Executive Summary

CD38 has matured from a niche myeloma target into a major plasma-cell biology platform. In 2026, the commercial center remains multiple myeloma, led by daratumumab and followed by isatuximab, while the next strategic frontier is split between formulation competition, front-line regimen expansion, biosimilar entry planning, and attempts to translate CD38-mediated plasma-cell depletion into autoimmune and renal diseases.

The practical landscape is no longer a simple two-product oncology comparison. Daratumumab has the dominant commercial base, extensive front-line use, a subcutaneous formulation, and a newly approved high-risk smoldering multiple myeloma indication. Isatuximab is smaller but increasingly relevant in front-line transplant-ineligible disease, EU transplant-eligible disease, and subcutaneous on-body injector development.

The most important readout for industry strategy is not only efficacy. It is convenience, durability of exclusivity, geographic expansion, and whether newer anti-CD38 programs can move beyond malignant plasma cells into pathogenic antibody-driven disease without reproducing the same treatment burden.