Dublin, July 14, 2026 (GLOBE NEWSWIRE) -- The "Helicobacter Pylori (H. Pylori) Infection - Market Insights, Epidemiology, and Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.
Helicobacter pylori (H. pylori) Infection - Market Insights, Epidemiology and Market Forecast - 2036 report projects that the H. pylori infection market will expand from approximately USD 270 million in 2025 to nearly USD 720 million by 2036 across the six major markets (6MM): the United States, Germany, France, Italy, Spain, and the United Kingdom. The market is expected to grow at a CAGR of 9.4% from 2026 through 2036.
The United States represented the largest regional H. pylori infection market in 2025, generating approximately USD 230 million. Growth through 2036 is expected to be driven by the transition from low-cost generic regimens to premium branded therapies, persistent eradication failures with existing standards of care, expanding access to non-invasive diagnostics, and greater use of resistance-guided treatment.
H. pylori Epidemiology and Disease Burden
The report estimates that approximately 148 million diagnosed prevalent H. pylori infection cases were recorded across the 6MM in 2025. Spain accounted for the highest diagnosed prevalence among the EU4 and the United Kingdom, while the United Kingdom reported the lowest. Spain's elevated burden is associated with persistent intrafamilial transmission, historically high infection rates among older cohorts, and regional socioeconomic and household factors.
Although the overall infection burden is declining as hygiene, sanitation, living conditions, and antibiotic access improve, prevalence remains substantial. In the United States, prevalence generally increases with age, reflecting historical exposure and slower declines among older populations.
Treatment Landscape Shifts Toward Resistance-Guided Therapy
Rising antibiotic resistance and continued eradication failures are reshaping the H. pylori treatment landscape. Molecular testing, including PCR-based detection of resistance mutations such as 23S rRNA mutations associated with clarithromycin resistance, is increasingly supporting individualized treatment selection instead of empirical therapy.
Current treatment options include omeprazole magnesium, amoxicillin, and rifabutin marketed as TALICIA; vonoprazan-based VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK; and the bismuth, metronidazole, and tetracycline combination PYLERA. Bismuth quadruple therapy also remains important where clarithromycin resistance is high or susceptibility is unknown.
TALICIA, developed by RedHill BioPharma and co-commercialized in the United States with Cumberland Pharmaceuticals, provides a rifabutin-based option for adult H. pylori infection. RedHill BioPharma has also submitted a UK Marketing Authorization Application for TALICIA, which is under review by the Medicines and Healthcare products Regulatory Agency.
VOQUEZNA-based regimens provide sustained acid suppression and are expected to play a significant commercial role. DelveInsight projects that VOQUEZNA DUAL PAK and VOQUEZNA TRIPLE PAK will generate the highest H. pylori therapy revenue in the United States by 2036.
Emerging H. pylori Pipeline
The H. pylori infection pipeline remains limited but includes several potentially important candidates. Key therapies in development include rifasutenizol (TNP-2198) from TenNor Therapeutics, linaprazan glurate from Cinclus Pharma, and tegoprazan/RQ-00000004 involving RaQualia Pharma, HK inno.N, and Braintree.
Rifasutenizol is an investigational oral antibacterial candidate designed to address resistant H. pylori strains. TenNor Therapeutics plans to initiate a Phase IIb clinical trial in the United States during the second half of 2026, followed by Phase III development. Based on the anticipated clinical and regulatory timeline, DelveInsight estimates a potential market launch in 2030.
Cinclus Pharma reported plans to begin H. pylori clinical studies in 2026, with results expected in 2027. The company aims to submit regulatory applications to the US Food and Drug Administration and European Medicines Agency in 2027, targeting potential approval in 2028 or 2029.
Market Opportunities and Unmet Needs
Major unmet needs include increasing treatment resistance, a limited number of consistently effective therapies, insufficient susceptibility testing, restricted diagnostic access, limited vaccine progress, and a shortage of current epidemiological and antibiotic resistance data. These gaps complicate disease burden assessment, treatment selection, surveillance, and prevention planning.
High eradication failure rates also prolong exposure to H. pylori-associated disease and increase the likelihood of repeated antibiotic treatment, further contributing to resistance. Therapies that improve eradication, simplify administration, and demonstrate effectiveness against resistant strains are therefore positioned for meaningful clinical and commercial uptake.
Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
4.1. Upcoming Key Catalysts
4.2. Key Conferences and Meetings
4.3. Key Transactions And Collaborations
4.4. News Flow
5. Epidemiology and Market Forecast Methodology
6. H. pylori Infection Market Overview at a Glance
6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
6.2. Market Share (%) Distribution of H. pylori Infection By Therapies in the 6MM, in 2025
6.3. Market Share (%) Distribution of H. pylori Infection By Therapies in the 6MM, in 2036
7. Disease Background and Overview
7.1. Introduction
7.2. Causes and Risk Factors
7.2.1. Associated risk factors
7.3. Physiopathology
7.4. Signs and Symptoms
7.5. Diagnosis
7.5.1. Differential Diagnosis
7.5.2. Diagnostic Algorithm
7.5.3. Diagnostic Guidelines
7.5.3.1. . American College of Gastroenterology (ACG) Clinical Guidelines (2025)
7.5.3.2. . The Maastricht V/Florence Consensus Report (2022)
8. Treatment of H. pylori Infection
8.1. Treatment Algorithm
8.2. Treatment Guidelines
8.2.1. ACG Clinical Guidelines (2024)
8.2.2. The Maastricht V/Florence Consensus Report (2022)
9. Epidemiology and Patient Population of H. pylori Infection
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Diagnosed Prevalent Cases of H. pylori Infection in the 6MM
9.4. The United States
9.4.1. Total Diagnosed Prevalent Cases of H. pylori Infection in the United States
9.4.2. Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States
9.4.3. Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States
9.5. EU4 and the UK
9.5.1. Total Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK
9.5.2. Subtype-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK
9.5.3. Age-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK
10. Patient Journey of H. pylori Infection
11. Marketed Therapies
11.1. Key Cross Competition
11.2. Omeprazole Magnesium, Amoxicillin, and Rifabutin (TALICIA): RedHill BioPharma/Cumberland Pharmaceuticals
11.2.1. Drug Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Summary of Pivotal Trials
11.2.5. Analyst Views
11.3. Vonoprazan, Amoxicillin, Clarithromycin (VOQUEZNA TRIPLE) and Vonoprazan, Amoxicillin (VOQUEZNA DUAL) PAKs: Phathom Pharmaceuticals
11.3.1. Drug Description
11.3.2. Regulatory Milestones
11.3.3. Other Developmental Activities
11.3.4. Summary of Pivotal Trials
11.3.5. Analyst Views
11.4. Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride (PYLERA): Juvise Pharmaceuticals/AbbVie
11.4.1. Drug Description
11.4.2. Regulatory Milestones
11.4.3. Other Developmental Activities
11.4.4. Summary of Pivotal Trials
11.4.5. Analyst Views
12. Emerging Drugs
12.1. Key Cross Competition
12.2. Rifasutenizol (TNP-2198): TenNor Therapeutics
12.2.1. Drug Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trials Information
12.2.4. Analyst Views
12.3. Linaprazan glurate: Cinclus Pharma
12.3.1. Drug Description
12.3.2. Other Developmental Activities
12.3.3. Analyst Views
12.4. Tegoprazan (RQ-00000004): RaQualia Pharma/ HK inno.N /Sebela Pharmaceuticals
12.4.1. Drug Description
12.4.2. Other Developmental Activities
12.4.3. Analyst Views
13. H. pylori Infection: 6MM Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Key Market Forecast Assumptions
13.3.1. Cost Assumptions
13.4. Conjoint Analysis
13.5. Total Market Size of H. pylori Infection in the 6MM
13.6. Total Market Size of H. pylori Infection by Therapies in the 6MM
13.7. The United States
13.7.1. Total Market Size of H. pylori Infection in the United States
13.7.2. Total Market Size of H. pylori Infection by Therapies in the United States
13.8. EU4 and the UK
13.8.1. Total Market Size of H. pylori Infection in EU4 and the UK
13.8.2. Total Market Size of H. pylori Infection by Therapies in EU4 and the UK
14. Unmet Needs of H. pylori Infection
15. SWOT Analysis of H. pylori Infection
16. KOL Views of H. pylori Infection
17. Market Access and Reimbursement of H. pylori Infection
17.1. The United States
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. United Kingdom
17.3. Summary and comparison of Market Access and Pricing Policy Developments in 2025
17.4. Market Access and Reimbursement of H. pylori Infection Therapies
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. Publisher Capabilities
20. Disclaimer
21. About the Publisher
List of Tables
Table 1: Summary of H. pylori Infection Epidemiology and Market (2026-2036)
Table 2: Upcoming Key Catalysts
Table 3: Conference Highlights
Table 4: Key Transactions and Collaborations
Table 5: News Flow
Table 6: Sensitivity, Specificity, and Limitations of H. pylori Detection
Table 7: Recommended Regimens for the Diagnosis of Patients With H. pylori Infection
Table 8: Guidelines for the Diagnosis of H. pylori Infection
Table 9: Recommended Regimens for Treatment-naive Patients With H. pylori Infection
Table 10: Recommended Salvage Regimens for Treatment-experienced Patients With Persistent H. pylori Infection
Table 11: Guidelines for the Management of H. pylori Infection
Table 12: Diagnosed Prevalence Rate of H. pylori in the 6MM
Table 13: Total Diagnosed Prevalent Cases of H. pylori Infection in the 6MM (2022-2036)
Table 14: Total Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Table 15: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Table 16: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Table 17: Total Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Table 18: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Germany (2022-2036)
Table 19: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in France (2022-2036)
Table 20: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Italy (2022-2036)
Table 21: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Spain (2022-2036)
Table 22: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the UK (2022-2036)
Table 23: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Table 24: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Germany (2022-2036)
Table 25: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in France (2022-2036)
Table 26: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Italy (2022-2036)
Table 27: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Spain (2022-2036)
Table 28: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the UK (2022-2036)
Table 29: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Table 30: Comparison of Marketed Therapies
Table 31: List of Pipeline/Emerging Therapies
Table 32: Rifasutenizol (TNP-2198), Clinical Trial Description, 2026
Table 33: Summary of Key Differences: VOQUEZNA vs TALICIA
Table 34: H. Pylori Treatment Regimens
Table 35: Management of H. pylori Infection and Effectiveness of First-Line Therapy Among Spanish Regions
Table 36: Key Market Forecast Assumptions of H. pylori Infection (1L setting) in the United States
Table 37: Key Market Forecast Assumptions of H. pylori Infection (2L and above setting) in the United States
Table 38: Key Market Forecast Assumptions of H. pylori Infection (1L setting) in EU4 and the UK
Table 39: Key Market Forecast Assumptions of H. pylori Infection (2L setting) in EU4 and the UK
Table 40: Total Market Size of H. pylori Infection in the 6MM, USD million (2022-2036)
Table 41: Total Market Size of H. pylori Infection by Therapies in the 6MM, USD million (2022-2036)
Table 42: Total Market Size of H. pylori Infection in the United States, USD million (2022-2036)
Table 43: Total Market Size of H. pylori Infection by Therapies in the United States, USD million (2022-2036)
Table 44: Total Market Size of H. pylori Infection in EU4 and the UK, USD million (2022-2036)
Table 45: Total Market Size of H. pylori Infection by Therapies in Germany, USD million (2022-2036)
Table 46: Total Market Size of H. pylori Infection by Therapies in France, USD million (2022-2036)
Table 47: Total Market Size of H. pylori Infection by Therapies in Italy, USD million (2022-2036)
Table 48: Total Market Size of H. pylori Infection by Therapies in Spain, USD million (2022-2036)
Table 49: Total Market Size of H. pylori Infection by Therapies in the UK, USD million (2022-2036)
Table 50: Total Market Size of H. pylori Infection by Therapies in EU4 and the UK, USD million (2022-2036)
Table 51: US Reimbursement for H. pylori Infection Therapies
Table 52: HAS Decisions for H. pylori Infection Therapies
Table 53: AIFA Assessment for H. pylori Infection Therapies
List of Figures
Figure 1: Pathophysiology of H. pylori
Figure 2: Signs and Symptoms of H. pylori
Figure 3: Diagnostic Methods
Figure 4: Diagnostic Algorithm
Figure 5: Treatment Algorithm
Figure 6: ACG Clinical Guidelines 2024
Figure 7: Total Diagnosed Prevalence of H. pylori Infection in the 6MM (2022-2036)
Figure 8: Total Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Figure 9: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Figure 10: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the United States (2022-2036)
Figure 11: Total Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Figure 12: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Figure 13: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2022-2036)
Figure 14: Prescription Trends of H. pylori Infection Therapies (1L) in Europe [2013-2022]
Figure 15: Variation in Treatment Duration of H. pylori Infection Therapies (1L) in Europe [2013-2022]
Figure 16: Variation in PPI Dosage of H. pylori Infection Therapies (1L) in Europe [2013-2022]
Figure 17: Effectiveness of H. pylori Infection Therapies (1L) in Europe [2013-2022]
Figure 18: Regional Variation Effectiveness of H. pylori Infection Therapies (1L) in Europe [2013-2022]
Figure 5: Strategic Roadmap With Dense Upcoming News Flow For Linaprazan Glurate
Figure 19: Total Market Size of H. pylori Infection in the 6MM in USD million (2022-2036)
Figure 20: Total Market Size of H. pylori Infection by Therapies in the 6MM in USD million (2022-2036)
Figure 21: Total Market Size of H. pylori Infection in the United States in USD million (2022-2036)
Figure 22: Total Market Size of H. pylori Infection by Therapies in the United States in USD million (2022-2036)
Figure 23: Total Market Size of H. pylori Infection in EU4 and the UK in USD million (2022-2036)
Figure 24: Total Market Size of H. pylori Infection by Therapies in EU4 and the UK in USD million (2022-2036)
Figure 25: HTA
Figure 26: The 6MM HTA Bodies
Figure 27: The US Healthcare Programs
Figure 28: Reimbursement Process of Germany
Figure 29: Reimbursement Process of France
Figure 30: Reimbursement Process of Italy
Figure 31: Reimbursement Process in Spain
Figure 32: Reimbursement Process in the United Kingdom
Figure 33: UK MHRA Approval Through IRF
A selection of companies mentioned in this report includes, but is not limited to: RedHill BioPharma
- Cumberland Pharmaceuticals
- Phathom Pharmaceuticals
- Juvise Pharmaceuticals
- AbbVie
- TenNor Therapeutics
- Cinclus Pharma
- RaQualia Pharma
- HK-inno.N
- Braintree (Sebela Pharmaceuticals)
For more information about this report visit https://www.researchandmarkets.com/r/wmmjvg
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