4 Opportunities For Advancing Drug Delivery

By Fran DeGrazio, Senior Industry & Technical Advisor, Drug Delivery Leader

As I look out onto the horizon of 2026 and beyond, I see four emerging trends in the biopharmaceutical industry worthy of commentary. Regarding each of those, I will offer my thoughts here. Many of these developments present significant opportunities to advance innovation and improve established practices within the field. At the outset, I acknowledge that trends in biopharma do not develop or conclude within a single year; rather, they evolve gradually over time. My aim here is to enhance understanding and awareness, encouraging consideration of how these directions may impact current work and future initiatives.

Emerging Opportunity #1: Prioritizing Diagnostics

The first opportunity is one of the most exciting to me because it can ultimately transform how patients are managed and treated, turning the current process on its head. This is the increasing importance of companion diagnostics and leading with these tools to achieve the ultimate in personalized medicine. The opportunity to be proactive by characterizing an individual’s needs opens the door to many positive potential outcomes.

There are currently many diagnostics approved, especially for use in oncology. More than 30% of FDA approvals since 2020 are labeled precision medicines, as noted in the Personalized Medicine at FDA report published by the Personalized Medicine Coalition.

Diagnostics Classifications And Types

The FDA classifies in vitro diagnostics (IVDs) as medical devices. Prior to use in a clinical trial, it is essential that an IVD undergoes validation to confirm its analytical reliability, particularly at critical clinical decision points. When developing a clinical trial strategy, it should be a priority to generate robust evidence supporting both the IVD and the relevant therapeutic intervention.

The FDA also classifies Next Generation Sequencing (NGS) tests as medical devices. These tests can identify genetic variants that help inform, diagnose, and treat human diseases. In the future, such diagnostics could proactively assess an individual's health — potentially even before any clinical symptoms appear. Of course, with this comes ethical challenges that must be addressed. These are things such as awareness of future health issues by employers or insurance companies.

Leveraging Diagnostics Early

If we follow the risk-based thinking that is now being inculcated into every facet of drug and biologic development and delivery, moving in this direction demonstrates the ultimate in commitment to patient centricity and risk mitigation. Leveraging diagnostics early in development aids in providing the data necessary to show its value in combination with drugs/biologics and their delivery systems, providing the ultimate combination product benefit.

An increase in focus on the benefits of various diagnostics should drive recognition of their growing value and provide advantages to patients and pharmaceutical organizations alike.

Emerging Opportunity #2:  Understanding Patient Tolerability

Because the need to deliver larger volumes of biologics to patients has expanded over the last several years, there have been many technologies developed to enable this. Standard volumes for subcutaneous injections were once considered <1.5 ml. Now the industry is addressing significant interest in delivering volumes from 3-20 ml.

New, large volume autoinjectors and on-body injectors have been developed to accommodate this. Many were designed by suppliers of constituent devices to meet this technological need. However, a key question remains: Are these volumes truly tolerable for a patient over a short injection period?

Increased Research Focus On Tolerability

Recently, I’ve observed an increase in research focused on patient tolerability. As a general example, there were at least 6 presentations/posters presented on this subject at the 2025 PDA Universe of Prefilled Syringes and Injection Devices Conference. While a few earlier studies existed, truly advancing large volume devices requires prioritizing patient needs, not simply relying on engineers to develop new delivery systems because it’s technically possible.

Usability data supports longer injection times, but some limitations may exist. Literature reviews show that until relatively recently (2023) there were few studies on injections greater than 2 ml.

Numerous variables influence patient tolerability of larger injection volumes. Factors such as the administration site, delivery technique, and drug formulation all contribute to the overall experience. Furthermore, as pain perception varies among individuals, a subset of patients may respond differently from the majority.

There is also ongoing work in multiphysics simulation of injections to supplement experimental, animal and clinical studies for large volume, high viscosity injections. During the aforementioned PDA Universe event in Vienna, Scott Lovald, PhD, P.E. of Exponent, showed how they have leveraged earlier work on injection pressures, drug transport, and PK modeling with the hope to incorporate physiological variables in the future. This type of activity helps with screening and optimization of what gets tested with patients.

Emerging Opportunity #3: Microdosing

Another opportunity for Innovation in industry ties to a more recent trend that I have observed. This is the development of microdosing as a potential option in drug delivery.

Historically, the term microdosing was tied to the practice of taking very small doses of psychoactive drugs such as LSD. More recently, this term is entering conversations in relationship to the current GLP-1 weight loss phenomenon.

