INDUSTRY FACT FILE · PHARMACEUTICALS & LIFE SCIENCES

Threat Landscape: Top Cyber Threats Facing Pharma and Life Sciences

The 18 most relevant cyber threats, attacks and industry challenges for drug manufacturers, biotech firms, CROs, laboratories and CDMOs.

Pharma faces three kinds of attacker: criminals seeking ransom by stopping plants, state-backed and competitive actors seeking research IP, and insiders taking formulations when they leave. Weak IT/OT boundaries and legacy lab systems add data integrity risk that regulators inspect.

Widely reported incidents—the 2017 NotPetya disruption of a major global drugmaker, a 2020 cyberattack on a leading Indian pharmaceutical company and pandemic-era advisories on state-backed targeting of vaccine research—show the scale of impact.

The list below is a practical assessment framework, not a statistical ranking. Priority varies by business model, technology exposure and existing controls.

The matrix is a qualitative guide for prioritising the first round of security reviews.

Figure 5: Qualitative threat relevance by pharma segment (Codec Networks assessment).

4.1 Ransomware and plant disruption

Dual-homed engineering workstations, shared credentials and flat networks let ransomware spread from IT into MES and SCADA, stopping production and batch release.

• Questions to test: Is there an IT/OT DMZ? Are dual-homed systems eliminated? Are OT assets inventoried and monitored? Are MES and batch records backed up offline?
• Relevant services: OT assessment and segmentation, OT monitoring, backup testing, OT incident exercises.

4.2 IP theft and insiders

Research data and process knowledge are valuable to competitors and state actors. Departing scientists and targeted phishing are common routes.

• Questions to test: Is research data classified? Are exports, uploads and USB use monitored? Are leavers' activities reviewed?
• Relevant services: IP protection programme, DLP, UEBA, forensic investigations.

4.3 Data integrity

Shared logins, disabled audit trails and unreviewed changes in LIMS and chromatography systems are both security weaknesses and inspection findings.

• Questions to test: Does every user have a unique account? Are audit trails enabled and reviewed? Are configurations controlled?
• Relevant services: computerised system and data integrity assessments, access reviews.

4.4 Clinical data and CROs

Trial data moves between sponsors, CROs and sites through EDC, CTMS and exports. Laptops, shared drives and weak CRO controls expose participant data.

• Questions to test: Does data stay in validated systems? Are endpoints encrypted? Do sponsors assess CRO security?
• Relevant services: clinical platform testing, CRO assessments, privacy programme.

4.5 Detection and the 6-hour clock

CERT-In requires reporting within six hours of noticing an incident. OT and lab environments are often unmonitored.

• Questions to test: Are IT and OT monitored 24x7? Is there a playbook covering production, quality and regulatory notifications?
• Relevant services: managed SOC for IT and OT, playbooks, tabletop exercises.

• CERT-In: incidents reported within six hours of noticing them.
• Drug regulators: incidents affecting quality data or batch records may need assessment under GMP and may be examined in inspections by CDSCO or export-market regulators.
• Clinical trials: incidents affecting trial data may require notification to sponsors and ethics committees.
• Privacy: personal data breaches must be intimated to the Data Protection Board once DPDP breach provisions commence in May 2027.
• Partners: sponsors, clients and licensors may audit after incidents.

• Could ransomware on an office PC reach our MES or SCADA?
• Are any systems connected to both IT and OT networks?
• Does every lab user have a unique account with audit trails enabled and reviewed?
• Would we detect a scientist copying research files before leaving?
• How do we assess the security of our CROs and CDMOs?
• Could we report an incident to CERT-In within six hours while protecting production?

Note: Threat descriptions and relevance ratings are general guidance, not findings about any specific organisation. Public incident references are summarised from widely reported events.