Hardest to Describe as Inactive

An IPEC-Europe panel at CPHI Milan asked whether innovation and excipients are mutually exclusive. A survey report published the same week suggests the field has already answered.

Last week at CPHI Milan, IPEC-Europe put a question to a panel drawn from a major pharma company, a global CDMO, two excipient suppliers and Ibumix: are innovation and excipients mutually exclusive? It is a fair question. Excipients are the part of a medicine that the label calls inactive, and the regulatory system is built around keeping them that way. Anything new has to prove it is safe before it can prove it is useful.

The same week, PharmaExcipients.com published a report that puts numbers on how the people who actually choose excipients see the next four years. Excipients 2026-2030: Innovation, Formulation and the Changing Role of Excipients draws on 185 survey responses and 13 expert interviews. It is worth reading carefully, and worth reading on its own terms.

What the report is, and is not

It is a sentiment survey, not a market forecast. There are no size-of-market figures in it, and it does not claim to be representative. The respondents selected themselves: 54% are in Europe, 20% in Asia-Pacific, 12% in North America. Just over a fifth work for excipient manufacturers, a fifth for pharmaceutical companies, 16% in academia, 10% as consultants. CDMOs, generics companies and distributors make up most of the rest. Only a handful of respondents are from biopharma or drug-delivery technology companies, and there are no regulators in the sample.

That matters for how the numbers should be read. This is what a European, supplier-leaning, experienced group of formulators (79% have more than ten years in pharma) believes. It is an informed opinion poll. Treated as that, it is useful, because these are the people who decide which materials get evaluated and which get left on the shelf.

Where the field says the problem is

Asked to name the biggest formulation challenge they face today, respondents put bioavailability first at 52%, solubility second at 49% and stability third at 42%. Asked which challenge will matter most by 2030, the answer shifts: oral biologics at 43%, bioavailability at 37% and patient-centric formulation at 36%.

Where the problem moves
Share of formulation professionals naming each as a top challenge
Biggest challenge today
Bioavailability52.4%
Solubility48.6%
Stability41.6%
Most important by 2030
Oral biologics43.2%
Bioavailability37.3%
Patient-centric formulation35.7%
Source: PharmaExcipients.com, Excipients 2026–2030, survey of 185 formulation professionals, multi-select. Both panels share one scale; bar length is the percentage of respondents. A sentiment survey with a self-selected sample, not a market measurement.

Read together, the two questions describe a field that expects its hardest problem to move from “small molecules that will not dissolve” to “large molecules that will not absorb”. Oral biologics are named as the formulation technology with the greatest expected impact (52%) and as the fastest-growing delivery platform (61%). Oral peptides are the single area respondents expect to drive the most excipient innovation, at 35%.

The expert interviews are more specific about why. Oral delivery of peptides and proteins is held back by permeability, by unpredictable absorption, by the effect of food, and by the molecule’s survival in the gut. One interviewee describes the breakthrough the field is waiting for as “a safe, generally adoptable permeation enhancer”. Another sets the bar as routine oral peptide bioavailability above 50%, a figure that is an order of magnitude beyond what approved products achieve today. A third notes that “dedicated excipient systems are still limited” for oral biologics, and that the race is becoming a platform race, combining protection, permeability, release and manufacturability in one system.

Which materials the field expects to win

Lipids are named as the fastest-growing excipient category by 51% of respondents, ahead of functional polymers (48%), protein stabilisers (44%), novel excipients (37%) and co-processed excipients (37%). Multifunctional excipients, materials that do more than one job in a formulation, are rated very important or critical by 68%. Asked what matters most when choosing an excipient, the top answer is functionality (41%), not price and not supply.

The most telling question asks who will benefit most from the changes the respondents expect. Drug-delivery technology providers (29%) and functional excipient suppliers (28%) come first. Traditional excipient suppliers come last, at 2%.

The paradox at the centre of the report

Novel excipients are rated as having the highest innovation potential of any category, by 32% of respondents. Yet only 16% of organisations say they evaluate novel excipients routinely. When asked why, the answer is not cost (17%) or toxicology (9%). It is regulatory uncertainty, named by 59% overall and by 93% of the CDMO respondents, the people who would have to put a new material into a client’s dossier.

This is the mutually-exclusive question in numerical form. The field wants new function and does not want new chemistry, because new chemistry means an unprecedented material, a full safety package, and a regulatory path nobody can estimate in advance. The FDA’s Novel Excipient Review Pilot Program, launched in 2021, was created precisely because no sponsor wanted to be the first to carry a new excipient through approval. The pilot exists because the barrier is real.

The excipient of 2030

The experts resolve the paradox in a way that is easy to miss on a first read. The excipient of 2030, one argues, “will not necessarily be chemically new”. It may be a familiar material whose function is understood well enough to be used deliberately, at a level and in a structure that asks it to do a specific job. The winning proposition, in the words of the report, is not new chemistry alone but a functional platform with reproducible performance, evidence in real formulations, scalable manufacture and a credible regulatory path.

The most valuable excipients are those “hardest to describe as inactive”.

That is the answer to the panel question. Innovation and excipients are not mutually exclusive. The innovation is in the function, the evidence and the engineering, not in the molecule. A material with decades of safe use, put to work in a way it has never been asked to work before, with the data to show that it does so reproducibly, is an innovation. It is also one that a CDMO can put in a dossier.

There is a second edge to that line, and the report is right not to hide it. An excipient that is hard to describe as inactive is one a regulator will want described. The question moves from “what is this material” to “what is this material doing in this formulation, at this level”. Precedent on identity does not settle a question about function. Anyone building on established materials should expect to answer the second question as rigorously as the first, and should plan the evidence accordingly.

What the experts ask for, and the survey does not

The survey respondents are optimistic. The experts are conditional. Across the interviews, the recurring demand is proof: performance in real formulations, at scale, with the variability characterised. Sentiment about which categories will grow is useful for direction. It does not substitute for data, and the interviewees say so.

Reading it on its own terms

The report is sponsored by three excipient companies, and the first few pages are theirs. The sample is self-selected and leans towards suppliers. None of that makes it wrong. It makes it a survey of what a knowledgeable part of the industry believes in 2026, which is a useful thing to know, provided it is quoted as that and not as a measurement of the market.

Credit to PharmaExcipients.com for commissioning it, and for publishing the respondent breakdown alongside the headline numbers. Reports that show their sample are the ones worth citing.

The panel in Milan did not settle its question in forty-five minutes. The report suggests the industry is settling it for itself: the excipient worth having in 2030 is the one that is hardest to call inactive.


George Forrest is CEO and co-founder of Ibumix and a Chartered Chemical Engineer. He previously ran Stepan Company’s UK manufacturing site.

Ibumix is a UK pre-clinical pharmaceutical company developing a series of new liquid drug delivery platforms. Ibumix was a panellist at the IPEC-Europe session “Are Innovation and Excipients Mutually Exclusive?” at CPHI Milan on 7 October 2026. Read the Newsroom report of the panel.

Sources