Helicobacter pylori Infection market size in the 7MM was approximately USD 2,672.5 million in 2022 and is projected to increase by 2034 | DelveInsight

Leading companies active in the Helicobacter pylori (H. pylori) infection treatment landscape include Servatus Biopharmaceuticals, Cinclus Pharma Holding AB, Crestone, EpiVax, Iguana Biotechnology, ImevaX GmbH, ImmunoBiology, Luoxin Pharmaceuticals, Nexbiome Therapeutics, Recce Pharmaceuticals, RedHill Biopharma Ltd, SCG Cell Therapy Pte Ltd, Shanghai High-Tech Bioengineering Co. Ltd, Takeda Pharmaceutical, TenNor Therapeutics, Trio Medicines, Xiamen Encheng Pharmaceutical Co. Ltd, others.
Helicobacter Pylori Infections Market Overview

In 2022, the United States represented the largest share of the H. pylori infection market within the 7MM, valued at approximately USD 1,064.8 million, with expectations of continued growth through 2034. Clarithromycin-based triple therapy - consisting of a proton pump inhibitor (PPI), clarithromycin, and either amoxicillin or metronidazole - remains the dominant treatment approach, generating around USD 351 million in revenue in 2022. Market expansion is primarily driven by increasing disease prevalence, though rising antimicrobial resistance remains a significant hurdle.

Existing therapies such as PREVPAC, PYLERA, and various generics are designed to eradicate the bacteria, promote ulcer healing, and reduce recurrence rates. Recently approved and relaunched therapies, including RedHill's TALICIA and Phathom Pharmaceuticals' VOQUEZNA (approved in 2022 and reintroduced in 2023), are reshaping the competitive landscape.

The pipeline continues to advance, with innovative candidates such as TenNor's Rifasutenizole (TNP-2198)ha dual-mechanism therapy anticipated to launch in 2027 and offering the potential to address resistance-related challenges - expected to further intensify market competition in the U.S.

(Albany, USA) DelveInsight's report, "Helicobacter Pylori Infections Market Insights, Epidemiology, and Market Forecast - 2034," delivers an in-depth analysis of the H. pylori infection market across the United States, EU5, and Japan. The study includes historical and forecasted epidemiology, current and emerging treatment patterns, market size projections from 2020-2034, and detailed drug-level market share assessments. Additionally, the report evaluates treatment pathways, major market drivers, limitations, and areas of unmet clinical need to identify growth opportunities and future market potential.

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Some facts of the Helicobacter Pylori Infections Market Report are:

* DelveInsight forecasts steady growth in the Helicobacter pylori (H. pylori) infections market, with the market expected to expand at a healthy CAGR through 2034.
* Across the 7MM, the H. pylori infections market was valued at roughly USD 2,672.5 million in 2022 and is anticipated to rise consistently over the 2023-2034 forecast period.
* Key industry players active in the H. pylori infections landscape include Servatus Biopharmaceuticals, Cinclus Pharma Holding AB, Crestone, EpiVax, Iguana Biotechnology, ImevaX GmbH, ImmunoBiology, Luoxin Pharmaceuticals, Nexbiome Therapeutics, Recce Pharmaceuticals, RedHill Biopharma Ltd, SCG Cell Therapy Pte Ltd, Shanghai High-Tech Bioengineering Co. Ltd, Takeda Pharmaceutical, TenNor Therapeutics, Trio Medicines, Xiamen Encheng Pharmaceutical Co. Ltd, among others.
* Several promising therapeutic candidates-such as Rifasutenizole (TNP-2198), SVT1C4610, Vonoprazan, SQ109, Tegoprazan, IMX-101, CRS3123, and others-are expected to enter the H. pylori infections market over the coming years.
* In March 2025, TenNor Therapeutics Inc. released findings from a Phase 3 clinical trial evaluating the efficacy and safety of Rifasutenizol (TNP-2198) combined with rabeprazole and amoxicillin for first-line treatment of H. pylori infection.
* In February 2025, TenNor Therapeutics Inc. published results from a Phase 1, single-center, double-blind, placebo-controlled trial assessing the pharmacokinetics and preliminary efficacy of multiple oral doses of TNP-2092 capsules in healthy volunteers with H. pylori infection.
* In December 2024, Daewoong Pharmaceutical Co. Ltd. announced data from a multicenter, randomized, double-blind, Phase III trial evaluating the safety and efficacy of DWP14012-based triple therapy for the eradication of H. pylori.
* In November 2024, TenNor Therapeutics reported that its antibiotic candidate rifasutenizol achieved all primary Phase III endpoints, demonstrating superior eradication rates compared to standard-of-care therapy. The multicenter, randomized, double-blind trial (NCT05857163) showed that rifasutenizol triple therapy exceeded a 90% eradication rate, outperforming bismuth-containing quadruple therapy (BQT) in treating H. pylori-a common cause of gastric ulcers.
* In March 2024, a study highlighted the strong diagnostic performance of stool antigen testing (SAT) and serum H. pylori IgG antibody assays in distinguishing acute from chronic infections. Conducted in Ibb Governorate, Yemen, the research evaluated 200 patients confirmed positive via immunochromatographic testing and further assessed using IgG antibody assays and SAT across multiple healthcare centers.
* In September 2022, the U.S. FDA granted linaprazan glurate a Qualified Infectious Disease Product (QIDP) designation for the treatment of H. pylori infection.
* A Phase III clinical study is currently underway in China to evaluate a large-scale screening and eradication strategy for H. pylori aimed at preventing gastric cancer in high-risk populations. The investigational drug has received both IND clearance and QIDP designation from the U.S. FDA.
* In 2022, the U.S. FDA approved Phathom Pharmaceuticals' VOQUEZNA triple and dual therapy packs. The triple pack combines vonoprazan (a P-CAB) with amoxicillin and clarithromycin, while the dual pack includes vonoprazan and amoxicillin only.

