Four Considerations to Safeguard Your Clinical Trial Supply
1. How New Tariffs Pose Immediate Risk
25% tariffs on pharmaceutical imports from China, India, and Ireland are now expected to take effect in the coming months (Politico, 2025).
- China and India produce about 80% of APIs for U.S. drugs (U.S. FDA, 2022)
- Ireland remains the second-largest pharmaceutical exporter to the U.S. (U.S. Census Bureau, 2023)
- In response, pharma imports into the U.S. surged in March 2025, with drugmakers accelerating procurement to get ahead of rising costs (Reuters, 2025)
Impact: Expect higher acquisition costs, unpredictable sourcing, and tighter supply chains for commercial and comparator drugs. These changes could disproportionately affect generic drug manufacturers, further worsening current drug shortages.
2. Supply Disruptions Create a Chain Reaction
Even a small sourcing issue can ripple across your entire study:
- First Patient In (FPI) delays
- Increased patient dropout rates (CenterWatch, 2022)
- Higher protocol deviations, driving costs up by 10–15% per patient (Tufts CSDD, 2023)
As of April 2025, there are over 270 active drug shortages in the U.S. (ASHP, 2025), many of which began more than two years ago.
Impact: Missed endpoints, operational budget overruns, and regulatory setbacks.