Helicobacter Pylori Diagnostics Market– Quick Tests Allowing Efficient Diagnosis by Leading Compaines: Thermo Fisher Scientific, Inc., Bio-Rad Laboratories Inc., Diasorin S.P.A., Quidel Corporation, F. Hoffmann-La Roche Ltd

In developing point-of-care and accurate diagnostics products to gain competitive advantage. For instance, in 2017, Exaleza Bioscience launched Automated BreathID Hp Lab Urea Breath Testing System for detection of Helicobacter pylori. The system is point-of-care, with 99% sensitivity and specificity for H. pylori. Furthermore, companies are focusing enhancing product portfolio through inorganic growth strategies.

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For instance, Abbott Laboratories acquired Alere Inc., the global leader in point of care diagnostics, in order to expand its product portfolio and geographic presence. With this acquisition, Abbott could access to Alere’s rapid diagnostics segment, which includes H. pylori detection kits. However, limitations associated with the currently available diagnostic assays are expected to restrain the Helicobacter pylori diagnostics market. For instance, urea breath test and stool antigen test cannot be used in patients undergoing proton pump inhibitors treatment.

New product approval and launches by market players to sustain in the competitive global helicobacter pylori diagnostics market, is expected to aid in growth of the market. For instance, in 2016, Diasorin S.P.A. launched fully automated solution, LIASION, for H. pylori detection, intended for markets outside the U.S. In the same year, Exalenz Bioscience received U.S. Food and Drug Administration (FDA) marketing clearance for its BreathID Lab System and breath-test kits, developed for H. pylori bacterium detection. Moreover, in March 2018, the company received approval from the U.S. FDA to market its lab system and its point-of-care device for H. pylori detection in pediatric patients. Moreover, inorganic strategies of market players are also propelling the market growth.

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Increasing prevalence of Helicobacter pylori in emerging economies is propelling demand for Helicobacter pylori diagnostic assay kits. For instance, according to Faculty of Medicine of The Chinese University of Hong Kong, 2017, Africa has the highest prevalence of Helicobacter pylori infections (which is around 79%). Moreover, unmet needs of detection and treatment is very high, as the there is no direct marketing of the products by market player and products are made available by the government only. Countries with declining incidence of Helicobacter pylori infection are also engaged in complete eradication of infection.

Eradication is supported by various government initiatives such as to provide diagnostics test at lower rates and increasing screening programs. For instance, in 2013, the Japanese government approved national health insurance coverage for antibiotic treatment for H. pylori infection in patients with chronic gastritis and diagnosed by endoscopic method. Furthermore, the sensitivity and specificity of diagnostic assays are studied by universities and research institutes to improve the available test kits. Such studies show that invasive methods are more accurate. For instance, rapid urease test have sensitivity and specificity of 80-95% and 97-99% respectively, and, immunohistochemistry based assay kits displays >97% and 100% of sensitivity and specificity.

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Some of the major players operating in the global Helicobacter pylori diagnostics market include Thermo Fisher Scientific, Inc., Bio-Rad Laboratories Inc., Diasorin S.P.A., Quidel Corporation, F. Hoffmann-La Roche Ltd.(Ventana Medical Systems, Inc.), Meridian Bioscience, Inc., Exalenz Bioscience Ltd., Abbott Laboratories, Cardinal Health, Inc., and Halyard Health, Inc.

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