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Cyber risks in pharma: what’s at stake

Cybersecurity for pharmaceutical production

As pharma embraces AI, smart factories, and digital connectivity, cyber risks are escalating. Discover how to protect your IT/OT infrastructure, ensure patient safety, maintain product integrity, and stay compliant with GxP, FDA, EMA, and NIS2 regulations.

Cyber risks in pharma: what’s at stake

Cyberattacks cost the pharmaceutical industry an average of $5.06 million per breach – more than healthcare, energy, or finance. Ransomware attacks surged 30% in 2025, and nearly 20% of sensitive files in healthcare organizations are accessible to every employee.

Pharma is a prime target due to valuable IP, clinical trial data, and proprietary R&D. Third-party software, supply chain weaknesses, and interconnected systems remain key entry points — and even brief disruptions can halt production, cause drug shortages, or directly compromise patient safety.

Siemens Digital Industries addresses these risks with a field-proven cybersecurity concept based on IEC 62443 and a Defense-in-Depth approach – covering secure remote access, multi-vendor environments, IP protection, and compliance with NIS2 and the Cyber Resilience Act (CRA).

Ein bärtiger Mann mit Brille und persönlicher Schutzausrüstung – darunter blaue Handschuhe und Gesichtsmaske – inspiziert ein Objekt in einer pharmazeutischen Produktionsanlage.

Key benefits

Speed up engineering and commissioning

Accelerate automation projects with modular, web-based tools and digital workflows that shorten ramp-up times and ensure secure system configurations from the start.

Improve plant security and safety

Protect your operations with integrated access control, monitoring, and fire prevention, combined with built-in functional safety up to SIL 3.

Integrate IT and OT

Unify tools and platforms to enhance collaboration, visibility, and productivity, and reduce downtime through the horizontal and vertical integration of secure systems.

Choose a holistic approach

Achieve plant security

Take control of your cyber resilience with plant security. Tailored evaluations based on IEC 62443 standards and pharmaceutical industry best practices reveal system vulnerabilities and deliver expert-guided remediation roadmaps. Gain full transparency over your security posture, implement targeted cybersecurity measures, and benefit from 24/7 monitoring and managed services for end-to-end protection.

Minimize downtime by IT/OT Integration

Secure distributed pharmaceutical production with real-time OT threat detection that minimizes downtime. SIEM integration enables full visibility and rapid response. Maintain operations and product quality with IT/OT network segmentation and continuous perimeter protection against unauthorized access to industrial automation.

Ensure system integrity

Protect your automation systems and control components with secure communication, AI-powered vulnerability detection, and strict user and access management for OT environments. Stay ahead of threats with continuous patch and vulnerability management. Safeguard system integrity against malware, and ensure business continuity with a robust strategy for backups, disaster recovery, and crisis management.