Lyme disease occurs due to bacterium Borrelia burgdorferi (Bb) and is transmitted to humans through the bite of infected blacklegged ticks. Its general symptoms include fatigue, headache, fever and a skin rash called erythema migrans. The infection can spread to heart, nervous system and joints if left untreated. Centers for Disease Control and Prevention (CDC) recommends a two-step process to diagnose Lyme infection. The first step uses a testing procedure called enzyme immunoassay (EIA) or, an indirect immunofluorescence assay (IFA). If the first screening step is negative, no additional testing is required. However, if the first screening step is positive or not clear, the second screening step i.e. Western blot test is performed. Results of the screening tests are considered positive only if both the tests are positive. CDC does not recommend avoiding the first screening step as it will increase the rate of false positive results that can lead to misdiagnosis and inappropriate treatment. The ELISA and Western blot are the commonly used tests to diagnose the disease. Western blot is the most accurate antibody test, whereas ELISA tests are not sensitive enough for screening. Manufacturers could focus on developing new tests for the diagnosis of Lyme disease. However, these tests should have FDA approval and exhibit high performance.
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Lyme Disease Diagnostics Market Dynamics
Lyme disease is a difficult medical condition to identify as it can be confused with increasing cases of tick-borne infectious diseases, emergence of new vector-borne diseases, and the complexity and variations of symptoms in each patient. Rising prevalence of Lyme disease and increasing focus of governments towards improvement of healthcare facilities is expected to drive growth of the Lyme disease diagnostics market during the forecast period. According to the National Institute of Allergy and Infectious Diseases (NIAID) 2016 report, there are over 300,000 reported cases of Lyme disease, annually in the U.S. alone. Various government organizations and institutes such as NIAID are working towards improving Lyme disease diagnostics. NIAID actively supports research on Lyme disease diagnostics. In collaboration with CDC, NIAID plays a key role in encouraging development of new methods to improve Lyme disease screening in people with co-infections such as the tick-borne infections. The institute is actively supporting research on Lyme disease diagnostics. NIAID grantees directly work in collaboration with CDC researchers to compare and evaluate the effectiveness of existing diagnostic methods.
Moreover, industry players are focusing on research and development of new tests for Lyme disease diagnosis and this is expected to aid in growth of the Lyme disease diagnostics market. For instance, in 2017, IGeneX Inc.—a Clinical Laboratory Improvement Amendments (CLIA) and New York-approved Reference Laboratory, specializing in testing for tick-borne diseases— launched three new tests that are more comprehensive and specific for assisting in diagnosis of tick-borne relapsing fever and Lyme disease. However, lack of awareness about the disease and inefficiency in Lyme disease testing significantly affects the market growth. Several individuals with Lyme-like symptoms are wrongly diagnosed, owing to existing serological tests that cannot identify antibodies of all the different strains of B. burgdorferi. Therefore, demand for better diagnostic tests for the disease is increasing. Since the symptoms of tick-borne relapsing fever and Lyme are similar, development of more accurate test is required for proper diagnosis.
Lyme Disease Diagnostics Market Regional Insights
Regional segmentation of lyme disease diagnostics market by Coherent Market Insights, includes North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America Lyme disease diagnostics market is expected to hold a dominant position over the forecast period. This is due to increasing government initiatives for diagnosing and treatment of various diseases. The Centers for Disease Control and Prevention (CDC) has increased their focus to develop novel strategies for the prevention of Lyme disease, in order to reduce the occurrence of disease in the target populations. Another factor aiding in growth of the market in the region is increasing pervasiveness of common tick disease, which has led to high demand for effective disease treatment. According to a research paper, Lyme disease is the most prevalent tick-borne infection in North America and Europe. It is the most commonly listed vector borne disease in the U.S. so far. According to CDC, in 2015, it was regarded as the sixth most common Nationally Notifiable disease in the country. Europe Lyme disease diagnostics market is expected to exhibit high growth, due to increasing number of infected patients. The incidence of Lyme disease has been increasing significantly in some European countries. According to Center for Health Protection, Lyme disease cases in Europe are expanding with about 100 cases per 100,000 population every year.
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Lyme Disease Diagnostics Market Competitive Analysis
Major players operating in the Lyme disease diagnostics market include Abbott Laboratories, Affymetrix Inc., Alere Inc., Baxter International Inc., Bio-Rad Laboratories, Boulder Diagnostics, Canon Life Sciences, Covance Inc., Fresenius Medical Care AG & Co., GlaxoSmithKline Pharmaceuticals Ltd., Roche Diagnostics International Ltd., Siemens AG, and T2 Biosystems, Immunetics Inc. Key players in the market are focusing on developing new diagnostic tools, in collaboration with government organizations or research institutes or by themselves.