APT-1011の新興薬剤に関する洞察と市場予測：2032年

APT-1011は、Adare社独自のAdvaTab技術を組み込んだフルチカゾンの新規経口製剤であり、口腔内での滞留時間を最小限に抑えながら食道への局所デリバリーを可能にします。先行臨床試験において、APT-1011はEoEと診断された成人の食道好酸球数と内視鏡所見を効果的に減少させました。APT-1011はFDAおよびEMAからODDを、FDAからFDTを取得しています。2019年の第II相試験（FLUTE I）の成功に続き、現在第III相開発中（FLUTE II）です。

今後数年間で、好酸球性食道炎（EoE）の市場シナリオは、世界中の広範な調査と医療費の増加により変化するとみられます。各社は、病状を治療/改善するための新たなアプローチに焦点を当てた治療法を開発し、課題を評価し、APT-1011の優位性に影響を与える可能性のある機会を模索しています。EoEに対する他の新興製品がAPT-1011に厳しい市場競争を与えることが予想され、近い将来に後発の新興治療薬が発売されれば、市場に大きな影響を与えるとみられています。

当レポートでは、主要7ヶ国におけるAPT-1011市場について調査し、市場の概要とともに、2023年～2032年の売上予測データ、競合情勢、および国別動向などを提供しています。

目次

第1章 レポートのイントロダクション

第2章 好酸球性食道炎（EoE）におけるAPT-1011の概要

• 製品の詳細
• 臨床開発
  • 臨床研究
  • 臨床試験情報
  • 安全性と有効性
• その他の開発活動
• 製品概要

第3章 競合情勢（上市済み治療法）

第4章 競合情勢（後期段階の新興治療法）

第5章 APT-1011市場評価

• EoEに対するAPT-1011の市場展望
• 主要7ヶ国市場分析
  • 主要7ヶ国におけるEoEに対するAPT-1011の市場規模
• 国別市場分析
  • 米国
  • ドイツ
  • 英国

第6章 SWOT分析

第7章 アナリストの見解

第8章 付録

第9章 DelveInsightのサービス内容

第10章 免責事項

第11章 DelveInsightについて

第12章 レポート購入オプション

List of Tables

• Table 1: APT-1011, Clinical Trial Description, 2023
• Table 2: APT-1011, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: APT-1011 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: APT-1011 Market Size in the US, in USD million (2019-2032)
• Table 7: APT-1011 Market Size in Germany, in USD million (2019-2032)
• Table 8: APT-1011 Market Size in France, in USD million (2019-2032)
• Table 9: APT-1011 Market Size in Italy, in USD million (2019-2032)
• Table 10: APT-1011 Market Size in Spain, in USD million (2019-2032)
• Table 11: APT-1011 Market Size in the UK, in USD million (2019-2032)
• Table 12: APT-1011 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: APT-1011 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: APT-1011 Market Size in the United States, USD million (2019-2032)
• Figure 3: APT-1011 Market Size in Germany, USD million (2019-2032)
• Figure 4: APT-1011 Market Size in France, USD million (2019-2032)
• Figure 5: APT-1011 Market Size in Italy, USD million (2019-2032)
• Figure 6: APT-1011 Market Size in Spain, USD million (2019-2032)
• Figure 7: APT-1011 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: APT-1011 Market Size in Japan, USD million (2019-2032)

“"APT-1011 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about APT-1011 for eosinophilic esophagitis (EoE) in the seven major markets. A detailed picture of the APT-1011 for EoE in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the APT-1011 for EoE. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the APT-1011 market forecast analysis for EoE in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in EoE.

Drug Summary:

APT-1011, a novel, oral formulation of fluticasone incorporating Adare's proprietary AdvaTab technology, allows for topical delivery of the drug to the esophagus whilst minimizing residence time in the oral cavity. In earlier clinical trials, APT-1011 effectively reduced esophageal eosinophil counts and endoscopic findings in adults with a diagnosis of EoE. APT-1011 has received ODD from the FDA and EMA and FDT from FDA. It is currently in Phase III development (FLUTE II), following the successful completion of its Phase II study (FLUTE I) in 2019.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the APT-1011 description, mechanism of action, dosage and administration, research and development activities in eosinophilic esophagitis (EoE).
• Elaborated details on APT-1011 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the APT-1011 research and development activities in EoE across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around APT-1011.
• The report contains forecasted sales of APT-1011 for EoE till 2032.
• Comprehensive coverage of the late-stage emerging therapies for EoE.
• The report also features the SWOT analysis with analyst views for APT-1011 in EoE.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

APT-1011 Analytical Perspective by DelveInsight

In-depth APT-1011 Market Assessment

This report provides a detailed market assessment of APT-1011 for eosinophilic esophagitis (EoE) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

APT-1011 Clinical Assessment

The report provides the clinical trials information of APT-1011 for EoE covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for eosinophilic esophagitis (EoE) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence APT-1011 dominance.
• Other emerging products for EoE are expected to give tough market competition to APT-1011 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of APT-1011 in EoE.
• Our in-depth analysis of the forecasted sales data of APT-1011 from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the APT-1011 in EoE.

Key Questions:

• What is the product type, route of administration and mechanism of action of APT-1011?
• What is the clinical trial status of the study related to APT-1011 in eosinophilic esophagitis (EoE) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the APT-1011 development?
• What are the key designations that have been granted to APT-1011 for EoE?
• What is the forecasted market scenario of APT-1011 for EoE?
• What are the forecasted sales of APT-1011 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to APT-1011 for EoE?
• Which are the late-stage emerging therapies under development for the treatment of EoE?

Table of Contents

1. Report Introduction

2. APT-1011 Overview in EoE

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. APT-1011 Market Assessment

• 5.1. Market Outlook of APT-1011 in EoE
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of APT-1011 in the 7MM for EoE
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of APT-1011 in the United States for EoE
  • 5.3.2. Market Size of APT-1011 in Germany for EoE
  • 5.3.3. Market Size of APT-1011 in France for EoE
  • 5.3.4. Market Size of APT-1011 in Italy for EoE
  • 5.3.5. Market Size of APT-1011 in Spain for EoE
  • 5.3.6. Market Size of APT-1011 in the United Kingdom for EoE
  • 5.3.7. Market Size of APT-1011 in Japan for EoE

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options