The global Single-Use Assemblies (SUA) market is experiencing rapid growth, driven by the biopharmaceutical industry’s increasing adoption of flexible, contamination-reducing, and cost-effective manufacturing technologies. Valued at an estimated USD 2.63 billion in 2024, the market is projected to nearly double, reaching USD 4.89 billion by 2029, growing at a robust CAGR of 13.2% during the forecast period.

This surge reflects a broad industry shift from traditional stainless steel to disposable systems, enabling streamlined bioprocessing workflows, faster production cycles, and enhanced safety profiles. In this blog, we explore the evolving market landscape, regional opportunities, growth drivers, and challenges shaping the future of single-use assemblies in biopharma manufacturing.

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What Are Single-Use Assemblies and Why Are They Important?

Single-use assemblies are pre-sterilized, disposable components such as bags (2D, 3D), filtration units, bottles, mixing systems, and tubing assemblies used in bioprocessing. These assemblies facilitate various manufacturing processes including:

• Filtration & purification

• Cell culture

• Storage and transfer of biologics

• Mixing and formulation

The adoption of single-use technology (SUT) in upstream and downstream bioprocessing has revolutionized the manufacturing of monoclonal antibodies (mAbs), vaccines, and cell and gene therapies (CGT). Their ability to reduce cross-contamination risk, eliminate cleaning and sterilization requirements, and support flexible production scales makes them indispensable in modern biologics manufacturing.

Market Applications: Filtration & Purification Lead the Way

Among the application segments, filtration and purification hold the largest share of the SUA market in 2023. This segment is critical to ensuring sterility and removing contaminants during biopharmaceutical production.

With increasing regulatory approvals for biopharmaceuticals and biosimilars, manufacturers are motivated to adopt cost-effective single-use filtration assemblies. Unlike traditional stainless steel systems, single-use assemblies drastically reduce the time, labor, and costs associated with cleaning validation and changeover. This not only accelerates production timelines but also improves product quality and safety.

The shift toward continuous and modular manufacturing facilities further amplifies the demand for filtration and purification assemblies that offer flexibility and scalability.

End User Landscape: CROs & CMOs Set for Fastest Growth

The end-user segmentation reveals an important market trend: Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are expected to register the highest growth rate during the forecast period.

As pharmaceutical and biopharmaceutical companies increasingly outsource research, clinical manufacturing, and commercial production to reduce operational costs and improve efficiency, CROs and CMOs are rapidly expanding their capabilities. Single-use assemblies enable these organizations to offer flexible, scalable, and contamination-controlled manufacturing services, positioning them as crucial partners in the biologics supply chain.

Nevertheless, pharmaceutical and biotechnology companies continue to hold the largest share of the SUA market, driven by their significant internal manufacturing activities and investments in biologics and advanced therapies.

Regional Dynamics: North America Leads, Asia Pacific Accelerates

Geographically, North America dominates the single-use assemblies market, benefiting from:

• A mature pharmaceutical and biotech industry

• Robust R&D infrastructure

• High investment in bioprocessing innovation

• Presence of key market players such as Thermo Fisher Scientific, Danaher Corporation, and Sartorius AG

This region serves as a global innovation hub, driving demand for advanced single-use technologies due to its strong intellectual property framework and regulatory environment.

Meanwhile, the Asia Pacific region is the fastest-growing market, buoyed by:

• Significant investments in biopharmaceutical R&D

• Rapid expansion of CMOs with US FDA approvals and GMP certifications

• Large patient populations in China and India demanding access to advanced biologics

• Increasing government support and healthcare modernization efforts

This region’s growth is especially promising as biopharma companies diversify manufacturing footprints to reduce costs and improve supply chain resilience.

Key Factors Driving Market Growth

The rapid expansion of the single-use assemblies market is underpinned by several strategic and operational drivers:

1. Increased Adoption of Single-Use Technologies in Biopharma

According to BioPlan’s 21st Annual Report, single-use systems’ usage reached 87% in 2024, underscoring the widespread industry shift away from stainless steel. The benefits—contamination control, reduced cleaning needs, rapid setup, and increased process flexibility—are making SUAs the standard in biologics manufacturing.

2. Rise in Biologics, Vaccines, and Cell & Gene Therapies

The boom in monoclonal antibodies, vaccines (especially post-pandemic), and cell & gene therapies requires adaptable manufacturing solutions. Single-use assemblies cater to these demands by facilitating complex, small-batch, and multi-product production environments with quick turnaround.

3. Increasing Outsourcing to CROs & CMOs

Biopharma companies’ growing reliance on contract organizations to manage costs and speed to market is driving demand for disposable assemblies, as these technologies support versatile and contamination-controlled manufacturing across multiple clients.

4. Shift Toward Modular and Continuous Manufacturing

The industry’s transition to modular, flexible production lines and continuous bioprocessing leverages single-use assemblies to achieve operational agility, reduce capital expenditure, and accelerate scale-up and scale-out efforts.

5. Regulatory Push for Sterility and Contamination Control

Stricter regulations governing biologic production quality have led to enhanced scrutiny on contamination risks. Single-use systems simplify compliance by eliminating cross-contamination potential and lowering validation burdens.

Challenges and Future Outlook

Despite robust growth, the single-use assemblies market faces hurdles:

• Material Standardization & Compatibility: The diversity of polymers and component designs can complicate integration and regulatory approval.

• Sustainability Concerns: Increased use of disposable plastics raises environmental challenges, pushing the market to innovate in recyclable and biodegradable materials.

• Stringent Regulations: Regulatory bodies are intensifying scrutiny on single-use products’ quality, traceability, and safety.

Innovations in material science, recycling technologies, and circular economy initiatives will be crucial in addressing these concerns, enabling sustainable growth.

Leading Players and Competitive Landscape

Key industry leaders shaping the market include:

• Thermo Fisher Scientific Inc. (US)

• Sartorius AG (Germany)

• Danaher Corporation (US)

• Merck KGaA (Germany)

• Avantor, Inc. (US)

• Parker Hannifin Corporation (US)

• Saint-Gobain (France)

• Repligen Corporation (US)

• Corning Incorporated (US)

• Lonza (US)

These companies are investing heavily in R&D, strategic partnerships, and geographic expansion to capitalize on the growing demand and deliver customized, integrated solutions to biopharmaceutical manufacturers globally.

Conclusion

The single-use assemblies market is at the forefront of transforming biopharmaceutical manufacturing by delivering safer, faster, and more flexible production solutions. As biologics, vaccines, and advanced therapies continue to dominate the pharmaceutical pipeline, the reliance on single-use technologies will only deepen.

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