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

Introduction And Strategic Context

The Global Single-Use Assemblies Market is poised to experience substantial growth between 2024 and 2030 , with a robust CAGR of 9.5% , projected to reach USD 8.27 billion by 2030 , up from USD 4.8 billion in 2024 , as confirmed by Strategic Market Research .

Single-use assemblies, designed for applications in sectors like biopharmaceuticals, vaccines, and clinical manufacturing, have transformed the landscape of pharmaceutical manufacturing. The technology has gained immense popularity due to its flexibility, reduced contamination risks, and cost-efficiency compared to traditional multi-use equipment. As drug manufacturing processes become more complex, demand for single-use solutions—ranging from tubing and connectors to fully integrated systems—has surged.

 

The strategic relevance of this market is underpinned by macro forces such as regulatory standards , technological advancements , and the growing demand for biologics . As the biopharma industry continues its shift toward personalized and biologic treatments, single-use assemblies remain pivotal in improving production speed and scaling processes effectively. Additionally, heightened regulatory pressure for better contamination controls and environmental sustainability continues to drive the adoption of single-use systems.

 

Key stakeholders in this space include Original Equipment Manufacturers (OEMs), biopharmaceutical companies, regulatory bodies, investors, and research and development (R&D) labs .

 

The global and regional revenue numbers for Single-Use Assemblies (USD 4.8B in 2024 → USD 8.27B by 2030 at 9.5% CAGR). Building on that foundation, the updated regional trajectories indicate:

• United States: USD 1.86B (2024) → ~USD 3.15B (2030) at ~9.2%

• Europe: USD 1.2B (2024) → ~USD 1.94B (2030) at ~8.3%

• Asia-Pacific: USD 984M (2024) → ~USD 1.89B (2030) at ~11.5%

Together, these three regions represent ~85% of global SUA demand by 2030.

Biopharmaceutical expansion, accelerated biologics approvals, CGT commercialization, and modular cleanroom construction are driving rapid adoption of pre-assembled disposable fluid paths, filtration manifolds, and sterile bag systems across all manufacturing scales.

Regulatory approvals also support growth:

• 69 FDA approvals (CDER+CBER) in 2023—one of the highest on record (FDA annual approval summary).

• 77 EMA positive opinions in 2023, including multiple biologics, biosimilars, and ATMPs (EMA Human Medicines Highlights).

• 63 U.S. biosimilars approved, 43 launched (FDA Purple Book).

This expansion in biologics pipelines directly increases demand for closed, validated single-use assembly trains.

 

Single-Use Assemblies Market Size & Growth Insights

• WHO/UN estimates show biologics now represent 38–40% of global pharmaceutical spending, with growth outpacing small molecules in every region.

• Eurostat data show biopharma production value in the EU increased >25% between 2018–2023, with strong antibody, vaccine, and sterile-product growth.

• U.S. cleanroom construction for biologics and CGT expanded at >15% CAGR (2019–2023) based on FDA facility registrations (CDER/CBER).

• Japan, Korea, and Singapore collectively added >1.6 million liters of new biologics capacity between 2020–2024 (manufacturer-disclosed expansions).

 

Implication for SUA

Single-Use Assemblies scale proportionally with:

• Total bioreactor volume deployed in upstream

• Filtration throughput in downstream

• Fill-finish throughput for sterile injectables

• Number of multi-product clinical facilities

SUA share is highest in:

• Clinical-scale facilities (>90% upstream single-use)

• CGT viral vector suites (~100% single-use)

• Modular biomanufacturing pods (~100% single-use)

 

Key Market Drivers

1. Biologics & Advanced Therapies Expansion

• FDA approved 63 biosimilars to date; growth in biosimilar manufacturing increases high-volume filter and bag assembly consumption.

• EMA recorded 39 new active substances in 2023, the majority biologics.

• ClinicalTrials.gov lists >1,500 CAR-T trials and >3,000 gene-therapy trials (cumulative), each relying heavily on closed SU assemblies.

2. cGMP Facility Growth

• U.S. FDA’s Establishment Registration database shows steady year-on-year growth in biologics manufacturing sites.

• EDQM & EMA GMP databases confirm a rise in sterile/aseptic and ATMP-certified facilities in Europe, increasing demand for sterile manifolds and fill-finish assemblies.

• Korea MFDS reports rapid expansion in domestic CGT production units, nearly all designed around single-use.

3. Supply-Chain Digitalization

Manufacturers increasingly require complete assembly genealogy (sterilization lot records, material ID), driving demand for digitally traceable, pre-validated SUA.

 

Market Challenges & Restraints

1. Polymer Resin & Film Constraints

• UN Comtrade data show global import concentration in EVA, PP, and PE resins, with only a few countries supplying bioprocess-grade resin.

• Academic analyses indicate that single-use films require multi-layer structures, increasing dependence on specialty resin supply.

2. Sterilization Capacity Limitations

• BPSA white papers confirm gamma irradiation capacity remains constrained, especially for complex manifolds and large-format assemblies.

• Movement toward X-ray and e-beam sterilization continues but requires re-qualification for many assemblies.

3. Plastic Waste Burden

• Peer-reviewed LCAs show a typical mAb batch generates >700 kg of plastic waste from SU components.

• EU’s tightening of waste-handling and EPR directives increases operational burdens for large SU-intensive facilities.

 

Trends & Innovations

1. Sensor-Integrated Single-Use Fluid Paths

• Manufacturers have disclosed SU assemblies with integrated pH, DO, conductivity, and optical cell-density sensors, enabling closed-loop bioprocessing.

2. High-Value Filtration Manifolds

• Industry case studies show filtration (sterile, virus, depth) to be the most universally deployed SUA sub-system, representing the highest unit consumption.

3. Recyclable SU Films & Mono-Material R&D

• Academic work demonstrates the feasibility of mechanically recycling SU containers into secondary plastics with acceptable tensile properties.

4. Regional SU Manufacturing Footprints

• Asia-Pacific suppliers have disclosed end-to-end film, bag, and assembly manufacturing capacity, reducing import dependence.

 

Competitive Landscape

Global Platform Providers

Companies with publicly disclosed SU portfolios include:

• Sartorius, Cytiva, Thermo Fisher, Merck Millipore, Pall/Danaher, ABEC, Entegris
  These companies publish validated extractables/leachables data, sterilization compatibility, and manufacturing-site certifications (FDA/EMA/ISO), making them preferred vendors for regulated markets.

Regional Manufacturers

• China-based suppliers have expanded production of multi-layer SU films, mixing bags, and sterile manifolds, serving APAC biologics and vaccine producers.

• Latin American integrators now provide validated fill-finish bottle assemblies for aseptic operations.

 

Single-Use Assemblies Market Outlook: U.S., Europe, Asia-Pacific, LATAM

United States

• FDA’s annual approvals, high biosimilar penetration, and large CGT trial density position the U.S. as the largest SUA consumer (>35% market share).

• Increasing outpatient and decentralized manufacturing models (especially for autologous therapies) rely heavily on disposable, closed fluid paths.

Europe

• EMA’s steady biologics/ATMP authorization rate supports high-complexity SUA demand, especially sterile sampling assemblies and chromatography manifolds.

• Europe’s strict E&L expectations encourage use of premium-grade assemblies with extensive validation packages.

Asia-Pacific

• With ~11.5% CAGR, APAC is the fastest-growing SUA market, driven by biosimilar manufacturing in India, large vaccine operations in China, and CGT expansion in Korea & Japan.

• Local film production and SU manufacturing reduce lead times and cost barriers.

LATAM

• Brazil and Mexico are constructing SU-centric facilities, increasing demand for storage, mixing, and fill-finish assemblies.

 

8. Segmental Insights

8.1 By Product Type

Product Type	Market Share	Revenue (USD)
Bag Assemblies (bioreactor, mixing, storage)	~38%	~USD 1.82B
Filtration Assemblies (sterile, depth, viral)	~27%	~USD 1.30B
Tube Assemblies	~14%	~USD 0.67B
Bottle Assemblies	~11%	~USD 0.53B
Others (sampling sets, connectors, manifolds)	~10%	~USD 0.48B

 

8.2 By Application

Application	Share	Drivers
Filtration	~32%	High frequency per batch; sterile & virus filtration
Cell Culture & Mixing	~28%	Seed trains, media/buffer prep
Storage	~20%	Media, buffer, intermediate pools
Sampling	~10%	Aseptic QC operations
Fill-Finish	~10%	Vial/bottle manifold sets

 

8.3 By End User (2024 Share)

End User	Share	Notes
Biopharmaceutical Companies	~52%	Commercial-scale batches, multiproduct sites
Contract Manufacturers (CMOs/CDMOs)	~38%	Highest SU intensity per m²
Academic / Institutes	~10%	Process development & small-batch work

 

Bag Assemblies – Market Size & Share

Bag assemblies represent the largest single-use sub-category, driven by their presence across media preparation, seed expansion, buffer storage, mixing, and bioreactor configurations.

Market Share & Size (2024)

• Estimated global share: ~38% of SUA

• Market size: ~USD 1.82 billion out of USD 4.8B

• Regional distribution (share of bag assemblies):

  • United States: ~USD 0.71B

  • Europe: ~USD 0.46B

  • Asia-Pacific: ~USD 0.37B

Market Positioning

Bag assemblies gain share as facilities shift from stainless-steel seed trains to fully single-use upstream lines, especially in biosimilars, vaccines, and cell/gene therapy small-batch processing. Their growth is further reinforced by the rise in 3,000–6,000 L single-use bioreactors disclosed by manufacturers, which require large-format 3D bag systems with complex manifold connections.

Growth Outlook

• By 2030, bag assemblies are projected to reach ~USD 3.1–3.2B, maintaining their leadership due to adoption in upstream perfusion, GMP buffer hold steps, and sensor-integrated bag designs.

 

Filtration Assemblies – Market Size & Share

Filtration manifolds—sterile, depth, virus-removal, and tangential-flow variants—represent the second-largest revenue block of the SUA industry.

Market Share & Size (2024)

• Estimated global share: ~27%

• Market size: ~USD 1.30 billion

• Regional distribution:

  • United States: ~USD 0.51B

  • Europe: ~USD 0.32B

  • Asia-Pacific: ~USD 0.28B

Market Positioning

Filtration assemblies are indispensable due to:

• Mandatory sterile filtration for all parenteral biologics

• High filtration frequency across mAb, recombinant protein, and vaccine lines

• Increasing virus-filtration steps in biosimilar and ATMP operations

• Manufacturing preference for pre-sterilized, ready-to-connect manifold assemblies

In downstream operations, filtration is approaching near-universal single-use penetration, especially in small- and mid-capacity GMP plants.

Growth Outlook

By 2030, filtration assemblies are expected to expand to ~USD 2.1–2.2B, supported by rising viral safety requirements and multi-product facility formats that favor ready-made SU filtration manifolds.

 

Monoclonal Antibodies (mAbs) – Market Impact & SUA Demand Contribution

Monoclonal antibodies remain the largest driver of single-use assembly consumption globally due to their:

• High batch volumes

• Dependence on large-scale upstream and downstream operations

• Multiple filtration, media, buffer, and transfer steps

Market Impact

• mAbs represent ~45–50% of biologics manufacturing worldwide, according to FDA/EMA authorization trends and manufacturer disclosures.

• This segment accounts for an estimated ~40% of total SUA consumption, driven by large batch sizes, multi-product operations, and high-throughput downstream steps.

Contribution to SUA Revenue (2024)

• ~USD 1.9–2.0 billion SUA spending attributable to mAb production

  • United States: ~USD 0.75B

  • Europe: ~USD 0.48B

  • Asia-Pacific: ~USD 0.42B

Growth Outlook

As multiple blockbuster biologics lose exclusivity and biosimilar pipelines increase, mAb manufacturing will continue to fuel high-volume demand for:

• Storage & mixing bag assemblies

• Sterile & virus filtration assemblies

• Harvest/clari?cation manifolds

• Seed-train bioreactor bag sets

• High-volume transfer assemblies

mAbs remain the anchor revenue segment in the single-use assemblies market through 2030.

 

CROs & CMOs – Market Size & End-User Share

Contract research organizations (CROs) and contract manufacturing organizations (CMOs/CDMOs) are the fastest-growing SUA end-user category, with single-use adoption exceeding traditional in-house biopharma in speed and intensity.

Market Share & Size (2024)

• Combined CRO/CMO share: ~38% of global SUA revenue

• Market size: ~USD 1.82 billion out of USD 4.8B

• Distribution:

  • United States: ~USD 0.73B

  • Europe: ~USD 0.43B

  • Asia-Pacific: ~USD 0.40B

Market Positioning

Growth is driven by:

• Outsourcing of mAb, recombinant protein, viral vector & plasmid manufacturing

• Multi-product clinical pipelines requiring rapid changeover

• Modular GMP facility construction that relies almost entirely on single-use

• Increasing biosimilar and CGT workloads transferred to CDMOs

CDMOs operate at much higher SU intensity per batch than large in-house plants due to diverse client processes and the need for fast turnaround.

Growth Outlook

By 2030, CROs/CMOs are expected to reach ~USD 3.0B in SU assembly consumption, becoming the primary demand center for complex bag manifolds, seed-train assemblies, and aseptic fill-finish connection systems.

 

Investment & Future Outlook

• Expansion of biologics, biosimilars, and ATMPs ensures double-digit SU assembly demand growth in APAC and steady high-single-digit growth in the U.S. and Europe.

• Regulatory expectations for robust contamination control will move more facilities toward fully closed, fully single-use flow paths.

• Sustainability reporting (EPR, waste tracking, Scope-3 audits) will push manufacturers to adopt traceable, recyclable, and lower-impact SU assemblies.

 

Evolving Landscape

• EU CTR drives harmonization for multi-country trials, encouraging standardized assembly qualification.

• National policies on plastics (e.g., India’s single-use restrictions) increase pressure on biopharma to demonstrate responsible SU disposal pathways.

• Digital batch records and MES adoption require digitally coded assemblies, creating competitive differentiation.

 

R&D and Technological Innovation

• Film engineering: new gas-permeability-optimized and gamma/X-ray stable multilayer structures.

• Integrated SU sensors enabling continuous processing.

• Recycling pilots demonstrating viable mechanical recycling of SU bags and manifolds.

• Modular micro-factories relying entirely on SU assemblies for rapid deployment.

 

Clinical Trial & Regulatory Landscape

• 69 FDA approvals (2023) and EMA’s 77 medicines indicate sustained biologics momentum.

• CGT trials exceed 3,000 globally, with autologous workflows relying exclusively on closed SU assemblies.

• EU ATMP trial data show gene therapies represent >75% of ATMP pipeline—high single-use consumption environments.

 

Pipeline & Competitive Landscape

• Oncology biologics, autoimmune therapies, rare-disease biologics, and vaccines dominate late-stage pipelines.

• High-potency, low-volume modalities (viral vectors, cell therapies) mandate closed SU fluid paths, ensuring rising assembly counts per batch.

 

Strategic Landscape

• Global suppliers expanding sterilization, film extrusion, and assembly-cleanroom capacity.

• Regional partners in China, India, Brazil emerging as preferred assembly integrators.

• CDMOs standardizing on vendor-certified assembly libraries to reduce validation time.

 

Key Companies with Market-Leading Assets

• Sartorius, Cytiva, Thermo Fisher, Merck Millipore, Pall/Danaher, ABEC, Entegris (global leaders in validated SU systems).

• APAC manufacturers offering regionalized film and bag production.

• Latin American integrators supporting bottle assemblies and aseptic fill-finish sets.

 

Emerging Players & Disruptive Startups

• Film-innovation startups focused on mono-material recyclable films.

• Modular bioprocessing firms enabling containerized SU production pods.

• Regional manufacturers bridging supply gaps in India, China, Brazil, Saudi Arabia.

 

Strategic Recommendations

For Global SU Assembly Suppliers

• Prioritize sterilization capacity diversification (gamma + X-ray + e-beam).

• Expand regional assembly cleanrooms in APAC and LATAM.

• Offer digitally traceable assemblies to support MES-ready environments.

For Biopharma & CDMOs

• Standardize SU configurations across sites to reduce E&L validation costs.

• Embed sustainability (waste compaction, recycling partners) early in facility planning.

• Adopt high-value filtration and fill-finish assemblies to support CGT and multi-product operations.

 

19. Strategic Highlights & Takeaways

• U.S., Europe, and APAC will exceed USD 7B combined SUA revenue by 2030.

• Filtration and bag assemblies represent ~65% of total market share.

• CGT programs grow >3,000 trials globally, making SU assemblies non-optional.

• Regulatory clarity accelerates demand for validated, sensorized fluid paths.

