5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies
By Matt Jones, PA Consulting
Not long ago, many experts in the pharmaceutical industry were looking at the so-called patent cliff of small molecules and wondering where the next blockbuster drug or therapy innovation would come from.
One could be forgiven for feeling the same way about the current world of drug delivery devices, with an increasingly standardized set of established device types dominating the market.
However, as we look forward to 2025, the future of drug development appears as exciting and fast-moving as it’s ever been. The next generation of blockbuster therapies is already taking shape, alongside other remarkable innovations in clinical pipelines. This article explores how these advances, along with other important global trends, could demand new device development and why we expect that 2025 will be the year for pharmaceutical companies to revisit their device strategies or risk being left behind.
1. The Scale And Competitiveness Of The GLP-1/GIP Agonist Market Could Require Companies To Differentiate By Enhancing The Patient Experience.
GLP-1/GIP agonists are predicted to be the most successful class of medication on record, with research estimating that the market size will reach more than $100 billion by 2030. It now seems likely that in the near future, these drugs will not just help patients manage obesity and cardiovascular disease but also a wide range of other conditions, such as neurodegenerative diseases, addiction, liver disease, and kidney disease.
New players are entering the market looking to capture a share of the opportunity, and there are many next-generation versions of this class of drug in development, such as tri-agonists and formulations targeted at combatting side effects such as nausea.
Given the size and scope of the GLP-1/GIP market, companies may need to differentiate their product from that of competitors by innovating the device or the method of supplying, explaining, or presenting the drug. For example:
- Improved sustainability: In terms of usability and suitability for the low viscosity and relatively small dose volumes currently needed for GLP-1/GIPs, the disposable two-step autoinjector device is well optimized. However, there is an opportunity to develop a more sustainable version that doesn’t compromise this optimization. There is also potential to go beyond the device design and look at factors such as how the device is supplied to the patient or how instructions for use are communicated.
- Links to adjacent services: Companies may add features or link to adjacent services, such as those that help to manage common challenges associated with the therapy or the target disease, like reduced muscle mass.
The rapidly increasing demand for GLP-1/GIP medications has put enormous pressure on supply chains. To respond, companies may need to make strategic specification decisions in 2025, such as prioritizing primary pack formats that hold more doses or can be filled faster. Additionally, organizations may choose to start developing their own device, rather than licensing one. This will reduce risks of being low on the priority list when supplies are limited or the possibility of a competitor acquiring their supplier.
2. Alongside GLP-1/GIP Agonists, The Continuing Biologics Boom Could Drive Further Research In Alternative Routes Of Administration.
Alongside the surge in peptide formulations (which includes GLP-1/GIP agonists), the high interest in biologic medications seems likely to continue, with recent yearly approvals consistently more than double what they were a decade earlier.
Currently, the vast majority of these two important chemical forms are administered via subcutaneous injection, which is set to remain the leading route of administration in 2025. However, looking at clinical pipelines, it’s clear that the pharmaceutical industry recognizes that many patients would prefer, or benefit from, an alternative route of administration. As the peptide and biologic markets grow, even a small share of this expanding sector is large enough in absolute terms to justify research investment in delivery via alternative routes.
Particularly notable from a device perspective are transdermal and pulmonary delivery. While more subcutaneous autoinjector variants can be expected to reach the market in 2025, companies may decide that broader patient populations could be reached using one of these alternative routes. As a result, they may elect to invest in the development of new transdermal devices – such as those featuring improved technology for patch application or inhalation systems capable of conveniently delivering large doses without damaging these fragile molecules.
3. Increased Scrutiny On The Environmental Impact Of Healthcare Is Likely To Drive Companies To Invest More In The Development Of Sustainability-Focused Device Systems.
Reducing the environmental impact of drug delivery devices is a growing priority for many pharmaceutical companies, leading to investment in new device innovations. However, the long time frame required for development has meant that relatively few devices with a specific sustainability focus have reached the market thus far.
The development of a reusable auto-injector, for example, could unlock significant sustainability benefits, particularly given the ubiquity of disposable auto-injectors. Some reusable models are already available, and it has been publicly disclosed that more are in development by major pharmaceutical companies. There are two key challenges that have limited more widespread acceptance of these devices. First, the disposable refill tends to be relatively complex, featuring a large quantity of polymer, in addition to the glass, metal, and rubber of the syringe. Second, reusable devices require more user steps than a disposable autoinjector, potentially reducing convenience and increasing the risk of use errors.
