Global Helicobacter Pylori Test 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/Fecal Antigen Test.By Technology;
Immunoassays, Point-Of-Care (POC), and Molecular Diagnostics.By End User;
Hospitals & Clinics, Diagnostics Laboratories, and Others.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Helicobacter Pylori Test Market (USD Million), 2021 - 2031
In the year 2024, the Global Helicobacter Pylori Test Market was valued at USD 651.72 million. The size of this market is expected to increase to USD 1,053.38 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 7.1%.
The Global Helicobacter Pylori Test Market is a rapidly evolving sector within the broader diagnostic industry, driven by the growing need to detect and manage H. pylori infections effectively. Helicobacter pylori is a type of bacteria that infects the stomach lining, leading to conditions such as gastritis, peptic ulcers, and even gastric cancer. The increasing prevalence of these gastrointestinal disorders, coupled with rising awareness about the importance of early detection and treatment, is propelling the demand for accurate and reliable H. pylori testing solutions. The market encompasses various testing technologies, including immunoassays, point-of-care (POC) tests, and molecular diagnostics, each offering unique benefits and applications in different healthcare settings.
Technological advancements and innovations play a crucial role in the development and adoption of H. pylori testing methods. Traditional diagnostic approaches such as serology and urea breath tests have been complemented by more sophisticated techniques like polymerase chain reaction (PCR) and next-generation sequencing (NGS). These modern diagnostics provide higher accuracy and specificity, particularly in detecting antibiotic-resistant strains of H. pylori. The integration of artificial intelligence and machine learning into diagnostic processes is further enhancing the efficiency and precision of these tests, enabling better patient outcomes and streamlined clinical workflows.
The market is also characterized by its diverse end-user base, including hospitals, clinics, diagnostic laboratories, and home healthcare providers. Each of these segments has distinct requirements and preferences for H. pylori testing, influenced by factors such as accessibility, cost, and patient demographics. Geographically, the market shows significant variation, with North America and Europe being major contributors due to their advanced healthcare infrastructures and high awareness levels. Meanwhile, the Asia-Pacific region is expected to witness the fastest growth, driven by a large patient pool and increasing healthcare investments. Overall, the Global Helicobacter Pylori Test Market is poised for substantial growth, underpinned by technological advancements, increasing healthcare awareness, and the rising prevalence of H. pylori-related diseases.
Global Helicobacter Pylori Test Market Recent Developments
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In October 2018, DiaSorin S.p.A collaboration with Meridian Bioscience, Inc. to sell DiaSorin’s FDA-approved stool agent test to detect H. pylori.
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In December 2023, Biomerica, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect Stool Antigen ELISA test, a new product that is designed to detect the presence of the H. pylori bacteria. This approval helped the company to improve its competitiveness in the market.
Segment Analysis
The Global Helicobacter Pylori Test Market has been segmented by test type into invasive and non-invasive categories. Invasive tests, such as Histology, Rapid Urease Test, and HP Culture, involve procedures like endoscopy or biopsy to collect samples from the stomach for detecting H. pylori infection, with Histology examining tissue samples, Rapid Urease testing for urease activity, and HP Culture growing bacteria from biopsy samples. Non-invasive tests include Serologic Tests, which detect antibodies in the blood, and Urea Breath Tests, which measure carbon dioxide produced after ingesting urea, indicating bacterial presence. The Stool/Fecal Antigen Test is another non-invasive method that identifies H. pylori antigens in stool samples, making it suitable for initial diagnosis and post-treatment confirmation. These tests offer a range of options for diagnosing H. pylori infection, with each type selected based on clinical needs, patient condition, and diagnostic requirements.The comprehensive report on the Global Helicobacter Pylori Test Market provides a detailed segmentation analysis, encompassing various technological, end-user, and geographical segments. Each segment is thoroughly examined to offer a deep understanding of market dynamics and trends. The segmentation by technology includes Immunoassays, Point-Of-Care (POC) tests, and Molecular Diagnostics, each of which is analyzed for its historical and forecasted revenue contributions. By examining these segments, the report highlights the technological advancements, adoption rates, and comparative efficacy of different diagnostic methods in detecting H. pylori infections.
