生物製药发酵系统市场－全球产业规模、份额、趋势、机会及预测（依产品类型、应用、最终用户、地区及竞争格局划分），2021-2031年

全球生物製药发酵系统市场预计将从 2025 年的 276.8 亿美元成长到 2031 年的 455.9 亿美元，复合年增长率达到 8.67%。

这些系统由专门的生物反应器和整合控制单元组成，旨在培养细菌和真菌等微生物，以大规模生产治疗性蛋白质、疫苗和其他生物製药。推动这一市场成长的关键因素包括：全球对生物製药和生物相似药的需求不断增长、合约研发生产机构（CDMO）的能力迅速提升，以及需要生物疗法的慢性疾病病例不断增加。

对药物研发的大力财政支持进一步推动了该行业的扩张：欧洲製药工业协会联合会（EFPIA）报告称，2024年，以研发为基础的製药业将在欧洲投入约550亿欧元用于研发。儘管投资环境有利，但该市场仍面临重大障碍：建造和维护符合严格监管标准的上游工程加工设施需要大量的资本投资和技术专长。

市场驱动因素

全球慢性病发病率的上升推动了生物製药研发管线的快速成长，这也是生物製药发酵系统应用的主要驱动因素。为了满足单株抗体和重组蛋白日益增长的商业性需求，生产商正在对上游工程基础设施进行大量投资，这需要建造配备先进生物反应器的大型设施。例如，诺和诺德在2024年6月发布的新闻稿《诺和诺德将在北卡罗来纳州投资41亿美元》中宣布，计划新建一座生产建设计画，以扩大其慢性病治疗药物的产能。

同时，製药公司越来越多地将生产外包给合约研发生产机构（CDMO）以降低技术风险，从而推动了市场活跃度。 CDMO不断升级其发酵生产线，并配备高密度生物反应器，以支援从疫苗到细胞疗法等多元化的客户组合。三星生物製剂于2024年10月发布的「2024年第三季财务业绩」报告印证了这一趋势，报告显示，由于客户需求增长，其合併累计销售额达到3.2兆韩元。除了外包之外，成熟企业也正在扩大其内部生产能力。例如，赛诺菲于2024年5月宣布，将在维特里-苏尔-塞纳投资11亿欧元新建一座生技生产设施，使其单株抗体产能翻倍。

市场挑战

建立和维护符合规范的上游工程加工设施所需的大量资本投入和技术专长，是全球生物製药发酵系统市场发展的一大阻碍因素。这种高进入门槛对中小型生物製药公司的影响尤其显着，这些公司往往缺乏足够的财力来投资商业规模发酵所需的昂贵设备和复杂基础设施。因此，这些系统的市场严重依赖大型製药企业和合约研发生产机构（CDMO），这有效地限制了潜在基本客群，并减缓了系统的广泛应用。

严峻的资金筹措环境进一步加剧了这种财务压力，限制了这些资本密集型基础设施计划的可用流动性。当企业无法获得足够的资金筹措时，它们将被迫推迟或取消建造设施或升级设备的计划。据英国生物产业协会称，英国生技产业在2024年面临严峻的公开市场环境，连续第二年没有出现首次股票公开发行（IPO）。这种无法进入公开资本市场的局面直接阻碍了成长型企业筹集扩大生产基地所需资金的能力，使它们无法获得发酵系统的新订单。

市场趋势

人工智慧 (AI) 和机器学习的融合正在改变全球生物製药发酵系统市场，推动生产营运转型为智慧化、数据驱动型製造。市场参与者正将 AI 演算法整合到生物反应器控制单元中，以实现预测性维护和即时代谢物监测，从而最大限度地减少批次失败并提高滴度产量。安进公司在 2024 年 2 月发布的新闻稿中重点介绍了其“人工智慧赋能的俄亥俄州生物製造工厂”，凸显了向数位化成熟基础设施的转变。该公司投资 3.65 亿美元建造了该工厂，该工厂配备了先进的自动化系统，旨在优化生物製药的生产可靠性。

同时，人们对永续和环境友善生物加工方法的日益关注，正促使发酵系统的设计和运作朝着严格的环境标准转变。製造商们正积极寻求能够减少碳排放和消费量的生物反应器解决方案和设施配置，市场也正朝着节能环保且相容可再生能源的技术方向发展。默克集团（Merck KGaA）于2024年1月宣布与华润电力签署长期绿色电力合同，凸显了这一战略转变。该公司签署了一份为期10年的协议，将供应300吉瓦时的再生能源，旨在实现其生产和供应链营运的脱碳。

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 全球生物製药发酵系统市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 依产品类型（上游工程产品（生物反应器/发酵槽、生物製程分析仪、製程监控系统等）、下游加工产品（过滤/分离、层析法、耗材、配件等））
  • 依应用领域（抗生素、重组蛋白等）
  • 依最终用户（生物製药产业、受託研究机构、学术研究机构、其他）划分
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章 北美生物製药发酵系统市场展望

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

7. 欧洲生物製药发酵系统市场展望

• 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. 亚太地区生物製药发酵系统市场展望

• 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

第九章：中东和非洲生物製药发酵系统市场展望

• 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

第十章：南美洲生物製药发酵系统市场展望

• 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 全球生物製药发酵系统市场：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

• Agilent Technologies, Inc.
• Thermo Fisher Scientific Inc
• Lonza Group AG
• Sartorius Stedim Biotech GmbH
• Eppendorf SE
• Danaher Corp
• F Hoffmann-La Roche AG
• Nova Biomedical Corp
• Merck KGaA
• Becton Dickinson & Co

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 Biopharmaceutical Fermentation System Market is projected to expand from USD 27.68 Billion in 2025 to USD 45.59 Billion by 2031, achieving a CAGR of 8.67%. These systems consist of specialized bioreactors and integrated control units engineered to cultivate microorganisms, including bacteria and fungi, for the mass production of therapeutic proteins, vaccines, and other biological products. Key factors driving this market growth include the rising global demand for biologics and biosimilars, the rapid enhancement of capabilities within contract development and manufacturing organizations, and the increasing burden of chronic diseases that require biological treatments.

A strong financial dedication to drug development further reinforces the expansion of this sector. As reported by the European Federation of Pharmaceutical Industries and Associations, the research-based pharmaceutical industry allocated approximately €55,000 million to R&D across Europe in 2024. Despite this favorable investment atmosphere, the market encounters a major hurdle due to the significant capital expenditure and specialized technical expertise needed to construct and sustain upstream processing facilities that meet strict regulatory standards.

Market Driver

The swift growth of the biologics pipeline, spurred by the rising global incidence of chronic diseases, acts as a primary catalyst for the adoption of biopharmaceutical fermentation systems. Manufacturers are heavily investing in upstream processing infrastructure to satisfy the soaring commercial requirements for monoclonal antibodies and recombinant proteins, necessitating the construction of large-scale facilities equipped with advanced bioreactors. For instance, Novo Nordisk announced in a June 2024 press release titled 'Novo Nordisk to invest 4.1 billion USD in North Carolina' that it plans to build a new manufacturing plant to expand production capacity for its chronic disease therapies.

Concurrently, the increase in outsourcing to Contract Development and Manufacturing Organizations fuels market activity as pharmaceutical innovators seek to lower technical risks. CDMOs are continuously upgrading their fermentation lines with high-density bioreactors to handle diverse client portfolios ranging from vaccines to cell therapies. This trend is evident in Samsung Biologics' 'Third Quarter 2024 Financial Results' from October 2024, which reported a cumulative consolidated revenue of KRW 3.2 trillion due to rising client demand. Beyond outsourcing, established players are boosting internal capacities; for example, Sanofi committed €1.1 billion in May 2024 to create a new bioproduction site at Vitry-sur-Seine to double its monoclonal antibody production capacity.

Market Challenge

The significant capital expenditure and technical expertise required to establish and maintain regulatory-compliant upstream processing facilities serve as a major constraint on the Global Biopharmaceutical Fermentation System Market. This high barrier to entry disproportionately impacts small and medium-sized biopharmaceutical enterprises, which often lack the financial resilience to invest in costly capital equipment and the sophisticated infrastructure needed for commercial-scale fermentation. Consequently, the market for these systems relies heavily on large pharmaceutical corporations and Contract Development and Manufacturing Organizations, effectively limiting the potential customer base and slowing broader adoption.

This financial pressure is worsened by a tightening funding environment that restricts the liquidity available for such capital-intensive infrastructure projects. When companies are unable to secure sufficient backing, they are forced to delay or cancel plans for facility construction and equipment upgrades. According to the BioIndustry Association, the UK biotech sector faced a difficult public market environment in 2024, recording zero initial public offerings for the second consecutive year. This lack of access to public capital markets directly impedes the ability of growing companies to raise the necessary funds for expanding their manufacturing footprint, thereby hampering new orders for fermentation systems.

Market Trends

The integration of Artificial Intelligence and Machine Learning is transforming the Global Biopharmaceutical Fermentation System Market by shifting operations toward intelligent, data-driven manufacturing. Market players are embedding AI algorithms into bioreactor control units to facilitate predictive maintenance and real-time metabolite monitoring, thereby minimizing batch failures and maximizing titer yields. This move toward digitally mature infrastructure is exemplified by Amgen's February 2024 press release regarding its 'AI-enabled Ohio biomanufacturing facility,' where the company invested $365 million to establish a site featuring advanced automation designed to optimize biologic production reliability.

Simultaneously, the growing emphasis on sustainable and green bioprocessing practices is influencing the design and operation of fermentation systems to align with rigorous environmental standards. Manufacturers are actively pursuing bioreactor solutions and facility configurations that reduce carbon footprints and water consumption, pushing the market toward energy-efficient and renewable-compatible technologies. This strategic shift is highlighted by Merck KGaA's January 2024 announcement of a long-term green power agreement with China Resources Power, finalizing a ten-year contract for 300 gigawatt hours of renewable electricity to decarbonize its manufacturing and supply chain operations.

Key Market Players

• Agilent Technologies, Inc.
• Thermo Fisher Scientific Inc
• Lonza Group AG
• Sartorius Stedim Biotech GmbH
• Eppendorf SE
• Danaher Corp
• F Hoffmann-La Roche AG
• Nova Biomedical Corp
• Merck KGaA
• Becton Dickinson & Co

Report Scope

In this report, the Global Biopharmaceutical Fermentation System Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biopharmaceutical Fermentation System Market, By Product Type

• Upstream Products
  • (Bioreactors/Fermentors, Bioprocess Analyzers, Process Monitoring System, Others)
• Downstream Products
  • (Filtration & Separation, Chromatography, Consumables, Accessories, Others)

Biopharmaceutical Fermentation System Market, By Application

• Antibiotics
• Recombinant Proteins
• Others

Biopharmaceutical Fermentation System Market, By End User

• Biopharmaceutical Industries
• Contract Research Organization
• Academic Research Institutes
• Others

Biopharmaceutical Fermentation System 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 Biopharmaceutical Fermentation System Market.

Available Customizations:

Global Biopharmaceutical Fermentation System 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 Biopharmaceutical Fermentation System Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product Type (Upstream Products (Bioreactors/Fermentors, Bioprocess Analyzers, Process Monitoring System, Others), Downstream Products (Filtration & Separation, Chromatography, Consumables, Accessories, Others))
  • 5.2.2. By Application (Antibiotics, Recombinant Proteins, Others)
  • 5.2.3. By End User (Biopharmaceutical Industries, Contract Research Organization, Academic Research Institutes, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Biopharmaceutical Fermentation System Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product Type
  • 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 Biopharmaceutical Fermentation System 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 Type
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By End User
  • 6.3.2. Canada Biopharmaceutical Fermentation System 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 Type
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By End User
  • 6.3.3. Mexico Biopharmaceutical Fermentation System 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 Type
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By End User

7. Europe Biopharmaceutical Fermentation System Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product Type
  • 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 Biopharmaceutical Fermentation System 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 Type
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By End User
  • 7.3.2. France Biopharmaceutical Fermentation System 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 Type
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By End User
  • 7.3.3. United Kingdom Biopharmaceutical Fermentation System 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 Type
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By End User
  • 7.3.4. Italy Biopharmaceutical Fermentation System 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 Type
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By End User
  • 7.3.5. Spain Biopharmaceutical Fermentation System 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 Type
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By End User

8. Asia Pacific Biopharmaceutical Fermentation System Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product Type
  • 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 Biopharmaceutical Fermentation System 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 Type
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By End User
  • 8.3.2. India Biopharmaceutical Fermentation System 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 Type
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By End User
  • 8.3.3. Japan Biopharmaceutical Fermentation System 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 Type
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By End User
  • 8.3.4. South Korea Biopharmaceutical Fermentation System 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 Type
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By End User
  • 8.3.5. Australia Biopharmaceutical Fermentation System 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 Type
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By End User

9. Middle East & Africa Biopharmaceutical Fermentation System Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product Type
  • 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 Biopharmaceutical Fermentation System 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 Type
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By End User
  • 9.3.2. UAE Biopharmaceutical Fermentation System 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 Type
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By End User
  • 9.3.3. South Africa Biopharmaceutical Fermentation System 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 Type
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By End User

10. South America Biopharmaceutical Fermentation System Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product Type
  • 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 Biopharmaceutical Fermentation System 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 Type
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By End User
  • 10.3.2. Colombia Biopharmaceutical Fermentation System 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 Type
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By End User
  • 10.3.3. Argentina Biopharmaceutical Fermentation System 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 Type
      • 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 Biopharmaceutical Fermentation System 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. Agilent Technologies, 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. Thermo Fisher Scientific Inc
• 15.3. Lonza Group AG
• 15.4. Sartorius Stedim Biotech GmbH
• 15.5. Eppendorf SE
• 15.6. Danaher Corp
• 15.7. F Hoffmann-La Roche AG
• 15.8. Nova Biomedical Corp
• 15.9. Merck KGaA
• 15.10. Becton Dickinson & Co

16. Strategic Recommendations

17. About Us & Disclaimer