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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


ID: MRFR/HC/17829-HCR | 100 Pages | Author: Rahul Gotadki| December 2023

US Helicobacter Pylori Test Market Overview


As per MRFR analysis, the US Helicobacter Pylori Test Market Size was estimated at 748.67 (USD Million) in 2023. The US Helicobacter Pylori Test Market Industry is expected to grow from 830(USD Million) in 2024 to 1,500 (USD Million) by 2035. The US Helicobacter Pylori Test Market CAGR (growth rate) is expected to be around 5.527% during the forecast period (2025 - 2035).


Key US Helicobacter Pylori Test Market Trends Highlighted


The US Helicobacter Pylori Test Market is witnessing a notable shift towards non-invasive testing methods, which is driven by the increasing demand for patient comfort and convenience. The rise in awareness regarding the health implications of Helicobacter Pylori infection, such as peptic ulcers and gastric cancer, is encouraging patients to seek testing solutions promptly. Current trends show a preference for rapid diagnostic tests that offer results in a shorter timeframe, enhancing both clinical workflow efficiency and patient experience. 


Furthermore, a growing emphasis on preventive healthcare is propelling the demand for routine testing in at-risk demographics, including individuals with a history of gastrointestinal issues.There are significant opportunities to be captured in the US market, particularly through innovations in testing technology. Manufacturers are exploring next-generation testing kits that combine higher accuracy with ease of use. Collaborations with healthcare providers to facilitate widespread screening programs can also enhance market access and education regarding Helicobacter Pylori. 


The integration of telehealth services for consultation and testing follow-up presents an additional avenue for increasing testing rates and providing support to patients remotely. Recent trends also indicate a rising interest in personalized medicine, where treatment plans for Helicobacter Pylori are tailored based on specific patient profiles.This approach highlights the importance of understanding genetic factors and microbial resistance patterns, ultimately leading to more effective management of the infection. Public health initiatives in the US are emphasizing the importance of early detection and treatment to mitigate long-term health consequences, further fostering a proactive approach within the healthcare system. As such, the US Helicobacter Pylori Test Market is evolving rapidly in response to these various healthcare dynamics.


US Helicobacter Pylori Test Market size

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


US Helicobacter Pylori Test Market Drivers


Rising Prevalence of Helicobacter Pylori Infection


The increasing incidence of Helicobacter Pylori infections among the US population serves as a significant driver for the US Helicobacter Pylori Test Market Industry. According to the Centers for Disease Control and Prevention (CDC), approximately 30 to 40 percent of adults in the United States are estimated to be infected with Helicobacter Pylori at some point in their lives. This high prevalence creates a growing demand for effective diagnostic testing.Furthermore, the American Gastroenterological Association indicates that H. Pylori infection is a major cause of peptic ulcers and has been linked to gastric cancer, driving the need for early detection and treatment solutions. Medical professionals, including those affiliated with the American Gastroenterological Association, emphasize the importance of testing, especially for patients presenting symptoms indicative of gastrointestinal distress.Therefore, the rising number of diagnosed cases is anticipated to substantially boost the demand for Helicobacter Pylori tests in the US market, directly correlating with market growth.


Advancements in Diagnostic Technology


The continuous advancements in diagnostic technology significantly contribute to the growth of the US Helicobacter Pylori Test Market Industry. Innovations such as non-invasive breath tests, stool antigen tests, and advanced endoscopic biopsy methods have improved the accuracy and reliability of H. Pylori detection. The American Society for Gastrointestinal Endoscopy (ASGE) has published guidelines endorsing new diagnostic technologies that allow for quicker results and higher patient satisfaction.The growing penetration of these advanced diagnostic methodologies has led to an increase in the number of healthcare facilities adopting H. Pylori testing. This trend is encouraged further by support from medical technology companies that are developing user-friendly, efficient testing tools tailored for clinical environments in the US. As hospitals and diagnostic centers increasingly rely on innovative testing options, the US Helicobacter Pylori Test Market is projected to experience robust growth.


Increased Focus on Preventative Healthcare Initiatives


There is an increasing emphasis on preventative healthcare initiatives across the United States, which is a vital driver for the US Helicobacter Pylori Test Market Industry. The US government and healthcare organizations, such as the National Institutes of Health (NIH), have implemented comprehensive public health programs aimed at raising awareness about gastrointestinal diseases linked to Helicobacter Pylori. These initiatives cater to educating the public on the risks associated with untreated infections, thereby highlighting the importance of testing.Moreover, as healthcare policies shift toward valuing preventative care, there is a growing trend among insurance providers to cover H. Pylori testing as part of routine health check-ups, especially for at-risk populations. This growing focus on preventative measures is likely to increase the number of individuals undergoing H. Pylori testing, thereby propelling market growth in the US.


US Helicobacter Pylori Test Market Segment Insights


Helicobacter Pylori Test Market Type Insights


The US Helicobacter Pylori Test Market is characterized by its diverse types that cater to various diagnostic needs, primarily categorized into Non-endoscopic and Endoscopic methods. Non-endoscopic tests, which typically include breath tests, stool antigen tests, and serology tests, are favored for their non-invasive nature, making them more accessible and preferable for patients. This group serves a significant portion of the population as it is easier to administer and allows for quicker screening without the discomfort associated with invasive procedures. In contrast, Endoscopic testing, often viewed as the gold standard for diagnosing Helicobacter Pylori, involves more invasive techniques such as biopsy and is crucial in patients who present with severe symptoms or conditions like gastrointestinal bleeding. 


The importance of Endoscopic procedures is underscored by their accuracy in detecting not only Helicobacter Pylori but also other gastrointestinal disorders, thus ensuring comprehensive patient assessment. As the population in the US increasingly becomes aware of gastrointestinal health, the demand for both testing types continues to grow. The ongoing advancements in technology further enhance the efficiency and sensitivity of these tests, thereby improving patient outcomes and diagnosis accuracy. Furthermore, factors such as the rising prevalence of Helicobacter Pylori-related diseases, coupled with the growing emphasis on preventive healthcare, contribute to the evolving landscape of the US Helicobacter Pylori Test Market. 


However, challenges remain, including variations in test accuracy, accessibility to advanced diagnostic tools in rural areas, and the need for continuous education around the importance of testing. Overall, the Type segmentation within the US Helicobacter Pylori Test Market highlights a balanced interplay between patient comfort and procedural accuracy, driving the growth and evolution of testing methodologies in addressing Helicobacter Pylori infections across the nation.


US Helicobacter Pylori Test Market segment


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Helicobacter Pylori Test Market Technology Insights


The US Helicobacter Pylori Test Market, focusing on the Technology aspect, showcases a diverse range of testing methodologies, each playing a distinct role in diagnosing and managing Helicobacter pylori infections. Immunoassays are widely utilized due to their effectiveness in rapid testing and ease of use, making them an essential tool in primary care settings. Point of care technology testing continues to gain traction, allowing for immediate results that enhance patient management by facilitating timely treatment decisions, thus improving outcomes. Molecular Diagnostics, recognized for their high specificity and sensitivity, are increasingly significant in complex cases where traditional methods may not suffice.This segment continues to evolve, benefiting from advancements in technology and R&D initiatives aimed at improving diagnostic accuracy. The growing prevalence of Helicobacter pylori infections in the US has intensified the demand for innovative testing solutions, further propelling the development of these technologies. Collectively, these segments are pivotal in shaping the US Helicobacter Pylori Test Market, addressing clinical needs while also contributing to overall public health efforts against gastrointestinal diseases associated with H.pylori.


Helicobacter Pylori Test Market End User Insights


The US Helicobacter Pylori Test Market is significantly influenced by its End User segments, which include Hospitals and clinics, Diagnostic laboratories, and Others. Hospitals and clinics are crucial as they typically serve as primary healthcare providers, conducting a high volume of tests due to patient inflow related to gastrointestinal issues. These facilities leverage advanced diagnostic tools to ensure accurate and timely detection, driving demand in the market. Diagnostic laboratories play a vital role by specializing in various testing methodologies, thus enabling a wider range of testing options that cater to specific patient needs.Such laboratories enhance patient care through accurate and efficient testing services. The “Others” segment encompasses various healthcare settings, contributing to market flexibility and accessibility. Overall, the diverse End User landscape is essential for fulfilling the increasing demand for effective Helicobacter Pylori testing solutions, especially in an era where gastrointestinal health is receiving heightened attention across the US. Strategies aimed at improving awareness and expanding testing capabilities in these segments are expected to further catalyze market growth.


