The past two decades have seen huge growth in the market for injectable drug delivery products; this shows little sign of slowing down with a further 9.1% of annual growth predicted until 2030.1 Biotherapeutics have played a significant part, with biologics and biosimilars mostly administered via subcutaneous injection. With a growing number of biosimilars set to come onto the market (more than 30 biologics will lose exclusivity in the US alone between 2023–20282), we are likely to see the market for subcutaneous drug delivery devices develop further.
As the market gets more crowded, manufacturers of both biologics and biosimilars can differentiate from competitors through the device itself. One area of focus is digitalisation: connected drug delivery devices which capture a variety of data related to drug administration, are becoming increasingly sophisticated, by providing step-by-step guidance to patients, for instance. There is great potential for these devices to improve patient care, particularly as treatment and drug administration are increasingly taking place outside of a hospital setting.
Given the increasing shift towards self-administration, creating connected drug delivery devices that are intuitive and easy to use is also a necessity, and will in turn help to improve treatment adherence. Moreover, as we continue to see growth and innovation within the industry, more benefits are emerging for both patients and healthcare professionals. This article will draw on our own research here at Owen Mumford Pharmaceutical Services, as well as discussions with industry experts, to analyse key trends that are set to shape the connected device market in the coming years.
Optimal Device Choice and Adaptability
Evolution in the connected drug delivery device market has led to a number of different device variations and therefore options for pharmaceutical companies. Reusable devices may be prioritised by pharma companies due to their reduced cost and environmental impact compared to single-use devices. Yet, single use devices may be more appropriate for certain less frequent therapy regimens or specific patient groups due to their small size and convenience. Additionally, from the device manufacturers’ perspective there is the choice between creating new devices that integrate connectivity features from the earliest stages of development, or adding connectivity to an existing product on the market.
Opinions on optimal connectivity features are shifting often in line with the evolution of wireless technologies and the performance of electrical components. Likewise, changes to regulations can see the commercial arguments on the most suitable device choice evolve as well. One example is the FDA’s guidance on cybersecurity in medical devices which was updated in 2018 and then again in 2022 due to the speed of change in this area.3 The guidance provides recommendations on secure design, labelling, and the documentation to include in premarket submissions for devices with cybersecurity risk. The need to meet these requirements makes the selection of a reliable and supportive device partner doubly important.