Drug Delivery Trends From 2025: Top 4 For Momentum Gains In 2026

By Fran DeGrazio, executive editor, Drug Delivery Leader

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:

1. Digitalization
2. Sustainability
3. Patient centricity
4. 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).

Sustainability Must Be Increasingly … Sustainable

Sustainability ties very closely to drug packaging and delivery. Europe has adopted the Packaging and Packaging Waste regulation, which mandates that pharmaceutical packaging must meet recyclability requirements by 2035. Sustainability is becoming a part of new business tenders, as well.

Pharma manufacturers are adopting policies which shift responsibilities upstream for sustainability. Pharma companies are integrating environmental stewardship into their missions and corporate goals. Keeping a circular mindset in pharma is now a requirement in relation to the entire drug manufacturing and delivery process. Aspects such as the improved management of waste, wastewater, and overall energy consumption are now required.

A focus on the sustainability of materials should inform design and procurement to aid in the consideration of recyclability. Reducing carbon emissions, from the sourcing of raw materials to end-of-life disposal, is needed and becoming mandatory.

One relevant example involves regional considerations within supply chain management. By sourcing materials from suppliers located near a pharmaceutical manufacturing facility, organizations can effectively reduce the carbon footprint associated with products received from third parties. This approach represents a practical strategy for enhancing sustainability efforts.

Patient Centricity Means Focusing Care On … You Guessed It: Patients

Patient-focused care requires ease-of-use, clinical benefit, and system-wide value. Integrating a thorough understanding of patient needs early in development is essential to the process. Aging-in-place has increased demand for in-home care, and drugs are now often administered by non-professional caregivers, or even self-administered. These changes in where and by whom medicines and therapies are administered have illuminated requirements that were not previously considered for drug delivery.

It becomes critical, then, to understand the entire user interaction with the delivery method or system. This includes aspects such as packaging, labeling, Instructions for Use (IFU), and the device itself. As integration of drug-device combination products with smart connected devices becomes more common, the aspect of digital user interfaces becomes significant. Standards that reference the use of human factors engineering and the usability of the entire user interface include guidances such as IEC 62366-1 Medical Devices: Application of Usability engineering to Medical Devices. Another is ISO 14971, which is the international standard for Risk Management, focusing on the safety, security, and risks associated with medical devices .

The increased attention to patient centricity was furthered by the recent release of the book entitled, Patient-focused Development of Biopharmaceutical Products. Part of the AAPS Advances in Pharmaceutical Sciences series, the book was edited by Robert Nesbitt and Wolfgang Fraunhofer of AbbVie, along with Ramakrishna Venugopalan of Continuity Biosciences LLC. This book is open access and, therefore, easily downloaded and referenced. It focuses on the unique challenges of developing combination products and the need to be patient-focused throughout the process.

Drug Delivery And Patient Care: A Personal Account

A practical example illustrating the significance of fully understanding the impact of delivery methods on positive outcomes for patients comes from my own personal circle: a friend’s mother, a 93-year-old who requires daily administration of eyedrops. In her care scenario, the doctor recommended drops that came in what is described as “vials.” These vials are small, plastic blow/fill/seal containers. each holding a couple of drops.

To open, the user must twist and pull the tab to remove it and then squeeze the container to apply the drops. While this elderly woman is currently living on her own, she, unfortunately, cannot independently use these eyedrop vials. The problem is not in removing the top but, rather, in squeezing the container to apply the drops. Her hands are simply not strong enough to manage this step. The result is that she avoids the process until she has a visitor. Thus, she is not getting her daily drops. From a medicinal efficacy perspective, these gaps in application would be considered a patient adherence challenge.

Understanding the profiles of particularly challenged users in target patient populations (those characterized by age, disability, etc.) is essential to providing a satisfactory patient experience.

Biologics Delivery: The Larger The Payload, The Bigger The Challenge

Lastly, an important consideration for enhancing patient quality-of-life is the effective delivery of larger volumes of biopharmaceuticals. With the ongoing expansion of biologics and the transition from intravenous (IV) to subcutaneous (subQ) administration, there is an increasing need for methods that facilitate higher volume delivery with ease. As an example, IVs are given over several hours. By contrast, delivery in a subQ format is typically  delivered in seconds via an autoinjector or in a few minutes via an on-body injector.

A representative example is Merck’s Keytruda Qlex™. Approved in September 2025, it is the first and only checkpoint inhibitor that can be injected subcutaneously into a patient by a provider and in only a minute. Prior to this delivery was by IV.

Industry Collaboration Advances Formulation Science Along With Delivery Tech

Speaking of subcutaneous administration, significant momentum in that space is guided by the efforts of the Subcutaneous Drug Delivery and Development Consortium. Formed in 2018 to identify challenges and share information among the industry, the SC Consortium has  identified three ways of aiding in high volume biologics delivery. These are:

• Formulation technologies that form fluid suspensions
• Formulation technologies that minimize intermolecular interactions in solution to reduce viscosity of high-concentration formulations
• Devices that allow for SC (or, subQ) injection of high viscosity formulations

The consortium’s goal is to accelerate advances through industry and academic partnership. Research and understanding continues to be driven by this collaborative association and by individual research being conducted within pharma organizations and medical device suppliers.

Delivery Trends Begin And End With Patients

Reflecting on the recent past while looking onto the near horizon, I find it remarkable to see the advances achieved across numerous sectors. Technology continues to drive greater capacity, digitalization fosters operational efficiencies, and sustainability remains a key priority for future development. Frankly, however, the central focus of the industry must remain on the patient. Beginning with their needs will always be the foremost objective.