Precision Fermentation Inches Into US Drug Manufacturing

Drugmakers are testing precision fermentation for select ingredients, drawn by cost pressure, supply risks, and the promise of tighter control

17 Dec 2025

A measured but meaningful shift is taking place inside US pharmaceutical manufacturing plants. Precision fermentation, long a laboratory tool, is beginning to influence how certain drug ingredients are made. The change is real, but modest. 

The forces behind it are familiar. Drugmakers are squeezed by rising costs, fragile supply chains, and growing demand for complex biologics. Precision fermentation offers a different route. Instead of relying on chemical synthesis or imported inputs, companies program microbes to produce specific ingredients. In theory, that can reduce waste, shorten timelines, and bring parts of production closer to home.

So far, the technology is being used selectively. It is not replacing conventional manufacturing. Companies are experimenting through pilot projects and partnerships, targeting molecules where fermentation has a clear advantage. The approach is cautious by design.

One collaboration drawing close attention brings together Ginkgo Bioworks and the US Pharmacopeia, with support from the Advanced Research Projects Agency for Health. Their goal is to develop standards and tools for engineered microbes used in drug production. That work may sound technical, but it is critical. Clear rules around quality and safety are widely seen as a prerequisite for broader adoption.

Contract manufacturers are also placing measured bets. Lonza and others have expanded their microbial and biologics capabilities, responding to client demand for more flexible, data-driven production. These investments do not signal a sweeping shift. They suggest growing confidence that fermentation-based methods can work for the right applications.

“These technologies are changing how companies think about fermentation economics,” said one biomanufacturing analyst. “But most use cases are still early or narrowly defined.”

Beyond efficiency, there is a strategic angle. Precision fermentation fits neatly with efforts to strengthen domestic drug supply chains, especially for ingredients now sourced overseas. Faster development cycles could eventually offer a competitive edge as processes mature.

The hurdles remain significant. Microbial engineering requires scarce expertise. Regulatory pathways are still taking shape. Capital costs are high, and many ingredients simply cannot be made this way.

For now, precision fermentation looks less like a revolution than a new pillar under construction. As federally backed projects move forward and standards solidify, its role in US drug manufacturing is likely to grow, carefully and selectively.