US Helicobacter Pylori Diagnostics Market Size, Share, Growth Drivers, Trends, Opportunities & Forecast 2025-2030

US Helicobacter Pylori Diagnostics Market valued at USD 290 million, driven by rising H. pylori infections, non-invasive tests like urea breath and stool antigen, and tech advancements for accurate diagnostics.

The US Helicobacter Pylori Diagnostics Market is valued at USD 290 million, based on a five-year historical analysis. This growth is primarily driven by the increasing prevalence of H. pylori infections, rising awareness about gastrointestinal health, and advancements in diagnostic technologies. The market is also supported by the growing demand for non-invasive testing methods, such as urea breath tests and stool antigen tests, which enhance patient comfort and compliance. Recent trends also highlight the adoption of molecular diagnostic techniques and the need for accurate, rapid, and cost-effective solutions to address antibiotic resistance concerns in H. pylori strains.

Key players in this market include major cities such as New York, Los Angeles, and Chicago, which dominate due to their advanced healthcare infrastructure, high patient volumes, and access to cutting-edge medical technologies. These urban centers also benefit from a concentration of research institutions and healthcare facilities that facilitate innovation and the adoption of new diagnostic methods.

In 2023, the US government implemented regulations requiring all diagnostic tests for H. pylori to meet stringent accuracy and reliability standards. The most relevant regulatory instrument is the FDA’s 510(k) clearance process, administered by the US Food and Drug Administration, which mandates that H. pylori diagnostic tests demonstrate substantial equivalence in safety and effectiveness to legally marketed devices. For example, in December 2023, Biomerica, Inc. received FDA 510(k) clearance for its HP Detect Stool Antigen ELISA test (K232892), establishing operational requirements for test sensitivity, specificity, and post-market surveillance.

US Helicobacter Pylori Diagnostics Market Segmentation

By Type:

The market is segmented into various types of diagnostic tests, each catering to different diagnostic needs and preferences. The subsegments include Serological Tests, Urea Breath Tests, Endoscopic Biopsy-Based Tests, Stool Antigen Tests, Molecular Diagnostic Tests (e.g., PCR), Rapid Diagnostic Tests (Point-of-Care), Reagents, Instruments, and Others. Among these, Urea Breath Tests and Stool Antigen Tests are gaining significant traction due to their non-invasive nature and high accuracy, making them a preferred choice for both patients and healthcare providers. Molecular diagnostics, such as PCR, are increasingly adopted for their enhanced sensitivity and specificity, especially in cases of antibiotic resistance.

By End-User:

The end-user segmentation includes Hospitals, Diagnostic Laboratories, Outpatient Clinics, Home Care Settings, Research Institutions, and Others. Hospitals are the leading end-users due to their comprehensive diagnostic capabilities and the high volume of patients requiring H. pylori testing. Diagnostic laboratories also hold a significant share, driven by the demand for specialized testing and the availability of advanced equipment. The increasing number of outpatient procedures and the shift towards home care settings are contributing to the growth of these segments. Research institutions play a key role in innovation and clinical validation of new diagnostic methods.

US Helicobacter Pylori Diagnostics Market Competitive Landscape

The US Helicobacter Pylori Diagnostics Market is characterized by a dynamic mix of regional and international players. Leading participants such as Abbott Laboratories, Thermo Fisher Scientific Inc., Hologic, Inc., Siemens Healthineers, Roche Diagnostics, Bio-Rad Laboratories, Inc., Cepheid, Becton, Dickinson and Company, QuidelOrtho Corporation, Meridian Bioscience, Inc., GenMark Diagnostics, Inc., Eiken Chemical Co., Ltd., DiaSorin S.p.A., Grifols S.A., Quest Diagnostics Incorporated, Biomerica, Inc., Coris BioConcept, Certest Biotec S.L. contribute to innovation, geographic expansion, and service delivery in this space.

US Helicobacter Pylori Diagnostics Market Industry Analysis

Growth Drivers

Increasing Prevalence of Helicobacter Pylori Infections:

The prevalence of Helicobacter Pylori infections in the United States is estimated to affect around 30% of the population, translating to approximately 100 million individuals. This high infection rate drives demand for effective diagnostic solutions. According to the CDC, the annual healthcare costs associated with H. Pylori-related diseases exceed $6 billion, highlighting the urgent need for improved diagnostic methods to manage and treat these infections effectively.

Advancements in Diagnostic Technologies:

The US market is witnessing significant advancements in diagnostic technologies, with the introduction of non-invasive tests such as urea breath tests and stool antigen tests. The FDA has approved several new diagnostic devices in recent years, enhancing accuracy and speed. These innovations are expected to reduce the average time for diagnosis from 14 days to just a few days, significantly improving patient outcomes and driving market growth.

Rising Awareness About Gastrointestinal Health:

Public awareness campaigns regarding gastrointestinal health have increased significantly, with over 60% of adults now recognizing the importance of early diagnosis of H. Pylori infections. The National Institute of Diabetes and Digestive and Kidney Diseases reported a significant increase in screening rates over the past few years. This growing awareness is expected to further boost the demand for H. Pylori diagnostic tests, contributing to market expansion.

Market Challenges

High Cost of Advanced Diagnostic Tests:

The cost of advanced diagnostic tests for H. Pylori can range from $100 to $500, which poses a significant barrier to widespread adoption. Many healthcare providers face budget constraints, limiting their ability to invest in these technologies. According to the American Medical Association, nearly 40% of patients report financial concerns that prevent them from accessing necessary diagnostic tests, hindering market growth.

Lack of Skilled Professionals:

The US healthcare system is currently facing a shortage of skilled professionals trained in advanced diagnostic techniques. The Bureau of Labor Statistics projects strong growth in medical laboratory technician jobs in future, but this still falls short of meeting the increasing demand. This skills gap can lead to delays in diagnosis and treatment, negatively impacting patient outcomes and limiting market potential.

US Helicobacter Pylori Diagnostics Market Future Outlook

The future of the US Helicobacter Pylori diagnostics market appears promising, driven by technological advancements and increasing healthcare investments. The integration of artificial intelligence in diagnostic processes is expected to enhance accuracy and efficiency, while the expansion of telemedicine services will facilitate remote consultations and diagnostics. As healthcare providers increasingly focus on personalized medicine, tailored diagnostic solutions will likely emerge, further propelling market growth and improving patient care.

Market Opportunities

Development of Point-of-Care Testing Solutions:

The demand for point-of-care testing solutions is on the rise, with an estimated market value of $5 billion in future. These tests offer rapid results and convenience, making them attractive to both patients and healthcare providers. The ability to diagnose H. Pylori infections in a clinical setting can significantly improve patient management and treatment outcomes.

Growing Demand for Home Testing Kits:

The home testing kit market is projected to reach $3 billion in future, driven by consumer preference for convenience and privacy. As more individuals seek to manage their health proactively, the introduction of reliable home testing kits for H. Pylori will cater to this demand, providing an accessible option for early diagnosis and treatment.