幽门螺旋桿菌感染 - 全球市场回顾、流行病学和市场预测 (2034)

主要亮点

• 幽门螺旋桿菌感染盛行率的地理差异可能是由于卫生条件、城乡生活方式、社会经济条件、幽门螺旋桿菌菌株多样性和抗生素使用造成的。
• 预计幽门螺旋桿菌感染市场在预测期内（2023-2034 年）将持续成长。 由于患者人数的增加，七大市场幽门螺旋桿菌感染的市场规模预计将扩大。
• 美国FDA已批准NEXIUM、PREVPAC等多种治疗药物，官方仿製药也已上市。 Cumberland Pharmaceuticals 的 OMECLAMOX-PAK 和 AbbVie 的 PYLERA 分别为克拉霉素三重疗法和铋四联疗法。
• RedHill Biopharma 的 TALICIA 是最近批准的一种基于利福布丁的疗法，被广泛用作二线治疗。 另一种值得注意的药物是 Phathom Pharmaceuticals 的 P-CAB 组合 VOQUEZNA。 它有三联装和双联装，于 2022 年获得美国 FDA 批准，最近重新配製并于 2023 年在美国上市。
• 目前幽门螺旋桿菌的治疗策略旨在根除该细菌，仅此一项就可以治癒消化性溃疡并预防復发。 然而，抗生素抗药性的蔓延已成为全球性挑战。 作为幽门螺旋桿菌根除治疗的首选，由抗生素、分泌抑制剂、质子帮浦抑制剂和其他酸调节剂组成的三重疗法是各种指南推荐的治疗方法之一，占大多数。
• 2022年，美国在七大主要市场中幽门螺旋桿菌感染市场规模最大，约10.648亿美元。 预计到 2034 年，这一数字将进一步增加。

幽门螺旋桿菌感染市场前景

幽门螺旋桿菌感染是世界上最常见的慢性细菌感染之一，影响着世界上大约一半的人口。 幽门螺旋桿菌是一种具有螺旋鞭毛的革兰氏阴性细菌，定植于人类胃中，通常会感染胃和小肠。 众所周知，它是非贲门胃腺癌的最强危险因素，非贲门胃腺癌通常在儿童时期发生，在胃癌中发病率最高，也与消化性溃疡病有关。 在缺乏单一准确的诊断工具或方法的情况下，目前的诊断依赖于侵入性和非侵入性方法。 幽门螺旋桿菌感染已被世界卫生组织指定为 I 类致癌物，并根据美国 FDA 的 GAIN 法案被指定为合格病原体。

第一个有效治疗幽门螺旋桿菌感染的方法于 20 世纪 80 年代推出，但自那时以来发生了很大变化。 目前幽门螺旋桿菌感染的治疗策略是治疗性的，而不是预防性的。 目的是根除幽门螺旋桿菌，而单纯根除对于治癒消化性溃疡和预防復发来说是最重要的。 然而，抗生素抗药性细菌的传播已成为全球性挑战。

• 2022 年，七个主要市场的幽门螺旋桿菌感染总市场规模约为 26.725 亿美元，预计在预测期内（2023-2034 年）将扩大。
• 到 2022 年，美国幽门螺旋桿菌感染市场规模约为 10.648 亿美元，由于人们对该疾病的认识提高以及新疗法的推出，预计该市场规模将继续增长。
• 2022年欧洲四个国家和英国的市场规模约为10.283亿美元，约占七大市场总市场收入的38%。
• 在欧洲四个国家和英国中，法国2022年市场规模最大，约2.373亿美元，其次是德国，约2.212亿美元，2022年最小市场规模约为2.373亿美元是英格兰。
• 在美国，基于克拉霉素的三联疗法在目前使用的治疗方法中拥有第二高的市场份额，2022 年收入约为 3.51 亿美元。
• 2022年，日本幽门螺旋桿菌感染市场规模约5.794亿美元，在七大市场中位居第二，预计到2034年将大幅成长。

本报告调查分析了幽门螺旋桿菌感染的七个主要市场（美国、德国、西班牙、义大利、法国、英国和日本），包括每个地区的市场规模、目前治疗方法、未满足的需求和新药情况。

目录

第 1 章重要注意事项

第2章报告简介

第3章幽门螺旋桿菌感染市场概况

• 幽门螺旋桿菌感染市占率分布（2020年）
• 幽门螺旋桿菌感染市占率分布（2034年）

第4章幽门螺旋桿菌感染流行病学及市场调查方法

第5章幽门螺旋桿菌感染的执行摘要

第6章重要事件

第7章疾病背景与概论

• 幽门螺旋桿菌感染简介
• 与幽门螺旋桿菌感染相关的症状
• 原因
• 风险因素
  • 社会经济状况、环境条件
  • 生活习惯
  • 职业危害
• 感染途径
• 幽门螺旋桿菌感染的病理生理学
  • 胃黏膜幽门螺旋桿菌感染的免疫病理学
  • 相关疾病及临床症状
• 诊断
  • 非侵入性测试
  • 侵入性方法
• 治疗
  • 处理演算法
• 治疗指南

第 8 章病人旅程

第 9 章流行病学与病患群体

• 主要发现
• 假设与理由：7 个主要市场
• 7个主要市场确诊幽门螺旋桿菌感染的总人数
• 美国
• 4 个欧洲国家/英国
• 日本

第10章已上市药品

• 主要比赛
• TALICIA (RHB-105)：RedHill Biopharma
• VOQUEZNA TRIPLE PAK 与 VOQUEZNA DUAL PAK：Phathom Pharmaceuticals
• TAKECAB（vonoprazan）：武田製药/大冢製药
• PYLERA：Juvise Pharmaceuticals/AbbVie
• OMECLAMOX-Pak：坎伯兰製药公司
• RABECURE 和 RABEFINE：卫材公司

第11章新药

• 主要比赛
• 利福舒替尼唑 (TNP-2198)：TenNor Therapeutics

第12章幽门螺旋桿菌感染：市场分析

• 主要发现
• 主要市场预测假设
• 市场前景
• 7大市场幽门螺旋桿菌感染总市场规模
• 七大市场幽门螺旋桿菌感染的市场规模：依治疗方法划分
• 美国幽门螺旋桿菌感染的市场规模
  • 美国幽门螺旋桿菌感染的总市场规模
  • 美国幽门螺旋桿菌感染市场规模（依治疗方法）
• 欧洲4国及英国幽门螺旋桿菌感染市场规模
  • 四个欧洲国家和英国幽门螺旋桿菌感染的总市场规模
  • 四个欧洲国家和英国的幽门螺旋桿菌感染市场规模：依治疗方法划分
• 日本幽门螺旋桿菌感染市场规模
  • 日本幽门螺旋桿菌感染的总市场规模
  • 日本幽门螺旋桿菌感染市场规模：依治疗方法分类

第13章KOL浏览量

第14章SWOT分析

第 15 章未满足的需求

第16章市场进入与赎回

• 美国
• 4 个欧洲国家/英国
  • 德国
  • 法国
  • 义大利
  • 西班牙
  • 英国
• 日本

第17章附录

第18章DelveInsight服务内容

第19章免责声明

第 20 章关于 DelveInsight

Key Highlights:

• The geographic disparity in the prevalence of H. pylori infection could be due to sanitation, urban versus rural lifestyle, socioeconomic status, variability of the H. pylori strains, and antibiotic usage.
• The H. pylori infection market is projected to witness consistent growth throughout the forecast period (2023-2034). The market size of H. pylori infection in the 7MM is expected to increase, driven by the increasing prevalent population.
• The US FDA has approved many therapies, like NEXIUM, PREVPAC, etc., with authorized generics in the market. Cumberland Pharmaceuticals OMECLAMOX-PAK and AbbVie's PYLERA are the branded versions of clarithromycin triple therapy and bismuth-quadruple therapy.
• RedHill Biopharma's TALICIA a recently approved rifabutin-based therapy is a therapy that is prescribed widely as the second-line therapy. Another drug to look out for will be Phathom Pharmaceuticals' P-CAB combination, VOQUEZNA. Available as triple and dual pak, the drug was approved in 2022 by the US FDA and recently was reformulated and launched in the US in 2023.
• The current treatment regime for H. pylori aims to eradicate the bacteria, as this alone is paramount for healing associated peptic ulcers and preventing relapses. However, the growing prevalence of antibiotic resistance has made it a global challenge. Triple therapies, which combine antibiotics with either antisecretories, proton pump inhibitors, or other acid-regulating drugs as the first line of treatment for the eradication of H. pylori, are among the majority of treatments recommended by various worldwide guidelines.
• In 2022, the US had the largest market size of H. pylori infection among the 7MM, accounting for approximately USD 1,064.8 million. This is expected to increase further by 2034.

