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US Helicobacter Pylori Test Market

ID: MRFR/HC/17829-HCR
100 Pages
Rahul Gotadki
October 2025

US Helicobacter Pylori Test Market Research Report By Type (Non-endoscopic, Endoscopic), By Technology (Immunoassays, Point of care, Molecular Diagnostics) and By End User (Hospitals & clinics, Diagnostic laboratories, Others) - Forecast to 2035

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US Helicobacter Pylori Test Market Summary

As per MRFR analysis, the US helicobacter pylori-test market Size was estimated at 582.21 USD Million in 2024. The US helicobacter pylori-test market is projected to grow from 615.4 USD Million in 2025 to 1071.5 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 5.7% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US helicobacter pylori-test market is experiencing growth driven by technological advancements and increasing awareness of gastrointestinal health.

  • Technological advancements in testing are enhancing the accuracy and speed of helicobacter pylori diagnostics.
  • The largest segment in the market is the laboratory-based testing, while the fastest-growing segment is point-of-care testing.
  • Rising awareness of gastrointestinal health is contributing to increased demand for helicobacter pylori testing among consumers.
  • Key market drivers include the increasing prevalence of helicobacter pylori infections and advancements in diagnostic technologies.

Market Size & Forecast

2024 Market Size 582.21 (USD Million)
2035 Market Size 1071.5 (USD Million)

Major Players

Abbott Laboratories (US), Thermo Fisher Scientific (US), F. Hoffmann-La Roche Ltd (CH), Siemens Healthineers (DE), Becton, Dickinson and Company (US), Halyard Health (US), Bio-Rad Laboratories (US), Meridian Bioscience, Inc. (US)

US Helicobacter Pylori Test Market Trends

The helicobacter pylori-test market is currently experiencing notable developments driven by increasing awareness of gastrointestinal health and the rising prevalence of related disorders. As more individuals seek diagnostic solutions for conditions linked to Helicobacter pylori, the demand for effective testing methods is on the rise. This trend is further supported by advancements in technology, which have led to the introduction of more accurate and user-friendly testing options. Healthcare providers are increasingly adopting these innovative solutions to enhance patient care and streamline diagnostic processes. Moreover, the regulatory landscape is evolving, with agencies emphasizing the importance of reliable testing methods. This shift is likely to encourage manufacturers to invest in research and development, aiming to create tests that not only meet regulatory standards but also address the specific needs of healthcare professionals and patients. As a result, the helicobacter pylori-test market is poised for growth, reflecting a broader trend towards improved health outcomes and patient-centric care in the medical field.

Technological Advancements in Testing

Recent innovations in testing methodologies are transforming the helicobacter pylori-test market. New technologies, such as molecular diagnostics and point-of-care testing, are enhancing the accuracy and speed of results. These advancements are likely to improve patient outcomes and increase the adoption of testing in clinical settings.

Rising Awareness of Gastrointestinal Health

There is a growing recognition of the importance of gastrointestinal health among the general population. This heightened awareness is driving more individuals to seek testing for Helicobacter pylori, thereby expanding the market. Educational campaigns and healthcare initiatives are playing a crucial role in promoting testing.

Regulatory Changes and Standards

The regulatory environment surrounding the helicobacter pylori-test market is evolving, with agencies focusing on ensuring the reliability and accuracy of diagnostic tests. These changes may lead to increased scrutiny of existing products and encourage manufacturers to enhance their offerings to comply with new standards.

US Helicobacter Pylori Test Market Drivers

Rising Healthcare Expenditure

The increase in healthcare expenditure in the US is likely to bolster the helicobacter pylori-test market. As individuals and families allocate more resources towards health services, there is a corresponding rise in the demand for diagnostic tests, including those for H. pylori. According to recent data, healthcare spending in the US has been projected to grow at an annual rate of 5.4%, reaching approximately $6 trillion by 2027. This financial commitment to health services may lead to greater accessibility and affordability of testing options, encouraging more patients to seek diagnosis and treatment for H. pylori infections. Consequently, the helicobacter pylori-test market stands to gain from this upward trend in healthcare investment.

Growing Focus on Preventive Healthcare

The shift towards preventive healthcare in the US is a significant factor driving the helicobacter pylori-test market. With an increasing emphasis on early detection and management of health conditions, healthcare providers are advocating for routine screening for H. pylori, especially in high-risk populations. This proactive approach is expected to lead to a higher uptake of testing services, as patients become more engaged in their health management. The market could see a notable increase in demand as healthcare policies evolve to support preventive measures, potentially reducing the burden of gastrointestinal diseases associated with H. pylori. As a result, the helicobacter pylori-test market may benefit from this growing trend in preventive healthcare.