Helicobacter Pylori Infections Overview

Helicobacter pylori (H. pylori) infection is a common bacterial condition caused by Helicobacter pylori , typically acquired during childhood and persisting if untreated. The bacterium colonizes the stomach lining, leading to chronic gastritis, peptic ulcers, and increasing the risk of gastric cancer. Transmission occurs mainly through contaminated food, water, or person-to-person contact. Many individuals remain asymptomatic, while others experience abdominal pain, nausea, bloating, or indigestion. Diagnosis is made through stool antigen tests, urea breath tests, blood antibody tests, or endoscopic biopsy. Standard treatment involves combination antibiotic therapy with acid-suppressing agents to eradicate the bacteria and prevent complications.

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Helicobacter Pylori Infections Market Outlook

In 2022, the Helicobacter pylori (H. pylori) infection market across the 7MM was valued at approximately USD 2,672.5 million, with steady growth expected through 2034. The United States dominated the market at USD 1,064.8 million, supported by rising awareness and the introduction of newer treatment options. The combined EU4 and UK market reached USD 1,028.3 million, representing around 38% of the total 7MM market. Within Europe, France generated the highest revenue (USD 237.3 million), closely followed by Germany (USD 221.2 million), while the UK accounted for the smallest share. Japan contributed USD 579.4 million, placing it second overall, with significant expansion anticipated by 2034.

The H. pylori infection market is categorized based on therapy types. Major approved treatments include TALICIA and VOQUEZNA in the U.S., OMECLAMOX-Pak and PYLERA across the U.S. and EU, and Japan-specific regimens such as VONOSAP, VONOPION, TAKECAB, RABECURE, and RABEFINE. Additionally, several pipeline candidates - most notably rifasutenizole (TNP-2198) are currently being investigated.

Helicobacter Pylori Infections Epidemiology

In 2022, the 7MM recorded an estimated 321.2 million diagnosed cases of Helicobacter pylori infection. The US represented about 37% of this burden (~118.6 million cases), with numbers expected to rise as awareness and diagnostic rates improve. EU4 and the UK together accounted for roughly 43% (~138.4 million cases), with France contributing the largest share (about 23%), followed by Germany and Italy; the UK reported the lowest prevalence in the region. Japan made up the remaining 20%, with around 64.2 million cases, making it the second-highest country among the 7MM.

In the US, the infection showed a slight male predominance (52% male vs. 48% female in 2022). Prevalence was highest among individuals over 40 years (~77.1 million cases), and projections suggest continued growth through 2034, with the 20-40 age group forming about 25% and those under 20 accounting for about 10% of total diagnosed cases.

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Helicobacter Pylori Infections Drugs Uptake

Rifasutenizole (TNP-2198): TenNor Therapeutics

Rifasutenizole (TNP-2198) is a novel multitarget drug conjugate exhibiting a synergistic mechanism of action, providing potent bactericidal activity against drug-resistant H. pylori strains while maintaining a very low spontaneous resistance rate. Its therapeutic potential extends to infections including H. pylori , bacterial vaginosis, and Clostridioides difficile .

TNP-2198 has received support from China's National Major New Drug Innovation grant and holds IND approval and QIDP designation from the U.S. FDA for H. pylori treatment. The program has completed five clinical trials in China and is currently in a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study, designed to evaluate a safe, efficient, and simplified eradication regimen compatible with urea breath test (UBT) monitoring. This strategy may enable large-scale H. pylori screening and eradication to reduce gastric cancer incidence in high-risk populations. Additionally, TNP-2198 is under investigation in Phase II trials for bacterial vaginosis and C. difficile infection.

Helicobacter Pylori Infections Competitive Landscape

* TALICIA (RHB-105): RedHill Biopharma
* VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK: Phathom Pharmaceuticals
* TAKECAB (vonoprazan): Takeda Pharmaceutical/Otsuka Pharmaceutical
* PYLERA: Juvise Pharmaceuticals/AbbVie
* Rifasutenizole (TNP-2198): TenNor Therapeutics
* BGA-1901: Nexbiome therapeutics
* Linaprazan glurate: Cinclus Pharma
* Esomeprazole: Elpen Pharmaceutical
* TNP-2198: TenNor Therapeutics
* Vonoprazan: Phathom Pharmaceuticals
* Tegoprazan: HK inno.N Corporation
* Levofloxacin: Deva Holding A.S.
* Lansoprazole (Lanton): Meridian Bioscience, Inc.
* Vonoprazan: Takeda
* RHB-105: RedHill Biopharma
* rabeprazole sodium: Janssen Cilag Pharmaceutica
* TAK-438: Takeda
* Ilaprazole + Amoxicillin: Il-Yang Pharm
* Omeprazole, amoxicillin, clarithromycin: Forest Laboratories

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Helicobacter Pylori Infections Therapeutics Assessment

Major key companies are working proactively in the Helicobacter Pylori Infections Therapeutics market to develop novel therapies which will drive the Helicobacter Pylori Infections treatment markets in the upcoming years are RedHill Biopharma Ltd, Takeda Pharmaceutical, Recce Pharmaceuticals, TenNor Therapeutics, Nexbiome Therapeutics, ImevaX GmbH, Iguana Biotechnology, SCG Cell Therapy Pte Ltd, Xiamen Encheng Pharmaceutical Co. Ltd., Crestone, Trio Medicines, Luoxin Pharmaceuticals, Shanghai High-Tech Bioengineering Co. Ltd., ImmunoBiology, Cinclus Pharma Holding AB, Servatus Biopharmaceuticals, EpiVax, and several other emerging players.

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Helicobacter Pylori Infections Report Key Insights

* Overview of the Helicobacter pylori infections patient population
* Evaluation of market size and emerging trends for Helicobacter pylori infections
* Analysis of major competitive players within the H. pylori treatment landscape
* Market dynamics, including primary growth drivers and key challenges
* Potential opportunities within the H. pylori infections market
* Review of available therapeutic strategies for managing H. pylori infections
* Assessment of the developmental pipeline for upcoming H. pylori therapies
* Summary of current treatment guidelines and clinical management practices
* Examination of how new and emerging therapies will influence the future market

Table of Contents

1. Key Insights

2. Executive Summary

3. Helicobacter Pylori Infections Competitive Intelligence Analysis

4. Helicobacter Pylori Infections Market Overview at a Glance

5. Helicobacter Pylori Infections Disease Background and Overview

6. Helicobacter Pylori Infections Patient Journey

7. Helicobacter Pylori Infections Epidemiology and Patient Population

8. Helicobacter Pylori Infections Treatment Algorithm, Current Treatment, and Medical Practices

9. Helicobacter Pylori Infections Unmet Needs

10. Key Endpoints of Helicobacter Pylori Infections Treatment

11. Helicobacter Pylori Infections Marketed Products

12. Helicobacter Pylori Infections Emerging Therapies

13. Helicobacter Pylori Infections Seven Major Market Analysis

14. Attribute Analysis

15. Helicobacter Pylori Infections Market Outlook (7 major markets)

16. Helicobacter Pylori Infections Access and Reimbursement Overview

17. KOL Views on the Helicobacter Pylori Infections Market

18. Helicobacter Pylori Infections Market Drivers

19. Helicobacter Pylori Infections Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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