The Global "Lyme Disease Diagnostics Market" is expected to grow at a high CAGR during the forecasting period (2022-2029).
Lyme Disease Diagnostics are the diagnostic tests used for diagnosing the signs & symptoms, and other diseases such as neurologic, cardiac symptoms associated with Lyme Disease. These diagnostic tests identify the antibodies produced by the immune system in response to the infection. Lyme Disease Diagnostics predicts the likelihood of whether the patient is exposed to infected blacklegged ticks.
**Source: DataM Intelligence Analysis
The market growth is driven by the rising demand for Lyme Disease diagnosis due to the rising prevalence of Lyme Disease. According to the Lyme Disease Association, Lyme Disease is the most common tick-borne bacterial infection in the world. It was focally endemic in several countries such as North America, Europe, and Asia in 2013.
The market is witnessing the launch and clearance of new validated diagnostic tests for accurate diagnosis of Lyme Disease. For instance, in July 2019, Zeus Scientific had received the expanded market clearance from Food and Drug Administration (US FDA) for its diagnostic tests such as Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM, Borrelia burgdorferi IgG/IgM, Borrelia burgdorferi IgM and Borrelia burgdorferi IgG Test Systems for Lyme disease. These diagnostic tests include the concurrent use of two enzyme immunoassays (EIA, instead of the existing two-step process requiring an initial EIA test followed by a Western Blot protein test.
In February 2020, DiaSorin had received clearance from the Food and Drug Administration (US FDA) for Liaison Lyme Total Antibody Plus assay and Liaison Lyme Total Antibody Plus Control Set. This assay uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma samples.
Moreover, the organizations are providing grants for the development of Lyme Disease diagnostic tests. For instance, in July 2019, Enable Biosciences had received the award of one-year Phase I Small Business Innovative Research (SBIR) grant for USD 225,000 from the National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) for the development of an improved Lyme disease test.
The global Lyme disease diagnostics market is segmented based on diagnostic technology as a serological test, urine antigen tests, lymphocytic transformation test, immunofluorescent staining, nucleic acid test, and others. The serological test segment accounts for the highest market share due to the high usage of Serological tests for diagnosing Lyme disease. This test involves the initial screening assay for the detection of antibodies leading to the development of Lyme Disease. Enzyme-Linked Immunosorbent Assay (ELISA) and Western Blot are the commonly used serological tests for Lyme Disease diagnosis.
The urine antigen tests segment is expected to have positive market growth due to growing research and development activities for urine antigen tests for the diagnosis of Lyme Disease. Ceres Nanosciences had developed the urine-based Nanotrap Lyme Antigen test for detecting Lyme disease. The urine antigen tests segment is dominated by the presence of the development of urine antigen tests products that have received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). For instance, In July 2018, Ceres Nanosciences had received the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its new point-of-care Nanotrap Lyme Antigen Test System.
Further, the market is also classified based on application into hospitals, public/private laboratories, and physician’s offices. The hospital segment is expected to witness the highest market growth due to Lyme Disease diagnostic tests' high usages with the rising hospitalization cases.
The public/private laboratories segment is expected to have positive market growth due to the increase in the number of public/private laboratories for diagnosing Lyme Disease. The majority of the public/private laboratories are providing Lyme disease testing using urine or other body fluids and serological tests.
**Source: DataM Intelligence Analysis
By region, the global Lyme disease diagnostics market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, the North American region dominated the global Lyme disease diagnostics market due to the high prevalence of Lyme Disease. According to the Centers for Disease Control and Prevention (CDC), approximately 300,000 people are suffering from Lyme Disease in the United States every year. The United States accounts for the highest market share of XX% in 2019. 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 Diseases diagnostics. Several institutes have increased their focus on developing novel diagnostic tests. For instance, in November 2019, the National Institutes of Health (NIH) had planned a five-year strategic plan to accelerate research initiatives leading to better prevention, diagnosis, and treatment of tick-borne diseases. In March 2020, a leading sponsor of Lyme disease research in the United States i.e. Bay Area Lyme Foundation had opened the San Diego collection site of the Bay Area Lyme Foundation’s Lyme Disease Biobank to provide researchers with blood and urine samples from people with early Lyme Disease from multiple endemic regions across the country.
Europe is expected to witness positive market growth due to the drastic increase in Lyme Disease cases. Over the last decade, the incidence of cases of Lyme Disease has increased by three times in Europe. The market is witnessing the development of novel diagnostic tests with technological advancement. These emerging diagnostic tests would help in the accurate diagnosis of Lyme Disease.
**Source: DataM Intelligence Analysis
The global Lyme disease diagnostics market is fragmented with the presence of many local and international players. Abbott Laboratories, Bio-Rad Laboratories, Affymetrix, Inc., Roche Diagnostics, T2 Biosystems, and GlaxoSmithKline Pharmaceuticals are the leading companies with a significant market share.
Technology advancement, product diversification, market expansion, and new product launches intensify the market competition. For instance, T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.
Ceres Nanosciences had developed the urine-based Nanotrap Lyme Antigen test for detecting Lyme disease. This Nanotrap enrichment technology would detect Lyme antigens in patient urine at the early stages of the disease. This technology would use Nanotrapto uses hydrogel particles to capture, preserve, and enrich target analytes and allow the more sensitive detection of low abundance molecules.
In July 2018, Gold Standard Diagnostics, Corp. had received the clearance for its Borrelia burgdorferi IgG/IgM ELISA assay from the Food and Drug Administration (US FDA). This test is recommended for two-steps testing for evidence of antibodies against the Lyme disease bacteria.
The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to increase the demand for Lyme Disease Diagnostics and their expansion across the globe. For instance, in June 2019, Qiagen and DiaSorin entered into the collaboration to develop an ultra-sensitive QuantiFERON-based diagnostic test to detect Lyme disease early. QuantiFERON technology comprises a sample collection component with its assay stimulus/initiation and a read-out component to measure the stimulus's signals. This component would be run on DiaSorin’s LIAISON family of fully-automated analyzers.
In July 2019, PerkinElmer had entered into the collaboration with and EverlyWell for accelerating the innovation in and accessibility of consumer-initiated health testing, by adding PerkinElmer’s CLIA-certified and CAP-accredited lab facilities to EverlyWell’s network of laboratory providers. The first offerings resulting from this collaboration include the Lyme disease and food sensitivity tests for which PerkinElmer would provide the expertise behind EverlyWell’s panels.
Market players are raising investment and fundings to increase their production capabilities around the globe. For instance, in February 2017, Ceres Nanosciences had closed the USD 3 million in Series A financing. The company would use the funding for the further development of Lyme disease diagnostic.
**The global Lyme Disease Diagnostics report will provide access to approximately 53 market data tables, 44 figures, and 178 pages
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