The $120M Bet That Human Organoids Will Replace Animal Testing

The morning after the FDA issued its most concrete blueprint yet for replacing animal studies with human-based testing methods, one of the world's largest life sciences suppliers is quietly operating the bet of the decade on exactly that transition.

MilliporeSigma — the U.S. and Canadian arm of Merck KGaA — completed its €104 million ($120 million) acquisition of HUB Organoids 14 months ago. In the time since, it has layered on partnerships with Promega for real-time assay readout, Opentrons for automated workstations, and imec for microphysiological systems. It has restructured its own business to put organoids front and center. And it has a chief technology officer who says, with the directness of someone who has been in the industry long enough to be blunt: 2D cell culture is not enough to predict what happens in humans.

"What we see, driven by our customers and the need in biology, is that the 2D cell culture is not enough to predict what actually happens in humans," Karen Madden, PhD, senior vice president and chief technology officer at MilliporeSigma, told GEN. "People have been wanting to move to more sophisticated models like 3D cell culture, and now ultimately organoids of different types, and ideally organoids that are derived from human tissue, because that's even more predictive."

The timing is not incidental. Wednesday's FDA draft guidance — laying out a framework for validating new approach methodologies (NAMs) for regulatory use — is the kind of policy signal that changes investment calculus inside companies like Merck KGaA. So is a milestone from last October: the FDA approved the first investigational new drug application supported entirely by human vascularized organoid-based combination studies, without traditional animal efficacy testing. The applicant was SillaJen, a South Korea-based oncolytic virus developer. The preclinical efficacy data came from a vascularized tumor immune microenvironment model (vTIME) built by Qureator.

HUB Organoids' origins are academic. The company — short for Hubrecht Organoid Technology — spun out in 2013 from the Hubrecht Institute, UMC Utrecht, and the Royal Netherlands Academy of Arts and Sciences. Its foundational asset is a patent portfolio covering organoid technology and services that include generating new models, developing assays, and high-throughput screening. CEO Robert Vries, in a video posted last year to mark the company's 10th anniversary, put it plainly: "We set out to develop the technology and we always said, we want to be the market leader in this organoid field."

Merck KGaA is funding that ambition at scale. At the start of this year, it broke up its former Science and Lab Solutions unit — a business that generated €8.98 billion ($10.36 billion) in revenue last year across its life sciences portfolio — into two units: Advanced Solutions and Discovery Solutions. HUB Organoids landed in Discovery Solutions. That business generated €2.829 billion ($3.26 billion) in sales last year, with organic growth ranging from -4% to +3% quarter-over-quarter. Q4 2025 took a hit from the U.S. federal government shutdown and funding uncertainty, the company told analysts in March.

The Promega partnership, announced in October, is specifically about solving the readout problem — how to extract meaningful signal from organoid models once you've grown them. MilliporeSigma brings organoids and synthetic chemistry; Promega brings cell-based assay technologies. The stated goal is co-developing assays capable of tracking cellular activity in real time using reporter systems embedded in organoids that mimic human biology.

"Promega is world-renowned for these very novel cell-based assay types that they have," Madden said. "We're partnering with them to provide a very intricate, very specific, very informative readout to these organoid models that we have, so that we can bring those joint solutions to our customers."

The Opentrons deal, signed early last year, is about throughput and reproducibility — automating assay kits on a custom Opentrons Flex workstation to reduce manual processing, increase consistency, and let customers "do more with less." The imec partnership, announced in May, is the most ambitious: integrating induced pluripotent stem cells and patient-derived organoids with a sensor-heavy hardware platform to create what Merck KGaA calls a "connected in vitro and in silico pipeline" for generating high-quality biological training data.

Whether the FDA's Wednesday guidance and the broader NAM push translates into durable revenue for organoid suppliers depends on a question the agency itself has not fully answered: how fast will sponsors actually move? The guidance is a framework, not a mandate. The first companies to file NAM-heavy INDs will set precedents. That creates opportunity for suppliers — and it also creates risk, if adoption is slower than the companies building for it expect. MilliporeSigma has made its bet. The FDA just gave it a more favorable wind.