地缘政治不确定性下外包药品检测的采购韧性策略

By Deepika Paliwal, Senior Analyst, Category Specialization, Pharma R&D, Beroe Inc.

Pharmaceutical testing — analytical, bioanalytical, microbiology, and stability testing — connects drug development, manufacturing, and regulatory submission. As pharmaceutical companies increasingly rely on global testing networks, geopolitical fragmentation is making testing continuity a strategic procurement priority. Supply-chain disruptions, trade restrictions, cyber risks, and evolving regulatory expectations can affect laboratory operations, sample integrity, testing inputs, and product-release timelines. A delayed assay or compromised sample quickly escalates from a laboratory delay into a regulatory roadblock and a patient-access risk.

In September 2026, the continuing U.S.-Israel-Iran conflict was disrupting traffic through the Strait of Hormuz, with attacks on tankers and continuing naval restrictions reported in the region.¹ For pharmaceutical companies, the testing relevance is direct: disruption to shipping and courier routes can affect temperature-controlled clinical samples, laboratory reagents, reference standards, and other testing inputs.

Trade policy adds another layer. A U.S. Section 232 proclamation imposes a 100% duty on specified patented pharmaceuticals and associated ingredients, effective July 31 for listed companies and September 29 for other companies, subject to specified lower rates and exemptions.² While the measure targets pharmaceutical imports rather than laboratory services, procurement teams must assess potential effects on the availability and cost of inputs supporting testing and manufacturing.

The strategic shift is therefore from laboratory efficiency toward testing continuity and resilience through supplier diversification, regional laboratory networks, digital traceability, and proactive risk management. Organizations that integrate resilience into procurement and supplier governance will be better positioned to ensure regulatory compliance, operational continuity, and uninterrupted patient access in an increasingly uncertain global environment.

Geopolitical Forces Reshaping Pharmaceutical Testing

Source: Beroe Analysis based on information available through various press releases.^1-4

Trade policy, war, and cybercrime are now hitting the same supply chains pharma testing depends on. Since the U.S. reimposed its Hormuz blockade on July 14, 2026, U.S. forces have redirected 109 commercial vessels (as of September 20).⁵ The International Maritime Organization (IMO) has verified 80 attacks on shipping in and around the strait since the conflict began in late February, with at least 22 seafarers killed.^6,7 Traffic has collapsed: on September 13, just 8 vessels transited the strait, against a pre-crisis baseline of 85 per day.⁸ Gulf-routed reagents and cold-chain shipments now compete with tanker convoys for space.

The Section 232 tariff is adding pressure: reference standards and outsourced assay work often ship under the same customs codes as the drugs they support, so a tariff that can double landed costs forces labs to renegotiate contracts or source locally.²

Cybersecurity is the third front. Healthcare breaches averaged $6.64 million in 2026, the costliest of any sector for the thirteenth consecutive year,^9,10 and the Novo Nordisk breach showed clinical-trial databases are now prime targets.³

Governments and regulators are responding. The EU's Critical Medicines Act (provisional agreement, May 12, 2026) mandates vulnerability assessments across 200+ substances and requires resilience criteria, not just lowest price, in public procurement of critical medicines.^{11, 12} In the U.S., the FDA's Precheck pilot is speeding up approval of new domestic API and finished-dose plants,¹³ backed by Section 232 tariffs of up to 100% on patented drugs and APIs from companies without onshoring plans.¹⁴ India is rebuilding active-ingredient capacity: under its bulk-drug PLI scheme, 18 APIs were in commercial production as of March 2026.¹⁵

Operational Impact Across Testing Disciplines

The pressures described above do not hit every part of pharmaceutical testing equally. How exposed each discipline is depends on three things: what it buys, how time-sensitive its materials are, and how easily a delayed or lost input can be replaced. Disciplines that rely on temperature-controlled samples or long-running scheduled studies have the least room to absorb disruption, because a missed window often cannot be recovered. Disciplines built on standard consumables have more alternatives but are still exposed to the tariff and freight costs discussed earlier. The table below summarizes the main spend areas, the operational impact, and the relative level of exposure for each discipline.

Decentralized clinical trials can provide additional flexibility by using local laboratories, local healthcare providers, and home-based sample collection. FDA guidance explicitly permits these decentralized elements, provided applicable clinical-laboratory and trial requirements are maintained.¹⁶ However, decentralization can also increase the number of custody handoffs and supplier interfaces that require oversight.

Procurement Priorities For Building Resilience

Managing these exposures requires more than reactive sourcing. Figure 3 sets out a six-step procurement resilience framework for pharmaceutical testing. It begins by mapping exposure across critical assays, suppliers, inputs, and routes, then qualifies alternative laboratories and logistics providers. Contracts are strengthened with capacity, tariff, and recovery clauses, supported by end-to-end digital visibility. Continuity plans are stress-tested against conflict, cyberattack, trade, and logistics shocks, with continuous monitoring closing the loop.

Putting the framework into practice means turning each step into concrete procurement actions. The priorities below focus on where testing continuity is most exposed: laboratory qualification, supplier depth, contract terms, digital visibility, and regulatory alignment. Acting on these before disruption occurs is cheaper than recovering lost samples, data, or timelines.

• Multi-region laboratory qualification should prioritize release-critical assays, stability programs, and high-value clinical testing. Backup laboratories should be assessed for method transfer, equipment compatibility, data standards, capacity, and regulatory acceptance before disruption occurs.
• Supplier diversification should extend beyond the primary laboratory or CRO to critical fourth parties supplying reagents, reference materials, specialist testing, and logistics. Geographic diversification provides limited protection if multiple suppliers depend on the same vulnerable route.
• Contract resilience should include disruption-specific force-majeure provisions, tariff pass-through mechanisms, alternative-routing obligations, capacity commitments, recovery timelines, and breach-notification requirements.
• Digital visibility should connect sample status, shipment location, temperature, customs clearance, laboratory capacity, and turnaround time. This allows procurement and clinical teams to intervene before delays affect an assay window or scheduled stability pull.

Regulatory resilience is also becoming more explicit. In 2026, EMA initiated vulnerability assessments for supply chains supporting critical medicines, reinforcing the broader shift toward structured supply-chain risk management.¹¹

Strategic Recommendations and Conclusion

Geopolitical events increasingly reach pharmaceutical testing through the infrastructure laboratories and clinical trials depend on, such as cross-border logistics, testing inputs, digital systems, and laboratory networks. Protecting testing continuity therefore requires deliberate, forward-looking procurement action rather than improvised, case-by-case sourcing. The following steps set out five strategic recommendations spanning network diversification, digital visibility, supplier governance, geopolitical monitoring, and predictive procurement, each designed to reduce concentration risk before disruption reaches the laboratory or clinic.

• Diversify testing and CRO networks across regions, with predefined transfer protocols for critical assays.
• Digitize sample and shipment visibility to monitor chain of custody, temperature, customs and turnaround.
• Strengthen supplier governance by assessing geopolitical exposure, fourth-party dependencies, cybersecurity and recovery capability.
• Integrate geopolitical monitoring into category management, tracking conflicts, sanctions, trade measures, shipping routes and regulatory changes.
• Build predictive procurement capabilities that trigger alternate laboratories, logistics routes or safety stock before disruption affects testing.

The current U.S.-Israel-Iran conflict highlights the importance of protecting sample movement and laboratory continuity, while trade measures and regulatory resilience initiatives reinforce the need to reduce concentration risk. Pharmaceutical testing should therefore be managed as a strategic resilience capability, embedded in procurement and supplier governance rather than treated solely as a quality or compliance activity.

References:

1. Aljazeera, "Aljazeera," 6 September 2026. [Online]. Available: https://www.aljazeera.com/news/2026/9/6/us-iran-engaged-in-tanker-war-where-is-the-months-long-conflict-headed. [Accessed 2026].
2. "The White House," 02 04 2026. [Online]. [Accessed 2026]. Available: https://www.whitehouse.gov/presidential-actions/2026/04/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states/
3. "Clinical Research News," Cambridge Healthtech Institute, 23 06 2026. [Online]. Available: https://www.clinicalresearchnewsonline.com/news/2026/06/23/novo-nordisk-clinical-trial-data-targeted-in-data-attack.
4. "Congress*gov," 07 08 2026. [Online]. Available: https://www.congress.gov/crs-product/R45281.
5. T. Tribune, "The Tribune," 21 09 2026. [Online]. Available: https://www.tribuneindia.com/news/usa-news/us-forces-redirect-109-commercial-vessels-near-strait-of-hormuz-to-enforce-blockade.
6. "Balitang Marino," 21 09 2026. [Online]. Available: https://www.balitangmarino.com/post/fresh-tanker-strikes-hit-strait-of-hormuz-as-seafarer-death-toll-rises.
7. "International Maritime Organization," [Online]. Available: https://www.imo.org/en/mediacentre/hottopics/pages/middle-east-strait-of-hormuz.aspx.
8. "Straits," 22 09 2026. [Online]. Available: https://straits.live/briefs/2026-09-22.
9. IBM, "Cost of a Data Breach Report 2026," IBM, 2026. Available: https://www.ibm.com/reports/data-breach
10. S. Alder, "Global Data Breach Cost Rises 12% to Almost $5 Million," The HIPAA Journal, 2026. Available: https://www.hipaajournal.com/2026-cost-data-breach-study-ibm/
11. "European Medicines Agency," 12 05 2026. [Online]. Available: https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-critical-medicines-act.
12. "European Council Council of the EU," 12 05 2026. [Online]. Available: https://www.consilium.europa.eu/en/press/press-releases/2026/05/12/critical-medicines-act-council-and-parliament-reach-provisional-deal/
13. "FDA," [Online]. Available: https://www.fda.gov/industry/fda-precheck-pilot-program.
14. S. Appezzato, "FAQ: Where US Pharma Reshoring Stands in 2026," Pharmaceutical Commerce, 2026. Available: https://www.pharmaceuticalcommerce.com/view/faq-where-us-pharma-reshoring-stands-in-2026
15. "Socil News XYZ," 06 09 2026. [Online]. Available: https://www.socialnews.xyz/2026/09/06/indian-pharma-sector-must-lead-in-research-and-development-new-molecules-biotech-piyush-goyal/#google_vignette.
16. FDA, Conducting Clinical Trials With Decentralized Elements, 2024. Available: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties

About The Author:

Deepika Paliwal is a senior analyst specializing in pharmaceutical research and development at Beroe, Inc. She has four years of experience in market intelligence, procurement strategy, and consulting. She specializes in clinical and preclinical research, supporting global pharma and biotech clients across analytical testing, biomarkers, and some clinical R&D categories, which include primary research, supplier landscaping, category strategy, sourcing optimization, and risk mitigation. Paliwal holds a master's degree in biotechnology from Delhi University and has experience at the National Institute of Biologicals and the Rajiv Gandhi Cancer Institute and Research Centre.