Eosinophilic Esophagitis - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The total market size of eosinophilic esophagitis in 2023 was approximately USD 1.80 trillion in the 7MM, which is expected to grow during the forecast period (2020-2034).
• Among EU4 and the UK, Germany will capture the maximum revenue share, followed by France and UK in 2034.
• In the 7MM, the US accounted for the highest diagnosed prevalent cases of eosinophilic esophagitis in 2023, with around 65% of the total diagnosed prevalent cases across the 7MM; these numbers are expected to increase during the forecast period (2024-2034).
• The analysis reveals that a higher diagnosed prevalence of eosinophilic esophagitis is observed in the male gender across the 7MM.
• Among age-specific cases, patient with more than 18 yrs of age represents a higher prevalence compared to patient with less than 18 yrs of age.
• Proton Pump Inhibitors have been the cornerstone of eosinophilic esophagitis management
• In recent years therapies like DUPIXENT, EOHILIA, JORVEZA have been approved for the treatment of EoE in the 7MM countries.
• The pipeline for Eosinophilic Esophagitis is strong, with many candidates like VELSIPITY, TEZSPIRE, ESO-101, Cendakimab and others.
• In February 2024, the US FDA approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with EoE.
• In January 2024, US FDA approved DUPIXENT (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with EoE.
• In September 2024, Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of DUPIXENT (dupilumab) in the European Union for EoE in children down to 1 year of age. The recommendation is for children aged 1-11 years who weigh at least 15 kg. The European Commission is expected to announce a final decision in the coming months.

This report delivers an in-depth understanding of the Eosinophilic Esophagitis historical and forecasted epidemiology as well as the Eosinophilic Esophagitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Eosinophilic Esophagitis market report provides current treatment practices, emerging drugs, Eosinophilic Esophagitis market share of individual therapies, and current and forecasted Eosinophilic Esophagitis market size from 2020 to 2034, segmented by seven major markets. The report also covers current Eosinophilic Esophagitis treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

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

Eosinophilic Esophagitis (EoE): Understanding and Treatment Algorithm

Eosinophilic Esophagitis Overview

Eosinophilic Esophagitis (EoE) is an emerging chronic inflammatory disease of the esophagus characterized by upper gastrointestinal symptoms, including dysphagia and esophageal food impaction. The histopathological manifestations involve intraepithelial infiltration of eosinophils (=15 Eos/HPF) and remodeling of the esophageal epithelium, including Basal Zone Hyperplasia (BZH) and Dilated Intercellular Spaces (DIS), which can lead to strictures and narrow-caliber esophagus.

EoE is a complex disease characterized by heterogeneous clinical presentation (age of onset, symptomology, varying clinical manifestations and comorbidities, natural history, and responsiveness to therapy). Despite challenges in disease diagnosis and management, there is corroborative clinical and experimental evidence to suggest that EoE is driven by an underlying CD4+ T helper type 2 (Th2) allergic inflammatory response to dietary food allergens in the esophageal mucosa. EoE-derived signals (e.g., Thymic Stromal Lymphopoietin (TSLP) and interleukin (IL-13) are thought to induce Type-2 allergic cytokines, including IL-5 and IL-13, which stimulate the recruitment and activation of the allergic effector cells, eosinophils, and mast cells. Eosinophil and mast cell-derived mediators stimulate dysregulation of epithelial barrier regulatory and proliferative response genes within the esophageal epithelial compartment leading to esophageal epithelial remodeling and fibrosis. Compelling evidence supporting a role for allergic inflammatory cells (CD4+ Th2-type cells, eosinophils, and mast cells) and cytokines in EoE has led to using biologics that target these inflammatory cells and mediators as potential treatments for EoE.

Eosinophilic Esophagitis Diagnosis

EoE is characterized by clinical symptoms of esophageal dysfunction and esophageal eosinophilia, defined by =15 Eosinophils per High-powered Field (Eos/HPF) on biopsy. Before solidifying a diagnosis of EoE, clinicians should consider other etiologies of esophageal eosinophilia.

Endoscopy, Barium Esophagram, Reflux testing, Impedence planimetry and others methods are used for the diagnosis of EoE.

Eosinophilic Esophagitis Treatment

The treatment of EoE seeks to relieve symptoms, improve histopathology, reverse existing disease complications, and prevent future disease consequences. The primary approach involves treatment with Proton pump inhibitors, swallowed topical steroids, and diet therapy. Medical and diet therapies that significantly reduce esophageal inflammation may not effectively reverse existing esophageal strictures. In contrast, esophageal dilation can effectively manage esophageal strictures, thereby alleviating dysphagia in the absence of improvement in esophageal inflammation. Endoscopic features, as delineated by the EREFS system, identify remodeling aspects of the disease, including esophageal rings and strictures that are associated with symptom outcomes of dysphagia and food impaction risk and are not verifiable on mucosal biopsies.

Eosinophilic Esophagitis Epidemiology

The Eosinophilic Esophagitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the Total Diagnosed Prevalent Cases of Eosinophilic Esophagitis, Gender-specific Cases of Eosinophilic Esophagitis, Age-specific Cases of Eosinophilic Esophagitis, Treated Cases of Eosinophilic Esophagitis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the US accounted for the highest diagnosed prevalent cases of eosinophilic esophagitis in 2023, with around 445,000 cases; these numbers are expected to increase during the forecast period.
• Eosinophilic Esophagitis predominantly affected males, with approximately 290,000 males diagnosed compared to 156,000 females in 2023 in the US.
• In the 7MM, individuals over the age of 18 were the most affected by Eosinophilic Esophagitis, with approximately 156,000 cases reported in 2023.

Eosinophilic Esophagitis Drug Chapters

The drug chapter segment of the Eosinophilic Esophagitis report encloses a detailed analysis of the marketed, late-stage (Phase III), and mid-stage (Phase II) pipeline drugs. The marketed drugs segment encloses DUPIXENT, EOHILIA, JORVEZA. Furthermore, the current key players for emerging drugs and their respective drug candidates include Celgene (Cendakimab), Astrazeneca & Amgen (Tezspire), Pfizer (Velsipity), Ellodi pharmaceuticals (APT-1011), EsoCap (ESO-101) and others. The drug chapter also helps understand the Eosinophilic Esophagitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

DUPIXENT (dupilumab): Sanofi/Regeneron Pharmaceuticals

DUPIXENT, which was invented using Regeneron’s proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the Interleukin-4 (IL-4) and Interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is approved for the treatment of DUPIXENT, which was invented using Regeneron’s proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the Interleukin-4 (IL-4) and Interleukin-13 (IL-13) pathways and is not an immunosuppressant.

In January 2024, US FDA approved DUPIXENT (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with EoE andIn May 2022, US FDA approved DUPIXENT (dupilumab) to treat EoE in adults and pediatric patients 12 years and older weighing at least 40 Kg. In January 2023, the European Commission expanded the marketing authorization for DUPIXENT (dupilumab) in the European Union to treat EoE in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Emerging Drugs

Cendakimab (CC-93538/RPC4046): Bristol Myers Squibb (BMS)

Cendakimab/RPC4046/CC-93538 is a recombinant humanized, high affinity, selective, anti-IL-13 mAb. RPC4046 binds an IL-13 epitope that prevents its binding to both IL-13R (alpha) 1 and IL-13R (alpha) 2, providing potential efficacy and/or safety advantages. The drug has been granted ODD for the treatment of EoE by the US FDA. In the Phase II study, RPC4046 demonstrated positive results. Currently, the company is conducting two Phase III clinical studies to evaluate the efficacy and safety of CC-93538 in adult and adolescent participants with EoE.

TEZSPIRE (Tezepelumab) : AstraZeneca/Amgen

TEZSPIRE (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP. This key epithelial cytokine sits at the top of multiple inflammatory cascades. It is critical in the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness. TEZSPIRE acts at the top of the inflammation cascade and has the potential to help address a broad population of severe asthma patients irrespective of biomarker levels.

TEZSPIRE is approved in the US, EU, Japan, and other countries for the treatment of severe asthma. TEZSPIRE is also in development for other potential indications, including Chronic Obstructive Pulmonary Disease (COPD), chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and EoE. In October 2021, tezepelumab was granted an Orphan Drug Designation (ODD) by the FDA for the treatment of EoE.

Eosinophilic Esophagitis Market Outlook

The market for Eosinophilic Esophagitis is driven by significant unmet needs, particularly in the development of novel treatments and the establishment of comprehensive guidelines for adolescents and adults. Current treatments, like proton pump inhibitors and corticosteroids therapy, manage symptoms but come with serious side effects due to high steroid dosages. Although in recent years therapies like DUPIXENT, EOHILIA and JOrveza got approved in 7MM countries but still there is huge scope for emerging. There are some promising therapies in the pipeline, including Cendakimab, Tezepelumab, APT-101, Etrasimod and others which are advancing through clinical trials. These emerging therapies are expected to enter the market by 2025, offering potentially disease-modifying options that could significantly improve patient outcomes and drive market growth.

Key Findings

• In 2023, the United States held the largest market share for Eosinophilic Esophagitis among the 7MM, accounting for approximately 75% of the total market.
• In 2023, DUPIXENT dominated the Eosinophilic Esophagitis therapy market in the United States. However, by 2034, Cendakimab is expected to take the lead, commanding the largest market share.
• In 2023, Proton Pump Inhibitor and steroid combination treatments for Eosinophilic Esophagitis generated approximately USD 500 million in revenue across the 7MM countries.

Eosinophilic Esophagitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Eosinophilic Esophagitis Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics. Companies like Astrazeneca/Amgen, Pfizer, BMS, EsoCap and others are actively engaging their product in research and development efforts for Eosinophilic Esophagitis. The pipeline of Eosinophilic Esophagitis possesses many potential drugs and there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024-2034).

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Eosinophilic Esophagitis emerging therapy.

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 the Eosinophilic Esophagitis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Endocrinologist, Pediatricians, and others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the National Institutes of Health, Cincinnati Children’s Hospital Medical Center, Boston Children's Hospital, Great Ormond Street Hospital, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Eosinophilic Esophagitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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.

Market Access and Reimbursement

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, 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 Eosinophilic Esophagitis, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Eosinophilic Esophagitis market, 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 KOL views, patient journey, and treatment preferences that help shape and drive Eosinophilic Esophagitis market.

Eosinophilic Esophagitis Report Insights

• Patient Population
• Therapeutic Approaches
• Eosinophilic Esophagitis Pipeline Analysis
• Eosinophilic Esophagitis Market Size and Trends
• Existing and Future Market Opportunity

Eosinophilic Esophagitis Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Eosinophilic Esophagitis Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Eosinophilic Esophagitis Report Assessment

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

FAQs

• What was the Eosinophilic Esophagitis market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for Eosinophilic Esophagitis?
• What are the disease risks, burdens, and unmet needs of Eosinophilic Esophagitis? What will be the growth opportunities across the 7MM concerning the patient population with Eosinophilic Esophagitis?
• What are the current options for the treatment of Eosinophilic Esophagitis? What are the current guidelines for treating Eosinophilic Esophagitis in the 7MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the patient share in Eosinophilic Esophagitis?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Eosinophilic Esophagitis 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.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of current therapies, 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.