Single-use Assemblies Market (By Product: Bag Assemblies, Filtration Assemblies; By Application: Filtration, Storage; By Solution: Customized, Standard) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2025-2034

Single-use Assemblies Market Size and Top Companies 

The global single-use assemblies market size was accounted at USD 13.52 billion in 2024 and it is projected to hit around USD 61.20 billion by 2034, growing at a CAGR of 16.3% from 2025 to 2034. The market growth is driven by the growing demand for biologics and personalized medicines, the Single-use Assemblies Market is experiencing robust growth. 

Key Pointers

• By region, North America led the market with the largest market share of 38% in 2024.
• By region, Asia Pacific is expected to expand at the highest CAGR from 2025 to 2034.
• By Product, the filtration assemblies held the largest revenue share of 29% in 2024.
• By Application, the filtration segment registered the maximum market share of 29% in 2024.
• By Application, the cell culture & mixing segment is anticipated to grow at the noteworthy CAGR of 20.56% from 2025 to 2034.
• By Solution, the customized solutions contributed the largest market share of 72% in 2024.
• By End-use, the biopharmaceutical and pharmaceutical contributed the largest market share of 50% in 2024.

Report Scope of the Single-use Assemblies Market

Single-use Assemblies Market Overview 

The global single-use assemblies market has witnessed significant growth in recent years, driven by increasing adoption of single-use technologies in biopharmaceutical manufacturing. These assemblies, which include tubing, connectors, filters, and sensors, are pre-assembled and sterilized for immediate use, reducing the risk of contamination and cross-contact. They offer operational flexibility, lower labor costs, and faster turnaround times, making them ideal for small-batch and multi-product facilities. With the growing demand for biologics, vaccine, and cell and gene therapies, single-use assemblies are becoming indispensable in streamlining production processes and maintaining high standards of sterility and quality assurance.

What are the Growth Factors of Single-use Assemblies Market? 

The growth of the single-use assemblies market is primarily driven by the rising demand for biopharmaceuticals, including monoclonal antibodies, vaccines, and cell and gene therapies. As these therapies often require highly sterile and flexible manufacturing environments, single-use assemblies provide an ideal solution by reducing the risk of cross-contamination and eliminating the need for extensive cleaning procedures. This not only improves operational efficiency but also accelerates the production timeline, which is critical for time-sensitive therapies.

Another key growth factor is the increasing reliance on contract research organizations (CROs) and contract manufacturing organizations (CMOs), which often utilize single-use systems to enhance scalability and lower production costs. These assemblies also support the shift toward small-batch and personalized medicine production, where traditional stainless-steel systems may lack the required flexibility.

What are the Trends in Single-use Assemblies Market? 

• Integration with Automation and IoT: Single-use assemblies are increasingly being integrated with automation and smart sensors, enabling real-time process monitoring and control. This trend supports data-driven manufacturing and improves product consistency and regulatory compliance.
• Growth in Modular Biomanufacturing: The rise of modular and flexible manufacturing facilities is boosting demand for customizable single-use assemblies. These systems offer faster setup and scalability, aligning with the shift toward multi-product and small-batch production.
• Sustainability Initiatives: Manufacturers are focusing on developing eco-friendly single-use components and improving recycling options. This addresses growing concerns around plastic waste and aligns with global sustainability goals in bioprocessing.

What are the Key Challenges Faced by Single-use Assemblies Market? 

One of the primary challenges faced by the single-use assemblies market is the environmental impact associated with the disposal of plastic-based components. Since these systems are designed for one-time use, they generate substantial amounts of biomedical and plastic waste, raising concerns around sustainability and regulatory compliance. While efforts are being made to develop recyclable or biodegradable materials, the industry still lacks standardized protocols for waste management and recycling.

Another significant challenge is the risk of supply chain disruptions and quality inconsistencies. The single-use assemblies market heavily relies on specialized components and materials, and any delay or shortage can significantly impact biomanufacturing timelines. Moreover, ensuring product compatibility and consistent quality across different batches and suppliers remains a hurdle. Regulatory requirements for validation and documentation are also stringent, especially when switching suppliers or integrating new materials, adding further complexity.

Which Region Dominates the Single-use Assemblies Market?

North America held the largest share of the regional market in 2024, accounting for 38% of the total revenue. North America held the largest share of the global single-use assemblies market, primarily driven by the strong presence of leading biopharmaceutical companies, advanced healthcare infrastructure, and high investment in R&D activities. The region benefits from early adoption of innovative bioprocessing technologies, stringent regulatory standards, and a mature ecosystem of contract manufacturing organizations. The United States, in particular, plays a crucial role due to its well-established biologics production capabilities and growing demand for cell and gene therapies. 

