Mononucleosis Diagnostic Market

Market Overview

The global mononucleosis diagnostic market size was valued at USD 1.7 billion in 2023 and is projected to reach USD 3.9 billion by 2032, registering a CAGR of 9.4% during the forecast period (2024-2032). The mononucleosis diagnostic market share is expected to increase as diagnostics technologies advance, diagnostics facilities and products become more available, and the biotechnology sector expands.

Mononucleosis diagnosis is the process of detecting and verifying the existence of mononucleosis, often known as glandular fever or mono. Mononucleosis is primarily caused by the Epstein-Barr virus (EBV) or, less frequently, cytomegalovirus (CMV). Mononucleosis is diagnosed using a variety of laboratory testing and clinical examinations to identify particular indicators associated with the viral infection.

The global mononucleosis diagnostic market is estimated to develop incrementally over the forecast period due to the rising prevalence of mononucleosis epidemics worldwide and the use of sophisticated diagnostic facilities. The Epstein-Barr Virus causes mononucleosis, an infectious disease marked by sore throat, tiredness, and fever. Furthermore, increased health consciousness and education among patients and the collateral effect of other disease outbreaks with comparable symptoms, such as AIDS, strep throat, Lyme disease, and so on, are predicted to drive market expansion over the next seven years. 

Similarly, the adoption of sophisticated technology such as chemiluminescence technology, chromatographic immunoassay, immuno-latex test, Reverse Transcription Polymerase Chain Reaction test (RT-PCR), DNA probes, and solid-phase immunoassay, which facilitate accurate and precise results, qualitative detection, error minimization, reducing unnecessary antibiotic use, and time conservation, is expected to boost the mononucleosis diagnostic industry over the forecast period.

Highlights

• Monospot Test dominates the market by type.
• The hospital generates the highest revenue share by end-user.

Market Dynamics

Global Mononucleosis Diagnostic Market Drivers

Increasing Incidence of Mononucleosis Cases

The increased global prevalence of mononucleosis cases is a significant driver of the diagnostic industry. Increased awareness, improved diagnoses, and shifting lifestyle patterns increase mononucleosis diagnosis rates, resulting in a growing demand for diagnostic testing. For example, the Centers for Disease Control and Prevention (CDC) has reported increasing mononucleosis cases in the United States, particularly among teenagers and young adults. This increase can be linked to various variables, including changes in lifestyle, more social connections, and improved diagnostic skills, which contribute to higher detection rates.

According to NCBI, the Epstein-Barr virus (EBV) will account for 66.5% of mono cases in men in 2023. Mono is present in approximately 54% of children aged 6 to 8 and 82.9% of teenagers aged 18 to 19. More women than men are infected, although the difference is negligible. To be more specific, in industrialized countries such as the United States, people may be exposed to EBV later in childhood and early adulthood, when symptoms are more likely to manifest. For example, seroprevalence is approximately 55% in the 5-11 year age range, rising to 65-70% in the 12-18 year group. The rate is approximately 88% for individuals aged 19 to 24 and 90% for those aged 25 and up.

Furthermore, academics' retrospective review of healthcare databases indicated a considerable increase in mononucleosis-related hospitalizations and emergency department visits during the previous decade. This increase in healthcare utilization for mononucleosis highlights the disease's growing clinical burden and the importance of good diagnostic tools to handle cases quickly.

Global Mononucleosis Diagnostic Market Restraints

Limited Specificity of Diagnostic Tests

The mono-spot test, a famous quick screening test for mononucleosis, may have limited specificity due to possible cross-reactivity with other viral diseases or nonspecific immune responses. As a result, false-positive results may occur, causing unneeded testing, therapy, and patient concern. The test is particular, with commercially available kits being 70-92% sensitive and 96-100% exact. However, the test's sensitivity is poorer in the first two weeks after clinical symptoms appear. Hence, it is not recommended for general use. The test's sensitivity rates for children under four range from 27 to 76%, and it is generally not recommended for individuals aged 30 and up. 

Furthermore, a study published in the Journal of Medical Virology evaluated the mono spot test's specificity in separating EBV-induced infectious mononucleosis from other viral diseases, including cytomegalovirus (CMV) and human herpesvirus 6 (HHV-6). The study found that the mono spot test had poorer specificity than more precise EBV serological assays, resulting in a more significant percentage of false-positive results.

