Alexion, AstraZeneca Rare Disease, is committed to advancing drug delivery systems that enhance patient autonomy and treatment adherence. This project, in collaboration with the Device Development Group in Alexion, aimed to assess the current market landscape for subcutaneous (SC) drug delivery devices and combination products. The research focused on identifying SC molecules currently approved in the US and EU that utilize prefilled syringes, autoinjectors, and pen injectors, or large-volume devices, while also gathering data on their indications and intended use.

Additionally, an analysis of complaints and recalls provided insights into safety trends and the maturity of these technologies. The project further explored emerging device and combination product technologies designed for >5mL SC delivery and evaluate drug formulation advancements that enable high-concentration solutions to minimize injection volume. A comparative analysis of different SC delivery platforms was conducted to assess advantages, limitations, and regulatory considerations. The final deliverables include a comprehensive dataset, graphical insights, and key trends that highlight the competitive landscape, technological evolution, and market dynamics. These findings support Alexion’s strategic decision-making in device development, ensuring the continued innovation of patient-centric delivery systems. By leveraging data analytics and visualization tools, the project provided a clearer understanding of the SC drug delivery ecosystem, aiding in the identification of opportunities for future development. The insights gained from this project will help Alexion refine its approach to high-volume SC delivery solutions, aligning with industry trends and patient needs to drive advancements in self-administration technologies and improve treatment outcomes.