The mononucleosis diagnostic market was valued at USD 1.86 Billion in 2024 and is projected to grow from USD 2.03 Billion in 2025 to USD 4.17 Billion by 2033, registering a CAGR of 9.4% during the forecast period.

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Mononucleosis, often called “mono” or glandular fever, is primarily caused by the Epstein-Barr virus (EBV) and, less commonly, cytomegalovirus (CMV). With rising cases worldwide, better awareness, and access to advanced diagnostic facilities, demand for testing is climbing rapidly. Hospitals remain the top end-users, while the Monospot Test continues to dominate the market by test type.

Market Growth Drivers

• Rising incidence of mononucleosis: Growing cases among teenagers and young adults are fueling the need for accurate diagnosis. For example, according to CDC, mono cases are increasing significantly in the U.S. due to lifestyle changes and improved detection.
• Technological advancements: Sophisticated tools such as PCR assays, chemiluminescence, and next-generation sequencing (NGS) are enabling early, precise detection, reducing false positives, and improving patient management.

Market Challenges

Despite growth, the market faces challenges with the limited specificity of the Monospot Test, which can lead to false positives. This limitation highlights the need for confirmatory testing using advanced EBV serological assays.

Market Opportunities

The rise of molecular diagnostics and point-of-care testing (POCT) presents strong opportunities. PCR and NGS-based platforms are revolutionizing detection with higher accuracy and faster results, while portable POCT kits allow for quick testing in decentralized settings.

Regional Insights

• North America dominates the market and is expected to grow at a 9.2% CAGR, supported by advanced healthcare systems, favorable reimbursement, and high EBV prevalence.
• Asia-Pacific is anticipated to record the fastest growth at a 9.7% CAGR, driven by its large adolescent population vulnerable to EBV infections.
• Europe shows steady growth, backed by strong healthcare awareness and investments in diagnostic technologies.
• Latin America, Middle East, and Africa are expected to see rapid expansion as access to modern diagnostic tools improves.

Key Players

• Abbott (U.S.)
• DAIICHI SANKYO COMPANY, LIMITED (Japan)
• Bio-Rad Laboratories, Inc. (U.S.)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Johnson & Johnson Services, Inc. (U.S.)
• BD (U.S.)
• DiaSorin Molecular LLC (U.S.)
• Beckman Coulter, Inc. (U.S.)
• bioMérieux (France)
• Siemens (Germany)
• Cardinal Health (U.S.)
• Thermo Fischer Scientific Inc. (U.S.)

Other notable players include Biotest AG, Genzyme, Sekisui Diagnostics, ELITechGroup, Immunostics Inc., and Meridian Bioscience.

Recent Developments

• April 2024: Abbott received FDA clearance for a whole blood rapid test to assist in concussion assessment at patient bedside.
• April 2024: ENHERTU® by Daiichi Sankyo and AstraZeneca was approved in the U.S. for HER2-positive solid tumors.

Segmentations

• By Test Type: Monospot Test, EBV Antibody Test, Complete Blood Count Test
• By End-User: Hospitals, Laboratories
• By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa

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