Helicobacter Pylori Infections Market

Key Findings

• In 2021, the H. pylori Infection diagnosed prevalent cases estimated to be approximately 321,978,200 in the 7MM. These cases are expected to increase by 2032 at a CAGR of 0.2% during the study period (2019–2032).
• The H. pylori Infection market size in the seven major markets was approximately USD 3,411 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 1.9% for the study period (2019–2032).
• Some of the key companies in the H. pylori Infection market include Phathom Pharmaceuticals, Redhill Biopharma, Takeda Pharmaceutical, Otsuka Pharmaceutical, Juvisé Pharmaceuticals, AbbVie, Cumberland Pharmaceuticals, Pernix Therapeutics, Eisai Co., and others.
  

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DelveInsight’s ‘H. pylori Infection - Market Insights, Epidemiology, and Market Forecast–2032’ report deliver an in-depth understanding of the H. pylori Infection, historical and forecasted epidemiology as well as the H. pylori Infection market trends in the United States, EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The H. pylori Infection market report provides current treatment practices, emerging drugs, market share of the individual therapies, and the current and forecasted 7MM H. pylori Infection market size from 2019 to 2032. The Report also covers current H. pylori Infection market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• The EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019–2032

H. pylori Infection Understanding and Treatment Algorithm

H. 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. H. pylori is designated as a Class I carcinogen by WHO and is a Qualifying Pathogen under the US FDA GAIN Act. It is the strongest known risk factor for non-cardia gastric adenocarcinoma and is usually associated with chronic gastritis, the development of preneoplastic lesions, or peptic ulcer disease.

Though clinically silent, the symptoms associated with H. pylori infections are synonymous with other gastric conditions. Patients harboring the bacteria show symptoms, such as abdominal pain, nausea, vomiting, and the development of dyspepsia only after gastritis and peptic ulcer disease initiate. The infection is usually transmitted by the fecal–oral, gastric–oral, oral–oral, or sexual routes, and its prevalence varies widely with geography. Generally, the prevalence is higher in developing and resource-poor countries than in developed countries and is usually impacted by climatic conditions, host–microbe interaction, genetics, GI microbiota, or medication.

H. 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.

Continued in the report…..

H. pylori Infection Treatment

The treatment regime for H. pylori 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. With monotherapies being ineffective, most treatment guidelines prescribe triple therapies (consisting of a PPI, amoxicillin, and clarithromycin or metronidazole) as the first line of treatment. With increasing clarithromycin and metronidazole resistance, bismuth-quadruple therapy or concomitant therapy are also prescribed in the first line. Levofloxacin triple therapy, bismuth therapies, or high-dose dual therapies are given as second-line or rescue therapies.

The US FDA has approved many therapies over the years, like NEXIUM, PREVPAC, etc., that even have their approved generics in the market. Recent FDA developments of including H. pylori in the GAIN pathogen list have 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.

However, there exists a regional variation among approved therapies, with different therapies being approved in different countries at different times, e.g., TAKECAB was approved only in Japan almost a decade back. Even its combinations, VONOSAP and VONOPION, were approved in 2016. On the other hand, Europe has no latest approval except for a few local recommendations. These variations in approval and lack of a universally accepted treatment regime do complicate the treatment patterns, but considering the local variability of infection, there is a need for antimicrobial stewardship to prevent resistance and improve eradication rates.

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H. pylori Infection Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Diagnosed Prevalent Cases of H. pylori Infection, Gender-specific Diagnosed Prevalent Cases of H. pylori Infection, and Age-specific Diagnosed Prevalent Cases of H. pylori Infection scenario of H. pylori Infection in the 7MM covering the United States, EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• In 2021, the diagnosed prevalent cases of H. pylori Infection were estimated to be approximately 321,978,200 cases in the 7MM. These cases are expected to increase by 2032 at a CAGR of 0.2% during the study period (2019–2032).
• Among the 7MM, the United States accounted for approximately 37% of the total diagnosed prevalent cases of H. pylori Infection in the 7MM in the year 2021. The cases are expected to further increase by 2032.
• Among EU5 countries, France had the highest diagnosed prevalent cases of H. pylori Infection with approximately 31,931,498 cases in 2021, while the United Kingdom had the lowest diagnosed prevalent population of H. pylori Infection with approximately 23,913,563 cases in 2021.
• In 2021, the diagnosed prevalent population of H. pylori Infection in Japan was found to be approximately 64,413,456 which is expected to decrease for the study period of 2019–2032.
• According to estimates based on DelveInsight’s epidemiology model for H. pylori Infection, the gender distribution of the disease suggests a male predominance across the 7MM, with approximately 62,422,016 male and approximately 56,837,414 female cases in the US in 2021.
• According to estimates based on DelveInsight’s epidemiology model for H. pylori Infection, the age-specific distribution of the disease suggests that in the US, the >40 age group makes up the majority of the H. pylori Infection cases (approximately 65%), followed by 20–40 age group ( approximately 25%). While there were least cases in the 0–20 age group.

Country-Wise H. pylori Infection Epidemiology

The epidemiology segment also provides the H. pylori Infection epidemiology data and findings across the United States, EU-5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

H. pylori Infection Drug Chapters

The drug chapter segment of the H. pylori Infection report encloses the detailed analysis of H. pylori Infection marketed drugs, and pipeline drugs. It also helps to understand the H. pylori Infection clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

H. pylori Infection Marketed Drugs

VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK: Phathom Pharmaceuticals

VOQUEZNA TRIPLE and DUAL PAKs developed by Phathom Pharmaceuticals are co-packaged products containing potassium-competitive acid blockers (P-CABs) in combination with antibiotics for the treatment of H. pylori infection in adults. VOQUEZNA TRIPLE PAK 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. Vonoprazan is the first novel acid suppressant from a new drug class to be approved in the US in over 30 years. However, it is approved for the treatment of H. pylori infection and other acid-related diseases in many countries, including Japan.

