Recent BioSpace industry conference conversations point to sponsors pushing earlier on safety, quality and performance data, leading to demand for nitrosamine analysis, IVRT/IVPT and microbiome database capabilities.
In conversations at recent industry conferences, BioSpace heard from lab service providers on three increasing areas of demand: nitrosamine testing, in vitro release and in vitro permeation testing and microbiome database capabilities.
The uptick in these services indicate sponsors are increasingly keen on derisking safety and performance quality, early and quantitatively. Labs are shifting from test vendors to collaborators who help sponsors navigate evolving quality standards and extract more actionable data.
1. Nitrosamine testing
Nitrosamines are chemical compounds classified as probable human carcinogens that form unintentionally as byproducts or impurities during drug manufacturing. They are of increased concern for biotech development, especially during final product development for clinical trials and formula specifications, said Samuel Garcia, business development manager at AMSbiopharma.
In the past several months, AMSbiopharma has received more than 10 inquiries on excipients, active pharmaceutical ingredients and final products related to nitrosamines, Garcia said.
Nitrosamines have made wider trade press news: in April 2024, Novartis announced that considering recently evolving regulatory guidance on intake limits for nitrosamines in medications, enrollment of new patients in ribociclib early breast cancer studies has been paused.
In late autumn 2023, the FDA had issued final guidance on the recommended acceptable intake limits for nitrosamine impurities.
2. IVRT/IVPT testing
Shifting to another service offering, equipment vendors are marketing in vitro release testing (IVRT) and in vitro permeation testing (IVPT) for topical products per a recent EMA guideline. They are positioning this as a cost‑ and time‑saving regulatory option.
The importance of in vitro tests such as IVRT and IVPT has increased significantly, wrote Dr. Michael Felkel, regulatory affairs manager at Dermapharm AG, in an e-mail to BioSpace. The EMA guideline, which came into effect in April 2025, has a clear position, where IVRT is considered a critical quality attribute.
“In addition, according to the equivalence concept provided in the EMA guideline, IVRT can be a useful tool for demonstration of equivalence, in particular for so-called simple formulations,” he added.
IVPT may be part of adequate product characterization as well, such as showing equivalence (when pharmaceutical equivalence as described in the EMA guideline is not sufficient to assume therapeutic equivalence).
There are some challenges when the proposed equivalence concepts are based on in vitro tests such as IVRT and IVPT, Felkel said. “These include meeting the equivalence criteria of the guideline and lack of harmonization (EMA guideline vs. FDA/USP requirements), which might be critical for globally acting companies,” he added.
In any case, there must be a good understanding of the underlying reference products (including their variability) to agree on a reasonable equivalence concept.
A trend is ongoing in a switch from clinical endpoint studies to adequate comparative in vitro data (which may also be supported by further tests). There may be more restraint regarding clinical endpoint studies for topicals, Felkel said.
“Consequently, lab service providers offering in vitro tests such as IVRT and IVPT (and other tests, where applicable) will benefit from this trend, provided that they have sufficient experience and know-how in performing those tests,” he wrote.
3. Microbiome databases
Finally in the testing realm is microbiome testing. Microbiome data can help drug developers identify responders and what biological pathways are being changed. Yet, gut microbial metabolism is often neglected in the drug discovery and development process. There is growing interest in the potential exploitation of gut microbiomes as a diagnostic application in medicine.
Providers of microbiome databases include Sequential Bio, Bio-Me and Microba Life Sciences.
The global microbiome diagnostics market size, valued at $163 million in 2024, is forecasted to reach $678 million by 2035. A key goal of microbiome service providers is to work with CROs, noted Carla Brown, sales associate at Sequential Bio, noting past collaboration with service providers in Scotland and the U.K.
Sequential Bio announced in March that it had raised its first equity round, securing $3.5 million.
Lab service providers say demand is rising for nitrosamine and IVRT/IVPT testing, and microbiome data, as sponsors push to derisk safety and prove product performance earlier in development. The shift is elevating labs from routine testing vendors to regulatory‑savvy partners.
