Zero Trust Assessment for Pharmaceutical and BioTech Companies: A Practical Implementation Guide

If you're a CISO or security leader at a pharmaceutical or BioTech company, you already know the game has changed. The days of relying on firewalls and hoping for the best are over. Between the manufacturing facilities churning out critical medications, research labs protecting billions in drug development investments, and clinical systems holding sensitive patient data, the attack surface has exploded. Add in the reality that a single breach could literally cost lives—not just dollars—and it's clear why Zero Trust isn't just another buzzword anymore. It's become the only viable path forward for protecting what matters most in pharmaceutical environments.

This Zero Trust assessment guide specifically addresses the unique challenges pharmaceutical companies face when securing complex environments spanning offices, laboratories, and manufacturing facilities. For CISOs and Security Architects overseeing environments with thousands of devices, the question isn't whether to implement Zero Trust, but how to conduct an effective Zero Trust assessment and chart a path forward. This guide provides a practical framework for evaluating your pharmaceutical organization's Zero Trust maturity, with a specific focus on microsegmentation as the foundational capability that enables this transformation.

The stakes couldn't be higher. Recent ransomware attacks on pharmaceutical companies have disrupted production lines and delayed critical drug deliveries. A cyber incident in this sector doesn't just mean financial losses—it can directly impact patient lives. Yet many organizations struggle with where to begin their Zero Trust journey, particularly when dealing with the unique challenges of converged IT/OT environments, legacy lab equipment, and stringent regulatory requirements.

Understanding Zero Trust: Evolution and Imperatives

The Journey to Zero Trust

Zero Trust's evolution reflects the changing threat landscape and the dissolution of traditional network perimeters. The journey began with the Jericho Forum's de-perimeterization concept in 2004, gained momentum with Google's BeyondCorp implementation in 2014, and reached formal definition with NIST Special Publication 800-207 in 2020. The Federal Zero Trust Strategy in 2021 marked the transition from concept to mandate, establishing Zero Trust as the standard for modern cybersecurity architecture.

According to NIST SP 800-207, Zero Trust represents "a collection of concepts and ideas designed to minimize uncertainty in enforcing accurate, least privilege per-request access decisions in information systems and services in the face of a network viewed as compromised." This fundamental shift from implicit trust based on network location to continuous verification regardless of position has profound implications for how pharmaceutical companies must approach security.

Government and Regulatory Push

The regulatory landscape has accelerated Zero Trust adoption across the life sciences sector. Executive Order 14028 on Improving the Nation's Cybersecurity mandated federal agencies adopt Zero Trust principles, setting the tone for broader industry adoption. The Department of Defense Zero Trust Reference Architecture provides detailed implementation guidance that many private sector organizations now follow.

CISA's Zero Trust Maturity Model, evolving from version 1.0 in 2021 to the current version 2.0 in 2023, offers a practical roadmap for implementation. This model defines five core pillars—Identity, Devices, Networks, Applications & Workloads, and Data—supported by three cross-cutting capabilities: Visibility & Analytics, Automation & Orchestration, and Governance. Organizations progress through four maturity stages: Traditional, Initial, Advanced, and Optimal, with each stage requiring greater levels of protection and sophistication.

The regulatory imperative extends beyond general cybersecurity frameworks. PCI DSS 4.0 now explicitly requires network segmentation for cardholder data environments. The proposed HIPAA Security Rule updates for 2025 emphasize enhanced access controls and continuous monitoring—core Zero Trust principles. FDA's recent cybersecurity guidance for medical device manufacturers calls for "network segregation" and "layered defensive posture" in manufacturing environments, directly aligning with Zero Trust architecture.

Perhaps most significantly, the momentum is undeniable: research shows that 86.5% of organizations have started implementing at least one Zero Trust pillar, reflecting the transition from theoretical framework to operational necessity.

Why Microsegmentation Matters in Biotech & Pharma

Unique Environmental Challenges

Pharmaceutical environments present distinctive security challenges that make microsegmentation not just beneficial but essential. Unlike typical corporate networks, these environments feature an extraordinary diversity of devices and systems. A single pharmaceutical manufacturing site can contain thousands of connected devices spanning traditional IT infrastructure, specialized laboratory equipment, industrial control systems, and IoT sensors. Industry projections indicate that OT/IoT device footprints in these environments are typically 5× larger than traditional IT devices.

The prevalence of flat, legacy networks in laboratories and manufacturing facilities creates expansive attack surfaces. Many of these environments evolved organically over decades, with new systems layered onto existing infrastructure without comprehensive security architecture. Lab equipment running specialized software, SCADA systems controlling production processes, and clinical trial endpoints collecting patient data often share network segments with minimal isolation.

High-value intellectual property compounds the risk. Drug formulations, clinical trial data, and manufacturing processes represent billions in research investment and competitive advantage. The convergence of IT and OT networks, while enabling operational efficiency and data analytics, also creates pathways for threats to move between previously isolated systems.

Microsegmentation as a Zero Trust Enabler

Conducting a comprehensive Zero Trust assessment in pharmaceutical environments reveals that microsegmentation addresses the sector's most pressing security challenges. Unlike generic security assessments, a pharmaceutical-focused Zero Trust assessment must account for GxP systems, validated environments, and the critical nature of production systems.

Network segmentation and its evolution into microsegmentation serve as the foundational control for Zero Trust implementation. CISA's Zero Trust Maturity Model explicitly identifies granular network segmentation as a requirement for achieving Advanced and Optimal maturity levels. NIST frameworks emphasize that preventing lateral movement—the primary benefit of microsegmentation—is core to Zero Trust architecture.

Modern microsegmentation enables granular policy enforcement at multiple levels: application-to-application, user-to-application, and workload-to-workload communications. This granularity is essential in pharmaceutical environments where a single compromised device could potentially access critical systems across the enterprise. By implementing identity-based policies rather than relying on network constructs like VLANs or IP addresses, organizations can create dynamic security boundaries that adapt to changing environments.

The technology directly supports regulatory compliance requirements for data isolation, operational safety, and intellectual property protection. Whether protecting patient data under HIPAA, securing manufacturing processes per FDA guidelines, or isolating payment systems for PCI compliance, microsegmentation provides the technical controls to meet these diverse requirements through a unified approach.

The CISA Zero Trust Maturity Model: Core Pillars and How to Assess Readiness

Understanding the Five Pillars

The CISA Zero Trust Maturity Model provides a structured framework for assessment across five interconnected pillars. Each pillar represents a critical domain where organizations must evolve from traditional, perimeter-based approaches to dynamic, risk-based controls. Understanding how these pillars work together is essential for comprehensive Zero Trust implementation.

Identity forms the foundation, requiring organizations to move from simple password-based authentication to continuous verification with risk-based multi-factor authentication. In pharmaceutical environments, this includes not just employees but also contractors, research partners, and automated systems accessing critical resources.

Devices encompasses all endpoints connecting to the network—from traditional workstations to specialized lab equipment and IoT sensors. The challenge lies in gaining visibility and applying consistent security policies across managed and unmanaged devices that may not support traditional security agents.

Networks focuses on segmentation and secure communication, moving from flat networks with implicit trust to granular, identity-based access controls. This pillar is where microsegmentation plays its most critical role.

Applications & Workloads addresses how software and services are accessed and protected, requiring a shift from network-based security to application-aware controls that follow workloads across on-premises and cloud environments.

Data represents the ultimate asset requiring protection, necessitating classification, encryption, and access controls that persist regardless of where data resides or travels.

Zero Trust Assessment Framework for Pharmaceutical Organizations

To effectively evaluate your organization's Zero Trust readiness, consider these assessment questions for each pillar:

1. Identity Assessment:
   • Are all user identities centrally managed and subject to continuous verification?
   • Is risk-based multi-factor authentication implemented for all critical system access?
   • Do you have processes for rapid de-provisioning when users change roles or leave?
   • Can you correlate user behavior across systems to detect anomalies?
2. Device Assessment:
   • Do you maintain a complete, real-time inventory of all devices on your networks?
   • Are devices continuously assessed for compliance, vulnerabilities, and risk before granting access?
   • Can you enforce policies on unmanaged devices like lab equipment and IoT sensors?
   • Is device trust dynamically adjusted based on behavior and risk indicators?
3. Network Assessment:
   • Have you implemented microsegmentation beyond basic VLAN separation?
   • Can you enforce granular east-west traffic policies between workloads?
   • Are network policies based on identity rather than IP addresses?
   • Do you have visibility into all network communications, including OT environments?
4. Application & Workload Assessment:
   • Are applications accessed through secure, encrypted channels regardless of location?
   • Can you enforce least-privilege access at the application level?
   • Do workload protection policies follow applications across environments?
   • Is application behavior continuously monitored for anomalies?
5. Data Assessment:
   • Is sensitive data classified and tagged across all systems?
   • Are encryption and access controls applied consistently in transit and at rest?
   • Can you track and audit all access to critical data assets?
   • Do data protection policies extend to research partners and third parties?

Score each area as Traditional (0-25%), Initial (26-50%), Advanced (51-75%), or Optimal (76-100%) based on implementation completeness. This scoring aligns with CISA's maturity model and provides a baseline for improvement planning.

Zero Trust Assessment Tools for Pharmaceutical Environments

When conducting a Zero Trust assessment for pharmaceutical companies, specialized tools and frameworks can accelerate the process. Modern assessment platforms should evaluate not just technical controls but also regulatory alignment, operational impact, and validation requirements specific to life sciences environments. Look for assessment tools that can map current state to both CISA maturity levels and industry-specific frameworks like FDA cybersecurity guidance.

Conducting Your Zero Trust Assessment in Pharmaceutical Manufacturing

Comprehensive Evaluation Framework

Moving beyond basic maturity scoring, pharmaceutical organizations need a practical framework for assessing microsegmentation readiness that considers technical, operational, and organizational factors. This vendor-neutral approach helps identify gaps and prioritize investments for maximum security impact.

Architecture Readiness forms the foundation. Evaluate whether your current infrastructure can support segmentation without massive hardware refreshes. Modern microsegmentation solutions should leverage existing network switches and infrastructure rather than requiring wholesale replacements. Consider whether your environment can support identity-based policies that don't depend on rigid network constructs like VLANs.

Risk Identification requires mapping critical assets and communication flows. In pharmaceutical manufacturing environments, this means understanding not just IT systems but also how lab equipment communicates, which systems share data with manufacturing execution systems, and where sensitive research data flows. Identify current gaps in lateral movement controls and quantify the potential blast radius of a breach in different network segments.

Operating Model Alignment addresses the human and process elements. Successful microsegmentation requires coordination between security, IT, networking, and operational technology teams. Assess whether these teams share common goals, have established communication channels, and possess the skills needed for implementation and ongoing management. Consider how microsegmentation policies will be created, tested, and updated as the environment evolves.

Business Driver Alignment

Microsegmentation initiatives succeed when they align with core business drivers specific to pharmaceutical organizations. Frame your assessment around these critical needs:

Secure Collaboration with research partners and contract manufacturers requires granular access controls that traditional network security cannot provide. Microsegmentation enables partners to access only the specific resources they need, when they need it, without exposing broader network environments.

Intellectual Property Protection demands controls that prevent unauthorized access and data exfiltration. With microsegmentation, even if an attacker compromises a single system, they cannot move laterally to access drug formulations, clinical trial data, or manufacturing processes.

Operational Continuity in manufacturing environments requires security controls that don't disrupt production. Modern microsegmentation solutions provide protection without requiring downtime for policy changes or network reconfigurations, ensuring continuous operation of critical processes.

Building Toward an Optimal Zero Trust Architecture

Zero Trust Architecture Patterns

The Zero Trust assessment process for pharmaceutical companies must evaluate not just technical readiness but also the ability to maintain validated states while implementing new controls. Organizations like GSK and Andelyn Biosciences demonstrate that proper Zero Trust assessment and planning can accelerate implementation from years to weeks.

The evolution toward optimal Zero Trust architecture follows established patterns documented by NIST and implemented successfully in pharmaceutical environments. Understanding these patterns helps organizations chart their transformation journey.