DelveInsight's "Helicobacter pylori Infection - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Helicobacter pylori Infection, historical and forecasted epidemiology, as well as the Helicobacter pylori Infection market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Helicobacter pylori Infection market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Helicobacter pylori infection market size from 2020 to 2034. The report also covers Helicobacter pylori infection treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Helicobacter pylori Infection Understanding and Treatment Algorithm

Helicobacter pylori Infection Overview

Helicobacter pylori (H. pylori) is a spiral-shaped, flagellated Gram-negative bacterium colonizing the human stomach that usually infects the stomach and small intestine. It is one of the most common chronic bacterial infections worldwide, usually acquired during childhood, yet most infected individuals remain asymptomatic.

Helicobacter pylori Infection Diagnosis

There is no single accurate diagnostic tool or method, and the current diagnosis regime is usually a combination of invasive and noninvasive methods.

The noninvasive methods that determine eradication rates are based on the presence of bacterial enzymes, antigens, antibodies, or DNA sequences and include 13C or 14C UBT, SAT, serology, etc. In contrast, the invasive methods include endoscopy and gastric biopsy followed by RUT, histology, culture, or a clinically significant PCR.

Further details related to country-based variations are provided in the report...

Helicobacter pylori Infection Treatment

The treatment regime for H. pylori infection is therapeutic and not prophylactic. The current treatment aims to eradicate the bacteria, but with increasing antibiotic resistance, the cure rates have declined with a simultaneous increase in re-infection.

The US FDA has approved many therapies over the years, like NEXIUM, PREVPAC, etc., that even have their approved generics in the market.

The US FDA development of including H. pylori infection in the GAIN pathogen list has led to major changes in the approved market scenario, as many novel therapies received approval in the past couple of years with Phathom Pharmaceuticals P-CAB combination VOQUEZNA TRIPLE and DUAL PAK being the most recent. Others include TALICIA, OMECLAMOX-PAK, and PYLERA, among others.

Helicobacter pylori Infection Epidemiology

As the market is derived using a patient-based model, the Helicobacter pylori Infection epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of helicobacter pylori infection, gender-specific diagnosed prevalent cases of helicobacter pylori infection, and age-specific diagnosed prevalent cases of helicobacter pylori infection in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the total diagnosed prevalent cases of helicobacter pylori infection were estimated to be approximately 321,217,226 in 2022, of which the US accounted for around 37%, while EU4 and the UK accounted for nearly 43%, and Japan accounted for approximately 20% of the total diagnosed prevalent cases.
• Among the 7MM, the US accounted for nearly 118,650,370 total diagnosed prevalent cases of helicobacter pylori infection, in 2022. These cases are expected to increase during the study period due to an increase in disease awareness and diagnosis.
• As per DelveInsight analysis, EU4 and the UK accounted for around 138,397,508 diagnosed prevalent cases of helicobacter pylori infection in 2022. These cases are expected to change during the study period (2020-2034).
• Among the EU4 and the UK, France accounted for the highest diagnosed prevalent cases of helicobacter pylori infection, representing nearly 23% of the cases, followed by Germany and Italy, while the UK had the least cases in 2022.
• According to estimates based on DelveInsight's epidemiology model, helicobacter pylori infection exhibits a higher male preponderance than females in the US. Of the total diagnosed prevalent cases in the US, nearly 52% were males and 48% were females, in 2022.
• In the US, the highest age-specific diagnosed prevalent cases of helicobacter pylori infection were for the age group above 40 years, with nearly 77,122,741 cases, in 2022. As per the analysis, these cases are expected to increase, and the age group 20-40 years will contribute around 25% of the diagnosed prevalent cases, while the age groups 0-20 years will contribute 10% respectively by 2034.
• In 2022, among the 7MM, Japan had the second-highest cases of Helicobacter pylori infection, with approximately 64,169,348 total diagnosed prevalent cases of Helicobacter pylori infection.

Helicobacter pylori infection Drug Chapters

The drug chapter segment of the helicobacter pylori infection report encloses a detailed analysis of helicobacter pylori infection-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the helicobacter pylori infection clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

TALICIA (RHB-105): RedHill Biopharma

TALICIA (RHB-105) is an oral, all-in-one capsule with a three-drug combination of omeprazole, a PPI, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of H. pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, it is strongly advised that TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. In November 2019, the US FDA approved TALICIA in the US to treat H. pylori infection in adults.

Note: Further marketed drugs and their details will be provided in the report...

Emerging Drugs

Rifasutenizole (TNP-2198): TenNor Therapeutics

Rifasutenizole (TNP-2198) is a unique, multitargeting drug conjugate that through a synergistic mechanism of action, delivers potent bactericidal activities against drug-resistant H. pylori strains as well as an extremely low spontaneous resistance frequency. It has a wide range of applications in treating infections such as H. pylori infection, bacterial vaginosis, and Clostridium difficile infection.

TNP-2198 is supported by the National Major New Drug Innovation grant in China and has received IND approval and QIDP designation from the US FDA for the treatment of H. pylori infection patients. Furthermore, the company has completed five clinical trials in China and is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy controlled Phase III clinical trial in support of its New Drug Application in China and the US. This Phase III trial for TNP-2198 in the treatment of H. pylori infection is being carried out to explore an efficient, safe, and simplified eradication regimen that can seamlessly connect with a urea breath test (UBT). Furthermore, it offers the possibility to carry an H. pylori infection screening-eradication strategy on a large scale to prevent gastric cancer in populations with relatively high incidences of gastric cancer. Additionally, the drug candidate is also being investigated in a Phase II trial for Clostridioides difficile infection and bacterial vaginosis.

Note: Further emerging therapies and their detailed assessment will be provided in the final report.

Drug Class Insights

The first line of defense against H. pylori infections is medications called Proton Pump Inhibitors (PPIs). These drugs work by significantly reducing the amount of acid produced by the stomach. This creates a less hospitable environment for the bacteria, making it difficult for them to survive. Omeprazole, lansoprazole, pantoprazole, rabeprazole, and esomeprazole are all commonly used PPIs.

However, PPIs alone aren't enough to eradicate H. pylori. Physicians typically prescribe a combination therapy that includes two or more antibiotics along with a PPI. The specific antibiotics chosen will depend on factors like local antibiotic resistance patterns and the patient's medical history. Some commonly used antibiotics for H. pylori include clarithromycin, amoxicillin, metronidazole, rifabutin, and tetracycline. Each class targets the bacteria in a different way, making it harder for them to develop resistance.

Antibacterial drugs, including clarithromycin, amoxicillin, metronidazole, and tetracycline, are vital in Helicobacter pylori eradication therapy. Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, while amoxicillin disrupts cell wall synthesis by inhibiting transpeptidase enzymes. Metronidazole undergoes intracellular activation, damaging bacterial DNA and inhibiting nucleic acid synthesis, while tetracycline inhibits protein synthesis by binding to the 30S ribosomal subunit. These antibiotics collectively target H. pylori growth and replication.

Antisecretory drugs, particularly proton pump inhibitors (PPIs) like omeprazole and lansoprazole, complement antibacterial therapy by irreversibly inhibiting the H+/K+-ATPase proton pump on gastric parietal cells, reducing gastric acid secretion. Lowered gastric acidity enhances antibiotic activity against H. pylori and promotes healing of associated gastrointestinal mucosal damage, such as peptic ulcers and gastritis, by reducing acid-mediated tissue injury and inflammation. The combination of antibacterial and antisecretory drugs optimizes bacterial eradication and ulcer healing, leading to successful treatment outcomes in H. pylori infection.

TALICIA (RHB-105) marketed by RedHill Biopharma is an oral, all-in-one capsule with a three-drug combination of omeprazole, a PPI, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of H. pylori infection in adults. Omeprazole reduces gastric acid secretion, creating a favorable environment for antibiotics. Amoxicillin disrupts bacterial cell walls, leading to cell death, while rifabutin inhibits bacterial RNA synthesis. This triple therapy approach addresses bacterial growth, reduces gastric acidity, and targets antibiotic resistance, offering a promising treatment option for H. pylori infection.

TAKECAB (vonoprazan) or TAK-438, developed by Takeda, is an antisecretory drug targeting acid-related diseases like Helicobacter pylori infection. It belongs to the class of potassium-competitive acid blockers (P-CABs), which operate through a unique mechanism by competitively inhibiting the binding of potassium ions to H+, K+ ATPase in gastric parietal cells, disrupting the final step of gastric acid secretion. By effectively blocking this process, TAKECAB provides potent and sustained inhibition of acid secretion. This mechanism differs from traditional proton pump inhibitors (PPIs), offering a potentially more robust and prolonged antisecretory effect.

Helicobacter pylori Infection Market Outlook

H. pylori infection is one of the most common chronic bacterial infections worldwide, infecting approximately half of the global population. It is a spiral-shaped, flagellated gram-negative bacterium colonizing the human stomach that usually infects the stomach and small intestine. Usually acquired during childhood, it is the strongest known risk factor for non-cardia gastric adenocarcinoma, the most prevalent form of gastric cancer, and is also linked to peptic ulcer disease. With no single accurate diagnostic tool or method, the current diagnosis depends on both invasive and noninvasive methods. The treatment regime has seen many changes, with H. pylori infection designated as a Class I carcinogen by WHO and a Qualifying Pathogen under the US FDA GAIN Act.

