生物製程验证市场－全球产业规模、份额、趋势、机会和预测，依测试类型、阶段、模式、地区和竞争格局划分，2020-2030年预测

2024年全球生物製程验证市场规模为3.3892亿美元，预计2030年将以13.80%的复合年增长率成长至7.3612亿美元。生物製程验证是指透过严谨的记录，建立科学证据，证明生物製药生产流程能够持续生产符合预定品质属性和监管标准的产品，从而确保药物的安全性、有效性和整体品质。该市场的成长主要受全球对复杂生物製药产品（包括生物製剂和生物相似药）日益增长的需求以及全球卫生监管机构日益严格的监管要求的驱动，这些要求促使企业必须严格遵守品质和安全规程。

主要市场驱动因素

主要市场挑战

这些高昂的程序成本会直接阻碍市场成长，因为它们可能会减缓新型生物製药的研发和市场推广速度。

主要市场趋势

目录

第一章：产品概述

第二章：研究方法

第三章：执行概要

第四章：顾客之声

第五章：全球生物製程验证市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 按测试类型（萃取物和浸出物测试、生物製程残留物测试、病毒清除测试、过滤和发酵系统测试、其他）
  • 依阶段划分（製程设计、製程确认、持续製程验证）
  • 按模式（内部开发、外包）
  • 按地区
  • 按公司（2024 年）
• 市场地图

第六章：北美生物製程验证市场展望

• 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

第七章：欧洲生物製程验证市场展望

• 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

第八章：亚太地区生物製程验证市场展望

• 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：中东和非洲生物製程验证市场展望

• 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
  • 阿联酋
  • 南非

第十章：南美洲生物製程验证市场展望

• 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
• 挑战

第十二章：市场趋势与发展

• 併购（如有）
• 产品发布（如有）
• 最新进展

第十三章：全球生物製程验证市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商议价能力
• 顾客的力量
• 替代产品的威胁

第十五章：竞争格局

• Merck KGaA
• SGS SA
• Eurofins Scientific SE
• Sartorius AG
• Pall Corporation
• Cobetter Filtration Equipments Co., Ltd
• Laboratory Corporation of America Holdings
• DOC Srl
• Meissner Corporation
• Thermo Fisher Scientific, Inc.

第十六章：策略建议

第17章调查会社について・免责事项

The Global Bioprocess Validation Market, valued at USD 338.92 Million in 2024, is projected to experience a CAGR of 13.80% to reach USD 736.12 Million by 2030. Bioprocess validation refers to the meticulously documented process of establishing scientific evidence that a biopharmaceutical manufacturing procedure consistently produces products meeting predetermined quality attributes and regulatory standards, thereby ensuring drug safety, efficacy, and overall quality. The market's expansion is fundamentally driven by the escalating global demand for complex biopharmaceutical products, including biologics and biosimilars, alongside increasingly stringent regulatory mandates from health authorities worldwide that necessitate rigorous adherence to quality and safety protocols.

Key Market Drivers

The growing demand for biologics and biopharmaceuticals represents a primary catalyst for the bioprocess validation market. As medical advancements yield sophisticated treatments for complex diseases, the pipeline for biological drugs consistently expands, necessitating robust validation throughout their manufacturing lifecycle. These therapeutic agents, including monoclonal antibodies, vaccines, and gene therapies, require precise and consistent production to ensure safety and efficacy. According to the research article 'Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023' published in Biomedicines in September 2024, the FDA authorized 17 biologics in 2023, with monoclonal antibodies accounting for 70% of these approvals. This increasing rate of new biologic approvals directly translates into a heightened need for comprehensive process validation activities.

Key Market Challenges

A significant challenge impeding the expansion of the Global Bioprocess Validation Market is the inherent complexity of advanced bioprocesses. This complexity necessitates specialized expertise and robust validation methodologies, ultimately contributing to high procedural costs. Such demands require substantial investment in highly skilled personnel, sophisticated analytical equipment, and extensive research to develop and implement rigorous validation protocols throughout the product lifecycle. These considerable requirements translate into elevated operational expenditures for biopharmaceutical companies, creating significant financial barriers to both new entrants and existing players.

These high procedural costs directly hamper market growth by potentially slowing the development and market introduction of novel biopharmaceuticals

Key Market Trends

Integration of Advanced Digital Technologies and AI is revolutionizing bioprocess validation through enhanced efficiency and data analysis. The pharmaceutical industry is significantly advancing its digital transformation; the "not started" category for Pharma 4.0 adoption dropped from 31.2% in 2021 to 15.1% in 2023, as per the 7th ISPE Pharma 4.0(TM) Survey, indicating a clear shift towards active digital implementation. Advanced digital technologies, including Artificial Intelligence, enable real-time monitoring and automated data processing, streamlining validation protocols. This integration is crucial for managing complex bioprocesses and accelerating market entry. For instance, Siemens AG acquired Dotmatics for $5.1 billion in April 2025, expanding its AI-powered product lifecycle management software, demonstrating substantial investment in these transformative technologies.

Key Market Players

• Merck KGaA
• SGS S.A.
• Eurofins Scientific SE
• Sartorius AG
• Pall Corporation
• Cobetter Filtration Equipments Co., Ltd
• Laboratory Corporation of America Holdings
• DOC S.r.l
• Meissner Corporation
• Thermo Fisher Scientific, Inc.

