PUBLISHER: DelveInsight | PRODUCT CODE: 1544157
PUBLISHER: DelveInsight | PRODUCT CODE: 1544157
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.
Study Period: 2020-2034
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.
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.
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.
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.
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.
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.
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.
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies