嗜酸性食管炎药物市场份额，规模，趋势，行业分析报告，由产品（非标签药物，预烯胺口服悬浮液，氟替卡松，莫斯皮亚，石油司，司石，Dupilunab，omalizumab，QAX576，Akoo2和Losartan）;诊断;通过治疗;按地区;分部预测，2021 - 2028

报告摘要

全球嗜酸性食管炎药物市场在2020年的价值为115.3亿美元，预计预测期内的复合年增长率为6.5％。嗜酸性粒细胞性食管炎（EOE）是一种抗原介导的慢性食管疾病，其在临床上通过食管功能障碍，并通过与嗜酸性粒细胞的食道炎症组织学表征。

Eosinophilic esophagitis development is due to the presence of a deficient mucosal barrier in the esophagus and reverse immune reaction causing fissures/lesions, fibrosis, and dysmotility in the esophagus, mediated by Th2 interleukins. Eosinophilic esophagitis is multi-factorial, with around a 7 percent risk of genetic inheritance. Food allergies, and exposure to excessive use of antibiotics, acid suppression, and early life symptoms of gastro-intestinal disorders are also predominant market factors.

If left untreated, eosinophilic esophagitis could lead to a stricture in the esophagus, possible risks of food impaction, and dysphagia. As per the study conducted by Dellon and Hirano, in 2017, eosinophilic esophagitis has an annual incidence of 5 to 10 cases per 100,000 individuals and a prevalence of around 50 - 100 cases per 100,000 individuals. Clinical symptoms vary with age and sex, being predominant in males as compared to females. Infants with eosinophilic esophagitis face feeding difficulties, school kids suffer from vomiting and pain while eating, and adults show food impaction and dysphagia.

Despite pathologic advances in eosinophilic esophagitis, still there is no single FDA-approved drug for EoE. Currently, EoE is being treated with off-label treatments using 3 Ds: topical corticosteroids, dietary restrictions, and endoscopic dilation. Though in the past decade, few new eosinophilic esophagitis treatments were evolved such as steroid formulations optimizing mucosal deposition, with the recent approval of budesonide effervescent tablet in the European market, biologics used in the TH2-mediated diseases, such as atopic dermatitis, asthma, and other allergic reaction, currently being in clinical trials, and novel dietary restrictions.

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Industry Dynamics

增长司机
最近ly, the potential drug candidates for the treatment of eosinophilic esophagitis have received promising results, which is expected to drive the market forward. In September 2020, Sanofi’s drug candidate Dupixent (dupilumab) received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) to treat eosinophilic esophagitis patients of 12 years and older in collaboration with Regeneron.

Dupixent是抑制白细胞介素4和5蛋白的信号传导的完全人单克隆抗体，被认为是2型炎症中的主要氧化剂，包括eoE。该名称基于患有EOE患者的第3阶段试验的A部分A的正面结果。目前，没有FDA批准的嗜酸性食管炎药物，患有型2型炎症性疾病损害食管的功能。

在美国，仅有大约160,000人患有嗜酸性食管炎，并通过未经批准的标签药物和饮食修饰治疗。其中，大约50,000人重复的疗程。第3阶段试验的一部分是随机，双盲，安慰剂对照试验，其中81名患者满足初级和次要终点。注册的患者在24周的治疗期间用每周剂量的Dupixent 300mg施用。检查的患者对食道粘膜膜的初级症状，食管炎症和降低的嗜酸性粒细胞计数降低。

Moreover, in August 2019, AstraZeneca announced that FDA has granted orphan drug designation to its drug candidate Fasenra (benralizumab), used in the treatment of EoE. FDA grants this status to drug candidates which are intended to prevent rare disorders/diseases, affecting less than 200,000 individuals in the U.S. market. Drug depletes eosinophils present in both blood and connective tissue during eosinophilic esophagitis treatment and is undergoing clinical trials to test its specificity and efficacy. Currently, there are no FDA-approved drugs for eosinophilic esophagitis treatment, so there is a race among market players to have a first-mover advantage.

嗜酸性嗜热性食管炎药物市场报告范围

The market has been segmented on the basis of product, diagnosis, treatment, and region:

由产品	By Diagnosis	通过治疗	按地区
非标签药物 预烯胺口服悬浮液 Fluticasone ODT Mepolizumab Reslizumab 北大利关 Dupilunab omalizumab. QAX576 akoo2. 莱斯坦坦	上内窥镜检查 食道活检 Blood Tests 其他	饮食治疗 药物 扩张 其他	北美（美国，加拿大） 欧洲（法国，德国，英国，意大利，西班牙，荷兰，奥地利） 亚太（日本，中国，印度，马来西亚，印度尼西亚，韩国） 拉丁美洲（巴西，墨西哥，阿根廷） 中东和非洲（沙特阿拉伯，阿联酋，以色列，南非）

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Insight by Product

基于该产品，嗜酸性食管炎药物市场被分类为非标签药物，预皂苷口服悬浮液，氟替卡松Odt，Mepolizumab，Reslazumab，Benralizumab，Dupilunab，omalizumab，Qax576，Akoo2和Losartan。2020年，杜普纳布市场分部占收入最大的份额。Dupixent是抑制白细胞介素4和5蛋白的信号传导的完全人单克隆抗体，被认为是2型炎症中的主要氧化剂，包括eoE。该名称基于患有嗜酸性食管炎患者的第3阶段试验的A部分的正面结果。

治疗洞察力

基于治疗，全球嗜酸性食管炎药物市场分叉进入膳食疗法，药物，扩张，其他。2020年，膳食疗法市场分部占最大的份额，其中包括最大的份额。这种高位市场分部份额是由于未满足的需求，例如，嗜酸性食管炎患者的食物致敏和相关反应的自然历史尚不清楚。研究表明，不到10％的孩子恢复了他们以前从他们的常规饮食中消除的食物的能力。然而，与被引入的食物对齐的临床特征仍然难以捉摸，并且没有任何预测指标的成功或失败。

此外，嗜酸性食管炎的食物触发器的电流过敏测试具有可变的结果，这取决于测试类型和正在测试的食物。在儿童中，组合的蛋白饮食和皮肤刺的饮食率适中成功率50-60％，然而，在成人中，这些测试表现出非常低的成功比率，以预测过敏性食物触发。在eoe中仍有许多问题，包括抗原特异性T细胞的证据，以及在食物反应期间的免疫移位的定时从先天性到适应症免疫。这些问题与EoE中的食物触发器的影响结合使用，驱动EOE的新过敏测试测试的需求。

Geographic Overview

Geographically, the market is segregated as North America, Asia Pacific, Europe, South America, and Middle East & Africa. North America market is the largest regional revenue contributor followed by Europe and the Asia Pacific market. The competition among market players to have first-mover advantage, as there is no FDA approved drug for EoE and rising economic burden. In the U.S. alone, around 160,000 people are suffering from eosinophilic esophagitis and are treated with un-approved off label drugs and diet modifications. The annual healthcare burden of EoE in the U.S. alone costs about USD 1.4 billion.

若干专门的协会和学术机构如罕见的疾病临床研究网络（CEGIR）和美国嗜酸性疾病的美国伙伴关系（APFED），特别是发达经济体的良好伙伴关系负责提供研究拨款和资金。例如，在2020年，美国过敏院，哮喘和免疫学（AAAAI）和APFED获得了140,000美元的赠款，以研究免疫系统如何与导致患者发病的食物过敏物质相互作用。该研究还将有助于确定药物发育和疾病发病机制的新目标。

此外，Joshua B. Wechsler，西北大学Feinberg医学院的助理教授获得了2020-21美元的研究许可，为其项目了解肥大细胞在嗜酸性食管炎，内窥镜异常和影响中的作用治疗。该项目将分析活组织检查的新途径，理解肥大细胞和相关介质的相互作用。

Competitive Insights

The prominent market players operating are Regeneron Pharmaceuticals, Adare Pharmaceuticals, Inc., Bristol-Myers Squibb, Takeda (Shire), DBV Technologies, Dr. Falk Pharma GmbH, Allakos, Inc., Arena Pharmaceuticals, and Ception Therapeutics.

2020年9月，基于美国的私募股权公司TPG Capital宣布在市场上建立新的“Ellodi Pharmaceuticals”。新公司将致力于APT-1011的临床开发，这是一种治疗EOE的新候选人，从Adare Pharmaceuticals纺出来。APT-1011目前进入第3阶段（长笛II）的研究。