Single Use Assemblies Market By Product Type (Bag Assemblies, Tube Assemblies, Filtration Assemblies, Bottle Assemblies, Others); By Application (Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-Finish); By End User (Biopharmaceutical Companies, CMOs, Academic Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

1. Introduction and Strategic Context

The Global Single Use Assemblies Market will witness a robust CAGR of 17.6% , valued at $3.1 billion in 2024 , and is expected to appreciate and reach $8.2 billion by 2030 , confirms Strategic Market Research.

Single use assemblies (SUAs) refer to ready-to-use, pre-assembled fluid transfer components designed for use in biopharmaceutical and biotechnology manufacturing processes. These systems often include a combination of tubing, connectors, filters, and fittings made from polymeric materials. They have rapidly become vital for ensuring sterility, flexibility, and cost efficiency in small- to medium-scale biologics production. From upstream cell culture to downstream purification, SUAs reduce cross-contamination risk and enable faster turnaround compared to traditional stainless-steel systems.

The relevance of this market has heightened significantly in the post-COVID biomanufacturing landscape. Increased biologics development, booming cell and gene therapy pipelines, and the need for rapid facility scale-up have made disposable technologies essential. Furthermore, the growing emphasis on regulatory compliance (e.g., from the FDA, EMA) and the shift toward modular manufacturing architectures have made single use assemblies a cornerstone of modern GMP practices .

Strategically, the market benefits from converging macro forces:

• Biopharma innovation : Expanding pipelines in monoclonal antibodies ( mAbs ), vaccines, and cell therapies demand scalable, sterile, and flexible production solutions.
• Regulatory momentum : Accelerated product approvals and harmonized GMP standards are pushing the industry toward pre-validated, single-use components.
• Global health equity : Decentralized vaccine manufacturing in emerging markets (e.g., Africa, Southeast Asia) fuels demand for plug-and-play assembly systems.
• Sustainability and cost containment : Though single-use raises questions about plastic waste, it substantially reduces water, cleaning agents, and downtime, yielding environmental and operational gains.

Key stakeholders in this industry include:

• OEMs such as system integrators and component fabricators
• Biopharmaceutical manufacturers , particularly those engaged in multiproduct facilities
• CMOs/CDMOs seeking agility in handling varied client molecules
• Regulatory authorities overseeing compliance and sterility
• Investors and strategic acquirers entering life sciences infrastructure and bioprocess automation

The rapid shift toward continuous processing, modular cleanrooms, and point-of-care biomanufacturing is expected to solidify single use assemblies as a foundational technology through 2030.

2. Market Segmentation and Forecast Scope

The global single use assemblies market can be segmented across four primary dimensions: By Product Type, By Application, By End User, and By Region . This segmentation reflects the industry's operational needs and the flexible, customizable nature of these assemblies in modern bioprocessing.

By Product Type

• Bag Assemblies
• Tube Assemblies
• Filtration Assemblies
• Bottle Assemblies
• Others (Mixing, Sampling, Transfer Systems)

Among these, bag assemblies account for the largest market share in 2024 at approximately 33% , driven by their widespread use in media storage, buffer prep, and transport operations. These assemblies are highly adaptable and are often integrated with sensors or aseptic connections for real-time monitoring and control.

However, filtration assemblies are projected to be the fastest-growing segment through 2030, as stringent quality assurance demands and regulatory oversight intensify across downstream bioprocessing.

By Application

• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-Finish

The filtration segment dominates, supported by growing requirements for sterile fluid transfer during vaccine and mAb production. As high-throughput biologic development accelerates, demand for sterile, low-shedding assemblies for both virus filtration and sterile-grade filtration is expected to climb rapidly.

By End User

• Biopharmaceutical & Pharmaceutical Companies
• Contract Manufacturing Organizations (CMOs)
• Academic & Research Institutes

Biopharmaceutical companies are the leading end users, accounting for over 50% of the market in 2024. They rely on SUAs to boost flexibility and reduce turnaround time in multiproduct facilities.

Meanwhile, CMOs are the fastest-growing end-user group. As outsourcing of biologics manufacturing expands, CMOs seek to standardize operations across diverse clients with validated, ready-to-deploy assemblies that minimize changeover times.

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)

North America holds the largest share of the market in 2024, owing to its established biologics infrastructure, heavy R&D investments, and dominant CDMO footprint. However, Asia Pacific is expected to register the highest CAGR through 2030 , driven by expansions in China, India, and South Korea and the localization of biotech manufacturing.

This multi-dimensional segmentation reveals clear strategic pathways — from product innovation to geographic expansion — that are shaping the future of the single use assemblies market.

3. Market Trends and Innovation Landscape

The single use assemblies market is being actively reshaped by a blend of technological innovation, material science evolution, and bioprocessing strategy shifts. As the biopharmaceutical landscape grows increasingly complex, manufacturers demand solutions that are not only sterile and disposable but also intelligent, scalable, and regulatory-compliant.

1. Shift Toward Smart and Sensor-Integrated Assemblies

One of the most critical innovation trends is the incorporation of sensors, RFID tags, and digital connectivity within single use assemblies. These components allow real-time monitoring of pressure, flow rate, temperature, and even media composition. This digital augmentation transforms passive fluid pathways into active quality-control systems, ensuring greater process control and reducing deviation rates in GMP environments.

“The era of ‘smart bioprocessing’ is here — assemblies are no longer just plastic parts, but information-enabled conduits critical for compliance and performance,” notes a senior engineer at a global CMO.

2. Customization & Modular Design Evolution

With the rapid proliferation of modular biomanufacturing facilities , demand for customizable assemblies has skyrocketed. Vendors now offer on-demand design services using 3D prototyping and flexible component libraries to reduce validation timelines and simplify facility fit-outs. Assemblies are increasingly being co-developed in collaboration with end users, shortening product development cycles.

This trend supports fast-track production for personalized medicine, where batch sizes are small but quality standards are uncompromising.

3. Innovations in Polymer Materials

Materials used in single use assemblies — such as thermoplastic elastomers, fluoropolymers, and gamma-stable polyolefins — are witnessing accelerated innovation to improve chemical compatibility, low extractables / leachables (E&L), and thermal resistance. This is particularly important in downstream purification and aseptic filling where product integrity is paramount.

Moreover, sustainable material sourcing and recyclable polymer design are gaining traction as biomanufacturers commit to environmental targets.

4. Mergers, Acquisitions, and Capacity Expansion

The last few years have seen intense M&A activity and facility investments among major single use suppliers:

• Thermo Fisher Scientific expanded its capacity in the U.S. and Europe to support demand surges post-pandemic.
• Sartorius integrated complementary component manufacturers to offer end-to-end assembly solutions.
• Danaher Corporation (via Cytiva ) continues to invest in digitalized assembly systems as part of its broader bio-process automation roadmap.

These actions aim to secure supply chain resilience, reduce lead times, and build vertically integrated product ecosystems.

5. Partnerships for Globalization and Localization

Strategic partnerships are being forged to serve emerging markets and decentralize manufacturing. For instance, suppliers are working with regional CDMOs in Asia and Latin America to co-design assemblies that meet local regulatory and operating conditions. This ‘local-for-local’ strategy is critical in a world where pandemic response, supply continuity, and geopolitical risk are now constant factors.

As the biomanufacturing industry continues its pivot toward agility, speed, and sterility, the innovation ecosystem around single use assemblies will remain dynamic — a mix of smart integration, sustainable design, and regional adaptability.

4. Competitive Intelligence and Benchmarking

The global single use assemblies market is characterized by a mix of established bioprocessing giants and specialized component innovators . Competitive advantage is shaped by depth of portfolio, vertical integration, global supply footprint, and co-development capabilities. In recent years, vendors have also prioritized digital enablement and sustainability to gain market share among top-tier biopharma clients.

Below are key companies shaping this competitive landscape:

Thermo Fisher Scientific

As a dominant player, Thermo Fisher Scientific offers a full-stack portfolio of single use solutions, from bioprocess containers to custom-configured assemblies. Its vertically integrated model allows tight control over component quality and supply continuity. The company continues to expand its Quick-to-Clinic™ and Quick-to-Commercial™ platforms, emphasizing speed and standardization for clients scaling up rapidly. Thermo Fisher's dual capability in biomanufacturing and equipment supply positions it as a go-to partner for CDMOs.

Sartorius

Sartorius stands out for its robust design and validation infrastructure , offering flexible assemblies tailored to upstream, downstream, and fill-finish applications. The company’s recent acquisitions of fluid management and filtration specialists have reinforced its presence in the assembly value chain. Its BioPAT ® platform integrates analytics into assemblies, catering to the emerging demand for real-time process data.

Danaher Corporation (via Cytiva )

Under the Cytiva brand, Danaher offers one of the broadest global assembly networks. Its FlexFactory ™ and KUBio ™ modular systems are engineered around single use workflows. What differentiates Cytiva is its digital-first approach — integrating design, simulation, and performance analytics directly into single use platforms. Additionally, its early involvement in gene therapy manufacturing makes it a leader in next-gen assembly applications.

Merck KGaA ( MilliporeSigma in North America)

Merck KGaA leverages deep bioprocessing expertise to deliver robust single use assemblies across cell culture, purification, and sterile fill. With extensive focus on extractables and leachables (E&L) profiling, its assemblies are often favored for high-risk biologic products. The company continues to invest in gamma-stable polymers and contamination control , reinforcing its position in regulated markets.

Saint-Gobain Life Sciences

Originally a materials science company, Saint-Gobain has carved out a competitive niche by offering precision-engineered tubing, connectors, and custom assemblies for complex drug manufacturing environments. Its advantage lies in proprietary materials that resist chemical degradation and offer clarity and flexibility critical for manual inspection workflows.

Repligen Corporation

Known for its fluid management and filtration focus , Repligen has gained ground through strategic acquisitions and partnerships that enhance its presence in downstream assembly solutions. It stands out in niche applications such as perfusion and tangential flow filtration (TFF), where assemblies must perform under continuous and variable flow.

Colder Products Company (CPC)

CPC specializes in aseptic connectors and disconnection technologies — essential components within single use assemblies. Its innovative valve and coupling technologies ensure sterility while offering modularity, making it a preferred vendor for facilities handling multiple product types or frequent changeovers.

Competitive Summary Table (Benchmarking Dimensions)

The market is increasingly favoring vendors that not only provide component quality and sterility, but also serve as co-engineering partners across the product lifecycle — from R&D scale-up to global commercialization.

5. Regional Landscape and Adoption Outlook

The single use assemblies market exhibits distinct adoption patterns and growth trajectories across key global regions, shaped by the maturity of biomanufacturing infrastructure, regulatory frameworks, and localized production needs. While North America and Europe lead in technological maturity, Asia Pacific is rapidly emerging as a bioprocessing powerhouse, and LAMEA (Latin America, Middle East & Africa) represents white-space opportunities with long-term strategic potential.

North America

North America remains the largest regional market in 2024, driven by the concentration of biopharma headquarters, robust CMO/CDMO activity, and early adoption of disposable technologies. The U.S. alone accounts for over 40% of global demand , supported by:

• Expansive biologics manufacturing (vaccines, mAbs , ADCs)
• Government funding for pandemic readiness and decentralized manufacturing
• Regulatory emphasis on GMP compliance and single-use validation standards (e.g., USP <665>, <1665>)

The trend toward continuous manufacturing and hybrid facilities across Massachusetts, California, and North Carolina strengthens the demand for modular, single-use systems.

Europe

Europe is the second-largest region, led by Germany, France, the UK, and Switzerland , where a strong ecosystem of biopharma companies and CDMOs (e.g., Lonza , Recipharm ) exists. Regulatory alignment across the EU under EMA guidelines has created a harmonized platform for rapid SUAs deployment.

Germany, in particular, continues to drive innovation in polymer sciences and bioprocess validation, with academic-industry partnerships supporting the development of next-generation disposable technologies.

The push for sustainability — especially under REACH and environmental circularity goals — is also influencing material selection and disposal protocols in the region.

Asia Pacific

Asia Pacific is the fastest-growing regional market , projected to grow at a CAGR above 20% from 2024 to 2030. Key drivers include:

• Government initiatives in China, South Korea, and India to localize vaccine and biologic manufacturing
• Rising investment in GMP-compliant manufacturing parks (e.g., Genome Valley in India)
• A surge in local CDMOs catering to global biopharma clients
• Expansion of global OEM facilities and partnerships in Asia

“Single use assemblies are enabling leapfrog manufacturing capabilities in countries without legacy stainless steel infrastructure,” notes a process engineer from a South Korean biomanufacturer .

Japan and Singapore, while smaller in market size, remain leaders in quality compliance and innovation, often piloting smart assembly integration before global rollout.

Latin America and Middle East & Africa (LAMEA)

LAMEA is still an emerging market, with fragmented adoption and limited local production capacity. Brazil and South Africa show the most promise due to:

• Public-private vaccine and biosimilar initiatives
• WHO-backed infrastructure projects for biopharma manufacturing
• Multinational partnerships aimed at regional healthcare security

However, lack of skilled workforce, inconsistent regulation, and high import dependency for SUAs remain barriers.

There is growing international interest in enabling regional manufacturing nodes in Africa and the Middle East — a potential long-term opportunity for single use vendors that can scale affordably and train local personnel.

Regional Snapshot

This regional diversity underscores the need for global players to adopt flexible go-to-market strategies — from high-tech integration in the West to affordability and training support in developing regions.

6. End-User Dynamics and Use Case

The demand for single use assemblies (SUAs) varies significantly across end-user segments, shaped by operational scale, regulatory exposure, and production flexibility requirements. The primary end users include biopharmaceutical companies , contract manufacturing organizations (CMOs/CDMOs) , and academic or research institutes — each with distinct adoption drivers and pain points.

1. Biopharmaceutical & Pharmaceutical Companies

This group remains the largest consumer segment , accounting for over 50% of global SUA demand in 2024 . These companies increasingly rely on single use assemblies for:

• Reducing cleaning validation and downtime
• Accelerating changeovers between small-batch biologics
• Enhancing contamination control in multiproduct facilities

Global pharmaceutical majors now design entire production lines around single use workflows to support complex portfolios including vaccines, monoclonal antibodies, and emerging RNA therapies.

2. Contract Manufacturing Organizations (CMOs/CDMOs)

CMOs and CDMOs are the fastest-growing user group , propelled by the biopharma industry's aggressive outsourcing strategies. Their growth is driven by:

• High-volume client turnover and short production cycles
• Requirement for flexible, rapid reconfiguration of equipment
• Pressure to meet global GMP standards without legacy constraints

SUAs offer CMOs a cost-effective way to scale across diverse molecules without compromising on sterility or throughput.

3. Academic & Research Institutes

While smaller in total demand, research institutes and early-stage biotech labs leverage single use assemblies for:

• Pilot-scale biologics development
• Process development and validation studies
• Aseptic transfer and cell line testing

Many institutes value the plug-and-play nature of SUAs, which enable high-fidelity bioprocess simulation with minimal infrastructure.

Use Case Scenario

A tertiary biologics research and production facility in South Korea implemented single use filtration assemblies to support rapid production of a personalized cell therapy targeting rare pediatric leukemia.

• The facility previously relied on semi-automated, stainless steel-based purification systems that required up to 72 hours of cleaning validation between patient-specific runs.
• By integrating gamma-irradiated, ready-to-use filter assemblies, the team reduced downtime by 68% and increased patient throughput by 40% within four months.
• The shift also allowed process engineers to customize flow rates and pressure parameters for each batch — improving yield uniformity and reducing cross-contamination risk.

This use case exemplifies how SUAs enable precision manufacturing in highly sensitive, patient-specific therapeutic areas.

As biomanufacturing evolves from blockbuster models to personalized and distributed paradigms, the flexibility, safety, and scalability offered by single use assemblies will become non-negotiable across all end-user segments.

7. Recent Developments + Opportunities & Restraints

Recent Developments (2022–2024)

• Thermo Fisher Scientific announced a $200 million expansion of its single-use technology manufacturing site in Massachusetts to meet growing biologics demand and reduce lead times.
• Sartorius opened a new manufacturing facility in Tunisia to support global demand and address supply chain resilience in EMEA markets.
• Cytiva (Danaher) partnered with Multiply Labs to integrate robotic automation with single use workflows in cell therapy production.
• Repligen launched a new line of high-performance single use TFF assemblies, targeting high-throughput downstream processing.
• Saint-Gobain Life Sciences introduced recyclable tubing options as part of its sustainable single use initiative, aligning with biopharma environmental goals.

Opportunities

• Emerging Market Localization : Expansion of vaccine and biosimilar manufacturing in Asia, Africa, and Latin America opens vast white-space for cost-optimized SUAs tailored to local GMP conditions.
• Digital Bioprocessing Integration : There is growing demand for assemblies equipped with inline sensors and data capture to support real-time release strategies and compliance tracking.
• Next-Gen Therapies : As cell and gene therapy production scales, there’s a surge in demand for closed, sterile, and modular fluid pathways — precisely where SUAs excel.

Restraints

• Environmental Pressure and Waste Management : Single use systems face criticism due to plastic waste generation. Though offset by reduced cleaning requirements, lack of scalable recycling solutions presents a reputational and operational challenge.
• Skilled Workforce Gap : Especially in developing regions, the lack of trained personnel familiar with single use system setup and validation can limit adoption speed and efficiency.

While innovation and demand remain strong, addressing environmental impact and talent gaps will be crucial to unlocking the full potential of SUAs across global markets.