Single-use Assemblies Market Summary

The global single-use assemblies market was valued at USD 13.47 billion in 2024 and is projected to reach USD 31.87 billion by 2030, expanding at a strong compound annual growth rate (CAGR) of 16.24% from 2025 to 2030. Single-use (SU) assemblies refer to preassembled, self-contained plastic fluid paths designed for one-time use in bioprocessing workflows. These assemblies eliminate the need for cleaning and sterilization, significantly reducing turnaround time and contamination risks.

The market growth is being driven by multiple factors, including the rapid expansion of the biologics sector, ongoing technological advancements in bioprocessing, increasing investments in biopharmaceutical research and development (R&D), and the rising adoption of single-use technologies by contract manufacturing organizations (CMOs). As manufacturers aim to enhance flexibility, scalability, and operational efficiency, single-use assemblies are becoming an integral part of biopharmaceutical production workflows.

Key Market Trends & Insights

• In 2024, the filtration assemblies segment emerged as the leading category, accounting for the highest share of 28.87% of the overall market revenue. This dominance is due to rising regulatory requirements and the critical need to minimize contamination risks in both bulk and final fill operations. The use of filtration assemblies ensures safer and more efficient processing, especially for sensitive biologic products.
• Filtration as an application held the largest revenue share in 2024, driven by the significant benefits of single-use technologies (SUTs) in this area. These solutions are designed to save both time and cost, reducing up to 90% of integrity testing, sterile connections, and tubing time—streamlining bioprocessing and improving productivity in manufacturing environments.
• Based on solutions, the global market is segmented into customized and standard solutions. The customized solutions segment led the market in 2024, holding the largest revenue share of 71.71%. This segment is expected to expand at the fastest CAGR over the forecast period, as biomanufacturers increasingly seek tailored assembly designs that meet specific process requirements, allowing greater control, efficiency, and compatibility with modular facility designs.
• Among end-user segments, biopharmaceutical and pharmaceutical companies dominated the market in 2024, contributing 49.45% of the total revenue. The expansion of biopharmaceutical manufacturing facilities, especially for monoclonal antibodies, vaccines, and cell & gene therapies, is fueling the demand for single-use assemblies. These products provide efficient fluid management systems that support faster and safer drug production.
• North America was the leading regional market in 2024, capturing 37.19% of the global revenue. This leadership is attributed to robust growth in the biotechnology and pharmaceutical sectors, significant product innovation, increasing prevalence of chronic diseases such as cancer, and rising R&D investments in novel drug discovery. The region benefits from strong regulatory support and a well-established manufacturing ecosystem.
• The United States played a central role in North America's dominance. The U.S. market is characterized by the rapid expansion of biologics, cell and gene therapy production, and a mature biopharmaceutical industry. These factors drive the demand for scalable, contamination-free, and flexible manufacturing technologies like single-use assemblies.
• Europe also represents a major market, supported by stringent regulatory frameworks, a growing pipeline of biosimilars, and rising levels of automation in biomanufacturing. The region's push toward sustainable and cost-effective operations, along with investment in modular and flexible facilities, is accelerating the deployment of single-use technologies in both R&D and commercial applications.
• The Asia Pacific region is projected to grow at the fastest CAGR of 19.53% from 2025 to 2030. Rapid industrialization, increased focus on biopharmaceuticals, and strategic investments by key players are driving growth in this region. For example, in 2021, Sartorius significantly expanded its presence in China and Beijing by adding cleanroom capacity to produce single-use bags and filters locally, addressing the regional demand more efficiently.
• In the Middle East and Africa (MEA), the market is still in its early development stage. However, the region is witnessing increased attention toward strengthening healthcare infrastructure, expanding domestic pharmaceutical manufacturing, and enhancing biosecurity. Countries such as the UAE and South Africa are exploring opportunities in biotechnology, with government initiatives aiming to attract foreign investment and reduce dependence on pharmaceutical imports.

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Market Size & Forecast

• 2024 Market Size: USD 13.47 Billion
• 2030 Projected Market Size: USD 31.87 Billion
• CAGR (2025-2030):16.24%
• North America: Largest market in 2024

Key Companies & Market Share Insights

A heat map analysis in the single-use assemblies industry reveals that Danaher (via Cytiva and Pall) and Thermo Fisher Scientific are dominant players with extensive global reach, robust manufacturing capabilities, and comprehensive product portfolios spanning upstream and downstream applications. Sartorius follows closely, particularly strong in Europe and Asia, leveraging its integrated bioprocessing platforms and strategic partnerships. Merck (MilliporeSigma) maintains a strong position, especially in material science and filtration integration, supported by its innovation-driven approach and regulatory expertise.

Other players, including Saint-Gobain, Avantor, and Repligen, occupy niche yet growing spaces, offering specialized components or excelling in certain regional markets. The competitive intensity is highest in North America and Europe, with Asia-Pacific emerging rapidly due to local biomanufacturing investments and strategic expansions.

Key Players

• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Sartorius AG
• Danaher Corporation
• Avantor
• Lonza
• Saint-Gobain
• Corning Incorporated
• Entegris
• KUHNER AG

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Conclusion

The single-use assemblies market is poised for robust expansion, fueled by the rising demand for efficient, scalable, and contamination-free biomanufacturing solutions. As biopharmaceutical production continues to evolve, manufacturers are increasingly adopting SU technologies to optimize flexibility and reduce operational burdens. North America leads the market due to strong infrastructure and innovation, while Asia Pacific is emerging as a high-growth region driven by local investments and capacity expansion. With growing R&D spending, the rise of biologics, and regulatory support across regions, single-use assemblies are becoming essential components in modern bioprocessing, offering cost-effective, safe, and streamlined production across clinical and commercial applications.