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Non-invasive Helicobacter Pylori Testing - Global Stategic Business Report

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    Report

  • 176 Pages
  • April 2025
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 6070108
The global market for Non-invasive Helicobacter Pylori Testing was estimated at US$316.3 Million in 2024 and is projected to reach US$445.9 Million by 2030, growing at a CAGR of 5.9% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Non-invasive Helicobacter Pylori Testing market.

Global Non-Invasive Helicobacter Pylori Testing Market - Key Trends & Drivers Summarized

Why Is Non-Invasive Testing Emerging as the Preferred Route for Detecting H. Pylori?

The global healthcare landscape is witnessing a profound shift in the diagnosis of Helicobacter pylori (H. pylori) with non-invasive testing rapidly replacing traditional, invasive approaches. Historically, endoscopy with biopsy was the gold standard for identifying this gastric pathogen, but it came with considerable discomfort, higher costs, and procedural risks - especially for asymptomatic or pediatric patients. Non-invasive tests such as the urea breath test (UBT), stool antigen test (SAT), and serology are now gaining widespread clinical and commercial traction for their simplicity, speed, and patient-friendly nature. These methods allow for efficient detection without sedation, specimen collection through invasive means, or hospital-based procedures. The urea breath test, in particular, stands out due to its high accuracy, rapid turnaround time, and suitability for both initial diagnosis and post-treatment follow-up. Additionally, stool antigen tests have become widely adopted due to their reliability and ease of sample collection, especially in pediatric settings. Serological tests, while limited in post-eradication monitoring, are still widely used in low-resource settings where affordability and accessibility are paramount. The global increase in awareness of gastrointestinal health and early testing - fueled by growing concerns around gastritis, ulcers, and gastric cancers - is significantly propelling the adoption of these non-invasive solutions. In a world where healthcare providers are shifting toward value-based care, non-invasive H. pylori diagnostics offer a powerful blend of clinical efficiency and patient compliance, redefining standards in gastrointestinal disease management.

How Are Advancements in Testing Technology Enhancing Accuracy and Patient Outcomes?

Technological progress has played a central role in elevating the accuracy, accessibility, and scalability of non-invasive H. pylori diagnostics. Innovations in mass spectrometry, immunoassays, and labeled carbon isotopes have considerably improved the sensitivity and specificity of urea breath tests, allowing clinicians to detect active infections with exceptional confidence. Similarly, the development of monoclonal antibody-based stool antigen tests has enhanced diagnostic precision by minimizing false negatives and providing robust results even in low bacterial load scenarios. In recent years, advancements in sample preparation, transport media, and at-home testing kits have further expanded the reach of these diagnostics, making them more suitable for community and telehealth models. Mobile breath testing units and portable analyzers are also entering the market, enabling on-site diagnosis in rural clinics, refugee camps, and remote health settings. Furthermore, the integration of AI-driven analytics in lab-based testing environments is streamlining workflow and supporting quicker result interpretation, which is especially useful in high-throughput public health labs. Some emerging companies are even exploring breath biomarker detection using non-isotopic sensors, potentially reducing the cost and complexity of urea breath testing. Collectively, these innovations are not only raising the bar for diagnostic quality but also enabling faster treatment decisions, lowering disease progression risks, and improving patient adherence to follow-up regimens. With rapid and accurate tools now available outside of hospital walls, H. pylori testing is becoming more aligned with modern healthcare expectations - convenience, speed, and precision.

Are Shifting Public Health Priorities and Screening Initiatives Boosting Market Momentum?

Changing public health priorities and the growing emphasis on early gastrointestinal screening are key contributors to the increasing adoption of non-invasive H. pylori testing. With the bacterium implicated in a wide array of gastric disorders - including peptic ulcers, chronic gastritis, and gastric cancer - early detection and eradication have become focal points in global health strategies, especially in regions with high prevalence rates such as Asia-Pacific, Latin America, and Eastern Europe. National screening programs in countries like Japan and South Korea have already institutionalized non-invasive testing as part of routine preventive health check-ups, leading to measurable reductions in gastric cancer incidence. In Western countries, increased awareness about the link between untreated H. pylori infection and long-term gastrointestinal complications has spurred general practitioners to recommend screening even in the absence of overt symptoms. The COVID-19 pandemic has further accelerated the shift toward non-invasive diagnostics, as healthcare systems sought ways to minimize in-clinic procedures and reduce the burden on hospital infrastructure. Non-invasive tests fit seamlessly into these revised protocols, supporting home-based sample collection and contactless consultations. Additionally, health insurers and payers are increasingly recognizing the cost-effectiveness of early, non-invasive detection, and are extending reimbursement coverage to breath and stool-based tests. Non-governmental organizations and public health agencies are also funding low-cost testing initiatives in high-burden, underserved areas, reinforcing equity in access. As these programs expand and prove successful, the case for non-invasive H. pylori testing as a cornerstone of preventive gastrointestinal care becomes increasingly compelling.

What Factors Are Driving the Expansion of the Non-Invasive H. Pylori Testing Market?

The growth in the non-invasive Helicobacter pylori testing market is driven by several factors linked to technological innovation, healthcare delivery trends, changing patient preferences, and disease burden dynamics. At the technological level, rapid advancements in diagnostic platforms have led to more reliable and efficient breath and stool-based tests, making them suitable for widespread clinical and at-home use. These platforms are increasingly integrated with digital health tools, enabling result tracking, automated alerts, and seamless communication between patients and providers. On the clinical front, a growing preference for outpatient care and early diagnosis is motivating physicians to opt for non-invasive methods that minimize risk, streamline workflows, and accelerate treatment initiation. End-user demand is also being influenced by rising consumer awareness around gut health, foodborne pathogens, and the long-term risks of untreated infections. Patients, particularly in younger age groups and those with access to digital health resources, are actively seeking less invasive, more convenient testing options. In parallel, the increasing prevalence of H. pylori - driven by factors such as poor sanitation, antibiotic resistance, and changing dietary patterns - is fueling the need for scalable, cost-effective diagnostics across both developed and emerging markets. Healthcare systems under pressure to reduce costs and improve preventive care metrics are investing in screening programs that prioritize non-invasive solutions. Lastly, favorable regulatory landscapes and greater involvement from pharmaceutical companies - particularly those marketing antibiotics for eradication therapy - are encouraging widespread testing by bundling diagnostics with treatment protocols. These converging factors are ensuring strong, sustained growth in the non-invasive H. pylori testing market on a global scale.

Report Scope

The report analyzes the Non-invasive Helicobacter Pylori Testing market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.

Segments: Test Type (Serologic Test, Urea Breath Test, Stool/Fecal Antigen Test); Method (Laboratory-based Test Method, Point of Care Test Method); End-Use (Diagnostic Laboratories End-Use, Hospitals End-Use, Clinics End-Use, Other End-Uses)

Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the Serologic Test segment, which is expected to reach US$250.9 Million by 2030 with a CAGR of a 6.3%. The Urea Breath Test segment is also set to grow at 4.8% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, estimated at $83.2 Million in 2024, and China, forecasted to grow at an impressive 5.8% CAGR to reach $71.8 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

  • Detailed Market Analysis: Access a thorough analysis of the Global Non-invasive Helicobacter Pylori Testing Market, covering all major geographic regions and market segments.
  • Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
  • Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Non-invasive Helicobacter Pylori Testing Market.
  • Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

  • How is the Global Non-invasive Helicobacter Pylori Testing Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of players such as Abbott Laboratories, Biohit Oyj, Biomerica, Inc., Bio-Rad Laboratories, Inc., Cardinal Health, Inc. and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Select Competitors (Total 44 Featured):

  • Abbott Laboratories
  • Biohit Oyj
  • Biomerica, Inc.
  • Bio-Rad Laboratories, Inc.
  • Cardinal Health, Inc.
  • Certest Biotec S.L.
  • Coris Bioconcept SPRL
  • DiaSorin S.p.A.
  • Exalenz Bioscience Ltd.
  • Fujirebio Holdings, Inc.
  • Hoffmann-La Roche Ltd
  • Luminex Corporation
  • Meridian Bioscience, Inc.
  • Otsuka Holdings Co., Ltd.
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Quidel Corporation
  • Sekisui Diagnostics, LLC
  • Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd.
  • Thermo Fisher Scientific Inc.

Tariff Impact Analysis: Key Insights for 2025

Global tariff negotiations across 180+ countries are reshaping supply chains, costs, and competitiveness. This report reflects the latest developments as of April 2025 and incorporates forward-looking insights into the market outlook.

The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.

What’s Included in This Edition:

  • Tariff-adjusted market forecasts by region and segment
  • Analysis of cost and supply chain implications by sourcing and trade exposure
  • Strategic insights into geographic shifts

Buyers receive a free July 2025 update with:

  • Finalized tariff impacts and new trade agreement effects
  • Updated projections reflecting global sourcing and cost shifts
  • Expanded country-specific coverage across the industry

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Abbott Laboratories
  • Biohit Oyj
  • Biomerica, Inc.
  • Bio-Rad Laboratories, Inc.
  • Cardinal Health, Inc.
  • Certest Biotec S.L.
  • Coris Bioconcept SPRL
  • DiaSorin S.p.A.
  • Exalenz Bioscience Ltd.
  • Fujirebio Holdings, Inc.
  • Hoffmann-La Roche Ltd
  • Luminex Corporation
  • Meridian Bioscience, Inc.
  • Otsuka Holdings Co., Ltd.
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Quidel Corporation
  • Sekisui Diagnostics, LLC
  • Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd.
  • Thermo Fisher Scientific Inc.

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