• In May 2022, Biomerica, Inc. unveiled its hp+detect diagnostic test, securing CE Mark approval for its efficacy in detecting Helicobacter pylori bacteria. With this regulatory milestone achieved, the company is poised to introduce and distribute the hp+detect diagnostic test across the European Union (EU) and various international markets. Biomerica, Inc. plans to commence marketing and sales of the hp+detect test upon completion of product registration in each respective country where it will be available for purchase.

• In April 2021, Otsuka Pharmaceutical Co., Ltd. has launched QuickNavi, a rapid detection kit for H. pylori, capable of delivering test results within eight minutes

In this report, the Global Helicobacter Pylori Diagnostics Market has been segmented by Type, Test Type, Method, Technology, End Users, and Geography.

Global Helicobacter Pylori Diagnostics Market, Segmentation by Type

The Global Helicobacter Pylori Diagnostics Market has been segmented by Type into Instruments, Reagents, and Services.

Instruments

Instruments form an essential part of the Helicobacter pylori diagnostics market, holding about 28% share. These devices, including endoscopy systems and biopsy analyzers, are widely used for invasive diagnostic techniques such as histology and rapid urease testing. Their demand is supported by the increasing focus on accurate and early-stage detection in clinical settings.

Reagents

Reagents dominate the market with an estimated 52% share, driven by the frequent need for diagnostic kits in non-invasive tests like urea breath analysis and stool antigen detection. As these tests are performed routinely for initial screening and post-treatment monitoring, the demand for reagents remains consistently high.

Services

The services segment accounts for approximately 20% of the market. Diagnostic laboratories and healthcare institutions offering H. pylori testing as a service are witnessing growth due to higher outsourcing trends, especially in regions where public health initiatives are expanding access to gastrointestinal disease diagnostics.

Global Helicobacter Pylori Diagnostics Market, Segmentation by Test Type

The Global Helicobacter Pylori Diagnostics Market has been segmented by Test Type into Non-Invasive Test, and Invasive Test.

Non-Invasive Test

Non-invasive testing methods dominate the Helicobacter pylori diagnostics market with a 68% share. These tests—such as urea breath tests, stool antigen assays, and blood antibody tests—are widely adopted due to their ease of use, high patient compliance, and suitability for both initial screening and post-treatment monitoring. The rising preference for non-invasive diagnostics is driving their adoption across primary healthcare settings globally.

Invasive Test

Invasive diagnostic tests account for approximately 32% of market demand. Conducted through endoscopy, these tests include histological examination, biopsy-based urease testing, and bacterial culture. While more resource-intensive, invasive tests are preferred in patients with alarm symptoms, suspected gastric ulcers, or when therapeutic decisions depend on antibiotic susceptibility testing.

Global Helicobacter Pylori Diagnostics Market, Segmentation by Method

The Global Helicobacter Pylori Diagnostics Market has been segmented by Method into Laboratory Based Test, and Point of Care Test.

Laboratory Based Test

Laboratory-based testing dominates the Helicobacter pylori diagnostics market with an estimated 70% share. These methods, including urea breath tests, ELISA, and histological examination, are preferred for their diagnostic accuracy and clinical reliability. They are typically performed in specialized labs with trained personnel and are the gold standard for confirmatory testing and treatment monitoring.

Point of Care Test

Point-of-care testing holds around 30% of the market and is growing steadily. These tests offer rapid, on-the-spot results and are especially valuable in primary care or rural healthcare settings where access to centralized labs is limited. POC tests are increasingly adopted for initial H. pylori screening due to their convenience and low cost.

Global Helicobacter Pylori Diagnostics Market, Segmentation by Technology

The Global Helicobacter Pylori Diagnostics Market has been segmented by Technology into Immunoassays, POC, and Molecular Diagnostics.

Immunoassays

Immunoassays dominate the Helicobacter pylori diagnostics market, holding a 50% share. ELISA and rapid lateral flow tests are among the most common methods for detecting H. pylori antigens or antibodies. These technologies are valued for their cost-effectiveness, simplicity, and versatility across both laboratory and point-of-care environments.

Point-of-Care (POC)

POC diagnostics represent about 30% of the market and are steadily expanding, especially in low-resource and rural settings. These tests offer immediate results, improving early detection and treatment. Their convenience, minimal training requirement, and portability make them ideal for screening in primary care clinics.

Molecular Diagnostics

With a 20% market share, molecular diagnostics are gaining traction for their high specificity and ability to detect antibiotic resistance. PCR-based methods allow for early detection and improved treatment decision-making. As demand for precision medicine grows, molecular tools are expected to play an increasingly important role in H. pylori management.

Global Helicobacter Pylori Diagnostics Market, Segmentation by End Users

The Global Helicobacter Pylori Diagnostics Market has been segmented by End Users into Hospitals, Diagnostic Centers, Clinics, and Others.

Hospitals

Hospitals lead the Helicobacter pylori diagnostics market with a 42% share, as they are the most common site for comprehensive gastrointestinal diagnostics. Equipped with advanced tools and multidisciplinary teams, hospitals conduct a wide range of tests—from endoscopy and histopathology to rapid urease testing—especially for high-risk or symptomatic patients.

Diagnostic Centers

Diagnostic centers contribute around 30% of the market, driven by their efficiency and testing capacity. These facilities play a key role in high-volume H. pylori diagnostics using laboratory-based tools such as ELISA, stool antigen assays, and molecular diagnostics, making them preferred for routine and large-scale screening.

Clinics

Clinics represent approximately 20% of the market and are growing steadily due to the increasing availability of point-of-care testing. These settings provide early screening and quick diagnostics for patients with non-specific GI symptoms, helping streamline referral decisions for more advanced interventions.

Others

The “Others” segment, accounting for 8%, includes non-traditional healthcare settings such as mobile health units, academic research labs, and government health programs. These entities are essential in expanding access to H. pylori testing in remote, underserved, or low-resource regions.

Global Helicobacter Pylori Diagnostics Market, Segmentation by Geography

In this report, the Global Helicobacter Pylori Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Global Helicobacter Pylori Diagnostics Market Share (%), by Geographical Region

North America

North America dominates the Helicobacter pylori diagnostics market with approximately 35% of the global share. The U.S. and Canada benefit from sophisticated diagnostic networks, early adoption of advanced technologies such as PCR and urea breath tests, and high levels of clinical awareness about H. pylori-related conditions like ulcers and gastric cancer.

Europe

Europe commands nearly 28% of the market, with countries like Germany, France, and the UK leading in diagnostic volumes. The region’s mature healthcare infrastructure, along with growing emphasis on early detection and screening programs, fuels consistent demand for both laboratory-based and point-of-care tests.

Asia Pacific

Asia Pacific is home to around 23% of the market and is witnessing the fastest growth globally. This is largely due to the high burden of H. pylori infection, increased healthcare access in developing countries, and rising investment in public health awareness and diagnostics.

Middle East & Africa

Middle East & Africa hold about 7% of the global market share. Improvements in healthcare delivery, government-led screening initiatives, and expansion of urban medical facilities are gradually enhancing H. pylori detection capabilities in this region.

Latin America

Latin America represents approximately 7% of the market. Countries like Brazil and Mexico are leading adopters of non-invasive tests, supported by growing investments in public health and increased availability of diagnostic services across public and private sectors.

This report provides an in depth analysis of various factors that impact the dynamics of Global Helicobacter Pylori Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Rising prevalence of Helicobacter pylori infections
• Rising Awareness of H. pylori-related Diseases

• Growing Healthcare Expenditure - Increasing healthcare expenditure significantly boosts the demand for Helicobacter pylori diagnostics worldwide. Enhanced investments from governments and private sectors lead to better funding for advanced diagnostic technologies and improved patient care. This financial support allows healthcare providers to adopt innovative tools that deliver higher accuracy and faster diagnostic results.

  With increased budgets, widespread screening programs become feasible, especially in regions with a high prevalence of Helicobacter pylori infections, thereby accelerating market growth. Improved healthcare funding also leads to advancements in healthcare infrastructure and accessibility, enabling early and precise detection, which is essential for effective treatment and preventing complications.

  Growing expenditure promotes patient education and awareness initiatives about gastrointestinal diseases caused by Helicobacter pylori. Enhanced awareness encourages more individuals to seek timely testing and treatment, which in turn drives demand for efficient diagnostic solutions. Collectively, these factors create a solid foundation for the market's sustained expansion.

Restraints

• High Cost of Advanced Diagnostic Tools
• Limited Access to Healthcare in Developing Regions

• Lack of Skilled Healthcare Professionals - The shortage of skilled healthcare professionals poses a major challenge to the Helicobacter pylori diagnostics market. Effective diagnosis and management require trained specialists who can accurately interpret results and suggest suitable treatments. However, many regions—particularly developing countries face a deficit of such qualified personnel, limiting the reach and efficacy of diagnostic services.

  This lack of expertise restricts the adoption of advanced diagnostic technologies, as operating sophisticated equipment demands specialized knowledge. It can lead to delays in diagnosis and treatment, negatively impacting patient outcomes and adding strain on healthcare systems.

  Isufficient skilled staff hinders large-scale screening initiatives, which require coordinated efforts to maintain test quality and follow-up care. This workforce shortage slows market penetration and limits growth in areas with high infection rates. Addressing this issue demands focused investment in healthcare education and training.

Opportunities

• Development of Point-of-Care Testing
• Adoption of Non-Invasive Diagnostic Methods

• Expansion of Healthcare Infrastructure - The expansion of healthcare infrastructure creates promising opportunities for growth in the Helicobacter pylori diagnostics market. As new and modernized healthcare facilities emerge globally, the capacity to adopt advanced diagnostic equipment and increase patient screening expands significantly.

  Infrastructure growth typically involves improved laboratory setups, integration of modern technologies, and better data management systems, all of which contribute to more efficient and accurate diagnosis. This is especially impactful in emerging markets where healthcare resources have historically been limited.

  As governments and private entities invest in healthcare access, diagnostic services become more widely available, helping reduce disease burden and supporting early intervention strategies. Additionally, new infrastructure encourages adoption of digital health solutions like telemedicine and electronic health records, which streamline diagnostic processes and improve communication between patients and providers.

Key players in Global Helicobacter Pylori Diagnostics Market include:

• Thermo Fisher Scientific, Inc.
• Bio-Rad Laboratories Inc.
• Diasorin S.P.A.
• Quidel Corporation
• F. Hoffmann-La Roche Ltd. (Ventana Medical Systems, Inc.)
• Meridian Bioscience, Inc.
• Exalenz Bioscience Ltd.
• Abbott Laboratories
• Cardinal Health, Inc.
• Halyard Health, Inc.

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis