MDNA55の新興薬剤に関する洞察と市場予測：2032年

MDNA55は、新規のファースト・イン・クラスのインターロイキン4強化サイトカイン（IL4-EC）です。この独自の標的薬剤分子は、分子トロイの木馬として設計されました。これは2つの分子の遺伝子融合です。遺伝子融合により、標的となるIL-4受容体（IL-4R）を過剰発現しているがんに対するスーパーカインの選択性を利用し、細胞殺傷毒素を腫瘍、その微小環境、がん幹細胞に直接送り込むことができます。IL-4レセプターは健康な脳には存在せず、外毒素はがん細胞の細胞質でのみ活性を示すので、健康な細胞が影響を受けないことを保証するのに役立ちます。

MDNA55が標的IL-4Rに結合すると、エンドサイトーシスによって腫瘍細胞内に飲み込まれます。腫瘍内に入ると、プロテアーゼが薬剤を切断し、外毒素の触媒ドメインを活性化して、伸長因子-2と呼ばれるタンパク質が関与するアポトーシス（細胞死）のプロセスを開始します。MDNA55は、118人のrGBM患者を対象とした5つの臨床試験で研究されており、その結果、現在の標準治療よりも優れた有効性があることが実証されています。

今後数年間で、多形性膠芽腫（GBM）の市場シナリオは、世界中の広範な研究と医療支出の増加により変化します。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、MDNA55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。GBMに対する他の新興製品がMDNA55に厳しい市場競争を与えることが予想され、近い将来、後発の新興治療薬が上市されれば、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MDNA55市場について調査し、市場の概要とともに、2025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 多形性膠芽腫（GBM）に対するMDNA55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 MDNA55市場評価

• GBMに対するMDNA55の市場見通し
• 主要7ヶ国市場分析
  • 主要7ヶ国におけるGBMに対するMDNA55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: MDNA55, Clinical Trial Description, 2023
• Table 2: MDNA55, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: MDNA55 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: MDNA55 Market Size in the US, in USD million (2019-2032)
• Table 7: MDNA55 Market Size in Germany, in USD million (2019-2032)
• Table 8: MDNA55 Market Size in France, in USD million (2019-2032)
• Table 9: MDNA55 Market Size in Italy, in USD million (2019-2032)
• Table 10: MDNA55 Market Size in Spain, in USD million (2019-2032)
• Table 11: MDNA55 Market Size in the UK, in USD million (2019-2032)
• Table 12: MDNA55 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: MDNA55 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: MDNA55 Market Size in the United States, USD million (2019-2032)
• Figure 3: MDNA55 Market Size in Germany, USD million (2019-2032)
• Figure 4: MDNA55 Market Size in France, USD million (2019-2032)
• Figure 5: MDNA55 Market Size in Italy, USD million (2019-2032)
• Figure 6: MDNA55 Market Size in Spain, USD million (2019-2032)
• Figure 7: MDNA55 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: MDNA55 Market Size in Japan, USD million (2019-2032)

“"MDNA55 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about MDNA55 for glioblastoma multiforme (GBM) in the seven major markets. A detailed picture of the MDNA55 for GBM 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 MDNA55 for GBM. 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 MDNA55 market forecast analysis for GBM in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in GBM.

Drug Summary:

MDNA55 is a novel first-in-class interleukin-4 empowered cytokine (IL4-EC). This proprietary targeted drug molecule was designed to be a molecular trojan horse. It is a genetic fusion of two molecules: A circularly permuted IL-4 Superkine, and the catalytic domain of the pseudomonas exotoxin A. Genetic fusion allows the drug to harness the selectivity of the superkine for cancers that overexpress the target IL-4 receptor (IL-4R) and deliver the cell-killing toxin directly into the tumor, its microenvironment, and cancer stem cells. Since the IL-4 receptor is not found in a healthy brain and the exotoxin is only active in the cancer cell cytoplasm, this helps ensure that healthy cells are unaffected.

When MDNA55 binds the target IL-4R, it is swallowed inside the tumor cell through endocytosis. Once inside the tumor, proteases cleave the drug and activate the catalytic domain of the exotoxin to begin the process of apoptosis (cell death) involving a protein called elongation factor-2. MDNA55 has been studied in five clinical trials in 118 patients with rGBM, in which it has demonstrated compelling indications of superior efficacy to the current standard of care.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the MDNA55 description, mechanism of action, dosage and administration, research and development activities in glioblastoma multiforme (GBM).
• Elaborated details on MDNA55 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the MDNA55 research and development activities in GBM across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around MDNA55.
• The report contains forecasted sales of MDNA55 for GBM till 2032.
• Comprehensive coverage of the late-stage emerging therapies for GBM.
• The report also features the SWOT analysis with analyst views for MDNA55 in GBM.

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.

MDNA55 Analytical Perspective by DelveInsight

In-depth MDNA55 Market Assessment

This report provides a detailed market assessment of MDNA55 for glioblastoma multiforme (GBM) 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.

MDNA55 Clinical Assessment

The report provides the clinical trials information of MDNA55 for GBM covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for glioblastoma multiforme (GBM) 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 MDNA55 dominance.
• Other emerging products for GBM are expected to give tough market competition to MDNA55 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 MDNA55 in GBM.
• Our in-depth analysis of the forecasted sales data of MDNA55 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the MDNA55 in GBM.

Key Questions:

• What is the product type, route of administration and mechanism of action of MDNA55?
• What is the clinical trial status of the study related to MDNA55 in glioblastoma multiforme (GBM) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the MDNA55 development?
• What are the key designations that have been granted to MDNA55 for GBM?
• What is the forecasted market scenario of MDNA55 for GBM?
• What are the forecasted sales of MDNA55 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 MDNA55 for GBM?
• Which are the late-stage emerging therapies under development for the treatment of GBM?

Table of Contents

1. Report Introduction

2. MDNA55 Overview in GBM

• 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. MDNA55 Market Assessment

• 5.1. Market Outlook of MDNA55 in GBM
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of MDNA55 in the 7MM for GBM
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of MDNA55 in the United States for GBM
  • 5.3.2. Market Size of MDNA55 in Germany for GBM
  • 5.3.3. Market Size of MDNA55 in France for GBM
  • 5.3.4. Market Size of MDNA55 in Italy for GBM
  • 5.3.5. Market Size of MDNA55 in Spain for GBM
  • 5.3.6. Market Size of MDNA55 in the United Kingdom for GBM
  • 5.3.7. Market Size of MDNA55 in Japan for GBM

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