Helicobacter Pylori Testing Market Report

Helicobacter Pylori Testing Market Synopsis

The Global Helicobacter Pylori Testing Market was valued at USD 458.5 million in 2024 and is expected to grow from USD 490.9 million in 2025 to USD 847.6 million by 2033, reflecting a CAGR of 7.1% over the forecast period.

The helicobacter pylori testing market encompasses non-invasive tests like urea breath tests, stool antigen tests, and blood antibody tests, or invasive tests like endoscopy with biopsy. The increasing popularity of gastrointestinal disorders, the growing popularity of the importance of early diagnosis, and the development of quick and effective methods of diagnosis drive growth. The increasing utilization of point-of-care testing and increasing healthcare accessibility in the up-and-coming markets also contributes to demand.

Key Takeaways of the Helicobacter Pylori Testing Market

o   On the basis of Test Type, the Non-invasive segment is expected to lead the Helicobacter Pylori Testing Market with the revenue share of 62.4% throughout the forecast period.

o   The Laboratory based tests, by Method, is projected to be the most significant shareholder of 56.9% of the Helicobacter Pylori Testing Market through the projection period.

o   In terms of End-Use, the Diagnostic labs category is forecasted to the biggest market share of 61.2% of Helicobacter Pylori Testing Market throughout the forecast period.

o   North America is expected to dominate the market over the forecast period with the revenue share of 34.1%.

Helicobacter Pylori Testing Market Driver Analysis

Increasing Awareness About Early Diagnosis and Preventive Healthcare

Raising awareness regarding early diagnosis and preventive medical care is one of the leading drivers of the Helicobacter Pylori Testing Market. Patients and health practitioners are appreciating the value of ensuring that H. pylori infections are detected at an early stage to avoid the complications associated with the infection, including ulcer, chronic gastritis, and gastric cancer. Governments, health care organizations, and non-governmental organizations are also actively supporting screening methods and sensitization programs that emphasize the advantages of early testing. This increased focus on prevention, as opposed to late-stage treatment, is motivating the deployment of non-invasive and dependable diagnostic tools, which will eventually increase the demand of H. pylori testing throughout the world.

Helicobacter Pylori Testing Market Restraint Analysis

Limited Access to Advanced Diagnostic Tools in Low-Resource Settings

A significant constraint on the Helicobacter Pylori Testing Market is the limited access to sophisticated diagnostic tools in low-resource situations. Most developing areas do not have proper healthcare facilities, well-trained personnel, and current laboratories to carry out proper tests like urea breath test or molecular analysis. Patients are not always able to obtain reliable testing due to high prices and a shortage of advanced equipment in the rural or underserved regions. This causes numerous infection cases to go un-diagnosed or diagnosed at a later stage which increases risks of serious gastrointestinal diseases and causes the market to grow more slowly.

Helicobacter Pylori Testing Market Opportunity Analysis

Expansion of Point-of-care and Home-based Diagnostic Testing

The point-of-care and home-based diagnostic testing is one of the opportunities which the Helicobacter Pylori Testing Market has in the future. These solutions enable quick, convenient and less expensive diagnosis of infections, without using special laboratory facilities. Portable point-of-care devices and home-based kits increase access to testing to underserved or remote areas, as well as decreasing the workload on hospitals and diagnostic centers. As the number of patients wants to get faster results and the number of patients opting to use self-testing methods increases, the creation of diagnostic tools that are reliable and easy to use will help in enhancing the rate of market growth and also increase the rates of early detection.

Helicobacter Pylori Testing Market Trend Analysis

Increasing Adoption of Molecular Diagnostics for Higher Sensitivity

The adaptation of molecular diagnostics to greater sensitivity is a new trend in the Helicobacter Pylori Testing Market. Polymerase chain reaction (PCR) is a molecular method that offers better and more reliable results to indicate the presence of H. pylori than conventional methods. The tests are able to detect bacterial DNA even at low concentration thereby minimising cases of false negatives and enhancing early detection. Also, molecular diagnostics is able to identify antibiotic resistance to assist the physician in making good treatment regimens. With the increasing popularity of precision medicine, a transition towards more complex molecular-based testing will likely become instrumental in the future of the market.

Helicobacter Pylori Testing Market Segment Analysis

The Helicobacter Pylori Testing Market is segmented on the basis of Test Type, Method, and End-Use.

