Helicobacter is a spiral shaped gram-negative bacteria, causing chronic inflammation and infection in stomach and duodenum leading to ulceration. H. pylori is found in 50-80% of patients with gastric ulcers and in 90% of patients with duodenal ulcers. An estimated one in six individuals infected with H. pylori are expected to eventually develop peptic ulcer disease. Infected individuals experience long asymptomatic conditions with nearly 70% of individuals having minimal symptoms such as belching, bloating, nausea, vomiting, abdominal discomfort as occasional, whereas, major symptoms includes abdominal pain, peptic ulcer, bad breath etc.
Helicobacter infection can be diagnosed by invasive that requires gastric mucosa samples, which are obtained through endoscopy and used for biopsy or non-invasive tests that requires blood or stool samples. Invasive tests include immunoassay, rapid urease test, and histology whereas non-invasive includes stool antigen assays serology tests and urea breath test.
The global Helicobacter pylori diagnostics market size was valued at US$ 437.3 million in 2017 and is expected to witness a CAGR of 7.1% over the forecast period (2018 – 2026).
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Prevalence of helicobacter pylori is declining in developed countries, whereas its prevalence in emerging economies is increasing. For instance, according to the Faculty of Medicine of The Chinese University of Hong Kong (CUHK), 2017, around 4.4 billion people worldwide are infected with Helicobacter pylori (H. pylori). Furthermore, same source suggested that prevalence in Africa is up to 80%, which is the highest globally, while in Asia, over 50% of the population was infected with H. pylori. Moreover, according to the International Agency for Research on Cancer report 2014, in 2012, around 952,000 new gastric cancer cases occurred globally and around 734,000 gastric cancers were estimated to occur due to H. pylori infection. Such high prevalence of Helicobacter pylori in Africa and Asia is expected to fuel the regional helicobacter market growth.
The limitations associated with diagnostic tests are expected to be a major factor restraining growth of the Helicobacter pylori diagnostics market. For instance, serology-based assays have low sensitivity and specificity, as they are unable to differentiate between active infection and IgG antibodies present in case of post treatment.
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Market players are investing 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. 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.
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