Lyme Disease Testing Market – By Diagnostic Technology, By Sample Type, By Patient Type, By End Use – Global Forecast, 2025 to 2034

Report ID: GMI12557
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Published Date: December 2024
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Report Format: PDF

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Lyme Disease Testing Market Size

The global lyme disease testing market size was valued at USD 6.7 billion in 2024 and is expected to exhibit growth at a CAGR of 5.7% from 2025 to 2034 period. The markets are influenced by many factors which together contribute to the growth of the market. The first of these factors is the growing number of Lyme disease patients, especially in endemic regions such as North America and Northern Europe.
 

Lyme Disease Testing Market

According to the Centers for Disease Control and Prevention (CDC) 2024 statistics, which estimated just under half a million cases of Lyme disease are diagnosed each year in the U.S. Another major factor includes the new technology leaps in the development of diagnostic methods. The emergence of exquisitely sensitive and specific approaches, molecular diagnostics (e.g., PCR) as well as novel serological assays such as ELISA enable recognition of diseases in pre-symptomatic patients.

Additionally, point of care (POC) tests and at-home testing kits are also gaining popularity and are being used as simple and quick ways of diagnosing patients. Increased awareness regarding the long-term consequences that may arise from untreated Lyme disease such as chronic neurological and musculoskeletal conditions is forcing patients to get themselves tested and treated at early stages. This has been compounded by public health campaigns being run by government bodies and non-government organizations. On the other hand, regulatory bodies are slowly beginning to provide funding for research into tick-borne diseases and this is aiming to improve the growth of the market in the future.
 

Lyme disease testing is the process involved in the diagnosis of Borrelia burgdorferi, which is the virus that causes Lyme disease and is most often carried through the feces of an infected tick. Moreover, there are serological methods such as ELISA and Western Blot tests, molecular diagnostics such as PCR, and antigen-based tests. These can apply blood, cerebrospinal fluid (CSF), or urine samples to determine the stage of an infection and therefore treat it effectively. The earlier the infection is detected, the less invasive the treatment is likely to become.
 

Lyme Disease Testing Market Trends

The growing burden of lyme disease has led to an increase in targeting lyme disease market size. The market is driven by the growing incidence of Lyme-borne disease caused by the spirochete bacterium Borrelia burgdorferi, primarily located in endemic regions such as North America and Europe.
 

  • The Centers for Disease Control and Prevention (CDC) puts the annual diagnosed and treated cases for the U.S. at close to 476,000, meaning the disease is endemic in its nature. The increasing number of cases is linked to climate change because populations of deer and rodents that carry the vectors are growing, which in turn lengthens periods of tick activity.
     
  • The TB detection and treatment market is expected to grow due to rapid increase in demand for diagnostic tests that are both reliable in predicting an infection and timely in providing treatment to the affected, particularly with the possibility of lyme disease becoming chronic leading to long-term damage to the neurological, cardiovascular, and musculoskeletal systems.
     
  • There is huge demand for reliable testing solutions as there are considerable investments being made in enhancing the diagnostic infrastructure in countries with a significant burden of lyme disease.
     
  • Additionally, the increasing awareness surrounding lyme disease has contributed to patients getting testing even if they show minor, or sometimes none at all, symptoms of the disease. The use of tools such as the ELISA and Western Blot to perform sensitive and dexterous serological examinations, as well as the method of molecular polymerase chain reaction, has been increased due to the pace with which Lyme disease is growing.
     
  • Furthermore, initiatives pertaining to public health along with the focus being shifted on preventive diagnostic tests by healthcare providers are also crucial to the sustainable growth of this market.
     
  • Considering the rising prevalence of the disease, and the continuous technological advancements, the testing market is expected to expand, considering the market has been placed as a focus for early-stage detection of health concerns to avoid long-lasting impacts.
     

Lyme Disease Testing Market Analysis

Lyme Disease Testing Market, By Diagnostic Technology, 2021 - 2034 (USD Billion)

Based on diagnostic technology, the market is segmented into serological test, nucleic acid test, urine antigen testing, lymphocytic transformation test, and immunofluorescent staining. The serological test segment is expected to expand at a CAGR of 6.2%, reaching USD 5 billion by 2034.
 

