Currently, biologics represent one of the fastest growing classes of the pharmaceutical industry. In fact, the US Food and Drug Administration (USFDA) has approved more than 630 biologic products till date, while over 8,000 such drug candidates are being evaluated in clinical studies. Primarily, biologic candidates are being designed for delivery via the parenteral route. However, this route is associated with the need for frequent medication, administered by a professional, in clinics or hospitals. Such visits pose an additional financial burden and are also very time consuming, thereby, negatively impacting the medical adherence.
Further, low adherence to prescribed medications is reported to result in a loss of approximately USD 188 billion per year, in the US alone. A number of the aforementioned challenges can be mitigated by delivering drugs via the subcutaneous route, as it enables self-medication by patients. Other benefits associated with the subcutaneous administration include highly effective delivery of biologics (including vaccines, growth hormones and insulin) and substantial cost saving opportunities. Considering the various advantages offered by the subcutaneous route for the delivery of biologics, a shift in the preference towards this route has been observed in the pharmaceutical industry.
Presently, more than 330 subcutaneous biologics formulations are being evaluated in different clinical stages. In addition, several approved intravenous therapeutics are being reformulated and evaluated for delivery via the subcutaneous route of administration. However, there are certain concerns associated with the subcutaneous route. For instance, most protein-based therapeutics, such as monoclonal antibodies, need to be administered in large quantities and have been demonstrated to form highly viscous formulations when reformulated for subcutaneous delivery. In order to overcome this challenge, companies have developed / are developing a number of novel technology platforms, intended to facilitate the delivery of viscous drug formulations. Such innovations are gradually facilitating a shift towards subcutaneous delivery of biologics, primarily driven by the rising demand for self-administrable therapeutics.