Helicobacter Pylori Diagnostics Market Size, Share, Growth, Analysis Forecast to 2031

The global Helicobacter pylori (H. pylori) diagnostics market continues to expand steadily as payers and clinical guidelines push “test-and-treat” strategies for dyspepsia and gastric cancer risk reduction. The Helicobacter Pylori Diagnostics Market is expected to register a CAGR of 5.90% from 2025 to 2031, with a market size expanding from US$ XX million in 2024 to US$ XX Million by 2031. Growth is supported by rising test volumes in primary care and gastroenterology, along with a gradual mix-shift toward higher-value noninvasive assays.

Demand Drivers

Several forces underpin the growth of H. pylori diagnostics. Despite a gradual decline in prevalence across developed countries, H. pylori remains widespread, with nearly 44% prevalence globally, sustaining a large base for both initial testing and test-of-cure. Second, updated clinical guidelines have expanded the requirement for eradication verification after therapy, thereby lifting testing intensity per patient. Third, adoption of noninvasive diagnostic options such as stool antigen tests and urea breath tests is moving earlier in the care pathway, especially in primary care settings.

Guideline Tailwinds

The 2024 guidelines from the American College of Gastroenterology stress that proof of H. pylori eradication is required in all patients, usually through fecal antigen or urea breath testing. This verification is performed after a washout period of at least four weeks following antibiotics and two weeks after proton pump inhibitors or PCABs. This recommendation is pivotal for the market because it effectively doubles the testing opportunity for most patients—one at diagnosis and one post-treatment. Rising antibiotic resistance has also reshaped first-line treatment regimens, increasing the need for reliable test-of-cure diagnostics to confirm eradication.

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Product and Revenue Structure

Reagents and consumables—including breath test kits, antigen cartridges, calibrators, and controls—form the largest share of recurring revenues, typically contributing 40–55% of market value. Instruments and related services follow. On the technology side, immunoassays lead the market due to their installed base advantage, while molecular diagnostics (PCR assays) are emerging as a niche option, particularly in tertiary care centers or bundled gastrointestinal pathogen panels. Companies with broad portfolios, covering multiple testing modalities, and strong distribution networks hold competitive advantages.

Regional Dynamics

Regional variations highlight interesting dynamics. Asia–Pacific, Latin America, and parts of Eastern Europe represent the largest testing pools, driven by high prevalence rates and increasing awareness of gastric cancer prevention strategies. Meanwhile, North America and Western Europe deliver higher revenue per test, thanks to stronger reimbursement frameworks and greater penetration of urea breath tests. In several health systems, there is growing interest in implementing organized screening or population-based eradication programs, which could further accelerate demand over the coming years.

Competitive Landscape

The competitive field is fragmented across diagnostic types. In the urea breath testing segment, companies such as Kibion (Mayoly) are key players, offering devices and consumables. In stool antigen testing, diversified global in vitro diagnostics (IVD) companies compete with regional players, focusing on accuracy, automation, and analyzer compatibility. While molecular diagnostics remain niche, they represent an area of potential growth as concerns around antibiotic resistance drive demand for advanced detection methods. Overall, success in this market is defined by a combination of strong consumables sales, ease of use, and alignment with clinical guidelines.

Policy and Operational Considerations

Operational guidance within updated clinical practice frameworks further shapes commercial opportunities. For example, the requirement of washout periods before eradication verification testing drives predictable follow-up visits and test utilization. Primary care providers often prefer point-of-care stool antigen tests when payer rules support their use, while hospital laboratories emphasize automated immunoassays and in-house UBT capabilities to deliver same-day results. Vendors that simplify these workflows and provide reliable logistical support stand to benefit significantly.

Risks and Opportunities

While the market outlook is positive, challenges remain. Pricing pressures on immunoassays, isotope supply issues for urea breath tests, and variability in reimbursement policies can temper growth. However, several upside opportunities exist: the global decline in H. pylori prevalence underscores the importance of targeted eradication strategies, while the growing need for resistance surveillance could expand the role of molecular diagnostics in specialty centers. Companies with diversified portfolios that include both urea breath tests and stool antigen solutions, coupled with educational initiatives for physicians, are well-positioned to capture long-term market growth.

Conclusion

The Helicobacter pylori diagnostics market is poised for consistent mid-single-digit growth over the next five years. With guideline-driven demand, expanding use of noninvasive testing, and increasing emphasis on eradication verification, the market offers a strong recurring revenue model led by consumables. Companies that can align with evolving clinical practices, secure reimbursement, and offer user-friendly testing solutions are best placed to gain share in this expanding global market.