Microsegmentation Architecture based on the DoD's SV-1 model creates secure zones with controlled communication paths. Unlike traditional network segmentation, modern microsegmentation is identity-driven, meaning policies follow users and devices regardless of network location. This approach has proven particularly effective in pharmaceutical manufacturing environments where devices frequently move between areas or new equipment is regularly added.

Software-Defined Perimeter (SDP) extends Zero Trust principles by making resources invisible until users and devices are authenticated and authorized. This "dark cloud" approach significantly reduces the attack surface by eliminating the concept of a network perimeter entirely. Resources only become accessible after establishing an encrypted micro-tunnel based on verified identity and device trust.

Dynamic Authorization and Policy Enforcement represents the optimal state where access decisions are made in real-time based on continuous risk assessment. Rather than static policies, the system adapts to changing conditions—automatically tightening controls when risk increases or streamlining access for verified, low-risk scenarios.

Implementation Progression

Organizations typically progress through three stages in their Zero Trust journey. The Traditional State features perimeter-based security with VLANs and firewalls providing coarse segmentation. The Hybrid State introduces identity-based controls and microsegmentation in critical areas while maintaining legacy systems. The Pure Zero Trust Architecture achieves dynamic, risk-based access control across all resources with no implicit trust.

For pharmaceutical environments, this progression must account for the reality of legacy systems that cannot be immediately replaced. Modern microsegmentation platforms like Elisity enable organizations to protect these systems without requiring wholesale infrastructure changes, allowing gradual evolution rather than disruptive transformation.

Regulatory Compliance as a Driver

Mapping Compliance Requirements

Regulatory compliance serves as both a driver and validator for Zero Trust implementation in life sciences. Understanding how microsegmentation maps to specific regulatory requirements helps justify investments and prioritize implementation phases.

HIPAA Security Rule 2025
proposed updates emphasize enhanced risk assessments, granular access controls, and comprehensive audit trails. Microsegmentation directly addresses these requirements by providing detailed visibility into all network communications, enforcing least-privilege access at the network level, and maintaining comprehensive logs of all access attempts. The ability to demonstrate that patient data is isolated from general network traffic becomes a powerful compliance tool.

FDA Cybersecurity Guidance
for medical device and pharmaceutical manufacturers explicitly calls for network segmentation to protect manufacturing systems. The guidance emphasizes the need for a "layered defensive posture" and specifically mentions isolating critical systems—requirements that microsegmentation fulfills more effectively than traditional approaches. Organizations can demonstrate compliance by showing how manufacturing networks are isolated from corporate IT while still enabling necessary data flows for production monitoring and quality systems.

PCI DSS 4.0
requirements for network segmentation have become more stringent, requiring organizations to validate segmentation effectiveness regularly. Microsegmentation platforms provide continuous validation through real-time traffic monitoring and policy enforcement, eliminating the guesswork from compliance audits. The ability to instantly demonstrate that payment processing systems are isolated from other network segments streamlines compliance efforts.

NERC CIP standards for critical infrastructure protection mandate electronic security perimeters and access controls for operational technology. Microsegmentation enables granular enforcement of these requirements without the operational overhead of managing hundreds of firewall rules or dealing with the limitations of VLAN-based segmentation.

Compliance as Business Enabler

Forward-thinking pharmaceutical organizations are discovering that robust microsegmentation doesn't just meet compliance requirements—it becomes a competitive advantage. GSK's Global CISO noted that their microsegmentation deployment has become a differentiator when working with partners and customers who seek assurance about data protection and operational security. Similarly,  Andelyn Biosciences reported that their comprehensive microsegmentation has become a selling point for clients entrusting valuable drug development projects to their facilities.

Final Recommendations for CISOs and Architects

Start with Measurement

Every Zero Trust assessment for pharmaceutical organizations should begin with a clear understanding of the unique constraints and opportunities in life sciences environments. Unlike other industries, pharmaceutical companies must balance security transformation with validated processes, regulatory compliance, and the critical nature of drug production.

The Zero Trust journey begins with a honest assessment. Use the CISA Zero Trust Maturity Model as your north star, but recognize that progress isn't linear across all pillars. Many successful organizations start by achieving Advanced maturity in Networks through microsegmentation, which provides immediate risk reduction while building the foundation for progress in other areas.

Focus initial efforts on gaining comprehensive visibility—you cannot protect what you cannot see. Modern microsegmentation platforms can discover and classify devices in days, providing the asset inventory essential for risk assessment and policy development. This visibility often reveals surprising insights about the true scope of the environment, particularly in terms of unmanaged OT and IoT devices.

Prioritize Based on Risk and Value

Network segmentation and identity modernization consistently deliver the highest return on security investment. The case studies from GSK and Andelyn Biosciences demonstrate that organizations can achieve meaningful risk reduction within weeks rather than the years required by traditional approaches. GSK reduced their projected costs from $200M to $50M—a 75% reduction—by choosing modern microsegmentation over traditional firewall-based approaches.

Start with critical environments where the combination of high-value assets and elevated risk justifies immediate action. For most pharmaceutical companies, this means manufacturing environments producing critical therapies and research labs housing valuable intellectual property. These "wins" build momentum and demonstrate value to stakeholders.

Build Cross-Functional Partnerships

Zero Trust transformation requires collaboration across traditionally siloed teams. Security, IT, networking, and operational technology teams must work together with shared goals and metrics. Successful implementations like those at GSK emphasize the importance of this collaboration, with security and networking teams co-developing solutions that meet both security requirements and operational needs.

Establish clear governance structures and communication channels early in the process. Regular stakeholder meetings, shared dashboards, and collaborative policy development processes ensure that microsegmentation enhances rather than hinders business operations.

Embrace the Journey Mindset

Zero Trust maturity is a journey, not a destination. Technology and threats continuously evolve, requiring ongoing adaptation and improvement. Organizations that view Zero Trust as a one-time project inevitably fall behind. Instead, build continuous improvement into your processes, regularly reassessing maturity and adjusting strategies based on emerging threats and business needs.

Resources and Tools

To support your Zero Trust assessment and implementation journey, leverage these authoritative resources:

• CISA Zero Trust Maturity Model v2.0
  : Provides the comprehensive framework for assessment and planning
• NIST SP 800-207
  : Offers detailed technical guidance on Zero Trust Architecture principles and implementation
• DoD Zero Trust Reference Architecture
  : Delivers implementation patterns proven in demanding environments
• Microsoft Zero Trust Adoption Framework
  : Presents practical guidance for cloud and hybrid environments
• Industry-Specific Resources: FDA cybersecurity guidance, ISPE GAMP guidelines, and sector-specific security frameworks

Organizations seeking to accelerate their microsegmentation journey should evaluate modern platforms that can deliver rapid implementation without infrastructure overhaul. The experiences of Andelyn Biosciences—achieving 2,700 enforced policies in 90 days—and GSK—reducing implementation time from years to weeks—demonstrate that with the right approach and technology, Zero Trust transformation is not only achievable but can be accomplished without disrupting critical operations.

What's Next?

The path to Zero Trust maturity in pharmaceutical companies requires careful assessment, strategic planning, and the right technology foundation. Microsegmentation emerges as the critical enabler, providing the granular control necessary to protect diverse environments while maintaining operational efficiency. By following this practical guide, CISOs and Security Architects can assess their readiness, prioritize investments, and chart a course toward comprehensive Zero Trust implementation that enhances both security and business value.

The time for action is now. With regulatory requirements tightening, cyber threats escalating, and the stakes measured in human lives, pharmaceutical organizations cannot afford to delay their Zero Trust transformation. Start with assessment, prioritize microsegmentation, and build the resilient security architecture that modern life sciences demand.

For those ready to take the next step in evaluating microsegmentation solutions, Elisity's comprehensive Buyer's Guide for Microsegmentation provides detailed evaluation criteria, implementation considerations, and a practical checklist to ensure you select the right platform for your pharmaceutical environment. The guide includes insights from security leaders at GSK and other pharmaceutical companies who have successfully navigated this transformation.