MONJUVI(타파시티맙-cxix)는 레날리도미드와 함께 투여하는 처방약으로, 재발하거나 이전 치료에 반응하지 않고(불응성) 줄기세포 이식을 받을 수 없는 특정 유형의 DLBCL 성인 환자를 치료하기 위해 사용됩니다. 타파시티맙(MOR208)은 B세포 표면에 광범위하게 발현되는 항원 CD19에 대한 단클론항체입니다. MOR208(타파시티맙)의 Fc 영역은 암세포에 대한 신체 면역체계의 반응을 강화하도록 설계되었으며, 이러한 Fc 강화는 항체 의존성 세포 매개 세포 손상(ADCC) 및 항체 의존성 세포 포식(ADCP)을 크게 강화하는 것으로 나타났습니다. MONJUVI의 승인은 일종의 반응률에 근거한 것으로, MONJUVI의 임상적 유용성을 확인하기 위한 시험이 진행 중입니다. 2020년 7월 미국 FDA의 가속승인에 이어 2021년 8월 캐나다 보건부와 유럽위원회, 2021년 10월 MHRA가 해당 적응증에 대한 레날리도마이드와의 병용요법으로 MINJUVI(타파시티맙)의 조건부 판매 승인을 부여했습니다. 이 환자군에 대한 의료 미충족 수요가 높습니다.
본 보고서는 주요 7개국 몬주비(MONJUVI) 시장에 대해 조사했으며, 시장 개요와 함께 2023-2032년까지의 매출 예측 데이터, 경쟁 상황, 국가별 동향 등을 정리하여 전해드립니다.
목차
제1장 보고서 서론
제2장 DLBCL의 MONJUVI 개요
- 제품 상세
- 임상 개발
- 규제상 마일스톤
- 기타 개발 활동
- 제품 프로파일
제3장 경쟁 상황(출시된 치료법)
제4장 경쟁 상황(후기 단계 새로운 치료법)
제5장 MONJUVI 시장 평가
- DLBCL에 대한 MONJUVI 시장 전망
- 주요 7개국 분석
- 주요 7개국의 DLBCL에 대한 MONJUVI 시장 규모
- 국가별 시장 분석
제6장 SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 보고서 구입 옵션
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"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
