Helicobacter Pylori Infections Market Outlook 2034 – Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Helicobacter Pylori Infections Market

Helicobacter Pylori Infections Market Summary

In 2022, the U.S. held the largest share of the Helicobacter pylori (H. pylori) infection market among the 7MM, valued at about USD 1,064.8 million, and is projected to grow further by 2034. Clarithromycin triple therapy, a combination of PPI, clarithromycin, and either amoxicillin or metronidazole, remains the most widely used, generating USD 351 million in revenue in 2022. The market expansion is fueled by rising prevalence, though antibiotic resistance poses a growing challenge. Current therapies, including PREVPAC, PYLERA, and generics, aim at bacterial eradication to heal ulcers and prevent relapses. New entrants like RedHill’s TALICIA and Phathom’s VOQUEZNA (approved in 2022 and relaunched in 2023) are reshaping the treatment landscape. Ongoing research is driving innovation, with promising pipeline drugs like TenNor’s Rifasutenizole (TNP-2198), expected to launch in 2027, offering dual-action efficacy and reduced resistance risk, potentially intensifying competition in the U.S. H. pylori infection market.

(Albany, USA) DelveInsight’s “Helicobacter Pylori Infections Market Insights, Epidemiology, and Market Forecast-2034” report provides a comprehensive overview of H. pylori infections, covering historical and projected epidemiology and market trends across the US, EU5, and Japan. It details current treatment practices, emerging therapies, individual drug market shares, and market size forecasts from 2020–2034. The report also examines treatment algorithms, key drivers, barriers, and unmet needs to highlight opportunities and assess the market’s growth potential.

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Some facts of the Helicobacter Pylori Infections Market Report are:

• According to DelveInsight, Helicobacter Pylori Infections market size is expected to grow at a decent CAGR by 2034.
• The total Helicobacter pylori Infection market size in the 7MM was approximately USD 2,672.5 million in 2022 and is projected to increase during the forecast period (2023–2034).
• Leading Helicobacter Pylori Infections companies working in the market are 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 and others.
• Key Helicobacter Pylori Infections Therapies expected to launch in the market are Rifasutenizole (TNP-2198), SVT1C4610, Vonoprazan, SQ 109, Tegoprazan, IMX 101, CRS3123, and many others.
• In March 2025, TenNor Therapeutics Inc announced results of a Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection
• In February 2025, TenNor Therapeutics Inc. announced results of a Phase 1, Single-center, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics (PK) and Preliminary Efficacy of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects With Helicobacter Pylori Infection.
• In December 2024, Daewoong Pharmaceutical Co. LTD announced results of a Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori
• In November 2024, TenNor Therapeutics has revealed that its antibiotic candidate, rifasutenizol, has successfully met all primary endpoints in a Phase III trial, outperforming the current standard of care (SoC). The multicenter, randomized, double-blind, controlled trial (NCT05857163) demonstrated that rifasutenizol triple therapy achieved an eradication rate of over 90%, surpassing the effectiveness of bismuth-containing quadruple therapy (BQT) in treating Helicobacter pylori (H. pylori) infection, a prevalent bacterial infection of the stomach often responsible for stomach ulcers.
• In March 2024, The stool antigen test (SAT) and serum Helicobacter pylori (H. pylori) IgG antibody assays are highly effective in diagnosing H. pylori infections and differentiating between acute and chronic cases. This study aimed to assess the diagnostic value of serum H. pylori IgG antibodies and SAT in detecting H. pylori infections among patients with chronic H. pylori infection in Ibb Governorate, Yemen. A total of 200 patients, confirmed to have H. pylori infection through positive results from the serum immunochromatographic antibody test, were selected for further confirmation using serum H. pylori IgG antibodies and SAT at various hospitals and gastroenterology and hepatology clinics in Ibb Governorate.
• In September 2022, the US FDA granted linaprazan glurate a QIDP for the treatment of H. pylori infection.
• Currently a Phase III clinical trial is being conducted in China for the treatment of H. pylori infection to explore screening-eradication strategy on large scale so as to prevent gastric cancer in populations with relatively high incidence of gastric cancer. The drug has received IND approval and Qualified Infectious Disease Product (QIDP designation) from the US FDA.
• In 2022, the US FDA approved Phathom Pharmaceuticals, P-CAB combination, VOQUEZNA. as triple and dual pak. It contains vonoprazan, a PCAB, with amoxicillin, a penicillin class antibacterial with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms, and clarithromycin, a semi-synthetic macrolide antimicrobial for oral use, while, the DUAL PAK contains vonoprazan and amoxicillin only.

Helicobacter Pylori Infections Overview

Helicobacter pylori (H. pylori) is a type of bacteria that infects the stomach lining, causing various gastrointestinal disorders. It is one of the most common bacterial infections worldwide, with an estimated two-thirds of the global population infected. H. pylori is primarily transmitted through contaminated food, water, or direct contact with saliva or feces of infected individuals. While many infected individuals remain asymptomatic, H. pylori infection can lead to various gastrointestinal conditions, including gastritis (inflammation of the stomach lining), peptic ulcers (sores in the lining of the stomach or small intestine), and even stomach cancer in some cases. Symptoms of H. pylori infection may include abdominal pain, bloating, nausea, vomiting, and loss of appetite. Diagnosis typically involves a combination of tests, such as breath tests, stool tests, blood tests, and endoscopic examinations. Treatment for H. pylori infection usually involves a combination of antibiotics and acid-suppressing medications to eradicate the bacteria and alleviate symptoms. Early detection and treatment of H. pylori infection are essential to prevent complications and reduce the risk of developing more serious gastrointestinal diseases.

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Helicobacter Pylori Infections Market Outlook

In 2022, the total H. pylori infection market size across the 7MM was about USD 2,672.5 million and is projected to grow through 2034. The U.S. led with USD 1,064.8 million, driven by awareness and emerging therapies, while EU4 and the UK together accounted for USD 1,028.3 million (~38% of the 7MM market). Within Europe, France held the largest share (USD 237.3 million), followed by Germany (USD 221.2 million), while the UK had the lowest. Japan contributed USD 579.4 million, ranking second overall, with strong expected growth by 2034.

The Helicobacter pylori (H. pylori) infection market is segmented by therapies, with key approved products including TALICIA and VOQUEZNA (US only), OMECLAMOX-Pak and PYLERA (US and EU), and VONOSAP, VONOPION, TAKECAB, RABECURE, and RABEFINE (Japan only). Pipeline therapies such as rifasutenizole (TNP-2198) are under evaluation.

Helicobacter Pylori Infections Epidemiology

The Helicobacter Pylori Infections epidemiology section provides insights into the historical and current Helicobacter Pylori Infections patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Helicobacter Pylori Infections market report also provides the diagnosed patient pool, trends, and assumptions.

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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: Juvisé 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 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, and others.

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Helicobacter Pylori Infections Report Key Insights

1. Helicobacter Pylori Infections Patient Population

2. Helicobacter Pylori Infections Market Size and Trends

3. Key Cross Competition in the Helicobacter Pylori Infections Market

4. Helicobacter Pylori Infections Market Dynamics (Key Drivers and Barriers)

5. Helicobacter Pylori Infections Market Opportunities

6. Helicobacter Pylori Infections Therapeutic Approaches

7. Helicobacter Pylori Infections Pipeline Analysis

8. Helicobacter Pylori Infections Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the Helicobacter Pylori Infections 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

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