US Helicobacter Pylori Test Market Key Players and Competitive Insights


The US Helicobacter Pylori Test Market is characterized by a dynamic environment driven by advancements in diagnostic technologies and increased awareness regarding the prevalence of Helicobacter pylori infections. As healthcare providers and patients prioritize accurate diagnosis and effective management of gastrointestinal disorders, the competition within this market has intensified. A variety of testing methods are offered, including serological tests, urea breath tests, and stool antigen tests, catering to diverse patient needs and clinical settings. This competitive landscape is shaped by the presence of established companies, emerging players, and the introduction of innovative solutions that address both current and evolving market demands. The market dynamics are influenced by factors such as regulatory approvals, reimbursement policies, and ongoing research focused on enhancing diagnostic accuracy and patient outcomes.


Hologic has positioned itself as a strong competitor in the US Helicobacter Pylori Test Market by leveraging its expertise in molecular diagnostics and other advanced testing methodologies. The company emphasizes maintaining high-quality standards for its products, which are designed to deliver reliable results that aid clinicians in making informed decisions regarding patient treatment. Hologic’s strength lies in its comprehensive portfolio of diagnostic solutions that support gastrointestinal health, allowing the company to cater to a wide range of clinical applications. Additionally, its established relationship with healthcare providers and presence in various healthcare settings solidify Hologic’s competitive edge, enhancing its capability to penetrate the market effectively while also promoting innovations that improve diagnostic precision.


Eiken Chemical has carved out a significant role in the US Helicobacter Pylori Test Market through its commitment to offering dependable diagnostic solutions that address critical healthcare challenges. The company's portfolio includes key products such as the immunoassay and molecular diagnostic kits that enable quick and accurate detection of Helicobacter pylori infections. Eiken Chemical's strengths lie in its strong emphasis on research and development, which allows for the continuous improvement of its offerings. The company has also pursued strategic partnerships and collaborations that bolster its market presence and enhance its product range within the US. Moreover, Eiken Chemical actively participates in educational initiatives that promote awareness of Helicobacter pylori infections, strengthening its position in the market while also supporting healthcare professionals in managing these infections effectively.


Key Companies in the US Helicobacter Pylori Test Market Include



  • Hologic

  • Eiken Chemical

  • Quidel Corporation

  • BioRad Laboratories

  • Abbott Laboratories

  • F. HoffmannLa Roche

  • Genetix Biotech

  • Thermo Fisher Scientific

  • Cepheid

  • Meridian Bioscience

  • Siemens Healthineers

  • Orgentec Diagnostika

  • NantHealth

  • BD


US Helicobacter Pylori Test Market 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.


US Helicobacter Pylori Test Market Segmentation Insights


Helicobacter Pylori Test Market Type Outlook



  • Non-endoscopic

  • Endoscopic


Helicobacter Pylori Test Market Technology Outlook



  • Immunoassays

  • Point of care

  • Molecular Diagnostics


Helicobacter Pylori Test Market End User Outlook



  • Hospitals & clinics

  • Diagnostic laboratories

  • Others

Report Attribute/Metric Source: Details
MARKET SIZE 2018 748.67(USD Million)
MARKET SIZE 2024 830.0(USD Million)
MARKET SIZE 2035 1500.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 5.527% (2025 - 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 Hologic, Eiken Chemical, Quidel Corporation, BioRad Laboratories, Abbott Laboratories, F. HoffmannLa Roche, Genetix Biotech, Thermo Fisher Scientific, Cepheid, Meridian Bioscience, Siemens Healthineers, Orgentec Diagnostika, NantHealth, BD
SEGMENTS COVERED Type, Technology, End User
KEY MARKET OPPORTUNITIES Rising prevalence of H. pylori infections, Increasing demand for non-invasive tests, Advancements in diagnostic technologies, Growing awareness of gastrointestinal health, Expanding healthcare access and affordability
KEY MARKET DYNAMICS increasing prevalence of H. pylori, rising demand for non-invasive tests, advancements in diagnostic technologies, growing awareness of gastrointestinal diseases, shift towards home-based testing solutions
COUNTRIES COVERED US


Frequently Asked Questions (FAQ) :

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

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

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

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

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

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

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

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

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

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

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