Helicobacter Pylori Testing Market – By Test Type (Invasive [Histology, Rapid Urease Test], Non-Invasive [Serologic Test]), Method (Point-of-Care Test, Laboratory Based Test), End-use (Hospitals, Clinics, Diagnostic Laboratories), & Forecast, 2024-2032

Helicobacter Pylori Testing Market Size

Helicobacter Pylori Testing Market size was valued at USD 483 million in 2023 and is anticipated to witness growth at a CAGR of 6.8% from 2024 to 2032. The high market growth is attributed to rising prevalence of various gastrointestinal disorders, growing demand for point of care testing, and increasing adoption of non-invasive helicobacter pylori testing among others.
 

The rise in the prevalence of gastric ulcers is a key driver for the growth of helicobacter pylori (H. pylori) testing market. Gastric ulcers, frequently caused by H. pylori infection, are becoming more common due to factors such as increased stress, smoking, and the overuse of nonsteroidal anti-inflammatory drugs (NSAIDs). As the incidence of gastric ulcers rises, there is a heightened demand for diagnostic testing to accurately identify the presence of H. pylori. For instance, according to the data published by American Gastroenterological Association’s (AGA) Clinical Practice Update, Diagnosis and Treatment of Helicobacter pylori Infection in 2021 stated that H. pylori is found in 70-90% of patients with peptic ulcers. This data supports the critical need for H. pylori testing in managing ulcer-related conditions.
 

Helicobacter pylori (H. pylori) testing refers to a series of diagnostic procedures used to detect the presence of the H. pylori bacterium in the gastrointestinal tract. This bacterium is commonly associated with various stomach conditions, including peptic ulcers, chronic gastritis, and in some cases, gastric cancer. Testing helps in diagnosing active infections, guiding appropriate treatment, and monitoring the effectiveness of therapy.
 

Helicobacter Pylori Testing Market Trends

Significant technological developments in testing landscape are offering favourable opportunities for market growth.
 

• Traditional methods such as invasive endoscopic procedures and biopsy-based testing are being supplemented or replaced by non-invasive techniques such as serology, urea breath tests (UBT), and stool antigen tests (SAT). These advancements enhance patient comfort, reduce procedural risks, and improve diagnostic accuracy.
   
• Additionally, recent improvements in urea breath tests include enhanced sensitivity and specificity, reducing false-positive and false-negative results. Advanced isotopic and non-isotopic UBTs offer quicker results and improved patient convenience.
   
• Moreover, PCR-based methods detect H. pylori DNA directly from clinical samples. Recent advancements in PCR technology have reduced turnaround times and increased sensitivity, making them valuable tools in both diagnosis and monitoring treatment response.
   
• Furthermore, POC tests for H. pylori offer quick results within minutes, allowing healthcare providers to diagnose and initiate treatment during the same visit. These tests are particularly beneficial in resource-limited settings and emergency departments.
   
• The companies are actively involved in development and introduction of technologically advanced testing products, which is further expected to have positive impact on market growth during the forecast period.
   

Helicobacter Pylori Testing Market Analysis

Based on test type, the market is segmented into invasive and non-invasive tests. The non-invasive tests segment held a leading market share of 56.6% in 2023.

• Non-invasive tests, such as the urea breath test (UBT) and stool antigen test (SAT), are generally well-tolerated by patients compared to invasive methods like endoscopy. They involve minimal discomfort and do not require sedation or anesthesia, making them suitable for all age groups.
   
• Additionally, many non-invasive tests provide rapid results, typically within hours for UBT and within days for SAT, allowing healthcare providers to promptly initiate treatment or further diagnostic evaluations as needed. This quick turnaround time is crucial for timely patient management. These factors contribute to segmental growth.  
   

Based on method, the helicobacter pylori testing market is classified as point of care (PoC) tests and laboratory-based tests. The laboratory-based tests segment accounted for the highest market share and was valued at USD 300.6 million in 2023.
 

• Laboratory based tests conducted in clinical laboratories offer comprehensive diagnostic capabilities that are essential for accurate detection and management of H. pylori infection.
   
• Additionally, laboratory-based tests such as polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), and culture methods provide high sensitivity and specificity in detecting H. pylori. They are crucial for confirming infection status, assessing antibiotic resistance patterns, and monitoring treatment efficacy.
   

Based on end-use, the helicobacter pylori testing market is categorized into hospitals, clinics, diagnostic laboratories, and other end-users. The diagnostic laboratories segment held majority market share and is projected to reach USD 390.9 million by 2032.
 

• Diagnostic labs play a crucial role in the accurate detection and management of H. pylori infections, offering a range of specialized tests that contribute to timely diagnosis and effective treatment planning.
   
• Additionally, healthcare providers increasingly rely on laboratory tests to confirm H. pylori infection status, assess antibiotic resistance profiles, and monitor treatment outcomes. These tests include non-invasive methods such as urea breath tests (UBT) and stool antigen tests (SAT), as well as molecular techniques such as polymerase chain reaction (PCR) and culture methods, each providing specific advantages depending on clinical needs and patient circumstances, hence contributes to the segmental growth.
   

North America helicobacter pylori testing market size in 2023 was valued at USD 170.1 million and is predicted to grow at a CAGR of 4.3% over the analysis timeframe.
 

• Increasing prevalence of gastric cancers coupled with rising awareness about H. pylori infections is anticipated to drive the regional market growth during the forecast period.
   
• In addition, ongoing research and development efforts in gastrointestinal diagnostics technologies drive innovation in H. pylori testing. Advances such as rapid point-of-care tests and molecular diagnostic techniques continue to improve testing accuracy, turnaround times, and cost-effectiveness, expanding market opportunities.
   

U.S. helicobacter pylori testing market is anticipated to grow at a CAGR of 4.2% to reach USD 232.9 million by the end of the forecast timeframe.
 

• The growth of the U.S. market is attributed to growing advancements in testing technologies, rising prevalence of H. pylori infections, and active government involvement to contain the infection.
   
• In addition, industrial developments by market players in the country are also projected to have positive impact on the market growth.
   

UK helicobacter pylori testing market is projected to grow remarkably in the coming years.
 

• There is a rising demand for helicobacter pylori (H. pylori) testing driven by increasing awareness of its role in gastrointestinal health. The bacterium's association with conditions like peptic ulcers and its potential link to gastric cancer has heightened diagnostic interest among healthcare providers.
   
• Moreover, advancements in non-invasive testing methods have made screening more accessible and efficient, encouraging broader adoption. This growing demand underscores the importance of early detection and treatment, contributing to improved patient outcomes and reduced healthcare costs associated with managing H. pylori-related illnesses.
   

China is experiencing high market growth in the helicobacter pylori testing market.
 

• Increasing research and development activities for stomach cancer along with focus on controlling the H. pylori infections are major factor driving the market growth in the country.
   
• Additionally, China's investments in healthcare infrastructure and technology enhancements are expanding the availability and quality of diagnostic services. This includes the development and deployment of advanced H. pylori testing methods, contributing to market growth.
   

Helicobacter Pylori Testing Market Share

The market industry is characterized by the presence of several established and emerging players that offers variety of testing products across the globe. The market players compete based on factors such as testing efficiency, products innovation, regulatory compliance, customer service, and pricing strategies.
 

Helicobacter Pylori Testing Market Companies

Prominent players operating in the market industry include:

• Abbott Laboratories
• Advance Pharma
• Avanos Corporate
• Biohit Oyj
• bioMerieux SA
• Bio-Rad Laboratories, Inc.
• Cardinal Health, Inc.
• Epitope Diagnostics
• Gulf Coast Scientific
• Laboratory Corporation of America, Inc.
• Medline Industries
• Meridian Biosciences, Inc.
• Quidel Corporation
• TECHLAB, Inc
• Thermo Fischer Scientific Corporation
   

Helicobacter Pylori Testing Industry News:

• In December 2023, Biomerica, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect Stool Antigen ELISA test, a new product that is designed to detect the presence of the H. pylori bacteria. This approval helped the company to improve its competitiveness in the market.
   
• In July 2023, Meridian Bioscience, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Premier HpSA FLEX for the diagnosis of H. pylori in both preserved and unpreserved stools. This approval expanded the company’s product portfolio and enabled them with increased customer base.
   

The helicobacter pylori testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 - 2032 for the following segments:

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Market, By Test Type

• Invasive
  • Histology
  • Rapid urease test           
  • HP culture   
• Non-invasive
  • Serologic test
  • Urea breath test
  • Stool/fecal antigen test

Market, By Method

• Point of care (POC) tests                             
• Laboratory based tests

Market, By End-use

• Hospitals
• Clinics   
• Diagnostic labs 
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa