Pharma delays push dual sourcing trend
- STADA supply-chain chief Rodrigo Alponti used a new Supply Chain Now episode to spell out a pharma reality: one delay can cascade globally, so resilience beats lean. - The hard numbers are getting uglier: USP says over 90% of U.S. shortages are persistent, average duration now tops four years, and 69% involve injectables. - Regulators now treat continuity as an operating duty, pushing drugmakers toward dual sourcing, earlier risk mapping, and less tolerance for single-country exposure.
Pharma supply chains are built for precision, but they break in ugly, nonlinear ways. One late ingredient, one quality deviation, one held shipment — and suddenly a hospital can’t get a sterile injectable half a world away. That’s why the interesting shift right now isn’t just more talk about resilience. It’s that drugmakers and regulators are starting to treat continuity of supply as a core requirement, not a nice extra, and that is pushing procurement toward dual sourcing, backup capacity, and more visibility across the chain. ### Why does one delay spread so far? A drug is not one factory making one thing. It is starting materials, APIs, excipients, stoppers, vials, packaging, testing, release, shipping, and regulatory signoff across multiple countries. Rodrigo Alponti, STADA’s SVP of global supply chain, framed the job around patient outcomes and resilience in a late-April Supply Chain Now episode, with AI showing up as a practical tool for planning and training rather than some futuristic add-on. The point is simple — when the chain is this interlocked, one missed step can freeze everything downstream. (podcasts.apple.com) ### Why is pharma more fragile than it looks? Because the visible supplier is often not the real chokepoint. USP’s April 2026 vulnerability update flagged 100 acute and chronic medicines at risk of disruption and said 48% had at least one key starting material made in only one country. That is the nasty version of concentration risk — you can think you have multiple manufacturers, but they may all depend on the same upstream input. If that input gets hit by export controls, a plant shutdown, or a regulatory action, the whole network fails at once. (podcasts.apple.com) ### What do the shortage numbers say? They say this is not a temporary hangover from the pandemic. USP’s 2025 annual shortages report said more than 90% of U.S. drug shortages are now persistent, and the average duration has climbed to more than four years. More than 40 medicines have been in shortage for over three years, and five have been in shortage for at least 10 years. That is not a blip. That is a structural supply problem. (fiercepharma.com) ### Why are injectables always in the middle of this? Because they are hard to make and often not very profitable. USP said 69% of shortages in its 2025 report involved sterile injectables, and its 2026 vulnerability list said 63% of at-risk medicines were injectables too. These products need complex sterile manufacturing, tight quality control, and expensive upkeep. But many are generics with thin margins, so the business case for redundant capacity has historically been weak. (biospace.com) ### Where do regulators come in? They are increasingly pushing companies to plan for continuity before a shortage happens. EMA’s guidance tells manufacturers and marketing authorization holders to maintain continuous supply, build shortage prevention and mitigation plans, optimize quality systems, and increase resilience in complex multinational supply chains. In the U.S., GAO’s April 2025 report argued drug shortages remain a serious public-health problem and tied them to weak incentives to invest in quality and supply resilience. (biospace.com) ### So why does dual sourcing keep coming up? Because single sourcing now looks cheap only until it fails. If one supplier slips, the cost is not just higher freight or a missed batch. It can mean a shortage notification, lost sales, emergency tech transfer, and patient harm. Dual sourcing does add complexity — more validation, more quality agreements, more coordination — but it buys optionality. In this environment, optionality is becoming the product. (ema.europa.eu) ### What changes inside procurement? Procurement stops optimizing only for unit cost and starts optimizing for survivability. Teams map upstream dependencies, look for single-country exposure in starting materials, qualify second suppliers earlier, and use AI tools to improve demand planning and scenario modeling. The old model rewarded lean concentration. The new one rewards controlled redundancy. (pharmtech.com) ### Bottom line? Pharma is relearning a blunt lesson — the cheapest supply chain is not the safest one. As shortages drag on, upstream bottlenecks stay hidden, and regulators demand continuity, dual sourcing is shifting from contingency plan to default design. (ema.europa.eu) (podcasts.apple.com)
