一次性组件市场 - 全球产业规模、份额、趋势、机会及预测（按产品、应用、最终用户、地区和竞争格局划分），2021-2031年

全球一次性组件市场预计将从 2025 年的 35.7 亿美元成长到 2031 年的 50.2 亿美元，复合年增长率为 5.85%。

这些组件由整合式预灭菌塑胶零件组成，例如连接器、管路和歧管，形成一个用于管理生物製药流体的整合系统。市场成长的关键驱动因素是迫切需要消除生产批次间的交叉污染风险，以及对能够降低资本成本并最大限度缩短换线时间的灵活生产设定的需求。生物製程系统协会 (BPSA) 报告称，随着物流的改善，预计到 2024 年，此类产品的供应链安全担忧将减少 14%，这表明人们对该行业的信心正在增强。

儘管该行业呈现成长态势，但一次性产品产生的塑胶废弃物日益增多，给环境带来了沉重负担，也给该行业带来了严峻挑战。处理此类不可生物降解的材料需要复杂的废弃物管理通讯协定，以符合国际永续性目标。因此，在环境法规严格的地区，将废弃物处理方式与生态学目标相协调的复杂性可能会减缓市场接受度。

市场驱动因素

全球对生物製药和生物製药的需求不断增长，是推动一次性组件应用的核心动力。随着产业加速疫苗、单株抗体和细胞疗法的生产，生产商越来越依赖一次性技术来维持供应链的稳定性并满足大规模生产需求。从临床试验到商业化生产的过渡需要耐用的流体管理系统，以实现快速部署并避免永久性基础设施常见的延误。这一发展动能也反映在财务表现上。在2025年10月发布的「2025财年第三季」公布财报中，赛多利斯报告称，其生物工艺解决方案部门按固定汇率计算的收入增长了9.9%。这一成长主要得益于生物製造耗材的强劲销售。为了满足这项不断增长的需求，赛多利斯将在2025年投资3.05亿欧元，用于扩大其全球生产和研发设施，彰显了对产业未来产能的承诺。

此外，随着企业将营运与严格的环境目标相契合，降低生物加工过程中的能源和水资源消耗已成为推动市场接受度的重要因素。透过以一次性组件取代传统的不銹钢设备，生产基地可以省去高能耗的蒸气灭菌 (SIP) 和原位清洗 (CIP) 工艺，从而显着降低用水量和公用设施占用。这种转变不再只是合规问题，而是一项核心策略重点。正如 Cytiva 在 2024 年 9 月发表的题为《一次性使用与永续性》的报导中所述，62% 的生物製药公司将永续性列为未来五年的首要任务。这种趋势正在推动从可重复使用容器和永久性管道向一次性解决方案的广泛转变，从而确保营运效率与环境保护相容。

市场挑战

全球一次性组件市场扩张的一大障碍是塑胶废弃物处理造成的严重环境影响。与可清洗和重复使用的传统不銹钢系统不同，一次性组件仅供一次性使用，导致固态废弃物的可再生废弃物和操作难度阻碍了传统设备的全面替代。

近期产业对废弃物累积的预测凸显了这项挑战的严峻。根据生物製程系统联盟 (BPSA) 发布的 2024 年预测，与生物製药生产相关的塑胶废弃物预计将大幅成长，到 2028 年将达到每年 11,700 吨。这项预测的成长凸显了废弃物管理的沉重负担，迫使企业在一次性技术的营运弹性与其日益增长的生态影响之间寻求平衡。因此，如何使这些一次性产品符合循环经济标准仍然是限制其市场渗透的关键因素。

市场趋势

随着生物製药公司分散生产以确保本地供应并降低地缘政治风险，区域化製造地和供应链枢纽的兴起正在改变一次性技术格局。这项策略演变涉及在关键区域市场建立标准化的「一站式」设施，从而能够使用一次性组件复製生产流程，而无需传统不銹钢工厂所需的大规模基础设施。财务数据也印证了这个趋势。药明生物在2025年3月发布的「2024财年财务业绩」中宣布，其非新冠疫情相关收入同比增长13.1%，并将这一增长直接归功于製造地。

同时，在细胞和基因疗法对标准严苛的推动下，专用组件的研发正在加速前进。与传统生物製药不同，细胞和基因疗法通常需要能够承受低温储存并严格限制颗粒污染的组件，以保护小批量患者用药。然而，目前产业内存在显着的能力缺口。根据Cytiva于2025年10月发布的《2025年全球生物製药指数》，超过25%的生物製药企业高层认为其现有供应链无法支持细胞和基因疗法等先进治疗方法，这凸显了市场对客製化一次性组件的巨大需求。

目录

第一章概述

第二章调查方法

第三章执行摘要

第四章：客户评价

第五章 全球一次性组件市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 依产品分类（袋式组件（二维袋组件、三维袋组件）、过滤组件、瓶式组件、管式组件、其他）
  • 依应用领域（过滤、储存、细胞培养/混合、取样、填充/精加工、其他）
  • 依最终用户（生物製药/製药公司、CRO/CMO、学术/研究机构）划分
  • 按地区
  • 按公司（2025 年）
• 市场地图

6. 北美一次性组件市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国家分析
  • 我们
  • 加拿大
  • 墨西哥

7. 欧洲一次性组件市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国家分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

8. 亚太地区一次性组件市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

9. 中东和非洲一次组装市场展望

• 市场规模及预测
• 市占率及预测
• 中东和非洲：国家分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

10. 南美洲一次性组装市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国家分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 司机
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 最新进展

第十三章 全球一次性组件市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的可能性
• 供应商电力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor, Inc.
• Parker Hannifin Corp.
• Repligen Corporation
• Corning Incorporated
• Meissner Filtration Products, Inc.
• Dover Corporation
• TSE Industries, Inc.
• Fujimori Kogyo Co., Ltd.

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Single-use Assemblies Market is projected to expand from USD 3.57 Billion in 2025 to USD 5.02 Billion by 2031, registering a CAGR of 5.85%. These assemblies comprise integrated, pre-sterilized plastic components-such as connectors, tubing, and manifolds-that form a cohesive system for managing biopharmaceutical fluids. The primary catalysts for market growth are the urgent need to negate cross-contamination risks between production batches and the demand for flexible manufacturing setups that lower capital costs and minimize changeover times. Reflecting improved logistics, the Bio-Process Systems Alliance noted in 2024 that apprehension regarding supply chain security for these products declined by 14%, signaling increased industry confidence.

Despite this growth trajectory, the sector confronts substantial hurdles related to the environmental footprint of rising plastic waste from these disposable items. The disposal of such non-biodegradable materials requires sophisticated waste management protocols to comply with international sustainability targets. Consequently, in regions with rigorous environmental regulations, the complexity of aligning waste practices with ecological goals could potentially decelerate the rate of market adoption.

Market Driver

The escalating global demand for biopharmaceuticals and biologics serves as the central force driving the uptake of single-use assemblies. As the industry hastens the output of vaccines, monoclonal antibodies, and cell therapies, producers are increasingly depending on disposable technologies to maintain supply chain consistency and manage large-scale processing needs. Moving from clinical trials to commercial production requires durable fluid management systems that allow for rapid deployment, avoiding the delays common with permanent infrastructure. This momentum is highlighted by financial results; Sartorius reported in its '9M 2025 Earnings Release' in October 2025 that its Bioprocess Solutions Division achieved a 9.9 percent revenue increase in constant currencies, growth specifically attributed to the robust sales of biomanufacturing consumables. To meet this rising need, Sartorius invested 305 million euros in 2025 toward global production and research facilities, underscoring the industry's dedication to future capacity.

Additionally, the reduction of energy and water consumption in bioprocessing has become a critical influence on market adoption as firms align their operations with rigorous environmental targets. By substituting traditional stainless steel apparatus with single-use assemblies, manufacturing sites can remove energy-heavy steam-in-place (SIP) and clean-in-place (CIP) processes, thereby drastically reducing their water usage and utility footprint. This transition represents a strategic core rather than simple regulatory adherence. As noted in a September 2024 Cytiva article titled 'Single-use and sustainability', 62% of biopharma companies have identified sustainability as their top priority for the coming five years. This focus is catalyzing a broad shift away from reusable vessels and permanent piping toward disposable options, ensuring operational efficiency remains compatible with environmental stewardship.

Market Challenge

A significant obstacle restricting the wider growth of the Global Single-use Assemblies Market is the considerable environmental impact caused by the disposal of plastic waste. In contrast to conventional stainless-steel systems that are sanitized and reused, single-use assemblies are intended for a single application, resulting in a steady stream of solid bio-hazardous refuse. This dependence on disposable multi-layer polymers stands in direct opposition to the strict net-zero objectives and sustainability mandates increasingly embraced by regulatory bodies and biopharmaceutical manufacturers. Therefore, in areas with stringent environmental laws, the high expense and operational difficulty involved in incinerating or handling this non-recyclable waste deter the complete substitution of traditional equipment.

The scale of this challenge is highlighted by recent industry forecasts concerning waste buildup. In 2024, the Bio-Process Systems Alliance estimated that plastic waste linked to biopharmaceutical manufacturing is set to rise sharply, reaching 11,700 metric tons annually by 2028. This anticipated growth underscores the heavy burden of waste management, effectively compelling companies to balance the operational agility of single-use technologies against their mounting ecological consequences. Consequently, the struggle to reconcile these disposable products with circular economy standards persists as a major factor slowing market penetration.

Market Trends

The landscape of single-use technologies is being transformed by the rise of regionalized manufacturing and supply chain hubs, as biopharmaceutical firms decentralize production to guarantee local supply and reduce geopolitical vulnerabilities. This strategic evolution involves building standardized "cookie-cutter" facilities in crucial regional markets, employing single-use assemblies to duplicate processes without the extensive infrastructure demanded by conventional stainless-steel plants. Financial data supports this trend; in its '2024 Annual Results' released in March 2025, WuXi Biologics announced a 13.1% year-over-year rise in non-COVID revenue, a growth directly credited to the successful expansion of its manufacturing operations in Europe and other areas.

Simultaneously, the creation of specialized assemblies tailored for cell and gene therapies is accelerating, spurred by the rigorous standards required for these advanced treatments. Unlike standard biologics, cell and gene therapies often demand assemblies capable of enduring cryopreservation temperatures and strictly limiting particulate contamination to safeguard small-volume patient batches. Nevertheless, the industry confronts a significant gap in capabilities; according to Cytiva's 'Global Biopharma Index 2025' published in October 2025, over 25% of biopharma executives indicated that their existing supply chains are ill-equipped to handle advanced modalities like cell and gene therapies, underscoring a critical market demand for purpose-built disposable components.

Key Market Players

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor, Inc.
• Parker Hannifin Corp.
• Repligen Corporation
• Corning Incorporated
• Meissner Filtration Products, Inc.
• Dover Corporation
• TSE Industries, Inc.
• Fujimori Kogyo Co., Ltd.

Report Scope

In this report, the Global Single-use Assemblies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Single-use Assemblies Market, By Product

• Bag Assemblies (2D bag assemblies, 3D bag assemblies)
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Others

Single-use Assemblies Market, By Application

• Filtration
• Storage
• Cell Culture & Mixing
• Sampling
• Fill-finish Applications
• Others

Single-use Assemblies Market, By End user

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

Single-use Assemblies Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Single-use Assemblies Market.

Available Customizations:

Global Single-use Assemblies Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Single-use Assemblies Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Bag Assemblies (2D bag assemblies, 3D bag assemblies), Filtration Assemblies, Bottle Assemblies, Tubing Assemblies, Others)
  • 5.2.2. By Application (Filtration, Storage, Cell Culture & Mixing, Sampling, Fill-finish Applications, Others)
  • 5.2.3. By End user (Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutes)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Single-use Assemblies Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Application
  • 6.2.3. By End user
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Single-use Assemblies Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By End user
  • 6.3.2. Canada Single-use Assemblies Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By End user
  • 6.3.3. Mexico Single-use Assemblies Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By End user

7. Europe Single-use Assemblies Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Application
  • 7.2.3. By End user
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Single-use Assemblies Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By End user
  • 7.3.2. France Single-use Assemblies Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By End user
  • 7.3.3. United Kingdom Single-use Assemblies Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By End user
  • 7.3.4. Italy Single-use Assemblies Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By End user
  • 7.3.5. Spain Single-use Assemblies Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By End user

8. Asia Pacific Single-use Assemblies Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Application
  • 8.2.3. By End user
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Single-use Assemblies Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By End user
  • 8.3.2. India Single-use Assemblies Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By End user
  • 8.3.3. Japan Single-use Assemblies Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By End user
  • 8.3.4. South Korea Single-use Assemblies Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By End user
  • 8.3.5. Australia Single-use Assemblies Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By End user

9. Middle East & Africa Single-use Assemblies Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Application
  • 9.2.3. By End user
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Single-use Assemblies Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By End user
  • 9.3.2. UAE Single-use Assemblies Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By End user
  • 9.3.3. South Africa Single-use Assemblies Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By End user

10. South America Single-use Assemblies Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Application
  • 10.2.3. By End user
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Single-use Assemblies Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By End user
  • 10.3.2. Colombia Single-use Assemblies Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By End user
  • 10.3.3. Argentina Single-use Assemblies Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By End user

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Single-use Assemblies Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Thermo Fisher Scientific Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Sartorius AG
• 15.3. Danaher Corporation
• 15.4. Merck KGaA
• 15.5. Avantor, Inc.
• 15.6. Parker Hannifin Corp.
• 15.7. Repligen Corporation
• 15.8. Corning Incorporated
• 15.9. Meissner Filtration Products, Inc.
• 15.10. Dover Corporation
• 15.11. TSE Industries, Inc.
• 15.12. Fujimori Kogyo Co., Ltd.

16. Strategic Recommendations

17. About Us & Disclaimer