The pharmaceutical market is in a period of transition as the introduction of new biosimilars increases.
FREMONT, CA: The transition in the pharmaceutical market is set to continue between 2018 and 2023. Seventeen original reference biologics are coming off patent, opening a critical window of opportunities for the manufacturers of competing biosimilars.
A conservative estimate on the market opportunity represented for biosimilar manufacturers suggests that this could be equal to $5.24 billion per year. A lesser-known but essential factor influencing this transitional period's success is the delivery device design of such biosimilars. The global healthcare regulators, clinicians, and managers are keen on harnessing the cost reductions and broader access to treatment that biosimilar competition allows, but switching patients from original biologics to biosimilars is a not an easy task. Numerous clinical and regulatory issues surround it.
Drug Delivery device plays a critical role.
A high volume of evidence shows that the design of the device for subcutaneous delivery of biologics, typically an auto-injector or prefilled syringe, plays a critical role in facilitating the switch from biologic to a biosimilar. Specifically, larger molecule biological drugs tend to be more viscous and can present challenges regarding the volume of drug to be delivered, ease of administration as well as potential pain on administration.
Additionally, many healthcare systems encourage the adoption of self-administration for chronic diseases to reduce the heavy burden on their networks and enable patients to access treatment in a more familiar and relaxed setting. Therefore, the usability of drug delivery devices, especially for patients suffering from debilitating, degenerative pathologies that may affect their mobility, is even more critical.
The delivery device design has taken an essential role in the healthcare market, especially as home administration becomes more prevalent. Our estimates expect it to also take on an increasingly important part in the future of competition within the biosimilars market. Therefore, it is clear that close attention needs to be placed on device design to ensure that competitive advantage is not lost and that device design provides a supporting role through optimal usability and safety.