Once again, there is opportunity in a non-standard approach. What I mean by this is often the industry looks at opportunity as “the more, the better.” As an example, Novo Nordisk recently filed for FDA approval of a higher dose of Wegovy injection (7.2 mg). This could provide greater weight loss potential for those that are obese. I am sure this is an opportunity for both patients and Novo. But consider this: What happens when all these people that are losing weight reach their goal? How is maintenance done?

This is also a huge opportunity that we have not heard much about from the two market leaders, Novo and Lilly. Lilly has stated it is against microdosing because the approach has not been proven effective for weight loss. There is potential to enhance this concept through rigorous studies aimed at supporting sustained weight loss. While such research may already be underway, further innovation in this field presents a substantial opportunity. This applies not only to the pharmaceutical compound itself, but also to advancements in delivering microdosed quantities. Exploring methods for effective administration of smaller volumes could open avenues for device development and improved sustainability, among other notable prospects.

Weighing Delivery Options For Weight Loss Microdosing

Recently, the FDA approved a Novo Nordisk oral semaglutide for weight loss. This is currently being positioned as an alternative to the injectable version of Wegovy for weight loss. As a pill, it will be more accessible to the general marketplace; however, there is still a question as to its ability to maintain weight loss once a goal is reached.

There are also challenges with the oral formulation as it is a peptide and sensitive to digestive enzymes. Novo uses a carrier molecule that temporarily limits the impact of digestion. However, it must be taken under a strict patient protocol: 1) the stomach must be empty, 2) it must be taken with no more than 4 oz of water, and 3) the patient must wait at least 30 minutes before ingesting any other food, liquid, or medication.

Lilly has a small molecule (orforglipron) in clinical trials that does not require fasting. They are still trying to understand the safety data associated with it, so studies are ongoing. Ultimately, an oral dosage form may not be a panacea for some time.

Additionally, I believe there is significant opportunity for a long-acting injectable (LAI), especially for maintenance. Personally, I would much rather take a monthly self-injection than a daily pill. Understanding patient wants and needs around addressing Type 2 diabetes, weight loss, and the maintenance of both over time presents a huge opportunity for patients and industry.

Emerging Opportunity #4: Developing New Analytical Methodologies

Lastly, an area in which I see momentum is the development and utilization of new test techniques and methods. More than 15 years ago, I was part of a team that investigated analytical options for testing subvisible particles. At that time, there were very few options that could meet cGMP requirements for validation, etc. Today, there has been some progress, but this is limited. Many new tools are designed for use in an R&D environment but cannot meet the rigorous needs of a cGMP operational environment.

The Need For Advanced Particle Analysis

There has been a great focus on visible particles through the years when, in my estimation, the greater safety concern is subvisible particles. Of course, the concern with visible is the potential of it indicating a breach of biological contamination  Typically, a visible particle in a sterile product is limited to one or two units. This should be caught before the lot is released and could be culled out. You will not see visible particles across every vial, syringe, or bag unless there is a total process failure.

Subvisible particles, however, are present in every unit. Not only are they present but, in some cases, they can be tied to immunological health-related effects. So why not focus more on updating these testing technologies?

The Need For Advanced CCI Analysis

Another example is the need for container closure integrity (CCI) of an entire combination product, such as a syringe in an autoinjector. The syringe can be tested separately; however, until recently, there was not a good option for testing the complete combination product by a deterministic method. Dye penetration tests, long the standard of the industry, were adapted to try to meet testing of combination products. However, they are messy, lack sensitivity, and are destructive in nature.

The most common CCI deterministic testing alternatives are high voltage leak detection    (HVLD), laser-based headspace analysis, helium leak detection, and pressure-based alternatives such as vacuum, pressure, or mass extraction.

Until relatively recently, there was not a piece of equipment or new technique that could be offered to the broad industry that could be easily adapted for combination products and meet the current USP 1207 general chapter that provides guidance on Package Integrity Evaluation for Sterile Products. Companies were on their own to figure how to deal with this challenge. Recently, several types of techniques that utilize vacuum decay or headspace analysis have been introduced for meeting this challenge.

These are just two examples of critical areas that need testing innovation to aid in moving the industry forward. There are many other analytical challenges out there, and providing adequate tools that can be leveraged in support of the various types of combination product needs is a true opportunity for the future.

The Potential Impact Of Drug Delivery Advances

With focused commitment, advancement in each of these four areas of opportunity can yield significant advantages for the industry. Over time, I have observed that the absence of these enablers can hinder or even halt progress in fulfilling both business objectives and patient requirements. The trends previously mentioned have the potential, when advanced, to serve as key drivers for regulatory achievement and enhanced patient satisfaction.