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(Albany, US) October 01, 2026 – DelveInsight’s “Lyme Disease Market Insight, Epidemiology and Market Forecast 2034” report offers an in-depth understanding of Lyme disease, including historical and forecasted epidemiology, market trends, treatment practices, and emerging therapies across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Highlights from the Lyme Disease Market Report

• Lyme disease, or Lyme borreliosis, is caused primarily by the bacterium Borrelia burgdorferi and, in rare instances, Borrelia mayonii, and is transmitted to humans through the bite of infected blacklegged ticks.

• There is a notable gender disparity in Lyme disease incidence, with men more likely to be affected than women; 58% of reported cases occurred in men.

• No vaccines are currently marketed for Lyme disease, though demand is rising amid increasing US and European infection rates linked to factors such as climate change, with Moderna’s recent interest signaling additional prophylactic options over the longer term.

• The US FDA has not approved any therapy specifically indicated for Lyme disease; treatment instead relies on antibiotics approved for other bacterial infections and used off-label.

• Key emerging therapies include VLA15 (Valneva and Pfizer), TP-05 (Tarsus Pharmaceuticals), and mRNA-1982 and mRNA-1975 (Moderna), among others.

• In April 2025, researchers engineered a modified version of the Lyme bacterial protein CspZ that triggered a strong immune response in preclinical studies, published in Nature Communications, offering a potential next-generation vaccine target.

• Key Lyme Disease Companies: Valneva, Tarsus, Moderna, and others.

• Key Lyme Disease Therapies: VLA15, TP-05, mRNA-1982, mRNA-1975, and others.

Lyme Disease Overview Lyme

Lyme disease is the most common vector-borne infectious disease in the United States and one of the fastest-growing tick-borne illnesses across Europe. It is caused by Borrelia burgdorferi in North America and by Borrelia afzelii and Borrelia garinii in Europe and Asia. The disease progresses through multiple stages, beginning with early localized infection, typically characterized by erythema migrans and flu-like symptoms. If untreated, Lyme disease can advance to early disseminated and late-stage disease, affecting the joints, nervous system, and cardiovascular system.

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Lyme Disease Epidemiology Insights

The epidemiology segment of the report tracks historical and forecasted incident cases of Lyme disease across the 7MM. The highest incidence of Borrelia infection is observed in children aged 5–15 years and in adults over 50, while in the UK the highest incidence falls within the 30–49 and 50–69 year age groups. The Centers for Disease Control and Prevention estimates that approximately 476,000 Americans are diagnosed and treated for Lyme disease each year, with at least a further 130,000 cases reported across Europe. In Germany, the incidence of Lyme borreliosis is estimated at 37.2 cases per 100,000 person-years, while in Japan, the Infectious Agents Surveillance Report puts the incidence rate at 0.008 cases per 100,000 people. Of reported cases across the markets studied, 58% occurred in men.

Lyme Disease Epidemiology Segmentation

The Lyme disease market report provides epidemiological analysis for the study period 2020–2034 across the 7MM, segmented into:

• Incident Cases of Lyme Disease

• Gender-specific Incident Cases of Lyme Disease

• Age-specific Incident Cases of Lyme Disease

• Treatable Cases of Lyme Disease

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Lyme Disease Therapies and Key Companies

• VLA15 – Valneva and Pfizer

• TP-05 – Tarsus Pharmaceuticals

• mRNA-1982 and mRNA-1975 – Moderna

Emerging Lyme Disease Drugs Uptake

The emerging drugs uptake section of the report evaluates the anticipated adoption of Lyme disease therapies expected to launch between 2025 and 2034, as novel medicines look set to redefine current standards of care. VLA15, the most advanced Lyme disease vaccine candidate in clinical development, is a multivalent recombinant protein vaccine targeting six Borrelia serotypes; it works by inducing antibodies against outer surface protein A (OspA) to block bacterial transmission from the tick. The candidate holds FDA Fast Track Designation granted in 2017, and Pfizer, in partnership with Valneva, plans to submit a BLA to the FDA and an MAA to the EMA in 2026, pending positive trial outcomes; it is currently in Phase III. TP-05, an oral systemic formulation of the anti-parasitic agent lotilaner from Tarsus Pharmaceuticals, is believed to be the only non-vaccine, drug-based preventive therapy in development that targets and kills infected tick vectors before Borrelia transmission can occur, offering on-demand protection. It is currently being assessed in a Phase IIa trial.

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Lyme Disease Market Forecast

The current preventive landscape for Lyme disease is dominated by vaccine-based approaches, with no approved drug-based prophylaxis yet available. TP-05 represents a novel market entrant that could reshape the prevention landscape by addressing unmet needs among populations for whom vaccination may be unsuitable or unavailable, potentially expanding prevention options and driving market growth in the years ahead.

Key Lyme disease market drivers include:

• Rising case numbers and expanded disease surveillance across the US and Europe

• Growing demand for faster, higher-volume diagnostics, including ELISA, modified two-tier algorithms, PCR, and point-of-care assays

• Multi-billion-dollar global testing market growth at mid-single-digit to low-double-digit CAGRs

• Advancement of emerging vaccine and drug candidates from Valneva/Pfizer, Tarsus Pharmaceuticals, and Moderna

• Continued climate-linked expansion of tick habitats and infection rates These factors, together with continued clinical and pipeline progress, are expected to support market growth through 2034.

Scope of the Lyme Disease Market Report

• Study Period: 2020–2034

• Coverage: 7MM – The United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan

• Key Lyme Disease Companies: Valneva, Tarsus, Moderna, and others

• Key Lyme Disease Therapies: VLA15, TP-05, mRNA-1982, mRNA-1975, and others

• Lyme Disease Therapeutic Assessment: Current marketed and emerging therapies

• Lyme Disease Market Dynamics: Market drivers and market barriers

• Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis, and market entry strategies

• Additional Analysis: Unmet needs, KOL views, analyst views, market access, and reimbursement

About DelveInsight

DelveInsight is a leading healthcare business consulting and market research firm focused exclusively on the life sciences industry. The company supports pharmaceutical and biotechnology organizations with comprehensive, end-to-end solutions designed to improve business performance and support strategic decision-making. DelveInsight also provides healthcare consulting services covering market analysis, competitive intelligence, commercial strategy, and other areas that help life sciences companies identify opportunities, overcome challenges, and accelerate business growth.

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