Helicobacter Pylori Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Instruments, Reagents, Services), By Technology (Immunoassays, POC, Molecular Diagnostics), By End user (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 605.78 Million
CAGR (2026-2031)	4.31%
Fastest Growing Segment	Immunoassays
Largest Market	North America
Market Size (2031)	USD 780.32 Million

Market Overview

The Global Helicobacter Pylori Diagnostics Market will grow from USD 605.78 Million in 2025 to USD 780.32 Million by 2031 at a 4.31% CAGR. The Global Helicobacter Pylori Diagnostics Market comprises invasive and non-invasive modalities, such as urea breath tests, stool antigen assays, and endoscopic biopsies, utilized to identify bacterial colonization in the gastric mucosa. Market growth is fundamentally supported by the high global prevalence of peptic ulcers and the critical need to mitigate gastric cancer risks through early pathogen detection. According to the American College of Gastroenterology, in 2024, the prevalence of Helicobacter pylori infection in North America was reported to persist between 30% and 40%, indicating a sustained clinical need for accurate diagnostic interventions.

One significant challenge impeding market expansion is the economic and logistical barrier to implementing high-precision testing in developing nations. While these regions bear the highest infection burden, the cost of advanced non-invasive diagnostics and limited laboratory infrastructure often prevent widespread screening and surveillance. This gap in accessibility restricts market penetration in low-resource settings, thereby limiting the overall revenue potential despite the vast patient population.

Key Market Drivers

The rising incidence of H. pylori-associated peptic ulcers and gastric cancer serves as the foremost catalyst for market growth. As this pathogen is the strongest identifiable risk factor for non-cardia gastric cancer, clinical guidelines increasingly mandate eradication therapy, which relies heavily on accurate initial diagnosis to prevent malignancy. This direct correlation between long-term infection and oncology drives screening volumes, particularly in high-risk regions where early intervention is prioritized. According to the International Agency for Research on Cancer, February 2024, in the 'Global Cancer Burden 2022' press release, stomach cancer accounted for approximately 970,000 new cases globally, underscoring the critical need for early bacterial detection to mitigate oncological risks.

Concurrently, a decisive shift in preference from invasive biopsies to breath and stool antigen tests is reshaping the diagnostic landscape. Healthcare systems and patients increasingly favor non-invasive modalities due to their lower cost, ease of use, and reduced procedural discomfort compared to endoscopic methods. This trend is evident in the expanding revenue streams of major diagnostic manufacturers focusing on breath testing technologies. According to Otsuka Holdings Co., Ltd., February 2024, in the 'Consolidated Financial Results for Fiscal 2023', the Medical Devices division, primarily driven by urea breath test systems, reported sales of 15,640 million yen, reflecting the commercial viability of non-invasive solutions. Furthermore, the market's trajectory is reinforced by the immense burden of untreated infections; according to Phathom Pharmaceuticals, in 2024, there are an estimated 115 million infected individuals in the United States alone, representing a substantial addressable market for diagnostic utilization.

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Key Market Challenges

The economic and logistical obstacles to deploying high-precision testing in developing nations constitute a significant impediment to the growth of the Global Helicobacter Pylori Diagnostics Market. Although these regions exhibit the highest density of bacterial colonization, the substantial costs of non-invasive modalities render them financially inaccessible for widespread screening. This pricing disparity effectively excludes a vast segment of the potential patient pool from the addressable market, as healthcare systems in low-resource settings prioritize acute care over preventative surveillance. Consequently, diagnostic manufacturers face diminished revenue realization in geographies that hold the highest volume of latent demand.

Furthermore, the deficiency in laboratory infrastructure severely limits the scalability of accurate detection methods. Many diagnostic protocols require specialized equipment often unavailable in underfunded medical centers, forcing reliance on empiric treatment and stalling the adoption of modern technologies. The magnitude of this missed opportunity is significant given the persistent disease burden. According to the American Gastroenterological Association, in 2024, the global prevalence of Helicobacter pylori infection among children and adolescents was reported to persist at 35.1%. This statistic confirms a continuous reservoir of infection that current market strategies fail to reach due to these logistical barriers.

Key Market Trends

The Rise of Antimicrobial Susceptibility Testing Capabilities is fundamentally altering the clinical approach to Helicobacter pylori management, driven by the escalating failure rates of traditional empiric therapies. With global antibiotic resistance reaching critical levels, healthcare providers are increasingly prioritizing diagnostic tools that can identify specific bacterial resistance profiles, particularly for clarithromycin and metronidazole, prior to prescribing treatment. This transition from simple detection to detailed susceptibility profiling is essential to prevent the administration of ineffective regimens and to steward antibiotic use. According to the National Institutes of Health, December 2024, in the 'Global prevalence of Helicobacter pylori antibiotic resistance among children' systematic review, primary resistance rates were reported at 35.3% for metronidazole and 32.6% for clarithromycin, underscoring the urgent market demand for diagnostics that provide comprehensive resistance data.

Concurrently, a Shift Toward Personalized Precision Medicine Diagnostics is gaining traction, leveraging genotypic insights to tailor eradication strategies for individual patients. This trend moves the market beyond binary positive/negative results, encouraging the adoption of molecular assays that guide the selection of the most efficacious first-line therapies based on the patient's specific bacterial strain. By integrating genotypic resistance testing into routine care, clinicians can significantly improve treatment outcomes compared to standard trial-and-error methods. According to Digestive Disease Week, May 2025, in the 'Helicobacter Pylori Genotypic Resistance Testing-Guided Treatment' study abstract, the implementation of genotypic resistance testing to guide first-line therapy increased eradication success rates to 93%, compared to just 77% with empiric therapy, validating the clinical and commercial value of precision diagnostics.

Segmental Insights

The Immunoassays segment is positioned as the fastest-growing category in the Global Helicobacter Pylori Diagnostics Market, primarily due to the increasing demand for non-invasive and cost-efficient testing methods. This expansion is supported by the widespread adoption of enzyme-linked immunosorbent assays and lateral flow tests, which facilitate rapid detection of antigens in stool samples. Furthermore, clinical guidelines often aligned with frameworks like the Maastricht V/Florence Consensus recommend these non-invasive immunoassays for initial diagnosis and confirmation of eradication. This preference for accessible point-of-care solutions over invasive endoscopic procedures significantly accelerates the segment's market expansion.

Regional Insights

North America commands the leading position in the Global Helicobacter Pylori Diagnostics Market, driven by a highly developed healthcare infrastructure and rising awareness regarding the link between infection and gastric cancer. The region benefits significantly from broad reimbursement coverage and the strong presence of major diagnostic manufacturers. Additionally, stringent yet supportive regulatory frameworks provided by the U.S. Food and Drug Administration facilitate the timely approval and commercialization of new diagnostic assays. These factors collectively ensure the continuous expansion of testing volumes and revenue generation across the United States and Canada.

Recent Developments

• In August 2024, MP Biomedicals expanded its gastrointestinal diagnostics portfolio with the launch of the Rapid H. pylori Antigen Test Card. This new product is an in-vitro qualitative immunochromatographic assay designed for the rapid detection of Helicobacter pylori antigens in human stool specimens. The introduction of this test provides clinical laboratories and healthcare providers with an efficient and non-invasive method to identify active infections. The launch aligns with the broader market trend of increasing the availability of rapid, cost-effective diagnostic solutions that support timely decision-making and effective management of H. pylori-associated gastrointestinal diseases.
• In July 2024, Biohit Oyj announced that its GastroPanel Quick Test NT had been recognized by the scientific community through a nomination for a key industry award, highlighting its impact on clinical diagnostics. The test is a rapid, non-invasive point-of-care solution that detects Helicobacter pylori infection and biomarkers for atrophic gastritis from a blood sample in approximately fifteen minutes. By facilitating the early identification of patients at risk for gastric cancer and other stomach conditions, the system aids in triaging patients for gastroscopy. This development underscores the market's shift towards diagnostic tools that streamline referral pathways and reduce the burden of unnecessary invasive procedures.
• In February 2024, Microbix Biosystems Inc. presented performance data for its new Quality Assessment Product (QAP) developed to support molecular diagnostic tests for Helicobacter pylori. During the Labquality Days congress, the life sciences company demonstrated the efficacy of its swab-formatted control in ensuring the accuracy of nucleic acid amplification tests used to detect the bacterium. This product development addresses the increasing industry demand for reliable third-party quality controls to validate clinical laboratory workflows. By verifying the performance of molecular assays, the new control material aims to enhance the reliability of test results for the pathogen responsible for gastric ulcers and related conditions.
• In January 2024, ARJ Medical Inc. received approval from the U.S. Food and Drug Administration (FDA) for a Premarket Approval (PMA) supplement for its PyloPlus UBT System. This regulatory decision expanded the indicated use of the urea breath test to include pediatric patients aged 3 to 17 years, complementing its existing approval for adults. The non-invasive diagnostic system is designed to detect urease associated with Helicobacter pylori infection in the human stomach. This approval enables healthcare providers to utilize the device for both initial diagnosis and post-treatment monitoring across a wider age range, thereby improving access to accurate testing for younger patient populations.

Key Market Players

• Thermo Fisher Scientific inc.
• Biohit Oyj
• Quest Diagnostics Incorporated
• Meridian Bioscience
• Bio-Rad Laboratories
• Alpha Laboratories Ltd
• F. Hoffmann-La Roche Ltd
• Coris BioConcept
• Certest Biotec
• Epitope Diagnostics, Inc

By Type	By Technology	By End user	By Region
Instruments Reagents Services	Immunoassays POC Molecular Diagnostics	Hospitals & Clinics Ambulatory Care Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Helicobacter Pylori Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Helicobacter Pylori Diagnostics Market, By Type:

• Instruments
• Reagents
• Services

• Helicobacter Pylori Diagnostics Market, By Technology:

• Immunoassays
• POC
• Molecular Diagnostics

• Helicobacter Pylori Diagnostics Market, By End user:

• Hospitals & Clinics
• Ambulatory Care Centers
• Others

• Helicobacter Pylori Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE