세계의 일회용 어셈블리 시장 : 제품, 워크플로우, 용도, 최종 용도별 - 예측(2025-2030년)

The Single Use Assemblies Market was valued at USD 7.51 billion in 2024 and is projected to grow to USD 8.39 billion in 2025, with a CAGR of 11.39%, reaching USD 14.35 billion by 2030.

Single Use Assemblies are rapidly reshaping the landscape of modern manufacturing and processing, fostering innovation and efficiency in ways that were once unimaginable. The emergence of these assemblies marks a significant shift in how products are designed, tested, and implemented across various industry verticals. Over the past few years, countless advancements in materials science, engineering processes, and quality assurance techniques have combined to drive improvements in both performance and sustainability.

In an environment where regulatory compliance and the demand for rapid product development are paramount, Single Use Assemblies provide a flexible and cost-effective solution. The technology is not only streamlining operations but also reducing the significant overhead associated with traditional manufacturing systems. With reduced downtime, minimized cross-contamination risks, and enhanced modularity, the assemblies are setting new benchmarks across multiple sectors.

This transformative approach is steering the industry toward a future where operational efficiency meets cutting-edge innovation. By embracing high-integrity components that can be rapidly deployed and even easily reconfigured, manufacturers are better positioned to respond to evolving market demands. The resulting agility is critical in today's fast-paced industrial environment. As market dynamics continue to evolve, understanding the drivers behind these changes is essential for companies aiming to maintain a competitive edge.

Transformative Shifts Redefining the Industry Landscape

Recent innovations in Single Use Assemblies have catalyzed transformative shifts in the industry, fundamentally redefining how organizations approach product innovation and operational efficiency. Striking innovations in design, coupled with advancements in smart technologies, are now underpinning the shift from traditional assembly methods to more agile, single use platforms.

Emerging trends driven by digital integration and automation are reshaping every stage of the manufacturing process. Companies are embracing state-of-the-art solutions that facilitate not only real-time monitoring but also predictive maintenance and process optimization. In turn, these changes contribute to significant cost savings and improved product outcomes. Manufacturers can now rapidly reconfigure systems to meet evolving production demands and quality controls, which offers them the flexibility necessary to tackle challenges in a volatile economic environment.

Furthermore, the emphasis on environmental stewardship and sustainability has led to the adoption of eco-friendly materials and innovative waste reduction practices. This dual emphasis on performance and sustainability is a powerful combination, bolstering competitive positioning for early adopters. In summary, the transformative shifts witnessed in this sector are not merely incremental improvements, but rather a comprehensive recalibration of how industries can leverage technology and data to drive operational excellence.

Key Segmentation Insights Driving Market Strategies

A deeper dive into the segmentation of the Single Use Assemblies market reveals a nuanced framework that illuminates specific growth opportunities and tailored strategies. From a product perspective, studies are stratified across bag assemblies, bottle assemblies, filtration assemblies, and mixing system assemblies. This classification provides a granular view of the product landscape, each category contributing unique performance characteristics and cost implications.

When examining the workflow category, distinct focus areas such as downstream processing, fill-finish operations, quality control and analytics, and upstream processing emerge as critical factors. This segmentation ensures that every stage of the production process is optimized, from initial assembly to final quality checks.

Application-based segmentation further distinguishes the market through specific operational needs including aseptic filling, cell culture, filtration, mixing, purification, sampling, and storage. Such diversity in application paves the way for customization and targeted marketing strategies, whereby each application benefits from tailored performance enhancements.

From an end user standpoint, the market is analyzed across academic and research institutes, contract manufacturing organizations and contract research organizations, as well as pharmaceutical and biotechnology companies. By capturing variations in demand, regulatory requirements, and technological readiness, this multi-faceted segmentation framework provides invaluable insight and strategic direction to companies aiming to serve a diverse customer base.

Based on Product, market is studied across Bag Assemblies, Bottle Assemblies, Filtration Assemblies, and Mixing System Assemblies.

Based on Workflow, market is studied across Downstream Processing, Fill-Finish Operations, Quality Control & Analytics, and Upstream Processing.

