By Dr. Sarah Wade, Business Development and Alliance Manager, January 2026.

Competition Has Increased. Reliability Has Not.

The oral solid dose (OSD) manufacturing market has become dramatically more competitive. More CDMO/CMO service providers have entered the space, bids are increasingly aggressive, and pricing pressure now touches nearly every program. Yet despite this expanding supplier landscape, one critical outcome has remained unchanged.

A review of the FDA drug shortage list shows movement at the product level, but almost none at the system level. Individual OSD products rotate on and off the list, but the total number of OSD shortages remains remarkably stable year after year. Between 2020 and 2025, the FDA reported 22-27 oral solid dose products in shortage annually, even after excluding products listed due to discontinuation.

This is not a capacity problem. It is a selection problem.

If a growing supplier base reliably improved supply security, shortages would be trending downward. They are not. The continued persistence of OSD shortages in a crowded market sends a clear message - expansion is not translating into reliability.

If CDMO/CMO selection consistently rewarded strong execution, strong regulatory performance, and proven long-term delivery, the market would see fewer shortages. It does not.

Price is undeniably a powerful lever for profitability. But choosing the lowest-priced supplier often comes with trade-offs - reduced service quality and increased supply risk. The FDA shortage data strongly suggests these trade-offs are real - and costly.

As a CDMO/CMO, the first question we are almost always asked is; “Can you match the lower price of competitor X?”

This question assumes all CMO/CDMOs are essentially interchangeable. Only once pricing is aligned do discussions shift to the factors that truly determine supply reliability - technical capability, regulatory history, commercial execution, and continuity of supply - but, by then, the preliminary decision is often already made. These become box-ticking exercises rather than meaningful differentiators.

If the industry wants fewer shortages, it must compete on the factors that truly sustain supply.

Demonstrated regulatory credibility

Proven execution at commercial scale

Transparent, partnership-driven operating models

A track record of keeping products off the shortage list

Price matters.

But price without performance is a direct path to ongoing shortages - and a risk the industry can no longer afford.