Introduction

For decades, pharmaceutical development treated delivery as an execution problem. Once a molecule was identified and proven, the formulation team figured out how to put it in a pill. The science was in the discovery. Everything after that was engineering.

That separation has become harder to sustain. Delivery now directly shapes how well a therapy performs and how much of it reaches the target, whether patients actually take it, and whether the clinical promise holds up in real-world conditions. The global orally disintegrating tablet market is projected to grow from approximately US$25 billion in 2025 to US$48 billion by 2032. The WHO estimates adherence to chronic therapies in developed countries averages around 50%. These figures describe the same underlying problem: a gap between what a therapy can do and what it actually does.

Keith Dodson has worked across branded pharma, CDMO services, softgel technologies, and consumer healthcare manufacturing.His approach to closing that gap starts earlier than most: "Letting the science of the API guide the process."

For Dodson, a delivery platform only has value when it solves a genuine scientific, therapeutic, or patient problem.

Start With the Chemistry

Development teams that begin with a platform often end up reverse- engineering a rationale for the technology they want to apply. The chemistry gets bent to fit the container rather than the other way around.

Formulation decisions grounded in the API itself look different. Some molecules have properties that make rapid oral disintegration genuinely valuable: absorption kinetics that benefit from mucosal delivery, bioavailability profiles that a lipid-based system can meaningfully improve, or first-pass metabolism that sublingual administration sidesteps. Those are real advantages worth building toward. Others have none of those characteristics, and applying an advanced delivery format adds manufacturing cost and development complexity without improving how the drug works.

"You don't shoehorn a modality where it doesn't belong just for differentiation." says Keith Dodson.

The FDA defines orally disintegrating tablets as dosage forms that disintegrate in the mouth within approximately 30 seconds without water. This is a real capability, and one with genuine clinical applications. Prior formulation work that Dodson referenced showed a shift from conventional oral capsules to lipid-based delivery, improving bioavailability by nearly 8 to 9 times. Lower API utilization reduces dose burden and potentially results in fewer side effects. When the chemistry calls for it, the returns are substantial. When it does not, the investment produces little clinical value.

What Patients Actually Experience

A 37.4% rate of adults reporting difficulty swallowing tablets or capsules is not a niche concern. A European study found that figure, and went further: 58.8% of those patients modified their medicines in ways that could compromise safety or efficacy, and 9.4% stopped taking them altogether.

Development teams focused on molecule optimization and clinical endpoints often underestimate how much of this is happening. The populations most affected, pediatric patients, elderly adults, dysphagic patients, people in psychiatric care, and patients dependent on caregivers for administration, are also among those with the most complex therapeutic needs.

Dodson points to pediatric acetaminophen as a case where formulation changes the administration reality entirely. Conventional suspensions create inconsistent dosing, caregiver burden, and errors at the point of administration. A rapidly dissolving dosage form that a child can take without water or assistance removes most of those variables. The clinical question driving that work, as Dodson frames it: "What can we actually improve for the end consumer?"

Delivery as Part of the Pharmacological Strategy

The route of administration has always influenced how a drug behaves. What has changed is how deliberately that relationship is being used.

For molecules with viable buccal or sublingual absorption, evaluating those pathways is part of understanding what the drug can do, including how fast it reaches therapeutic levels, whether it bypasses metabolism that would otherwise limit its effect, and whether a lower dose achieves the same outcome with better tolerability. That is a pharmacological strategy, with delivery as one of the variables.

The industry-wide move toward oral alternatives to injectables reflects the same thinking at scale. Patient preference, injection fatigue, administration complexity, and manufacturing economics all create pressure in that direction. Oral semaglutide represents how far that effort has come. But Dodson notes the trade-offs that come with those transitions. Higher API loading requirements, tolerability issues, or no discernible patient benefit all weaken the case, regardless of how technically sophisticated the oral platform is.

Manufacturing Cost and Development Reality

Lyophilized ODT technologies can cost several times more to manufacture than conventional tablets, capsules, or softgels. In a development environment where approximately 90% of therapiesnts entering clinical trials do not warrant approval, the economics of advanced delivery formats deserve honest early evaluation

Scalability, manufacturability, and reproducibility determine whether a platform that works at development scale can work at commercial scale. These are not administrative considerations. They shape whether a therapy is viable to produce and price for the markets it is intended to reach.

Dodson's position is pragmatic: the technical sophistication of a delivery system is secondary to what it actually delivers for patients and for the business supporting their treatment.

What CDMOs Are Now Being Asked to Do

The role of CDMO partners in pharmaceutical development has expanded. Regulatory credibility, supply-chain resilience, regional manufacturing presence, and the capacity to scale alongside a program have become core to how clients evaluate partners, alongside, and sometimes ahead of, technical capability alone.

The market reflects the demand. The global pharmaceutical CDMO sector was estimated at approximately US$155.5 billion in 2024 and is projected to reach nearly US$293.6 billion by 2033. Asia-Pacific represented approximately US$58.93 billion of that in 2024 and continues to grow as a manufacturing base.

Smaller specialized organizations face a particular version of this challenge. Demonstrating operational credibility, regulatory track record, quality systems, and the ability to support a program through scale-up matters as much as the delivery technology itself.

Dodson's approach with Instapill is to build the specialized platform within a broader ecosystem of regulatory, manufacturing, and scientific expertise. As he puts it: "We punch above our weight class."

Conclusion

The pharmaceutical industry has always understood that a good molecule poorly delivered underperforms. What has shifted is how seriously formulation strategy is being taken from the beginning of development, and how much earlier delivery considerations are entering the conversation.

Dodson's framework is straightforward: understand what the API actually needs, build accordingly, and resist the pull toward complexity that does not improve outcomes. The platforms that gain traction will be those where the science made the case first.