Trump Tariff Impact on the Single Use Assemblies

Hidden Costs. Operational Disruptions. It’s Time for a Tariff Strategy.

The proposed Trump reciprocal tariffs — potentially reaching up to 54% on imports — are placing increased pressure on biopharma supply chains. For companies operating in the single use assemblies (SUA) market, which is heavily reliant on international suppliers for key components, the ripple effects are significant. From soaring input costs and supplier disruptions to shifting regulatory hurdles, the industry must prepare for a fundamental supply chain rethink.

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US Tariff Impact on SUA Supply Chains and Cost Structures

• Heavy dependence on imported polymer components from Europe and Asia
• Tariffs on raw materials like silicone, polypropylene, and PVC increasing BoM costs
• Supply bottlenecks and port congestion driving up lead times and logistics spend
• More companies exploring onshore or dual sourcing strategies to de-risk operations
• Supplier contracts under pressure; margin forecasts under revision

Trump Tariff Impact on Biopharma Production and Flexibility

• Cost pressures forcing cutbacks in flexible manufacturing capacity
• Custom SUAs for cell & gene therapy becoming cost-prohibitive for smaller players
• Risk of delayed production schedules due to component requalification
• Shift toward standardized assemblies to simplify sourcing under tariff constraints
• Strained CapEx budgets and slowed facility commissioning timelines

US Tariff Impact Accelerating Domestic Manufacturing Push

• Increased interest in localizing SUA component manufacturing
• High setup costs, cleanroom requirements, and tech transfer timelines pose hurdles
• Limited domestic capacity for high-spec, validated single use components
• Reshoring strategies gaining attention — with an eye on federal incentives
• Need for regulatory-ready systems, quality validation, and compliance frameworks

Regulatory and Quality Implications of SUA Supply Chain Shifts

• Alternate suppliers triggering new documentation, validations, and filings
• Risk of non-compliance or production halts due to unapproved component changes
• Time-to-market delays from QA requalification bottlenecks
• Regulatory variation across regions creating friction in global operations
• Internal compliance teams burdened with growing documentation needs

Sectors and Companies Likely to Be Affected by US Tariff Impact

Biopharma Manufacturers
Companies with complex bioproduction lines (e.g., Amgen, Bristol Myers Squibb, Genentech) may face major sourcing and cost challenges.

SUA and Bioprocessing Suppliers
Firms like Sartorius, Thermo Fisher Scientific, Cytiva, and Merck KGaA may experience order reshuffling, customer risk reassessment, and new reshoring opportunities.

CDMOs and CMOs
Contract manufacturers reliant on customized SUA kits (e.g., Lonza, Catalent, Samsung Biologics) must adapt quickly or face service delays and cost overruns.

Emerging Biotechs and CGT Innovators
Startups and advanced therapy players face risks to product timelines and scalability due to tighter budgets and limited sourcing options.

Sterile Packaging and Tubing Providers
Adjacent markets such as sterile connectors, tubing, and film (e.g., AdvantaPure, Saint-Gobain, Entegris) may see supply volatility or demand spikes.

What You Can Do Now

We’ve developed a targeted solution to help companies in the SUA ecosystem rapidly assess:

• Where you’re exposed – across SKUs, suppliers, and manufacturing workflows
• What it’s costing you – including component markups, operational delays, and margin squeeze
• What to do next – from sourcing realignment and validation support to reclassification and tariff engineering

A brief overview of our “Tariff Threat Assessment” engagement is included — built to help you act fast, with clarity and control.

Conclusion: Responding to the Trump Tariff Impact on SUA

The SUA market is a critical enabler of modern biomanufacturing — but also highly exposed to global trade disruptions. Trump-era tariffs could reshape the competitive landscape, and businesses must adapt or risk falling behind. By acting now — with a clear strategy for supply chain risk, regulatory readiness, and cost resilience — you can ensure your operations remain agile, compliant, and profitable.

Get your Single Use Assemblies Trump Tariff Readiness Assessment

Related Reports:

Single Use Assemblies Market by Product (Bag (2D, 3D), Filtration, Bottle, Mixing, Tubing Assemblies), Solution (Customized, Standard), Modality (mAbs, Vaccines, CGT), Application (Filtration, Cell Culture, Storage, Transfer) - Global Forecasts to 2029

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