In 2025, delays in small molecule CDMO projects remain a persistent challenge—with 63% of programs failing to meet original timelines. Two recurring culprits stand out: raw material sourcing issues and evolving regulatory demands.
1. Supply Chain Instability
Global disruptions continue to affect the availability of key intermediates and specialty reagents. Many CDMOs rely on limited suppliers, often overseas, making them vulnerable to geopolitical tensions, quality deviations, and shipping delays.
2. Increased Scrutiny on Starting Materials
Regulators are paying closer attention to the traceability and compliance of raw materials. Unexpected audits or the need to requalify suppliers can halt progress, particularly in Phase II/III programs.
3. Shifting Regulatory Guidelines
Agencies like the FDA and EMA are tightening expectations around impurity profiling, genotoxicity, and process validation. Even well-planned CDMO strategies often require rework to align with updated requirements.
4. Poor Forecasting and Communication
CDMO delays are sometimes exacerbated by clients underestimating the lead times for documentation, stability studies, and regulatory review. Misalignment between sponsors and CDMOs adds friction to already strained timelines.
Conclusion
Delays in small molecule development aren't just operational—they're often systemic. Addressing raw material risks and regulatory agility early in the CDMO partnership is now essential to avoid costly project setbacks.
