Lyme Disease Testing Market Size Analysis:

Lyme Disease Testing Market size was valued at USD 10.32 billion in 2023 and is expected to reach USD 21.52 billion by 2032, growing at a CAGR of 8.56% from 2024-2032.

The Lyme Disease Testing Market report offers a comprehensive analysis of Lyme disease incidence and prevalence between 2023 and 2032, including regional patterns and the most impacted regions. It analyzes the uptake of sophisticated testing technologies, including nucleic acid amplification and next-generation serological assays, with a focus on their effect on diagnostic efficiency. The report also discusses accuracy and sensitivity trends, assessing test performance and specificity improvements. Moreover, it evaluates healthcare spending on Lyme disease diagnosis, classifying expenditure from government, commercial, private, and out-of-pocket payers. Finally, it discusses regulation approvals and guidelines, monitoring important policy developments shaping the market environment.

The U.S. Lyme Disease Testing Market size was USD 1.44 billion in 2023 and is expected to reach USD 2.80 billion by 2032, growing at a CAGR of 7.72% over the forecast period of 2024-2032.

The market is driven by the rising prevalence of Lyme disease and the growing awareness of early diagnosis and treatment. Technological advancements in diagnostic methods, including molecular and serological testing, are enhancing the accuracy and efficiency of Lyme disease detection. Increased research funding and government initiatives to improve disease surveillance are also contributing to market growth.

Lyme Disease Testing Market Dynamics

Drivers

• The increasing rate of Lyme disease is a principal growth driver for the Lyme Disease Testing Market.

The CDC has estimated that an estimated 476,000 people are treated and diagnosed with Lyme disease every year in the United States, depicting a heavy burden on public health. The high incidence of tick-borne illnesses in North America and Europe, particularly in those areas where there is a high-density tick population, has increased demand for early detection and precise tests. Moreover, the expanded tick habitats due to climate change have resulted in higher rates of disease transmission. To cope with the situation, companies are creating more sensitive and specific tests, including multiplex assays and next-generation ELISAs, aimed at enhancing the accuracy of diagnosis. An important development is Diasorin's recent submission of LIAISON LymeDetect to the FDA in 2023, reflecting the commitment of the industry to developing Lyme disease diagnostics.

• Advancements in Diagnostic Technologies propelling market growth.

Technological innovation is transforming Lyme disease diagnosis through increasing accuracy, sensitivity, and quickening turnaround time. Classic two-tiered serological testing is being supplemented by new-generation approaches such as PCR-based assays, chemiluminescence immunoassays (CLIA), and multiplex ELISA. Organizations like Roche and Siemens Healthineers are putting money into AI-based diagnostics and automation, enhancing efficacy in the clinic. In addition, point-of-care (POC) testing is also gaining popularity, with rapid Borrelia antibody detection available without the requirement of special laboratory infrastructure. In August 2024, Siemens Healthineers introduced India's first AI-based green multi-testing diagnostic analyzer, marking the way forward towards sustainability in diagnostic technology. These developments are not only making the tests more accessible but also decreasing false positives and false negatives, allowing for earlier and more precise detection of Lyme disease.                                                                       

Restraint

• One of the key constraints in the Lyme Disease Testing Market is the prevalence of high false positives and false negatives in current diagnostic techniques.

The conventional two-tiered testing system, which involves ELISA followed by Western Blot, tends to be insensitive in the initial stages of infection, resulting in delayed or missed diagnoses. Research indicates that routine serological tests miss as many as 50% of early Lyme disease infections, leaving them to potentially develop severe complications if untreated. Additionally, cross-reactivity with other types of bacterial infection impacts test accuracy. These challenges to accuracy negatively impact physician and patient confidence and lead to reluctance to implement particular tests. To solve this, researchers and firms are targeting next-generation molecular diagnostics, but regulatory clearances and wide-scale acceptance are challenges for market expansion.

Opportunities

• The Lyme Disease Testing Market offers a tremendous opportunity with the creation of sophisticated molecular diagnostics and point-of-care (POC) testing technologies.

 Conventional serological tests are usually of low sensitivity in early Lyme disease, resulting in misdiagnosis. This has driven demand for next-generation nucleic acid-based assays and quick POC tests, which provide greater accuracy, quicker results, and early detection. Firms are investing in PCR-based and isothermal amplification methods, which enhance the reliability of diagnostics. Also on the rise is portable diagnostic equipment coupled with AI-based interpretation, which is increasing accessibility in rural and high-risk settings. As more regulatory approvals and research funding become available, the commercialization of new Lyme disease diagnostic platforms will transform the market, providing effective and patient-friendly solutions to current testing drawbacks.

