查看购物车
  • Traditional Chinese
  • English
  • Japanese
封面
市场调查报告书
商品编码
1961058

全球一次性生物製程市场：依产品、应用、最终用户、工作流程和地区划分—市场规模、产业动态、机会、分析和预测（2026-2035年）

Global Single-Use Bioprocessing Market: By Product, Application, End User, Workflow, Region - Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2026-2035
出版日期: | 出版商: Astute Analytica | 英文 280 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

一次性生物製程市场持续显着扩张，预计到2025年将达到 301.2亿美元。这一令人瞩目的市场规模预计将在未来十年内大幅成长，到2035年将飙升至 1,229.2亿美元。这意味着从2026年到2035年，该市场将保持 15.1%的强劲年复合成长率（CAGR），反映出一次性技术在生物製药生产中日益普及和重要。

推动市场快速成长的关键因素很多。一次性生物製程系统的主要优势之一是其资本成本远低于传统的不銹钢基础设施。由于无需购买昂贵的固定设备和进行大规模的设施建设，企业可以减少初始投资并更有效地分配资源。此外，一次性系统快速的设定时间使製造商能够加快专案进度，更快地将产品推向市场，并灵活地适应不断变化的生产需求。

值得关注的市场趋势

一次性生物製程市场的竞争格局呈现出寡占的特征，由少数几家全球性企业主导，包括Thermo Fisher Scientific、Sartorius、Danaher (透过其Cytiva division)、Merck KGaA。这些公司历来以产品创新为竞争核心，并不断提升其一次性技术的效能、可靠性和整合度。然而，随着製造商寻求在地化生产和分销网路以提高回应速度、缩短交货週期并降低全球供应链中断带来的风险，竞争的重点正日益转向供应链区域化。

标誌着此策略转变的重要进展是，印度首个专门用于一次性生物製程设计和放大生产的设施 "Telangana 1 Bio" 于2025年12月在Genome Valley落成。这次落成意义尤其重大，因为它恰逢Genome Valley谷成立25週年。这个成熟的生命科学中心已成为该地区生物技术和製药创新中心。

此外，为了满足全球对一次性生物製程解决方案日益成长的需求，Sartorius Stedim Biotech于2025年6月大幅扩建了其洁净室，面积几乎翻了一番，达到约9000平方米。此次扩建将使该公司能够显着提高产量，满足全球生物製药製造商快速成长的需求。这些策略举措 - 开设新的区域设施和扩大产能 - 凸显了领先企业如何调整营运以应对供应链挑战，同时继续支持一次性生物製程市场的创新和成长。

核心成长驱动因子

慢性病日益增多和全球人口老化显着提升了对先进生物製药疗法的需求，例如单株抗体、疫苗和细胞疗法。这些疗法已成为癌症、自体免疫疾病、传染病和老年相关疾病管理和治疗的重要工具。随着全球人口老化和慢性病发病率的上升，对高效、可扩展的生产方法的需求日益成长，以满足不断成长的治疗需求。

新机会

一个重要但又有些出乎意料的趋势重塑一次性生物加工市场，那就是 "绿色生物" 倡议的兴起。传统上，由于生物製药生产过程会产生大量塑胶垃圾，这一细分市场一直备受诟病。据估计，生物製药产业每年产生 9.4万至20万吨一次性塑胶垃圾，对环境构成重大挑战。批评人士认为，一次性塑胶的堆积是严重的生态负担，并质疑一次性系统的可持续性，儘管它们具有操作优势。

最佳化障碍

随着一次性生物加工市场转向塑胶填充和包装应用，监管机构对塑胶材料中化学物质迁移的审查力度显着加大。这种关注的增加反映出人们日益担忧，从塑胶组件迁移到药物产品中的化学物质（可浸出物和可萃取物，简称 L&E）可能会影响药物的安全性和有效性。监管机构，特别是美国食品药物管理局（FDA），已采取应对措施，实施更严格的测试和验证要求，以确保一次性系统符合产品完整性和病患安全的最高标准。