Additionally, a comprehensive review and meta-analysis published in Clinical Infectious Diseases also examined the efficacy of several mononucleosis diagnostic techniques, such as the mono spot test and serological assays. The study highlighted the heterogeneity in specificity reported with the mono spot test across different studies and groups, underlining the importance of confirmatory testing with more specific assays to avoid misdiagnosis and improper treatment.

Global Mononucleosis Diagnostic Market Opportunity

Advancements in Diagnostic Technologies

Recent advances in diagnostic technologies have created innovative mononucleosis assays with higher sensitivity, specificity, and turnaround times. For example, molecular diagnostic platforms such as polymerase chain reaction (PCR) assays provide improved accuracy and rapid detection of Epstein-Barr virus (EBV) DNA in patient samples, allowing for early diagnosis and management of mononucleosis infections. In addition, a study published in the Journal of Clinical Microbiology compared the efficacy of PCR assays to traditional serological tests for mononucleosis diagnosis. The study found that PCR assays had higher sensitivity and specificity than standard serological assays, especially in the early stages of infection. PCR-based techniques revealed EBV DNA in patient samples with great sensitivity, allowing for early identification of mononucleosis and discrimination from other viral diseases.

Similarly, next-generation sequencing technologies enable the thorough analysis of viral genomes, host immunological responses, and viral-host interactions in mononucleosis infections. NGS-based techniques allow for identifying viral variations, assessing viral load dynamics, and detecting co-infections, offering essential insights into disease pathophysiology and diagnostic indicators for mononucleosis. For example, Chinese researchers used MinION Mk1C, a product from Oxford Nanopore Technologies (UK), to sequence COVID-19 samples. Furthermore, factors such as the widespread implementation of NGS technologies in clinical diagnostics due to faster results and processing are expected to provide a favorable environment for market expansion over the forecast period. Advances in POCT platforms, such as lateral flow immunoassays and nucleic acid amplification tests (NAATs), allow for the quick and decentralized diagnosis of mononucleosis in various healthcare settings. 

Moreover, researchers from various disciplines are attempting to improve bio-sensing technologies by inventing new binding technologies, utilizing sophisticated materials, integrating cutting-edge transducers and instrumentation, and investigating novel techniques for biomarker analysis. Furthermore, the safe transmission, interpretation, and analysis of data generated by bio-sensing devices are critical to successful implementation. Furthermore, continuous connectedness to the larger world remains a driving factor in advancing bio-sensing technology.

Regional Analysis

The global mononucleosis diagnostic market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global mononucleosis diagnostic market shareholder and is estimated to grow at a CAGR of 9.2% over the forecast period.  North America dominates the mononucleosis diagnostic market due to the region's well-developed healthcare infrastructure and favorable reimbursement policies, as well as the rising incidence rate of infectious mononucleosis (IM), advancements in healthcare infrastructure that support novel testing, and increased research and development activities by major players in the region. The United States Department of Health and Human Services (HHS) has released guidelines for diagnostic testing for mononucleosis. These guidelines urge that all patients suspected of having mononucleosis have an appropriate test.

Furthermore, according to a November 2022 article published by Verywell Health, 25% to 50% of children in low-income families in the United States will have been infected with EBV by the age of four. Furthermore, 75% of young people will be diagnosed with mono following an EBV infection. This, together with an increase in cases of EBV followed by mononucleosis in the region, is likely to drive market expansion throughout the projection period.

Asia-Pacific is anticipated to exhibit a CAGR of 9.7% over the forecast period. One of the primary reasons projected to fuel market expansion over the forecast period is an increase in the region's adolescent population, vulnerable to EBV infections. Mononucleosis, for example, is a condition caused by the Epstein-Barr virus that primarily affects teens, according to a February 2022 Lancet article. However, this virus is widespread, with two peak occurrences in an individual's life: first, around 3-4 years, and then again at 15-16 years of age. When an Epstein-Barr virus originates in childhood, the risk of having mononucleosis is modest, but it increases significantly during puberty. This suggests that many people are infected with the Epstein-Barr virus, unaware of it.

Additionally, the United Nations Children's Fund predicts that by January 2022, the East Asia and Pacific region will have 329 million adolescents, accounting for approximately 25% of all teens globally. The large youth population indicates a considerable demand for mononucleosis diagnostic testing. In addition, significant regional firms, such as Cardinal Health and Abbott, are helping to drive market expansion. There are so many teenagers in the neighborhood, and there will be plenty of excellent market prospects in the coming years. 

Europe is expected to develop moderately over the projected period due to its established healthcare infrastructure and intense awareness of the importance of early detection and treatment of infectious diseases. The rising prevalence of mononucleosis and other viral illnesses, combined with the increased usage of cutting-edge diagnostic methods, is projected to drive market growth in this field. Furthermore, the European market is expected to grow due to the increased emphasis on healthcare spending and the desire for rapid diagnostic testing.

Latin America, the Middle East and Africa (MEA) will likely experience significant growth over the forecast period. This expansion can be linked to the increasing prevalence of mononucleosis and other viral illnesses, a greater appreciation of the importance of early detection and treatment, and an increased use of modern diagnostic tools in the field. Market expansion in these regions is expected to be driven by rising demand for POCT and molecular diagnostic tests and increased focus on healthcare infrastructure development. The high cost of diagnostic testing and a shortage of skilled healthcare staff may hinder market expansion in specific locations.

Segmental Analysis

The global mononucleosis diagnostic market is segmented based on type and end-user.

The market is further segmented by type into EBV Antibody Test, Monospot Test, and Complete Blood Count Test.

The mono-spot test segment is likely to experience significant expansion. The mono spot test, or the heterophile antibody test, is a quick way to detect infectious mononucleosis caused by EBV. This test detects heterophile, nonspecific antibodies the immune system produces in response to EBV infection. The mono-spot test produces speedy results in minutes and is commonly used in clinical settings for initial mononucleosis screening. However, it may have poorer sensitivity in the early stages of infection and produce false-negative results in some circumstances, necessitating further confirmation with more precise serological assays.

Furthermore, according to an article published in StatPearls in August 2021, mononucleosis is detected with the monospot (or heterophile antibody) test, which is virtually 100% specific to the condition. This test's sensitivity is closer to 85%. Such studies significantly boost patient acceptance of mono-spot test types, contributing to sector growth. According to research published in the Clinical Journal of Sports Medicine in November 2021, the mono spot test achieved 80.0% sensitivity and 90.6% specificity. Increased transaminase levels are strongly associated with acute infectious mononucleosis and may aid diagnosis. A positive mono spot test result is the most reliable method for diagnosing infectious mononucleosis (IM). As a result, excellent sensitivity and specificity will likely help the segment grow in the coming years.

The EBV antibody test detects specific antibodies the immune system produces in response to Epstein-Barr virus (EBV) infection. This serological test determines the levels of IgM and IgG antibodies to EBV antigens. IgM antibodies often emerge during the acute phase of illness, whereas IgG antibodies last longer, indicating previous or recent exposure to EBV. The EBV antibody test is frequently used to confirm the diagnosis of mononucleosis and evaluate the immunological response to EBV infection.

By end-user, the market can be further bifurcated into Hospitals and laboratories.

Hospitals are essential end users in the mononucleosis diagnostic market because they offer complete healthcare services to patients, including diagnostic testing, treatment, and management of infectious disorders like mononucleosis. Hospitals often include centralized laboratories outfitted with specialized equipment and skilled workers to perform various diagnostic procedures, such as serological assays, molecular testing, and imaging investigations for mononucleosis detection. Diagnostic data guide patient management, initiate appropriate treatment, and track illness development in hospital settings. Hospitals also play an essential role in handling severe cases of mononucleosis, which may necessitate hospitalization, supportive care, and specific treatment measures.

Diagnostic laboratories are another significant end-user segment in the mononucleosis diagnostic market, providing specialized testing services to healthcare practitioners, clinics, and patients. These laboratories may be independent clinical laboratories, reference laboratories, or hospital-based laboratories that offer a wide range of diagnostic tests and services for mononucleosis diagnosis. Diagnostic laboratories use serological assays, molecular testing, and other laboratory-based procedures to identify particular markers of mononucleosis infection in patient samples. By providing quick and accurate diagnostic testing, laboratories help to diagnose, manage, and control mononucleosis infections, which benefits patient care and public health activities.

Recent Developments

• April 2024- Abbott received FDA clearance for a whole blood rapid test to help in the assessment of concussion at the patient's bedside.
• April 2024- ENHERTU® (fam-trastuzumab deruxtecan-nxki) by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) approved in the US for adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.