Daiichi Sankyo
Daiichi Sankyo is a leading global pharmaceutical company headquartered in Tokyo, Japan. Formed in 2005 through the merger of Daiichi Pharmaceutical and Sankyo, the company is dedicated to discovering, developing, and delivering innovative medicines that improve patients' quality of life worldwide
With more than 120 years of scientific expertise and operations across more than 30 countries and regions, Daiichi Sankyo is particularly recognized for its strong focus on oncology, cardiovascular disease, and other areas of unmet medical need. The company combines advanced research capabilities with a commitment to innovation, driving the development of breakthrough therapies that address serious and complex health conditions.
Daiichi Sankyo has been in the spotlight in 2026 for strengthening its leadership in oncology through new approvals and clinical successes for its cancer therapies, particularly Enhertu and Datroway. The company has also attracted significant attention through its strategic partnerships with AstraZeneca and Merck, which are helping accelerate the development and commercialization of innovative antibody-drug conjugate (ADC) therapies for cancer patients worldwide. These collaborations, combined with Daiichi Sankyo's ambitious plan to become a global top-five oncology company by 2035, have made it one of the most closely watched pharmaceutical companies this year
"With a strong oncology pipeline and landmark partnerships with AstraZeneca and Merck, Daiichi Sankyo continues to shape the next generation of cancer care in 2026."
Datopotamab deruxtecan (Datroway)
Mechanism of Action: DNA topoisomerase I inhibitors Drug Class: Monoclonal antibodies Indication: Unresectable or metastatic triple-negative breast cancer (TNBC)
Approved: In July 2026, the European Commission approved datopotamab deruxtecan as monotherapy for first-line treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy. Financial impact: EU approval of Datroway for first-line metastatic TNBC is expected to boost Daiichi Sankyo’s European sales and strengthen its shared revenue with partner AstraZeneca.
The European approval of Datroway as a first-line treatment for eligible metastatic triple-negative breast cancer (TNBC) patients is expected to strengthen Daiichi Sankyo’s commercial position by expanding its European market reach, supporting potential sales growth, and increasing shared revenues through its partnership with AstraZeneca.
Daiichi Sankyo's Oncology Growth Fueled by AstraZeneca and Merck Partnerships
Daiichi Sankyo is making waves in 2026 with an ambitious oncology-led growth strategy, targeting ¥2.3 trillion in oncology revenue by 2030 and positioning itself among the world's top five oncology companies by 2035. The company is driving this growth through five major antibody-drug conjugate (ADC) launches and expanding indications for key cancer therapies including Enhertu, Datroway, and ifinatamab deruxtecan (I-DXd). Strong global demand for Enhertu and Datroway helped boost Q1 FY2026 revenue by 21.1% year-over-year to ¥574.7 billion, prompting an upward revision of its financial outlook
A major contributor to this momentum is Daiichi Sankyo's strategic partnerships with AstraZeneca and Merck. The collaboration with AstraZeneca continues to advance blockbuster ADCs Enhertu and Datroway, securing important regulatory expansions in breast cancer treatment. Meanwhile, the partnership with Merck, built on a multi-billion-dollar licensing agreement covering ADC candidates such as ifinatamab deruxtecan, raludotatug deruxtecan, and patritumab deruxtecan, has gained further traction with the FDA's priority review of I-DXd for extensive-stage small cell lung cancer. Together, these alliances are accelerating innovation, expanding global patient access, and reinforcing Daiichi Sankyo's leadership in next-generation cancer therapies.
Global Oncology Drug Market Revenue Growth
The global oncology drug market has expanded significantly, rising from over $150 billion in 2020 to approximately $217–225 billion in 2025. Keytruda (pembrolizumab) led sales among cancer drugs, generating $14.38 billion in 2020 and $17.19 billion in 2021. By 2022, leading companies reported substantial oncology revenues, including Bristol Myers Squibb ($27.9 billion), Merck ($23 billion), and Roche ($21.62 billion). Global spending on cancer medicines reached $223 billion in 2023, highlighting oncology’s position as the largest and fastest-growing therapeutic segment in the pharmaceutical market.
Six-years market revenue of Oncology drugs (2020-2025)
Fig 4: Market revenue of Oncology drugs
Daiichi Sankyo-Merck
Type: Co-development and co-commercialisation partnership
Focus: Antibody drug conjugates
Deal value: $5.5 billion
Financial impact: Merck will pay Daiichi Sankyo $5.5 billion upfront to co-develop three cancer drugs, with the deal potentially worth up to $22 billion to Daiichi Sankyo based on development and commercial success.
Daiichi Sankyo’s global revenue has shown strong growth, rising from $9.01 billion in 2020 to $9.6 billion in 2021, $11 billion in 2022, $12.4 billion in 2023, $14 billion in 2024, and $14.1 billion in 2025, with revenue projected to reach $15.6 billion in 2026. For FY2026, Daiichi Sankyo expects global revenue of ¥2.28–¥2.34 trillion. The company’s long-term outlook is further supported by its multi-billion-dollar collaboration with Merck and upfront funding. However, near-term profitability and supply adjustments are facing significant cost provisions related to contract manufacturing adjustments.
"Daiichi Sankyo’s revenue growth and strong 2026 outlook highlight its expanding global momentum, supported by strategic partnerships and long-term growth opportunities."
Seven-years market revenue of Daiichi Sankyo (2020-2026)
Fig 5: Market revenue of Daiichi Sankyo
Daiichi Sankyo Deruxtecan (DXd) ADC Pipeline
Daiichi Sankyo's July 2026 pipeline is heavily concentrated in Breast Cancer, NSCLC, and other solid tumors, with a robust progression from early development through regulatory review. The strongest late-stage opportunities are built around ENHERTU® (T-DXd) and DATROWAY® (Dato-DXd), supported by an expanding portfolio of ADCs and immunotherapy combinations targeting unmet needs across multiple tumor types
Phase 1
The Phase 1 portfolio focuses on expanding ENHERTU®, DATROWAY®, HER3-DXd, I-DXd, and R-DXd across breast cancer, NSCLC, solid tumors, renal cell carcinoma, ovarian cancer, and pediatric indications. Key studies include DESTINY-Breast08, DESTINY-Lung03, TROPION-Lung02, TROPION-Lung04, TROPION-PanTumor01, HERTHENA-PanTumor02, and REJOICE-Ovarian02. Several early-stage combination strategies are being assessed with pembrolizumab, durvalumab, osimertinib, and other immunotherapy partners.
Phase 1/2
Phase 1/2 studies continue to evaluate efficacy and safety in a broader patient population, particularly in HER2-positive breast cancer, gastric cancer, TNBC, NSCLC, and solid tumors. Notable trials include DESTINY-Breast07, DESTINY-Gastric03, BEGONIA, TROPION-PanTumor02, HERTHENA-Breast01, and KEYMAKER-U06 substudies. These programs aim to establish proof of concept and identify promising combinations for later-stage development.
Phase 2
Daiichi Sankyo's Phase 2 oncology pipeline demonstrates a broad and diversified development strategy across lung, breast, gastrointestinal, and multiple solid tumor indications. The portfolio is heavily focused on advancing targeted therapies and antibody-drug conjugates (ADCs), particularly through the HERTHENA, KEYMAKER-U01, REJOICE, ORCHARD, NeoCOAST-2, and TROPION clinical programs.
Key development areas include non-small cell lung cancer (NSCLC), where several KEYMAKER-U01 sub-studies are evaluating novel combinations in both squamous and non-squamous second-line settings, as well as stage IV first-line NSCLC. The pipeline also includes targeted approaches for EGFR-mutated NSCLC through the ORCHARD study and perioperative treatment strategies in resectable early-stage disease through NeoCOAST-2.
Beyond lung cancer, Daiichi Sankyo is advancing therapies in solid tumors through the TROPION-PanTumor03 and REJOICE-PanTumor01 studies, while also pursuing opportunities in gastrointestinal cancers via REJOICE-GI01. In breast cancer, the HERTHENA-Breast03 trial focuses on high-risk early-stage triple-negative and HR-low/HER2-negative disease in the neoadjuvant and adjuvant settings. Additionally, HERTHENA-PanTumor01 is exploring treatment potential across a broad range of advanced solid tumors.
Overall, the Phase 2 portfolio highlights Daiichi Sankyo's commitment to expanding precision oncology treatments and immunotherapy combinations across multiple tumor types, with a particular emphasis on lung cancer and ADC-based therapeutic approaches that could support future pivotal studies and regulatory submissions.
Phase 2/3
Daiichi Sankyo's late-stage oncology pipeline continues to demonstrate the company's strong focus on antibody-drug conjugates (ADCs), with multiple Phase 2/3 programs targeting areas of high unmet need. The current Phase 2/3 portfolio includes TROPION-Urethial03, evaluating DATROWAY® (Datopotamab Deruxtecan; Dato-DXd) in combination with pembrolizumab for urothelial cancer (UC) following prior treatment with enfortumab vedotin and pembrolizumab. This study aims to address treatment challenges in patients with advanced disease who have limited therapeutic options.
In addition, the REJOICE-Ovarian01 trial is investigating R-DXd for platinum-resistant ovarian cancer, a setting associated with poor prognosis and significant unmet medical need. Notably, this program has received both Breakthrough Therapy Designation (U.S.) and Orphan Drug Designation, highlighting its potential to provide meaningful clinical benefit for patients with a rare and difficult-to-treat cancer.
Daiichi Sankyo's Phase 2/3 pipeline reflects a focused effort to leverage its innovative DXd ADC technology to improve outcomes in challenging oncology indications. With programs in advanced urothelial cancer and platinum-resistant ovarian cancer, along with regulatory recognitions supporting accelerated development pathways, the company is well-positioned to strengthen its presence in the evolving oncology landscape.