If the devices in development can successfully address these issues, this format could become expected by patients and HCPs or even required by future sustainability regulation.
Another factor driving sustainable innovation is the rapidly evolving range of available eco-friendly materials. To date, most developers have focused on materials that use sustainable feedstocks, but which are chemically identical to their unsustainable equivalents. These materials have the advantage of medical certification that guarantees consistency of properties and traceability of ingredients. However, such guarantees are not yet available for more novel and innovative materials and hence their application within drug delivery devices has lagged compared to other industries. Overcoming these challenges and regulatory constraints would make way for further improved sustainability, including devices that can be easily recycled or produced with biodegradable elements.
Given the high interest and investment in this area, those companies not already developing an auto-injector — or other drug delivery device — that meaningfully improves sustainability may decide to start in 2025.
Outside devices themselves, less explored areas that could see increased investment in 2025 are improvements to the sustainability of secondary packaging and the peripherals associated with manufacturing, such as transport trays. In these areas, the requirements for material traceability and consistency of properties are potentially less critical, increasing the range of materials that can be used and giving companies a way to reduce the environmental impact of the device system with lower risk.
4. Device Innovations That Enable Delivery Of New, Longer Acting Formulations To Patients Will Bring Potentially Significant Treatment Benefits.
Many drugs in clinical pipelines right now are being formulated, or reformulated, to require less frequent administration, often using innovative new vehicles such as nano particles. The potential benefits to patients are clear. However, these advances present new challenges for the devices that are used to deliver them. These drugs are often formulated as suspensions, giving them higher viscosity and introducing the risk of needle blockage. The dose volumes required also can be much larger.
As part of efforts to overcome these challenges, industry experts have already been exploring pain and tolerability of large-volume subcutaneous injection for some time.
Companies interested in developing these longer acting formulations will need to start to explore the development or availability of new devices equipped with innovative power packs capable of safely generating the energies needed to dispense high-viscosity fluids and large doses, as well as user interfaces to manage the discomfort and inconvenience associated with increased dispense times.
5. Digital And Connected Drug Delivery Solutions Capitalize On The Advances In Electronic Hardware And Artificial Intelligence (AI).
Over the last 20 years, large investments have been made into a wide variety of digital and connected drug delivery devices. However, only a handful have made it to market and provided a genuine return on those investments.
As a result, interest in these systems has waned in recent years. But sensing and broader electronics technology continues to advance, as does the capability and understanding of AI and ML systems. These developments present the possibility to use and draw treatment-relevant insights from large and complex data sets from a wide variety of sources.
Given these advancements, it may be prudent for companies to revisit their strategy on digital and connected drug delivery systems in 2025.
The key to success will be selecting the right application. The days of developing connectivity for connectivity’s sake are over. The format of tomorrow’s device might also not resemble what has gone before, commonly a Bluetooth connected module attached to, or integrated into, a delivery device. For example, new systems may utilize the camera or other sensor functionality of a phone or tablet, thereby simplifying the device’s construction or reducing the need for any special modifications to the device.
There are many fascinating discoveries and positive global trends emerging across the pharmaceutical industry that have the potential to drive device innovation in the near future.
While it’s impossible to predict with certainty which aspects of this innovation will be best for patients or commercial success, the pace of change means that inaction is not an option. We expect that in 2025 pharmaceutical companies will revisit their device strategies to ensure they are well positioned to capitalize on opportunities, adapt to new treatments, improve patient experiences, and remain competitive.
About The Author:
Matt Jones is a drug delivery device design and development expert at PA Consulting. Over the last 22 years, he has worked on a broad spectrum of drug delivery technology types and routes of administration — injection, inhalation, nasal and topical, manually operated, spring-driven, electromechanical, and connected devices — including work on a number of award-winning and successfully marketed devices. He has extensive experience in leading multi-disciplinary teams to support clients and drive projects through the toughest challenges at all stages of the design and development process: from devising product strategies and roadmaps, project planning and budgeting, through all aspects of design and evaluation, to detailed support of industrialization and post-market. Jones has a MEng in mechanical engineering from Bristol University.