Mononucleosis Diagnostic Market is expected to reach US$ 222.15 Million by 2031

Monospot Test Segment to Bolster Mononucleosis Diagnostic Market Growth During 2023–2031  

According to our new research study on "Mononucleosis Diagnostic Market Forecast to 2031 – Global Analysis – by Type and End User," the market was valued at US$ 151.44 million in 2023 and is projected to reach US$ 222.15 million by 2031; it is anticipated to record a CAGR of 4.9% from 2023 to 2031. The mononucleosis diagnostic market trends, along with drivers and deterrents affecting the market growth, are emphasized in the report.   

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 Share, by Region, 2023 (%)

Source: The Insight Partners Analysis

High Risk among Adolescent Population Bolsters Mononucleosis Diagnostic Market Growth

According to the United Nations Children's Fund (UNICEF), there are 1.3 billion adolescents in the world, making up 16% of the total population of the world. As defined by the United Nations, the adolescent population (10–19 years of age) experiences a transition period from childhood to adulthood with significant growth and development. Mononucleosis, often referred to as "the kissing disease," primarily affects adolescents and young adults. The incidence of this disease is rising with the growing adolescent population. Epstein-Barr virus (EBV) is the most common cause of this disease, which often spreads through saliva while kissing or sharing drinks.

Healthcare providers experience a high demand for effective diagnostic tests to identify and confirm mononucleosis in adolescents. Monospot tests, EBV antibody tests, and throat cultures are the established diagnosis methods for this disease. The monospot test involves the detection of specific antibodies in the blood, while the EBV antibody test specifically focuses on detecting anti-EBV antibodies. Many healthcare providers are also focusing on offering point-of-care testing and telehealth services, which cater specifically to younger patients who prefer the convenience of quick, at-home diagnostics. These innovations ease the timely diagnoses, eventually reducing barriers to access and increasing the overall testing rate. The ability to rapidly identify mononucleosis cases leads to better patient management and minimizes the disease impact on academic and social life. Thus, the high risk of mononucleosis among adolescents results in a significant demand for diagnostic products and services for this condition.

Mononucleosis Diagnostic Market Report Scope:

The mononucleosis diagnostic market analysis has been carried out by considering the following segments: type, end user, and geography.

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 share of the market 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.

Mononucleosis Diagnostic Market Analysis: Based on Geography

The geographic scope of the mononucleosis diagnostic market report includes the assessment of the market performance in North America (US, Canada, and Mexico), Europe (Spain, UK, Germany, France, Italy, and Rest of Europe), Asia Pacific (South Korea, China, India, Japan, Australia, and Rest of Asia Pacific), South & Central America (Brazil, Argentina, and Rest of South & Central America), and the Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa).

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