Global Single-Use Assemblies Market Overview

The Global Single-Use Assemblies Market, valued at USD 2.25 billion, is projected to expand at a robust CAGR of 22% through 2026. Market growth is driven by the increasing adoption of ready-to-use single-use assemblies, strong funding support for the development of single-use technologies, the expanding biologics and vaccines market, and rising investments in biopharmaceutical R&D.

Single-use assemblies are custom-engineered, ready-to-use systems composed of multiple plastic components configured into a unified, sterile solution based on specific process requirements. These assemblies play a crucial role in modern bioprocessing, offering flexibility, sterility, and operational efficiency compared to traditional stainless-steel systems.

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Key Advantages Driving Market Growth

Traditionally, bioprocessing end users have performed in-house assembly of single-use systems, which often increases the risk of improper connections, leakage, and cross-contamination—leading to costly production delays. In contrast, pre-assembled single-use systems mitigate these risks by providing standardized, sterile, and quality-controlled solutions.

Major advantages of single-use assemblies include:

• Faster integration of single-use components within bioprocess workflows

• Lower risk of contamination and system leakage

• Reduced labor, material, and operational costs

• Elimination of cleaning requirements and downtime

• Significant savings in water and energy consumption

• Improved documentation and quality control

• Enhanced overall process efficiency

Growing Funding Support Accelerates Market Expansion

The increasing preference for disposable and flexible production systems has led nearly every sterile manufacturing segment to transition toward single-use alternatives. These systems substantially reduce facility setup and cleaning costs, minimize batch contamination risks, and enhance production agility—key benefits driving widespread adoption.

Governmental and institutional funding initiatives are further boosting production capabilities across the sector.

Notable examples include:

• High Purity New England received a USD 15 million grant (January 2022) from the Biomedical Advanced Research and Development Authority (BARDA) to expand production of single-use assemblies, pumps, and sterile packaged components.

• Meissner Filtration Products secured a USD 13.4 million BARDA contract (April 2021) to accelerate the manufacturing capacity of single-use systems vital for COVID-19 vaccine and therapeutic production.

“Single-use assemblies deliver everything bioprocessors need—from bags and connectors to filters and tubing—enabling flexible and scalable manufacturing for a wide range of therapies. They are essential to the global vaccine and biologics supply chain.”
— Senior Director, Leading Single-use Assembly Manufacturer, United States

Market Challenge: Risk of Leachables

Despite their advantages, leachables remain a key concern in the use of single-use systems. These are chemical compounds that may migrate from plastic or elastomeric components into drug formulations during processing or storage. The presence of leachables can compromise drug purity, product quality, and patient safety.

To address this challenge, industry stakeholders are implementing:

• Comprehensive extractables and leachables studies

• Risk-based assessments and toxicological evaluations

• Adoption of standardized characterization protocols

• Collaborative guidance development between suppliers and end users

Such proactive measures are expected to mitigate contamination risks and sustain the long-term adoption of single-use technologies across the biopharmaceutical sector.

Competitive Landscape

The global single-use assemblies market is characterized by the presence of several established players competing through technological innovation, capacity expansion, and strategic partnerships. Leading companies include:

• Thermo Fisher Scientific, Inc.

• Sartorius Stedim Biotech

• Danaher Corporation

• Merck KGaA

• Avantor, Inc.

• Saint-Gobain

• and other emerging regional manufacturers.

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About Medi-Tech Insights

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy. Our methodology includes rigorous secondary research combined with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply side decision-makers.