Lyme Disease Testing Market By Test Type (Serological Tests, Molecular Tests, Others); By Technology (ELISA, Western Blot, PCR, Lateral Flow Assays, Microfluidics); By End User (Hospitals & Clinics, Diagnostic Laboratories, Research Institutes, Homecare Settings); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global Lyme Disease Testing Market climbs at a robust CAGR of 8.9%, scaling from $933.6 million in 2024 to $1.55 billion by 2030, fueled by serology, two-tier testing, ELISA, immunoblot, rapid test kits—as highlighted by Strategic Market Research.
 

This upward trajectory reflects a growing convergence of public health urgency, rising tick-borne disease incidence, diagnostic innovation, and global expansion of infectious disease surveillance infrastructure.

 

Lyme disease, caused by the Borrelia burgdorferi bacterium and transmitted by Ixodes ticks, represents the most common vector-borne illness in the U.S. and parts of Europe. Despite being underdiagnosed historically, increasing clinical awareness, mandatory reporting protocols, and improved serological diagnostics have expanded the global visibility and demand for testing. The strategic importance of Lyme disease testing lies in its role in reducing misdiagnosis, mitigating long-term complications, and enabling early intervention in both endemic and emerging regions.

 

As of 2024, market growth is being catalyzed by several macro-level drivers:

• Escalating disease prevalence across North America and parts of Europe and Asia due to climate change and habitat encroachment.

• Regulatory push from public health agencies like the CDC and ECDC for early diagnostics and surveillance.

• Technological advancements in serological and molecular diagnostics, including ELISA and Western blot confirmation platforms.

• Digital healthcare integration , allowing rapid test deployment and results sharing across clinical networks and rural outreach programs.

The market is also experiencing momentum from cross-disciplinary R&D collaborations that blend microbiology, biotechnology, and informatics, especially in the development of point-of-care diagnostics and multiplex testing kits.

 

Key stakeholders in this evolving market include:

• OEMs and diagnostics manufacturers , such as test kit producers and lab equipment companies.

• Clinical laboratories and hospitals , which are both providers and procurement centers for test solutions.

• Public health institutions and research entities , driving surveillance and epidemiological testing.

• Investors and strategic buyers , eyeing mergers, diagnostics-as-a-service models, and AI-enabled test integration platforms.

The Lyme disease testing market now forms a critical link in the global infectious disease management value chain—one that’s rapidly shifting from reactive diagnostics to proactive population-level screening and home-based diagnostics . The 2024–2030 window presents a rare opportunity to address both unmet clinical needs and public health gaps with scalable, high-sensitivity testing innovations.

 

Comprehensive Market Snapshot

• The Global Lyme Disease Testing Market climbs at a robust CAGR of 8.9%, scaling from $933.6 million in 2024 to $1.55 billion by 2030.

• The USA Lyme Disease Testing Market will register a healthy 8.3% CAGR, expanding from $317.4 million in 2024 to $512.2 million by 2030, with the U.S. accounting for 34% of global market share.

• The Europe Lyme Disease Testing Market will grow at a 7.6% CAGR, expanding from $252.1 million in 2024 to $391.2 million by 2030, representing 27% of the global market.

• The APAC Lyme Disease Testing Market will grow at the fastest pace with a 10.4% CAGR, expanding from $149.4 million in 2024 to $270.5 million by 2030, supported by a 16% global market share.

 

Market Segmentation Insights

By Test Type

• Serological Tests accounted for approximately 68% of the total market share in 2024, driven by their central role in guideline-recommended two-tier testing workflows and widespread use in hospital and outpatient screening.

• Molecular Tests (PCR-based) represented nearly 22% of market revenue, supported by growing demand for early-stage detection and higher analytical specificity.

• Other Diagnostic Methods (including culture-based and emerging antigen assays) held about 10% share, reflecting limited clinical adoption but increasing research and validation activity.

By Technology

• ELISA remained the leading technology, accounting for approximately 45% of testing volume in 2024, due to its scalability, affordability, and suitability for high-throughput laboratory screening.

• Western Blot represented around 23% of the market, supported by its role in confirmatory testing following positive or equivocal ELISA results.

• Polymerase Chain Reaction (PCR) captured nearly 17% share, driven by demand for direct pathogen detection in early or atypical presentations.

• Lateral Flow Assays accounted for approximately 10%, reflecting their growing use in rapid and point-of-care testing scenarios.

• Microfluidics and Lab-on-Chip Platforms contributed an estimated 5% of revenue, but are projected to grow at the fastest pace as decentralized and portable diagnostics gain traction.

By End User

• Diagnostic Laboratories accounted for approximately 42% of total market revenue in 2024, driven by centralized processing, payer alignment, and large-scale screening programs.

• Hospitals & Clinics represented nearly 35%, reflecting routine testing in acute and outpatient care pathways.

• Research Institutes held about 13% share, supported by epidemiological studies and assay development.

• Homecare Settings accounted for approximately 10% and are expected to witness the fastest growth, driven by pilot self-testing initiatives and expansion of consumer-accessible diagnostics.

Regional Insights

• North America accounted for the largest market share at approximately 45% in 2024, supported by high disease awareness, established reimbursement frameworks, and concentrated testing demand in endemic U.S. regions.

• Asia Pacific is expected to expand at the fastest CAGR during 2024–2030, driven by rising surveillance of tick-borne diseases, expanding laboratory infrastructure, and improving diagnostic access.

 

Strategic Questions Driving the Next Phase of the Global Lyme Disease Testing Market

1. What test types, diagnostic technologies, and clinical-use scenarios are explicitly included within the Lyme disease testing market, and which diagnostic approaches fall outside its defined scope?

2. How does the Lyme disease testing market differ structurally from adjacent infectious disease diagnostics, autoimmune testing, and general serology markets in terms of demand drivers and reimbursement dynamics?

3. What is the current and forecasted size of the global Lyme disease testing market, and how is market value distributed across major test types and technologies?

4. How is revenue allocated between serological assays, molecular diagnostics, and emerging rapid or decentralized testing formats, and how is this mix expected to evolve through 2030?

5. Which diagnostic segments (screening, confirmatory testing, early-stage detection, and post-treatment monitoring) account for the largest and fastest-growing revenue pools?

6. Which testing segments generate disproportionate value through pricing power, reimbursement stability, or repeat testing frequency rather than sheer test volume?

7. How does diagnostic demand differ across early, disseminated, and late-stage Lyme disease presentations, and how does this influence test selection and sequencing?

8. How are first-line screening algorithms and confirmatory testing pathways evolving in response to clinical accuracy requirements and guideline updates?

9. What role do repeat testing, diagnostic uncertainty, and physician retesting behavior play in sustaining segment-level revenue growth?

10. How are disease prevalence, regional endemicity, diagnostic awareness, and access to laboratory infrastructure shaping demand across geographic markets?

11. What technical, clinical, or regulatory limitations constrain adoption of molecular and next-generation Lyme disease diagnostic technologies?

12. How do reimbursement policies, payer scrutiny, and test-cost sensitivity influence commercial uptake across centralized and decentralized testing formats?

13. How robust is the current and mid-term diagnostic development pipeline, and which emerging platforms (e.g., microfluidics, antigen detection, multiplex testing) are likely to reshape the market?

14. To what extent will pipeline diagnostics expand early detection and previously untested populations versus intensify competition within established serological segments?

15. How are assay sensitivity, turnaround time, and sample requirements being improved through advances in diagnostic chemistry and device engineering?

16. How will commoditization, test standardization, and competitive pricing affect differentiation and margins across Lyme disease testing segments?

17. What role will rapid tests and home-based diagnostics play in improving access while potentially disrupting centralized laboratory testing economics?

18. How are leading diagnostic companies aligning their test portfolios, regulatory strategies, and geographic focus to defend or expand market share?

19. Which geographic regions are expected to outperform global growth in Lyme disease testing demand, and which diagnostic segments are driving this acceleration?

20. How should diagnostic manufacturers, investors, and public health stakeholders prioritize technologies, regions, and care settings to maximize long-term value creation?

 

Segment-Level Insights and Market Structure

The Lyme disease testing market is organized around distinct diagnostic modalities and care-delivery settings that reflect differences in clinical intent, disease stage, and testing infrastructure. Each segment contributes differently to overall market value, competitive intensity, and long-term growth potential, shaped by diagnostic accuracy requirements, testing algorithms, and public-health priorities. Unlike therapeutic markets, value creation in Lyme disease testing is driven by test sequencing, repeat utilization, and clinical confidence, rather than treatment duration.

 

Test Type Insights

Serological Testing

Serological testing forms the backbone of Lyme disease diagnosis and represents the most established segment of the market. These tests are deeply embedded in guideline-based diagnostic workflows and are widely used for both initial screening and confirmatory assessment. From a commercial standpoint, serological assays benefit from high test volumes, standardized reimbursement, and broad clinician familiarity. Although innovation within this segment is incremental rather than disruptive, serological testing remains a stable and indispensable contributor to market revenue due to its central role in routine clinical practice.

Molecular Diagnostics

Molecular diagnostics represent a more selective but strategically important segment of the Lyme disease testing market. These tests are primarily used in scenarios where early detection, atypical presentation, or low antibody titers limit the utility of serology. While adoption is narrower compared to serological testing, molecular diagnostics command higher perceived clinical value in specific use cases. Over time, improvements in assay sensitivity, workflow integration, and cost efficiency are expected to strengthen their role, particularly in early-stage and complex diagnostic scenarios.

Other Diagnostic Approaches

Other diagnostic methods, including culture-based techniques and emerging antigen-focused assays, occupy a smaller but evolving segment of the market. Their use is currently concentrated in research, validation studies, and niche clinical applications rather than routine care. Commercially, this segment reflects exploratory innovation rather than scale. However, continued methodological refinement may gradually expand its relevance as unmet diagnostic gaps are addressed.

 

Technology Insights

ELISA-Based Platforms

ELISA-based testing remains the most widely deployed technology in Lyme disease diagnostics due to its scalability, cost efficiency, and compatibility with high-throughput laboratory operations. Its dominance is reinforced by established laboratory workflows and consistent payer acceptance. As a result, ELISA platforms anchor the current market structure and provide predictable, volume-driven revenue streams.

Western Blot

Western blot testing plays a complementary but critical role as a confirmatory technology. Its use is closely tied to diagnostic algorithms rather than standalone demand, making it structurally dependent on upstream screening volumes. While not a growth engine in isolation, Western blot remains essential for diagnostic certainty and therefore maintains a durable position within the technology mix.

PCR and Advanced Molecular Platforms

PCR-based technologies represent a technically advanced segment focused on direct pathogen detection. Their adoption is driven by clinical need rather than routine screening, which limits overall volume but enhances strategic importance. As laboratories increasingly seek faster turnaround times and improved diagnostic confidence, molecular platforms are expected to gain incremental share within targeted clinical contexts.

Rapid and Microfluidic Technologies

Rapid testing formats, including lateral flow and microfluidic systems, reflect a shift toward decentralized diagnostics. Although still a minority segment, these technologies are gaining attention for use in endemic regions, mobile testing programs, and settings with limited laboratory access. Their commercial relevance lies in future expansion rather than current scale, positioning them as a key area of long-term innovation.

 

End-User Insights

Diagnostic Laboratories

Diagnostic laboratories represent the primary revenue-generating end-user segment, driven by centralized testing volumes and standardized workflows. These facilities serve as the core execution point for both screening and confirmatory testing and benefit from economies of scale. From a market perspective, laboratories anchor test utilization patterns and strongly influence technology adoption.

Hospitals and Clinics

Hospitals and clinics contribute significantly to testing demand through acute care, outpatient evaluation, and referral-based diagnostics. Their role is particularly important in early patient presentation and clinical decision-making. While testing volumes may be lower than centralized labs, hospitals and clinics shape downstream testing behavior and diagnostic sequencing.

Research Institutes

Research institutes occupy a smaller but strategically important niche within the market. Their testing activity supports epidemiological surveillance, assay development, and clinical validation. Although not a major revenue driver, this segment plays a critical role in shaping future diagnostic standards and innovation pipelines.

Homecare and Decentralized Settings

Homecare settings represent an emerging frontier in Lyme disease testing. Adoption remains limited but is expanding as decentralized diagnostic models gain credibility. This segment reflects a shift toward patient-initiated testing and public-health outreach rather than traditional clinical workflows. Over the forecast period, homecare testing is expected to influence access dynamics more than immediate revenue scale.

 

Segment Evolution Perspective

The Lyme disease testing market is evolving from a volume-driven, serology-centric structure toward a more stratified diagnostic ecosystem. Established serological and laboratory-based segments will continue to anchor near-term revenue, while molecular and decentralized technologies gradually reshape diagnostic pathways. Together, these shifts are expected to redefine how value is distributed across segments as early detection, diagnostic confidence, and access become increasingly central to market growth.

 

Table: Key Commercial and Late-Stage Emerging Platforms for Lyme Disease Testing

Product / Platform (examples)	Company	Development / Market Status	What differentiates it (diagnostic “mechanism”)
C6 B. burgdorferi (Lyme) ELISA Kit	Immunetics, Inc.	FDA 510(k) cleared; commercial (K003754)	Detects antibodies to the C6 (VlsE-derived) peptide (a conserved epitope used widely in Lyme serology algorithms).
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System	ZEUS Scientific	FDA 510(k) cleared; commercial (K191240)	Uses recombinant antigens (VlsE1 + pepC10) for qualitative IgG/IgM detection; labeling explicitly references confirmation via STTT (immunoblot) or MTTT (ELISA-based) approaches.
LIAISON Lyme IgM assay	DiaSorin	FDA 510(k) cleared; commercial (K202573)	Automated chemiluminescent immunoassay for scalable central-lab throughput and standardization on the LIAISON workflow.
LIAISON Lyme IgG assay	DiaSorin	FDA 510(k) cleared; commercial (K202574)	Paired IgG/IgM menu on the same automation stack; used in high-throughput lab algorithms.
VIDAS® Lyme IgM II / VIDAS® Lyme IgG II	bioMérieux	FDA-cleared assays; commercial	Automated VIDAS workflow with separate IgM/IgG assays; positioned for standardized processing on VIDAS systems.
EUROIMMUN Lyme ELISA (IgG/IgM)	EUROIMMUN US	FDA 510(k) cleared; commercial (K142038)	High-volume first-tier ELISA option used within two-tier or modified two-tier workflows.
EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)	EUROIMMUN US	FDA 510(k) cleared; commercial (K161513)	Second-tier IgG immunoblot for band-based confirmatory interpretation in classic two-tier testing.
Borrelia burgdorferi IgG/IgM ELISA Test Kit	Gold Standard Diagnostics	FDA 510(k) cleared; commercial (K180264)	Routine IgG/IgM antibody ELISA positioned for presumptive first-tier screening.
Sofia® Lyme FIA	QuidelOrtho	FDA 510(k) cleared; commercial (K173691)	Instrument-read FIA format designed for rapid workflow using the Sofia platform (near-patient / decentralized settings).
Lyme Disease Antibody with Reflex to Immunoassay (IgG, IgM)	Quest Diagnostics	Commercial lab service (MTTT)	Uses an initial immunoassay and (if positive/equivocal) reflexes to separate FDA-cleared IgG and IgM immunoassays (instead of an immunoblot), aligning to modified two-tier testing.
Lyme Antibodies, Modified 2-Tier Testing Profile (Test #164226)	Labcorp	Commercial lab service; explicitly states “FDA-cleared assays”	Special instructions: initial total antibody immunoassay → reflex to separate IgG and IgM immunoassays targeting additional B. burgdorferi proteins.
Lyme Disease, Molecular Detection, PCR (Blood) – Test ID PBORB	Mayo Clinic Laboratories	Clinical lab offering (PCR); adjunctive	Mayo explicitly frames PCR as supportive/adjunct to serology; notes blood is generally not the preferred specimen for Bbsl PCR (with nuance for certain species scenarios).
Borrelia Species by PCR (Lyme Disease) – Test #0055570	ARUP Laboratories	Clinical lab offering (PCR)	PCR-based detection offered as a targeted molecular option (typically specimen- and indication-dependent in clinical practice).
iDart Lyme IgM ImmunoBlot Kit (test kit) + IGeneX ImmunoBlot ecosystem	ID-FISH Technology, Inc. / IGeneX (commercialization ecosystem)	FDA 510(k) cleared iDart Lyme IgM ImmunoBlot Kit (K242872) + commercial specialty testing	ImmunoBlot format with expanded band design/interpretation positioning; IGeneX materials describe conversion of their LDT approach into FDA-cleared iDart kits.
T2Lyme Panel (direct-from-blood molecular concept on T2Dx)	T2 Biosystems	Not FDA-cleared as a Lyme test; company communications describe planned / staged commercialization (LDT path referenced)	Designed around direct detection from whole blood (not dependent on antibody development), positioned for earlier-window detection if commercialized.

 

Key Recent Developments

DiaSorin

• U.S. regulatory push for “LymeDetect” cellular+serology approach (USA)
  DiaSorin disclosed its submission of the LIAISON® LymeDetect® test for FDA review, highlighting a differentiated Lyme workflow that combines chemiluminescent immunoassays with a QuantiFERON-based cellular immune readout (partnered with QIAGEN) to improve earlier detection versus antibody-only timing constraints.

T2 Biosystems

• “direct-from-blood” T2Lyme commercialization plans and partnering (USA)
  T2 Biosystems outlined launch plans for the T2Lyme™ Panel as an LDT and separately communicated steps toward a strategic partnership for Lyme—positioning its direct-from-blood molecular approach as a route to earlier actionable detection without waiting for seroconversion.

ID-FISH / IGeneX

• FDA clearances expand beyond LDTs into kit-based Lyme ImmunoBlots (USA)
  ID-FISH/IGeneX announced FDA clearance milestones for its Lyme IgG ImmunoBlot (cleared Aug 2024) and Lyme IgM ImmunoBlot (cleared Jun 2025), signaling movement from specialty LDT positioning toward broader kit distribution and standardization, with public statements indicating shipment plans timed around late 2025.

Quest Diagnostics

• Real-world evidence on modified vs standard two-tier protocols (USA)
  Quest-supported investigators published a real-world comparison of Modified Two-Tier Testing (MTTT) vs Standard Two-Tier Testing (STTT) in PLoS ONE (June 30, 2025), reinforcing the industry shift toward immunoassay-based second-tier confirmation and providing an evidence backbone for labs optimizing accuracy, throughput, and reporting consistency.

Labcorp

• Large-lab operational transition to MTTT highlighted in 2025 infectious-disease forum (USA)
  An Open Forum Infectious Diseases supplement abstract (2025) describes Labcorp’s full transition of Lyme serology from STTT to MTTT (transition completed in 2022), underscoring how scale laboratories are standardizing around FDA-cleared immunoassay-to-immunoassay algorithms to streamline turnaround time and interpretation.

CDC

• Updated MTTT results-reporting interpretation tightens lab standardization (USA)
  CDC published a suggested results-reporting/interpretation guide for Modified Two-Tier Testing (May 2024), including guidance on timing-related negatives and repeat testing windows—a practical “market shaper” that influences how assay vendors, labs, and EHR order sets structure Lyme reporting.

InBios

• AI-assisted, single-tier multiplex serology positioned as next-gen workflow (USA)
  InBios reported a next-generation Lyme diagnostic concept combining multiplex antigen responses with machine-learning–guided interpretation (publicly presented July 2025), targeting a potential move beyond rigid two-tier sequencing toward single-test decision support; parallel peer-reviewed discussion of multiplex performance reinforces this as a meaningful pipeline direction.

 

Market Segmentation And Forecast Scope

The Lyme disease testing market is segmented along four strategic dimensions: by Test Type, Technology, End User, and Region . These segmentation lines allow a granular analysis of demand dynamics, clinical adoption, and technology penetration from 2024 through 2030.

By Test Type

This segmentation is based on the clinical workflow commonly followed for Lyme disease diagnosis:

• Serological Tests (including ELISA and Western Blot)

• Molecular Tests (such as PCR)

• Other Diagnostic Methods (like culture tests and newer antigen-based assays)

As of 2024 , Serological Tests account for over 68% of the global market share, largely due to their widespread use in first-line screening and confirmatory diagnosis across hospital and outpatient settings. However, Molecular Tests are projected to be the fastest-growing segment through 2030, fueled by demand for higher specificity, faster turnaround times, and adaptability to low-bacterial-load cases in early-stage infections.

 

By Technology

• Enzyme-Linked Immunosorbent Assay (ELISA)

• Western Blot

• Polymerase Chain Reaction (PCR)

• Lateral Flow Assays

• Microfluidics and Lab-on-Chip Platforms

Among these, ELISA remains dominant due to its affordability and compatibility with mass screening. Yet, the emergence of microfluidics and rapid lateral flow formats is reshaping point-of-care (POC) diagnostics in endemic zones , especially in mobile testing units and home kits.

 

By End User

• Hospitals and Clinics

• Diagnostic Laboratories

• Research Institutes

• Homecare Settings

In 2024, Diagnostic Laboratories form the largest revenue-contributing end-user segment due to their role in centralized, high-volume testing. Meanwhile, Homecare Settings represent a niche but high-growth frontier, particularly as startups and public health programs pilot self-administered Lyme tests in rural North America and Central Europe.

 

By Region

• North America

• Europe

• Asia Pacific

• LAMEA (Latin America, Middle East & Africa)

North America is expected to hold the dominant share throughout the forecast period, led by the U.S., where Lyme disease is endemic in over a dozen states and public awareness is high. However, Europe , particularly Germany, Sweden, and Austria, is emerging as a competitive regional hub driven by ecological factors and increased testing reimbursement policies.

Strategically, the segmentation points to two critical battlegrounds for innovation and market expansion: molecular diagnostics and decentralized, user-friendly testing formats. As early detection becomes a priority in endemic and climate-sensitive zones, segmentation-driven product tailoring will play a pivotal role in maximizing adoption.

 

Market Trends And Innovation Landscape

The Lyme disease testing market is undergoing a transformation fueled by technology convergence, public health urgency, and innovation in diagnostic modalities. From traditional two-tiered diagnostics to rapid, AI-enabled platforms, the market is on the cusp of evolving from laboratory-dependent workflows to integrated, field-deployable, and patient-centric testing solutions.

A. R&D Evolution and Diagnostic Reform

A significant trend reshaping the market is the shift toward next-generation diagnostics that move beyond antibody-only detection. Companies and research labs are investing in multi-target assays capable of detecting Borrelia burgdorferi antigens, DNA, and co-infection biomarkers (e.g., Babesia, Anaplasma ).

Recent pre-clinical prototypes have demonstrated early success in detecting Lyme disease within 72 hours of infection using microfluidic biosensors—an enormous improvement over traditional antibody tests that require weeks for seroconversion. This R&D evolution signals a pathway toward ultra-early detection, particularly valuable in endemic regions where rapid treatment can significantly reduce post-treatment complications.

 

B. AI Integration and Algorithmic Interpretation

Artificial intelligence is playing an increasing role in Lyme disease testing through AI-assisted serological pattern recognition and predictive analytics . Startups and diagnostics players are embedding machine learning algorithms into cloud-connected platforms that assist clinicians in interpreting equivocal test results.

“AI tools are beginning to close the interpretation gap in borderline ELISA titers ,” explains a computational biologist working on infectious disease diagnostics. “This will reduce false negatives and improve patient triage in early-stage cases.”

 

C. Digital Interfaces and Home Testing Evolution

The rise of digital diagnostics —test kits that sync with smartphone apps—is another prominent innovation. These platforms allow test-takers to scan results and receive AI-backed interpretations along with next-step clinical recommendations. This is particularly impactful in rural or tick-endemic geographies where lab access is limited.

In 2024, several companies have initiated pilot programs for connected home-based Lyme testing kits , bundled with teleconsultation support. This trend mirrors the success of digital COVID-19 tests and holds high promise for decentralizing Lyme disease screening.

 

D. Collaborations, M&A, and Tech Alliances

Notable developments in the innovation ecosystem include:

• Strategic partnerships between diagnostics companies and academic research centers for biomarker discovery

• M&A activity where larger IVD players are acquiring startups with niche Lyme detection platforms

• Government-backed innovation grants in the U.S. and EU to fund low-cost test development in underserved rural communities

“Lyme testing innovation is now a matter of public health sovereignty,” notes a biotech policy expert. “Governments want to localize R&D and minimize the burden of late-stage diagnosis.”

In summary, the Lyme disease testing market is trending toward multiplexing, miniaturization, and machine learning-enhanced diagnostics , enabling earlier, more accessible, and more accurate detection. Innovation leadership will increasingly depend on the ability to unify high sensitivity with decentralized usability.

 

Competitive Intelligence And Benchmarking

The Lyme disease testing market is characterized by a diverse mix of established diagnostics firms , emerging biotech innovators , and research-driven institutions , all competing to enhance diagnostic precision, reduce time to results, and expand testing into decentralized settings.

Here are the leading players shaping this market:

1. bioMérieux

A global leader in in-vitro diagnostics, bioMérieux maintains a robust presence in Lyme testing through automated immunoassay platforms integrated into hospital laboratories. The company emphasizes standardized test reproducibility , especially for ELISA-based diagnostics. Its geographic focus spans Europe and North America , where its systems are widely used for infectious disease panels.

 

2. ZEUS Scientific

ZEUS Scientific holds significant share in the U.S. due to its FDA-cleared Lyme disease ELISA and Western blot kits. The firm stands out for its dual-platform validation and high sensitivity score , and it’s gaining traction in clinical labs transitioning from legacy manual assays to semi-automated workflows.

 

3. QuidelOrtho

Following its merger, QuidelOrtho has expanded its diagnostics portfolio, including Lyme assays. Known for scalable platforms and aggressive pricing strategies , it is penetrating mid-sized clinical labs and urgent care centers in both urban and suburban areas. The firm is focusing on integrating Lyme testing with respiratory and flu panels on single multiplex analyzers .

 

4. Thermo Fisher Scientific

 

Thermo Fisher leverages its global reach and broad IVD ecosystem to support Lyme disease test development, particularly PCR-based platforms . The company is investing in molecular diagnostics that enable detection at earlier stages, often before antibody formation. Its strength lies in R&D infrastructure and hospital-lab partnerships across North America and Western Europe.

 

5. DiaSorin

An IVD specialist with a strong footprint in Europe, DiaSorin is known for its CLIA-based Lyme test kits . The firm is differentiating through high-throughput solutions and chemiluminescence platforms suitable for high-volume labs. With increasing automation demands in European markets, DiaSorin is well-positioned to scale.

 

6. Abcam

Abcam plays a niche but critical role, particularly in the research-use-only (RUO) segment, supplying Lyme disease-specific antibodies and antigens for custom assay development. Their presence is more visible in academic institutions and biotech R&D labs innovating next-gen diagnostics.

 

7. Trinity Biotech

Trinity Biotech is a notable player in point-of-care Lyme testing , emphasizing affordable, compact, and rapid test formats . Its solutions are frequently used by primary care clinics and rural health missions , particularly in endemic states in the U.S. Its affordability-first model appeals to Medicaid and community-based testing programs.

Overall, competition in this market is being redefined not just by product accuracy, but by deployment flexibility, connectivity, and clinical workflow integration. Players who can bridge lab-grade sensitivity with consumer-grade usability will be best positioned for dominance through 2030.

