Single-Use Assemblies Market Set For Strong Growth As Biopharma Adoption Accelerates And USP 665 Standards Unlock New Opportunities

(MENAFN- GlobeNewsWire - Nasdaq) Biologics, cell and gene therapies, biosimilars and CDMOs are driving single-use adoption, creating opportunities in smart sensors, regional supply hubs and sustainable materials.

Dublin, Sept. 23, 2026 (GLOBE NEWSWIRE) -- "Single-Use Assemblies Market Summary 2026: Trends, Regulatory Standards (USP <665>), and Growth Forecast" has been added to ResearchAndMarkets.com's offering.

Single-use assemblies have become a critical component of biopharmaceutical manufacturing, supporting fluid transfer, mixing, filtration, storage and containment across upstream and downstream processes. These pre-sterilized systems typically integrate bioprocess bags, tubing, connectors, clamps, filters and sensors into application-specific configurations. Their growing use reflects the pharmaceutical industry's shift toward flexible, closed and scalable bioprocessing infrastructure.

Adoption has accelerated as manufacturers seek to reduce cross-contamination risk, cleaning requirements, water consumption and facility turnaround times. Single-use technologies also support faster product changeovers and lower initial capital expenditure than conventional stainless-steel infrastructure. These advantages are especially important for multiproduct facilities, clinical manufacturing and biologics produced in smaller batches.

Single-Use Assemblies Market Size and Forecast

The global single-use assemblies market is estimated to be valued between USD 6.0 billion and USD 9.5 billion in 2026. The market is projected to expand at a compound annual growth rate of approximately 14.5% to 17.5% from 2026 through 2031.

Growth is being supported by expanding pipelines for monoclonal antibodies, vaccines, biosimilars, antibody-drug conjugates, and cell and gene therapies. Investment in new biopharmaceutical facilities and the conversion of existing plants to hybrid manufacturing models are also increasing demand for single-use bioprocessing systems.

Regulatory standardization is expected to strengthen commercial adoption. USP General Chapter <665>, covering plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing, became effective in May 2026 alongside supporting guidance in USP <1665>. These chapters establish a more consistent framework for evaluating extractables and leachables, material suitability and patient safety.

Regional Market Analysis

• North America: The region remains the largest market, with estimated annual growth of 14% to 16%. Demand is driven by established biotechnology clusters, personalized medicine investment, commercial-scale adoption and efforts to localize pharmaceutical manufacturing.
• Europe: Growth is estimated at 13% to 16%, supported by biomanufacturing operations in Germany, Switzerland, Ireland and France. Companies are modernizing stainless-steel facilities and investing in hybrid or fully disposable production platforms.
• Asia-Pacific: With projected growth of 17% to 22%, Asia-Pacific is the fastest-expanding regional market. China and India are increasing domestic biomanufacturing capacity, while South Korea and Singapore remain important biologics production hubs. CDMOs in Taiwan, China are also adopting flexible single-use systems to serve international clients.
• Latin America: Estimated growth of 10% to 14% is being led by Brazil and Mexico, particularly in biosimilars, vaccines and local fill-finish operations.
• Middle East and Africa: The region is expected to grow by 9% to 13%, supported by vaccine self-sufficiency programs and modular biopharmaceutical facility investments in Saudi Arabia and the United Arab Emirates.

Market Segmentation

Bag assemblies represent the largest product segment, including 2D storage and sampling bags and 3D systems used in bioreactors and mixing applications. Demand is shifting toward advanced multilayer films with improved gas-barrier performance, reduced extractables and greater suitability for frozen storage.

Filtration assemblies are gaining importance as manufacturers move toward closed bioprocessing. These systems support media, buffer, process-stream and final-product filtration. Single-use mixing assemblies are also replacing fixed vessels for media and buffer preparation by reducing cleaning validation and improving facility turnover.

Other important product categories include bottle assemblies, tubing manifolds, transfer sets and integrated sensor assemblies. Demand for single-use sensors is expanding as manufacturers implement real-time process monitoring and automated control strategies.

Biopharmaceutical and pharmaceutical companies account for a substantial share of demand, particularly in clinical manufacturing, biologics production and high-containment applications. Contract research, development and manufacturing organizations are among the most active adopters because single-use platforms facilitate rapid product changeovers within multiproduct facilities. Academic institutions and research laboratories also use these systems for process development and scale-up studies.

Competitive Landscape and Supply Chain

The single-use assemblies market depends on a specialized value chain encompassing medical-grade resins, multilayer films, tubing, connectors, filters, sensors, cleanroom assembly, sterilization and sterile-barrier logistics. Gamma irradiation remains the leading sterilization method, although capacity constraints are increasing interest in X-ray processing.

Leading market participants include Thermo Fisher Scientific, Sartorius, Danaher through Cytiva and Pall, Merck KGaA through MilliporeSigma, Avantor, Saint-Gobain, Entegris, Repligen and Parker-Hannifin. Competition centers on material performance, customization, validation support, global manufacturing capacity, delivery reliability and portfolio integration.

Market Opportunities

• Cell and gene therapy manufacturing: Patient-specific and small-batch workflows are creating demand for specialized, closed and compact single-use assemblies.
• Regional manufacturing expansion: Local assembly and distribution hubs can reduce lead times, improve supply continuity and support regional biopharmaceutical investment.
• Biosimilar production: Cost-sensitive manufacturers increasingly favor single-use facilities to reduce capital requirements and accelerate capacity deployment.
• Process intensification: Higher-productivity workflows are increasing demand for advanced filtration, fluid management and integrated sensing technologies.

Industry Challenges

Extractables and leachables remain a significant technical and regulatory consideration. Suppliers must generate extensive material characterization data, while manufacturers must assess compatibility with specific process fluids and drug formulations.

Sustainability is another priority. Although single-use systems can reduce water and energy consumption, multilayer bioprocess films are difficult to recycle. The industry is therefore investing in waste segregation, take-back programs, alternative sterilization methods and improved life-cycle assessment.

Supply chain concentration also presents risk. Dependence on a limited number of resin, film and component suppliers can affect production continuity during periods of disruption. Manufacturers are responding through dual sourcing, regional production, inventory planning and greater standardization of components.

Through 2031, the global single-use assemblies market is expected to maintain strong growth as biologics pipelines expand and manufacturers prioritize flexible, contamination-controlled production. Regulatory clarity, regional capacity investment and innovation in materials, sensors and closed processing will remain central to the market's long-term development.

