The shift towards patient-centered subcutaneous drug delivery systems for high concentration biologics is critical as it directly impacts patient adherence and satisfaction. Companies that innovate in delivery devices and formulations are likely to gain a competitive advantage in the growing market for biologics. Regulatory context from MHRA (Guidance: COVID-19 test validation approved products) supports the near-term read. Assessment grounded in 14 ranked evidence items (11 high-relevance).