In terms of end-user segmentation, the report covers Hospitals and Clinics, Diagnostic Laboratories, and Others, which include academic research institutions, pharmaceutical companies, and home healthcare providers. The analysis provides insights into how each of these end-user categories contributes to market revenue, based on factors such as patient volume, accessibility of diagnostic services, and preference for specific testing methods. Historical data is used to establish baseline performance, while forecasted data helps in identifying growth opportunities and potential shifts in demand within these end-user categories. The inclusion of diverse data points ensures that the analysis reflects real-world usage patterns and market needs.
Geographically, the report segments the market into key regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. For each region, the report provides a revenue analysis for both the historical period and the forecast period, highlighting regional market trends, healthcare infrastructure developments, and prevalence rates of H. pylori infections. This geographical analysis helps in understanding the regional variations in market dynamics and identifying regions with high growth potential. Insights generated from this analysis are critical for stakeholders to make informed decisions about market entry, expansion, and investment strategies. The report’s thorough examination of data trends and patterns across all segments provides a robust foundation for strategic planning and market positioning.
Global Helicobacter Pylori Test Segment Analysis
In this report, the Global Helicobacter Pylori Test Market has been segmented by Test Type, Technology, End User and Geography.
Global Helicobacter Pylori Test Market, Segmentation by Test Type
In this report, the Global Helicobacter Pylori Test Market has been segmented by Test Type into Invasive, Histology, Rapid Urease Test, HP Culture, Non-Invasive, Serologic Test, Urea Breath Test, and Stool/Fecal Antigen Test.
The Global Helicobacter Pylori Test Market has been segmented by test type into both invasive and non-invasive categories, each designed to diagnose H. pylori infection through different methods. Invasive tests require procedures where a sample is taken directly from the patient’s body, typically through endoscopy or biopsy. Histology is a common invasive test that involves examining tissue samples under a microscope to detect the presence of H. pylori bacteria. The Rapid Urease Test, another invasive method, checks for the presence of urease enzyme produced by H. pylori in stomach tissue, helping to confirm infection. HP Culture, which involves growing bacteria from a biopsy sample, is another invasive method that provides confirmation but is less commonly used due to its complexity and time requirements.
Non-invasive tests are simpler and less intrusive, offering an alternative to invasive procedures, and are often used for routine screening or follow-up tests. Serologic tests fall under this category and detect antibodies in the blood, indicating a past or present infection with H. pylori. These tests are widely used due to their ease of administration and non-invasive nature, though they may not distinguish between past and current infections. The Urea Breath Test, another non-invasive method, measures the amount of carbon dioxide produced after the patient ingests urea, which is broken down by H. pylori’s urease enzyme. This test is highly accurate and often used as a follow-up to treatment to confirm eradication of the bacteria.
The Stool/Fecal Antigen Test is another non-invasive option that detects H. pylori antigens in stool samples. It is commonly used for initial diagnosis and to confirm the eradication of the bacteria after treatment. This test is preferred for its ease of use, high sensitivity, and ability to detect active infection. Each of these tests plays a critical role in diagnosing and monitoring H. pylori infections, with healthcare providers selecting the most appropriate method based on clinical needs, patient condition, and testing availability. The market for these tests continues to expand with advancements in technology and growing awareness of the importance of accurate H. pylori diagnosis.
Global Helicobacter Pylori Test Market, Segmentation by Technology
In this report, the Global Helicobacter Pylori Test Market has been segmented by Technology into Immunoassays, Point-Of-Care (POC), and Molecular Diagnostics.
The Global Helicobacter Pylori Test Market is segmented by technology into Immunoassays, Point-Of-Care (POC) tests, and Molecular Diagnostics. Immunoassays are widely used due to their ability to detect specific antigens or antibodies related to H. pylori with high sensitivity and specificity. Common immunoassays include enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests that are easy to use and provide quick results. These tests are often employed in both clinical and laboratory settings, making them a versatile option for healthcare providers. The reliability and efficiency of immunoassays have solidified their position as a leading technology segment in the market.
