ASC22の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

envafolimabとしても知られるASC22は、B型慢性肝炎（CHB）の機能的治癒を目的としたファーストインクラスの皮下投与型PD-L1抗体です。この抗体は、皮下注射が可能であり、室温での安定性が高いという利点を有します。Ascletis Pharmaは、ASC22のウイルス性の適応症に関する世界的な独占開発権および商業化権を保持しています。

現在、本薬はCHB治療におけるASC22の単回および複数回投与後の安全性と有効性を評価するフェーズII試験（NCT04465890）で評価されています。中国のフェーズIIb臨床試験の中間結果では、ASC22の1mg/kgとNAの24週間投与はCHB患者において良好な忍容性を示しました。ベースラインのHBsAgが100IU/mL未満であった患者の42.9％が持続的なHBsAgの消失を示し、このことは機能的治癒の可能性を示しています。

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B型慢性肝炎（CHB）向けASC22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 B型慢性肝炎におけるASC22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 ASC22市場の評価

• B型慢性肝炎におけるASC22の市場見通し
• 主要7市場と中国の分析
  • 主要7市場と中国のB型慢性肝炎向けASC22の市場規模
• 市場の分析：国別
  • 米国のB型慢性肝炎向けASC22の市場規模
  • ドイツのB型慢性肝炎向けASC22の市場規模
  • 英国のB型慢性肝炎向けASC22の市場規模
  • 中国のB型慢性肝炎向けASC22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: ASC22, Clinical Trial Description, 2023
• Table 2: ASC22, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Late-stage Emerging Therapies)
• Table 5: ASC22 Market Size in the 7MM and China, in USD million (2019-2032)
• Table 6: ASC22 Market Size in the US, in USD million (2019-2032)
• Table 7: ASC22 Market Size in Germany, in USD million (2019-2032)
• Table 8: ASC22 Market Size in France, in USD million (2019-2032)
• Table 9: ASC22 Market Size in Italy, in USD million (2019-2032)
• Table 10: ASC22 Market Size in Spain, in USD million (2019-2032)
• Table 11: ASC22 Market Size in the UK, in USD million (2019-2032)
• Table 12: ASC22 Market Size in Japan, in USD million (2019-2032)
• Table 13: ASC22 Market Size in China, in USD million (2019-2032)

List of Figures

• Figure 1: ASC22 Market Size in the 7MM and China, USD million (2019-2032)
• Figure 2: ASC22 Market Size in the United States, USD million (2019-2032)
• Figure 3: ASC22 Market Size in Germany, USD million (2019-2032)
• Figure 4: ASC22 Market Size in France, USD million (2019-2032)
• Figure 5: ASC22 Market Size in Italy, USD million (2019-2032)
• Figure 6: ASC22 Market Size in Spain, USD million (2019-2032)
• Figure 7: ASC22 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: ASC22 Market Size in Japan, USD million (2019-2032)
• Figure 9: ASC22 Market Size in China, USD million (2019-2032)

"ASC22 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about ASC22 for chronic hepatitis B in the seven major markets and China. A detailed picture of the ASC22 for chronic hepatitis B in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China for the study period 2019 -2032 is provided in this report along with a detailed description of the ASC22 for chronic hepatitis B. 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 ASC22 market forecast analysis for chronic hepatitis B in the 7MM and China, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in chronic hepatitis B.

Drug Summary:

ASC22, also known as envafolimab, is a first-in-class, subcutaneously administered PD-L1 antibody for chronic hepatitis B (CHB) functional cure. It has the advantages of SC injection and good stability at room temperature. These would be of great value to improve patient's compliance and quality of life and to help realize the goal of long-term management of chronic diseases such as chronic hepatitis B. Ascletis Pharma retains the global and exclusive rights to develop and commercialize ASC22 on viral indications.

Currently, the drug is being evaluated in a Phase II (NCT04465890) trial to evaluate the safety and efficacy of ASC22 in treating CHB after single and multiple drug administration. Interim results from the China Phase IIb clinical trial showed 1 mg/kg of ASC22 plus NAs for 24-week treatment were well-tolerated in CHB patients. 42.9% of patients with baseline HBsAg <=100 IU/mL obtained sustained HBsAg loss, which indicates the potential of functional cure.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the ASC22 description, mechanism of action, dosage and administration, research and development activities in chronic hepatitis B.
• Elaborated details on ASC22 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the ASC22 research and development activities in chronic hepatitis B across the United States, Europe, Japan, and China.
• The report also covers the patents information with expiry timeline around ASC22.
• The report contains forecasted sales of ASC22 for chronic hepatitis B till 2032.
• Comprehensive coverage of the late-stage emerging therapies for chronic hepatitis B.
• The report also features the SWOT analysis with analyst views for ASC22 in chronic hepatitis B.

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.

ASC22 Analytical Perspective by DelveInsight

• In-depth ASC22 Market Assessment

This report provides a detailed market assessment of ASC22 for chronic hepatitis B in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, Japan, and China. This segment of the report provides forecasted sales data from 2027 to 2032.

• ASC22 Clinical Assessment

The report provides the clinical trials information of ASC22 for chronic hepatitis B covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for chronic hepatitis B 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 ASC22 dominance.
• Other emerging products for chronic hepatitis B are expected to give tough market competition to ASC22 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 ASC22 in chronic hepatitis B.
• Our in-depth analysis of the forecasted sales data of ASC22 from 2027 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ASC22 in chronic hepatitis B.

Key Questions:

• What is the product type, route of administration and mechanism of action of ASC22?
• What is the clinical trial status of the study related to ASC22 in chronic hepatitis B and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ASC22 development?
• What are the key designations that have been granted to ASC22 for chronic hepatitis B?
• What is the forecasted market scenario of ASC22 for chronic hepatitis B?
• What are the forecasted sales of ASC22 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China?
• What are the other emerging products available and how are these giving competition to ASC22 for chronic hepatitis B?
• Which are the late-stage emerging therapies under development for the treatment of chronic hepatitis B?

Table of Contents

1. Report Introduction

2. ASC22 Overview in Chronic hepatitis B

• 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. ASC22 Market Assessment

• 5.1. Market Outlook of ASC22 in Chronic hepatitis B
• 5.2. 7MM and China Analysis
  • 5.2.1. Market Size of ASC22 in the 7MM and China for Chronic hepatitis B
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of ASC22 in the United States for Chronic hepatitis B
  • 5.3.2. Market Size of ASC22 in Germany for Chronic hepatitis B
  • 5.3.3. Market Size of ASC22 in France for Chronic hepatitis B
  • 5.3.4. Market Size of ASC22 in Italy for Chronic hepatitis B
  • 5.3.5. Market Size of ASC22 in Spain for Chronic hepatitis B
  • 5.3.6. Market Size of ASC22 in the United Kingdom for Chronic hepatitis B
  • 5.3.7. Market Size of ASC22 in Japan for Chronic hepatitis B
  • 5.3.8. Market Size of ASC22 in China for Chronic hepatitis B

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