Selatogrelの市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

Selatogrelは、強力で、選択性が高く、即効性があり、可逆的なP2Y12受容体拮抗薬であり、心筋梗塞再発リスクの高い患者の心筋梗塞治療薬として開発されています。この薬剤は、AMIを示唆する症状が発現した際に、ドラッグデリバリーデバイス（自己注射器）を介して皮下に自己投与します。

慢性冠症候群患者とAMI患者を対象とした2つのフェーズII試験が発表され、血小板凝集の速やかで可逆的な抑制が示されました。Selatogrel 16mgのSC投与は15分以内の迅速な作用発現を示し、その効果の規模は約8時間に及びました。Selatogrelの安全性と忍容性はいずれの試験においても良好でした。

2021年6月、Idorsiaは、AMIが疑われる患者を対象とした自己注射Selatogrelの有効性と安全性を評価するフェーズ3登録試験「SOS-AMI」の開始を発表しました。

特別プロトコルの評価がFDAと合意されました。これは、将来の販売申請をサポートすることを目的とした試験において、プロトコルデザイン全体の特定の重大な要素（例えば、エントリー基準、投与量の選択、エンドポイント、計画された解析）が適切であり、受け入れ可能であることにFDAが同意したことを示すものです。

Selatogrelを用いたフェーズ3試験は、AMI再発リスクの高い患者約1万4,000人の登録を目標に患者を募集しています。患者募集は、より多くの施設が参加するにつれて活発化しており、約45ヶ国、500施設以上を目標としています。

当レポートでは、主要7市場（米国・ドイツ・フランス・イタリア・スペイン・英国・日本）における心筋梗塞向けSelatogrelについて調査分析し、作用機序、用法と用量、研究開発活動についての考察、収益の予測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 心筋梗塞におけるSelatogrel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
• 製品プロファイル

第3章 競合情勢（上市済みの治療法）

第4章 競合情勢（後期の新治療法）

第5章 Selatogrel市場の評価

• 心筋梗塞におけるSelatogrelの市場見通し
• 主要7市場の分析
  • 主要7市場の心筋梗塞向けSelatogrelの市場規模
• 市場の分析：国別
  • 米国の心筋梗塞向けSelatogrelの市場規模
  • ドイツの心筋梗塞向けSelatogrelの市場規模
  • 英国の心筋梗塞向けSelatogrelの市場規模

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

List of Figures

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

"Selatogrel Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about selatogrel for myocardial infarction in the seven major markets. A detailed picture of the selatogrel for myocardial infarction 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 selatogrel for myocardial infarction. 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 selatogrel market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.

Drug Summary:

Selatogrel is a potent, highly selective, fast-acting, and reversible P2Y12 receptor antagonist, being developed for treating AMI in patients at high risk of recurrent AMI. It is self-administered subcutaneously via a drug delivery device (autoinjector) upon the occurrence of symptoms suggestive of an AMI.

Two published Phase II studies, one in patients with chronic coronary syndromes and one in patients with AMI, showed fast and reversible inhibition of platelet aggregation. SC administration of selatogrel 16 mg has demonstrated a rapid onset of action, within 15 min, with the magnitude of the effect extending over approximately 8h. Selatogrel was safe and well-tolerated in both studies.

In June 2021, Idorsia announced the initiation of the Phase III registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered SC selatogrel in suspected AMI.

A special protocol assessment has been agreed upon with the FDA. This indicates the FDA agrees with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support a future marketing application.

The Phase III study with selatogrel is recruiting patients, with a target enrollment of approximately 14,000 patients at high risk of recurrent AMI. Patient recruitment is ramping up as more sites become involved, with a target of more than 500 sites in about 45 countries.

Scope of the Report:

The report provides insights into:

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

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.

Selatogrel Analytical Perspective by DelveInsight

• In-depth Selatogrel Market Assessment

This report provides a detailed market assessment of selatogrel for myocardial infarction 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 2026 to 2032.

• Selatogrel Clinical Assessment

The report provides the clinical trials information of selatogrel for myocardial infarction covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for myocardial infarction 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 selatogrel dominance.
• Other emerging products for myocardial infarction are expected to give tough market competition to selatogrel 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 selatogrel in myocardial infarction.
• Our in-depth analysis of the forecasted sales data of selatogrel from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the selatogrel in myocardial infarction.

Key Questions:

• What is the product type, route of administration and mechanism of action of selatogrel?
• What is the clinical trial status of the study related to selatogrel in myocardial infarction and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the selatogrel development?
• What are the key designations that have been granted to selatogrel for myocardial infarction?
• What is the forecasted market scenario of selatogrel for myocardial infarction?
• What are the forecasted sales of selatogrel 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 selatogrel for myocardial infarction?
• Which are the late-stage emerging therapies under development for the treatment of myocardial infarction?

Table of Contents

1. Report Introduction

2. Selatogrel Overview in myocardial infarction

• 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. Selatogrel Market Assessment

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

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