Point-Of-Care (POC) tests are gaining significant traction in the H. pylori test market due to their convenience and rapid turnaround times. POC tests, such as urea breath tests and stool antigen tests, can be administered and analyzed quickly, often at the patient’s bedside or in a primary care setting. These tests are particularly valuable in rural or resource-limited areas where access to full laboratory services may be restricted. The increasing demand for immediate and accurate diagnostic results has driven the adoption of POC testing, making it a rapidly growing segment. Furthermore, advancements in POC technology continue to improve their accuracy and ease of use, enhancing their appeal to both patients and healthcare providers.
Molecular diagnostics represent the cutting edge of H. pylori testing technology, offering highly accurate and specific detection of the bacterium’s genetic material. Techniques such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) are used to identify H. pylori infections, even in cases where bacterial load is low or in samples that are challenging to test by other methods. Molecular diagnostics are particularly valuable for detecting antibiotic resistance, which is crucial for guiding effective treatment strategies. While these tests are generally more expensive and require specialized equipment and expertise, their superior accuracy and ability to provide detailed genetic information make them an important component of the diagnostic landscape. The increasing prevalence of antibiotic-resistant H. pylori strains and the growing emphasis on precision medicine are likely to drive the expansion of the molecular diagnostics segment in the coming years.
Global Helicobacter Pylori Test Market, Segmentation by End User
In this report, the Global Helicobacter Pylori Test Market has been segmented by End User into Hospitals & Clinics, Diagnostics Laboratories, and Others.
The Global Helicobacter Pylori Test Market is segmented by end user into Hospitals and Clinics, Diagnostic Laboratories, and Others. Hospitals and clinics represent a significant portion of the market due to their integral role in primary and specialized healthcare services. These healthcare settings often serve as the first point of contact for patients experiencing symptoms of H. pylori infection, such as peptic ulcers or gastritis. Hospitals and clinics are equipped with advanced diagnostic tools and staffed by healthcare professionals trained to conduct a variety of H. pylori tests, including blood tests, breath tests, and endoscopic procedures. The high patient throughput in these settings contributes to the substantial market share of this segment.
Diagnostic laboratories also hold a considerable market share in the Global Helicobacter Pylori Test Market. These laboratories are pivotal in conducting specialized tests that require sophisticated equipment and expertise, such as stool antigen tests and polymerase chain reaction (PCR) assays for H. pylori. Diagnostic laboratories often collaborate with hospitals and clinics to provide comprehensive diagnostic services, ensuring accurate and timely results. The increasing demand for precise and reliable diagnostic outcomes has driven the growth of this segment. Additionally, the trend towards outsourcing diagnostic services to specialized laboratories for cost efficiency and expertise further bolsters this segment's market position.
The Others category includes a diverse range of end users such as academic research institutions, pharmaceutical companies, and home healthcare providers. Academic research institutions contribute to the market by conducting studies that improve the understanding of H. pylori infection and develop new diagnostic methodologies. Pharmaceutical companies invest in the market to develop and validate diagnostic tests that complement their therapeutic products. Home healthcare providers are gaining traction, especially with the growing preference for non-invasive and at-home testing solutions. This segment is expected to grow as more patients seek convenient and accessible healthcare options, and as technological advancements make home testing increasingly feasible and reliable.
Global Helicobacter Pylori Test Market, Segmentation by Geography
In this report, the Global Helicobacter Pylori Test Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Helicobacter Pylori Test Market Share (%), by Geographical Region, 2024
The Global Helicobacter Pylori Test Market is segmented by geographical regions, with North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa being the primary markets. North America holds a significant share of the market, driven by the high prevalence of gastrointestinal disorders, advanced healthcare infrastructure, and increased awareness about H. pylori infections. The United States, in particular, contributes substantially to the market due to the availability of sophisticated diagnostic tools and robust reimbursement policies. Additionally, ongoing research and development activities aimed at improving diagnostic accuracy further bolster the market share in this region.
Europe also represents a considerable portion of the global market, with countries like Germany, France, and the United Kingdom leading the way. The market in Europe benefits from strong healthcare systems, a high prevalence of H. pylori infections, and extensive government initiatives focused on early diagnosis and treatment. The European market is characterized by a growing demand for non-invasive testing methods and the adoption of advanced diagnostic technologies. Collaborations between research institutions and diagnostic companies in this region contribute to continuous innovation and market growth.
The Asia-Pacific region is expected to witness the fastest growth in the Global Helicobacter Pylori Test Market. This growth is fueled by the increasing incidence of H. pylori infections, expanding healthcare infrastructure, and rising healthcare expenditures in countries such as China, India, and Japan. The large population base, coupled with heightened awareness and improved access to healthcare services, drives the demand for H. pylori testing in this region. Additionally, the increasing focus on preventive healthcare and government initiatives to combat gastric diseases support the market expansion. Emerging economies in the Asia-Pacific region are becoming key markets for diagnostic companies, offering significant growth opportunities in the coming years.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Helicobacter Pylori Test Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Diagnostic accuracy advancements
- Rising prevalence globally
- Increasing awareness campaigns
- Technological innovations driving
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Growing demand for non-invasive : The Global Helicobacter Pylori Test Market is witnessing a significant surge in demand for non-invasive diagnostic solutions. This trend is primarily driven by the growing preference among patients and healthcare providers for tests that minimize discomfort, reduce the need for invasive procedures, and offer convenient testing options. Non-invasive tests, such as breath tests and stool antigen tests, are gaining popularity due to their simplicity, accuracy, and patient-friendly nature. As awareness about the importance of early detection and management of H. pylori infections increases, the demand for non-invasive testing methods is expected to further escalate.
Technological advancements have played a crucial role in enhancing the performance and reliability of non-invasive H. pylori tests. Innovations in diagnostic tools and techniques have led to the development of highly sensitive and specific tests that can accurately detect the presence of H. pylori bacteria without the need for invasive procedures such as endoscopy. These advancements have not only improved diagnostic accuracy but have also expanded access to testing, particularly in regions with limited healthcare infrastructure.
The rising incidence of gastrointestinal disorders globally has fueled the demand for non-invasive H. pylori testing. As the prevalence of conditions such as peptic ulcers and gastric cancer continues to increase, there is a growing emphasis on early detection and management of H. pylori infections, which are known to be major risk factors for these diseases. Non-invasive testing methods offer a convenient and cost-effective means of screening individuals for H. pylori infection, enabling timely intervention and improved patient outcomes. As a result, the demand for non-invasive tests in the global H. pylori test market is expected to remain robust in the coming years, driven by both clinical necessity and patient preference.
Restraints
- Regulatory hurdles impacting
- High cost of diagnostic
- Limited access in remote
- Concerns regarding invasive
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False-negative results affecting : False-negative results pose a significant challenge in the Global Helicobacter Pylori Test Market, impacting both patient care and healthcare provider decision-making. Despite advancements in diagnostic technologies, certain factors can contribute to inaccurate test results, leading to the misdiagnosis or delayed diagnosis of H. pylori infection. One of the primary causes of false-negative results is the presence of low bacterial load in the stomach, which can occur in some patients, particularly those who have recently completed antibiotic therapy or proton pump inhibitor (PPI) treatment. In such cases, conventional diagnostic tests may fail to detect the bacteria, leading to false-negative outcomes and potential treatment delays.
The heterogeneity of H. pylori strains and genetic variations among different populations can also influence the accuracy of diagnostic tests, contributing to false-negative results. Variability in bacterial virulence factors and antigen expression patterns can affect the performance of antibody-based tests and molecular assays, leading to discrepancies in test results across different patient populations. Additionally, factors such as improper specimen collection, inadequate sample processing, and technical errors during testing procedures can further increase the risk of false-negative outcomes, compromising the reliability of H. pylori diagnostic tests.
False-negative results not only undermine the effectiveness of H. pylori testing but also have implications for patient management and clinical outcomes. In cases where patients receive negative test results despite being infected with H. pylori, there is a risk of undertreatment or delayed initiation of appropriate therapy, which can lead to the progression of gastric disorders and associated complications. Furthermore, false-negative results can erode patient confidence in diagnostic testing and healthcare providers, potentially resulting in dissatisfaction and suboptimal adherence to follow-up recommendations. Addressing the challenges associated with false-negative results requires ongoing efforts to improve the sensitivity and specificity of H. pylori diagnostic tests, as well as enhanced awareness among healthcare professionals regarding the limitations of current testing modalities and the importance of clinical judgment in interpreting test results.
Opportunities
- Emerging markets expansion
- Development of rapid
- Increased adoption
- Personalized medicine approaches
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Integration of artificial intelligence : The integration of artificial intelligence (AI) holds significant promise for revolutionizing the Global Helicobacter Pylori Test Market by enhancing diagnostic accuracy, efficiency, and patient care. AI-powered algorithms can analyze vast amounts of clinical data, including patient history, laboratory results, and imaging studies, to assist healthcare providers in making more informed decisions regarding H. pylori testing and management. By leveraging machine learning and pattern recognition techniques, AI algorithms can identify subtle patterns and correlations in diagnostic data that may not be apparent to human observers, thereby improving the sensitivity and specificity of H. pylori diagnostic tests.
One area where AI has shown particular potential is in the development of predictive models for H. pylori infection risk assessment. By analyzing a combination of demographic, clinical, and lifestyle factors, AI algorithms can stratify individuals based on their likelihood of being infected with H. pylori, enabling targeted screening and preventive interventions. Additionally, AI-driven decision support systems can aid healthcare providers in selecting the most appropriate diagnostic tests and treatment strategies for individual patients, taking into account factors such as antibiotic resistance patterns, comorbidities, and treatment preferences.
AI technologies can facilitate the development of novel diagnostic tools and techniques for H. pylori testing, including non-invasive screening methods and point-of-care testing devices. By harnessing AI for image analysis, sensor data interpretation, and algorithm optimization, researchers can accelerate the development and commercialization of innovative diagnostic solutions that offer improved accuracy, affordability, and accessibility. AI-enabled diagnostics have the potential to streamline the diagnostic process, reduce turnaround times, and expand access to testing in resource-limited settings, ultimately leading to better outcomes for patients with H. pylori-related conditions. As AI continues to evolve and mature, its integration into the Global Helicobacter Pylori Test Market is expected to drive significant advancements in diagnostic technology and patient care.
Competitive Landscape Analysis
Key players in Global Helicobacter Pylori Test Market include:
- Bio-Rad Laboratories, Inc.
- Thermo Fisher Scientific Inc.
- Meridian Bioscience, Inc.
- F. Hoffmann-La Roche Ltd
- Abbott Laboratories
- Quidel Corporation
- Sekisui Diagnostics
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 Technology
- Market Snapshot, By End User
- Market Snapshot, By Region
- Global Helicobacter Pylori Test Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Diagnostic accuracy advancements
- Rising prevalence globally
- Increasing awareness campaigns
- Technological innovations driving
- Growing demand for non-invasive
- Restraints
- Regulatory hurdles impacting
- High cost of diagnostic
- Limited access in remote
- Concerns regarding invasive
- False-negative results affecting
- Opportunities
- Emerging markets expansion
- Development of rapid
- Increased adoption
- Personalized medicine approaches
- Integration of artificial intelligence
- Drivers
- PEST Analysis
- Technological Analysis
- Social Analysis
- Economic Analysis
- Political 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 Test Market, By Test Type, 2021 - 2031 (USD Million)
- Invasive
- Histology
- Rapid Urease Test
- HP Culture
- Non-Invasive
- Serologic Test
- Urea Breath Test
- Stool/fecal Antigen Test
- Invasive
- Global Helicobacter Pylori Test Market, By Technology, 2021 - 2031 (USD Million)
- Immunoassays
- Point-Of-Care (POC)
- Molecular Diagnostics
- Global Helicobacter Pylori Test Market, By End User, 2021 - 2031 (USD Million)
- Hospitals & Clinics
- Diagnostics Laboratories
- Others
- Global Helicobacter Pylori Test 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 (Association of South East Asian Countries)
- 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 Test Market, By Test Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Bio-Rad Laboratories, Inc.
- Thermo Fisher Scientific Inc.
- Meridian Bioscience, Inc.
- F. Hoffmann-La Roche Ltd
- Abbott Laboratories
- Quidel Corporation
- Sekisui Diagnostics
- Company Profiles
- Analyst Views
- Future Outlook of the Market