Global Helicobacter Pylori Testing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Test Type;
Invasive - Histology, Rapid Urease Test & HP Culture, Non-Invasive - Serologic Test, Urea Breath Test, and Stool Antigen Test.By Method;
Point of Care Testing and Laboratory Based Testing.By End User;
Hospitals, Clinics, Diagnostic Labs, and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Helicobacter Pylori Testing Market (USD Million), 2021 - 2031
In the year 2024, the Global Helicobacter Pylori Testing Market was valued at USD 644.19 million. The size of this market is expected to increase to USD 1,118.42 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 8.2%.
The global Helicobacter pylori (H. pylori) testing market has seen significant growth in recent years, driven by the increasing prevalence of H. pylori infections worldwide. H. pylori is a bacterium that infects the stomach lining and is a major cause of peptic ulcers and gastritis, and it has been linked to stomach cancer. The need for accurate and early diagnosis has spurred advancements in various testing methods, including non-invasive breath tests, blood antibody tests, stool antigen tests, and invasive biopsy-based tests. This growing demand for effective diagnostic tools has led to the expansion of the H. pylori testing market.
Technological advancements in diagnostic testing have greatly enhanced the accuracy, speed, and convenience of H. pylori detection. Non-invasive tests, such as the urea breath test and stool antigen test, are gaining popularity due to their ease of use and reliability. The development of point-of-care testing (POCT) devices has made it possible to conduct tests in diverse healthcare settings, including remote and underserved areas, thereby improving accessibility to H. pylori diagnostics. These innovations not only facilitate early detection and treatment but also contribute to the overall growth of the market.
Market growth is further fueled by increasing awareness about H. pylori-related health issues among both healthcare professionals and the general public. Governments and health organizations around the world are implementing screening programs and educational campaigns to promote early diagnosis and treatment of H. pylori infections. The rise in healthcare expenditure and the expansion of healthcare infrastructure in developing countries are providing a significant boost to the market. As a result, the global H. pylori testing market is poised for continued expansion, driven by the convergence of technological advancements, heightened awareness, and improved healthcare access.
Global Helicobacter Pylori Testing Market Recent Developments
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In December 2023, Biomerica, Inc. announced that it had obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Hp Detect Stool Antigen ELISA test, which was designed to detect the presence of H. pylori bacteria. This approval improved the company's competitiveness in the market.
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In July 2023, Meridian Bioscience, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Premier HpSA FLEX for the diagnosis of H. pylori in both preserved and unpreserved stools. This approval expanded the company’s product portfolio and enabled it to reach an increased customer base.
Segment Analysis
The Global Helicobacter Pylori Testing Market is segmented by Test Type, Method, End User and Geography, Test Type into Invasive Tests and Non-invasive Tests. Invasive tests involve procedures such as endoscopy with biopsy, where a tissue sample is taken from the stomach lining to detect the presence of Helicobacter pylori. This method is typically used when a more detailed examination is needed, especially in cases of chronic gastritis or peptic ulcers. Non-invasive tests include methods like the urea breath test, serology, stool antigen test, and rapid urease tests. Non-invasive tests are increasingly popular due to their simplicity, faster results, and patient comfort. These tests are widely used for initial diagnosis and monitoring of infection.
The market is also segmented by Method into Molecular Diagnostics, Immunoassays, and Others. Molecular diagnostics, such as PCR (polymerase chain reaction), are used to detect the DNA of H. pylori in a sample, providing high sensitivity and specificity. Immunoassays like enzyme-linked immunosorbent assay (ELISA) detect antibodies or antigens associated with the bacteria, offering a cost-effective solution for diagnosis and screening. Others include tests like lateral flow assays and monoclonal antibody-based tests, which are being increasingly adopted due to their convenience, speed, and affordability in point-of-care settings.
The Global Helicobacter Pylori Testing Market is also segmented by End User into Hospitals, Diagnostic Laboratories, and Home Care Settings. Hospitals are the largest end users due to their capability to perform both invasive and non-invasive testing, especially in critical care and specialty gastroenterology departments. Diagnostic laboratories play a key role in processing tests for H. pylori infection, offering a wide range of diagnostic options for both public and private healthcare facilities. Home care settings are growing in popularity with the availability of non-invasive, easy-to-use test kits, allowing patients to test from the comfort of their homes. Geographically, the market spans across North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa, with North America and Europe leading in market share, driven by advanced healthcare infrastructure and high adoption of diagnostic technologies. The Asia-Pacific region is expected to see rapid growth due to increasing awareness and healthcare accessibility, while Latin America and the Middle East & Africa are emerging markets with rising demand for cost-effective and accessible testing solutions.
Global Helicobacter Pylori Testing Segment Analysis
In this report, the Global Helicobacter Pylori Testing Market has been segmented by Test Type, Method, End User and Geography.
