PUBLISHER: DelveInsight | PRODUCT CODE: 1605427
PUBLISHER: DelveInsight | PRODUCT CODE: 1605427
DelveInsight's " Eosinophilic Esophagitis (EoE)- Market Insight, Epidemiology, and Market Forecast - 2034" 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.
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.
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.
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.
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
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.
DelveInsight's 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.