Helicobacter Pylori Diagnostics Market Growing at 10.86% CAGR | Point-of-Care Testing Advancements & Rising Antimicrobial Resistance Concerns | DataM Intelligence

Leander, Texas and Tokyo, Japan - Nov 18, 2025
The Global Helicobacter Pylori Diagnostics Market was valued at US$317.64 million in 2021 and is estimated to reach US$703.26 million by 2031, growing at a CAGR of 10.86% during the forecast period (2024-2031). This robust growth is propelled by the increasing global prevalence of H. pylori infections, rising demand for non-invasive diagnostic methods, growing awareness about gastric cancer prevention, escalating antimicrobial resistance concerns requiring accurate diagnosis, and technological advancements in rapid testing platforms.

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Recent Developments (November 2025)

✅ Molecular Point-of-Care Breakthrough - New PCR-based rapid tests received regulatory approval, delivering accurate results in under 30 minutes and detecting clarithromycin resistance markers simultaneously.

✅ Stool Antigen Test Innovation - Next-generation monoclonal antibody-based stool tests achieved 98% sensitivity and specificity, becoming the preferred non-invasive diagnostic method.

✅ Breath Test Technology Enhancement - Advanced 13C-UBT systems with automated analysis reduced operator dependency and improved test reproducibility across healthcare settings.

✅ Antibiotic Resistance Testing Integration - Multiplex PCR panels expanded to include multiple resistance genes, enabling tailored eradication therapy and improving treatment success rates.

✅ Telehealth Testing Kits - Direct-to-consumer H. pylori testing kits with telehealth consultation gained FDA clearance, expanding access to screening and diagnosis.

Market Trends & Drivers

The Helicobacter Pylori Diagnostics Market is experiencing significant growth driven by the global burden of H. pylori-related diseases, shifting diagnostic preferences toward non-invasive methods, and increasing focus on antimicrobial stewardship. Key trends include the development of multiplex molecular assays, advancement of rapid point-of-care platforms, integration of resistance testing into routine diagnostics, and expansion of screening programs in high-prevalence regions. The growing awareness of H. pylori's role in gastric cancer, improving healthcare infrastructure in emerging markets, and rising geriatric population susceptible to gastrointestinal disorders are significantly accelerating market expansion.

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Competitive Landscape

The market features strong competition between global diagnostic companies, specialized infectious disease test manufacturers, and laboratory service providers.

1. Abbott Laboratories launched the AdviseDx H. pylori combo assay with simultaneous detection and resistance testing, capturing 25% market share and reporting 40% growth in molecular diagnostics segment.

2. Quest Diagnostics Incorporated introduced the H. pylori Fecal PCR Panel with comprehensive resistance profiling, securing contracts with 500+ healthcare systems and achieving 35% revenue growth.

3. Sekisui Diagnostics expanded its OSOM Ultra Rapid Test portfolio with enhanced sensitivity, dominating the point-of-care segment with 30% market share and 50 million tests sold annually.

4. Meridian Bioscience, Inc. developed the Illumigene Molecular H. pylori assay with 99% accuracy, securing FDA clearance and reporting 45% growth in laboratory adoption.

5. Bio-Rad Laboratories, Inc. launched the BioPlex 2200 H. pylori Panel with multiplex detection capabilities, capturing 20% of the automated testing market and expanding into 30 new countries.

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Segmentation Analysis

By Diagnostic Method
• Non-Invasive Methods dominate the market, driven by patient preference, cost-effectiveness, and expanding applications in screening and treatment monitoring
• Invasive Methods maintain importance for specific clinical scenarios requiring histological evaluation and culture-based antibiotic susceptibility testing

By Test Type
• Laboratory-based Testing represents the largest segment, valued for high accuracy, comprehensive profiling, and ability to perform resistance testing
• Point of Care Testing shows the fastest growth, driven by rapid results, convenience, and expanding adoption in primary care and resource-limited settings

By End-User
• Hospitals lead the market, performing the majority of diagnostic tests and managing complex H. pylori cases
• Diagnostic Centers show robust growth with increasing outsourcing of specialized testing and screening programs
• Clinics demonstrate rapid expansion with growing point-of-care testing adoption and primary care screening initiatives

Key Growth Drivers:

1. High Global Prevalence: Significant disease burden in developing regions and persistent infection rates in developed countries
2. Gastric Cancer Prevention: Growing awareness of H. pylori as a major risk factor for gastric malignancy
3. Antimicrobial Resistance: Rising resistance rates necessitating accurate diagnosis and susceptibility testing
4. Non-Invasive Preference: Patient and physician preference for stool antigen tests and breath tests over endoscopy
5. Technological Advancements: Development of faster, more accurate, and cost-effective diagnostic platforms
6. Screening Programs: Increasing implementation of population screening in high-risk regions

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Regional Analysis:

Asia-Pacific dominates the Helicobacter Pylori Diagnostics Market, driven by high infection prevalence, growing healthcare expenditure, and increasing gastric cancer awareness in China, India, and Japan. Europe and North America show steady growth with focus on antimicrobial resistance monitoring and improved diagnostic accuracy. Latin America and Middle East & Africa demonstrate significant growth potential with high disease burden and improving diagnostic infrastructure. The global nature of H. pylori infection and universal need for accurate diagnosis create consistent market opportunities across all regions.

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Sai Kiran
DataM Intelligence 4market Research LLP
Phone: +1 877-441-4866
Email: Sai.k@datamintelligence.com

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This release was published on openPR.