High-dose biologics are gradually moving from intravenous administration to subcutaneous injections, representing a significant shift in the way patients are treated.[1][3] Traditionally, subcutaneous injections were limited to a volume of 1–2 ml, but recently they have been increased to approximately 3 ml, which allows the administration of higher doses of biological agents.[2] The global market for high-dose subcutaneous biological therapies was valued at $92.6 billion in 2025 and is expected to reach $211.4 billion by 2032, growing at a CAGR of 12.6%.[1] Subcutaneous administration reduces the burden on patients who otherwise have to spend long hours in infusion centers and improves their comfort and compliance.[3] The main challenges in the development of high-dose subcutaneous drugs are the high viscosity of the formulations, the complexity of production and the need to ensure tolerance at the injection site.[1][2] Experts predict that in the next five years, most biologic therapies will be administered subcutaneously, requiring pharmaceutical companies to prioritize innovative strategies in this area.[3]