The first effective therapy for H. pylori infection was introduced in the 1980s; since then, there have been major changes. The current treatment regime for H. pylori infection is therapeutic and not prophylactic; the goal is to eradicate the bacteria, as eradication alone is paramount for healing associated peptic ulcers and preventing relapses. But the growing prevalence of antibiotic resistance has made it a global challenge.

Most treatment guidelines recommend triple therapies, a combination of antibiotics with either antisecretories or PPIs or other acid-regulating agents, as the first line of treatment for eradicating H. pylori. Monotherapies prove ineffective as stomach acidity reduces the efficacy of antibiotics. Moreover, increasing antibiotic resistance has added to the troubles with only a few antibiotics active against H. pylori, including clarithromycin, amoxicillin, metronidazole, fluoroquinolone (levofloxacin, norfloxacin), tetracycline, and rifabutin.

It is important to understand that current guidelines advocate that choosing H. pylori infection eradication therapy should be based on the knowledge of the regional prevalence of clarithromycin antibiotic resistance and according to the local needs as such factors broadly impact the infection. There is a regional variation among approved therapies, with different ones being approved in different countries at different times.

RedHill Biopharma's TALICIA an approved rifabutin-based therapy is prescribed widely as the second-line therapy. With an 8-year market exclusivity, it may prove to be a game changer for individuals with clarithromycin and metronidazole resistance.

Another drug to look out for will be Phathom Pharmaceuticals, P-CAB combination, and VOQUEZNA. Available as triple and dual pak, the drug was approved in 2022 by the US FDA and recently was reformulated and launched in the US in 2023.

Although antibiotic resistance rates have increased in the last decade and reduced the efficacy of recommended treatments. However, due to the guideline update and designation, the H pylori treatment landscape has also seen many FDA approvals. With a restrictive emerging pipeline for H. pylori, where there are limited novel mid or late-stage therapies and most trials are limited to improvements in combinations already approved the market for H. pylori is projected to witness some changes upon the entry of TenNor Therapeutics' rifasutenizole (TNP-2198) during the forecast period.

Continued in report...

The current market segmentation is based on the therapies prescribed. Various marketed products for H. pylori infection include TALICIA, VOQUEZNA, approved only in the US OMECLAMOX-Pak, PYLERA in the US and EU, VONOSAP, VONOPION, TAKECAB, RABECURE, and RABEFINE in Japan only. These are the major segments covered in the forecast model. Several key players are evaluating their lead candidates in different stages of clinical development like rifasutenizole (TNP-2198).

The market for Helicobacter pylori Infection is expected to experience positive growth.

• The total market size of Helicobacter pylori Infection in the 7MM was approximately USD 2,672.5 million in 2022 and is projected to increase during the forecast period (2023-2034).
• The market size of Helicobacter pylori Infection in the US was approximately USD 1,064.8 million in 2022, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of EU4 and the UK was calculated to be approximately USD 1,028.3 million in 2022, which was nearly 38% of the total market revenue for the 7MM.
• According to DelveInsight's estimates, among EU4 and the UK, France accounted for the highest market with approximately USD 237.3 million in 2022, followed by Germany with approximately USD 221.2 million in the respective year, while the UK accounted for the lowest market in 2022.
• According to DelveInsight's analysis, in the US, among the currently used therapies, the second highest market share was of clarithromycin-based triple therapy, with a revenue of approximately USD 351.0 million, in 2022.
• In 2022, Japan with a revenue of approximately USD 579.4 million, accounted for the second-highest market size of Helicobacter pylori Infection among the 7MM, which is expected to increase significantly by 2034.

Helicobacter pylori Infection Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, TenNor Therapeutics' Rifasutenizole (TNP-2198), an investigational stable conjugate of rifamycin, is projected to be the first and only US FDA-approved, on-label, responsibly priced drug, with a medium uptake, will enter the US market in 2027.

Further detailed analysis of emerging therapies drug uptake in the report...

