美國的一次性使用集合市場評估:產品·解決方案·用途·終端用戶·各地區的機會及預測 (2018-2032年)

美國一次性組件市場規模預計將從 2024 年的 12.022 億美元增長到 2032 年的 39.7679 億美元，預測期內的複合年增長率為 16.13%。

生物製藥和個人化醫療的日益複雜使得人們迫切需要靈活、高效且無污染風險的製造系統。一次性組件對於當今靈活的生產需求至關重要，因為它可以實現快速轉換、減少驗證負擔並降低營運成本。美國監管的靈活性以及大量生產模式的日益普及進一步推動了這一趨勢。

例如，2024 年 3 月，SaniSure, Inc. 推出了 Bio-Ease Ultra 一次性填充組件，旨在優化生物製藥製造中的無菌液體轉移。該系統採用完全無菌、閉環設計，降低了污染風險並提高了製程效率。此組件包含高純度矽膠管、無菌連接器和可自訂組件，可靈活適應各種填充過程。隨著對確保生物加工無菌性的監管審查日益嚴格，Bio-Ease Ultra 提供了經過驗證的即用型解決方案，以提高製造一致性。這款新產品符合 SaniSure, Inc. 提供創新的一次性解決方案以滿足生物製藥行業日益增長的需求的目標。

本報告提供美國的一次性使用集合的市場調查，彙整市場定義和概要，市場規模的轉變·預測，各種區分的詳細分析，產業結構，影響市場成長因素的分析，案例研究，競爭情形，主要企業簡介等資訊。

目錄

第1章 計劃的範圍和定義

第2章 調查手法

第3章 美國的關稅的影響

第4章 摘要整理

第5章 美國的一次性使用集合市場展望

• 市場規模的分析·預測
• 市場佔有率的分析·預測
  • 各產品
    • 過濾組件
    • 瓶子組裝
    • 袋子組裝
    • 管組件
    • 混合系統組裝
    • 其他
  • 各解決方案
    • 客制化解決方案
    • 標準解決方案
  • 各用途
    • 過濾和淨化
    • 儲存與保存
    • 細胞培養/混合
    • 混合、填充和精加工
    • 採樣
    • 其他
  • 各終端用戶
    • 生物醫藥品·製藥公司
    • 學術研究機關
    • CRO·CMO
  • 各地區
    • 東北部
    • 中西部
    • 西部
    • 南部
  • 企業佔有率分析(前五名公司以及其他)
• 市場地圖分析

第6章 價值鏈分析

第7章 供應鏈分析

第8章 進出口分析

第9章 波特的五力分析

第10章 大環境分析

第11章 價格分析

第12章 市場動態

• 推動市場要素
• 市場課題

第13章 市場趨勢與發展

第14章 法律規範和革新

第15章 競爭情形

• 前五名公司的競爭矩陣
• 前五名公司的SWOT分析
• 前11名公司的形勢
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Cytiva Bioscience Holding Limited
  • Repligen Corporation
  • Parker Hannifin Corporation
  • Lonza Group AG
  • Eppendorf North America, Inc.
  • Meissner Filtration Products Inc.
  • Corning Incorporated
  • avintos AG
  • BioPulse Solutions, Inc.

第16章 策略性建議

第17章 關於本公司·免責聲明

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

List of Tables

• Table 1. Competition Matrix of Top 5 Market Leaders
• Table 2. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 3. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. United States Single-use Assemblies Market, By Value, In USD Million, 2018-2032F
• Figure 2. United States Single-use Assemblies Market, By Volume, In Units, 2018-2032F
• Figure 3. United States Single-use Assemblies Market Share (%), By Product, 2018-2032F
• Figure 4. United States Single-use Assemblies Market Share (%), By Solution, 2018-2032F
• Figure 5. United States Single-use Assemblies Market Share (%), By Application, 2018-2032F
• Figure 6. United States Single-use Assemblies Market Share (%), By End-user, 2018-2032F
• Figure 7. United States Single-use Assemblies Market Share (%), By Region, 2018-2032F
• Figure 8. By Product Map-Market Size (USD Million) & Growth Rate (%), 2024
• Figure 9. By Solution Map-Market Size (USD Million) & Growth Rate (%), 2024
• Figure 10. By Application Map-Market Size (USD Million) & Growth Rate (%), 2024
• Figure 11. By End-user Map-Market Size (USD Million) & Growth Rate (%), 2024
• Figure 12. By Region Map-Market Size (USD Million) & Growth Rate (%), 2024