 

Regional Landscape And Adoption Outlook

The Lyme disease testing market presents a highly regionalized adoption pattern, strongly influenced by disease endemicity, healthcare infrastructure, diagnostic access, and public awareness levels . While North America leads the market in both volume and value, other regions are showing notable momentum due to climate change and ecological shifts that are expanding tick habitats.

North America

North America —especially the United States —remains the epicenter of Lyme disease testing, accounting for more than 45% of the global market revenue in 2024 . The U.S. CDC reports over 476,000 estimated Lyme disease diagnoses annually, though this figure is widely believed to be underreported. Testing demand is centered in Northeastern and Upper Midwestern states , where the Ixodes scapularis tick is most prevalent.

Key regional characteristics include:

• Strong investment in public health surveillance and mandatory reporting laws

• Broad insurance coverage for two-tier testing (ELISA + Western blot)

• Rapid growth in home testing pilots , especially in states like Connecticut and Wisconsin

• Active market participation from regional reference labs and mobile diagnostic units

“Lyme testing is evolving from clinic-based requests to community-driven screening models,” notes a New York–based public health official.

 

Europe

Europe is the second-largest regional market, led by Germany, Austria, Switzerland, and the Scandinavian countries . Lyme disease, transmitted by Ixodes ricinus , is increasingly recognized as a serious public health issue, with rising cases in forested and rural zones.

Drivers in this region include:

• Government reimbursement programs supporting comprehensive tick-borne disease panels

• Increased research funding from the European Centre for Disease Prevention and Control (ECDC)

• Use of multiplex diagnostics for co-infections like tick-borne encephalitis (TBE)

Germany is emerging as a hotbed for innovation , with local biotech firms working on antigen-detection platforms and rapid PCR kits. Eastern Europe, while still underpenetrated, offers white space for low-cost, easy-to-use diagnostics in border regions experiencing tick migration.

 

Asia Pacific

Asia Pacific represents a high-potential but nascent market for Lyme disease testing. Though endemicity is lower compared to Western markets, regions in Northeast China, Japan, and South Korea have reported increasing tick-borne disease cases due to rising temperatures and forest encroachment.

Notable trends include:

• Growing surveillance by regional health agencies

• Academic-led clinical trials for localized strain detection

• Import-driven testing platforms, with potential for localized manufacturing

Australia, while not a recognized Lyme-endemic zone, has seen controversial public discourse around “Lyme-like illness” , prompting broader testing demand from patients and advocacy groups. This patient-driven momentum is creating a niche market for alternative diagnostic pathways.

 

LAMEA (Latin America, Middle East & Africa)

LAMEA is currently the least mature region for Lyme disease testing, with limited endemicity and sparse reporting infrastructure. However, environmental surveillance in parts of Brazil, South Africa, and Turkey indicates increasing tick exposure, particularly due to climate-induced habitat shifts and deforestation.

Barriers in this region include:

• Weak diagnostic infrastructure

• Low clinician awareness and underreporting

• Limited reimbursement support

Despite these challenges, non-governmental organizations (NGOs) and global health collaborations are introducing pilot testing initiatives in rural communities, especially where outdoor labor populations are at risk.

Regionally, the Lyme disease testing market is stratifying into three layers: mature (North America, parts of Europe), developing (Asia Pacific), and emergent (LAMEA). Tailoring test format, cost, and clinical workflows to regional disease patterns will be vital for sustained market penetration and impact.

 

End-User Dynamics And Use Case

The Lyme disease testing market serves a wide range of end users, each with distinct diagnostic priorities, budget constraints, and workflow preferences. These user groups play critical roles not just in test utilization, but also in influencing purchasing decisions, public trust, and long-term diagnostic accuracy outcomes.

Key End-User Categories

• Hospitals and Clinics These remain primary testing hubs for Lyme disease, particularly in endemic regions. Hospitals typically perform two-tier testing in accordance with CDC and ECDC guidelines, using ELISA as a preliminary screen followed by Western blot for confirmation. Larger hospital networks are also early adopters of multiplex PCR and high-throughput diagnostic systems.

• Diagnostic Laboratories Both centralized and reference labs are crucial volume drivers in this market. They serve as core processing centers for outpatient, insurance, and public health testing. Their high throughput and automation capabilities make them ideal customers for chemiluminescence immunoassays (CLIA) , ELISA platforms, and PCR analyzers . Many labs are also integrating AI into test interpretation for equivocal results.

• Research Institutes and Academic Labs These users are focused on Lyme biomarker discovery, pathogen genomics, and co-infection research. While not always commercial consumers, they generate early demand for research-use-only (RUO) test kits , biospecimen panels, and new detection methodologies. Insights generated here often translate into commercial test evolution.

• Homecare Settings and Telehealth Providers This emerging segment is growing rapidly due to the decentralization of diagnostics. Consumers now have access to at-home Lyme disease test kits , often linked with telehealth consultation services . Though still under regulatory observation, this end-user category is expected to disrupt traditional testing pathways by offering convenience and faster patient response.

 

Real-World Use Case

A Tertiary Hospital in South Korea Implements Multiplex Lyme and Co-Infection Testing for Imported Cases

A leading hospital in Seoul , South Korea, began seeing an uptick in patients presenting with post-travel febrile illness after visiting wooded regions in Central Europe. Although Lyme disease is rare domestically, a handful of confirmed cases prompted the hospital to adopt a multiplex PCR testing platform capable of detecting Borrelia burgdorferi and common co-pathogens such as Babesia microti and Anaplasma phagocytophilum .

By integrating this multiplex approach into their infectious disease triage protocol, the hospital reduced average time to diagnosis from 11 days to just under 48 hours , enabling early doxycycline treatment and full patient recovery. This implementation not only improved clinical outcomes but also prompted South Korea’s Ministry of Health to evaluate broader adoption of vector-borne disease testing in returning travelers .

The diverse needs of hospital-based diagnostics, lab automation, and remote patient testing are collectively shaping how Lyme disease diagnostics are produced, marketed, and adopted. Going forward, success will hinge on flexibility—ensuring the same diagnostic integrity across both high-tech hospital labs and mail-in test kits.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• FDA Clears AI-Powered Diagnostic Assistant for Lyme Disease A U.S.-based diagnostics company received FDA clearance for its AI-backed platform that assists clinicians in interpreting Lyme test results, especially in cases with low serological titers . The platform integrates with existing ELISA and Western blot systems to improve diagnostic accuracy in early infections. 

• Partnership Between German University and Biotech Firm for Antigen-Based Assay A strategic alliance was announced between a biotech company in Munich and a university virology lab to co-develop a rapid antigen detection test capable of identifying Borrelia proteins within 3 days post-infection. The project is partially funded by Germany’s federal health research program.

• QuidelOrtho Expands Multiplex Platform to Include Lyme Disease QuidelOrtho released an updated version of its multiplex analyzer that now supports Lyme disease detection as part of a broader tick-borne disease panel. This integration was designed for use in urgent care centers and hospital emergency departments .

• Pilot Program in Canada Introduces At-Home Lyme Test with Telemedicine Support A public-private pilot initiative in Ontario launched an at-home Lyme disease testing kit , paired with virtual clinician consultation. The program targets remote communities with limited lab access and has reported a high rate of test engagement within its first quarter.

 

Opportunities

• Rise of Decentralized Testing and At-Home Diagnostics The consumer shift toward self-testing and remote care opens a significant growth avenue for companies offering compact, easy-to-use Lyme test kits . These formats can greatly improve screening in rural, forested, or tick-endemic communities.

• Government Funding for Emerging Infectious Disease Surveillance National and regional governments are allocating grants for tick-borne disease detection platforms , including early-stage diagnostics and multiplex technologies. This funding is fostering R&D partnerships across industry and academia.

• Integration of Co-Infection Panels With overlapping symptoms and transmission vectors, co-infection detection (e.g., Lyme + Babesiosis + Anaplasmosis) is creating a demand for bundled test solutions. Players who can deliver multi-pathogen panels will enjoy competitive differentiation.

 

Restraints

• Regulatory Complexity in Home Testing Approvals While home-based Lyme testing is promising, stringent regulatory oversight —especially in the U.S. and EU—can delay commercialization. Manufacturers must meet high standards of accuracy, privacy, and remote result interpretation.

• False Negatives in Early Infection Stage Current antibody-based tests often produce false negatives during early infection , leading to underdiagnosis. This limitation affects clinical trust in testing workflows and pushes demand toward higher-cost molecular methods, increasing the financial burden on payers.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 933.6 Million
Revenue Forecast in 2030	USD 1.55 Billion
Overall Growth Rate	CAGR of 8.9% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Test Type, By Technology, By End User, By Region
By Test Type	Serological Tests, Molecular Tests, Others
By Technology	ELISA, Western Blot, PCR, Lateral Flow, Microfluidics
By End User	Hospitals & Clinics, Diagnostic Labs, Research Institutes, Homecare Settings
By Region	North America, Europe, Asia-Pacific, LAMEA
Country Scope	U.S., Germany, Canada, UK, Japan, South Korea, Brazil
Market Drivers	Rising Lyme cases, diagnostic innovation, regulatory support
Customization Option	Available upon request