By Fran DeGrazio, senior industry and technical advisor, Drug Delivery Leader
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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.
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.
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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.