Global Helicobacter Pylori Diagnostics Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• 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

The Global Helicobacter Pylori Diagnostics Market is segmented by Technology and End Users, each addressing specific aspects of the diagnostic process for Helicobacter pylori infections. In the Technology segment, the market is divided into Immunoassays, Point-of-Care (POC), and Molecular Diagnostics. Immunoassays, such as enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests (RDTs), are widely used due to their simplicity, cost-effectiveness, and quick turnaround times. These tests detect antibodies or antigens related to H. pylori infection and are often employed in outpatient clinics or primary care settings. POC diagnostics offer the advantage of immediate testing and results at the point of care, with technologies like breath tests and stool antigen tests allowing healthcare providers to diagnose H. pylori infections quickly. These tests are particularly useful in remote or resource-limited areas where laboratory access is limited. Molecular Diagnostics, which includes advanced techniques like polymerase chain reaction (PCR), offers the highest sensitivity and specificity, making it ideal for confirming the presence of H. pylori infection and detecting antibiotic resistance patterns. This method is typically used in more specialized clinical settings or research environments due to its complexity and cost.

The End Users segment of the market includes Hospitals, Diagnostic Centers, Clinics, and Others. Hospitals are one of the largest end-user segments, where a wide range of diagnostic tools are available, and H. pylori testing is typically carried out as part of comprehensive gastroenterological assessments. In hospitals, molecular diagnostics are often preferred for more accurate and definitive results, especially in cases where antibiotic resistance is a concern. Diagnostic Centers are dedicated facilities focused on conducting various tests and diagnostics. These centers offer high throughput testing for H. pylori and benefit from technologies such as immunoassays and POC diagnostics, providing fast and cost-effective services. They play a key role in diagnosing the infection in large populations, particularly in urban areas. Clinics often rely on rapid diagnostic tests and POC technologies to provide on-the-spot diagnoses for patients. With a focus on convenience and speed, clinics can quickly determine if a patient has an H. pylori infection and begin appropriate treatment, particularly in rural or underserved areas where access to hospitals may be limited.

The Others category in the end-user segment includes research laboratories, public health organizations, and remote healthcare facilities. These users rely on advanced technologies such as molecular diagnostics to study the prevalence of H. pylori and assess antibiotic resistance patterns across different populations. Additionally, mobile health units and telemedicine platforms are increasingly contributing to the market by providing remote testing and consultations, expanding access to diagnostics in underserved areas. The diverse range of end users and technologies ensures that the global market for Helicobacter pylori diagnostics can address various healthcare needs, from routine check-ups to specialized research, improving the accessibility and accuracy of H. pylori detection worldwide.

Global Helicobacter Pylori Diagnostics Segment Analysis

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

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.

The Global Helicobacter Pylori Diagnostics Market is segmented by Technology into three primary categories: Immunoassays, Point-of-Care (POC), and Molecular Diagnostics, each offering unique advantages for diagnosing Helicobacter pylori infections, which are linked to various gastrointestinal disorders, including ulcers and stomach cancer.

Immunoassays dominate a significant portion of the market due to their established use in detecting antibodies or antigens related to H. pylori infection. These tests are known for their convenience, relatively low cost, and fast results. Immunoassays include enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests (RDTs), which can detect H. pylori infection through blood, stool, or urine samples. These tests are widely used in clinical settings because they are non-invasive and easy to administer, making them an essential diagnostic tool, especially in primary care and outpatient clinics.

The Point-of-Care (POC) segment is gaining traction due to its ability to provide quick and accurate results directly at the patient's location, without the need for laboratory facilities. POC diagnostics, such as breath tests and rapid stool antigen tests, enable healthcare providers to immediately confirm the presence of H. pylori infection, facilitating faster treatment decisions. These tests are highly valuable in regions with limited access to advanced healthcare infrastructure and where immediate treatment decisions are essential. The Molecular Diagnostics segment, including PCR-based techniques, is the most precise method for detecting H. pylori. Molecular diagnostics offer a high level of sensitivity and specificity, capable of identifying the bacterial DNA in gastric biopsy samples. Though typically more expensive and requiring laboratory facilities, these tests are increasingly used in research and specialized clinical settings to confirm H. pylori infections and assess antibiotic resistance patterns, which is critical for effective treatment strategies.

Together, these technological advancements in diagnostics contribute to a more efficient, precise, and accessible diagnosis of H. pylori infections, improving patient care and outcomes globally.

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.

The segmentation of the Global Helicobacter Pylori Diagnostics Market by end users reflects the diverse range of healthcare settings involved in diagnosing and managing H. pylori infections. Hospitals, as primary healthcare providers, serve as crucial hubs for diagnosing and treating complex gastrointestinal disorders, including those caused by H. pylori. With their comprehensive facilities and specialized expertise, hospitals play a central role in the diagnosis and management of H. pylori-related conditions, making them key contributors to the market.

Diagnostic centers also constitute a significant segment within the market, offering specialized testing services tailored to the detection of H. pylori infections. These centers often employ state-of-the-art diagnostic technologies and specialized personnel, providing accurate and efficient testing services to healthcare providers and patients. Their focus on diagnostic excellence and efficiency further bolsters the capabilities of healthcare systems in combating H. pylori infections.

Clinics, along with other healthcare facilities categorized under "Others," also play essential roles in the Global Helicobacter Pylori Diagnostics Market. These settings offer primary care services and diagnostic testing to patients, often providing accessible and convenient options for H. pylori testing and management. The inclusion of clinics and other healthcare facilities underscores the widespread adoption of H. pylori diagnostics across various healthcare settings, ensuring that patients receive timely and effective care regardless of their healthcare provider or location.

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 and Africa, and Latin America.

Global Helicobacter Pylori Diagnostics Market Share (%), by Geographical Region, 2024

The Global Helicobacter Pylori Diagnostics Market, geographic segmentation into five regions provides insights into the regional dynamics shaping market trends and growth patterns. North America, as a leading region in healthcare innovation and infrastructure, holds a significant share of the market. The presence of advanced diagnostic technologies and a high prevalence of H. pylori infections contribute to the robust demand for diagnostic solutions in this region. Moreover, increasing awareness among healthcare professionals and patients regarding the importance of early detection and management further propels market growth.

Europe, with its well-established healthcare systems and emphasis on preventive medicine, represents another substantial market segment for H. pylori diagnostics. Countries within this region exhibit varying prevalence rates of H. pylori infections, driving demand for a range of diagnostic solutions tailored to regional needs. Additionally, collaborations between research institutions, healthcare providers, and industry players foster innovation and the development of advanced diagnostic tools, further fueling market expansion.

The Asia Pacific region, characterized by its large and diverse population, presents both opportunities and challenges for the Global Helicobacter Pylori Diagnostics Market. Rapid urbanization, changing lifestyles, and increasing healthcare expenditure contribute to the rising prevalence of H. pylori infections in this region. As a result, there is a growing demand for accurate and efficient diagnostic solutions, particularly in emerging economies. However, varying healthcare infrastructure and regulatory frameworks across countries in the Asia Pacific pose challenges for market penetration and distribution, necessitating tailored approaches to address regional disparities and capitalize on growth opportunities.

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:

• Increasing Prevalence
• Rising Awareness of H. pylori-related Diseases

• Growing Healthcare Expenditure - The growth in healthcare expenditure globally is a significant driver influencing the dynamics of the Global Helicobacter Pylori Diagnostics Market. As countries worldwide allocate more resources to healthcare, there is an increased focus on preventive measures and early detection of diseases, including those caused by H. pylori infections. With a larger budget dedicated to healthcare infrastructure, facilities, and diagnostic technologies, healthcare systems are better equipped to invest in advanced diagnostic tools for detecting H. pylori with greater accuracy and efficiency.

  The growing healthcare expenditure contributes to improved access to healthcare services, particularly in underserved regions where H. pylori infections may be prevalent. Increased funding enables the expansion of healthcare facilities, outreach programs, and screening initiatives, thereby enhancing the diagnosis and management of H. pylori-related diseases. This trend not only benefits patients by facilitating early detection and treatment but also stimulates market growth by creating a larger pool of potential consumers for H. pylori diagnostics.

