Lyme disease is the most common vector-borne disease in the Northern Hemisphere, yet its true scale remains remarkably poorly quantified. Caused by spirochetal bacteria of the Borrelia burgdorferi sensu lato complex and transmitted through the bite of infected Ixodes ticks, Lyme disease affects hundreds of thousands of people each year across North America, Europe, and increasingly beyond. For a significant minority, acute infection gives way to a chronic, debilitating condition known as Post-Treatment Lyme Disease Syndrome (PTLDS), or “Long Lyme”, that adds a compounding burden year on year.
Understanding the true scale of Lyme disease and Long Lyme is essential: for patients who deserve recognition, for clinicians who need better tools, and for the diagnostic industry that must rise to meet the challenge.
The United States: Far Larger Than the Official Count
The US carries the largest documented Lyme disease burden in the world. For years, the CDC’s national surveillance system recorded approximately 30,000 confirmed cases annually, a figure that became the widely cited benchmark. It was, however, a dramatic undercount. In 2013 the CDC revised its estimates upward, and subsequent analyses using insurance claims data have confirmed that the true incidence is approximately 476,000 new cases per year [1, 2]. Lyme disease is endemic across the Northeast, Mid-Atlantic, and Upper Midwest, though its geographic footprint is expanding as tick populations spread in response to climate change and shifting land use [3].
The gap between 30,000 reported cases and 476,000 estimated cases, a factor of nearly sixteen, underscores a systemic problem of underdiagnosis and underreporting that has profound consequences for patients and public health planning alike.
The United Kingdom: Small Numbers, Big Uncertainty
Official UK figures are far lower, but no less contested. The UK Health Security Agency reports approximately 1,000–2,000 laboratory-confirmed cases per year in England and Wales. However, NICE has acknowledged estimates of up to 8,000 cases annually across the UK when clinical diagnoses and underreporting are included [4]. Scotland, with extensive suitable tick habitat, reports disproportionately high rates relative to its population [5].
Patient advocacy organisations including Lyme Disease UK have long argued that these figures still understate reality, pointing to the well-documented insensitivity of standard serological testing, particularly in early disease, as a key driver of missed diagnoses [6]. The true burden in the UK remains a matter of active debate.
The European Union: A Continent-Wide Challenge
Europe collectively represents a vast Lyme disease burden. The European Centre for Disease Prevention and Control (ECDC) estimates approximately 200,000–230,000 cases per year across EU/EEA member states [7]. Incidence varies enormously by country: Germany alone accounts for an estimated 80,000–120,000 cases annually, with Austria, the Czech Republic, Slovenia, the Baltic states, and parts of Scandinavia and France also reporting high and rising rates [8].
The European picture is further complicated by pathogen diversity. Unlike North America, where B. burgdorferi sensu stricto predominates, Europe harbours multiple pathogenic genospecies including B. afzelii and B. garinii, each producing distinct clinical manifestations. This diversity has direct implications for diagnostic performance: assays optimised for a single genospecies may miss infections caused by others, contributing to geographic variation in diagnostic sensitivity [9].
Rest of World: An Expanding Frontier
Beyond North America and Europe, Lyme disease is increasingly recognised in Russia, which reports 6,000–9,000 confirmed cases annually across its western and Siberian regions, and in parts of China, Japan, and South Korea, where Borrelia species have been identified in tick populations and human cases documented [10, 11]. Climate modelling suggests that rising temperatures and expanding tick habitats will push Lyme disease into previously non-endemic regions across Asia and potentially into parts of the Southern Hemisphere over the coming decades [12].
Conservative global estimates place annual Lyme disease incidence at over 700,000 cases, with some models exceeding one million.
Long Lyme: The Compounding Crisis
An estimated 10–20% of patients treated for Lyme disease go on to develop persistent symptoms lasting six months or longer, with fatigue, musculoskeletal pain, cognitive dysfunction, and neurological symptoms chief among them [13]. Applied to current US incidence estimates alone, this implies roughly 50,000–100,000 new Long Lyme patients emerging each year in the United States, adding to a cumulative population that may already number in the low millions. Extrapolated globally, the Long Lyme population represents a substantial and growing cohort of chronically ill individuals, many of whom remain undiagnosed or misdiagnosed.
Unlike acute Lyme disease, Long Lyme has no validated diagnostic biomarker. Patients are identified, when they are identified at all, on the basis of clinical history and the exclusion of other conditions. This diagnostic vacuum is at the heart of the patient struggle that we explore in the companion to this article.
The Diagnostic Market: Growth Driven by Unmet Need
The global Lyme disease diagnostics market was valued at approximately USD 1.0–1.2 billion in 2023 and is projected to grow at a compound annual growth rate of 9–12%, reaching an estimated USD 2.0–2.5 billion by 2030 [14, 15]. The US accounts for the largest share, followed by Western Europe.
The market remains dominated by serological testing, principally the CDC-recommended two-tier algorithm employing an initial enzyme immunoassay (EIA) followed by a confirmatory Western blot or second EIA [16]. In 2019, the FDA cleared a modified two-tier testing (MTTT) protocol replacing the Western blot with a second EIA, improving standardisation and throughput [17]. Molecular diagnostics (PCR), point-of-care rapid tests, and emerging next-generation platforms (including multiplex immunoassay panels, T-cell assays, and direct antigen detection) represent smaller but fast-growing segments attracting significant investment.
Yet this growth is driven as much by diagnostic inadequacy as by rising incidence. Two-tier serology, the backbone of the market, has a sensitivity as low as 30–40% in early localised disease, precisely when timely diagnosis matters most [18]. For Long Lyme, no validated diagnostic test exists at all. The market is growing, but it is growing around a fundamental gap.
Closing that gap, with faster, more sensitive, and more clinically pertinent diagnostics, is the defining opportunity in Lyme disease today.
This is the first in a two-part series. In our next article, we explore the human cost of diagnostic failure in Lyme disease and Long Lyme, and how the multiplex serology approach that Attomarker has pioneered in Long Covid offers a path toward better answers for patients.
References
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[4] NICE. “Lyme disease. NICE guideline [NG95].” 2018.
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[6] Lyme Disease UK. “The challenges of Lyme disease diagnosis in the UK.” Position paper, 2022.
[7] ECDC. “Lyme borreliosis — Annual epidemiological report.” 2022.
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[14] Grand View Research. “Lyme Disease Diagnostics Market Size, Share & Trends Analysis Report.” 2023.
[15] MarketsandMarkets. “Lyme Disease Treatment Market — Global Forecast to 2030.” 2023.
[16] Branda JA et al. “Advances in serodiagnostic testing for Lyme disease are at hand.” Clin Infect Dis. 2018;66(7):1133–1139.
[17] FDA. “FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses.” 2019.[18] Wormser GP et al. “Clinical practice guidelines by the IDSA.” Clin Infect Dis. 2006;43(9):1089–1134.