Lyme Disease Diagnostics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Lyme Disease Diagnostics Market is segmented By Test Type (Serological Test, Urine Antigen Tests, Lymphocytic Transformation Test Immunofluorescent Staining, Nucleic Acid Test), By Test Sample (Blood, Cerebrospinal Fluid, Urine), By End-User (Hospitals, Diagnostic Centers, Ambulatory Surgical Centers, Public/Private Laboratories, Physician’s Office) and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

Lyme Disease Diagnostics Market Report Overview

Global Lyme Disease Diagnostics Market reached USD 1.6 billion in 2022 and is expected to reach USD 2.2 billion by 2030, growing with a CAGR of 4.3% during the forecast period 2023-2030.

Lyme disease diagnostics tests look for signs of infection in a sample of the blood or cerebrospinal fluid (CSF). CSF is a clear liquid that flows in and around the brain and spinal cord. The test checks samples for antibodies the immune system makes to fight the bacteria that cause Lyme disease. These diagnostic tests identify the antibodies produced by the immune system in response to the infection. Lyme disease diagnostics predict the likelihood of whether the patient is exposed to infected black-legged ticks.

Lyme Disease Diagnostics Market study analysis offers an in-depth outlook on the market containing quantitative and qualitative data. It gives an outlook and forecast of the global market based on market segmentation. It also provides global lyme disease diagnostics market size and growth, along with the latest trends, opportunities, and forecast till 2030.

Among all regions, the North America region is expected to hold the largest share of the global Lyme disease diagnostics market over the forecast period. North America shares a dominant position in the global Lyme disease diagnostics market.  The serological test segment holds a significant position in the market share.

Lyme Disease Diagnostics Market Scope

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Lyme Disease Diagnostics Market Dynamics

Increasing Technological Advancements and the Introduction of Novel Products are Expected to Drive Market Growth

The global Lyme disease diagnostics market growth is driven by several factors, such as various new innovations and products released in the market. According to the Lyme Disease Association, Lyme Disease is the most common tick-borne bacterial infection globally. The market is witnessing the launch and clearance of new validated diagnostic tests for accurate diagnosis of Lyme Disease.

For instance, on June 15, 2022, Adaptive Biotechnologies Corporation, a commercial-stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced the launch of T-Detect Lyme. This is the company’s second test to be made available from its growing T-Detect franchise. 

The increase in novel launches and the introduction of various products for lyme disease diagnosis are expected to elevate the market growth. For instance, on October 26, 2022, Digital diagnostics company ixlayer announced it would produce CVS Health's branded at-home sample collection kits. Ixlayer's kits can test for Lyme disease, Vitamin D levels, thyroid function, and sexually transmitted infections. Thus, the above factors are expected to drive the market growth. 

Growing Government Initiatives and Increased Focus on Ready-to-Use diagnostic Kits Drive Market Growth

The increased government initiatives in order to prevent infection are expected to drive market growth. For instance, on July 22, 2023, Hudson Valley Lawmakers’ bill to bolster funding to combat Lyme and tick-borne diseases was signed into law. Bipartisan legislation advanced by State Senators Pete Harckham and Sue Serino, along with Assemblymember Didi Barrett, that aims to bolster funding to more effectively combat the spread and better protect New Yorkers against tick-borne illness has been signed into law by Governor Kathy Hochul. 

The increased focus in introducing ready-to-use diagnostic kits is driving the market growth. For instance, on March 21, 2023, Jiangsu Bioperfectus Technologies Co., Ltd. has released six new Real-Time PCR Kits independently developed by BioPerfectus. BioPerfectus provides Vector-Borne Diseases Total Diagnostic Solutions from sample pre-processing to PCR amplification analysis for our partners to rapid response to a global health emergency.Thus, the initiatives taken by the government can enhance the market growth.

Lack of Awareness Associated with Lyme Disease Diagnostics is Expected to Hamper the Market Growth

Unawareness of Lyme disease diagnosis is expected to hinder the market's growth over the forecast period. A number of diagnostic tests and kits are available for lyme disease, which are not accessible by the under-developed areas. Only a few people may know about the disease and its diagnosis. In rural areas, people lack knowledge related to disease and its diagnosis. 

The lack of diagnostic centers with fully equipped equipment cannot aid in the proper diagnosis of the disease, which can impact the market growth. The availability of diagnostic tests will not reach the patients in underdeveloped areas, and the severity of the disease will increase, thus impacting the market growth. Hence, the market is expected to decline over the forecast period. 

