Press release
Single-Use Assemblies Market to Reach USD 28.5 Billion by 2030
Single-Use Assemblies
Single-use assemblies are pre-sterilized, customizable, and ready-to-use systems that support bioprocessing workflows-including media prep, buffer formulation, filtration, sampling, mixing, and final fill-finish operations. Their rapid installation, low cross-contamination risk, and operational efficiency make them essential for biologics, vaccines, mAbs, viral vectors, and CGT manufacturing.
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Key Takeaways
• Market Size 2023: USD 10.4 billion
• Market Size 2030: USD 28.5 billion
• CAGR (2024-2030): 14.2%
• Primary Growth Drivers: Biologics boom, flexible manufacturing demand, reduced cleaning/validation needs, and strong adoption by CDMOs.
• Fastest Growing Segment: Filtration and mixing assemblies for cell & gene therapy production.
Market Story
The shift from stainless-steel to single-use bioprocessing platforms is reshaping global biotech manufacturing. Companies adopting single-use assemblies benefit from:
• Rapid production scale-up
• Lower contamination risks
• Dramatically reduced CIP/SIP requirements
• Faster changeover between batches
• Simplified regulatory compliance
• Greater flexibility in multi-product facilities
Their use spans all areas of bioprocessing: upstream, downstream, formulation, and aseptic filling.
Emerging therapeutic areas-such as mRNA vaccines, cell therapies, viral vectors, oncolytic viruses, and advanced biologics-rely heavily on pre-sterilized, customizable assemblies for sterile, high-efficiency workflows.
As CDMOs expand capacity and smaller biotech firms enter the biologics space, the demand for scalable single-use assemblies continues to surge.
Market Segments
By Type
• Filtration Assemblies (Largest Segment)
• Mixing Assemblies
• Sampling Assemblies
• Fill-Finish Assemblies
• Bioreactor & Transfer Assemblies
• Tangential Flow Filtration (TFF) Assemblies
• Custom Configured Assemblies
Filtration assemblies dominate due to their essential role in upstream & downstream bioprocessing.
By Application
• Upstream Processing
- Media and buffer preparation
- Cell culture and fermentation
• Downstream Processing
- Clarification
- Filtration
- Purification
• Aseptic Filling & Formulation
• Sampling & Storage
• Vaccine and Viral Vector Production
• mAb Manufacturing
• CGT (Cell & Gene Therapy) Workflows
Aseptic processing and CGT manufacturing show rapid adoption due to sterility needs.
By End User
• Biopharmaceutical & Biotechnology Companies
• Contract Development & Manufacturing Organizations (CDMOs)
• Academic Research & Clinical Labs
• Diagnostic & Vaccine Manufacturers
• CMOs & CROs
CDMOs are among the fastest-growing customers as they handle multi-client biologics production.
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Recent Industry Developments
• 2024 - Sartorius expanded single-use filtration and mixing assemblies for high-volume GMP operations.
• 2024 - Thermo Fisher Scientific launched next-generation customizable assemblies with enhanced sterile integrity.
• 2023 - Danaher (Cytiva & Pall) integrated automated assembly systems for biologics and viral vector manufacturing.
• 2023 - Merck KGaA (MilliporeSigma) introduced gamma-sterilized connector and tubing solutions for fill-finish operations.
• 2023 - Saint-Gobain Life Sciences increased production capacity for high-demand single-use components.
Expert Quote
"Single-use assemblies have become essential to today's biomanufacturing ecosystem. They enable speed, sterility, and flexibility-critical advantages for biologics, vaccines, and cell & gene therapies."
- Irfan Tamboli, Business Development Executive, Exactitude Consultancy
Key Market Drivers
1. Rapid Expansion of Biopharmaceutical Production
Biologics, biosimilars, and mAbs rely heavily on sterile, contamination-free processing.
2. Growth of Cell & Gene Therapies
CGT workflows require small-batch, aseptic, and flexible systems-making single-use assemblies indispensable.
3. Reduction in Cleaning & Validation Costs
Single-use eliminates CIP/SIP, saving time and operational resources.
4. Increased CDMO Capacity Worldwide
Outsourcing and multi-product manufacturing stimulate higher demand.
5. Modular & Flexible Facility Design Trends
Single-use assemblies support fast facility build-outs and rapid switching between products.
Forecast Outlook (2024-2030)
Market evolution will be guided by:
• Automated assembly systems for GMP operations
• Growth of hybrid facilities combining stainless steel & single-use
• Increased adoption in viral vector purification
• Sustainability initiatives focused on recyclable materials
• Expansion of disposable assemblies in fill-finish operations
By 2030, automation-integrated, closed-loop single-use assemblies will dominate GMP bioprocessing.
Regional Insights
North America
Largest market due to strong biologics pipeline and leading CDMOs.
Europe
Growth led by biotech hubs in Germany, Switzerland, and the UK.
Asia-Pacific
Fastest-growing region (CAGR > 15%) driven by China, India, South Korea, and Singapore biomanufacturing expansion.
Latin America & Middle East
Growing adoption linked to modernization of pharmaceutical facilities.
Conclusion
The Single-Use Assemblies Market is set for strong expansion as biopharma continues its shift toward flexible, scalable, and contamination-free production platforms. With rising biologics demand and advanced therapy manufacturing, single-use assemblies will remain the backbone of next-generation GMP processing.
This report is also available in the following languages : Japanese (使い捨てアセンブリ市場), Korean (일회용 조립 시장), Chinese (一次性组件市场), French (Marché des assemblages à usage unique), German (Markt für Einwegbaugruppen), and Italian (Mercato degli assemblaggi monouso), etc.
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About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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https://exactitudeconsultancy.com/
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PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com
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