미국의 일회용 어셈블리 시장 평가 : 제품별, 솔루션별, 용도별, 최종사용자별, 지역별 기회 및 예측(2018-2032년)

United States single-use assemblies market is projected to witness a CAGR of 16.13% during the forecast period 2025-2032, growing from USD 1202.20 million in 2024 to USD 3976.79 million in 2032. The growing complexity of biologics and personalized therapies is urgently demanding flexible, contamination-free, and efficient manufacturing systems. Single-use assemblies enable rapid changeovers, reduce validation burdens, and lower operational costs, making them essential for today's agile production needs. This shift is further supported by regulatory flexibility and the increasing adoption of continuous manufacturing models in the United States.

For instance, in March 2024, SaniSure, Inc. introduced the Bio-Ease Ultra Single-Use Filling Assembly, designed to optimize aseptic fluid transfer in biopharmaceutical manufacturing. This system features a fully sterilized, closed-loop design that reduces contamination risks and ensures process efficiency. The assembly integrates high-purity silicone tubing, aseptic connectors, and customized configurations, making it adaptable to various filling operations. With increasing regulatory scrutiny on sterility assurance in bioprocessing, Bio-Ease Ultra provides manufacturers with a validated, ready-to-use solution to enhance production consistency. This launch aligns with SaniSure, Inc.'s goal of delivering innovative single-use solutions to meet the growing demands of the biopharmaceutical industry.

Growing Adoption of Single-Use Systems in the Bioprocessing Industry

The increasing shift toward single-use systems in the U.S. bioprocessing industry significantly transforms the manufacturing landscape. Unlike traditional stainless-steel systems, single-use assemblies eliminate the need for time-consuming cleaning and sterilization processes, reducing turnaround times between batches and minimizing the risk of cross-contamination. This efficiency ensures higher product safety and compliance with regulatory standards and enables faster production cycles, critical in the dynamic biologics and vaccine markets. Furthermore, these systems help reduce operational costs by reducing water, energy, and chemical consumption, leading to an average 40% reduction in carbon footprint. Single-use assemblies are now extensively used across upstream and downstream processes, such as bioreactor media and buffer preparation, filtration, chromatography, and final product filling. The demand for flexible, scalable, and disposable production solutions is growing with the continued expansion of high-value therapeutics, like monoclonal antibodies and mRNA vaccines. This trend is further strengthened by the increasing presence of CDMOs and biotech startups that prefer plug-and-play technologies to accelerate development timelines. The rising integration of single-use technologies is reshaping the U.S. biomanufacturing ecosystem. In January 2025, Cytiva partnered with Cellular Origins to integrate Cytiva's automated Sefia platform with Cellular Origins' robotics system, Constellation. This collaboration aims to scale cell and gene therapy manufacturing while preserving established processes.

Booming Biologics and Biosimilars Market

The exponential growth of biologics and biosimilars in the United States is a significant driver for adopting single-use assemblies. Biologics requires highly precise, sterile, and contamination-free production environments-conditions where single-use systems outperform traditional equipment. With 46 biosimilars approved in the U.S. and Europe in 2024 alone, manufacturers are increasingly adopting these technologies to address competitive pressure and cost challenges. Single-use systems facilitate faster process scale-up, reduce upfront infrastructure investments, and enhance production agility. They also support smaller production volumes, aligning with the rise of niche biologics and personalized treatments. The ability to integrate seamlessly into continuous processing workflows has made them ideal for contract manufacturing organizations (CMOs) and biotech firms looking for flexible solutions. Additionally, regulatory agencies like the FDA are increasingly recognizing the role of single-use technologies in ensuring quality compliance and process robustness. This endorsement encourages manufacturers to shift toward disposable systems for monoclonal antibodies, vaccines, fusion proteins, and other emerging therapeutic classes. As biologics dominate new drug pipelines, single-use assemblies will remain critical enablers of efficient, scalable, and cost-effective production.

Technological Advancements Leading Market Growth

Technological advancements are pivotal in propelling the United States single-use assemblies market forward. Innovation in materials science, design optimization, and automation integration has led to next-generation assemblies that offer improved durability, compatibility, and performance across diverse bioprocessing applications. Advanced sensor integration enables real-time monitoring and control of parameters such as pressure, flow, and temperature within single-use flow paths. This has significantly enhanced product consistency, process safety, and regulatory compliance. Additionally, modular and customizable single-use assemblies allow manufacturers to tailor bioprocessing workflows based on product-specific requirements, improving flexibility. These innovations are particularly beneficial for multi-product facilities that frequently adapt their operations. Moreover, with digitalization and smart manufacturing gaining momentum, automation-ready single-use platforms are being developed for seamless integration with Manufacturing Execution Systems (MES) and control platforms. As the biopharma industry continues to evolve toward more complex molecules and adaptive production strategies, these technological improvements in single-use systems will be crucial for ensuring manufacturing efficiency and product quality. In April 2024, Watson-Marlow Fluid Technology Solutions (WMFTS) introduced WMArchitect, a new line of single-use solutions designed to optimize fluid management in biopharmaceutical manufacturing. This innovation includes standard and customized single-use assemblies, reducing the burden of validation and ensuring seamless integration into various bioprocessing workflows. By offering an open architecture approach, WMArchitect enables flexible system compatibility while maintaining stringent regulatory compliance. The solution addresses key industry challenges, such as cross-contamination risks and operational inefficiencies, by providing high-quality, ready-to-use assemblies. WMArchitect also streamline process development by supporting end-to-end fluid handling applications, from upstream processing to final fill-finish.

Future Market Scenario (2025-2032F)

The United States Single-use Assemblies Market is poised for robust growth, driven by the expanding biologics and biosimilar pipeline, rising investment in modular biomanufacturing facilities, and increased reliance on contract development and manufacturing organizations (CDMOs). As precision medicine and cell and gene therapies gain momentum, the demand for flexible, scalable, and contamination-free production systems will surge. Additionally, government incentives for domestic biologics production and faster regulatory approvals for innovative therapies are expected to accelerate market expansion further. Technological innovations such as smart sensors and automation-ready assemblies will continue to reshape the bioprocessing landscape, making single-use solutions indispensable in the future of biomanufacturing. In November 2024, Avantor inaugurated its new Bridgewater Innovation Center in New Jersey, USA. This state-of-the-art facility tackles critical challenges in the life science, biopharma, and advanced technological sectors. The center focuses on scientific collaboration, material innovation, and process optimization to accelerate drug development and manufacturing.

Key Players Landscape and Outlook

The key players in the market are significantly investing in the development of single-use assemblies and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

In February 2025, Thermo Fisher announced plans to acquire Solventum's Purification and Filtration Business for approximately USD 4.1 billion. This acquisition is expected to complement Thermo Fisher's bioproduction capabilities, particularly in the bioprocessing market.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. United States Single-use Assemblies Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Product
    • 5.2.1.1. Filtration Assemblies
    • 5.2.1.2. Bottle Assemblies
    • 5.2.1.3. Bag Assemblies
      • 5.2.1.3.1. 2D Bags
      • 5.2.1.3.2. 3D Bags
    • 5.2.1.4. Tubing Assemblies
    • 5.2.1.5. Mixing System Assemblies
    • 5.2.1.6. Others
  • 5.2.2. By Solution
    • 5.2.2.1. Customized Solutions
    • 5.2.2.2. Standard Solutions
  • 5.2.3. By Application
    • 5.2.3.1. Filtration and Purification
    • 5.2.3.2. Storage
    • 5.2.3.3. Cell Culture and Mixing
    • 5.2.3.4. Formulation and Fill-Finish Applications
    • 5.2.3.5. Sampling
    • 5.2.3.6. Others
  • 5.2.4. By End-user
    • 5.2.4.1. Biopharmaceutical and Pharmaceutical Companies
    • 5.2.4.2. Academic and Research Institutes
    • 5.2.4.3. CROs and CMOs
  • 5.2.5. By Region
    • 5.2.5.1. Northeast
    • 5.2.5.2. Midwest
    • 5.2.5.3. West
    • 5.2.5.4. South
  • 5.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 5.3. Market Map Analysis, 2024
  • 5.3.1. By Product
  • 5.3.2. By Solution
  • 5.3.3. By Application
  • 5.3.4. By End-user
  • 5.3.5. By Region

6. Value Chain Analysis

7. Supply Chain Analysis

8. Import-Export Analysis

9. Porter's Five Forces Analysis

10. PESTLE Analysis

11. Pricing Analysis

12. Market Dynamics

• 12.1. Market Drivers
• 12.2. Market Challenges

13. Market Trends and Developments

14. Regulatory Framework and Innovation

15. Competitive Landscape

• 15.1. Competition Matrix of Top 5 Market Leaders
• 15.2. SWOT Analysis for Top 5 Players
• 15.3. Key Players Landscape for Top 11 Market Players
  • 15.3.1. Thermo Fisher Scientific Inc.
    • 15.3.1.1. Company Details
    • 15.3.1.2. Key Management Personnel
    • 15.3.1.3. Products and Services
    • 15.3.1.4. Financials (As Reported)
    • 15.3.1.5. Key Market Focus and Geographical Presence
    • 15.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 15.3.2. Merck KGaA
  • 15.3.3. Cytiva Bioscience Holding Limited
  • 15.3.4. Repligen Corporation
  • 15.3.5. Parker Hannifin Corporation
  • 15.3.6. Lonza Group AG
  • 15.3.7. Eppendorf North America, Inc.
  • 15.3.8. Meissner Filtration Products Inc.
  • 15.3.9. Corning Incorporated
  • 15.3.10. avintos AG
  • 15.3.11. BioPulse Solutions, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

16. Strategic Recommendations

17. About Us and Disclaimer