Point of Care Testing (POCT) is a medical diagnostic testing performed outside the clinical laboratory in close proximity, where the patient receives care. POCT devices are often hand held or may be small portable analyzers. POCT testing include blood glucose, urine dipsticks, blood gases, chemistry, hematology, coagulation, cardiac markers, and pregnancy tests, among others.
Market Drivers
The rising prevalence of hepatitis is one of the factor fueling the global point-of-care diagnostics market.
According to World Health Organization (WHO), hepatitis (especially hepatitis B and hepatitis C) was responsible for 1.34 million deaths in 2015 globally. Hepatitis A was the cause of death for 11,000 people in 2015.
According to World Health Organization (WHO), 240 million people are infected with the hepatitis B virus worldwide, with 786,000 people dying from complications of the disease each year.
According to World Health Organization (WHO), 71 million people are infected with hepatitis C worldwide, and the disease contributes to 399,000 deaths worldwide each year.
According to the Centers for Disease Control and Prevention (CDC), in 2016, there were about 4,000 new cases in the United States. Around 800,000 to 2.2 million people in the United States have chronic Hepatitis B.
According to the CDC, in 2016 there were about 3,000 reported cases of acute HCV. Approximately 3.5 million people in the United States are living with chronic HCV.
Several other infectious and rising deadly disease are the few factor fueling the global point-of-care diagnostics market.
Global point-of-care diagnostics market is segmented by product type, by platform, and by end users. The product type includes glucose monitoring products, cardiometabolic testing products, infectious disease testing products, coagulation testing products, pregnancy and fertility testing products, tumor/cancer marker testing products, urinalysis testing products, cholesterol testing products, hematology testing products, drugs-of-abuse testing products, fecal occult testing products, and other POC products
Infectious disease testing products segment dominate the global point-of-care diagnostics market during the forecast period, due to launch of new point-of-care diagnostics for infectious disease, and strategic collaboration between companies to develop new point-of-care diagnostics for infectious disease.
For instance, in July 2018, Abbott have introduced a new point-of-care test, m-PIMA HIV-1/2 VL in the Netherlands for quick, accurate and easy management of human immunodeficiency virus (HIV) infection.
In April 2018, Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, have entered into a collaboration agreement with LumiraDx to develop new POC diagnostic tests for infectious diseases. Under terms of the agreement, Chembio will receive funding from LumiraDx, subject to satisfying certain milestones, to develop certain new POC infectious disease tests.
The global point-of-care diagnostics market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa.
North America dominates the global point-of-care diagnostics market due to the increasing regulatory approval for point-of-care diagnostics.
For instance, in February 2019, OPKO Health, Inc., have received the U.S. Food and Drug Administration (FDA) approval for point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer. The product is indicated to quantitatively measure total PSA in whole blood from a fingerstick of blood collected by a healthcare professional and is used in conjunction with a digital rectal exam as an aid in the detection of prostate cancer in men aged 50 years and older.
In February 2018, Mesa Biotech Inc., have received 510(k) clearance from the US Food and Drug Administration (FDA) for point-of-care (POC) Accula Flu A/Flu B test, it is the first available test in the US market.
In February 2018, Siemens Healthineers have received 510(k) clearance from the U.S. Food and Drug Administration for its Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances.
Competitive Analysis
For instance, in February 2019, CENTOGENE have collaborated with Sarepta Therapeutics, Inc for a 12-month, for the identification of patients with Duchenne muscular dystrophy (DMD) in Middle East and North Africa. CENTOGENE will perform complete molecular diagnostic testing using deletion/duplication analysis and full length sequencing of the DMD gene in MLPA negative patients. Under the terms of the agreement with Sarepta, CENTOGENE will also provide diagnostic services to physicians treating patients exhibiting symptoms related to DMD.
In August 2018, Curetis N.V., a developer of next-level molecular diagnostic solutions, have entered into an exclusive distribution partnerships in Egypt with Future Horizon Scientific, Quimica Valaner S.A. de C.V., and Biko S.A.,. With this agreement Curetis, will focuse on identifying distributors that are experienced in commercializing innovative products for international molecular diagnostics companies.
In September 2018, DCN Dx, a developer and manufacturer of rapid point-of-care diagnostic tests, have partnered with Gehrke Lab for the design, development and manufacture of an innovative new infectious disease testing technology.
Major market players in the Point-of-Care Diagnostics market are Abbott Laboratories, Becton, Dickinson, and Company (BD), Chembio Diagnostics, Johnson & Johnson, Nova Biomedical, Roche Diagnostics, Siemens Healthineers, Quidel Corporation, Instrumentation Laboratory, and EKF Diagnostics.
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