Opinion: Biopharma Must Cope With the Fetal Bovine Serum Squeeze

Biopharma is running into a structural squeeze: policymakers want lower drug prices, while key inputs are getting scarcer, slower and more expensive. Fetal bovine serum (FBS) is one of those inputs, with tighter availability than in the past and release timelines stretching from weeks to months.

FBS is a nutrient-rich component collected from bovine fetuses that is used to cultivate and sustain cells across research and manufacturing. It supplies the growth factors and proteins that most cell lines depend on for viability and productivity. Some programs have explored potential substitutes, but each requires validation work and can behave differently in culture, making FBS difficult to replace once drug development is underway.

As executive director and co-founder of SeraPrime, I work with manufacturers and biopharma teams globally to supply FBS and other reagents. Here’s what we’re seeing, and what companies can do to adapt to the tight FBS market.

The pressure begins with capacity. The U.S. cattle base is lean, which limits the raw material available for domestic fetal bovine serum. The USDA’s midyear count reports 94.2 million head of cattle in the country as of July 1, 2025, the lowest July inventory on record. As the cattle base shrinks, the downstream effect magnifies.

Summer disease outbreaks in Europe added friction to that tight base. For example, in June 2025 France confirmed a case of lumpy skin disease, a highly infectious cattle disease, prompting culls of affected herds and exports restrictions on cattle and bovine products.

Even when exports are allowed, the USDA prohibits the import of bovine products with known disease outbreaks. Due to outbreaks in France and elsewhere, buyers re-routed orders to origins still eligible under animal-health import rules, driving increased interest in U.S.-approved supply and further tightening markets.

Demand has continued to rise as supply limits harden. Cell, gene and RNA therapy pipelines are growing, and many biologics and multi-site studies keep FBS to preserve comparability with earlier data and parallel sites. Moreover, once a program enters Phase II, the manufacturing process becomes locked to support consistent clinical material and regulatory comparability, and FBS is often part of the original process used in early development.

Time has become a constraint of its own. Imported FBS is released only after required safety testing at the National Veterinary Services Laboratories (NVSL), and the Animal and Plant Health Inspection Service (APHIS) has warned stakeholders about delays in that queue. During the recent government shutdown, those timelines lengthened further as staffing and throughput at NVSL temporarily declined. Although the shutdown is now over, its effects illustrate how even brief funding lapses can slow biologics testing and delay serum release across the supply chain. Sponsors are experiencing purchase-to-release gaps measured in months rather than weeks.

This combination of factors have driven fetal bovine serum prices up sharply in the U.S., with industry reports indicating increases of more than 300% over the past five years. Market analysts now value the global FBS sector at about $1 billion in 2025, projected to reach $1.3 billion by 2029, driven by expanding biopharma pipelines and constrained raw-material supply.

In 2025, a new layer of uncertainty arrived: U.S. “reciprocal” tariffs. While no additional duties have technically been applied yet, these measures are under quarterly review. The possibility of higher country-specific tariffs at entry has already prompted biopharma manufacturers and procurement teams to budget for increased costs. Thus, even without a formal duty, that expectation trickles down into end-product pricing.

As compounding pressures raise serum prices, those higher prices in turn lift the direct cost of each batch of therapy. Longer APHIS release adds carrying costs and idle time to the run. When shipments stall or new lots take months to clear testing, some teams turn to last-minute spot buys—short-term purchases made outside contracted allocations, often at a premium because suppliers reserve limited stock for urgent demand. Alternatively, companies can stockpile FBS to avoid those gaps, but this ties up cash and storage capacity, creating a different form of cost pressure. Late-stage switches to cheaper substitutes trigger comparability work and regulatory reviews that add both time and spend.

None of these outcomes help the policy goal of lower drug prices.

Across our network, the outlook is consistent: expect three to four more years of tightness. That doesn’t mean perpetual crisis; it does mean a higher baseline price, periodic spot scarcity and elongated release timelines when animal-health events or trade safeguards flare.

Fortunately, there are better ways for companies to alleviate the effects of the right FBS market.

For starters, companies should keep specs flexible. Where science and regulation allow, define acceptance criteria by safety testing and performance of FBS batches, not a single country of origin, so that more than one origin can qualify without compromising standards. Relatedly, standardize protocols before Phase II to avoid costly comparability or protocol changes later.

Drug developers could also diversify their FBS supply sources. Two or more origins and suppliers beat last-minute spot buys every time. In the same vein, plan buffers and longer lead times. Treat import-release as a four-to-five-month element in today’s market; size inventory and budgets accordingly, and sync with freight realities.

Finally, be sure to educate new procurement owners. FBS behaves like a constrained reagent, not a commodity SKU. Unlike standard materials that can be reordered at will, constrained reagents move on limited production and testing schedules. Treating FBS this way helps finance departments plan for longer lead times and carrying costs, align testing windows and process development build schedules that match availability.

Proactive governance, flexible specifications, redundant qualification and realistic clocks reduce risk more reliably than any single substitution. In my opinion, that’s how teams keep science moving while protecting downstream value for patients.