By Fran DeGrazio, executive editor
![]()
Of major impact on market growth in drug-led or biologic-led combination products are the rapidly accelerating efforts to enable patient self-administration of therapies and medications. Among routes of administration with significant potential for enablement across a broader range of therapeutic targets and patient populations, subcutaneous delivery (SC) is high on the list.
Within this general trend toward self-administration, what are specific market drivers for subcutaneous delivery approaches? What delivery challenges will need to be addressed? Top of mind for me, frankly, are these key drivers and challenges, three of each:
Market Driver #1: The Desire For Alternatives To Intravenous Delivery
One key driver comes in the delivery of biopharmaceutical formulations for which intravenous (IV) administration has historically been the preferred – if not the only – option. IV has generally required administration in a clinical setting by trained clinicians. Compared to IV-based methods, SC delivery offers benefits such as improved cost effectiveness, greater mobility for the patient, less potential for infection, and, generally, less invasiveness.
Furthermore, on the effectiveness front, SC injections can deliver biologics-based therapies locally, provide targeted delivery to the lymphatics, and have the potential for prolonging system exposure.
Many antibody drugs are designed for self-administration through SC injection. 40% of the antibodies approved by the FDA in 2024 were administered by SC. For biologics that may be initially commercialized for IV delivery, the move to SC can be part of product lifecycle management. Of course, a key aspect when evaluating the move from IV to SC must be pharmacokinetic comparability that can be proven.
An example of SC delivery's contribution to lifecycle planning is ZYMFENTRA™ (infliximab-dyyb), sold by Celltrion, Inc. for maintenance treatment of ulcerative colitis. The recently approved SC version, which is in an autoinjector format, is intended for bi-weekly, in-home administration.
Market Driver #2: The Increase In Geriatric Patient Populations
Another key driver behind SC delivery growth is the increasing size of the geriatric population. Per the World Health Organization (WHO), the global population of people aged 80 and older is expected to more than triple between 2015 and 2050. Common conditions with high potential to amplify as people age include age-related macular degeneration (AMD), diabetes, cancer, dementia, and infection management needs.
In addition to the benefit of in-home treatment options for a generally less mobile segment of the population, SC injections can help overcome a common delivery challenge – the difficulty of accessing veins for IV administration. Per a paper published during 2024 in the Journal of the American Geriatrics Society, older patients receiving antibiotics by SC vs IV injection had fewer adverse events by subcutaneous delivery.
Continue Reading…
Of major impact on market growth in drug-led or biologic-led combination products are the rapidly accelerating efforts to enable patient self-administration of therapies and medications. Among routes of administration with significant potential for enablement across a broader range of therapeutic targets and patient populations, subcutaneous delivery (SC) is high on the list.