Industry Trends & Insights
A comprehensive overview of rising external-party, regulatory, and operational risks across industries, highlighting why automated assurance and response solutions are becoming essential.
Pharmaceutical Regulatory Delays
In October 2025, FDA placed a clinical hold on Intellia’s two gene-editing trials following a serious liver-related adverse event. Clinical holds disrupt development timelines and increase operational costs while sponsors work through required regulatory actions.
Intellia Therapeutics – FDA Clinical Hold (2025)
In March 2025, FDA paused BioNTech’s malaria vaccine trial (BNT165e), halting progress until regulatory concerns were resolved. Such pauses can delay trial milestones and impact long-term development strategy.
BioNTech – Malaria Vaccine Clinical Hold (2025)
In July 2025, FDA missed the required deadline to review Coya’s IND for an ALS therapy, delaying the start of a planned Phase II trial. Timeline disruptions increase costs and extend time to commercialization.
Coya Therapeutics – Missed IND Review Deadline (2025)
The FDA publicly released over 200 prior CRLs, highlighting recurring issues such as manufacturing (CMC) deficiencies and insufficient regulatory responses. These patterns reflect rising scrutiny and more rigorous regulatory expectations.
FDA Releases Over 200 Complete Response Letters (2020–2024 Data Released in 2025)
Major External-Party & Supply Chain Incidents
Companies across sectors face growing financial and operational risk due to vulnerabilities in suppliers, cloud platforms, and outsourced service providers.
Cloud platform vulnerabilities resulted in unauthorized data exposure. Estimated remediation costs ranged from $10M to $40M across affected organizations.
Salesforce Cloud Exposure
A third‑party IT supplier outage disrupted Renault operations. Estimated losses exceeded $20M per day during downtime.
Renault Supplier Cyberattack
Exploited vulnerabilities forced organizations to initiate emergency patching and incident response efforts costing $1.5M to $7M each.
Ivanti Endpoint Management Vulnerabilities
Improperly configured cloud environments led to sensitive data exposure with remediation costs averaging $3M to $15M.
AWS Misconfiguration Exploits
A ransomware attack propagated through a contracted IT provider caused retail outages costing an estimated $8M to $12M.
Co‑Op Ransomware via Outsourced IT Provider
Cross-Industry Risk Trends
Broader analytics show systemic vulnerabilities across industries, particularly among organizations dependent on complex external ecosystems.
Regulatory and Compliance Pressures
Broader analytics show systemic vulnerabilities across industries, particularly among organizations dependent on complex external ecosystems.
Over 50% of breaches now originate from third parties.
Due diligence questionnaire volume is increasing 35–60% annually.
Regulatory bodies are increasing oversight of high‑risk external entities.
Delayed or incomplete regulatory responses can halt clinical programs or delay product releases.
Why These Trends Matter
Organizations need faster, more accurate, and more defensible methods for responding to regulatory queries, customer assurance questionnaires, risk assessments, and operational due‑diligence requests.
The landscape is shifting, and efficient response workflows are becoming a critical part of maintaining compliance, protecting revenue, and reducing operational risk.
