At 3.8% CAGR, the North America Helicobacter Pylori (H. pylori) Non-invasive Testing Market is projected to be worth US$ 265.21 Million by 2028, says Business Market Insights

According to Business Market Insights’ research, the North America helicobacter pylori (H. pylori) non-invasive testing market was valued at US$ 211.77 million in 2022 and is expected to reach US$ 265.21 million by 2028, registering an annual growth rate of 3.8% from 2022 to 2028. Increasing prevalence of H. pylori bacterial infection and new product launches & FDA approvals for noninvasive tests are the critical factors attributed to the market expansion.

Diagnosis of H. pylori infection is performed by invasive (endoscopy and endoscopic biopsy for histopathology, culture, and rapid urease test) and non-invasive (urea breath tests, stool antigen test, and serological tests) methods. The diagnostic decisions are based on the prevalence of H. pylori infection and age-related gastric cancer incidence. For instance, non-invasive techniques are preferred mostly where gastric cancer incidence is low.

However, increased accuracy is obtained by using multiple diagnostic tests. Although these tests have high accuracy, the endoscopy-based diagnostic methods are not recommended for screening purposes, mainly due to their invasiveness, high cost, and unavailability

Furthermore, the American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology, considering the adverse effects that may occur because of endoscopy, suggest the use of upper gastrointestinal endoscopy in patients who have dyspeptic symptoms and are above 60 years or if the patient belongs to a high-risk family or a region with gastric cancer. However, in a few European countries, endoscopy is recommended for patients over the age of 45 years who have a high chance of developing gastric cancer. Thus, the growing awareness spread by governments for proper diagnosis has led to the advent of breakthrough techniques, expected to fuel the market's growth. Further, in 2020, RedHill Biopharma launched a nationwide H. pylori disease state educational field led by its sales force. The launch is intended to provide greater awareness to healthcare professionals regarding the risk of H. pylori infection and the growing resistance of H. pylori to standard care of antibiotics, leading to 25-40% failure of current therapies.   

On the contrary, very low diagnosis rate hurdles the growth of North America helicobacter pylori (H. pylori) non-invasive testing market.

• Based on test type, the North America Helicobacter pylori (H. pylori) non-invasive testing market is segmented into serology, stool antigen, and urea breathe. In 2022, the urea breath segment is expected to hold the largest share of the market in 2022 with a share of 46.8%, amassing US$ 99.04 million. It is projected to garner US$ 130.11 million by 2028 to expand at 4.7% CAGR during 2022–2028.
• Based on test method, the North America Helicobacter pylori (H. pylori) non-invasive testing market is bifurcated into laboratory based and point of care. The laboratory based segment is expected to hold a larger share of the market in 2022 with a share of 75.6%, amassing US$ 160.20 million. It is projected to garner US$ 202.47 million by 2028 to expand at 4.0% CAGR during 2022–2028.
• Based on end user, the North America Helicobacter pylori (H. pylori) non-invasive testing market is segmented into hospitals, clinics, and diagnostic laboratories. The diagnostic laboratories segment is expected to hold the largest share of the market in 2022 with a share of 59.5%, amassing US$ 125.90 million. It is projected to garner US$ 160.21 million by 2028 to expand at 4.1% CAGR during 2022–2028.

Our regional analysis states that US captured 70.8% market share in 2022. It was assessed at US$ 150.20 million in 2022 and is likely to hit US$ 186.02 million by 2028, exhibiting a CAGR of 3.6% during the forecast period.

Key players dominating the North America helicobacter pylori (H. pylori) non-invasive testing market are Abbott Laboratories; Bio-Rad Laboratories Inc.; CerTest Biotec; Coris BioConcept; DiaSorin S.p.A.; Meridian Bioscience Inc.; QuidelOrtho Corporation; Sekisui Diagnostics; Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd; and Thermo Fisher Scientific Inc.

Below are mentioned a few key market developments by major players:

• In Dec 2021, Thermo Fisher Scientific Inc. announced that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion.

• In April 2020, Meridian Bioscience, Inc. has completed the acquisition of Exalenz Bioscience Ltd., the Modiin, Israel-based provider of the BreathID Breath Test Systems, a urea breath test platform for the detection of Helicobacter pylori.

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