Advancements in Diagnostic Technologies

Technological innovations in diagnostic testing are significantly influencing the helicobacter pylori-test market. The introduction of non-invasive testing methods, such as breath tests and stool antigen tests, has made it easier for patients to undergo screening. These advancements not only enhance patient comfort but also improve the accuracy and speed of diagnosis. For instance, the breath test has shown a sensitivity of over 90% in detecting H. pylori infections. As healthcare facilities adopt these advanced technologies, the market is likely to experience growth, driven by the increasing preference for rapid and reliable testing solutions. Furthermore, the integration of digital health technologies may facilitate remote testing and monitoring, further propelling market expansion.

Increasing Prevalence of Helicobacter Pylori Infections

The rising incidence of Helicobacter pylori infections in the US is a crucial driver for the helicobacter pylori-test market. Studies indicate that approximately 30-40% of the US population may be infected with this bacterium, which is linked to various gastrointestinal disorders, including peptic ulcers and gastric cancer. As awareness of these health issues grows, the demand for accurate and efficient testing methods is likely to increase. This trend is further supported by healthcare providers emphasizing the importance of early detection and treatment, which could potentially reduce the long-term healthcare costs associated with untreated infections. Consequently, the helicobacter pylori-test market is expected to expand as more individuals seek testing to confirm or rule out infections.

Increased Collaboration Between Healthcare Providers and Laboratories

The growing collaboration between healthcare providers and diagnostic laboratories is a notable driver for the helicobacter pylori-test market. As healthcare systems strive for improved patient outcomes, partnerships are being formed to streamline testing processes and enhance the quality of care. These collaborations often result in the development of integrated testing pathways, which can facilitate quicker diagnosis and treatment initiation for H. pylori infections. Additionally, shared resources and expertise can lead to innovations in testing methodologies, further advancing the market. This synergy between providers and laboratories is likely to foster a more efficient healthcare environment, ultimately benefiting the helicobacter pylori-test market.

Market Segment Insights

By Test Type: Non-endoscopic (Largest) vs. Endoscopic (Fastest-Growing)

In the US helicobacter pylori-test market, Non-endoscopic testing holds the largest market share, primarily due to its ease of use and cost-effectiveness, making it a preferred choice among healthcare providers and patients alike. This method has been widely adopted for its non-invasive approach, which has increased its penetration and utilization in various clinical settings, ensuring it remains a key player in the market. On the other hand, Endoscopic testing is witnessing the fastest growth, driven by technological advancements and the increasing prevalence of gastrointestinal diseases. This method offers enhanced diagnostic accuracy and provides direct visualization, which is crucial for effective treatment planning. The shift towards more precise testing protocols among healthcare professionals is fueling the demand for Endoscopic tests, thereby accelerating its growth trajectory in the market.

Testing Method: Non-endoscopic (Dominant) vs. Endoscopic (Emerging)

Non-endoscopic testing is the dominant method in the US helicobacter pylori-test market due to its user-friendly nature and affordability, catering to a broad demographic of patients. This segment includes various methodologies such as antigen tests and breath tests, which are increasingly preferred because they require less invasive procedures, leading to higher patient compliance. Conversely, Endoscopic testing is emerging as a vital alternative, particularly for cases where a more thorough diagnostic approach is needed. While it involves more complex procedures, the accuracy and ability to detect associated conditions position it as an appealing option in specialized medical settings. Both segments highlight the diverse requirements within the market, reflecting a balance between patient convenience and diagnostic precision.

By Technology: Immunoassays (Largest) vs. Molecular Diagnostics (Fastest-Growing)

In the US helicobacter pylori-test market, Immunoassays dominate the market share due to their widespread acceptance and efficacy in detecting H. pylori infections. These tests are user-friendly and relatively inexpensive, making them a preferred choice for both healthcare professionals and patients. Point of care testing is also gaining traction, but it still lags behind the Immunoassays in market share. Meanwhile, Molecular Diagnostics is emerging with a growing share, primarily driven by the need for accuracy in testing and faster result delivery. The growth trends in this segment reveal a shift towards more advanced testing methodologies, with Molecular Diagnostics showing the highest growth rate. This increase is attributed to technological advancements that enhance the precision and speed of H. pylori detection. Furthermore, the rise in awareness regarding gastrointestinal disorders and the importance of early detection contribute to the increasing adoption of these technologies in the market. As healthcare providers seek more reliable and efficient testing solutions, the demand for Molecular Diagnostics is expected to continue its upward trajectory.

Immunoassays: Dominant vs. Molecular Diagnostics: Emerging

Immunoassays remain the dominant technology in the US helicobacter pylori-test market due to their established reliability and cost-effectiveness. They facilitate rapid testing, which aligns with clinical needs for swift diagnosis and treatment decisions. In contrast, Molecular Diagnostics, characterized by high sensitivity and specificity, represent the emerging technology, catering to a niche yet expanding market segment. These tests utilize sophisticated techniques, such as PCR, to provide accurate results, addressing the evolving healthcare standards for infection management. As the healthcare landscape continues to prioritize precision medicine, both segment values will play vital roles, with Immunoassays maintaining their stronghold while Molecular Diagnostics positions itself as the future of testing.

By End User: Hospitals & Clinics (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

The US helicobacter pylori-test market is primarily dominated by hospitals and clinics, which account for a significant share of the overall market. This segment benefits from high patient footfalls and the integration of advanced testing technologies within these institutions. On the other hand, diagnostic laboratories, while smaller in comparison, are witnessing a rapid increase in demand due to their capacity to provide specialized services and quicker turnaround times for test results. Growth trends within the segment are driven by rising awareness about helicobacter pylori infections and their links to various gastrointestinal diseases. The convenience and efficiency provided by diagnostic laboratories cater well to this demand, making them the fastest-growing segment. Additionally, technological advancements and the increasing prevalence of related health issues continue to bolster market growth, emphasizing the need for accessible testing options across the healthcare landscape.

Hospitals & Clinics (Dominant) vs. Diagnostic Laboratories (Emerging)

Hospitals and clinics represent the dominant force in the US helicobacter pylori-test market, offering comprehensive care and extensive resources for diagnosis and treatment. Their established infrastructure allows for the integration of advanced testing methodologies, ensuring accurate results and robust patient management. In contrast, diagnostic laboratories are emerging as significant players, providing focused services that prioritize efficiency and speed in processing tests. Their adaptability to new technologies, coupled with lower overhead costs compared to larger medical institutions, gives them a competitive edge. This duality in market positioning illustrates the evolving dynamics, where hospitals and clinics remain foundational, while diagnostic laboratories capture the growing demand for specialized testing services.

Get more detailed insights about US Helicobacter Pylori Test Market

Key Players and Competitive Insights

The helicobacter pylori-test market is characterized by a competitive landscape that is increasingly shaped by innovation, strategic partnerships, and a focus on enhancing diagnostic accuracy. Key players such as Abbott Laboratories (US), Thermo Fisher Scientific (US), and F. Hoffmann-La Roche Ltd (CH) are at the forefront, leveraging their technological capabilities to drive growth. Abbott Laboratories (US) emphasizes innovation in its diagnostic solutions, aiming to enhance patient outcomes through advanced testing methodologies. Meanwhile, Thermo Fisher Scientific (US) focuses on expanding its product portfolio and enhancing its market presence through strategic acquisitions and collaborations, which collectively contribute to a dynamic competitive environment.

The business tactics employed by these companies reflect a concerted effort to optimize supply chains and localize manufacturing processes. The market appears moderately fragmented, with several players vying for market share while also collaborating to enhance their offerings. This competitive structure allows for a diverse range of products and services, catering to varying customer needs and preferences.

In October 2025, Abbott Laboratories (US) announced the launch of a new rapid diagnostic test for helicobacter pylori, which is expected to significantly reduce the time required for diagnosis. This strategic move not only enhances Abbott's product offerings but also positions the company as a leader in rapid testing solutions, potentially increasing its market share in the US. The introduction of this test aligns with the growing demand for quick and accurate diagnostics in the healthcare sector.

In September 2025, Thermo Fisher Scientific (US) expanded its partnership with a leading healthcare provider to enhance the distribution of its helicobacter pylori testing kits. This collaboration is likely to improve accessibility to advanced diagnostic tools, thereby increasing the company's footprint in the market. By strengthening its distribution channels, Thermo Fisher aims to capitalize on the rising prevalence of helicobacter pylori infections and the corresponding demand for effective testing solutions.

In August 2025, F. Hoffmann-La Roche Ltd (CH) unveiled a new digital platform designed to streamline the testing process for helicobacter pylori. This platform integrates AI technology to assist healthcare professionals in interpreting test results more efficiently. The strategic importance of this initiative lies in its potential to enhance diagnostic accuracy and reduce the burden on healthcare systems, thereby reinforcing Roche's commitment to innovation in diagnostics.

As of November 2025, the competitive trends in the helicobacter pylori-test market are increasingly influenced by digitalization, sustainability, and the integration of AI technologies. Strategic alliances among key players are shaping the landscape, fostering innovation and enhancing product offerings. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, supply chain reliability, and innovative solutions that address the complexities of modern healthcare needs.

Key Companies in the US Helicobacter Pylori Test Market market include

Industry Developments

Recent developments in the US Helicobacter Pylori Test Market indicate significant growth and advancements. Companies such as Hologic and Abbott Laboratories have been pushing forward with new diagnostic technologies, enhancing the accuracy and speed of H. pylori testing. In September 2022, Quidel Corporation announced an expansion of its product portfolio, focusing on point-of-care testing solutions that are crucial in more accessible treatment options for H. pylori-related conditions. Additionally, in June 2023, BioRad Laboratories reported an increase in demand for its testing kits, reflecting the growing awareness of gastric health in the US population.

Recent mergers and acquisitions have also been a defining aspect; for instance, in August 2023, Siemens Healthineers acquired a specialized diagnostics company to enhance their capabilities in gastrointestinal testing, which encompasses H. pylori diagnostics. Growth in the market can be attributed to rising incidences of digestive disorders linked to H. pylori and an increased emphasis on rapid diagnosis. Investments in Research and Development are projected to heighten innovation in testing methods, further driving the market forward. Over the past 2-3 years, concerted efforts by these companies have led to significant improvements in testing accuracy and patient outcomes.

Future Outlook

US Helicobacter Pylori Test Market Future Outlook

The helicobacter pylori-test market is projected to grow at a 5.7% CAGR from 2024 to 2035, driven by increasing prevalence of gastrointestinal disorders and advancements in diagnostic technologies.

New opportunities lie in:

  • Development of rapid point-of-care testing kits for remote diagnostics.
  • Expansion of telehealth services integrating H. pylori testing.
  • Partnerships with pharmaceutical companies for bundled treatment solutions.

By 2035, the market is expected to achieve substantial growth, reflecting evolving healthcare needs.

Market Segmentation

US Helicobacter Pylori Test Market End User Outlook

  • Hospitals & clinics
  • Diagnostic laboratories
  • Others

US Helicobacter Pylori Test Market Test Type Outlook

  • Non-endoscopic
  • Endoscopic

US Helicobacter Pylori Test Market Technology Outlook

  • Immunoassays
  • Point of care
  • Molecular Diagnostics

Report Scope

MARKET SIZE 2024 582.21(USD Million)
MARKET SIZE 2025 615.4(USD Million)
MARKET SIZE 2035 1071.5(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 5.7% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Abbott Laboratories (US), Thermo Fisher Scientific (US), F. Hoffmann-La Roche Ltd (CH), Siemens Healthineers (DE), Becton, Dickinson and Company (US), Halyard Health (US), Bio-Rad Laboratories (US), Meridian Bioscience, Inc. (US)
Segments Covered Test Type, Technology, End User
Key Market Opportunities Advancements in non-invasive testing methods enhance patient compliance in the helicobacter pylori-test market.
Key Market Dynamics Rising demand for non-invasive testing methods drives innovation in the helicobacter pylori-test market.
Countries Covered US

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FAQs

What is the current market size of the US Helicobacter Pylori Test Market in 2024?

The US Helicobacter Pylori Test Market is expected to reach a value of 830.0 million USD in 2024.

What is the projected market size for the US Helicobacter Pylori Test Market by 2035?

By 2035, the market for US Helicobacter Pylori Tests is projected to grow to 1500.0 million USD.

What is the expected CAGR for the US Helicobacter Pylori Test Market from 2025 to 2035?

The expected CAGR for the US Helicobacter Pylori Test Market from 2025 to 2035 is 5.527%.

Which segment is expected to dominate the US Helicobacter Pylori Test Market?

The Non-endoscopic segment is expected to dominate the market, valued at 500.0 million USD in 2024.

What will be the market size for the Endoscopic segment by 2035?

The Endoscopic segment is projected to reach 600.0 million USD by 2035.

Who are the key players in the US Helicobacter Pylori Test Market?

Major players in the market include Hologic, Quidel Corporation, and Abbott Laboratories.

What is the expected market size for Non-endoscopic tests by 2035?

The market size for Non-endoscopic tests is expected to grow to 900.0 million USD by 2035.

What challenges does the US Helicobacter Pylori Test Market face?

Challenges in the market include regulatory hurdles and competition among diagnostic approaches.

What growth opportunities exist within the US Helicobacter Pylori Test Market?

Opportunities for growth include advancements in diagnostic technology and increasing awareness of gastrointestinal health.

What factors are driving growth in the US Helicobacter Pylori Test Market?

Growth is driven by rising prevalence of Helicobacter Pylori infections and the demand for accurate diagnostic tests.

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