  • Due to its increasing acceptance, reliability, and innovation, the aspect is anticipated to experience considerable growth in the edge of market. Antibody tests such as enzyme-linked immunosorbent assay (ELISA) and numerous other techniques, Western blot, are among the most widely used procedures for the diagnosis of Borrelia burgdorferi antibody detection. One of its features that is a strong impetus for success is their ability to diagnose lyme disease in different stages.
     
  • Additionally, the serious health risk posed by lyme disease on people, especially in North America and Europe in endemic regions is the main driver of the increase in demand for serological tests. These are also crucial in the context of the public health approach where healthcare practitioners have the ability to diagnose the disease as early as possible to take preventive measures in a bid to reduce the severe consequences cut down the growth of such tests.
     
  • Furthermore, enhanced technologies for serological testing have increased sensitivity and specificity which will remove the false positive and negative results that had been a drawback of earlier technologies.
     
  • Moreover, approvals from regulatory bodies such as the American Centers for the Protection of Disease which starts with the two-pronged assessment recommending the use of ELISA now ensures the growth of the segment. The growing use of mechanical systems and point-of-care (POC) devices has made the tests more accessible especially in remote or underdeveloped areas.
     
  • In addition to this, the increase in the awareness campaigns implemented by governments and non-government organizations assist the healthcare at-risk groups on the necessity for Lyme disease testing resulting in higher adoption of serological tests. In conjunction with the increasing penetration of healthcare facilities and increasing focus on preventive diagnostics, these factors are expected to drive growth of the serological test segment during the period of projection.
     

Based on sample type, the lyme disease testing market is classified into blood, urine, CSF, and other blood samples. The blood segment held 52.2% share of the market in 2024, driven by several key factors.
 

  • The segment is anticipated to capture a substantial share owing to some key reasons. Blood samples are interrogated as the gold standard diagnosis performance of Lyme disease because of its capacity to identify antibodies and bacterial DNA.
     
  • Serological tests, for instance, ELISA (Enzyme-Linked Immunosorbent Assay) and Western blot, are blood samples taken during testing to check for lyme disease antibodies. Such blood and blood components-based testing methods are non-invasive and relatively easy to use, hence widely accepted in all health establishments.
     
  • Moreover, the ease in collecting blood samples also strengthens the market share of this segment. Blood can be collected in virtually every clinical setting, thus increasing the possibility of testing on a large scale particularly in regions where infections are common.
     
  • Moreover, with the improvement of blood-based molecular diagnostics for instance, the polymerase chain reaction (PCR) assay that works by replicating the bacterial DNA, the chances of detection at the early onset stage of the disease have been greatly enhanced.
     
  • Also, considering the fact that there is a growing understanding of Lyme disease and the critical need for the early diagnosis gets increasingly important to prevent further problems, it is very likely that blood tests consumables will be in increasing demand.
     
  • In addition, the development of good diagnostic services especially unmet needs area, is consistent with the further growth of the blood sample segment of the market.
     

Based on patient type, the lyme disease testing market is patient type into adult and pediatric. The adult segment was valued at USD 4.9 billion in 2024 and is expected to grow at a 6% CAGR between 2025 and 2034.
 

  • Pivotal growth pillars act to foster the robust growth of the adult segments in the market. For instance, the elementing factors such as outdoor activities, travel, and working in tick endocrine areas such as forests and grasslands contribute massively to the growing Covid rates worldwide.
     
  • The segment also experiences market growth through the growing awareness among the public regarding the symptoms of lyme disease and detection as of its importance. The reason behind this is that adults are more willing to visit the doctor when they experience symptoms such as fever and joint pains accompanied with fatigue.
     
  • Alongside this, growth in polymerase chain reaction (PCR), serological testing, ELISA, and Western blots have lowered the hurdles to quality healthcare. This makes the necessary testing simpler and correct, resulting in people being suited to testing.
     
  • Furthermore, the rising prevalence of diabetes or cardiovascular disease in adults, which may obfuscate the diagnosis and treatment of Lyme disease, in turn expands the testing need. Besides, the emerging concern among healthcare practitioners on the necessity of testing undiagnosed adult populations having chronic symptoms attributed to Lyme disease is promoting the market for diagnostic tools. Due to more outdoor activities and pet ownership, the adult segment is likely to remain dynamic and further accelerate.

 

Lyme Disease Testing Market, By End Use (2024)

Based on end use, the lyme disease testing market is segmented into hospitals, diagnostic laboratories, and other end users. The hospitals segment dominated the market in 2024 and is anticipated to reach USD 5.3 billion by 2034.
 

  • Owing to several driving factors, the hospitals segment is likely to keep holding the highest market share for years to come. Firstly, testing that involves a variety of approaches such as blood tests and molecular diagnostics are offered by numerous hospitals in an effort to detect Lyme disease in a timely and effective way. These hospitals employ advanced technology and competent health professionals are trained to deal with complex results, making them the go-to centers for diagnosing Lyme disease.
     
  • Moreover, there is increased hospital visitation because of tick-borne illnesses, and this has also increased the need for Lyme disease testing.
     
  • Further, the rising number of people having long-term Lyme disease that needs constant medical care makes the trend even stronger since hospitals are treating patients having chronic symptoms as well. Testing and therapies for diseases have advanced greatly and are now combined in hospitals.
     
  • In addition to this, as a response to the increasing occurrence of Lyme disease in endemic areas, the government and other regulatory bodies provide hospitals with assistance and support. Such aid encompasses coverage for the purchase of better quality diagnostic tools, which results in market development.
     
  • In addition, there is a trend toward the use of point-of-care testing in hospitals, which allows reducing the time spent waiting for test results, increasing the effectiveness of treatment and improving the quality of care.

 

U.S. Lyme Disease Testing Market, 2021 – 2034 (USD Million)

U.S. Lyme disease testing market was valued at USD 2.6 billion in 2024 and is projected to grow substantially in the coming years.
 

  • One notable driver of the market in the U.S. is the trend of the increasing number of lyme disease cases each year. They in addition seek further testing as it was observed that the range of occurrence of Lyme disease in the U.S. has been moving further north owing to environmental conditions and increased transmission potential of tick-borne diseases. There is a well – developed model of health care in the country, with the use of efficient diagnostics such as PCR, ELISA and Western blots which allow timely diagnostic and starting the treatment of the patients.
     
  • Furthermore, the activities carried out by the CDC and other health organizations have significantly increased the level of public awareness on lyme disease and consequently stimulated further testing in other regions where lyme disease is endemic. The allocation of government resources and research programs directed at improving the surveillance, prevention, and diagnosis of lyme disease further complement the expansion of the market.
     
  • Moreover, the growth of point-of-care testing (POC) is becoming ever more widespread, as it reduces the time it takes to deliver a diagnosis and thus the time taken to start the treatment. In the context of lyme disease continuing to be rampant and measures to tackle its detection and treatment still rolling, the U.S. is in a good position to keep increasing the demand for testing of lyme disease.
     

U.K. lyme disease testing market is projected to grow remarkably in the coming years.
 

  • The NHS has suggested serological tests such as ELISA and Western blot as the preferred methods for diagnosing Lyme disease, and with the test gaining traction within healthcare facilities, there is an increase in the size of the market. With heightened awareness surrounding Lyme disease, accurate diagnostic tests are in demand.
     
  • Moreover, increasing number of individuals are turning toward outdoor activities such as hiking and cycling, and so the chances of getting bitten by a tick are on the rise. Thus, individuals are getting tested for Lyme disease following the bite, and this is resulting in growth of the market.
     

China holds a dominant position in the Asia Pacific lyme disease testing market.
 

  • The increasing recognition of tick-borne diseases such as Lyme disease in the rural parts of China has led to the gradual growth of the market. There has been a lack of awareness about Lyme disease compared to other such diseases in China, and therefore it is of utmost importance that health authorities and other relevant authorities educate the public about the disease, which in the long run will lead to more demand for Lyme disease testing.
     