The Asia Pacific region is projected to witness the fastest growth during the forecast period. This expansion is fueled by the rapid development of biopharmaceutical infrastructure, favorable government initiatives, and rising investments by global pharmaceutical companies in countries such as China, India, and South Korea. The increasing prevalence of chronic diseases, expanding patient populations, and growing clinical trial activity in the region also contribute to the rising demand for cost-effective and scalable single-use solutions.

Segmental Insights

Product Insights

The filtration assemblies segment accounted for the largest share of the overall revenue, contributing 29% in 2024. These assemblies are essential for removing particulates, bacteria, and other impurities during upstream and downstream processing, ensuring product purity and safety. Filtration assemblies offer several advantages, including reduced risk of cross-contamination, shorter turnaround times, and minimal validation requirements. As biomanufacturers strive to enhance operational efficiency and maintain high-quality standards, the demand for pre-validated, ready-to-use filtration assemblies continues to grow.

The bag assemblies segment is projected to register the highest CAGR during the forecast period from 2025 to 2034. These assemblies are typically composed of multi-layer polymer films that ensure high levels of strength, flexibility, and sterility. Their adoption reduces the need for cleaning and sterilization, offering cost and time savings to manufacturers. Bag assemblies are particularly beneficial in modular and flexible manufacturing facilities, where speed and adaptability are crucial.

Application Insights

The filtration segment led the market, capturing the highest revenue share of 29% in 2024. Single-use filtration assemblies help in removing impurities, particulates, and microorganisms from process fluids to ensure product sterility and integrity. These systems are commonly utilized in both upstream and downstream processes, including harvest clarification, viral filtration, and final fill-finish steps. The use of disposable filtration assemblies minimizes the risk of cross-contamination, reduces cleaning validation efforts, and enhances overall process efficiency.

The cell culture and mixing segment is projected to experience the highest CAGR during the forecast period from 2025 to 2034. These assemblies are essential for cultivating cells in a controlled environment and for the consistent mixing of media, buffers, and other process fluids. Single-use systems provide flexible, closed-loop environments that maintain sterility while supporting high cell viability and productivity. Their use significantly reduces the setup time and operational complexities compared to traditional stainless-steel systems.

Solution Insights

The customized solutions segment led the global industry in 2024, capturing the largest share of 72% in 2024. These solutions are developed in close collaboration with end-users to ensure compatibility with existing systems, optimize workflow, and meet regulatory and operational standards. The flexibility to modify tubing lengths, connectors, filtration units, and other components makes customized assemblies ideal for complex bioprocessing needs, including multi-product and small-batch production environments.

Standard solutions, on the other hand, are gaining popularity for their cost-effectiveness, quick deployment, and ease of integration in less complex manufacturing environments. These pre-configured assemblies are designed to meet general bioprocessing needs and are readily available, which helps reduce procurement timelines and supports faster facility startup. Standard solutions are particularly beneficial for small and mid-sized companies or for early-stage production where rapid implementation is essential. While they may offer less flexibility compared to customized assemblies, advancements in standardization and modular design have significantly improved their performance and adaptability.

End Use Insights

The biopharmaceutical and pharmaceutical companies segment dominated the global industry, contributing the highest share of 50% to the overall revenue in 2024. These companies rely on single-use assemblies to maintain sterility, reduce downtime, and increase process flexibility. The adoption of single-use systems enables faster changeovers, minimizes cleaning and validation requirements, and supports the production of high-value biologics such as monoclonal antibodies, cell and gene therapies, and vaccines.

The CROs and CMOs segment is anticipated to record the fastest CAGR throughout the forecast period. These service providers play a critical role in outsourcing strategies adopted by biopharma companies, offering flexible and scalable manufacturing capabilities. Single-use assemblies allow CROs and CMOs to manage multiple client projects with varying process requirements while minimizing cross-contamination risks and operational turnaround times. The demand for these assemblies among CROs and CMOs is further fueled by the rise in clinical trials, especially for biologics and personalized medicine.

Top Companies in Single-use Assemblies Market

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Merck KGaA
• Danaher Corporation (Cytiva and Pall Corporation)
• Saint-Gobain Life Sciences
• Repligen Corporation
• Parker Hannifin Corporation
• Avantor, Inc.
• Entegris, Inc.
• Corning Incorporated

Market Segmentation

By Product 

• Bag Assemblies
• 2D bag assemblies
• 3D bag assemblies
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Other

By Application 

• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-finish Applications
• Other

By Solution 

• Customized Solutions
• Standard Solutions

By End-use 

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

By Regional 

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait