and growing health awareness about these diseases are forecasted to drive the Serological Testing Market trends in the forecast period.

  • Increasing state funds

There is a gradual increase in the investments by the governments of various countries to fight the pandemic and other infectious diseases. For instance, developing countries like India and China have started investing heavily on better functioning tests. In order to upgrade better life expectancy and lifestyle, there is a rapid increase in public awareness and constant pressure on state funds to invest in the research and development of the serology tests. This is set to drive the market growth during the forecast period 2020-2025.

Challenges – Serological Testing Market


  • High cost of serological tests

Though lowest cost-effect and cost minimization ratios were achieved by implementing a two-step single-marker screening protocol for high-risk subjects of serological testing, this newer concept of testing usually costs higher than the affordable medical costs of an average family. This is set to hamper the growth of the market.

Serological Testing Industry Outlook

Product launches, mergers and acquisitions, joint ventures and R&D activities are key strategies adopted by players in the Serological Testing Market. In 2019, Serological Testing Market share is consolidated by the top players present in the market. Serological Testing Market top 10 companies are Accelerate Diagnostics, Creative Diagnostics, Chembio Diagnostic Systems Inc., Randox Laboratories Ltd., Eurofins Scientific, Dickinson and Company, Quest Diagnostics, Thermo Fisher Scientific, Inc., Beckman Coulter and Becton among others.

Acquisitions/Product Launches

  • In April 2020, Accelerate Diagnostics and BioCheck announced collaboration agreement to distribute MS-FAST Chemiluminescence Immunoassay Analyzer and SARS-CoV-2 Antibody Tests.
  • In March 2020, Chembio Diagnostic Systems Inc. announced the launch of DPP COVID-19 Serological Point-of-Care Test.
  • In August 2019, Randox Laboratories Ltd. Developed Randox H-FABP assay, an independent marker of AKI following cardiac surgery, which can be used as a CSA-AKI risk assessment assay even in advance of the procedure.
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1. Serological Testing Market Overview
    1.1 Definitions and Scope
2. Serological Testing Market - Executive Summary
    2.1 Market Revenue and Key Trends by Company
    2.2 Key trends by Product Type
    2.3 Key trends by Mode of Ventilation 
    2.4 Key trends by Geography
3. Serological Testing Market – Comparative Analysis
    3.1 Product Benchmarking – Key Companies
    3.2 Financial Analysis – Key Companies
    3.3 Market Value Split by Key Companies
    3.4 Patent Analysis – Key Companies
    3.5 Pricing Analysis
4. Serological Testing Market - Startup Companies Scenario (Premium)
    4.1 Key Startup Company Analysis by
        4.1.1 Investment
        4.1.2 Revenue
        4.1.3 Venture Capital and Funding Scenario
5. Serological Testing Market – Industry Market Entry Scenario Premium (Premium)
    5.1 Regulatory Framework Overview
    5.2 New Business and Ease of Doing business index
    5.3 Case Studies of Successful Ventures
6. Serological Testing Market - Market Forces
    6.1 Market Drivers
    6.2 Market Constraints/Challenges
    6.3 Porters five force model
        6.3.1 Bargaining power of suppliers
        6.3.2 Bargaining powers of customers
        6.3.3 Threat of new entrants
        6.3.4 Rivalry among existing players
        6.3.5 Threat of substitutes 
7. Serological Testing Market – Strategic Analysis
    7.1 Value Chain Analysis
    7.2 Opportunities Analysis
    7.3 Market Life Cycle
8. Serological Testing Market – By Test Type (Market Size –$Million/$Billion)
    8.1 Primary Test
    8.2 Secondary Test
    8.3 Others
9. Serological Testing Market – By Product Type (Market Size –$Million/$Billion)
    9.1 Reagent
    9.2 Accessory Systems
10. Serological Testing Market – By Application (Market Size –$Million/$Billion)
    10.1 Hepatitis
    10.2 Coronavirus (COVID-19)
    10.3 Human Immunodeficiency Virus (HIV)
    10.4 Rubella immune status
    10.5 Rotavirus infections
    10.6 Others
11. Serological Testing Market – By End User (Market Size –$Million/$Billion)
    11.1 Retail Pharmacies
    11.2 Hospital Pharmacies
    11.3 Online Channels
12. Serological Testing Market - By Geography (Market Size –$Million/$Billion)
    12.1 North America
        12.1.1 U.S.
        12.1.2 Canada
        12.1.3 Mexico
    12.2 Europe
        12.2.1 U.K.
        12.2.2 Germany
        12.2.3 France
        12.2.4 Italy
        12.2.5 Spain
        12.2.6 Rest of Europe
    12.3 Asia-Pacific
        12.3.1 China
        12.3.2 India
        12.3.3 Japan
        12.3.4 South Korea
        12.3.5 Australia & New Zealand
        12.3.6 Rest of Asia-Pacific
    12.4 Rest of the World
        12.4.1 Middle East
        12.4.2 Africa
        12.4.3 South America
13. Serological Testing Market - Entropy
14. Serological Testing Market – Industry/Segment Competition Landscape (Premium) 
    14.1 Market Share Analysis
        14.1.1 Global Market Share – Key Companies
        14.1.2 Market Share by Region – Key companies
        14.1.3 Market Share by Countries – Key Companies
        14.1.4 Best Practices for Companies
15. Serological Testing Market – Key Company List by Country Premium (Premium)
16. Serological Testing Market Company Analysis
    16.1 Company 1
    16.2 Company 2
    16.3 Company 3
    16.4 Company 4
    16.5 Company 5
    16.6 Company 6
    16.7 Company 7
    16.8 Company 8
    16.9 Company 9
    16.10 Company 10 and more
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