  As healthcare expenditure continues to rise, there is a greater emphasis on research and development in the healthcare sector, driving innovation in diagnostic technologies. This leads to the development of novel diagnostic methods, such as point-of-care testing devices and non-invasive techniques, which offer greater convenience, speed, and accuracy in diagnosing H. pylori infections. The synergistic effect of growing healthcare expenditure and technological advancements fosters a dynamic landscape in the Global Helicobacter Pylori Diagnostics Market, paving the way for improved patient outcomes and market expansion.

Restraints:

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

• Lack of Skilled Healthcare Professionals - The lack of skilled healthcare professionals poses a significant challenge in the context of the Global Helicobacter Pylori Diagnostics Market. Accurate diagnosis and effective management of H. pylori infections require specialized expertise and training, particularly in interpreting diagnostic test results and recommending appropriate treatment options. However, shortages of skilled healthcare professionals, such as gastroenterologists, pathologists, and laboratory technicians, can impede the timely and accurate diagnosis of H. pylori-related diseases.

  In regions facing shortages of skilled healthcare professionals, healthcare systems may struggle to meet the growing demand for H. pylori diagnostics, resulting in delays in diagnosis and treatment. Moreover, the lack of specialized training and expertise among existing healthcare personnel may lead to errors in diagnostic interpretation, potentially resulting in misdiagnosis or inappropriate treatment decisions. Addressing this challenge requires investments in healthcare education and training programs to equip healthcare professionals with the necessary skills and knowledge to effectively diagnose and manage H. pylori infections.

  Innovative solutions such as telemedicine and digital health platforms can help overcome the limitations imposed by the lack of skilled healthcare professionals. Telemedicine allows for remote consultations and diagnostic support, enabling healthcare providers in underserved regions to access expertise and guidance from specialists elsewhere. Additionally, leveraging artificial intelligence and machine learning technologies can assist in automating diagnostic processes, reducing the reliance on human expertise and mitigating the impact of skilled workforce shortages on the accuracy and efficiency of H. pylori diagnostics. By addressing the challenge of skilled workforce shortages through a combination of training initiatives and technological innovations, the Global Helicobacter Pylori Diagnostics Market can better meet the needs of patients worldwide.

Opportunities:

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

• Expansion of Healthcare Infrastructure - The expansion of healthcare infrastructure is a pivotal factor driving the dynamics of the Global Helicobacter Pylori Diagnostics Market. As countries strive to improve access to healthcare services, investments in healthcare infrastructure play a crucial role in enhancing the capacity and reach of diagnostic facilities. The expansion of hospitals, clinics, and diagnostic centers enables greater accessibility to diagnostic tests for H. pylori infections, particularly in underserved regions where healthcare infrastructure may be lacking. This expansion not only facilitates early detection and management of H. pylori-related diseases but also contributes to overall improvements in public health outcomes.

  The expansion of healthcare infrastructure includes investments in laboratory facilities and equipment, which are essential for conducting diagnostic tests for H. pylori infections. State-of-the-art laboratories equipped with advanced diagnostic technologies enable accurate and efficient detection of H. pylori, thus improving diagnostic accuracy and reducing turnaround times. Additionally, the expansion of laboratory networks and the decentralization of diagnostic services to rural and remote areas enhance accessibility to diagnostic testing for individuals living in these regions, ultimately contributing to the broader goals of healthcare equity and universal access.

  The expansion of healthcare infrastructure fosters collaborations between public and private stakeholders, driving innovation and investment in diagnostic technologies for H. pylori detection. Public-private partnerships facilitate the sharing of resources, expertise, and technological advancements, leading to the development of novel diagnostic tools and approaches. These collaborations contribute to the continuous improvement of diagnostic capabilities in the Global Helicobacter Pylori Diagnostics Market, ultimately benefiting patients by enabling early detection, timely treatment, and improved management of H. pylori-related diseases.

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
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis