MONJUVIの薬剤に関する洞察と市場予測：2032年

MONJUVI（タファシタマブ-cxix）は、再発または前治療に反応せず（難治性）、幹細胞移植を受けることができない特定のタイプのDLBCLの成人患者を治療するために、レナリドミドとともに投与される処方薬です。タファシタマブ（MOR208）は、B細胞表面に広く発現している抗原CD19に対するモノクローナル抗体です。この抗体の一定のFc領域は、がん細胞に対する身体の免疫系の反応を増強するように設計されています。MOR208（タファシタマブ）のこのFc増強は、抗体依存性細胞媒介性細胞傷害（ADCC）および抗体依存性細胞貪食（ADCP）の大幅な増強につながることが示されています。MONJUVIの承認は一種の奏効率に基づいています。MONJUVIの臨床的有用性を確認するための試験が進行中です。2020年7月の米国FDAによる加速承認に続き、2021年8月にはカナダ保健省および欧州委員会、2021年10月にはMHRAが、同適応症に対するレナリドミドとの併用によるMINJUVI（タファシタマブ）の条件付き販売承認を付与しました。この患者群に対する医療のアンメットニーズは高いです。

当レポートでは、主要7ヶ国におけるMONJUVI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 DLBCLにおけるMONJUVI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
• 規制上のマイルストーン
• その他の開発活動
• 製品プロファイル

第3章 競合情勢（上市済み治療法）

第4章 競合情勢（後期段階の新興治療法）

第5章 MONJUVIの市場評価

• DLBCLに対するMONJUVIの市場展望
• 主要7ヶ国分析
  • 主要7ヶ国におけるDLBCLに対するMONJUVIの市場規模
• 国別の市場分析
  • 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

• 参考文献
• レポート調査手法

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

List of Figures

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

"MONJUVI Drug Insight and Market Forecast - 2032" report provides comprehensive insights about MONJUVI for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets. A detailed picture of the MONJUVI for DLBCL 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 MONJUVI for DLBCL. 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 MONJUVI market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.

Drug Summary:

MONJUVI (tafasitamab-cxix) is a prescription medicine given with lenalidomide to treat adults with certain types of DLBCL that have relapsed or did not respond to previous treatment (refractory) and who cannot receive a stem cell transplant. Tafasitamab (MOR208) is an investigational monoclonal antibody directed against the antigen CD19, broadly expressed on the surface of B cells. The constant Fc region of the antibody has been engineered to enhance the response of the body's immune system against cancer cells. This Fc-enhancement of MOR208 (tafasitamab) has been shown to lead to a substantial potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The approval of MONJUVI is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of MONJUVI; following accelerated approval by the US FDA in July 2020, in August 2021, Health Canada and the European Commission, and in October 2021, MHRA granted conditional Marketing Authorization for MINJUVI (tafasitamab) in combination with lenalidomide for the same indication. There is a high unmet medical need for this patient group.

Scope of the Report:

The report provides insights into:

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

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.

MONJUVI Analytical Perspective by DelveInsight

In-depth MONJUVI Market Assessment

This report provides a detailed market assessment of MONJUVI for Diffuse Large B-cell lymphoma (DLBCL) 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.

MONJUVI Clinical Assessment

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

Report Highlights:

• In the coming years, the market scenario for Diffuse Large B-cell lymphoma (DLBCL) 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 MONJUVI dominance.
• Other emerging products for DLBCL are expected to give tough market competition to MONJUVI 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 MONJUVI in DLBCL.
• Our in-depth analysis of the forecasted sales data of MONJUVI from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the MONJUVI in DLBCL.

Key Questions:

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

Table of Contents

1. Report Introduction

2. MONJUVI Overview in DLBCL

• 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. Regulatory Milestone
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. MONJUVI Market Assessment

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

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