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Helicobacter Pylori Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 191 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5639880
UP TO OFF until Jan 01st 2026
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The Helicobacter pylori diagnostics market is advancing as healthcare leaders prioritize effective, precise, and adaptive solutions to meet changing clinical demands. Robust diagnostics frameworks are enabling organizations to strengthen workflows, support regulatory compliance, and optimize patient care quality.

Market Snapshot: Helicobacter pylori Diagnostics Market Growth

The global Helicobacter pylori diagnostics market is projected to grow from USD 822.28 million in 2024 to USD 906.04 million in 2025, representing a compound annual growth rate (CAGR) of 10.06%. By 2032, this market is estimated to reach USD 1.77 billion. Growth is being driven by the adoption of molecular diagnostic techniques and a clear industry shift toward noninvasive testing solutions, such as urea breath and stool antigen tests. Healthcare systems are reconfiguring clinical protocols and resource deployment in response to evolving reimbursement policies and regulatory requirements, fostering flexible diagnostic workflows tailored to current and future operational pressures.

Scope & Segmentation: Strategic Overview

  • Test Types: Includes histological staining, molecular PCR diagnostics, rapid urease testing (C13 and C14 substrates), enzyme-linked immunosorbent assays, lateral flow assays, stool antigen tests, and urea breath analyses, serving a breadth of clinical needs from screening to acute intervention.
  • Product Types: Encompasses PCR reagent kits, rapid urease and antigen detection kits, consumables for breath analysis, lateral flow strips, specialty chemicals, breath analyzers, immunoassay platforms, PCR equipment, and modern endoscopy units, which collectively drive efficiency from sample collection through result delivery.
  • End Users: Solutions are established across ambulatory clinics, specialty centers, general and specialized hospitals, community health hubs, reference laboratories, and commercial diagnostic labs, designed for smooth integration with both centralized and decentralized care approaches.
  • Technologies: Utilizes invasive and noninvasive diagnostic technologies, giving clinicians options such as histological analysis, traditional culture, molecular diagnostics, antigen and serological testing, stool-based diagnostics, and breath testing to fit diverse care settings and patient needs.
  • Regions Covered: Spans North and South America (notably the US, Canada, Brazil, and Peru), Europe, the Middle East, Africa, and Asia-Pacific, allowing adaptation of strategies to regional regulatory pathways, infrastructure, and local innovation climates.
  • Key Companies Analyzed: Features leading players such as F. Hoffmann-La Roche Ltd, Abbott Laboratories, Danaher Corporation, bioMérieux SA, Thermo Fisher Scientific Inc., Siemens Healthineers AG, DiaSorin S.p.A., Bio-Rad Laboratories Inc., Fujirebio Inc., and Sekisui Medical Co., Ltd., each recognized for product reliability, scientific expertise, and strong lifecycle management.

Key Takeaways: Strategic Insights for Senior Decision-Makers

  • Molecular and isothermal amplification advances are raising laboratory accuracy standards and supporting more confident clinical decision-making in a broad range of care environments.
  • Noninvasive diagnostic options such as urea breath and stool antigen testing are improving patient accessibility and helping simplify the care pathway for more efficient service delivery.
  • Automated analyzer platforms and digital health solutions are fostering greater productivity in both centralized and distributed settings, bringing consistent results and scalability to diverse operational structures.
  • Developing localized manufacturing and reinforcing supplier partnerships can reduce risks tied to shifting regulatory or supply conditions, while supporting long-term stability.
  • Ongoing workforce development and regular software updates remain essential as diagnostic platforms advance, ensuring frictionless technology adoption and efficiency gains.
  • Standardized procurement and adoption practices help support compliance and cost management by aligning organizational resource use with established protocols.

Tariff Impact: Managing Cost and Supply Challenges

Shifting tariff regulations are prompting healthcare providers to diversify their supply chains and expand local production capabilities. By strengthening supplier agreements, applying advanced procurement processes, and reinforcing contracts, organizations are prioritizing service consistency and cost management throughout the diagnostic cycle.

Methodology & Data Sources

All market insights are developed through in-depth interviews with sector leaders, systematic reviews of secondary sources, and assessment of operational, financial, and supply chain indicators. Data is independently validated by industry experts to ensure actionable and market-relevant findings for decision-makers.

Why This Report Matters

  • Empowers executive teams to select and implement Helicobacter pylori diagnostics that enhance operational productivity and guide long-term business planning.
  • Sheds light on the balance between regional compliance, regulatory changes, and evolving technical demands, supporting cost-effective procurement and solution alignment.
  • Equips organizations to proactively adjust to shifting trends in the diagnostic landscape, supporting resilient and flexible strategies for future market movements.

Conclusion

Ongoing advancements in Helicobacter pylori diagnostics are supporting healthcare organizations in elevating care quality and operational efficiency. Senior leaders who apply these insights can foster organizational resilience and maintain performance in an evolving diagnostics marketplace.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of AI-enhanced endoscopic imaging platforms for real-time Helicobacter pylori detection and diagnostics
5.2. Expansion of point-of-care molecular diagnostic assays for rapid H pylori antibiotic resistance profiling
5.3. Growing adoption of noninvasive 13C-urea breath tests in primary care for early Helicobacter pylori screening
5.4. Development of multiplex serological panels combining Helicobacter pylori virulence factor detection with biomarker profiling
5.5. Emergence of integration between digital health platforms and H pylori diagnostic results for patient management
5.6. Increasing collaborations between diagnostic manufacturers and gastroenterology clinics to streamline H pylori testing workflows
5.7. Regulatory approval trends accelerating next-generation sequencing applications for Helicobacter pylori strain identification
5.8. Rising demand for stool antigen immunoassays in resource-limited settings for accessible Helicobacter pylori diagnosis
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Helicobacter Pylori Diagnostics Market, by Test Type
8.1. Histology
8.1.1. Hematoxylin And Eosin Staining
8.1.2. Special Stains
8.2. Molecular Test
8.2.1. Isothermal Amplification
8.2.2. Polymerase Chain Reaction
8.2.3. Real Time Polymerase Chain Reaction
8.3. Rapid Urease Test
8.3.1. Clo Test
8.3.2. PyloriTek Test
8.4. Serology Test
8.4.1. Enzyme Linked Immunosorbent Assay
8.4.2. Lateral Flow Assay
8.5. Stool Antigen Test
8.5.1. Enzyme Immunoassay
8.5.2. Lateral Flow Immunoassay
8.6. Urea Breath Test
8.6.1. 13C Urea Breath Test
8.6.2. 14C Urea Breath Test
9. Helicobacter Pylori Diagnostics Market, by Product Type
9.1. Consumables
9.1.1. Kits
9.1.1.1. PCR Kits
9.1.1.2. Rapid Urease Test Kits
9.1.1.3. Serology Test Kits
9.1.1.4. Stool Antigen Test Kits
9.1.1.5. Urea Breath Test Kits
9.1.2. Reagents
9.1.3. Test Strips
9.2. Instruments
9.2.1. Analyzer Equipment
9.2.1.1. Breath Test Analyzers
9.2.1.2. Immunoassay Analyzers
9.2.1.3. PCR Instruments
9.2.2. Endoscopy Systems
10. Helicobacter Pylori Diagnostics Market, by End User
10.1. Ambulatory Care Centers
10.1.1. Community Health Centers
10.1.2. Outpatient Clinics
10.2. Clinics
10.2.1. Primary Care Clinics
10.2.2. Specialty Clinics
10.3. Diagnostic Laboratories
10.3.1. Commercial Laboratories
10.3.2. Reference Laboratories
10.4. Hospitals
10.4.1. Large Hospitals
10.4.2. Small Hospitals
11. Helicobacter Pylori Diagnostics Market, by Technology
11.1. Invasive
11.1.1. Culture
11.1.2. Histology
11.1.3. Rapid Urease Test
11.2. Noninvasive
11.2.1. Antigen Test
11.2.2. Breath Test
11.2.2.1. Stool Antigen Test
11.2.2.2. Urea Breath Test
11.2.3. Molecular
11.2.4. Serology
12. Helicobacter Pylori Diagnostics Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Helicobacter Pylori Diagnostics Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Helicobacter Pylori Diagnostics Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. F. Hoffmann-La Roche Ltd
15.3.2. Abbott Laboratories
15.3.3. Danaher Corporation
15.3.4. bioMérieux SA
15.3.5. Thermo Fisher Scientific Inc.
15.3.6. Siemens Healthineers AG
15.3.7. DiaSorin S.p.A.
15.3.8. Bio-Rad Laboratories, Inc.
15.3.9. Fujirebio Inc.
15.3.10. Sekisui Medical Co., Ltd.

Companies Mentioned

The companies profiled in this Helicobacter Pylori Diagnostics market report include:
  • F. Hoffmann-La Roche Ltd
  • Abbott Laboratories
  • Danaher Corporation
  • bioMérieux SA
  • Thermo Fisher Scientific Inc.
  • Siemens Healthineers AG
  • DiaSorin S.p.A.
  • Bio-Rad Laboratories, Inc.
  • Fujirebio Inc.
  • Sekisui Medical Co., Ltd.

Table Information