Lyme Disease Diagnostics Market Segment Analysis

The global lyme disease diagnostic market is segmented based on test type, test sample, end-user, and region.

Serological Tests Segment is Expected to Hold the Largest Market Share in the Global Lyme Disease Diagnostics Market

The global Lyme disease diagnostics market is segmented based on test type such as serological tests, urine antigen tests, lymphocytic transformation tests, immunofluorescent staining, nucleic acid tests, and others. The serological tests segment holds a dominant share over the others segments because of the presence of the identifiable number of antibodies in the blood against the pathogen. Serologic tests indicates the presence of both IgG and IgM antibodies to Borrelia burgdorferi in the blood of the individual. 

The increased number of lsunches of the tests holds the segment in the dominant postion. For instance, on August 1, 2023, Incite Health, Inc., a CLIA-certified, CAP-accredited, high-complexity clinical laboratory specializing in immune system testing, announces the launch of a new paradigm in Lyme Disease testing, the ZEUS Scientific MTTT-2 ELISA system. Recently, the CDC updated its recommendation to state that serologic assays using a second ELISA test are an acceptable alternative to assays that use an immunoblot as a second test. Thus, holding the segment in the dominant position in the market share. 

Lyme Disease Diagnostics Market Geographical Share

North America Region Holds the Largest Market Share in the Global Lyme Disease Diagnostics Market

North America region is the dominating force in the global Lyme disease diagnostics market for the year 2022 due to the high prevalence of Lyme Disease. For instance, according to the CDC, it is estimated that approximately 476,000 people suffer Lyme disease each year in the United States, and every year, approximately 30,000 cases of Lyme disease are reported to the CDC by state health departments and the District of Columbia. 

There are rising government and private institutes initiatives to treat and diagnose Lyme diseases in countries in the region. There are a majority of the companies developing Lyme disease diagnostics. Several institutes have increased their focus on developing novel diagnostic tests. Thus, the above factors are expected to drive the market growth in the region. 

The increase in the government fundings is expected to drive the market growth in the region. For instance, on July 21, 2023, NIH awards announced that it will fund Post-Treatment Lyme Disease Syndrome research. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded five projects for research to understand better Post-treatment Lyme Disease Syndrome (PTLDS), which is a collection of symptoms, such as pain, fatigue, and difficulty thinking or “brain fog,” which linger following standard treatment for Lyme disease. Thus, the above factors are expected to raise the region’s market share. 

COVID-19 Impact on Lyme Disease Diagnostics Market

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global Lyme disease diagnostics market. As countries grappled with lockdowns, the diagnostic and treatment procedures were significantly impacted, negatively impacting the whole market.

The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting the appointments and delaying the diagnosis. The hospitals and the diagnostic centers were closed for non-essential diagnosis of the diseases. The research and new developments have been halted due to COVID-19. Thus, it has negatively impacted the Lyme disease diagnostics market. 

By Test Type                                        

• Serological Test
• Urine Antigen Tests
• Lymphocytic Transformation Test
• Immunofluorescent Staining
• Nucleic Acid Test
• Others

By Test Sample

• Blood 
• Cerebrospinal Fluid
• Urine
• Others

By End-User

• Hospitals
• Diagnostic Centers
• Ambulatory Surgical Centers 
• Public/Private Laboratories
• Physician’s Office

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

On April 21, 2023, Moderna released new treatments for Lyme disease. Moderna has unveiled two novel mRNA vaccine candidates for Lyme disease in its development pipeline: mRNA-1982 and mRNA-1975. Lyme disease is a bacterial infection spread to humans by infected ticks, which can cause various symptoms, including a rash and a fever.

Market Players

The global Lyme disease diagnostics market is fragmented, with the presence of many local and international players. T2 Biosystems, Inc., Bio-Rad Laboratories, Inc., Oxford Immunotec USA, Inc., Thermo Fisher Scientific Inc., Quidel Corporation, Quest Diagnostics, BioMérieux India Private Limited, Diasorin S.p.A, Meridian Bioscience Inc., and Cortez Diagnostics Inc. are the leading companies with a significant market share.

Why Purchase the Report?

• To visualize the global Lyme disease diagnostic market segmentation based on test type, test sample, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of Lyme disease diagnostic market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global Lyme disease diagnostic market report would provide approximately 61 tables, 58 figures, and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies