Cyber risk in pharmaceutical manufacturing is now a strategic, board-level issue affecting the entire organization. Leadership teams must recognize that drug supply stability relies not just on avoiding raw material disruptions, overseas sourcing, and quality failures, but also on defending manufacturing systems from rapidly growing and often hidden cyberattacks.
This risk now directly threatens supply stability.
In June 2025, the U.S. Food and Drug Administration (FDA) released a paper pointing out the need to embed cybersecurity in the advanced technologies used in medical product manufacturing. The FDA noted that manufacturing relies on a number of connected devices that were traditionally built for reliability rather than security.
Manufacturing Is Critical Infrastructure
The federal government classifies healthcare and public health as critical infrastructure. Agencies, including the U.S. Department of Health and Human Services and the Cybersecurity and Infrastructure Security Agency, have repeatedly warned that life sciences and pharmaceutical manufacturers are increasingly targeted by ransomware and nation-state actors.
These notes are important, as manufacturing is now the top target among the 16 critical infrastructure sectors identified by the U.S. government. On average, each manufacturer faces about 1,585 attempted cyberattacks per week, per reports from security vendors, and attacks on the sector have risen by 30 percent year over year (from 2025 data).
According to the FDA, commercially available manufacturing equipment “often does not meet national or international cybersecurity standards by default. This shortfall demands deliberate system design and configuration. Incorporating cybersecurity into standard industry practices, regardless of company size, will substantially lower risks to the U.S. medical product manufacturing sector and its supply chain.”
In its white paper, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, the FDA says a balance must be struck. It is important to create an operational environment that is easy to use and one that secures operations against as many threats as possible.
The scale of the threat environment is significant. Attackers understand that operational downtime puts pressure on operators to restore systems quickly. Adding to this complexity, pharmaceutical manufacturing environments are highly complex. Facilities rely on closely connected digital systems, such as:
- Manufacturing execution systems.
- Laboratory information management systems.
- Supervisory control and data acquisition platforms.
- Enterprise resource planning tools.
- Electronic quality management systems.
If attackers disrupt any of these systems, production can stall. Batch records may be inaccessible. Monitoring data may be unavailable. Release testing may freeze.
Pharmaceutical manufacturers cannot simply restart production after an incident. Every process must be validated, and every system change must be documented. If digital systems are compromised, manufacturers must fulfill compliance obligations before resuming operations.
When Cyber Becomes a Quality Event
OT cybersecurity starts by understanding the physical and digital setup of each production line and the larger enterprise infrastructure. Manufacturing equipment, sensors, plumbing, and electrical systems together form the operational environment. Digital technologies and controls connect to corporate networks, allowing remote monitoring and management of production.
Leaders across production environments clearly understanding these technologies and how they interact assures a secure OT environment. In regulated settings governed by Good Manufacturing Practice, sustaining high data quality across all systems is essential. If a cyberattack compromises audit trails, batch data, or laboratory results, manufacturers need to prove that product quality remains intact.
For manufacturers of high-volume sterile injectables or critical generics, even a single day of downtime can create supply gaps in the industry. There are few fail-safes. These products are made at limited sites, with exacting outcomes. When production stops, it resumes only after systems, validation, and quality checks are complete. Lost days can mean patient care outcomes are impacted. When a site goes offline unexpectedly, there is rarely surplus capacity to absorb the demand.
Let’s put this in perspective. The U.S. drug shortage problem remains persistent. The American Society of Health-System Pharmacists reported more than 300 active drug shortages in 2023, the highest level in nearly a decade. Many injectable medications are used in hospitals. These products often come from a limited number of manufacturing sites. The role manufacturing plays in the dance is vital to patient care.
Cyber Disruptions and Supply Shock
Recent incidents demonstrate how vulnerable the pharmaceutical supply can be to localized disruption. Manufacturing quality failures have previously triggered nationwide shortages. Generic drugs comprise more than 90 percent of the U.S. market (by volume). Perhaps even more concerning are the large concentrations of production of some medications in a single facility, particularly oncology medications.
In some cases, a single facility may be both the dominant producer of a given medication and the preferred alternative. For example, in 2023, manufacturing disruptions at a large sterile injectable facility, including those operated by Intas Pharmaceuticals and its U.S. subsidiary Accord Healthcare, contributed to severe oncology drug shortages after the U.S.
The Food and Drug Administration found that data integrity and quality system issues were the main concern in this event. Congressional scrutiny followed. However, any cyber incident in these critical environments can halt production, as well as degrade batch data quality, and disrupt validated quality systems – with the same operational impact as a traditional quality shutdown.
Manufacturers’ operational technology can create additional challenges, as many pharmaceutical facilities use legacy control systems that are not designed to address current cybersecurity threats. Patching or upgrading these systems may require formal change controls followed by validation, which means organizations face difficult trade-offs between swift security updates and validating system soundness.
Attackers know that highly regulated environments have low tolerance for downtime. This makes them enticing targets.
From IT Risk to Public Health Risk
In most industries, a cyberattack is a financial and reputational event. In pharmaceutical manufacturing, it can become a public health event. If production of an oncology injectable or critical antibiotic is interrupted, hospitals may need to ration supply, substitute alternative therapies, or delay treatment.
This risk is prompting regulators to focus more directly on resilience and protection against possible disruptions, and may require stronger cybersecurity efforts in critical manufacturing infrastructure. So, as digital integration expands across production and quality systems in these manufacturing environments, cybersecurity protection strategies are inseparable from quality governance.
Cyber resilience must become a core manufacturing performance metric, alongside uptime, yield, and deviation rates. To make progress, executive leaders can take several steps. These include:
- Establishing regular board-level reviews of cyber risk specific to manufacturing operations.
- Investing in the segmentation of operational technology environments to limit the probable impact of attacks.
- Requiring routine cyber incident response exercises involving multi-team groups.
Combined with mapping digital dependencies across production workflows, conducting cyber risk assessments specific to validated environments, and segmenting operational technology from enterprise networks, these steps help pharmaceutical manufacturers address and prepare for threats.
Additionally, drug manufacturers must engage, plan, and run incident response exercises customized to GMP facilities and develop responses for their facilities. Adopting recognized frameworks, such as the NIST Cybersecurity Framework or ISO/IEC 27001, can help benchmark security postures and align practices according to global standards.
Manufacturers should assume that intrusion will occur, as operating in this sector means attacks are almost guaranteed. The primary question is whether containment, recovery, and the regulatory response plans proactively prevent a cyber incident from developing into a supply crisis.
As such, executive inclusion is central in this process, and leadership teams must ensure that response plans are in place and regularly tested, updated, and reviewed. Active oversight plans are key for ensuring crisis prevention strategies stay robust and effective since cyber threats continue to evolve.
Drug shortages are complex and multifactorial. Raw materials, economic pressures, and quality obstacles will play a role. But as manufacturing environments become increasingly connected, cybersecurity is emerging as an important element in supply stability.
To help manufacturers direct their efforts and resources where they are most needed, a risk-based prioritization framework is vital. Leaders within these organizations should assess and rank cybersecurity risks, as well as possible supply chain threats such as raw material shortages and manufacturing quality issues.
By evaluating the relative likelihood and possible impact of each risk, manufacturers can distribute resources more effectively so cybersecurity challenges receive the attention they merit as an integral part of supply continuity. The next drug shortage may not start with a contaminated batch or a supplier delay, but with compromised credentials inside a manufacturer’s network.
