The Business of Biofabrication

The National Institutes of Health (NIH) has announced the creation of the nation’s first dedicated organoid development center, marking a pivotal step in reducing reliance on animal models for biomedical research. The new Standardized Organoid Modeling (SOM) Center, located at the Frederick National Laboratory for Cancer Research, will receive $87 million over the next three years to establish reproducible, human-relevant organoid systems for use in research, drug testing, and precision medicine.

Why Organoids, Why Now?

Organoids—miniaturized, stem cell–derived versions of human organs—have become a transformative tool in biomedical research. They offer insights into disease, drug safety, and organ function that are often more accurate than animal models. But their impact has been constrained by three persistent challenges:

• Reproducibility – labs often struggle to generate consistent results.
• Scalability – high costs and manual workflows limit widespread use.
• Regulatory acceptance – lack of standardized models slows adoption in drug pipelines.

The SOM Center was created to tackle these barriers directly, setting unified protocols and serving as a distribution hub for standardized organoid systems.

What the SOM Center Will Do

The NIH’s vision goes beyond research. The SOM Center is intended to be a national infrastructure that integrates robotics, automation, and artificial intelligence to make organoid culture reproducible and scalable. Its work will include:

• Developing standardized protocols for key tissues including liver, lung, heart, and intestine.
• Sharing open-access data, organoid lines, and reproducibility benchmarks with the broader community.
• Working with the Food and Drug Administration (FDA) to align protocols with regulatory requirements.

By embedding regulatory collaboration into its mission, the center may help organoid models gain faster approval for use in preclinical testing, reducing the “valley of death” between academic innovation and commercial adoption.

Implications for Biofabrication Businesses

For startups and established players in biofabrication, the NIH announcement represents a unique market signal. With the government underwriting reproducibility and standardization, companies can now build business models on top of validated infrastructure. Possible avenues include:

• Organoids-as-a-Service – supplying ready-made or custom organoids to pharma and biotech.
• Automation platforms – robotic bioreactors and microfluidic systems to scale production.
• Consumables and kits – reagents, scaffolds, and protocols standardized for broad use.
• Data analytics – platforms to interpret organoid-derived biological data.

While the center’s open-access nature may limit exclusivity, it creates a stronger ecosystem for companies to differentiate through customization, scale, or proprietary enhancements.

Looking Ahead

The NIH’s investment signals a broader shift in biomedical science: human-based organoid systems are no longer niche, but central to the future of research and clinical translation. Over the coming decade, organoids could expand from preclinical testing tools into platforms for personalized drug screening, regenerative medicine, and even transplantable tissue patches.

By anchoring the field with a national hub, NIH is accelerating this timeline, creating both a scientific foundation and a commercial springboard. For the biofabrication industry, the message is clear: the era of standardized, scalable organoids has arrived, and the opportunity to build on it is wide open.