The global Lyme disease diagnostics market has been experiencing steady growth, with an industry valuation of US$ 1.5 billion in 2022. With a projected CAGR of 3.8% from 2023 to 2031, the market is expected to surpass US$ 2.1 billion by 2031. The increasing prevalence of Lyme disease and growing awareness about the importance of early diagnosis are key factors fueling this expansion. The market is further driven by the advancements in diagnostic technologies, including nucleic acid amplification tests (NAATs), enzyme immunoassays (EIAs), and multiplex assays, which have significantly improved detection accuracy.
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Key Drivers and Industry Trends
Rise in Incidence of Lyme Disease
According to the Centers for Disease Control and Prevention (CDC), the confirmed cases of Lyme disease in the U.S. surged by 44.0% between 1999 and 2019. With Lyme disease being particularly prevalent in North America and Europe, more than 14.0% of the global population is estimated to be affected, as per a BMJ Global Health report published in June 2022. The increasing incidence of this tick-borne disease is prompting greater investments in research and development (R&D) to improve detection methods.
Growth in Adoption of Serological Tests
Serological tests, including ELISA and Western Blot, have emerged as the primary diagnostic methods due to their affordability and efficiency. ELISA tests accounted for the largest market share in 2022, owing to their high sensitivity in detecting antibodies against Borrelia burgdorferi, the bacterium responsible for Lyme disease. The widespread availability and cost-effectiveness of ELISA kits continue to drive their dominance in the market.
Increase in Usage of Blood Samples
The blood sample segment dominated the global Lyme disease diagnostics market in 2022 and is expected to maintain its stronghold throughout the forecast period. Blood-based testing methods, including enzyme immunoassay, immunofluorescence assay, and the Western blot method, enable accurate detection of Lyme disease, ensuring early diagnosis and treatment. The CDC-endorsed two-tiered serologic test is one of the most widely used diagnostic approaches.
Expansion of Diagnostic Laboratories
Diagnostic laboratories held a significant share of the Lyme disease diagnostics market in 2022. These laboratories offer cost-effective and reliable testing solutions, attracting a growing number of patients. Their role in collaborating with research institutes and industry partners has led to continuous improvements in testing methodologies. The segment is projected to dominate in the coming years due to faster turnaround times and enhanced accessibility for patients.
Regional Outlook
North America
North America is expected to maintain its leading position in the Lyme disease diagnostics market during the forecast period. The region’s dominance is attributed to the high incidence rates in the U.S., advanced healthcare infrastructure, and increased awareness about Lyme disease screening. Additionally, technological advancements and government initiatives are further driving market growth in this region.
Asia Pacific
Asia Pacific is expected to witness significant growth in the Lyme disease diagnostics market due to several factors, including expanding healthcare infrastructure, increased prevalence of Lyme disease, and growing R&D investments. Government-led screening programs and initiatives to enhance diagnostic capabilities are anticipated to contribute to the region’s steady market expansion.
Competitive Landscape
The global Lyme disease diagnostics market is characterized by a highly fragmented competitive landscape, with several leading players striving to enhance their market position through strategic collaborations, mergers, acquisitions, and new product launches. Key companies operating in the market include:
- LabCorp
- Quest Diagnostics
- Abbott Laboratories
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- DiaSorin S.p.A
- F. Hoffmann-La Roche AG
- T2 Biosystems, Inc.
- Meridian Bioscience, Inc.
- Quidel Corporation
- Thermo Fisher Scientific Inc.
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Market Developments
- April 2023: Abbott Laboratories collaborated with the Climate Amplified Disease and Epidemics (CLIMADE) consortium, which consists of over 100 scientists focused on assessing the impact of climate change on disease outbreaks using diagnostic testing and data science technology.
- July 2022: T2 Biosystems, Inc. received Breakthrough Device Designation from the FDA for its T2Lyme Panel, a molecular diagnostic test designed for direct blood detection of Lyme disease-causing bacteria.
- June 2022: Quidel Corporation partnered with the Global Lyme Alliance to raise awareness about Lyme disease and introduced the first FDA-approved rapid point-of-care Lyme disease diagnostic test.
Market Segmentation
By Diagnostic Test
- Serological Tests
- ELISA
- Western Blot
- Polymerase Chain Reaction (PCR) Tests
- Others (Culture Tests, Antigen Tests, etc.)
By Sample Type
- Blood
- Cerebrospinal Fluid (CSF)
- Others (Joint Fluid, Urine, etc.)
By End-User
- Hospitals
- Diagnostic Laboratories
- Others (Clinics, Research Institutes, etc.)
By Region
- North America (U.S., Canada)
- Europe (Germany, U.K., France, Italy, Spain)
- Asia Pacific (China, Japan, India, Australia & New Zealand)
- Latin America (Brazil, Mexico)
- Middle East & Africa (GCC Countries, South Africa)
Conclusion
The global Lyme disease diagnostics market is poised for steady growth, driven by increased disease prevalence, advancements in diagnostic technologies, and a rise in awareness about early detection. With key players focusing on innovation and strategic collaborations, the market is expected to see continued expansion, particularly in North America and Asia Pacific. Diagnostic advancements, such as molecular-based tests and rapid point-of-care solutions, will further enhance the market’s potential in the coming years.
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