Dato-DXd Sales Forecast, and Market Size Analysis - 2034
상품코드:1909207
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
Dato-DXd 성장 촉진요인
1. 시장 점유율 확대와 신규 환자 수 증가
Dato-DXd는 고형암, 특히 높은 미충족 요구가 존재하는 폐암 및 유방암을 비롯한 고형암 치료 환경에서 높은 잠재력을 지닌 항체-약물접합체(ADC)로 부상하고 있습니다.
표준 화학요법, 면역요법 또는 표적 치료제 진행 후 종양학자들이 차세대 ADC를 점점 더 많이 채택함에 따라 신규 환자 시작이 증가할 것으로 예상됩니다.
종양학계의 강한 관심은 다중 치료 경험 환자 집단에서 고무적인 효능 신호가 나타나 임상적 신뢰도가 높아지고 있기 때문입니다.
AstraZeneca와 Daiichi Sankyo의 공동 상업 및 의료 전략(연구자와의 긴밀한 협력 및 데이터 보급 포함)은 인지도와 채택을 가속화합니다.
2. 주요 적응증의 확대
비소세포폐암(NSCLC) : 다토-DXd는 화학요법 및 면역요법 후 치료 옵션이 제한된 환자를 포함한 이전 치료 경험이 있는 전이성 NSCLC에 대해 적극적으로 개발 중입니다.
유방암 : 호르몬 수용체 양성/HER2 저발현형 및 삼중음성 유방암(TNBC)에 중점적으로 노력하고 있습니다. 이 영역에서 항체 약물 복합체(ADC)는 치료 패러다임을 빠르게 변화시키고 있습니다.
광범위한 고형암 : 추가적인 TROP2 발현 종양에 대한 사용 가능성을 탐구하는 개발이 진행 중이며, 잠재적 대상 환자군을 확대하고 있습니다.
파이프라인 확장 및 병용 전략(예 : 면역 체크포인트 억제제와의 병용)은 해당 약물의 시장 접근성을 더욱 넓힐 것으로 예상됩니다.
3. 지리적 확대
Dato-DXd는 미국, 유럽, 일본, 중국 등 주요 시장을 목표로 한 세계 상업화 전략에 따라 개발이 진행되고 있습니다.
아시아태평양 지역은 높은 폐암 유병률, 증가하는 바이오마커 검사, 일본 및 중국 등에서의 강력한 ADC 도입으로 주요 성장 지역이 될 것으로 예상됩니다.
AstraZeneca와 Daiichi Sankyo는 확립된 암 치료 인프라, 규제 관련 전문 지식, 지역 파트너십을 활용하여 승인 후 신속한 도입을 지원합니다.
4. 신규 적응증 승인
Dato-DXd의 여러 종양 유형에 대한 규제 당국에 신청하면 향후 적응증이 크게 확대될 수 있습니다.
비소세포폐암(NSCLC) 및 유방암에 대한 승인은 수익원을 다각화하고 빠르게 성장하는 ADC 시장 내 경쟁적 입지를 강화할 것입니다.
미충족 의료 수요와 탄탄한 후기 단계 개발 프로그램을 고려할 때, Dato-DXd는 특정 적응증에서 가속화 또는 우선 심사 규제 경로의 혜택을 받을 수 있습니다.
5. 주요 암 영역의 견조한 판매 수량의 기세
폐암은 높은 환자 수와 면역항암제(IO) 치료 후 새로운 치료 옵션에 대한 지속적인 수요로 주요 성장 동력으로 남아 있습니다.
유방암은 특히 치료가 바이오 마커 정의 유형 및 ADC 기반 접근법으로 전환하는 동안 대규모의 지속적인 상업적 기회를 나타냅니다.
최근 임상 업데이트는 환자 등록 및 연구자 관심의 지속적인 모멘텀을 시사하며, 승인 후 장기적인 처방 증가를 뒷받침합니다.
6. 경쟁상의 차별화와 시장 동향
Dato-DXd의 ADC 프로파일은 표적 전달과 강력한 세포독성 페이로드를 결합하여 기존의 화학요법과의 차별화를 실현합니다.
이 약은 관리 가능한 안전성 프로파일을 유지하면서 강력한 항종양 활성을 발휘하도록 설계되어 있으며, 이는 만성암 치료에서 점점 더 중요한 요소입니다.
정밀암 치료, 바이오마커 기반 치료 선택, ADC 플랫폼의 급속한 확대 등 광범위한 시장 동향은 Dato-DXd의 위치를 강력하게 지지하고 있습니다.
실제 임상 증거(RWE) 및 승인 후 결과 데이터에 대한 강조가 증가함에 따라 시간이 지남에 따라 지불자와 의사의 신뢰도가 높아질 것으로 예상됩니다.
본 보고서는 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국)에서 HER2 음성 유방암, 비소세포 폐암, 삼중 음성 유방암과 같은 승인된 적응증 외에도 비뇨 생식기암, 고형암, 위암과 같은 잠재적 적응증에 대한 Dato-DXd의 종합적인 분석을 제공합니다. 본 보고서는 2020년부터 2034년까지의 조사기간 동안 7개국 시장에서 승인된 적응증 및 잠재적 적응증에 대한 기존의 사용상황, 진출 전망, 실적의 상세한 상황을 제공함과 동시에 승인 및 잠재적 적응증에 대한 Dato-DXd의 상세한 설명을 기재하고 있습니다. 또한 Dato-DXd의 판매 예측, 작용기전(MoA), 투여량 및 투여 방법, 규제상의 이정표를 포함한 R&D 및 기타 개발 활동에 대한 인사이트를 제공합니다. 또한 과거 및 현재 Dato-DXd의 실적, 미래 시장 평가, SWOT 분석, 분석가 견해, 경쟁업체의 종합적인 개요, 각 적응증에 대한 기타 신흥 치료법에 대한 개요도 포함되어 있습니다. 또한 Dato-DXd의 매출 예측 분석, 시장 주도 요인 등도 정리했습니다.
목차
제1장 보고서 개요
제2장 HER2 음성 유방암, 비소세포 폐암, 삼중 음성 유방암 등의 승인된 적응증 및 비뇨 생식기암, 고형암, 위암 등의 잠재적 적응증에 대한 Dato-DXd 개요
제품 상세
임상 개발
임상 연구
임상시험 정보
안전성과 유효성
기타 개발 활동
제품 프로파일
제3장 Dato-DXd : 경쟁 구도(시판 중인 치료제)
제4장 Dato-DXd : 경쟁 구도(개발 후기 치료제)
제5장 Dato-DXd : 시장 평가
승인 및 잠재적 적응증에 대한 시장 전망
주요 7개국 분석
승인 및 잠재적 적응증에 대한 주요 7개국 시장 규모
국가별 시장 분석
미국
독일
영국
제6장 Dato-DXd : SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 정보
제12장 보고서 구매 옵션
HBR
영문 목차
영문목차
Key Factors Driving Dato-DXd Growth
1. Market Share Gains and New Patient Starts
Dato-DXd is emerging as a high-potential ADC in the treatment landscape of solid tumors, particularly in lung and breast cancers with high unmet need.
Rising new patient starts are anticipated as oncologists increasingly adopt next-generation ADCs following progression on standard chemotherapy, immunotherapy, or targeted agents.
Strong interest from the oncology community is driven by encouraging efficacy signals in heavily pretreated populations, supporting growing clinical confidence.
AstraZeneca and Daiichi Sankyo's joint commercial and medical strategy, including robust investigator engagement and data dissemination, is accelerating awareness and adoption.
2. Expansion Across Key Indications
Non-Small Cell Lung Cancer (NSCLC): Dato-DXd is being actively developed for previously treated metastatic NSCLC, including patients with limited options after chemotherapy and immunotherapy.
Breast Cancer: Significant focus on HR-positive/HER2-low and triple-negative breast cancer (TNBC), where ADCs are rapidly reshaping treatment paradigms.
Broader Solid Tumors: Ongoing development explores use across additional TROP2-expressing tumors, expanding the potential addressable population.
Pipeline expansion and combination strategies (e.g., with immune checkpoint inhibitors) are expected to further broaden the drug's market reach.
3. Geographic Expansion
Dato-DXd is being developed with a global commercialization strategy, targeting major oncology markets including the US, Europe, Japan, and China.
Asia-Pacific is expected to be a key growth region, supported by high lung cancer prevalence, increasing biomarker testing, and strong ADC adoption in countries such as Japan and China.
AstraZeneca and Daiichi Sankyo are leveraging established oncology infrastructures, regulatory expertise, and regional partnerships to support rapid uptake post-approval.
4. New Indication Approvals
Regulatory submissions for Dato-DXd across multiple tumor types have the potential to significantly expand its label over time.
Approvals in NSCLC and breast cancer would diversify revenue streams and strengthen competitive positioning within the fast-growing ADC market.
Given the unmet need and robust late-stage development program, Dato-DXd may benefit from accelerated or priority regulatory pathways in select indications.
5. Strong Volume Momentum in Core Oncology Segments
Lung cancer remains a major growth driver, with high patient volumes and ongoing demand for novel post-IO treatment options.
Breast cancer represents a large and durable commercial opportunity, particularly as treatment shifts toward biomarker-defined and ADC-based approaches.
Recent clinical updates suggest sustained momentum in patient enrollment and investigator interest, supporting long-term prescription growth following approval.
6. Competitive Differentiation and Market Trends
Dato-DXd's ADC profile combines targeted delivery with potent cytotoxic payload, offering differentiation versus conventional chemotherapy.
The drug is designed to deliver strong antitumor activity with a manageable safety profile, an increasingly important factor in chronic oncology treatment.
Broader market trends-such as precision oncology, biomarker-driven treatment selection, and the rapid expansion of ADC platforms-strongly support Dato-DXd's positioning.
Growing emphasis on real-world evidence (RWE) and post-approval outcomes data is expected to enhance payer and physician confidence over time.
Dato-DXd Recent Developments
In December 2025, The European Medicines Agency (EMA) validated the Type II Variation marketing authorization application for DATROWAY (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
In October 2025, Positive results from the TROPION-Breast02 Phase III trial showed DATROWAY (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.
"Dato-DXd Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Dato-DXd for approved indications like HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer in the 7MM. A detailed picture of Dato-DXd's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Dato-DXd for approved and potential indications. The Dato-DXd market report provides insights about Dato-DXd's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Dato-DXd performance, future market assessments inclusive of the Dato-DXd market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Dato-DXd sales forecasts, along with factors driving its market.
Dato-DXd Drug Summary
Dato-DXd (also known as DATROWAY; datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads via tetrapeptide-based cleavable linkers.
DATROWAY (6 mg/kg) is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.
DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFRdirected therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial. The report provides Dato-DXd's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Dato-DXd is in the Phase II/III stage of clinical development for the treatment of patients with Urothelial Cancer (NCT07129993); and in Phase II stage for Solid Tumors/Gastric Cancer (NCT05489211).
Scope of the Dato-DXd Market Report
The report provides insights into:
A comprehensive product overview including the Dato-DXd MoA, description, dosage and administration, research and development activities in approved indications like HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer.
Elaborated details on Dato-DXd regulatory milestones and other development activities have been provided in Dato-DXd market report.
The report also highlights Dato-DXd's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
The Dato-DXd market report also covers the patents information, generic entry and impact on cost cut.
The Dato-DXd market report contains current and forecasted Dato-DXd sales for approved and potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The Dato-DXd market report also features the SWOT analysis with analyst views for Dato-DXd in approved and potential indications.
Methodology:
The Dato-DXd market 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.
Dato-DXd Analytical Perspective by DelveInsight
In-depth Dato-DXd Market Assessment
This Dato-DXd sales market forecast report provides a detailed market assessment of Dato-DXd for approved indications like HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer 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 current and forecasted Dato-DXd sales data uptil 2034.
Dato-DXd Clinical Assessment
The Dato-DXd market report provides the clinical trials information of Dato-DXd for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.
Dato-DXd Competitive Landscape
The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.
Dato-DXd Market Potential & Revenue Forecast
Projected market size for the Dato-DXd and its key indications
Commercial partnerships, licensing deals, and M&A activity
Dato-DXd Clinical Differentiation
Dato-DXd Efficacy & safety advantages over existing drugs
Dato-DXd Unique selling points
Dato-DXd Market Report Highlights
In the coming years, the Dato-DXd market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
The Dato-DXd companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Dato-DXd's dominance.
Other emerging products for HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer are expected to give tough market competition to Dato-DXd 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 Dato-DXd in approved and potential indications.
Analyse Dato-DXd cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted Dato-DXd sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Dato-DXd in approved and potential indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of Dato-DXd? How strong is Dato-DXd's clinical and commercial performance?
What is Dato-DXd's clinical trial status in each individual indications such as HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Dato-DXd Manufacturers?
What are the key designations that have been granted to Dato-DXd for approved and potential indications? How are they going to impact Dato-DXd's penetration in various geographies?
What is the current and forecasted Dato-DXd market scenario for approved and potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of Dato-DXd 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 Dato-DXd for approved and potential indications?
Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
How cost-effective is Dato-DXd? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. Dato-DXd Overview in approved indications like HER2 negative breast cancer, Non-small cell lung cancer, and Triple negative breast cancer; as well as potential indications like Urogenital cancer, Solid tumours, and Gastric cancer
