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.
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.
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.