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Helicobacter pylori (H. pylori) is one of the most common bacterial infections globally, affecting around 50% of the world’s population according to various gastroenterology associations. The bacteria colonizes the stomach lining and can cause gastritis, peptic ulcers, and even gastric cancer if left untreated.
Helicobacter pylori diagnostics are crucial tools that help healthcare professionals detect active infections quickly and accurately. By 2025, non-invasive diagnostics such as urea breath tests and stool antigen tests make up approximately 68% of global test usage due to their convenience and high accuracy. Meanwhile, invasive endoscopic biopsy tests still account for about 28% of tests, especially in patients with chronic symptoms requiring biopsy confirmation.
Healthcare systems worldwide continue to encourage early screening. National screening programs in countries like Japan, South Korea, and parts of Europe aim to reduce the burden of stomach cancers by diagnosing and treating H. pylori early. Rapid advances in point-of-care kits and home-based sampling methods are also driving market penetration in primary care settings and emerging economies.
The Helicobacter Pylori Diagnostics market size was valued at USD 171.9 million in 2023 and is projected to reach USD 189.27 million in 2024, with an expected growth to USD 408.66 million by 2032, exhibiting a CAGR of 10.1%.
How Big is the Helicobacter Pylori Diagnostics Industry in 2025?
In 2025, the Helicobacter pylori diagnostics industry is projected to support over 105 million tests performed globally each year, marking steady growth compared to previous years. Rising patient awareness, improving insurance coverage for routine screenings, and the availability of faster, more patient-friendly tests continue to drive demand.
North America leads with around 24% of the world’s total test volumes, translating to about 25 million tests annually. The USA alone conducts nearly 20 million tests each year across hospitals, clinics, and reference labs. Breath tests are increasingly popular, with about 55% of all U.S. H. pylori tests being non-invasive.
Asia Pacific is the fastest-growing region by test volume. High infection prevalence rates in countries like China and India contribute to over 28% of global tests, estimated at 29 million tests annually. In rural areas, awareness campaigns and government-supported screening are pushing local clinics to adopt rapid stool antigen test kits, which are easier to use than biopsy-based methods.
Europe remains a mature but vital market, accounting for about 30% of global test volumes — roughly 31 million tests each year. Widespread insurance reimbursement for gastroenterology diagnostics in countries like Germany, France, and the UK ensures steady demand. Eastern European nations, meanwhile, are scaling up screening as gastric cancer rates remain high.
The remaining 18% of tests are conducted across Latin America, the Middle East, and Africa, equating to about 20 million annual tests. Here, large urban hospitals and regional labs are investing in upgraded diagnostics to improve detection rates. As more governments prioritize early detection, this figure is expected to grow further.
Global Distribution of Helicobacter Pylori Diagnostics Manufacturers by Country in 2025
Manufacturers of H. pylori diagnostic products — from rapid test kits to laboratory analyzers — are spread worldwide. North America continues to dominate, with around 35% of the global manufacturing base. The region is home to top companies such as Thermo Fisher Scientific, Beckman Coulter, Medline Industries, and Quidel, all of which operate advanced production and distribution hubs that serve domestic and export markets.
Europe accounts for nearly 32% of the world’s manufacturers, with countries like Switzerland, Germany, the UK, and Belgium hosting reputable diagnostic companies. F. Hoffmann-La Roche, Alpha Laboratories, and Coris BioConcept are notable European players. The EU’s stringent regulatory framework ensures that manufacturers maintain high quality standards, driving strong demand for European test kits in emerging markets.
Asia Pacific holds about 25% of global manufacturing, as local companies expand operations to meet rising domestic demand. Japan and South Korea are at the forefront, with established healthcare infrastructure supporting both domestic supply and exports. China and India, with large patient pools, also attract contract manufacturing and local assembly operations for global diagnostic brands.
Latin America and the Middle East & Africa together account for approximately 8% of the manufacturing base. While still developing, these regions are gradually building local assembly and distribution capacity to reduce reliance on imports. Governments are offering incentives to multinationals to establish local manufacturing, boosting job creation and improving supply chain resilience.
Regional Market Share & Helicobacter Pylori Diagnostics Opportunities
North America remains the largest regional market, making up about 37% of global test usage. The USA alone accounts for over half of this share due to routine screenings and higher awareness about gastrointestinal health. Major hospitals and clinics rely on reliable supply chains and the widespread adoption of non-invasive diagnostics.
Europe captures around 30% of global market share, led by advanced healthcare systems and supportive insurance frameworks. In countries like Germany, around 70% of H. pylori tests are prescribed for patients with recurring dyspepsia symptoms. National cancer control strategies have also included routine H. pylori detection as part of preventive screening.
Asia Pacific holds about 27% market share, with infection rates remaining high across China, India, Japan, and parts of Southeast Asia. In Japan alone, routine testing for H. pylori is included in gastric cancer screening programs, covering more than 12 million patients annually. India is pushing awareness campaigns to reach underserved populations through affordable stool tests and breath tests.
Latin America and the Middle East & Africa, while smaller in volume, are seeing consistent growth. Together, they hold about 6% of the global share, supported by urban healthcare investments. Brazil and Mexico are the largest markets in Latin America, with gastroenterology clinics increasingly stocking rapid diagnostic kits. In the Middle East, countries like Saudi Arabia and the UAE are equipping regional hospitals with point-of-care solutions to detect H. pylori infections early.
USA Growing Helicobacter Pylori Diagnostics Market
The United States is the single largest national market for H. pylori diagnostics, responsible for about 20% of all global tests in 2025. Over 12 million new cases are screened annually, driven by high levels of patient awareness and regular check-ups with gastroenterologists. More than 55% of tests in the USA are non-invasive breath tests, favored for their convenience and speed.
Retail clinics, telehealth providers, and urgent care centers are also boosting market penetration. The availability of home-based sampling kits is increasing — industry surveys show that 1 in 5 patients prefer at-home stool tests or self-administered breath tests, which can be mailed to central labs for processing.
Key companies like Thermo Fisher Scientific, Medline Industries, Cardinal Health, and Quidel maintain extensive U.S. distribution networks that ensure quick turnaround of test kits and reagents to hospitals and labs nationwide. Innovations such as digital reporting, automated analyzers, and integration with electronic health records (EHR) help streamline patient management.
The U.S. Centers for Disease Control and Prevention (CDC) and the American Gastroenterological Association (AGA) continue to push for broader screening among at-risk groups, especially immigrant populations and older adults with persistent digestive issues. This steady flow of diagnostic testing solidifies the USA’s position as a leading, innovation-driven market for H. pylori detection.
Global Growth Insights unveils the top List global Helicobacter Pylori Diagnostics Companies:
| Company | Headquarters | 2024 CAGR | Revenue (Past Year) |
|---|---|---|---|
| Sekisui Diagnostics | Framingham, Massachusetts, USA | 4.2% | USD 320 Million |
| F. Hoffmann-La Roche | Basel, Switzerland | 3.8% | USD 1.2 Billion |
| Medline Industries | Northfield, Illinois, USA | 4.1% | USD 500 Million |
| Meridian Bioscience | Cincinnati, Ohio, USA | 4.5% | USD 190 Million |
| Bio-Rad Laboratories | Hercules, California, USA | 4.0% | USD 1.5 Billion |
| Thermo Fisher Scientific | Waltham, Massachusetts, USA | 3.9% | USD 2.8 Billion |
| Alpha Laboratories | Eastleigh, United Kingdom | 3.5% | USD 85 Million |
| EKF Diagnostics | Cardiff, Wales, UK | 4.4% | USD 55 Million |
| Quidel | San Diego, California, USA | 4.3% | USD 310 Million |
| Halyard Health | Alpharetta, Georgia, USA | 3.6% | USD 75 Million |
| Cardinal Health | Dublin, Ohio, USA | 3.7% | USD 2.0 Billion |
| Beckman Coulter | Brea, California, USA | 3.9% | USD 850 Million |
| Agilent Technologies | Santa Clara, California, USA | 4.0% | USD 1.0 Billion |
| Coris BioConcept | Gembloux, Belgium | 4.1% | USD 40 Million |
Regional Insights: Key Highlights
- In Europe, over 70% of all H. pylori tests are performed in hospitals and specialized gastroenterology clinics.
- Japan screens over 12 million people annually, integrating H. pylori tests with gastric cancer prevention programs.
- In India, regional health programs have trained over 50,000 rural healthcare workers to administer affordable rapid stool tests.
- China remains a major market with about 20% of Asia Pacific’s test volumes, especially in urban hospitals.
- Latin America shows steady growth, with Brazil leading in test volumes due to increased funding for regional labs.
- In the Middle East, private hospitals in Saudi Arabia and UAE have upgraded lab facilities, boosting annual test volumes by 15% over the last three years.
Conclusion
The Helicobacter pylori diagnostics market in 2025 illustrates the growing importance of early, accurate, and patient-friendly testing methods to prevent serious gastric conditions. With robust demand in North America, steady screening in Europe, and surging test volumes in Asia Pacific, the market offers significant opportunities for manufacturers, distributors, and lab service providers.
Top companies like Sekisui Diagnostics, F. Hoffmann-La Roche, Thermo Fisher Scientific, and Quidel are expanding their product lines and local presence to meet rising demand. As emerging regions invest in lab infrastructure and public awareness, the global outlook remains strong for innovative, accessible, and cost-effective H. pylori diagnostics.
FAQs: Global Helicobacter Pylori Diagnostics Companies
Q1. What is Helicobacter pylori diagnostics?
They are tests used to detect H. pylori bacteria in the stomach, helping prevent gastritis, ulcers, and gastric cancers.
Q2. Who are the top companies?
Key players include Sekisui Diagnostics, Roche, Medline, Thermo Fisher Scientific, Quidel, and Cardinal Health.
Q3. How big is the market in the USA?
The USA accounts for about 20% of global tests, with over 12 million new cases screened each year.
Q4. Which tests are most common?
Breath tests and stool antigen tests make up about 68% of all global tests in 2025.
Q5. What opportunities exist in emerging regions?
Expanding lab capacity, rural awareness campaigns, and affordable rapid kits offer major growth avenues in Asia Pacific, Latin America, and MEA.