Helicobacter pylori Infection Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Helicobacter pylori infection.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Helicobacter pylori infection evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Stanford University School of Medicine, University of Cardiff, UK, German Institute of Human Nutrition (DIFE) Potsdam-Rehbrucke, Arthur Schubert Strasse, University of Poitiers, France, Aichi Medical University School of Medicine, Okayama Medical Center, Okayama were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Helicobacter pylori infection market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

According to our primary research analysis, current treatment scenarios for Helicobacter pylori infection typically involve a combination of antibiotics and proton pump inhibitors (PPIs) or other acid-reducing agents. The most common first-line treatment is triple therapy, which includes a PPI along with two antibiotics such as clarithromycin and amoxicillin or metronidazole. However, due to increasing antibiotic resistance, especially to clarithromycin, alternative regimens may be necessary, such as quadruple therapy with a bismuth salt, a PPI, and two antibiotics (usually metronidazole and tetracycline). Sequential therapy and concomitant therapy are other options, involving a combination of antibiotics and PPIs administered over different time frames.

According to a KOL in the US, despite being widely available, noninvasive testing for active H. pylori infection is still not routinely employed in practice. Many doctors worry that decreasing eradication rates may result in less successful treatment. Despite this, it is still normal practice to utilize triple regimens that contain a PPI and clarithromycin

Another KOL in Germany found that H. pylori infections are typically acquired in children. There are currently 20-30 million H. pylori infections in Germany, with a number of these infections leading to consequences like stomach cancer and ulcers.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The reimbursement challenges related to medical care and treatment for individuals with Helicobacter pylori Infection can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, and therapies specific to Helicobacter pylori Infection. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

Further details will be provided in the report.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of Helicobacter pylori Infection, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Helicobacter pylori Infection, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Helicobacter pylori Infection market.

Helicobacter pylori Infection Report Insights

• Patient Population
• Therapeutic Approaches
• Helicobacter pylori Infection Pipeline Analysis
• Helicobacter pylori Infection Market Size and Trends
• Existing and Future Market Opportunity

Helicobacter pylori Infection Report Key Strengths

• 12 years Forecast
• The 7MM Coverage
• Helicobacter pylori Infection Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Helicobacter pylori Infection Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Market Insights

• What was the total market size of Helicobacter pylori Infection, the market size of Helicobacter pylori Infection by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will rifasutenizole (TNP-2198) affect the treatment paradigm of Helicobacter pylori Infection?
• How will TALICIA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK compete with upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Helicobacter pylori Infection? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Helicobacter pylori Infection?
• What is the historical and forecasted Helicobacter pylori Infection patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent Helicobacter pylori Infection population during the forecast period (2023-2034)?
• What factors are contributing to the growth of Helicobacter pylori Infection cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Helicobacter pylori Infection? What are the current clinical and treatment guidelines for treating Helicobacter pylori Infection?
• How many companies are developing therapies for the treatment of Helicobacter pylori Infection?
• How many emerging therapies are in the mid-stage and late stage of development for treating Helicobacter pylori Infection?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Helicobacter pylori Infection?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Helicobacter pylori Infection market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for Helicobacter pylori Infection, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. H. pylori Infection Market Overview at a Glance

• 3.1. Market Share (%) Distribution of H. pylori Infection in 2020
• 3.2. Market Share (%) Distribution of H. pylori Infection in 2034

4. Methodology of H. pylori Infection Epidemiology and Market

5. Executive Summary of H. pylori Infection

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction to H. pylori infection
• 7.2. Symptoms Associated with H. pylori Infection
• 7.3. Causes
• 7.4. Risk Factors
  • 7.4.1. Socioeconomic Status and Environmental Conditions
  • 7.4.2. Lifestyle Habits
  • 7.4.3. Occupational Hazards
• 7.5. Routes of Transmission
• 7.6. Pathophysiology of H. pylori infection
  • 7.6.1. Immunopathogenesis of H. pylori-induced Infection in Gastric Mucosa
  • 7.6.2. Related Conditions and Clinical Manifestations
• 7.7. Diagnosis
  • 7.7.1. Noninvasive Tests
  • 7.7.2. Invasive Methods
• 7.8. Treatment
  • 7.8.1. Treatment Algorithm
• 7.9. Treatment Guidelines
  • 7.9.1. American Clinical Guideline (ACG)
  • 7.9.2. The Maastricht V/Florence Consensus Report
  • 7.9.3. Japanese Society for Pediatric Gastroenterology, Hepatology and Nutrition (JSPGHAN)

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Diagnosed Prevalent Cases of H. pylori infection
  • 9.2.2. Gender-specific Diagnosed Prevalent Cases of H. pylori Infection
  • 9.2.3. Age-specific cases of H. pylori Infection
• 9.3. Total Diagnosed Prevalent Cases of H. pylori Infection in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of H. pylori Infection in the US
  • 9.4.2. Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the US
  • 9.4.3. Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the US
• 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. Gender-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
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of H. pylori Infection in Japan
  • 9.6.2. Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan
  • 9.6.3. Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan

10. Marketed Drugs

• 10.1. Key Cross Competition
• 10.2. TALICIA (RHB-105): RedHill Biopharma
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Developmental Activities
  • 10.2.4. Clinical Development
  • 10.2.5. Clinical Trials Information
  • 10.2.6. Safety and Efficacy
  • 10.2.7. Product Profile
• 10.3. VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK: Phathom Pharmaceuticals
  • 10.3.1. Product Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Clinical Development
  • 10.3.5. Clinical Trials Information
  • 10.3.6. Safety and Efficacy
  • 10.3.7. Product Profile
• 10.4. TAKECAB (vonoprazan): Takeda Pharmaceutical/Otsuka Pharmaceutical
  • 10.4.1. Product Description
  • 10.4.2. Regulatory Milestones
  • 10.4.3. Other Developmental Activities
  • 10.4.4. Clinical Development
  • 10.4.5. Clinical Trials Information
  • 10.4.6. Safety and Efficacy
  • 10.4.7. Product Profile
• 10.5. PYLERA: Juvise Pharmaceuticals/AbbVie
  • 10.5.1. Product Description
  • 10.5.2. Regulatory Milestones
  • 10.5.3. Other Developmental Activities
  • 10.5.4. Clinical Development
  • 10.5.5. Clinical Trials Information
  • 10.5.6. Safety and Efficacy
  • 10.5.7. Product Profile
• 10.6. OMECLAMOX-Pak: Cumberland Pharmaceuticals
  • 10.6.1. Product Description
  • 10.6.2. Regulatory Milestones
  • 10.6.3. Other Development Activities
  • 10.6.4. Safety and Efficacy
  • 10.6.5. Product Profile
• 10.7. RABECURE and RABEFINE: Eisai Co
  • 10.7.1. Product Description
  • 10.7.2. Regulatory Milestones
  • 10.7.3. Other Developmental Activities
  • 10.7.4. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Rifasutenizole (TNP-2198): TenNor Therapeutics
  • 11.2.1. Drug Description
  • 11.2.2. Other Development Activities
  • 11.2.3. Clinical Development
  • 11.2.4. Clinical Trial Information
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Product Profile
  • 11.2.7. Analysts' Views

12. H. pylori Infection: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Total Market Size of H. pylori Infection in the 7MM
• 12.5. Total Market Size of H. pylori Infection by Therapies in the 7MM
• 12.6. Market Size of H. pylori Infection in the US
  • 12.6.1. Total Market Size of H. pylori Infection in the US
  • 12.6.2. The Market Size of H. pylori Infection by Therapies in the US
• 12.7. Market Size of H. pylori Infection in EU4 and the UK
  • 12.7.1. Total Market Size of H. pylori Infection in EU4 and the UK
  • 12.7.2. The Market Size of H. pylori Infection by Therapies in EU4 and the UK
• 12.8. Market Size of H. pylori Infection in Japan
  • 12.8.1. Total Market Size of H. pylori Infection in Japan
  • 12.8.2. The Market Size of H. pylori Infection by Therapies in Japan

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Center for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

List of Tables

• Table 1: Summary of Epidemiology and Market (2020-2034)
• Table 2: Key Events for H. pylori Infection
• Table 3: Diagnostic Tests For H. pylori Infection
• Table 4: Recommendations for H. pylori Testing for Individuals and Populations (which individuals to test)
• Table 5: H. pylori Infection Therapies In Current Use
• Table 6: Recommendation Statements of ACG Clinical Guideline for the Treatment of H. pylori Infection
• Table 7: The Maastricht V/Florence Consensus Statements for Treatment of H. pylori Infection
• Table 8: JSPGHAN Guidelines for Treatment of H. pylori Infection
• Table 9: H. pylori Infection Prevalence and Number of People Living With H. pylori Infection in the General Population Within Each Country Grouped by UN Regions
• Table 10: Total Diagnosed Prevalent Cases of H. pylori Infection in the 7MM, in thousands (2020-2034)
• Table 11: Total Diagnosed Prevalent Cases of H. pylori Infection in the US, in thousands (2020-2034)
• Table 12: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the US, in thousands (2020-2034)
• Table 13: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the US, in thousands (2020-2034)
• Table 14: Total Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK, in thousands (2020-2034)
• Table 15: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK, in thousands (2020-2034)
• Table 16: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK, in thousands (2020-2034)
• Table 17: Total Diagnosed Prevalent Cases of H. pylori Infection in Japan, in thousands (2020-2034)
• Table 18: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan, in thousands (2020-2034)
• Table 19: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan, in thousands (2020-2034)
• Table 20: Key Cross of Marketed Drugs
• Table 21: TALICIA (RHB-105), Clinical Trial Description, 2024
• Table 22: VOQUEZNA TRIPLE and DUAL PAKs, Clinical Trial Description, 2024
• Table 23: TAKECAB (vonoprazan), Clinical Trial Description, 2024
• Table 24: PYLERA, Clinical Trial Description, 2024
• Table 25: Comparison of Emerging Drugs for Treatment
• Table 26: Rifasutenizole (TNP-2198), Clinical Trial Description, 2024
• Table 27: Key Market Forecast Assumptions for VOQUEZNA DUAL and TRIPLE PAK
• Table 28: Key Market Forecast Assumptions for Rifasutenizole (TNP-2198)
• Table 29: Total Market Size of H. pylori Infection in the 7MM, in USD million (2020-2034)
• Table 30: Total Market Size of H. pylori Infection by Therapies in the 7MM, in USD million (2020-2034)
• Table 31: Total Market Size of H. pylori Infection in the US, in USD million (2020-2034)
• Table 32: The Market Size of H. pylori Infection by Therapies in the US, in USD million (2020-2034)
• Table 33: Total Market Size of H. pylori Infection in EU4 and the UK, in USD million (2020-2034)
• Table 34: The Market Size of H. pylori Infection by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 35: Total Market Size of H. pylori Infection in Japan, in USD million (2020-2034)
• Table 36: The Market Size of H. pylori Infection by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Entrance and lodging of H. pylori infection in the stomach
• Figure 2: Symptoms of H. pylori Infection
• Figure 3: Causes of H. pylori Infection
• Figure 4: Risk Factors Associated with H. pylori Infection
• Figure 5: Routes of Transmission of H. pylori Infection
• Figure 6: Pathogenesis of H. pylori Infection
• Figure 7: Immunopathogenesis of H. pylori infection in Gastric Mucosa
• Figure 8: Conditions associated with H. pylori infection
• Figure 9: H. pylori Infection Eradication Algorithm According to Primary Clarithromycin Resistance and Management in Case of Treatment Failure
• Figure 10: Patient Journey
• Figure 11: Total Diagnosed Prevalent Cases of H. pylori Infection in the 7MM (2020-2034)
• Figure 12: Total Diagnosed Prevalent Cases of H. pylori Infection in the US (2020-2034)
• Figure 13: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in the US (2020-2034)
• Figure 14: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in the US (2020-2034)
• Figure 15: Total Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2020-2034)
• Figure 16: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2020-2034)
• Figure 17: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in EU4 and the UK (2020-2034)
• Figure 18: Total Diagnosed Prevalent Cases of H. pylori Infection in Japan (2020-2034)
• Figure 19: Gender-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan (2020-2034)
• Figure 20: Age-specific Diagnosed Prevalent Cases of H. pylori Infection in Japan (2020-2034)
• Figure 21: Total Market Size of H. pylori Infection in the 7MM, in USD million (2020-2034)
• Figure 22: Total Market Size of H. pylori Infection by Therapies in the 7MM, in USD million (2020-2034)
• Figure 23: Total Market Size of H. pylori Infection in the US, in USD million (2020-2034)
• Figure 24: The Market Size of H. pylori Infection by Therapies in the US, in USD million (2020-2034)
• Figure 25: Total Market Size of H. pylori Infection in EU4 and the UK, in USD million (2020-2034)
• Figure 26: The Market Size of H. pylori Infection by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 27: Total Market Size of H. pylori Infection in Japan, in USD million (2020-2034)
• Figure 28: The Market Size of H. pylori Infection by Therapies in Japan, in USD million (2020-2034)
• Figure 29: SWOT Analysis of H. pylori Infection
• Figure 30: Unmet Needs of H. pylori Infection
• Figure 31: Health Technology Assessment
• Figure 32: Reimbursement Process in Germany
• Figure 33: Reimbursement Process in France
• Figure 34: Reimbursement Process in Italy
• Figure 35: Reimbursement Process in Spain
• Figure 36: Reimbursement Process in the United Kingdom
• Figure 37: Reimbursement Process in Japan