Challenges

• Lack of worldwide standardized diagnostic procedures, which causes inconsistency in test performance, regulatory barriers, and inconsistent clinical interpretation.

Various nations and even healthcare institutions have different testing practices, including two-tier serological testing, Western blot, ELISA, or more recent molecular diagnostics, causing inconsistencies in diagnosis and treatment. The absence of a consensus on the most precise diagnostic method poses hindrances to market expansion and hinders extensive test adoption. Furthermore, changing Lyme disease strains and co-infections complicate standardization and precision of tests. This issue calls for harmonization of international regulatory guidelines, enhanced research collaborations, and the creation of universally recognized, high-sensitivity diagnostic protocols to guarantee accurate and timely diagnosis of Lyme disease in various healthcare settings.

Lyme Disease Testing Market Segmentation Analysis

By Technology

The Serological Test segment dominated the Lyme Disease Testing Market with a 38.45% market share in 2023 because of its universal use, low cost, and high accuracy in detecting the disease at early stages. The preferred gold-standard tests recommended by medical bodies such as the Centers for Disease Control and Prevention (CDC) and the European Centre for Disease Prevention and Control (ECDC) are Serological tests such as ELISA (Enzyme-Linked Immunosorbent Assay) and Western Blot. These tests identify Borrelia burgdorferi antibodies and are thus critical for Lyme disease diagnosis even when direct pathogen detection is difficult. Further, their high specificity and sensitivity, coupled with the capability to handle large volumes of samples in centralized labs, have reinforced their supremacy. With ongoing technological progress and regulatory guidelines supporting serological testing, this segment continued to lead in 2023.

By Sample Type

The Blood segment dominated the Lyme disease testing market with a 61.52% market share in 2023 because it has high accuracy, is easy to collect, and is accepted globally in clinical diagnosis. Tests conducted on blood, especially serological tests like ELISA and Western Blot, are the preferred ways to test for Borrelia burgdorferi antibodies that play a pivotal role in establishing Lyme disease. In addition, blood samples offer a consistent and steady medium for diagnostic technologies such as PCR (Polymerase Chain Reaction) and immunoassays, ensuring accurate detection. Blood-based testing is preferred in healthcare facilities due to the facility of mass screening, automation, and centralized processing in the lab, which lessens turnaround time and enhances diagnostic efficiency. Regulating bodies like the CDC and WHO also promote blood-based testing in Lyme disease diagnostic guidelines, further solidifying its supremacy in 2023.

By Patient Type

The Adult segment dominated the Lyme Disease Testing Market with a 58.46% market share in 2023 since Lyme disease more frequently occurs among adults than it does among the pediatric population. Adults, specifically those who expose themselves to outside activities like forestry work, hiking, and camping, are most likely to face exposure to the bites of ticks, the vector mode of transmittance in Borrelia burgdorferi. Furthermore, unconsciousness of a delay in signs and misdiagnosis among adults results in further demand for laboratory testing. Research has shown that the incidence of Lyme disease is highest among middle-aged and elderly patients, prompting higher testing and follow-up frequencies. Adult Lyme disease screening takes priority in healthcare infrastructure, especially in North America and Europe, based on occupational hazards and chronic manifestations of Lyme disease, further enhancing this segment's dominance in 2023.

By End Use

The hospital segment dominated the Lyme disease testing market with a 47.56% market share in 2023 because of its sophisticated diagnostic facilities, access to specialized healthcare providers, and greater patient flow. Hospitals are the first point of contact for Lyme disease diagnosis, particularly for patients with serious symptoms or suspected chronic Lyme disease cases that need extensive testing and follow-up treatment. The presence of various diagnostic technologies, including ELISA and Western Blot tests, and combined laboratory facilities allows hospitals to conduct quick and accurate detection of Lyme disease. Moreover, hospitals have better reimbursement coverage for Lyme disease testing compared to independent diagnostic centers, which makes them the most sought-after destination for patients. The growth in the number of hospital admissions for Lyme disease, especially within endemic areas like North America and Europe, further entrenched this segment's leadership position in 2023.

Lyme Disease Testing Market Regional Insights

Europe dominated the Lyme disease testing market with a 46.10% market share in 2023 owing to a high incidence of disease, developed healthcare infrastructure, and significant government backing for tick-borne disease research. Some of the top countries with Lyme disease incidence rates in the world are Germany, Sweden, and the Netherlands, resulting in growing demand for testing and widespread implementation of advanced diagnostic technologies. The region is also supported by robust diagnostic guidelines, like those defined by the European Centre for Disease Prevention and Control (ECDC), to help ensure regular and reliable testing. In addition, sound public awareness campaigns and reimbursement regulations promote early diagnosis, fueling market growth. European market leaders like DiaSorin and Euroimmun continue to develop innovative tests like high-sensitivity ELISA and Western Blot assays, solidifying the region's market leadership.