目录

第1章 执行摘要：全球一次性生物加工市场

第2章 报告概述

  • 研究框架
    • 研究目标
    • 市场定义
    • 市场区隔
  • 研究方法
    • 市场规模估算
    • 定性研究
    • 量化研究
    • 依地区划分的主要调查受访者细分
    • 资料三角验证
    • 研究假设

第3章 全球一次性生物加工市场概论

  • 产业价值链分析
    • 原料采购
    • 製造和组装
    • 经销商
    • 最终用户
  • 行业展望
    • 全球生物製药生产展望
    • 进出口分析
    • 监理框架
  • PESTLE 分析
  • 波特五力分析
    • 供应商议价能力
    • 买方议价能力
    • 替代品威胁
    • 新进入者威胁
    • 竞争强度
  • 市场成长与展望
    • 市场收入估计与预测（2020-2035）
    • 产品价格分析
  • 市场吸引力分析
    • 依产品
  • 可执行的见解（分析师建议）

第4章 竞争格局概览

  • 市场集中度
  • 公司占有率分析（基于价值，2025年）
  • 竞争格局分析与基准分析

第5章 全球一次性生物製程市场分析

  • 市场动态与趋势
    • 成长驱动因素
    • 限制因素
    • 机会
    • 关键趋势
  • 市场规模及预测（2020-2035年）
    • 依产品划分
    • 依工作流程划分
    • 依最终用途划分
    • 依地区划分

第6章 北美一次性生物製程市场分析

第7章 欧洲一次性生物加工市场分析

第8章 亚太地区一次性生物加工市场分析

第9章 中东与非洲一次性生物加工市场分析

第10章 南美洲一次性生物加工市场分析

第11章 公司简介

  • ABEC Inc.
  • Avantor Inc.
  • Cellexus
  • Celltainer Biotech BV
  • ESCO Bioengineering Co.
  • Danaher Corp
  • Distek Inc.
  • Entegris Inc.
  • Eppendorf AG
  • GEA Group
  • Meissner Filtration Products
  • Merck
  • OmniBRx Biotechnologies
  • Parker Hannifin（Domnick Hunter）
  • PBS Biotech Inc.
  • Repligen Corporation
  • Saint-Gobain Life Sciences
  • Sartorius AG
  • Solventum
  • Thermo Fisher Scientific Inc.
  • 其他主要参与者

第12章 附录

简介目录
Product Code: AA01261633

The Single-Use Bioprocessing Market is undergoing remarkable expansion, with its valuation reaching USD 30.12 billion in 2025. This impressive market size is expected to experience substantial growth over the next decade, projected to soar to USD 122.92 billion by 2035. This translates to a robust compound annual growth rate (CAGR) of 15.1% during the forecast period from 2026 to 2035, reflecting the increasing adoption and importance of single-use technologies in biopharmaceutical manufacturing.

Several key factors are driving this rapid market growth. One of the primary advantages of single-use bioprocessing systems is their significantly lower capital costs compared to traditional stainless steel infrastructure. By eliminating the need for expensive, fixed equipment and extensive facility construction, companies can reduce upfront investment and allocate resources more efficiently. Additionally, the faster setup times associated with single-use systems enable manufacturers to accelerate project timelines, bringing products to market more quickly and adapting more readily to changing production needs.

Noteworthy Market Developments

The competitive landscape of the single-use bioprocessing market is characterized by an oligopolistic structure dominated by a few global giants: Thermo Fisher Scientific, Sartorius, Danaher (through its Cytiva division), and Merck KGaA. These companies have historically competed on the basis of product innovation, continuously advancing the performance, reliability, and integration of single-use technologies. However, the focus of competition has increasingly shifted toward supply chain regionalization, as manufacturers seek to localize production and distribution networks to improve responsiveness, reduce lead times, and mitigate risks associated with global supply chain disruptions.

A significant development illustrating this strategic shift occurred in December 2025 when the state government of Telangana inaugurated India's first dedicated single-use bioprocess design and scale-up facility named Telangana 1 Bio, located within Genome Valley. This launch is especially noteworthy as it coincides with the 25th anniversary of Genome Valley. This well-established life sciences hub has become a focal point for biotechnology and pharmaceutical innovation in the region.

Further reflecting the rising global demand for single-use bioprocessing solutions, Sartorius Stedim Biotech notably expanded its cleanroom capacity in June 2025, nearly doubling its space to 9,000 square meters. This expansion enables the company to significantly increase production volumes and meet the surging needs of biopharmaceutical manufacturers worldwide. These strategic moves-regional facility launches and capacity expansions-highlight how leading players are adapting their operations to address supply chain challenges while continuing to support innovation and growth in the single-use bioprocessing market.

Core Growth Drivers

The increasing prevalence of chronic diseases, coupled with aging populations worldwide, is significantly driving demand for advanced biopharmaceutical treatments such as monoclonal antibodies, vaccines, and cell therapies. These therapies have become essential tools in managing and treating conditions like cancer, autoimmune disorders, infectious diseases, and age-related ailments. As the global population ages and the incidence of chronic illnesses rises, there is a growing need for efficient and scalable production methods capable of meeting this expanding therapeutic demand.

Emerging Opportunity Trends

A critical and somewhat counterintuitive trend reshaping the Single-Use Bioprocessing Market is the emergence of the "Green Bio" initiative. Traditionally, this market segment has faced criticism due to the substantial volume of plastic waste generated by biopharmaceutical manufacturing processes. Estimates indicate that the biopharma industry produces between 94,000 and 200,000 metric tons of disposable plastic waste annually, raising significant environmental concerns. Critics have viewed this accumulation of single-use plastics as a major ecological liability, questioning the sustainability of disposable systems despite their operational advantages.

Barriers to Optimization

As the single-use bioprocessing market increasingly shifts toward plastic fill-finish applications, regulatory scrutiny surrounding chemical migration from plastic materials has become significantly more stringent. This heightened focus reflects growing concerns over the potential for leachables and extractables (L&E)-chemical substances that can migrate from plastic components into pharmaceutical products-to affect drug safety and efficacy. Regulatory agencies, particularly the U.S. Food and Drug Administration (FDA), have responded by enforcing more rigorous testing and validation requirements to ensure that single-use systems meet the highest standards of product integrity and patient safety.

Detailed Market Segmentation

By Workflow, the upstream segment of the single-use bioprocessing market, which encompasses cell culture and fermentation processes, commands a substantial portion of the overall revenue share. This dominance is closely tied to the maturation of bioreactor technology, which has evolved into a highly efficient, plug-and-play solution that simplifies and accelerates biomanufacturing operations. The widespread adoption of single-use bioreactor systems has transformed upstream processing by offering manufacturers increased flexibility, reduced downtime, and enhanced control over critical production parameters.

By Product, the Simple and Peripheral Elements segment, which includes components such as tubing, filters, and connectors, serves as the primary revenue driver within the single-use bioprocessing market. This segment captures the largest revenue share, accounting for approximately 40% of the market. The dominance of these peripheral components is largely attributed to the industry-wide emphasis on maintaining "closed system" bioprocessing environments, which are essential for minimizing contamination risks and ensuring product integrity throughout production.

Segment Breakdown

By Product

  • Simple & Peripheral Elements
  • Tubing, Filters, Connectors, & Transfer Systems
  • Bags
  • Sampling Systems
  • Probes & Sensors
  • pH Sensor
  • Oxygen Sensor
  • Pressure Sensors
  • Temperature Sensors
  • Conductivity Sensors
  • Flow Sensors
  • Others
  • Others
  • Apparatus & Plants
  • Bioreactors
  • Upto 1000 L
  • Above 1000 L to 2000 L
  • Above 2000 L
  • Mixing, Storage, & Filling Systems
  • Filtration System
  • Chromatography Systems
  • Pumps
  • Others
  • Work Equipment
  • Cell Culture System
  • Syringes
  • Others

By Workflow

  • Upstream Bioprocessing
  • Fermentation
  • Downstream Bioprocessing

By End-Use

  • Biopharmaceutical Manufacturers
  • CMOs & CROs
  • In-house Manufacturers
  • Academic & Clinical Research Institutes

By Region

  • North America
  • The US
  • Canada
  • Mexico
  • Europe
  • Western Europe
  • The UK
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Western Europe
  • Eastern Europe
  • Poland
  • Russia
  • Rest of Eastern Europe
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
  • South America
  • Argentina
  • Brazil
  • Rest of South America

Geography Breakdown

  • North America's leadership in the single-use bioprocessing market is largely anchored in a strategic approach centered on retrofitting existing facilities rather than constructing entirely new greenfield sites. This approach leverages the region's extensive legacy infrastructure, transforming and upgrading it with modern single-use technologies to enhance efficiency and flexibility. By retrofitting, companies can reduce capital expenditures and shorten implementation timelines compared to building new facilities from scratch, allowing for quicker adaptation to evolving market demands and regulatory requirements.
  • Several key factors contribute to North America's dominant position in this market. The region is home to major industry players with vast production capacities, which enables large-scale adoption of single-use bioprocessing systems. These disposables offer notable advantages, such as reduced risk of cross-contamination, faster turnaround times between production batches, and decreased need for cleaning and sterilization, making them increasingly attractive to manufacturers. Additionally, North America's growing healthcare expenditure reflects a broader commitment to advancing medical technologies and therapies, driving demand for more efficient and scalable bioprocessing solutions.

Leading Market Participants

  • ABEC Inc.
  • Avantor Inc.
  • Cellexus
  • Celltainer Biotech BV
  • CESCO Bioengineering Co.
  • Danaher Corp
  • Distek Inc.
  • Entegris Inc.
  • Eppendorf AG
  • GEA Group
  • Meissner Filtration Products
  • Merck
  • OmniBRx Biotechnologies
  • Parker Hannifin (Domnick Hunter)
  • PBS Biotech Inc.
  • Repligen Corporation
  • Saint-Gobain Life Sciences
  • Sartorius AG
  • Solventum
  • Thermo Fisher Scientific Inc.
  • Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Single-Use Bioprocessing Market

Chapter 2. Report Description

  • 2.1. Research Framework
    • 2.1.1. Research Objective
    • 2.1.2. Market Definitions
    • 2.1.3. Market Segmentation
  • 2.2. Research Methodology
    • 2.2.1. Market Size Estimation
    • 2.2.2. Qualitative Research
      • 2.2.2.1. Primary & Secondary Sources
    • 2.2.3. Quantitative Research
      • 2.2.3.1. Primary & Secondary Sources
    • 2.2.4. Breakdown of Primary Research Respondents, By Region
    • 2.2.5. Data Triangulation
    • 2.2.6. Assumption for Study

Chapter 3. Global Single-Use Bioprocessing Market Overview

  • 3.1. Industry Value Chain Analysis
    • 3.1.1. Raw Material Sourcing
    • 3.1.2. Manufacturing and Assembly
    • 3.1.3. Distributors
    • 3.1.4. End Users
  • 3.2. Industry Outlook
    • 3.2.1. Global Biopharmaceutical Production Outlook
    • 3.2.2. EXIM Analysis
    • 3.2.3. Regulatory Framework
  • 3.3. PESTLE Analysis
  • 3.4. Porter's Five Forces Analysis
    • 3.4.1. Bargaining Power of Suppliers
    • 3.4.2. Bargaining Power of Buyers
    • 3.4.3. Threat of Substitutes
    • 3.4.4. Threat of New Entrants
    • 3.4.5. Degree of Competition
  • 3.5. Market Growth and Outlook
    • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
    • 3.5.2. Pricing Analysis, By Product
  • 3.6. Market Attractiveness Analysis
    • 3.6.1. By Product
  • 3.7. Actionable Insights (Analyst's Recommendations)

Chapter 4. Competition Dashboard

  • 4.1. Market Concentration Rate
  • 4.2. Company Market Share Analysis (Value %), 2025
  • 4.3. Competitor Mapping & Benchmarking

Chapter 5. Global Single-Use Bioprocessing Market Analysis

  • 5.1. Market Dynamics and Trends
    • 5.1.1. Growth Drivers
    • 5.1.2. Restraints
    • 5.1.3. Opportunity
    • 5.1.4. Key Trends
  • 5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.2.1. By Product
      • 5.2.1.1. Key Insights
        • 5.2.1.1.1. Simple & Peripheral Elements
          • 5.2.1.1.1.1. Tubing, Filters, Connectors, & Transfer Systems
          • 5.2.1.1.1.2. Bags
          • 5.2.1.1.1.3. Sampling Systems
          • 5.2.1.1.1.4. Probes & Sensors
            • 5.2.1.1.1.4.1. pH Sensor
            • 5.2.1.1.1.4.2. Oxygen Sensor
            • 5.2.1.1.1.4.3. Pressure Sensors
            • 5.2.1.1.1.4.4. Temperature Sensors
            • 5.2.1.1.1.4.5. Conductivity Sensors
            • 5.2.1.1.1.4.6. Flow Sensors
            • 5.2.1.1.1.4.7. Others
          • 5.2.1.1.1.5. Others
        • 5.2.1.1.2. Apparatus & Plants
          • 5.2.1.1.2.1. Bioreactors
            • 5.2.1.1.2.1.1. Upto 1000 L
            • 5.2.1.1.2.1.2. Above 1000 L to 2000 L
            • 5.2.1.1.2.1.3. Above 2000 L
          • 5.2.1.1.2.2. Mixing, Storage, & Filling Systems
          • 5.2.1.1.2.3. Filtration System
          • 5.2.1.1.2.4. Chromatography Systems
          • 5.2.1.1.2.5. Pumps
          • 5.2.1.1.2.6. Others
        • 5.2.1.1.3. Work Equipment
          • 5.2.1.1.3.1. Cell Culture System
          • 5.2.1.1.3.2. Syringes
          • 5.2.1.1.3.3. Others
    • 5.2.2. By Workflow
      • 5.2.2.1. Key Insights
        • 5.2.2.1.1. Upstream Bioprocessing
        • 5.2.2.1.2. Fermentation
        • 5.2.2.1.3. Downstream Bioprocessing
    • 5.2.3. By End Use
      • 5.2.3.1. Key Insights
        • 5.2.3.1.1. Biopharmaceutical Manufacturers
        • 5.2.3.1.2. CMOs & CROs
        • 5.2.3.1.3. In-house Manufacturers
        • 5.2.3.1.4. Academic & Clinical Research Institutes
    • 5.2.4. By Region
      • 5.2.4.1. Key Insights
        • 5.2.4.1.1. North America
          • 5.2.4.1.1.1. The U.S.
          • 5.2.4.1.1.2. Canada
          • 5.2.4.1.1.3. Mexico
        • 5.2.4.1.2. Europe
          • 5.2.4.1.2.1. Western Europe
            • 5.2.4.1.2.1.1. The UK
            • 5.2.4.1.2.1.2. Germany
            • 5.2.4.1.2.1.3. France
            • 5.2.4.1.2.1.4. Italy
            • 5.2.4.1.2.1.5. Spain
            • 5.2.4.1.2.1.6. Rest of Western Europe
          • 5.2.4.1.2.2. Eastern Europe
            • 5.2.4.1.2.2.1. Poland
            • 5.2.4.1.2.2.2. Russia
            • 5.2.4.1.2.2.3. Rest of Eastern Europe
        • 5.2.4.1.3. Asia Pacific
          • 5.2.4.1.3.1. China
          • 5.2.4.1.3.2. India
          • 5.2.4.1.3.3. Japan
          • 5.2.4.1.3.4. South Korea
          • 5.2.4.1.3.5. Australia & New Zealand
          • 5.2.4.1.3.6. ASEAN
              • 5.2.4.1.3.6.1.1. Indonesia
              • 5.2.4.1.3.6.1.2. Malaysia
              • 5.2.4.1.3.6.1.3. Thailand
              • 5.2.4.1.3.6.1.4. Singapore
              • 5.2.4.1.3.6.1.5. Rest of ASEAN
          • 5.2.4.1.3.7. Rest of Asia Pacific
        • 5.2.4.1.4. Middle East & Africa
          • 5.2.4.1.4.1. UAE
          • 5.2.4.1.4.2. Saudi Arabia
          • 5.2.4.1.4.3. South Africa
          • 5.2.4.1.4.4. Rest of MEA
        • 5.2.4.1.5. South America
          • 5.2.4.1.5.1. Argentina
          • 5.2.4.1.5.2. Brazil
          • 5.2.4.1.5.3. Rest of South America