Product’s detail in the report…

TALICIA (RHB-105): Redhill Biopharma

Redhill Biopharma’s TALICIA (RHB-105) is a delayed-release 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. TALICIA is the first and only FDA-approved rifabutin-based H. pylori therapy that addresses the high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy. TALICIA provides an excellent safety and efficacy profile that is not compromised by clarithromycin or metronidazole resistance.

Product’s detail in the report…

List of products to be continued in the report…

H. pylori Infection Emerging Drugs

There are not many drugs in late-stage development for H. pylori, and even the available drugs have no recent updates or are simple modifications to the approved therapy. However, the early phase pipeline for H. pylori is dynamic and robust, with multiple products developed and tested by various pharma companies. Some of these are in the preclinical phase or at the university level.

Servatus, RaQualia Pharma, MerLion Pharmaceuticals, TenNor Therapeutics, and Trio Medicines are conducting initial phase trials for their products. BAS 118, SCG321, and R435/R529 are a few therapies in the preclinical phase. All these create an opportunity for market expansion and growth.

Products detail in the report…

List of products to be continued in the report…

H. pylori Infection Market Outlook

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 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 was introduced in the 1980s; since then, there have been major changes. The current treatment regime for H. pylori 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 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.

Most international guidelines for treating H. pylori infection are consistent with triple therapy as the first-line treatment. Triple therapy consists of administering a PPI with clarithromycin, and amoxicillin for 1–2 weeks. The regimen has a high-eradication rate of >95% if followed for 14 days; however, growing clarithromycin resistance is a cause of concern as the eradication rates have decreased to <80%. Most guidelines recommend clarithromycin-based therapies as the choice of first-line therapies based on the local prevalence of antibiotic resistance. They should be abandoned in areas where the local clarithromycin resistance rate is more than 15%.

TAKECAB (vonoprazan) by Takeda and Otsuka was approved only in Japan almost a decade back, and it has more potent and prolonged acid-inhibitory effects than PPIs. Several Japanese reports have shown that the P-CAB regimen has higher success rates of first-line eradication than the PPI regimens when treating clarithromycin-resistant H. pylori strains. Even its combinations, VONOSAP and VONOPION, were made available in 2016 for the primary and secondary eradication of H. pylori.

Key Findings

• The market size of the H. pylori Infection in the seven major markets was approximately USD 3,411 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 1.9% for the study period (2019–2032).
• The United States accounts for the largest market size for H. pylori Infection, in comparison to EU-5 (Germany, Italy, France, Spain, and the United Kingdom) and Japan.
• The therapies already in the market together with the recent launch of Voquezna Dual and Triple Pak are expected to increase the market size of H. pylori infection in the coming years, assisted by other factors.
• Among EU5 countries, France had the highest market size with approximately USD 290 million in 2021, followed by Germany.
• The market size for H. pylori Infection in Japan was valued at approximately USD 591 million in 2021. It is expected that the market will increase during the forecast period (2022–2032).

The United States Market Outlook

This section provides the total H. pylori Infection market size and market size by therapies in the United States.

The EU-5 Market Outlook

The total H. pylori Infection market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total H. pylori Infection market size and market size by therapies in Japan are provided.

H. pylori Infection Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the H. pylori Infection market or expected to get launched in the market during the study period 2019–2032. The analysis covers the H. pylori Infection market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

H. pylori Infection Development Activities

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

H. pylori Infection Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for H. pylori Infection emerging therapies.

Reimbursement Scenario in H. pylori Infection

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitively and market Intelligence analysis of the H. pylori Infection market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers a descriptive overview of H. pylori Infection, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the H. pylori Infection epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for H. pylori Infection is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the H. pylori Infection market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM H. pylori Infection market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the H. pylori Infection market.
• The companies and academics are working to assess challenges and seek opportunities that could influence H. pylori Infection R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for H. pylori Infection. The launch of emerging therapies will significantly impact the H. pylori Infection market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

H. pylori Infection Report Insights

• Patient Population
• Therapeutic Approaches
• H. pylori Infection Pipeline Analysis
• H. pylori Infection Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

H. pylori Infection Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• H. pylori Infection Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

H. pylori Infection Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the H. pylori Infection market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the H. pylori Infection total market size as well as market size by therapies across the 7MM during the forecast period (2022–2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest H. pylori Infection market size during the forecast period (2022–2032)?
• At what CAGR, the H. pylori Infection market is expected to grow at the 7MM level during the forecast period (2022–2032)?
• What would be the H. pylori Infection market outlook across the 7MM during the forecast period (2022–2032)?
• What would be the H. pylori Infection market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of H. pylori Infection?
• What is the historical H. pylori Infection patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of H. pylori Infection at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to H. pylori Infection?
• Out of the above-mentioned countries, which country would have the highest incidence population of H. pylori Infection during the forecast period (2022–2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022–2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of H. pylori Infection along with the approved therapy?
• What are the current treatment guidelines for the treatment of H. pylori Infection in the US and Europe?
• What are the H. pylori Infection marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of H. pylori Infection?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of H. pylori Infection?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to H. pylori Infection therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for H. pylori Infection and their status?
• What are the key designations that have been granted for the emerging therapies for H. pylori Infection?
• What is the 7MM historical and forecasted market for H. pylori Infection?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving H. pylori Infection.
• To understand the future market competition in the H. pylori Infection market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for H. pylori Infection in the US, EU-5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the H. pylori Infection market.
• To understand the future market competition in the H. pylori Infection market.