By Fran DeGrazio, executive editor
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As I look back at 2025 and ahead into 2026 and beyond, I see four pivotal developments that have already had considerable impact on drug delivery and are far from reaching their full potential. I fully expect them to continue evolving in the years ahead. They are:
- Digitalization
- Sustainability
- Patient centricity
- High-volume biologics
Digital Transformation Is Becoming … Transformative
While AI and Pharma 4.0 are common topics, both rely on digitization — that is, converting analog information into digital formats to enhance business processes. By unlocking data from PDFs and siloed systems, organizations can use the information more effectively. Digital transformation brings strategic changes, enabling new business models, better customer experiences, and greater efficiency across operations. This transformation involves three key areas: processes, technologies, and people.
A primary area of emphasis within the industry is Pharma 4.0, which incorporates technologies such as artificial intelligence, big data, and digital twins to drive greater efficiency, strengthen compliance, and enhance work quality. These advancements are being implemented across the spectrum from research and development to manufacturing and supply chain management. The industry appears committed to establishing itself as a leader in leveraging these concepts as integral components of its business model.
As noted by the recent partnership of Eli Lilly and NVIDIA, a key area of focus will be drug discovery. The industry is anticipating experiments that, historically, took years to perform using traditional methodologies to soon, if not already, be reduced to months by utilizing advanced AI modeling techniques.
Digitalization Drives Process And Regulatory Efficiency
Additionally, digital transformation establishes a solid foundation for process understanding, which is essential for implementing Quality by Design in pharmaceuticals, as well as Design & Development Controls in medical devices and combination products. This approach enhances connectivity with control strategies across the entire development process and product lifecycle. Employing these strategic philosophies alongside advanced digital capabilities facilitates effective use of process-generated data and supports integration across functions — an increasingly critical factor in future drug development and delivery.
Digital transformation also drives increased efficiency in sectors such as regulatory, particularly as regulations and compliance requirements grow increasingly complex. Regulatory functions should, therefore, be prioritized for digitalization and the integration of AI and tailored software solutions moving forward. Based on my own observations, the regulatory function is ripe for digitalization but has been among the slowest to transition.
Digital Connectivity Means Smart Devices — And Smarter Care
Another area of growth over the last few years, specifically in relation to delivery devices, has been the introduction of connected devices. These solutions integrate digital connectivity with traditional delivery technologies toward the goal of improving adherence, tracking, and accuracy. These integrations have not yet accelerated as quickly as the digitalization of processes because there must be a clear benefit to the patient and the payor for market uptake to occur. It is my belief that, as at-home, often self-administered care and its role in the management of chronic conditions become the norm, the use of these connectivity technologies will advance at a much faster pace.
A notable example of a connected device is Bayer AG’s Betaconnect™ smart autoinjector, recently approved for treatment of relapsing forms of multiple sclerosis (MS). An optional app called BETA track™ can track the injection schedule, injection site rotation, and when injections occur. Other general examples that have been developed include smart insulin pens, connected insulin pumps, and smart inhalers that are used for conditions such as chronic obstructive pulmonary disease (COPD).
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As I look back at 2025 and ahead into 2026 and beyond, I see four pivotal developments that have already had considerable impact on drug delivery and are far from reaching their full potential. I fully expect them to continue evolving in the years ahead. They are: