CSL112の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

CSL112（アポリポタンパクA-I（ヒト））は、HDLの主要機能成分である血漿由来アポA-Iの新製剤です。静脈内投与に適したHDL様粒子として再構成されます。CSL112を点滴静注すると、コレステロール排出能が速やかに増強されることが研究で示されています。CSL112は、動脈硬化性プラーク病変を迅速に安定化させる新しいアプローチを提供する可能性があり、急性心筋梗塞患者の早期心血管系イベントのリスクを低減するために開発されています。

企業のR&D投資家向け説明会によると、フェーズ3試験（AEGIS-II）の募集は2022年12月のLPIに向けて順調に進んでいます。試験は進捗しており、80％以上の登録が達成され、3回目の中間解析が終了しました。試験は2023年までに完了し、上市は2025年第4四半期を予定しています。

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CSL112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CSL112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 CSL112市場の評価

• 心筋梗塞におけるCSL112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CSL112の市場規模
• 市場の分析：国別
  • 米国の心筋梗塞向けCSL112の市場規模
  • ドイツの心筋梗塞向けCSL112の市場規模
  • 英国の心筋梗塞向けCSL112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: CSL112, Clinical Trial Description, 2023
• Table 2: CSL112, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Late-stage Emerging Therapies)
• Table 5: CSL112 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: CSL112 Market Size in the US, in USD million (2019-2032)
• Table 7: CSL112 Market Size in Germany, in USD million (2019-2032)
• Table 8: CSL112 Market Size in France, in USD million (2019-2032)
• Table 9: CSL112 Market Size in Italy, in USD million (2019-2032)
• Table 10: CSL112 Market Size in Spain, in USD million (2019-2032)
• Table 11: CSL112 Market Size in the UK, in USD million (2019-2032)
• Table 12: CSL112 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: CSL112 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: CSL112 Market Size in the United States, USD million (2019-2032)
• Figure 3: CSL112 Market Size in Germany, USD million (2019-2032)
• Figure 4: CSL112 Market Size in France, USD million (2019-2032)
• Figure 5: CSL112 Market Size in Italy, USD million (2019-2032)
• Figure 6: CSL112 Market Size in Spain, USD million (2019-2032)
• Figure 7: CSL112 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: CSL112 Market Size in Japan, USD million (2019-2032)

"CSL112 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about CSL112 for myocardial infarction in the seven major markets. A detailed picture of the CSL112 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 CSL112 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 CSL112 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:

CSL112, apolipoprotein A-I (human), is a novel formulation of plasma-derived apoA-I, the primary functional component of HDL. It is reconstituted to form HDL-like particles suitable for IV infusion. Studies have shown that infusion of CSL112 rapidly enhances cholesterol efflux capacity. CSL112 may offer a new approach for rapidly stabilizing atherosclerotic plaque lesions and is being developed to reduce the risk of early cardiovascular events in acute MI patients.

As per the company's R&D investor briefing presentation, recruitment of the Phase III study (AEGIS-II) is on track for LPI December 2022. The study is progressing with >80% enrolment achieved and the third interim analysis completed. The trial is expected to be completed by 2023, and the launch is expected for Q4 of 2025.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the CSL112 description, mechanism of action, dosage and administration, research and development activities in myocardial infarction.
• Elaborated details on CSL112 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the CSL112 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 CSL112.
• The report contains forecasted sales of CSL112 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 CSL112 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.

CSL112 Analytical Perspective by DelveInsight

• In-depth CSL112 Market Assessment

This report provides a detailed market assessment of CSL112 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 2025 to 2032.

• CSL112 Clinical Assessment

The report provides the clinical trials information of CSL112 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 CSL112 dominance.
• Other emerging products for myocardial infarction are expected to give tough market competition to CSL112 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 CSL112 in myocardial infarction.
• Our in-depth analysis of the forecasted sales data of CSL112 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the CSL112 in myocardial infarction.

Key Questions:

• What is the product type, route of administration and mechanism of action of CSL112?
• What is the clinical trial status of the study related to CSL112 in myocardial infarction and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CSL112 development?
• What are the key designations that have been granted to CSL112 for myocardial infarction?
• What is the forecasted market scenario of CSL112 for myocardial infarction?
• What are the forecasted sales of CSL112 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 CSL112 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. CSL112 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. CSL112 Market Assessment

• 5.1. Market Outlook of CSL112 in myocardial infarction
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of CSL112 in the 7MM for myocardial infarction
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of CSL112 in the United States for myocardial infarction
  • 5.3.2. Market Size of CSL112 in Germany for myocardial infarction
  • 5.3.3. Market Size of CSL112 in France for myocardial infarction
  • 5.3.4. Market Size of CSL112 in Italy for myocardial infarction
  • 5.3.5. Market Size of CSL112 in Spain for myocardial infarction
  • 5.3.6. Market Size of CSL112 in the United Kingdom for myocardial infarction
  • 5.3.7. Market Size of CSL112 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