Navigating Large-Volume Subcutaneous Injections Of Biopharmaceuticals: A Systematic Review Of Clinical Pipelines And Approved Products

As biopharmaceutical therapies continue to grow in complexity, the industry is increasingly focused on moving care from infusion centers to more convenient outpatient and home settings. One of the key enablers of this shift is the development of large-volume subcutaneous (LVSC) delivery, allowing patients to receive higher doses of biologics with fewer administrations and reduced dependence on intravenous infusion.

A comprehensive review of clinical pipelines and approved products reveals a rapidly expanding landscape for LVSC therapies, spanning oncology, autoimmune diseases, neurological disorders, cardiovascular conditions, and rare diseases. The analysis identifies significant growth in therapies requiring injection volumes greater than 2 mL, with many candidates moving toward less frequent dosing schedules that improve patient convenience and support long-term treatment adherence. At the same time, these trends are creating new demands for innovative delivery systems, formulation strategies, and device technologies capable of supporting larger injection volumes safely and effectively.

For drug developers, device manufacturers, and healthcare stakeholders, understanding the evolving LVSC landscape is critical for anticipating future market needs and shaping the next generation of patient-centric drug delivery solutions.