Developing the Subcutaneous Drug Delivery Route

Biopharmaceuticals and biosimilars now represent the majority of the top 10 selling drugs. High development costs and requirement for most to be administered intravenously are noted drawbacks. Recent advances in subcutaneous drug delivery methods offer a viable alternative route for parenteral drug administration. Comparison studies have highlighted equivalent drug efficacies coupled with substantial cost savings. Allied to these developments are new closed-loop drug delivery systems which have the potential to revolutionize the biopharmaceutical sector through active patient engagement. First demonstrated in the insulin marketplace, these efforts represent formal embodiments of the precision medicine approach to disease management. This review will highlight key considerations for subcutaneous drug delivery, including patient preferences, drug formulation and needle and device design. We also provide an overview of the market evolution of subcutaneously administered drugs, highlighting those currently in clinical development, and predict areas for future innovation.