Asia Pacific is the fastest-growing area in the Lyme Disease Testing Market with a 9.14% CAGR throughout the forecast period, propelled by growing awareness, better healthcare access, and rising cases of tick-borne diseases in nations such as China, Japan, and India. In the past, Lyme disease cases within the region were not being reported adequately, but heightened disease surveillance initiatives and increased physician education are enhancing early detection. Furthermore, government efforts to increase infectious disease testing and the growing affordability of serological and molecular tests are driving market penetration. The region's growing biotechnology industry and domestic manufacturing of diagnostic kits are also driving cost savings and increased availability of sophisticated Lyme disease tests. As healthcare infrastructure improves and investment in molecular diagnostics increases, Asia Pacific is set for dramatic market growth in the forecast years.

Lyme Disease Testing Market Key Players

• Abbott Laboratories (Architect Lyme IgG/IgM Assay, Determine Lyme Test)​

• Bio-Rad Laboratories, Inc. (Lyme IgG/IgM ELISA Kit, Western Blot Lyme Disease Test)​

• DiaSorin S.p.A. (LIAISON Lyme IgG Assay, LIAISON Lyme IgM Assay)​

• Roche Diagnostics (Elecsys Lyme Assay, Cobas Lyme Test)​

• Siemens Healthineers (ADVIA Centaur Lyme Total Assay, IMMULITE 2000 Lyme Disease Test)​

• Thermo Fisher Scientific Inc. (ELISA Lyme Disease Test Kit, ImmunoCAP Lyme Assay)​

• Zeus Scientific (ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS Borrelia MTTT)​

• Trinity Biotech plc (Lyme IgG/IgM ELISA, MarBlot Strip Test)​

• Immunetics Inc. (C6 Lyme ELISA Kit, Quick ELISA Lyme Test)​

• Euroimmun AG (EUROLINE-WB Borrelia IgG/IgM, ELISA Borrelia afzelii IgG)​

• Viramed Biotech AG (ViraStripe Lyme IgG/IgM, ViraBlot IgG/IgM)​

• Mikrogen Diagnostik (recombine Borrelia IgG, recombine Borrelia IgM)​

• Seramun Diagnostica GmbH (Serazym ELISA Borrelia IgG/IgM, Serastest Borrelia Rapid Test)​

• Gold Standard Diagnostics (Borrelia burgdorferi IgG/IgM ELISA, Western Blot IgG/IgM)​

• Immuno-Biological Laboratories Inc. (IBL-America) (Lyme Disease ELISA Kit, Lyme Western Blot Assay)​

• NovaTec Immundiagnostica GmbH (NovaLisa Borrelia burgdorferi IgG/IgM ELISA, Borrelia Line Assay)​

• DRG International, Inc. (DRG Lyme IgG/IgM ELISA Kit, Borrelia burgdorferi Western Blot)​

• Sekisui Diagnostics (SeraQuest Lyme IgG/IgM ELISA, Lyme Disease Rapid Test)​

• Oxford Immunotec (T-SPOT.Lyme Test, Lyme ELISpot Assay)​

• Quidel Corporation (Sofia 2 Lyme FIA, QuickVue Lyme IgG/IgM Test)

Suppliers (These suppliers commonly provide critical raw materials such as antibodies, antigens, and reagents, as well as diagnostic instruments and equipment necessary for the development and production of Lyme disease test kits.) in Lyme Disease Testing Market

• Thermo Fisher Scientific Inc.​

• Bio-Rad Laboratories, Inc.​

• Merck KGaA​

• PerkinElmer, Inc.​

• Roche Diagnostics​

• Siemens Healthineers​

• Danaher Corporation​

• Agilent Technologies, Inc.​

• QIAGEN N.V.​

• Becton, Dickinson and Company

Recent Development in the Lyme Disease Testing Market

• January 25, 2024 – DiaSorin revealed it submitted its LIAISON LymeDetect test to the U.S. Food and Drug Administration (FDA) in December 2023. The news was initially reported at the Investor Day of the company on December 15, 2023.

• August 2024 – Siemens Healthineers, along with Mahajan Imaging & Labs, has launched India's first eco-friendly multi-testing diagnostic analyzer powered by artificial intelligence, the Atellica CI. In a statement released on Tuesday, the organization emphasized that this innovative technology is aimed at revolutionizing patient care by providing quicker and more accurate diagnostic results.