Phase 3
Daiichi Sankyo's Phase 3 oncology pipeline demonstrates a broad and ambitious late-stage development strategy centered on its antibody-drug conjugate (ADC) platform. The portfolio is led by ENHERTU® (trastuzumab deruxtecan; T-DXd) and DATROWAY® (datopotamab deruxtecan; Dato-DXd), with additional programs involving HER3-DXd, I-DXd, and R-DXd across multiple solid tumors.
The Phase 3 pipeline includes more than 20 registrational studies spanning breast, gastric, lung, endometrial, ovarian, urothelial, esophageal, and prostate cancers. ENHERTU continues to expand beyond HER2-positive indications into HER2-low and HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer (NSCLC), gastric cancer, biliary tract cancer, and gynecologic malignancies. Key studies such as DESTINY-Breast09, DESTINY-Lung04, DESTINY-BTC01, and DESTINY-Ovarian01 aim to broaden the therapy's role across earlier treatment settings and new tumor types.
DATROWAY is progressing through a comprehensive clinical program under the TROPION series of studies, targeting NSCLC, breast cancer, urothelial cancer, and endometrial cancer. Several trials are evaluating Dato-DXd both as monotherapy and in combination with checkpoint inhibitors such as pembrolizumab and durvalumab, reflecting the growing importance of ADC-immunotherapy combinations. Notable studies include TROPION-Lung07, TROPION-Lung08, TROPION-Breast03, TROPION-Breast04, and TROPION-Urothelial04.
The pipeline also highlights efforts to move therapies into earlier-stage and adjuvant treatment settings, with studies assessing use following surgery or neoadjuvant treatment. In addition, multiple programs have received Breakthrough Therapy Designation and Orphan Drug Designation, underscoring the potential clinical impact of these candidates and the unmet medical needs they address.
Overall, Daiichi Sankyo's Phase 3 portfolio reflects a strategic focus on expanding its ADC leadership, leveraging precision medicine, and establishing new standards of care across a wide range of solid tumors through innovative targeted therapies and combination approaches.
Regulatory Phase
Daiichi Sankyo's late-stage regulatory pipeline highlights the company's continued focus on advancing innovative antibody-drug conjugates (ADCs) across multiple oncology indications. The portfolio is led by ENHERTU® (trastuzumab deruxtecan; T-DXd), which has several regulatory submissions under review globally for HER2-positive breast cancer and HER2-expressing solid tumors. Key filings include treatment of HER2-positive breast cancer following neoadjuvant/adjuvant therapy (DESTINY-Breast05), first-line HER2-positive breast cancer in combination with pertuzumab (DESTINY-Breast09), and HER2-expressing solid tumors (DESTINY-PanTumor03).
Beyond breast cancer, ENHERTU is also progressing in first-line triple-negative breast cancer (TNBC) for patients not eligible for PD-1/PD-L1 inhibitor therapy through the TROPION-Breast02 study. Additionally, Daiichi Sankyo is seeking regulatory approval for DATROWAY® (datopotamab deruxtecan; Dato-DXd) in extensive-stage small cell lung cancer (ES-SCLC) based on the IDeate-Lung01 trial.
The pipeline demonstrates Daiichi Sankyo's strategy of expanding ADC therapies into earlier treatment settings and broader tumor types, reinforcing its position as a leader in precision oncology and next-generation cancer therapeutics.
Next Wave Pipeline
Daiichi Sankyo's next-wave R&D pipeline represents the company's strategy to build on the success of ENHERTU by advancing a diversified portfolio of innovative oncology and specialty medicine assets across all stages of clinical development. The pipeline includes a strong concentration of next-generation antibody-drug conjugates (ADCs), bispecific T-cell engagers, targeted therapies, and immunology programs designed to address significant unmet medical needs.
The oncology portfolio remains the primary growth engine, with multiple candidates targeting HER2, EGFR, DLL3, CD37, FLT3, and EZH1/2 pathways across solid tumors and hematologic malignancies. Several assets have progressed into Phase 2 and Phase 3 development, including VANFLYTA for acute myeloid leukemia and EZHARMIA for B-cell lymphoma, demonstrating the pipeline's increasing maturity and near-term commercialization potential.
In parallel, Daiichi Sankyo is broadening its therapeutic reach beyond oncology through specialty medicine programs addressing autoimmune diseases, including systemic lupus erythematosus and other immune-mediated disorders. This balanced approach strengthens the company's long-term growth outlook by combining near-term value creation opportunities with a sustainable flow of innovative early-stage assets.
The next-wave pipeline positions Daiichi Sankyo for continued innovation-driven growth, supported by a deep oncology franchise, expanding ADC leadership, emerging immunology capabilities, and multiple late-stage assets with the potential to become future blockbuster therapies.