By Test Type

o   Invasive

o   HP culture   

o   Histology

o   Rapid urease test           

o   Non-invasive

o   Urea breath test

o   Serologic test

o   Stool/fecal antigen test

By Method

o   Laboratory based tests

o   Point of care (POC) tests      

By End-Use

o   Hospitals

o   Clinics   

o   Diagnostic labs 

o   Other End-Users

By Region

o   North America (U.S., Canada, Mexico)

o   Eastern Europe (Bulgaria, The Czech Republic, Hungary, Poland, Romania, Rest of Eastern Europe)

o   Western Europe (Germany, UK, France, Netherlands, Italy, Russia, Spain, Rest of Western Europe)

o   Asia Pacific (China, India, Japan, South Korea, Malaysia, Thailand, Vietnam, The Philippines, Australia, New-Zealand, Rest of APAC)

o   Middle East & Africa (Turkey, Bahrain, Kuwait, Saudi Arabia, Qatar, UAE, Israel, South Africa)

o   South America (Brazil, Argentina, Rest of SA)

By Test Type, Non-invasive Segment is Expected to Dominate the Market During the Forecast Period

The non-invasive segment is likely to lead the helicobacter pylori testing market over the forecast period. Non-invasive tests like urea breath tests, stool antigen tests, and serology are quite popular as they are easily performed, do not cause discomfort to patients, and provide fast and precise results without requiring the use of endoscopy. They are cheaper, less risky, and can be done at large-scale screening programs, so they are more accessible in the developed and emerging markets. This segment is further being dominated by the increasing need to detect the disease at an early stage and the development of non-invasive technologies that are fast and reliable.

By Method, the Laboratory based tests Segment is Expected to Held the Largest Share

The laboratory-based tests segment is projected to occupy the highest share of the helicobacter pylori testing market. The application of laboratory testing procedures such as urea breath test, stool antigen test and molecular diagnostics is common because they are highly accurate, reliable and can handle large volumes of samples. These are the tests that are chosen in hospitals and diagnostic centers where the exact results play an important role in planning treatment. The presence of sophisticated devices, the increasing focus on evidence-based diagnosis, and the increased proportion of patients undergoing regular gastrointestinal screening are some of the reasons to believe that laboratory-based testing will dominate the forecast period.

By End-Use, the Diagnostic Labs Segment is Expected to Held the Largest Share

The diagnostic labs segment is projected to have the largest market share in the Helicobacter Pylori Testing Market. Laboratories offering diagnostic tests are the main facilities where proper and thorough examinations are done with the help of modernized equipment and qualified personnel. Labs are chosen because patients and medical practitioners believe that labs can provide accurate and reliable results on a variety of tests, such as urea breath, stool antigen, and molecular diagnostics. The high number of diagnostic labs in the market is being fueled by the growing demand of specialized gastrointestinal testing, rising number of referrals across hospitals and clinics and the trend to outsource diagnostic services.

Helicobacter Pylori Testing Market Regional Insights

North America is Expected to Dominate the Market Over the Forecast period 

North America is likely to dominate helicobacter pylori testing market during the forecast period. The strong awareness on gastrointestinal diseases, the well-established healthcare facilities, and the availability of sophisticated diagnostic measures have emerged as the strengths of the region. An increase in the prevalence of H. pylori infections, along with the increased attention to early diagnosis and preventive measures, further increases the demand of the test. In addition, the presence of leading diagnostic companies, favorable reimbursement regulations, and increased investments in research and development support the North American domination of the international market.

Recent Development

In December 2023, Biomerica, Inc. announced that it has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect Stool Antigen ELISA test, a new diagnostic product developed to identify the presence of H. pylori bacteria. This approval has strengthened the company’s competitive position in the market.

In July 2023, Meridian Bioscience, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Premier HpSA FLEX for diagnosing H. pylori in both preserved and unpreserved stool samples. This approval broadened the company’s product portfolio and helped expand its customer base.

Active Key Players in the Helicobacter Pylori Testing Market

o   Advance Pharma

o   Abbott Laboratories

o   Avanos Corporate

o   bioMerieux SA

o   Biohit Oyj

o   Bio-Rad Laboratories, Inc.

o   Epitope Diagnostics

o   Cardinal Health, Inc.

o   Gulf Coast Scientific

o   Medline Industries

o   Laboratory Corporation of America, Inc.

o   Meridian Biosciences, Inc.

o   Other Key Players

Global Helicobacter Pylori Testing Market Scope