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市場調查報告書
商品編碼
1961058

全球一次性生物製程市場：依產品、應用、最終用戶、工作流程和地區劃分—市場規模、產業動態、機會、分析和預測（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個工作天內

價格
簡介目錄

一次性生物製程市場持續顯著擴張，預計到2025年將達到 301.2億美元。這一令人矚目的市場規模預計將在未來十年內大幅成長，到2035年將飆升至 1,229.2億美元。這意味著從2026年到2035年，該市場將保持 15.1%的強勁年複合成長率（CAGR），反映出一次性技術在生物製藥生產中日益普及和重要。

推動市場快速成長的關鍵因素很多。一次性生物製程系統的主要優勢之一是其資本成本遠低於傳統的不銹鋼基礎設施。由於無需購買昂貴的固定設備和進行大規模的設施建設，企業可以減少初始投資並更有效地分配資源。此外，一次性系統快速的設定時間使製造商能夠加快專案進度，更快地將產品推向市場，並靈活地適應不斷變化的生產需求。

值得關注的市場趨勢

一次性生物製程市場的競爭格局呈現出寡占的特徵，由少數幾家全球性企業主導，包括Thermo Fisher Scientific、Sartorius、Danaher (透過其Cytiva division)、Merck KGaA。這些公司歷來以產品創新為競爭核心，並不斷提升其一次性技術的效能、可靠性和整合度。然而，隨著製造商尋求在地化生產和分銷網路以提高回應速度、縮短交貨週期並降低全球供應鏈中斷帶來的風險，競爭的重點正日益轉向供應鏈區域化。

標誌著此策略轉變的重要進展是，印度首個專門用於一次性生物製程設計和放大生產的設施 "Telangana 1 Bio" 於2025年12月在Genome Valley落成。這次落成意義尤其重大，因為它恰逢Genome Valley谷成立25週年。這個成熟的生命科學中心已成為該地區生物技術和製藥創新中心。

此外，為了滿足全球對一次性生物製程解決方案日益成長的需求，Sartorius Stedim Biotech於2025年6月大幅擴建了其潔淨室，面積幾乎翻了一番，達到約9000平方米。此次擴建將使該公司能夠顯著提高產量，滿足全球生物製藥製造商快速成長的需求。這些策略舉措 - 開設新的區域設施和擴大產能 - 凸顯了領先企業如何調整營運以應對供應鏈挑戰，同時繼續支持一次性生物製程市場的創新和成長。

核心成長驅動因子

慢性病日益增多和全球人口老化顯著提升了對先進生物製藥療法的需求，例如單株抗體、疫苗和細胞療法。這些療法已成為癌症、自體免疫疾病、傳染病和老年相關疾病管理和治療的重要工具。隨著全球人口老化和慢性病發病率的上升，對高效、可擴展的生產方法的需求日益成長，以滿足不斷成長的治療需求。

新機會

一個重要但又有些出乎意料的趨勢重塑一次性生物加工市場，那就是 "綠色生物" 倡議的興起。傳統上，由於生物製藥生產過程會產生大量塑膠垃圾，這一細分市場一直備受詬病。據估計，生物製藥產業每年產生 9.4萬至20萬噸一次性塑膠垃圾，對環境構成重大挑戰。批評人士認為，一次性塑膠的堆積是嚴重的生態負擔，並質疑一次性系統的可持續性，儘管它們具有操作優勢。

最佳化障礙

隨著一次性生物加工市場轉向塑膠填充和包裝應用，監管機構對塑膠材料中化學物質遷移的審查力度顯著加大。這種關注的增加反映出人們日益擔憂，從塑膠組件遷移到藥物產品中的化學物質（可浸出物和可萃取物，簡稱 L&E）可能會影響藥物的安全性和有效性。監管機構，特別是美國食品藥物管理局（FDA），已採取應對措施，實施更嚴格的測試和驗證要求，以確保一次性系統符合產品完整性和病患安全的最高標準。

目錄

第1章 執行摘要：全球一次性生物加工市場

第2章 報告概述

  • 研究框架
    • 研究目標
    • 市場定義
    • 市場區隔
  • 研究方法
    • 市場規模估算
    • 定性研究
    • 量化研究
    • 依地區劃分的主要調查受訪者細分
    • 資料三角驗證
    • 研究假設

第3章 全球一次性生物加工市場概論

  • 產業價值鏈分析
    • 原料採購
    • 製造和組裝
    • 經銷商
    • 最終用戶
  • 行業展望
    • 全球生物製藥生產展望
    • 進出口分析
    • 監理框架
  • PESTLE 分析
  • 波特五力分析
    • 供應商議價能力
    • 買方議價能力
    • 替代品威脅
    • 新進入者威脅
    • 競爭強度
  • 市場成長與展望
    • 市場收入估計與預測（2020-2035）
    • 產品價格分析
  • 市場吸引力分析
    • 依產品
  • 可執行的見解（分析師建議）

第4章 競爭格局概覽

  • 市場集中度
  • 公司佔有率分析（基於價值，2025年）
  • 競爭格局分析與基準分析

第5章 全球一次性生物製程市場分析

  • 市場動態與趨勢
    • 成長驅動因素
    • 限制因素
    • 機會
    • 關鍵趨勢
  • 市場規模及預測（2020-2035年）
    • 依產品劃分
    • 依工作流程劃分
    • 依最終用途劃分
    • 依地區劃分

第6章 北美一次性生物製程市場分析

第7章 歐洲一次性生物加工市場分析

第8章 亞太地區一次性生物加工市場分析

第9章 中東與非洲一次性生物加工市場分析

第10章 南美洲一次性生物加工市場分析

第11章 公司簡介

  • 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.
  • 其他主要參與者

第12章 附錄

簡介目錄
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