Chapter 6. North America Single-Use Bioprocessing Market Analysis

  • 6.1. Market Dynamics and Trends
    • 6.1.1. Growth Drivers
    • 6.1.2. Restraints
    • 6.1.3. Opportunity
    • 6.1.4. Key Trends
  • 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 6.2.1. By Product
    • 6.2.2. By Workflow
    • 6.2.3. By End Use
    • 6.2.4. By Country

Chapter 7. Europe Single-Use Bioprocessing Market Analysis

  • 7.1. Market Dynamics and Trends
    • 7.1.1. Growth Drivers
    • 7.1.2. Restraints
    • 7.1.3. Opportunity
    • 7.1.4. Key Trends
  • 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 7.2.1. By Product
    • 7.2.2. By Workflow
    • 7.2.3. By End Use
    • 7.2.4. By Country

Chapter 8. Asia Pacific Single-Use Bioprocessing Market Analysis

  • 8.1. Market Dynamics and Trends
    • 8.1.1. Growth Drivers
    • 8.1.2. Restraints
    • 8.1.3. Opportunity
    • 8.1.4. Key Trends
  • 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 8.2.1. By Product
    • 8.2.2. By Workflow
    • 8.2.3. By End Use
    • 8.2.4. By Country

Chapter 9. Middle East & Africa Single-Use Bioprocessing Market Analysis

  • 9.1. Market Dynamics and Trends
    • 9.1.1. Growth Drivers
    • 9.1.2. Restraints
    • 9.1.3. Opportunity
    • 9.1.4. Key Trends
  • 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 9.2.1. By Product
    • 9.2.2. By Workflow
    • 9.2.3. By End Use
    • 9.2.4. By Country

Chapter 10. South America Single-Use Bioprocessing Market Analysis

  • 10.1. Market Dynamics and Trends
    • 10.1.1. Growth Drivers
    • 10.1.2. Restraints
    • 10.1.3. Opportunity
    • 10.1.4. Key Trends
  • 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 10.2.1. By Product
    • 10.2.2. By Workflow
    • 10.2.3. By End Use
    • 10.2.4. By Country

Chapter 11. Company Profile (Company Overview, Company Timeline, Organization Structure, Key Product landscape, Financial Matrix, Key Customers/Sectors, Key Competitors, SWOT Analysis, Contact Address, and Business Strategy Outlook)

  • 11.1. ABEC Inc.
  • 11.2. Avantor Inc.
  • 11.3. Cellexus
  • 11.4. Celltainer Biotech BV
  • 11.5. ESCO Bioengineering Co.
  • 11.6. Danaher Corp
  • 11.7. Distek Inc.
  • 11.8. Entegris Inc.
  • 11.9. Eppendorf AG
  • 11.10. GEA Group
  • 11.11. Meissner Filtration Products
  • 11.12. Merck
  • 11.13. OmniBRx Biotechnologies
  • 11.14. Parker Hannifin (Domnick Hunter)
  • 11.15. PBS Biotech Inc.
  • 11.16. Repligen Corporation
  • 11.17. Saint-Gobain Life Sciences
  • 11.18. Sartorius AG
  • 11.19. Solventum
  • 11.20. Thermo Fisher Scientific Inc.
  • 11.21. Other Prominent Players

Chapter 12. Annexure

  • 12.1. List of Secondary Sources
  • 12.2. Key Country Markets- Macro Economic Outlook/Indicators