Report Scope:

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

Bioprocess Validation Market, By Testing Type:

• Extractables & Leachables Testing
• Bioprocess Residuals Testing
• Viral Clearance Testing
• Filtration & Fermentation Systems Testing
• Others

Bioprocess Validation Market, By Stage:

• Process Design
• Process Qualification
• Continued Process Verification

Bioprocess Validation Market, By Mode:

• In house
• Outsourced

Bioprocess Validation Market, By Region:

• North America
• Asia-Pacific
• Europe
• South America
• MEA

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Bioprocess Validation Market.

Available Customizations:

Global Bioprocess Validation 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 Bioprocess Validation Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing, Viral Clearance Testing, Filtration & Fermentation Systems Testing, Others)
  • 5.2.2. By Stage (Process Design, Process Qualification, Continued Process Verification)
  • 5.2.3. By Mode (In house, Outsourced)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. North America Bioprocess Validation Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Testing Type
  • 6.2.2. By Stage
  • 6.2.3. By Mode
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Bioprocess Validation 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 Testing Type
      • 6.3.1.2.2. By Stage
      • 6.3.1.2.3. By Mode
  • 6.3.2. Canada Bioprocess Validation 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 Testing Type
      • 6.3.2.2.2. By Stage
      • 6.3.2.2.3. By Mode
  • 6.3.3. Mexico Bioprocess Validation 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 Testing Type
      • 6.3.3.2.2. By Stage
      • 6.3.3.2.3. By Mode

7. Europe Bioprocess Validation Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Testing Type
  • 7.2.2. By Stage
  • 7.2.3. By Mode
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Bioprocess Validation 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 Testing Type
      • 7.3.1.2.2. By Stage
      • 7.3.1.2.3. By Mode
  • 7.3.2. France Bioprocess Validation 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 Testing Type
      • 7.3.2.2.2. By Stage
      • 7.3.2.2.3. By Mode
  • 7.3.3. United Kingdom Bioprocess Validation 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 Testing Type
      • 7.3.3.2.2. By Stage
      • 7.3.3.2.3. By Mode
  • 7.3.4. Italy Bioprocess Validation 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 Testing Type
      • 7.3.4.2.2. By Stage
      • 7.3.4.2.3. By Mode
  • 7.3.5. Spain Bioprocess Validation 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 Testing Type
      • 7.3.5.2.2. By Stage
      • 7.3.5.2.3. By Mode

8. Asia Pacific Bioprocess Validation Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Testing Type
  • 8.2.2. By Stage
  • 8.2.3. By Mode
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Bioprocess Validation 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 Testing Type
      • 8.3.1.2.2. By Stage
      • 8.3.1.2.3. By Mode
  • 8.3.2. India Bioprocess Validation 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 Testing Type
      • 8.3.2.2.2. By Stage
      • 8.3.2.2.3. By Mode
  • 8.3.3. Japan Bioprocess Validation 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 Testing Type
      • 8.3.3.2.2. By Stage
      • 8.3.3.2.3. By Mode
  • 8.3.4. South Korea Bioprocess Validation 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 Testing Type
      • 8.3.4.2.2. By Stage
      • 8.3.4.2.3. By Mode
  • 8.3.5. Australia Bioprocess Validation 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 Testing Type
      • 8.3.5.2.2. By Stage
      • 8.3.5.2.3. By Mode

9. Middle East & Africa Bioprocess Validation Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Testing Type
  • 9.2.2. By Stage
  • 9.2.3. By Mode
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Bioprocess Validation 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 Testing Type
      • 9.3.1.2.2. By Stage
      • 9.3.1.2.3. By Mode
  • 9.3.2. UAE Bioprocess Validation 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 Testing Type
      • 9.3.2.2.2. By Stage
      • 9.3.2.2.3. By Mode
  • 9.3.3. South Africa Bioprocess Validation 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 Testing Type
      • 9.3.3.2.2. By Stage
      • 9.3.3.2.3. By Mode

10. South America Bioprocess Validation Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Testing Type
  • 10.2.2. By Stage
  • 10.2.3. By Mode
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Bioprocess Validation 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 Testing Type
      • 10.3.1.2.2. By Stage
      • 10.3.1.2.3. By Mode
  • 10.3.2. Colombia Bioprocess Validation 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 Testing Type
      • 10.3.2.2.2. By Stage
      • 10.3.2.2.3. By Mode
  • 10.3.3. Argentina Bioprocess Validation 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 Testing Type
      • 10.3.3.2.2. By Stage
      • 10.3.3.2.3. By Mode

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 Bioprocess Validation 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. Merck KGaA
  • 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. SGS S.A.
• 15.3. Eurofins Scientific SE
• 15.4. Sartorius AG
• 15.5. Pall Corporation
• 15.6. Cobetter Filtration Equipments Co., Ltd
• 15.7. Laboratory Corporation of America Holdings
• 15.8. DOC S.r.l
• 15.9. Meissner Corporation
• 15.10. Thermo Fisher Scientific, Inc.

16. Strategic Recommendations

17. About Us & Disclaimer