Datopotamab deruxtecan-dlnk (Dato-DXd) API Market

Datopotamab deruxtecan-dlnk (Dato-DXd) (HBA) market is experiencing a CAGR of 8.8% during the forecast period, driven by growing demand for precision oncology therapies and advancements in antibody-drug conjugate (ADC) technology. Dato-DXd, an innovative TROP2-directed ADC developed by Daiichi Sankyo in collaboration with AstraZeneca, is currently in late-stage clinical trials for several solid tumors.

Among therapeutic segments, non-small cell lung cancer (NSCLC) dominates the market, representing the key segment due to high global prevalence and the need for more effective, targeted treatments. Dato-DXd is showing significant potential as a next-line therapy in NSCLC patients, particularly those unresponsive to standard immunotherapy or chemotherapy. Additional segments include triple-negative breast cancer (TNBC) and hormone receptor-positive/HER2-negative breast cancer, both characterized by limited treatment options and high unmet clinical need.

Geographically, the US is the key country driving innovation and commercialization of Dato-DXd. The US boasts favorable regulatory pathways such as the FDA’s Breakthrough Therapy designation, a robust oncology research ecosystem, and early access programs that support rapid market entry. Outside the U.S., Japan, where Daiichi Sankyo is headquartered, and China, with its fast-growing oncology market and increasing investment in ADCs, are emerging as significant contributors to future market growth.

Key players in the Dato-DXd API landscape include Daiichi Sankyo, which leads R&D and manufacturing, and AstraZeneca, which co-develops and commercializes the product globally. Additionally, leading contract development and manufacturing organizations (CDMOs) such as Lonza, WuXi Biologics, and Samsung Biologics are expected to play a crucial role in scaling up production to meet anticipated global demand following regulatory approval.

Recent Developments

• In January 2025, Datroway, a drug approved in the US for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer, was approved based on the TROPION-Breast01 Phase III trial.
• In January 2025, the FDA approved datopotamab deruxtecan-dlnk, a Trop-2-directed antibody, and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The drug’s efficacy was evaluated in a multicenter, open-label, randomized trial, and patients were excluded for certain factors.
• In November 2024, Datopotamab deruxtecan, a new biologic therapy, was submitted for accelerated approval in the US for patients with advanced EGFR-mutated non-small cell lung cancer. The FDA has withdrawn the previously submitted BLA for advanced or metastatic nonsquamous NSCLC. The new BLA is based on results from the TROPION-Lung05 Phase II trial and TROPION-Lung01 Phase III and TROPION-PanTumor01 Phase I trials.