Global Helicobacter Pylori Testing Market, Segmentation by Test Type
The Global Helicobacter Pylori Testing Market has been segmented by Test Type into Hearing AIDS, - [Analog Hearing Aids and Digital Hearing Aids] - Cochlear Implants, Bone-Anchored Hearing System, Auditory Brainstem Implants and Middle Ear Implants.
The Invasive testing primarily involves procedures like endoscopy and gastric biopsy, where tissue samples are collected from the stomach lining for analysis. These tests are considered highly accurate and are often used when detailed examination of the stomach lining is necessary, especially in cases where gastric cancer is suspected. The histology, culture, and rapid urease tests performed on biopsy samples provide definitive results, but the requirement for endoscopy makes these tests more complex and resource-intensive.
Non-invasive testing methods have gained considerable popularity due to their convenience and patient comfort. These tests include urea breath tests (UBT), stool antigen tests, and blood antibody tests. The urea breath test is particularly favored for its high sensitivity and specificity; it involves the patient ingesting a urea solution labeled with a carbon isotope, which is metabolized by H. pylori if present, leading to detectable changes in the patient's breath. Stool antigen tests are also widely used, offering direct detection of H. pylori antigens in fecal samples, which is a straightforward and non-invasive approach suitable for both initial diagnosis and post-treatment monitoring. Blood antibody tests, while useful for initial screening, are less reliable for confirming active infection due to the persistence of antibodies even after successful treatment.
The market dynamics between invasive and non-invasive tests are influenced by various factors, including technological advancements, patient preferences, and healthcare infrastructure. Non-invasive tests are increasingly preferred in primary care settings and for large-scale screening programs due to their ease of administration and quick turnaround times. This trend is driving substantial growth in the non-invasive segment, supported by ongoing innovations aimed at enhancing test accuracy and accessibility. The invasive segment continues to hold significance in specialized clinical settings where comprehensive diagnostic evaluation is required. The balance between these segments reflects the diverse needs of the global healthcare landscape in managing H. pylori infections effectively.
Global Helicobacter Pylori Testing Market, Segmentation by Method
The Global Helicobacter Pylori Testing Market has been segmented by Method into Point of Care Testing and Laboratory Based Testing.
The POCT has gained significant traction due to its convenience and rapid results. This method allows for immediate testing and diagnosis in various settings such as clinics, hospitals, and even at home. The portability and user-friendly nature of POCT devices make them highly suitable for early detection and prompt treatment of Helicobacter pylori infections, which are critical in preventing more severe gastrointestinal complications. The increasing adoption of POCT is driven by technological advancements and the rising need for efficient and accessible healthcare solutions.
On the other hand, Laboratory Based Testing remains a cornerstone in the Helicobacter pylori testing market, known for its high accuracy and comprehensive analysis. Laboratory tests, including urea breath tests, stool antigen tests, and serological tests, offer detailed insights into the presence of H. pylori infections. These tests are typically conducted in well-equipped facilities by trained professionals, ensuring reliability and precision in results. Laboratory based testing is particularly favored in cases requiring thorough investigation and confirmation of H. pylori presence, especially when initial POCT results are inconclusive or when there is a need for follow-up tests post-treatment.
The choice between Point of Care Testing and Laboratory Based Testing often depends on the clinical context, patient needs, and resource availability. While POCT provides quick and accessible options for initial screening, Laboratory Based Testing is indispensable for definitive diagnosis and comprehensive monitoring. Both methods collectively enhance the diagnostic landscape of H. pylori infections, offering diverse options to healthcare providers and patients. As the market continues to evolve, the integration of these testing methods is expected to improve patient outcomes and streamline the management of H. pylori-related diseases.
Global Helicobacter Pylori Testing Market, Segmentation by End User
The Global Helicobacter Pylori Testing Market has been segmented by End User into Hospitals, Clinics, Diagnostic Labs and Others.
The hospitals constitute the largest segment due to their comprehensive diagnostic and treatment facilities, catering to a high volume of patients. In hospitals, H. pylori testing is integrated into routine diagnostic procedures for patients presenting with gastrointestinal symptoms. The availability of advanced diagnostic equipment and skilled medical professionals in hospitals enhances the accuracy and reliability of H. pylori tests, contributing significantly to market growth.
Clinics also represent a substantial segment in the H. pylori testing market, particularly due to their accessibility and convenience for patients seeking initial consultation and diagnosis. Clinics often serve as the first point of contact for patients with symptoms of H. pylori infection, such as stomach pain or indigestion. The use of non-invasive testing methods like urea breath tests and stool antigen tests is common in clinic settings due to their simplicity and quick turnaround time. This segment is growing as more clinics adopt point-of-care testing (POCT) devices, which enable rapid and accurate diagnosis without the need for specialized laboratory infrastructure.
