Monospot Test Segment, by Type to Account Largest Share in Mononucleosis Diagnostic Market during 2023–2031 

According to our new research study on "Mononucleosis Diagnostic Market Forecast to 2031 – Global Analysis – by Type, End User, and Geography," the market was valued at US$ 151.44 million in 2023 and is projected to reach US$ 222.15 million by 2031; it is expected to register a CAGR of 4.9% during 2023–2031. High risk among the adolescent population, and the rising health awareness and knowledge about mononucleosis are contributing to the growing mononucleosis diagnostic market size. However, the low accuracy of existing diagnostic tests hampers the market growth. Further, advancements in molecular diagnostics in mononucleosis diagnostic are expected to bring in new mononucleosis diagnostic market trends in the coming years.  

Mononucleosis Diagnostic Market Analysis

A shift toward molecular diagnostics reflects advancements in medical technology and a growing focus on accurate, efficient, and timely diagnoses. Molecular diagnostic methods, particularly PCR testing, offer much higher sensitivity and specificity compared to traditional serological tests. Genetic material amplified through PCR can be used to detect specific EBV genes, which indicate positive mononucleosis diagnoses, even in the early stages of infection when antibody levels may not be detectable. The capability reduces the risk of false negatives, ensuring that more cases are accurately identified and treated. Advancements in molecular diagnostics have also led to faster turnaround times for test results. With the ability to perform tests directly using POC, healthcare providers can receive results within hours instead of waiting several days, unlike conventional laboratory tests.  

Further, the mononucleosis diagnostics market is benefiting from the increasing use of automated molecular diagnostic systems. These systems streamline the testing process, reducing the potential for human error and increasing throughput. Automation enhances operating efficiency in laboratories, enabling personnel to handle higher volumes of tests without compromising on accuracy. The burgeoning popularity of automation is likely to boost the acceptance and accessibility of molecular diagnostics. There is a growing awareness among healthcare professionals and patients owing to the ongoing education and training initiatives about the advantages of molecular diagnostics. As clinicians recognize the limitations of traditional tests, they are increasingly opting for molecular methods to ensure accurate diagnoses. Thus, advancements in molecular diagnostics serve as significant trends in the mononucleosis diagnostics market.

Mononucleosis Diagnostic Market Report Scope

Based on type, the mononucleosis diagnostic market is segmented into Epstein Barr Virus antibody test, complete blood count test, and monospot test. The monospot test segment held the largest mononucleosis diagnostic market share in 2023. The monospot test or heterophile antibody (HAb) test is a simple, nonspecific serological test for diagnosing and screening primary and recurrent mononucleosis infections. The HAb test is mainly dependent on the ability of a patient’s serum or plasma to agglutinate horse, goat, or sheep erythrocytes. Though the monospot test is considered to be specific, the sensitivity falls in the range of 70–90% and is particularly weak among children below 4 years of age. According to the article “Recent Advances in Diagnostic Approaches for Epstein–Barr Virus,” published by the National Library of Medicine, in March 2020, out of 85–90% of adults and teenagers who tested positive during the course of EBV infection, only ~50% were tested positive for the HAb infection in the first week. Apart from high false negative results recorded in children, non-specificity was another disadvantage exhibited by the HAb test; for example, it could generate false positive results in non-EBV infections (such as viral hepatitis, rubella, malaria, and HIV), malignancies, and autoimmune disorders. Moreover, the monospot test is cost-effective and provides faster results than its alternatives. Its role in facilitating timely diagnosis and management underlines its significance, contributing to better patient outcomes and informed healthcare decisions. Companies such as Meridian Biosciences, Arlington Scientific, Abbott, QuidelOrtho Corp, and Sekisui offer the monospot test for detecting EBV in the early stages of infection.

The Epstein-Barr virus (EBV) segment is the second largest segment in the market. The EBV antibody test plays a crucial role in diagnosing mononucleosis, as the EBV is the most common cause of the disease. This test detects antibodies against various EBV components, helping clinicians distinguish between active and past infections by utilizing distinctive antigens or substrates. Viral capsid antigen, early antigen (EA), and Epstein-Barr nuclear antigen are a few of the test antigens used for the detection of EBV antibodies, including IgM and IgG. Immunofluorescence assay, enzyme immunoassay, and Western blot assay are primarily used in EBV antibody testing. Creative Diagnostics offers recombinant antigens p18 and p23 (viral capsid antigens), p54 and p138 (EA), and EBNA1 (nuclear antigen). These recombinant antigens in immunoassays are suitable for detecting IgG and IgM antibodies against EBV in blood samples.

According to the Centers for Disease Control and Prevention (CDC), there is an increasing prevalence of EBV-related infections, ~9 in 10 adults have EBV antibodies, driving the demand for accurate testing such as EBV antibody testing. Companies are significantly focusing on providing various antigens for accurate EBV testing. In addition, technological advancements in diagnostic techniques such as enzyme-linked immunosorbent assays (ELISA) and rapid tests have improved testing speed and accessibility, enhancing the diagnostic landscape. For example, rapid tests can deliver results in less than an hour, making them invaluable in urgent care settings. 

Based on end user, the mononucleosis diagnostic market is categorized into hospitals, laboratories, and others. The hospitals segment dominated the market in 2023. The mononucleosis diagnostics market growth in the hospitals segment is driven by increasing awareness and rising patient count. Hospitals play a critical role in diagnosing mononucleosis, primarily through laboratory tests such as complete blood count (CBC) and heterophile antibody tests (monospot). Additionally, the integration of advanced diagnostic technologies, such as polymerase chain reaction (PCR) testing, has enhanced the accuracy of EBV detection, allowing hospitals to deliver timely and effective patient care. The presence of specialized infectious disease departments in large hospitals further allows them to streamline the diagnostic process, enabling quicker referrals and management strategies. Further, the rising incidence of mononucleosis among adolescents and young adults compels hospitals to develop targeted care pathways, including outpatient monitoring and support services. In addition, various healthcare insurance providers offer proper healthcare coverage, which helps patients to opt for diagnosis in hospitals. Hospitals such as Mount Sinai, UC Davis Health, and Mid and South Essex NHS Foundation Trust provide mononucleosis diagnosis services with simplified coverage for expenses.

Abbott Laboratories, Arlington Scientific Inc, Bio-Rad Laboratories Inc, Cardinal Health Inc, Meridian Bioscience Inc, Sekisui Diagnostics LLC, Thermo Fisher Scientific Inc, QuidelOrtho Corp, F. Hoffmann-La Roche Ltd, QIAGEN NV, Hologic Inc, bioMerieux SA, DiaSorin SpA, Immunostics Inc., Launch Diagnostics Ltd, Biorex Diagnostics, and ZEUS Scientific are among the leading companies operating in the global mononucleosis diagnostic market.    

Companies operating in the mononucleosis diagnostic market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the mononucleosis diagnostic market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall mononucleosis diagnostic market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

Contact Us

Contact Person: Sameer Joshi

Phone: +1-646-491-9876

Email Id: sales@premiummarketinsights.com