Based on Application, market is studied across Aseptic Filling, Cell Culture, Filtration, Mixing, Purification, Sampling, and Storage.

Based on End User, market is studied across Academic & Research Institutes, Contract Manufacturing Organizations & Contract Research Organizations, and Pharmaceutical & Biotechnology Companies.

Key Regional Insights Shaping the Market Dynamics

Regional dynamics play a critical role in shaping the evolution of Single Use Assemblies, and attention must be given to the geographical markets that act as growth catalysts. Analysis of market activity across the Americas reveals a mature landscape punctuated by advanced R&D, well-established supply chains, and strong customer trust in cutting-edge technologies. In many cases, this region serves as both an innovation hub and a key adopter of first-mover competitive strategies.

In the combined region of Europe, the Middle East & Africa, regulatory frameworks and sustainability initiatives have become primary drivers supporting the integration of single use technologies in manufacturing. Market participants in this region are particularly adept at balancing strict regulatory environments with the need for process efficiency and innovation.

Asia-Pacific emerges as a powerhouse of emerging opportunities, with rapid industrialization coupled with increasing investments in state-of-the-art manufacturing facilities. As the region continues to expand its technological footprint and embrace global best practices, Single Use Assemblies are becoming an attractive proposition to streamline operations and achieve consistent quality. These regional insights highlight emerging trends that global companies must consider in order to remain competitive in an ever-changing market.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key Companies Pioneering Innovation in Single Use Assemblies

A myriad of industry leaders is actively pioneering advances that drive the evolution of Single Use Assemblies. Trusted innovators like 3M Company and Accuflow Systems, Inc. have long been recognized for their commitment to quality and exploratory engineering, setting a benchmark for excellence. Likewise, AdvantaPure by NewAge Industries, Inc. and Ami Polymer Pvt. Ltd. continue to forge new paths in design and functional efficiency with products that underscore precision and reliability.

Critical contributions also come from companies such as Antylia Scientific, Avantor, Inc., and avintos AG, where research and robust manufacturing protocols converge to deliver high-performance assemblies. The presence of BioProcess Engineering Services Limited and BioPulse Solutions Pvt. Ltd. in the competitive sphere has catalyzed a shift towards more streamlined production cycles, while Cellexus Limited and Cobetter Filtration Group have become synonymous with innovation in integrated system architectures.

Other prominent players, including Colly Flowtech AB, Compagnie de Saint-Gobain S.A., and Corning Incorporated, have successfully harnessed advancements in material sciences to boost production capabilities. Global giants like Danaher Corporation, Distek, Inc., Dover Corporation, and DuPont de Nemours, Inc. further exemplify the synergy of engineering expertise and operational excellence. Contributions from DWK Life Sciences GmbH, Entegris, Inc., Foxx Life Sciences, and GE HealthCare Technologies Inc. underscore the vital role of technological integration in optimizing manufacturing processes.

Additional companies, including Getinge AB, ILC Dover LP, Intellitech, Inc., and Keofitt A/S, demonstrate innovative portfolio expansion that addresses both market demand and regulatory requirements. The roster is complemented by leaders such as Liquidyne Process Technologies, Inc., Lonza Group Ltd., and Meissner Corporation, who consistently push the envelope of precision. With forward-thinking strategies, Merck KGaA, Owen Mumford Limited, Parker-Hannifin Corporation, Pharsol Ltd., and Purity One continue to influence market trends. Notably, Repligen Corporation, Romynox B.V., SaniSure Inc., Sartorius AG, Satake Multimix Corporation, Single Use Support GmbH, Thermo Fisher Scientific Inc., Trelleborg AB, and WHK BioSystems, LLC all contribute to a vibrant ecosystem of innovation, thereby reinforcing the competitive landscape and setting industry benchmarks.

The report delves into recent significant developments in the Single Use Assemblies Market, highlighting leading vendors and their innovative profiles. These include 3M Company, Accuflow Systems, Inc., AdvantaPure by NewAge Industries, Inc., Ami Polymer Pvt. Ltd., Antylia Scientific, Avantor, Inc., avintos AG, BioProcess Engineering Services Limited, BioPulse Solutions Pvt. Ltd., Cellexus Limited, Cobetter Filtration Group, Colly Flowtech AB, Compagnie de Saint-Gobain S.A., Corning Incorporated, Danaher Corporation, Distek, Inc., Dover Corporation, DrM, Dr. Mueller AG, DuPont de Nemours, Inc., DWK Life Sciences GmbH, Entegris, Inc., Foxx Life Sciences, GE HealthCare Technologies Inc., Getinge AB, ILC Dover LP, Intellitech, Inc., Keofitt A/S, Liquidyne Process Technologies, Inc, Lonza Group Ltd., Meissner Corporation, Merck KGaA, Owen Mumford Limited, Parker-Hannifin Corporation, Pharsol Ltd., Purity One, Repligen Corporation, Romynox B.V., SaniSure Inc., Sartorius AG, Satake Multimix Corporation, Single Use Support GmbH, Thermo Fisher Scientific Inc., Trelleborg AB, and WHK BioSystems, LLC. Actionable Recommendations for Industry Leaders

To stay ahead in the rapidly evolving arena of Single Use Assemblies, industry leaders must adopt a proactive and multifaceted approach to innovation and strategy. First, continuous investment in R&D is essential, with a particular focus on integrating digital technologies that enhance real-time data analytics and automation. Emphasis should be placed on developing modular systems that can be quickly adapted to meet shifting regulatory requirements and market demands.

Companies should also prioritize building versatile partnerships with key suppliers and technology providers. These collaborative efforts can help in navigating supply chain challenges while simultaneously driving cost efficiencies. In addition, leveraging cross-functional expertise across departments such as quality control, operations, and strategic planning will be critical to capitalize on emerging trends and meet customer expectations.

Finally, organizations must remain agile by adopting a customer-centric mindset that not only responds to current market needs but also anticipates future demands. Implementing comprehensive training programs and investing in personnel development will ensure that teams are equipped to leverage new tools and technologies. Establishing clear, actionable milestones will allow companies to track progress and make data-driven adjustments that solidify their competitive position.

Conclusion: Embracing a Future of Innovation and Efficiency

The evolving landscape of Single Use Assemblies is a testament to the relentless pace of technological and operational change. As industries worldwide continue to transition away from traditional systems, the benefits of modularity, reduced contamination risk, and enhanced efficiency have never been more apparent. With comprehensive segmentation, robust regional insights, and the active participation of leading innovators, the market is poised for sustained growth and breakthrough advancements.

In embracing these dynamic changes, organizations stand to gain not only in terms of operational effectiveness but also in their ability to respond to global demands swiftly and responsibly. The future of manufacturing thereby rests on the twin pillars of innovation and sustainability, ensuring that companies remain at the forefront of technological progress.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Growing need for biologics and biosimilars increasing the use of flexible manufacturing systems
    • 5.1.1.2. Global emphasis on pandemic preparedness and outbreak response
  • 5.1.2. Restraints
    • 5.1.2.1. Issues regarding standardization and complexities in integrating the single-use assembly systems
  • 5.1.3. Opportunities
    • 5.1.3.1. Advancements in materials and the integration of automation and robotics with single-use systems
    • 5.1.3.2. Promoting single use assemblies in academic research labs to streamline experimental setups and outcomes
  • 5.1.4. Challenges
    • 5.1.4.1. Regulatory and compliance challenges, along with environmental and sustainability concerns associated with single-use bioprocessing adoption
• 5.2. Market Segmentation Analysis
  • 5.2.1. Product: Significant usage of the bag assemblies ideal for media preparation and cell culture processes
  • 5.2.2. End User: Integrating single use assemblies across contract research organizations for quicker processing and process changeover time
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Single Use Assemblies Market, by Product

• 6.1. Introduction
• 6.2. Bag Assemblies
• 6.3. Bottle Assemblies
• 6.4. Filtration Assemblies
• 6.5. Mixing System Assemblies

7. Single Use Assemblies Market, by Workflow

• 7.1. Introduction
• 7.2. Downstream Processing
• 7.3. Fill-Finish Operations
• 7.4. Quality Control & Analytics
• 7.5. Upstream Processing

8. Single Use Assemblies Market, by Application

• 8.1. Introduction
• 8.2. Aseptic Filling
• 8.3. Cell Culture
• 8.4. Filtration
• 8.5. Mixing
• 8.6. Purification
• 8.7. Sampling
• 8.8. Storage

9. Single Use Assemblies Market, by End User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Contract Manufacturing Organizations & Contract Research Organizations
• 9.4. Pharmaceutical & Biotechnology Companies

10. Americas Single Use Assemblies Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Single Use Assemblies Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Single Use Assemblies Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2024
• 13.2. FPNV Positioning Matrix, 2024
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Merck launches innovative single-use reactor
  • 13.3.2. Freudenberg's strategic expansion of biopharma portfolio with innovative single-use assemblies
  • 13.3.3. SaniSure launches Fill4Sure custom single-use filling assembly
  • 13.3.4. Repligen Announces Agreement to Acquire Fluid Management Innovator Metenova
  • 13.3.5. Qosina Adds OneShot Single-Use Filling Needles from Overlook Industries to Its Bioprocess Components Portfolio
  • 13.3.6. Sartorius and Repligen Launch Upstream Processing Intensification System
  • 13.3.7. Trelleborg Launches BioPharmaPro Product Line
  • 13.3.8. AdvantaPure Launches Single Use Solution for Tubing Management
  • 13.3.9. Getinge AB to Acquire High Purity New England, Inc., a Provider of Single-use Solutions for Bioprocessing Applications
  • 13.3.10. Merck KGaA Launches Ultimus Film to Offer Superior Strength and Leak Resistance in Single-use Assemblies
  • 13.3.11. U.S.-based Foxx Life Sciences to Invest INR 200 Crore in Telangana
  • 13.3.12. Thermo Fisher Scientific, Inc. Expands Single-Use Technology in China
  • 13.3.13. Merck Invests More than Euro 130 Million to Strengthen Manufacturing Capabilities in Molsheim, France
  • 13.3.14. Stevanato Group and Owen Mumford Sign Exclusive Collaboration Agreement for the Innovative Aidaptus Auto-Injector
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. 3M Company
• 2. Accuflow Systems, Inc.
• 3. AdvantaPure by NewAge Industries, Inc.
• 4. Ami Polymer Pvt. Ltd.
• 5. Antylia Scientific
• 6. Avantor, Inc.
• 7. avintos AG
• 8. BioProcess Engineering Services Limited
• 9. BioPulse Solutions Pvt. Ltd.
• 10. Cellexus Limited
• 11. Cobetter Filtration Group
• 12. Colly Flowtech AB
• 13. Compagnie de Saint-Gobain S.A.
• 14. Corning Incorporated
• 15. Danaher Corporation
• 16. Distek, Inc.
• 17. Dover Corporation
• 18. DrM, Dr. Mueller AG
• 19. DuPont de Nemours, Inc.
• 20. DWK Life Sciences GmbH
• 21. Entegris, Inc.
• 22. Foxx Life Sciences
• 23. GE HealthCare Technologies Inc.
• 24. Getinge AB
• 25. ILC Dover LP
• 26. Intellitech, Inc.
• 27. Keofitt A/S
• 28. Liquidyne Process Technologies, Inc
• 29. Lonza Group Ltd.
• 30. Meissner Corporation
• 31. Merck KGaA
• 32. Owen Mumford Limited
• 33. Parker-Hannifin Corporation
• 34. Pharsol Ltd.
• 35. Purity One
• 36. Repligen Corporation
• 37. Romynox B.V.
• 38. SaniSure Inc.
• 39. Sartorius AG
• 40. Satake Multimix Corporation
• 41. Single Use Support GmbH
• 42. Thermo Fisher Scientific Inc.
• 43. Trelleborg AB
• 44. WHK BioSystems, LLC