Diagnostic laboratories are critical players in the H. pylori testing market, providing specialized testing services and supporting both hospitals and clinics. These laboratories are equipped with sophisticated diagnostic tools and employ trained technicians to conduct a variety of H. pylori tests, including both invasive and non-invasive methods. The role of diagnostic laboratories is particularly vital in areas lacking advanced hospital infrastructure, as they offer centralized testing services that enhance diagnostic accuracy and reliability. The other segment, which includes academic and research institutions, contributes to the market by focusing on the development of new diagnostic technologies and improving existing testing methodologies. This continuous innovation drives the overall growth and advancement of the H. pylori testing market.
Global Helicobacter Pylori Testing Market, Segmentation by Geography
In this report, the Global Helicobacter Pylori Testing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Helicobacter Pylori Testing Market Share (%), by Geographical Region, 2024
In North America, the market is primarily driven by advanced healthcare facilities, high healthcare expenditure, and substantial awareness about gastrointestinal diseases. The presence of leading market players and ongoing research activities further bolster market growth in this region. The widespread adoption of non-invasive testing methods, such as urea breath tests and stool antigen tests, highlights the region's inclination towards innovative diagnostic solutions.
Europe follows closely, with significant contributions from countries like Germany, France, and the UK. The region benefits from a well-established healthcare system and strong governmental support for public health initiatives. High prevalence rates of H. pylori infections, coupled with increased awareness campaigns about early diagnosis and treatment, have led to a growing demand for diagnostic tests. Collaborations between academic institutions and diagnostic companies are enhancing research and development, thus driving market expansion in Europe. The availability of reimbursement policies for diagnostic tests also plays a crucial role in market growth.
In the Asia Pacific, the market is experiencing rapid growth due to increasing healthcare access, rising awareness about H. pylori-related diseases, and improving economic conditions. Countries like China, Japan, and India are witnessing significant advancements in healthcare infrastructure, which facilitate the adoption of advanced diagnostic technologies. The high prevalence of H. pylori infections in this region necessitates robust testing mechanisms, fostering market growth. The Middle East and Africa, along with Latin America, are also showing steady progress, albeit at a slower pace. Improvements in healthcare infrastructure, along with growing governmental and private sector investments, are gradually enhancing the capabilities for H. pylori testing in these regions.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Helicobacter Pylori Testing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Increasing Prevalence
- Diagnostic Technologies
- Non-Invasive Testing Methods
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Educational Campaigns: Educational campaigns play a pivotal role in the global Helicobacter pylori (H. pylori) testing market by raising awareness about the prevalence, risks, and treatment options for H. pylori infections. These campaigns are spearheaded by healthcare organizations, governments, and non-profit entities aiming to educate both the public and healthcare professionals about the importance of early detection and treatment of H. pylori. By disseminating information through various media channels such as social media, television, radio, and print media, these campaigns effectively reach a broad audience, helping to reduce the stigma associated with gastrointestinal issues and encouraging people to seek timely medical advice.
Healthcare professionals also benefit significantly from educational campaigns, which provide updated information on the latest diagnostic techniques and treatment protocols for H. pylori infections. Workshops, seminars, and continuous medical education (CME) programs are organized to enhance the knowledge and skills of doctors, nurses, and laboratory technicians. These initiatives ensure that healthcare providers are well-equipped to diagnose and manage H. pylori infections effectively, thereby improving patient outcomes. Educational materials such as brochures, pamphlets, and online resources are made available to healthcare facilities to support patient education and engagement.
Educational campaigns often collaborate with schools, community centers, and workplaces to conduct screening programs and informative sessions. These community-based initiatives are crucial in regions with high prevalence rates of H. pylori infections, as they target at-risk populations who may lack access to regular healthcare services. By fostering a culture of proactive health management, these campaigns not only drive the demand for H. pylori testing but also contribute to the overall reduction in the incidence of complications related to untreated infections. The cumulative impact of these educational efforts is a more informed public and a healthcare system better prepared to address the challenges posed by H. pylori.
Restraints
- Limited Accuracy
- Resistance Concerns
- Diagnostic Complexity
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Resource Limitations: Resource limitations in the Global Helicobacter Pylori Testing Market present challenges across various regions, impacting market dynamics and growth prospects. In North America, despite advanced healthcare infrastructure and significant investments, resource constraints can arise due to the high cost of diagnostic tests and treatments. Limited access to healthcare services among certain populations, particularly in rural areas or underserved communities, can hinder the widespread adoption of H. pylori testing. Healthcare disparities based on socioeconomic factors may restrict access to diagnostic facilities, affecting market penetration and revenue generation.
Europe, while boasting a well-established healthcare system, also faces resource limitations in the context of budget constraints and competing healthcare priorities. Despite governmental support for public health initiatives, including H. pylori awareness campaigns and screening programs, finite healthcare budgets may restrict the allocation of resources towards diagnostic testing. This can lead to disparities in testing availability and accessibility across different regions within Europe. The cost-effectiveness of various testing methods and treatments becomes crucial in resource-limited settings, influencing healthcare decision-making and market dynamics.
In the Asia Pacific region, resource limitations manifest in the form of disparities in healthcare infrastructure and access, particularly in less developed countries. While countries like China and India are witnessing rapid advancements in healthcare, resource constraints remain a significant challenge, impacting the availability and affordability of H. pylori testing services. Limited funding for healthcare, coupled with competing healthcare needs and priorities, can impede the expansion of diagnostic facilities and the adoption of advanced testing technologies. Addressing resource limitations requires concerted efforts from governments, healthcare providers, and industry stakeholders to ensure equitable access to H. pylori testing services across diverse socioeconomic settings in the Asia Pacific region.
Opportunities
- Point-of-Care Testing
- Screening Programs
- Increased Awareness
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Healthcare Infrastructure: The healthcare infrastructure plays a crucial role in shaping the dynamics of the global Helicobacter pylori (H. pylori) testing market. A well-developed healthcare infrastructure, particularly in regions like North America and Europe, facilitates widespread access to diagnostic facilities and fosters early detection and treatment of H. pylori infections. Hospitals, clinics, and diagnostic laboratories within robust healthcare systems are equipped with advanced diagnostic technologies and staffed by skilled healthcare professionals, enabling accurate and timely diagnosis of H. pylori.
In developing regions with evolving healthcare infrastructure, such as parts of Asia Pacific, Latin America, and Africa, the availability and accessibility of H. pylori testing services vary considerably. Limited healthcare resources and infrastructure constraints in these regions can impede the timely diagnosis and management of H. pylori infections. As healthcare infrastructure continues to improve and investments are made in expanding diagnostic capabilities, there is a growing opportunity for market expansion. Efforts to strengthen healthcare systems through infrastructure development initiatives and increased healthcare spending contribute to the growth of the H. pylori testing market in these regions.
The role of healthcare infrastructure extends beyond physical facilities to include healthcare policies, regulations, and reimbursement frameworks. Favorable healthcare policies and regulatory environments support the adoption of H. pylori testing and facilitate market growth by ensuring quality standards and patient safety. Reimbursement policies influence healthcare providers' decisions regarding diagnostic testing, with adequate reimbursement incentivizing the adoption of H. pylori testing in clinical practice. As healthcare infrastructure continues to evolve globally, it will play a pivotal role in shaping the trajectory of the H. pylori testing market, driving advancements in diagnostic technologies and improving access to testing services.
Competitive Landscape Analysis
Key players in Global Helicobacter Pylori Testing Market include:
- Abbott Laboratories
- ADI/American Diagnostica
- Agilent Technologies
- Bio-Rad Laboratories Inc
- Helena Laboratories
- Horiba
- Takara Bio
- EKF Diagnostics
- Exalenz Bioscience Ltd
- Sekisui Diagnostics LLC
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Test Type
- Market Snapshot, By Method
- Market Snapshot, By End User
- Market Snapshot, By Region
- Global Helicobacter Pylori Testing Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Prevalence
- Diagnostic Technologies
- Non-Invasive Testing Methods
- Educational Campaigns
- Restraints
- Limited Accuracy
- Resistance Concerns
- Diagnostic Complexity
- Resource Limitations
- Opportunities
- Point-of-Care Testing
- Screening Programs
- Increased Awareness
- Healthcare Infrastructure
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Helicobacter Pylori Testing Market, By Test Type, 2021 - 2031 (USD Million)
- Invasive
- Histology
- Rapid Urease Test
- HP Culture
- Non-Invasive
- Serologic Test
- Urea Breath Test
- Stool Antigen Test
- Invasive
- Global Helicobacter Pylori Testing Market, By Method, 2021 - 2031 (USD Million)
- Point of Care Testing
- Laboratory Based Testing
- Global Helicobacter Pylori Testing Market, By End User, 2021 - 2031 (USD Million)
- Hospitals
- Clinics
- Diagnostic Labs
- Others
- Global Helicobacter Pylori Testing Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia/New Zealand
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Helicobacter Pylori Testing Market, By Test Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Abbott Laboratories
- ADI/American Diagnostica
- Agilent Technologies
- Bio-Rad Laboratories Inc
- Helena Laboratories
- Horiba
- Takara Bio
- EKF Diagnostics
- Exalenz Bioscience Ltd
- Sekisui Diagnostics LLC
- Company Profiles
- Analyst Views
- Future Outlook of the Market