• Regional SU manufacturing centers emerging across Asia and Latin America.

 

Single-use assemblies are transitioning from supportive consumables to core bioprocess infrastructure. With rising biologics pressure in the U.S. and Europe and rapid facility construction in APAC and LATAM, the market will maintain robust multi-year expansion. Growth will be driven by closed-system compliance, speed-to-market demands, CGT expansion, and modular facility adoption, while challenges will center on sterilization, resin supply, plastic waste, and qualification burdens.

 

Market Segmentation And Forecast Scope

The Single-Use Assemblies Market is segmented based on various dimensions, such as product type, application, end-user, and region. This segmentation provides a granular view of the market, revealing both established and emerging growth areas.

By Product Type

• Single-Use Bioprocessing Systems : This category includes equipment like bioreactors, filtration systems, and mixers that have revolutionized manufacturing processes in biopharmaceutical production. Bioreactors, in particular, are projected to hold the largest market share, accounting for around 40% of the total market value in 2024. Their role in cell culture media, viral vector production, and monoclonal antibody generation contributes significantly to this dominance.

• Single-Use Components : Includes items such as connectors, tubing, pumps, and filters. These are highly flexible and cost-effective, driving demand across various sectors. While smaller in unit sales, this segment is growing rapidly and is expected to generate 29% of market revenue by 2024.

 

By Application

• Biopharmaceutical Manufacturing : This application dominates the market due to the rising demand for biologics, including monoclonal antibodies and gene therapies. This segment is expected to contribute over 45% of the market value by 2024 and continue to lead through 2030 as the biopharma industry expands its portfolio of biologic therapies.

• Vaccines : Single-use assemblies have gained significant traction in the vaccine manufacturing process due to their ability to reduce contamination risks and scale up production. The segment is anticipated to grow at a CAGR of 12% from 2024 to 2030, driven by the global need for more efficient vaccine production lines.

• Clinical Manufacturing : As clinical trials become increasingly complex and demand more precise and scalable production methods, single-use assemblies are playing a vital role. This segment is expected to hold 18% of the market share in 2024.

 

By End User

• Biopharmaceutical Companies : Representing the largest share of market demand, these companies are the main consumers of single-use assemblies for both clinical and commercial-scale manufacturing. This segment will continue to expand due to increased biologic drug development.

• Contract Manufacturing Organizations (CMOs) : CMOs that serve the biopharma industry by providing manufacturing services are increasingly adopting single-use systems due to their flexibility and cost-effectiveness. This segment is projected to grow at one of the highest CAGRs in the forecast period.

 

By Region

• North America : As the leading region for biopharmaceutical R&D, North America is expected to dominate the Single-Use Assemblies Market , accounting for 42% of the market share in 2024. The region benefits from strong healthcare infrastructure, regulatory support, and innovation within the biopharma industry.

• Europe : Following North America, Europe’s market is projected to be valued at USD 1.2 billion in 2024, driven by stringent regulatory standards and a robust biopharmaceutical manufacturing base. The region’s commitment to sustainability is also accelerating adoption.

• Asia-Pacific : The Asia-Pacific region is expected to experience the fastest growth , with a projected CAGR of 11.5% through 2030. The market is driven by rapid pharmaceutical expansion in countries like China and India, where the increasing demand for cost-effective, scalable production solutions aligns perfectly with the capabilities of single-use assemblies.

In summary, biopharmaceutical manufacturing is poised to remain the largest and fastest-growing application segment, with North America leading in market share, but the Asia-Pacific region providing substantial growth opportunities over the next decade.

This segmentation highlights how varied the demand for single-use assemblies is, with each sub-segment demonstrating unique growth trajectories based on regional and application-specific dynamics.

 

Market Trends And Innovation Landscape

The Single-Use Assemblies Market is evolving rapidly, with several key trends and innovations shaping its future. As the market adapts to the growing demands of the biopharma industry, these trends highlight how companies are leveraging technology to optimize efficiency, reduce costs, and meet regulatory standards.

1. Technological Integration and Advancements

Single-use assemblies have become more integrated into automated manufacturing systems. Advanced automation technologies are increasingly being used to improve the efficiency and reproducibility of bioprocesses. The introduction of smart sensors and real-time monitoring tools is revolutionizing single-use systems by allowing operators to gather more precise data during the manufacturing process. These sensors enable higher quality control, reducing human error and improving overall system reliability. As automation advances, it helps reduce operational costs and improve process consistency.

 

2. Customization and Modular Systems

Customization has become a major focus within the market, especially as pharmaceutical companies shift toward more personalized treatments. Single-use systems are increasingly modular, allowing biomanufacturers to tailor their equipment based on specific production needs. This flexibility allows for faster scale-ups and more efficient adaptations in production processes. For example, modular filtration systems allow for easier adjustments to the size and complexity of the production process.

As companies develop tailored solutions for gene therapy, personalized vaccines, and monoclonal antibodies, modular designs will likely become the standard to ensure flexibility in these specialized fields.

 

3. Integration with Other Biomanufacturing Technologies

The trend of integrating single-use systems with other biomanufacturing technologies is gaining momentum. For example, single-use bioreactors are now commonly integrated with in-line sensors and advanced data analytics to continuously monitor and adjust the manufacturing environment. This integration allows biopharmaceutical companies to scale up processes more efficiently while maintaining high product quality. Single-use systems with integrated filtration are increasingly used for aseptic processing, especially in vaccine manufacturing, where stringent controls are essential.

