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Report

The New Operating Model for Life Sciences Manufacturing

Moving from Compliance to Continuous Readiness

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Life sciences manufacturers face growing regulatory expectations around cybersecurity, data integrity, digital records, AI governance, and continuous quality oversight, making transparency, traceability, and control more important than ever. At the same time, these capabilities are becoming critical business enablers, with industry leaders investing in digital transformation to strengthen quality, improve operational performance and navigate an increasingly complex business environment.

Complexity escalates with challenges such as overcoming legacy equipment and data silos, adapting to shifting global supply chains shaped by dynamic demand and trade policies, supporting a broader range of production models from single-patient precision medicines to high-volume therapies such as GLP-1s, and responding to the growing adoption of connected and personalized medical technologies. These trends, alongside capacity expansion and new production facility investments, are increasing the need for more connected, resilient and scalable manufacturing operations.

This report examines the forces shaping this transition. Combining insights from Rockwell Automation's State of Smart Manufacturing research with the broader trends influencing the life sciences sector, it explores how manufacturers are preparing for a future where digital maturity, cyber resilience and AI readiness are becoming essential components of long-term success.

Progress Is Real, But Barriers to Readiness Remain

Connectivity Brings Complexity

As digital transformation continues, cybersecurity must be embedded into operational strategies, technology decisions and risk management programs

Data Is Growing Fast

Without a connected data foundation, efforts to support AI, improve decision-making and increase operational visibility become more difficult to sustain.

Technology Alone Is Not Enough

Successful transformation requires a foundation built on trusted data, clear governance and operational alignment.

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Where do life sciences manufacturers stand today?

According to the life sciences organizations surveyed

90%

believe digital transformation is necessary

58%

already deployed smart manufacturing technologies

64%

plan to expand AI and machine learning usage over the next 12 months

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BUILD A DIGITAL FOUNDATION REQUIRED FOR CONTINUOUS READINESS

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As manufacturers evaluate where technology can deliver the greatest business impact, priorities are increasingly focused on capabilities that improve operational performance while supporting long-term readiness.

Learn the technology investments expected to have the greatest impact by downloading the report.

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Use this data to strengthen your digital readiness, prioritize investments, and improve operational performance. Our experts are here to help.