Report Overview

The global serological testing market was pegged at US$ 3.1 billion in 2021 and is expected to register a revenue CAGR of 9.0% during the forecast period.

Serology tests, also known as antibody tests, detect antibodies or antigens. Antigens are foreign substances that cause infectious diseases and affect the immune system. The production of antibodies against a specific antigen is part of the immune response. Each antigen and antibody have a distinct biological nature and characteristics. Various methods are used for disease detection of antibodies, including hemagglutinin-inhibition tests, enzyme-linked immunosorbent assays (ELISAs), flocculation tests, neutralization tests, and chemiluminescence immunoassays. Serological testing is most commonly used to diagnose parasitic, viral, and bacterial diseases such as dengue, malaria, hepatitis, HIV, and others.

Market Dynamics

The global serological testing market is mainly driven by a high prevalence of infectious diseases, increasing HIV transmissions, increasing covid-19 cases, rising hepatitis cases, and a threat from new viruses. Additionally, precise diagnosis, cost-effective screening, and affordability contribute to the global serological testing market growth. Moreover, the market will also grow due to technological advancements and the rapid introduction of a novel diagnostic methodology for screening diseases. However, the risk of false positive outcomes, unfavorable reimbursement policies for diagnosis, and expensive genome testing are slowing the revenue growth of the global serological testing market. 

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Market Ecosystem

The global serological testing market has been analyzed from five perspectives: product, technology, application, end-user, and region. 

Serological Testing by Product 

Based on the product, the global serological testing market has been segmented into instruments (Immunoassay Analyzers, ELISA analyzers, ELFA analyzers, and POC analyzers) and reagents & consumables (ELISPOT Reagents & kits, ELISA Reagents & Kits, Western Blot Reagents & Kits, Rapid Test Reagents & Kits). Reagents and consumables are leading the global serological testing market owing to the affordability of reagents and the high consumption of reagents by diagnostic laboratories and research institutes. Additionally, the introduction of novel POCT devices, new rapid testing kits, and an increased number of market players are contributing to the global reagent and consumables market. The instruments segment is also expected to show high potential revenue growth in the coming years owing to automation, precise diagnosis outcomes, novel technology, and less turnaround time for diagnosis. 

Serological Testing by Technology

Based on technology, the global serological testing market has been segmented into enzyme-linked immunosorbent assay (ELISA), western blot, nucleic acid test (NAT), chemiluminescence microparticle immunoassay (CMIA), and lateral flow test. ELISA is an enzyme-linked immunosorbent plate-based molecular biology method commonly used for screening and diagnosing antibodies, proteins, and peptides. ELISA is leading the global serological testing market owing to a high number of infectious diseases screening, cheap & affordable reagents, long shelf-life of reagents, high specificity, high sensitivity, less turnaround time, and high cost. Additionally, technological advancement, high precision diagnosis, and less complex steps required for performing contribute to the ELISA testing segment growth. 

Serological Testing Market by Application

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Based on application, the global serological testing market has been segmented into blood group detection, COVID-19, dengue, torch test, hepatitis B, hepatitis C, HIV, malaria, syphilis, and others. COVID-19 was leading the global serological testing market due to the coronavirus pandemic outbreak and government regulations for compulsory screening of COVID-19. Additionally, technological advancement, rapid introduction of novel COVID-19 diagnostics, high demand for testing, and affordability of COVID-19 antibody testing contribute to the global COVID-19 serological testing market revenue growth.

Serological Testing Market by End-user

Based on end-user, the global serological testing market is segmented into hospitals, blood banks, diagnostic centers, and academic & research institutes. The diagnostic centers segment is leading the global serological testing market owing to increasing patient footfall for diagnosing infectious diseases, the presence of several diagnostic laboratories, and home sample collection services. Additionally, automation of diagnostic laboratories for improved efficiencies and mergers and acquisitions of key players augmenting their geographic outreach contribute to the global diagnostic testing market.

Serological Testing Market by Region

Based on region, the global serological testing market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World. North America dominates the global serological testing market, followed by the Asia Pacific. The large share of North America in the global serological testing market is attributed to increasing infectious diseases, the outbreak of COVID-19, and the high prevalence of HIV, hepatitis, etc. Additionally, developed infrastructure, increasing healthcare expenditure, favorable government policies, technological advancements such as automation, POCT testing, rapid antigen testing, and affordable RTPCR test contribute to North American serological testing market revenue growth. 

Competitive Landscape

Some prominent players operating in the global serological testing market are:

• Abbott Laboratories Inc.
• Quidel Corporation
• Beckman Coulter, Inc.
• Becton, Dickinson & Co.
• Merck KGaA,
• bioMérieux SA
• Grifols, S.A. 
• DiaSorin S.p.A 
• Eurofins Scientific SE
• F. Hoffmann-La Roche Ltd. 
• Mylab Discovery Solutions Pvt. Ltd.
• Tulip Diagnostics Ltd (PerkinElmer Inc.)
• Siemens Healthineers AG 
• Sysmex Corporation
• Thermo Fisher Scientific Inc. 

Strategic Developments

• In June 2022, Boditech Med launched a real-time PCR molecular diagnostics kit for monkeypox virus detection. It uses gene amplification and extractor technology and is only for research. Boditech Med is also starting a rapid diagnostic kit for the monkeypox virus.
• In December 2021, Boditech Med launched the world's first COVID-19 infection history diagnosis kit.
• In September 2020, Roche launched Elecsys® HIV Duo test in the U.S. It is a 4th generation HIV testing solution for separate detection of anti-HIV antibodies and HIV p24 antigen. Elecsys lit has high sensitivity and high specificity, which helps early detection.

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