 

4. Sustainability and Green Chemistry

Sustainability has become a key driving factor in the adoption of single-use assemblies. These systems are inherently more sustainable than traditional stainless steel equipment, as they require fewer cleaning cycles and generate less waste. Environmental regulations are pushing companies to reduce their ecological footprints, and single-use assemblies provide a clear advantage in this regard. Many manufacturers are now emphasizing green chemistry principles by reducing solvent and reagent use, promoting energy-efficient operations, and utilizing biodegradable materials for certain components.

In line with this, there is an increasing push toward disposable, environmentally friendly materials in the manufacturing of single-use assemblies. This trend is particularly strong in regions like Europe , where there are stringent environmental regulations pushing for more sustainable practices in pharmaceutical manufacturing.

“Single-use systems present a dual opportunity: reducing contamination risks while also lowering waste generation in an environmentally-conscious way,” said an industry expert at a leading biopharma firm.

 

5. Collaboration and Strategic Partnerships

The market is also seeing a rise in strategic partnerships and collaborations between OEMs and biopharmaceutical companies. This trend is driven by the need for companies to share R&D resources and collaborate on developing next-generation technologies. These collaborations are particularly important in the development of specialized systems for gene therapy and cell-based therapies, where production complexity is high. Such partnerships allow for better cross-industry knowledge sharing and a more efficient development of products that meet the specific needs of emerging therapies.

A notable collaboration occurred between GE Healthcare and Lonza to co-develop a modular cell-culture bioreactor system designed specifically for gene and cell therapy production. These types of partnerships are expected to increase, fostering innovation and expanding the use cases for single-use assemblies in specialized biopharmaceutical processes.

 

Conclusion:

These technological and strategic trends demonstrate how single-use assemblies are pushing the boundaries of innovation in the biopharma industry. As production needs become more complex, there is an increasing demand for more advanced, customizable, and sustainable solutions. The continued evolution of integration, sustainability, and modularity will ensure single-use assemblies remain a key component of biopharma manufacturing through 2030.

The future of the single-use assemblies market is bright—driven by technology, regulation, and sustainability. Those who innovate and adapt will position themselves for long-term success.

 

Competitive Intelligence And Benchmarking

The Single-Use Assemblies Market is a highly dynamic and competitive landscape, with a mix of established players and newer entrants offering innovative solutions. The market is shaped by key players who focus on advancing technology, improving product performance, and forming strategic partnerships to gain a competitive edge. Here’s a closer look at the key players in this space and how they differentiate themselves.

1. Thermo Fisher Scientific

Thermo Fisher is a global leader in scientific instrumentation, and its single-use assemblies portfolio is well integrated into its broader offering of bioprocessing solutions. The company has a strong presence in the biopharmaceutical sector and is known for its high-quality products that include single-use bioreactors, filtration systems, and custom configurations. Thermo Fisher focuses heavily on automation and integration within their systems, ensuring seamless transitions from early-phase clinical trials to commercial-scale production. Their market strategy is built around offering end-to-end solutions, from development through production, paired with strong customer support services.

• Strategy : Thermo Fisher differentiates itself with bundled offerings and the integration of single-use systems with other instruments, such as liquid chromatography and mass spectrometry .

• Global Reach : Strong presence in North America, Europe, and expanding into emerging markets in Asia-Pacific.

• Product Differentiation : Their single-use bioreactor systems are highly praised for their modularity and flexibility , enabling them to cater to diverse customer needs.

 

2. Sartorius Stedim Biotech

Sartorius Stedim Biotech is a dominant player in the bioprocessing market, with a broad portfolio of single-use technologies such as filtration, mixing, and bioreactor systems. Known for its cutting-edge bioprocessing solutions , Sartorius has built a reputation for providing both standardized and customized solutions that cater to biopharma companies of various sizes. The company's commitment to sustainability is evident in their continued development of environmentally-friendly single-use products, reducing waste and improving overall energy efficiency.

• Strategy : Sartorius focuses on continuous product innovation, particularly in the area of single-use bioreactors that integrate real-time monitoring technologies.

• Global Reach : Sartorius has a significant footprint in Europe and North America and is expanding its presence in Asia-Pacific, particularly in China and India .

• Product Differentiation : The company's BioPAT ® technology integrates process monitoring and control, allowing for optimized production processes, which enhances system reliability.

 

3. GE Healthcare

GE Healthcare is a major player in the field of biopharmaceutical manufacturing and has made notable strides in the single-use assemblies market with its WAVE bioreactor system. The company focuses on scalability and flexibility , with products that are specifically designed for both clinical trials and large-scale commercial production. GE Healthcare is a preferred partner for companies looking to scale their operations quickly while maintaining stringent quality control . Their products are widely used in gene therapy and cell therapy applications.

• Strategy : GE Healthcare emphasizes modular, scalable solutions and provides a strong focus on reducing contamination risks during production.

• Global Reach : GE Healthcare operates globally, with strong footholds in both North America and Europe .

• Product Differentiation : GE’s single-use platforms are known for their ability to scale from small research batches to full commercial production seamlessly, making them ideal for fast-growing biotech firms.

 

4. Merck KGaA

Merck is a leader in the bioprocessing technology sector, offering an extensive array of single-use products , including bioreactors, filtration systems , and tubing assemblies . Known for their commitment to precision and quality , Merck’s systems are widely used in biopharmaceutical and vaccine production . Their innovation in bioanalytics and process control technologies complements their product offerings, positioning them as a go- to choice for customers seeking high-performance, high-efficiency systems.

• Strategy : Merck focuses on high-performance single-use technologies and improving production processes through advanced automation and data analytics .

• Global Reach : Strong presence in Europe and North America , with growing operations in Asia-Pacific .

• Product Differentiation : Merck’s MilliporeSigma product line stands out for its customizable solutions that support a wide range of biomanufacturing processes , from early research to commercial-scale production.

 

5. Pall Corporation (Danaher)

Pall Corporation, part of Danaher Corporation , is recognized for its high-quality filtration and separation systems . Their single-use assemblies play a crucial role in the upstream and downstream processing of biologics. Pall’s PreDictor ™ single-use systems are particularly popular for their efficiency and flexibility in cell culture and virus filtration processes. Their technology is widely adopted in vaccine production and gene therapy , which continues to be a strong growth area.

• Strategy : Pall Corporation integrates advanced filtration and separation technologies into single-use systems, offering products that cater to both clinical trials and large-scale manufacturing .

• Global Reach : Strong presence in North America , Europe , and expanding efforts in Asia .

• Product Differentiation : Pall’s PreDictor ™ systems are valued for their compact, modular design, and their ability to support the flexibility needed in modern biomanufacturing operations.

 

Competitive Dynamics:

The competition in the Single-Use Assemblies Market is primarily driven by technological advancements and the increasing demand for personalized therapies . While large, established players like Thermo Fisher , Sartorius , and GE Healthcare dominate the high-value, large-scale production segment, there are significant opportunities for new entrants focused on niche applications and specialized systems . In particular, the integration of real-time data analytics and automation will serve as key differentiators in the years ahead.

The market is highly competitive, but the ability to innovate, offer integrated solutions, and meet stringent regulatory demands will determine long-term market leadership.

 

Regional Landscape And Adoption Outlook

The Single-Use Assemblies Market is experiencing varied growth across different regions. Regional dynamics are shaped by the pharmaceutical industry's development, regulatory environments, and the demand for biopharmaceutical products. The adoption of single-use assemblies is primarily driven by the demand for more flexible, efficient, and cost-effective solutions in drug manufacturing. Let’s break down how different regions are performing and where future opportunities lie.

North America

North America is the dominant region in the Single-Use Assemblies Market , accounting for approximately 42% of the global market share in 2024. The United States is the largest market, driven by the robust biopharmaceutical manufacturing sector, which continues to grow at an impressive rate due to the increasing focus on biologics and personalized medicine .

Key factors driving growth in this region include:

• Strong Regulatory Framework : The U.S. Food and Drug Administration (FDA) sets high standards for manufacturing processes, which enhances the adoption of single-use technologies that reduce contamination risks.

• R&D Investment : Continuous investments in biopharma R&D , particularly in the biologic and gene therapy sectors, are pushing the demand for scalable, cost-effective production technologies like single-use assemblies.

• Infrastructure and Technology : North America leads in adopting automated manufacturing systems integrated with single-use assemblies, making it easier for biopharma companies to scale their operations efficiently.

As the market is already saturated with high-end technologies, the biggest growth opportunities will come from increasing production capabilities and expanding into specialized treatments, such as gene therapies and vaccines.

 

Europe

Europe is the second-largest region in the Single-Use Assemblies Market , valued at around USD 1.2 billion in 2024. The region is driven by the strong presence of leading biopharmaceutical companies and robust regulatory requirements from entities like the European Medicines Agency (EMA) . The European market is also significantly influenced by the push toward sustainability , which aligns with the low waste and lower environmental impact that single-use systems offer.

Key drivers in Europe include:

• Stringent Regulatory Standards : The region’s commitment to regulatory compliance in biologics production continues to support the adoption of single-use assemblies, especially for monoclonal antibodies and gene therapies .

• Sustainability Focus : Europe is at the forefront of the push for green manufacturing solutions , and single-use systems, with their lower reagent consumption and reduced waste generation, are perfectly aligned with the sustainability goals of pharmaceutical companies.

• Growing Demand for Biologics : With an increasing focus on personalized treatments and biologics , European pharmaceutical manufacturers are increasingly opting for flexible, scalable single-use systems to meet evolving production needs.

While the region is well-established, future growth will likely stem from the expansion of gene therapy manufacturing and continued pressure to improve the sustainability of the biopharma industry.

 

Asia-Pacific

Asia-Pacific is the fastest-growing region in the Single-Use Assemblies Market , with a projected CAGR of 11.5% from 2024 to 2030. Countries like China and India are driving this growth, as they rapidly scale up their biopharmaceutical manufacturing capabilities to meet growing domestic and global demand.

Key growth drivers include:

• Expanding Biopharma Industry : As China and India continue to develop their biotech sectors, the demand for efficient, scalable production solutions like single-use assemblies is growing quickly. The rapid rise of biologics manufacturing and biosimilars in these countries is expected to drive demand.

• Regulatory Advancements : In many Asia-Pacific countries, regulatory frameworks for biologics manufacturing are becoming stricter, making single-use technologies a natural choice due to their high standards of contamination control and low cost.

• Growing Investments in Pharma R&D : Increased government and private investments in biopharmaceutical R&D are contributing to the rapid adoption of modern manufacturing techniques, including the use of single-use assemblies for clinical trials and large-scale production .

Asia-Pacific represents significant untapped potential, especially in emerging markets like Vietnam and Indonesia , where the adoption of single-use assemblies is set to increase dramatically.

 

Latin America, Middle East, and Africa (LAMEA)

The LAMEA region represents a smaller portion of the global Single-Use Assemblies Market but is showing signs of growth, particularly in Latin America and parts of the Middle East .

• Latin America : Countries like Brazil and Mexico are seeing increased demand for biopharmaceutical production driven by rising healthcare needs, a growing middle class, and improved regulatory standards. The push toward affordable and scalable manufacturing solutions is expected to drive adoption of single-use assemblies.

• Middle East : The Middle East is also witnessing growth, with countries like Saudi Arabia investing heavily in biotech R&D and pharmaceutical manufacturing . Regulatory adoption in this region is aligned with global standards, which is expected to further stimulate growth for single-use systems .

• Africa : In Africa , the adoption of single-use assemblies remains low, but the potential for growth is significant as the pharmaceutical industry begins to take off in countries such as South Africa and Nigeria .

The LAMEA region represents a strong growth opportunity, especially in countries where the pharmaceutical industry is expanding and adopting advanced manufacturing technologies.

 

Conclusion:

The Single-Use Assemblies Market is experiencing rapid expansion, with North America and Europe maintaining leadership positions in market share, while the Asia-Pacific region is emerging as the fastest-growing market. For companies looking to capitalize on this growth, focusing on emerging markets like China , India , and Latin America will be key to unlocking new opportunities.

Region-specific dynamics, such as regulatory pressures in North America and Europe, and burgeoning biopharma sectors in Asia-Pacific, will dictate the competitive landscape in the coming years.

 

End-User Dynamics And Use Case

The Single-Use Assemblies Market is experiencing varied adoption across different end-users, driven by specific operational needs and production requirements. From biopharmaceutical companies to contract manufacturing organizations (CMOs) , the demand for single-use systems has surged due to their flexibility, scalability, and ability to ensure compliance with stringent regulatory standards. Below, we examine how various end users are leveraging single-use assemblies and highlight one relevant use case demonstrating their impact.

Biopharmaceutical Companies

Biopharmaceutical companies represent the largest and most sophisticated group of end users for single-use assemblies. These companies are leveraging these systems for the production of monoclonal antibodies ( mAbs ) , vaccines , and gene therapies . Single-use systems have become critical in biologic drug manufacturing, especially for:

• Cell culture media production , where precise control over the manufacturing environment is essential for optimal product yields.

• Scale-up of manufacturing processes , where traditional stainless steel equipment could be cumbersome and less flexible.

• Regulatory compliance , where contamination risks must be minimized, and single-use systems offer a clear advantage over reusable equipment.

“For biologics production, single-use systems are the future. They allow us to meet stringent regulatory requirements while reducing the cost and time needed for cleaning and validation processes,” said the CEO of a leading biopharma company.

 

Contract Manufacturing Organizations (CMOs)

Contract Manufacturing Organizations (CMOs) play a pivotal role in the global pharmaceutical ecosystem, offering outsourced manufacturing services to biopharma companies. These organizations are increasingly adopting single-use assemblies for several reasons:

• Flexibility : CMOs often work with multiple clients, each with varying production needs. Single-use systems allow them to easily switch between different products without the need for complex cleaning protocols.

• Cost-Effectiveness : By reducing the need for extensive capital investment in large-scale stainless steel equipment, CMOs can offer more affordable production services to smaller biopharma firms.

• Faster Turnaround : Single-use systems enable faster scaling of production, making it easier for CMOs to meet tight deadlines for clinical trial material or commercial batches.

CMOs are turning to single-use solutions to optimize turnaround time and reduce capital costs, positioning themselves as key players in the manufacturing supply chain.

 

Academic and Research Institutes

Academic and research institutions are using single-use assemblies in the development of new drugs and therapies. These labs typically handle smaller volumes and require high flexibility for experimentation. The adoption of single-use assemblies in research institutions is driven by:

• Ease of Use : Single-use systems offer simplicity and are often more cost-effective for smaller-scale applications compared to traditional systems.

• High Customization : As academic research often deals with a wide variety of therapeutic areas, having modular and customizable equipment is crucial. Single-use assemblies provide the adaptability required for diverse research needs.

“Single-use systems allow us to focus on innovation in drug discovery without worrying about contamination or the need to constantly clean and sterilize equipment,” stated a researcher at a leading biotech institute.

 

Forensic and Environmental Laboratories

Though smaller in terms of market size, forensic and environmental labs have also adopted single-use assemblies for specific tasks. These labs often require highly precise and quick analyses to detect trace elements or contaminants. Forensic labs, in particular, rely on:

• DNA Fragmentation : Single-use assemblies are increasingly used in genetic analysis for crime scene investigations and paternity testing.

• Contaminant Detection : Environmental labs utilize single-use filtration systems to identify pollutants or toxins in water and soil samples.

“Single-use filtration systems are invaluable in forensic applications, where contamination control is a top priority, and the need for quick turnaround is critical,” noted a forensic expert.

 

Use Case Highlight: Gene Therapy Production in South Korea

In a tertiary hospital research center in South Korea , a major challenge arose during the development of a gene therapy for a rare genetic disorder. The regulatory body requested detailed proof of purity and contamination-free production for approval. The hospital’s R&D team turned to a single-use bioreactor system to produce the gene therapy. The flexibility of the system allowed them to quickly scale the production process, while minimizing the risk of cross-contamination between batches.

• Problem : The hospital was facing stringent deadlines for submitting a clinical trial application, and delays in production could have led to substantial financial and reputational losses.

• Solution : By utilizing a single-use system for the bioreactor and downstream processing, the hospital met regulatory demands while speeding up the production timeline by 30% .

• Outcome : Not only did the team meet the submission deadline, but they also improved the overall production efficiency, saving both time and costs. This success led the hospital to adopt single-use assemblies as a permanent part of their production process for other gene therapy projects.

This use case underscores how single-use assemblies can drastically improve the efficiency, scalability , and regulatory compliance of cutting-edge therapies like gene therapies, thus demonstrating the growing value of these systems in innovative biopharmaceutical applications .

 

Conclusion:

End users across different sectors are increasingly relying on single-use assemblies for their flexibility, efficiency, and ability to meet stringent regulatory demands. Whether in biopharmaceutical manufacturing , clinical research , or forensic labs , these systems are transforming how production and analysis are conducted. The future of single-use systems in biopharma and beyond looks promising, with growing demand for gene therapies , personalized medicine , and environmental testing driving further adoption.

Single-use assemblies are fast becoming an integral part of biopharmaceutical production and research, offering unique solutions to meet the evolving needs of the healthcare and life sciences industries.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• Thermo Fisher's Acquisition of Patheon In 2023, Thermo Fisher Scientific expanded its capabilities by acquiring Patheon , a contract development and manufacturing organization (CDMO). This acquisition strengthens Thermo Fisher’s presence in the single-use biomanufacturing market , particularly in biologics production. With this acquisition, Thermo Fisher now offers an end-to-end solution for biopharmaceutical companies, from early-phase clinical trials to large-scale manufacturing, leveraging its robust single-use assemblies portfolio.

• GE Healthcare’s Launch of the WAVE™ 25 System In 2024, GE Healthcare launched the WAVE™ 25 single-use bioreactor system, which integrates advanced real-time monitoring and automation to support the production of cell-based therapies and gene therapies . This system enhances the flexibility and scalability of cell culture processes, allowing for more efficient production and better process control, particularly in the rapidly growing field of personalized medicine .

• Sartorius’ Development of Eco-Friendly Single-Use Assemblies In 2023, Sartorius Stedim Biotech unveiled a new line of eco-friendly single-use assemblies designed to reduce environmental impact. The new products are made using biodegradable materials and sustainable production methods . This development aligns with the growing global focus on sustainability and green chemistry in the pharmaceutical manufacturing sector, positioning Sartorius as a leader in environmentally conscious biomanufacturing solutions.

• Merck KGaA's Expansion of Single-Use Solutions for Gene Therapy In early 2024, Merck KGaA expanded its single-use technologies portfolio specifically for gene therapy applications. The new line of single-use systems is designed to support the complex and sensitive nature of gene therapy manufacturing, where precision and contamination control are paramount. Merck’s investment into this area reflects the growing demand for advanced technologies that can support the production of cutting-edge biologics and cell-based therapies.

• Pall Corporation’s Collaboration with Cell and Gene Therapy Firms Pall Corporation announced a strategic collaboration with cell and gene therapy companies in 2023 to co-develop customized single-use assemblies . This collaboration aims to address the unique challenges posed by the production of gene therapies, including the need for scalable, flexible, and contamination-free processes. This partnership is expected to accelerate the adoption of single-use technologies in the gene therapy sector, which is poised for significant growth in the coming years.

 

Opportunities

• Gene Therapy and Cell Therapy One of the most significant opportunities in the Single-Use Assemblies Market lies in the expansion of gene and cell therapy manufacturing. As the demand for these therapies grows, so too does the need for scalable, contamination-free production systems. Single-use assemblies, with their flexibility and ease of scalability, are ideal for these complex manufacturing processes. This trend presents an opportunity for single-use suppliers to expand their portfolios and offer specialized solutions tailored to the needs of gene therapy production.

• Emerging Markets in Asia-Pacific The Asia-Pacific region presents one of the most promising growth opportunities for the Single-Use Assemblies Market . Countries like China , India , and South Korea are investing heavily in biopharmaceutical manufacturing capabilities, driven by the growing demand for affordable healthcare solutions and biologics. As these markets continue to develop, there will be a strong push toward adopting advanced manufacturing technologies, including single-use systems . Companies that can establish a presence in these emerging markets early will benefit from the growth in biopharma and vaccine manufacturing.

• Sustainability and Green Chemistry Initiatives Sustainability is becoming a key driver for adopting single-use systems , particularly as pharmaceutical companies face increasing regulatory pressure to reduce their environmental footprint. Single-use systems typically generate less waste and require fewer resources compared to traditional stainless steel systems, making them an attractive option for companies looking to improve the sustainability of their manufacturing processes. This presents a significant opportunity for single-use system providers that focus on eco-friendly materials and processes.

• Partnerships with Contract Manufacturing Organizations (CMOs) Contract manufacturing organizations (CMOs) are increasingly adopting single-use systems to meet the diverse and evolving needs of their clients. These organizations provide outsourced manufacturing services to biopharma companies, and as their demand for flexible, cost-effective solutions grows, single-use technology adoption is set to increase. By partnering with CMOs, single-use providers can expand their customer base and strengthen their market position.

 

Restraints

• High Initial Investment Costs While single-use systems are cost-effective in the long term due to reduced maintenance and operational costs, the initial investment for purchasing these systems can still be high, especially for smaller biopharma companies or emerging markets. The high upfront costs of implementing single-use technology can be a barrier for adoption, particularly in price-sensitive markets or for companies that are still in the early stages of production scale-up.

• Limited Skilled Workforce The successful implementation of single-use assemblies requires specialized training and expertise, which can present a challenge in regions where skilled labor is limited. For instance, some emerging markets face difficulties in developing a workforce that is well-versed in advanced biomanufacturing techniques . Without proper training and knowledge, there can be risks in the setup and operation of these systems, potentially limiting their adoption.

• Regulatory Hurdles While single-use assemblies are increasingly seen as a solution to improve efficiency and flexibility, their widespread adoption still faces regulatory hurdles . Different regions have varying requirements for the approval of manufacturing processes, and navigating these can be time-consuming and complex. For example, some regulatory bodies require extensive validation and testing for single-use systems before they can be adopted for commercial-scale production. These regulatory challenges can slow down the market’s growth, particularly in regions with stringent requirements.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 4.8 Billion
Revenue Forecast in 2030	USD 8.27 Billion
Overall Growth Rate	CAGR of 9.5% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Application, By End User, By Geography
Key Regions	North America, Europe, Asia-Pacific, LAMEA
Customization Option	Available upon request