Key Topics Covered:
Chapter 1 Report Overview 1
1.1 Study Scope 1
1.2 Research Methodology 2
1.2.1 Data Sources 2
1.2.2 Assumptions 3
1.3 Abbreviations and Acronyms 5
Chapter 2 Executive Summary 7
2.1 Global Single-Use Assemblies Market Size Estimates and Forecasts (2021-2031) 7
2.2 Global Single-Use Assemblies Market Share by Region (2026) 8
2.3 Key Market Trends and Emerging Technologies 9
2.4 Impact of Global Biopharmaceutical Supply Chain Shifts 11
Chapter 3 Market Dynamics and Value Chain Analysis 13
3.1 Market Drivers 13
3.1.1 Shift from Stainless Steel to Single-Use Technologies (SUT) 13
3.1.2 Growing Biologics Pipeline (mAbs, Vaccines, Cell & Gene Therapy) 14
3.2 Market Restraints 15
3.2.1 Leachables and Extractables (L&E) Concerns 15
3.2.2 Environmental Impact and Plastic Waste Management 16
3.3 Value Chain Analysis 17
3.3.1 Raw Material Suppliers (Resins, Films, Tubing) 17
3.3.2 Component Manufacturers vs. Integrators 18
3.3.3 Sterilization Service Providers (Gamma, X-Ray) 19
3.4 Porters Five Forces Analysis 20
Chapter 4 Global Single-Use Assemblies Market by Type 22
4.1 Global Single-Use Assemblies Market Size and Forecast by Type (2021-2031) 22
4.2 Bag Assemblies (2D Bags, 3D Bags, Storage, Sampling) 23
4.3 Filtration Assemblies (Depth Filters, Sterile Filters, TFF) 24
4.4 Bottle Assemblies 25
4.5 Mixing System Assemblies 26
4.6 Other Assemblies (Tubing Manifolds, Connectors, Sensors) 27
Chapter 5 Global Single-Use Assemblies Market by Application 29
5.1 Global Single-Use Assemblies Market Size and Forecast by Application (2021-2031) 29
5.2 Biopharmaceutical & Pharmaceutical Companies 30
5.2.1 Clinical Scale vs. Commercial Scale Adoption 30
5.3 CROs & CMOs (Contract Research & Manufacturing Organizations) 31
5.4 Academic & Research Institutes 32
Chapter 6 Manufacturing Technology and Regulatory Analysis 33
6.1 Film Technologies and Material Science 33
6.2 Cleanroom Assembly Standards (ISO Class 7) 34
6.3 Sterilization Trends: Gamma Irradiation vs. X-Ray Validation 35
6.4 Regulatory Landscape (USP < 665>, BPOG Guidelines) 36
Chapter 7 North America Single-Use Assemblies Market Analysis 38
7.1 North America Market Size and Forecast (2021-2031) 38
7.2 North America Market by Type and Application 39
7.3 United States 40
7.4 Canada 41
Chapter 8 Europe Single-Use Assemblies Market Analysis 42
8.1 Europe Market Size and Forecast (2021-2031) 42
8.2 Europe Market by Type and Application 43
8.3 Germany 44
8.4 France 45
8.5 United Kingdom 45
8.6 Italy 46
8.7 Switzerland 47
8.8 Rest of Europe 47
Chapter 9 Asia-Pacific Single-Use Assemblies Market Analysis 48
9.1 Asia-Pacific Market Size and Forecast (2021-2031) 48
9.2 Asia-Pacific Market by Type and Application 49
9.3 China 50
9.4 Japan 51
9.5 India 51
9.6 South Korea 52
9.7 Taiwan (China) 53
9.8 Singapore and Southeast Asia 53
Chapter 10 Rest of World Single-Use Assemblies Market Analysis 54
10.1 Latin America (Brazil, Mexico) 54
10.2 Middle East & Africa 55
Chapter 11 Global Competition Landscape 56
11.1 Global Market Share Analysis by Key Players (2026) 56
11.2 Market Concentration Ratio (CR3, CR5) 57
11.3 Mergers, Acquisitions, and Strategic Partnerships 58
11.4 Manufacturing Capacity Expansion Strategies 59
Chapter 12 Company Profiles 60
12.1 Thermo Fisher Scientific Inc. 60
12.1.1 Company Overview 60
12.1.2 SWOT Analysis 60
12.1.3 Single-Use Product Portfolio (BioProcess Containers, etc.) 61
12.1.4 Thermo Fisher Scientific Inc. Single-Use Assemblies Operating Data 62
12.2 Sartorius AG 64
12.2.1 Company Overview 64
12.2.2 SWOT Analysis 64
12.2.3 Single-Use Product Portfolio (Flexsafe, Flexboy, etc.) 65
12.2.4 Sartorius AG Single-Use Assemblies Operating Data 66
12.3 Danaher Corporation (Cytiva/Pall) 68
12.3.1 Company Overview 68
12.3.2 SWOT Analysis 68
12.3.3 Single-Use Product Portfolio 69
12.3.4 Danaher Corporation Single-Use Assemblies Operating Data 70
12.4 Merck KGaA 72
12.4.1 Company Overview 72
12.4.2 SWOT Analysis 72
12.4.3 Single-Use Product Portfolio (Mobius, etc.) 73
12.4.4 Merck KGaA Single-Use Assemblies Operating Data 74
12.5 Avantor Inc. 76
12.5.1 Company Overview 76
12.5.2 SWOT Analysis 76
12.5.3 Single-Use Product Portfolio 77
12.5.4 Avantor Inc. Single-Use Assemblies Operating Data 78
12.6 Saint-Gobain S.A. 80
12.6.1 Company Overview 80
12.6.2 SWOT Analysis 80
12.6.3 Single-Use Product Portfolio 81
12.6.4 Saint-Gobain S.A. Single-Use Assemblies Operating Data 82
12.7 Entegris Inc. 84
12.7.1 Company Overview 84
12.7.2 SWOT Analysis 84
12.7.3 Single-Use Product Portfolio 85
12.7.4 Entegris Inc. Single-Use Assemblies Operating Data 86
12.8 Repligen Corporation 88
12.8.1 Company Overview 88
12.8.2 SWOT Analysis 88
12.8.3 Single-Use Product Portfolio 89
12.8.4 Repligen Corporation Single-Use Assemblies Operating Data 90
12.9 Parker-Hannifin Corporation 92
12.9.1 Company Overview 92
12.9.2 SWOT Analysis 92
12.9.3 Single-Use Product Portfolio 93
12.9.4 Parker-Hannifin Corporation Single-Use Assemblies Operating Data 94
Chapter 13 Market Forecast (2027-2031) 96
13.1 Global Market Size Forecast by Region 96
13.2 Global Market Size Forecast by Type 97
13.3 Global Market Size Forecast by Application 98
Chapter 14 Conclusion and Recommendations 99
List of Figures
Figure 1 Research Methodology and Data Triangulation 2
Figure 2 Global Single-Use Assemblies Market Revenue (USD Million) and Growth Rate, 2021-2031 7
Figure 3 Global Single-Use Assemblies Market Volume (Units) and Growth Rate, 2021-2031 8
Figure 4 Global Single-Use Assemblies Market Share by Region, 2026 9
Figure 5 Single-Use Assemblies Industry Value Chain Analysis 17
Figure 6 Porters Five Forces Analysis 20
Figure 7 Global Single-Use Assemblies Market Share by Type, 2026 22
Figure 8 Global Single-Use Assemblies Market Share by Application, 2026 29
Figure 9 North America Single-Use Assemblies Market Revenue (USD Million), 2021-2031 38
Figure 10 North America Single-Use Assemblies Market Share by Country, 2026 39
Figure 11 Europe Single-Use Assemblies Market Revenue (USD Million), 2021-2031 42
Figure 12 Europe Single-Use Assemblies Market Share by Country, 2026 43
Figure 13 Asia-Pacific Single-Use Assemblies Market Revenue (USD Million), 2021-2031 48
Figure 14 Asia-Pacific Single-Use Assemblies Market Share by Country, 2026 49
Figure 15 Latin America Single-Use Assemblies Market Revenue (USD Million), 2021-2031 54
Figure 16 Middle East & Africa Single-Use Assemblies Market Revenue (USD Million), 2021-2031 55
Figure 17 Global Single-Use Assemblies Market Share by Key Players, 2026 56
Figure 18 Thermo Fisher Scientific Inc. Single-Use Assemblies Market Share (2021-2026) 63
Figure 19 Sartorius AG Single-Use Assemblies Market Share (2021-2026) 67
Figure 20 Danaher Corporation Single-Use Assemblies Market Share (2021-2026) 71
Figure 21 Merck KGaA Single-Use Assemblies Market Share (2021-2026) 75
Figure 22 Avantor Inc. Single-Use Assemblies Market Share (2021-2026) 79
Figure 23 Saint-Gobain S.A. Single-Use Assemblies Market Share (2021-2026) 83
Figure 24 Entegris Inc. Single-Use Assemblies Market Share (2021-2026) 87
Figure 25 Repligen Corporation Single-Use Assemblies Market Share (2021-2026) 91
Figure 26 Parker-Hannifin Corporation Single-Use Assemblies Market Share (2021-2026) 95
Figure 27 Global Single-Use Assemblies Revenue Forecast by Region (2027-2031) 96
List of Tables
Table 1 Abbreviations and Acronyms 5
Table 2 Global Single-Use Assemblies Market Revenue (USD Million) and Volume (Units), 2021-2031 7
Table 3 Global Single-Use Assemblies Market Revenue (USD Million) by Type, 2021-2031 22
Table 4 Global Single-Use Assemblies Market Revenue (USD Million) by Application, 2021-2031 29
Table 5 North America Single-Use Assemblies Market Revenue (USD Million) by Country, 2021-2031 38
Table 6 Europe Single-Use Assemblies Market Revenue (USD Million) by Country, 2021-2031 42
Table 7 Asia-Pacific Single-Use Assemblies Market Revenue (USD Million) by Country, 2021-2031 48
Table 8 Latin America Single-Use Assemblies Market Revenue (USD Million) by Country, 2021-2031 54
Table 9 Middle East & Africa Single-Use Assemblies Market Revenue (USD Million) by Country, 2021-2031 55
Table 10 Global Market Ranking of Key Single-Use Assemblies Players (2026) 56
Table 11 Thermo Fisher Scientific Inc. Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 62
Table 12 Sartorius AG Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 66
Table 13 Danaher Corporation Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 70
Table 14 Merck KGaA Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 74
Table 15 Avantor Inc. Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 78
Table 16 Saint-Gobain S.A. Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 82
Table 17 Entegris Inc. Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 86
Table 18 Repligen Corporation Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 90
Table 19 Parker-Hannifin Corporation Single-Use Assemblies Sales, Price, Cost and Gross Profit Margin (2021-2026) 94
Table 20 Global Single-Use Assemblies Market Revenue Forecast (USD Million) by Region, 2027-2031 96
Companies Featured

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor Inc.
• Saint-Gobain S.A.
• Entegris Inc.
• Repligen Corporation
• Parker-Hannifin Corporation

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