AI + Digital Maturity in Contract Development and Manufacturing
Global survey of CDMOs reveals critical implementation barriers and opportunities in 2025-6
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The digital divide is widening. 60% of Contract Development and Manufacturing Organizations (CDMOs) operate at preliminary maturity levels even as 92% report sponsors are now raising digital requirements in negotiations.
The results of PharmaSource’s survey of 50+ global CDMOs, in partnership with MasterControl, exposes the brutal economics of digital transformation in regulated manufacturing.
Contract manufacturing organizations recognize digital value but face resource constraints, legacy infrastructure, and the unique complexity of digitizing environments where compliance failures carry existential risks.
Digital readiness is shifting from competitive advantage to market requirement.
We surveyed organizations across the spectrum—revenue sizes from under $1 million to over $1 billion, facilities spanning Europe, North America, and Asia.
The findings reveal a sector in transition: ambitious about AI’s potential yet realistic about implementation timelines, eager to satisfy sponsor demands yet constrained by fundamental operational challenges.
The data reveals sharp contrasts. Laggards grapple with century-old facilities, limited resources, and cost-prohibitive transformation requirements. Leaders achieve enterprise-level integration through strategic system connectivity and measured AI deployment.
Between these extremes lies the majority—CDMOs running pilots, exploring possibilities, and working to bridge the gap between digital aspiration and manufacturing reality.
5 Strategic Imperatives for AI and Digitization Success
Five priorities emerge for CDMO leaders:
1. Build the foundation before chasing AI
Only 27% of CDMOs have integrated electronic batch records; just 25% use manufacturing execution systems.
Organizations pursuing AI without core digital systems and data infrastructure in place are more likely to fail. Foundation first, innovation second.
2. Target implementation gaps with proven ROI
Supply chain forecasting and predictive maintenance show the widest disparity between perceived value and deployment—making them prime candidates for near term investment with demonstrable returns.
3. Fix processes before digitizing them
Leading CDMOs follow the principle: “Don’t digitalize the chaos.” Process optimization must precede technological implementation.
Digital tools amplify existing processes—broken or functional.
4. Solve the sponsor integration problem
Zero CDMOs report full digital integration with sponsors, yet 92% hear these requirements in negotiations. Early movers who crack sponsor connectivity will capture outsized value as expectations crystallize into contract terms.
5. Deploy resources with surgical precision.
Resource constraints remain the primary transformation barrier. Digitally mature competitors succeed through “start small, pilot, scale” methodology.
Broad investments diffuse impact; focused deployments generate momentum and ROI that fund expansion
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