Addressing the needs for large-volume subcutaneous drug delivery: the case for on-body wearable injectors.

INTRODUCTION: The growth of biologic therapies has accelerated demand for large-volume subcutaneous delivery systems that are clinically feasible, patient-friendly, and suitable for assisted administration or self-administration outside a controlled clinical environment. For patients, subcutaneous delivery can reduce lengthy treatment times, disruptions to daily life, and resulting expenses. For healthcare systems, it can alleviate overburdening to providers by simplifying or decreasing lengthy in-clinic delivery. The transition to subcutaneous dosing of drugs with larger volumes and higher viscosities, however, has necessitated new delivery devices. AREAS COVERED: This critical perspective: (1) explores the crowded device landscape, noting the key benefits and tradeoffs for delivery methods, (2) surveys the state of the on-body injector field, highlighting commercial and in-development systems, their strengths, and potential drawbacks, and (3) proposes key strategic imperatives for developing large-volume subcutaneous delivery devices. In closing, a perspective on the field addresses the positioning of on-body injector systems against key competitors, and the inherent risk-sharing between device and pharmaceutical developers to build evidence for large-volume subcutaneous delivery systems. EXPERT OPINION: The maturation of large-volume subcutaneous delivery technologies signals a fundamental shift in biologic administration, and on-body injectors are uniquely positioned to bridge usability, volume capability, and at-home capability.