  • However, testing for Lyme disease in China is often viewed as a gradual process and involves a lack of knowledge of the disease, which can delay the diagnosis process. Despite of this, the growing awareness of the disease as well as its easier availability and continuous improvement in healthcare in the long term is bound to aid in the growth of the market while diminishing the challenges posed earlier.
     

Lyme Disease Testing Market Share

The market for Lyme disease testing is quite aggressive due to several major companies which have a good amount of market share. Many businesses have a strong market presence with a wide range of diagnostic tools such as advanced serological assays that include ELISA and Western blot, and PCR for molecular testing. Bio-Rad Laboratories, for instance, is well-known for its accurate diagnostics and enjoys extensive international business so that their market share is sizable because of the extensive use of serological testing in clinics. bioMérieux, Inc. is another essential company, which combines its market share with the use of immunoassays and other molecular diagnostic tools. It has a strong position in the market for these in North America and Europe.
 

Lyme Disease Testing Market Companies

Prominent players operating in the lyme disease testing industry include:

  • bioMérieux
  • Bio-Rad Laboratories
  • Ceres Nanosciences
  • DiaSorin
  • Galaxy Diagnostics
  • Gold Standard Diagnostics
  • IGeneX
  • Oxford Immunotec
  • T2 Biosystems
  • Thermo Fisher Scientific
  • Trinity Biotech
  • ZEUS Scientific
     

USPs for Top Players:

  • Bio-Rad Laboratories offers high-quality clinical and research testing devices that are made easy to operate and produce exact figures.
     
  • bioMérieux, embracing innovation, is known to develop diagnostic solutions that provide highly sensitive and specific tests for lyme disease along with other diseases for early detection purposes.
     
  • Thermo Fisher Scientific provides cutting-edge molecular and immunological diagnostic tests to assess lyme disease.
     

Lyme Disease Testing Industry News:

  • On July 2022, T2 Biosystems received approval from the U.S. Food and Drug Administration (USFDA) for the T2Lyme Panel. This diagnostic tool is designed to enhance the accuracy of early lyme disease detection, potentially improving patient care and outcomes. The T2Lyme Panel directly identifies the lyme disease-causing bacteria from a patient's blood sample.
     
  • On April 2022, Valneva and Pfizer shared promising results from the Phase 2 trial of their Lyme disease vaccine candidate, VLA15. Based on the positive data, the companies planned to advance with a three-dose primary vaccination schedule and initiate a Phase 3 clinical trial. This trial will evaluate VLA15 in both adults and children aged 5 and above, with plans to begin the trial in 2022, pending regulatory approval.
     

The lyme disease testing market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

Market, By Diagnostic Technology

  • Serological test
  • ELISA
  • Western blot
  • Nucleic acid test
  • Urine antigen testing
  • Lymphocytic transformation test
  • Immunofluorescent staining

Market, By Sample Type

  • Blood
  • Urine
  • CSF
  • Other blood samples

Market, By Patient Type

  • Adult
  • Pediatric

Market, By End Use

  • Hospitals
  • Diagnostic laboratories
  • Other end users

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada 
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Netherlands
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE

 

Authors: Mariam Faizullabhoy, Gauri Wani
Frequently Asked Question(FAQ) :
How big is the lyme disease testing market?
The global Lyme disease testing market was valued at USD 6.7 billion in 2024 and is expected to grow at a 5.7% CAGR from 2025 to 2034, driven by the increasing prevalence of Lyme disease in endemic regions.
What is the growth projection for the serological test segment?
How much is the U.S. Lyme disease testing industry worth?
Who are some of the prominent players in the Lyme disease testing market?
Lyme Disease Testing Market Scope
  • Lyme Disease Testing Market Size
  • Lyme Disease Testing Market Trends
  • Lyme Disease Testing Market Analysis
  • Lyme Disease Testing Market Share
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    Base Year: 2024

    Companies covered: 12

    Tables & Figures: 142

    Countries covered: 19

    Pages: 130

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