Daratumumab Market

The Daratumumab market is projected to grow at a CAGR of 7.6% from 2025 to 2035, fueled by the increasing prevalence of multiple myeloma and expanding indications in relapsed/refractory hematological malignancies. Daratumumab, a human IgG1κ monoclonal antibody targeting CD38, is a vital component of combination regimens in treating multiple myeloma, both in newly diagnosed and relapsed settings. Its mechanism, involving antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), positions it as a cornerstone in targeted oncology therapeutics.

Geographically, North America dominates the Daratumumab market due to high oncology drug uptake, rapid FDA approvals, and favorable insurance coverage. The U.S. sees strong demand from academic cancer centers and community hospitals alike. Europe follows with robust adoption through the EMA’s approval pathway and wide clinical guideline support. Asia-Pacific is witnessing the fastest growth rate, led by China, Japan, and South Korea, where biosimilar development and increasing access to advanced cancer care are key factors. Latin America and the Middle East present untapped potential as governments expand oncology infrastructure and initiate pricing reforms for biologics.

The Daratumumab market is evolving with strategic collaborations between biotech firms, biosimilar developers, and CDMOs (Contract Development and Manufacturing Organizations). Companies are focusing on improving upstream yields, enhancing cell-line productivity, and ensuring cold-chain integrity across the supply chain. Regulatory agencies are increasingly supporting biosimilar pathways, making the environment more favorable for cost-effective alternatives. Additionally, the integration of AI in clinical trial design, real-world evidence generation, and post-market surveillance is expected to further support sustainable growth and access expansion for Daratumumab-based therapies over the forecast period.