Securing Pharmaceuticals from OT Cyber Attacks

The pharmaceutical industry is facing an escalating threat from cyber attacks, particularly those targeting operational technology (OT) and industrial control systems (ICS). With critical operations and infrastructure reliant on these technologies, cyber threats pose a significant risk to production, regulatory compliance, and patient safety. As pharmaceutical companies embrace digital transformation, securing OT environments has become a top priority.

The Growing Threat of OT Cyber Attacks in Pharmaceuticals

Traditionally, pharmaceutical OT environments were isolated and operated via proprietary industrial protocols. However, with the convergence of IT and OT systems, they are now exposed to increasing cyber threats. Attackers recognize the high-value assets within pharmaceutical companies, such as intellectual property, sensitive patient data, and proprietary drug formulas, making them prime targets for ransomware and industrial malware.

According to the Dragos 2022 ICS/OT Cybersecurity Year in Review, ransomware attacks on industrial organizations, including pharmaceutical manufacturers, increased by 87%. This surge highlights the urgent need for robust cybersecurity measures tailored to OT environments.

Why Pharmaceutical OT Systems Are Vulnerable

Several factors contribute to the vulnerability of OT systems in the pharmaceutical industry:

• • Legacy Systems – Many OT environments still rely on outdated hardware and software with limited security mechanisms.

• • IT/OT Convergence – Increased connectivity between IT and OT networks exposes critical infrastructure to cyber threats.

• • Supply Chain Risks – Third-party vendors and suppliers introduce potential entry points for attackers.

• • Limited Visibility – Lack of centralized monitoring for OT assets leads to blind spots in security.

• • Weak Access Controls – Shared credentials and insufficient privileged access management (PAM) make systems easier to compromise.

Key Strategies for Securing OT in Pharmaceuticals

To mitigate these risks, pharmaceutical companies must adopt a defense-in-depth approach that includes preventive and responsive cybersecurity strategies.

1. Implement a Robust OT Cybersecurity Framework

A structured security framework, such as NIST CSF or ISA/IEC 62443, can guide organizations in securing OT environments. This includes risk assessments, incident response planning, and continuous monitoring.

2. Strengthen Network Segmentation

Network segmentation helps isolate OT systems from IT networks, reducing the risk of lateral movement by attackers. Implementing zero-trust policies and robust firewall rules enhances protection.

3. Continuous Vulnerability Assessment

Regular vulnerability assessments provide visibility into OT security gaps. Instead of relying solely on manual assessments, companies should leverage automated tools to monitor vulnerabilities in real-time.

4. Secure Remote Access & Third-Party Management

Ensuring secure remote access through multi-factor authentication (MFA) and VPNs minimizes exposure to cyber threats. Vendor security requirements and third-party audits should be a standard practice.

5. Advanced Threat Detection & Monitoring

Deploying security information and event management (SIEM) systems, intrusion detection, and threat intelligence solutions can help detect anomalies before they escalate into full-blown attacks.

6. OT-Specific Incident Response Planning

Incident response plans should be tailored for OT environments, with predefined protocols for isolating affected systems and ensuring minimal disruption to pharmaceutical production. Regular tabletop exercises (TTXs) help assess readiness.

7. Regulatory Compliance & Governance

Compliance with industry regulations, such as FDA CFR 21 Part 11 and other regional cybersecurity guidelines, ensures that OT security aligns with best practices. Regular audits and governance mechanisms enable business leaders to support cybersecurity initiatives.

Conclusion

The pharmaceutical industry must prioritize OT cybersecurity to protect against evolving cyber threats. With the rise of ransomware and ICS-specific malware, a proactive approach involving continuous monitoring, network segmentation, regulatory compliance, and incident response planning is essential. By implementing a strong OT security strategy, pharmaceutical companies can safeguard critical operations, ensure regulatory compliance, and maintain patient safety.