生物製程驗證市場－全球產業規模、佔有率、趨勢、機會和預測，依測試類型、階段、模式、地區和競爭格局分類，2020-2030年預測

2024年全球生物製程驗證市場規模為3.3892億美元，預計2030年將以13.80%的複合年成長率成長至7.3612億美元。生物製程驗證是指透過嚴謹的記錄，建立科學證據，證明生物製藥生產流程能夠持續生產符合預定品質屬性和監管標準的產品，從而確保藥物的安全性、有效性和整體品質。該市場的成長主要受全球對複雜生物製藥產品（包括生物製劑和生物相似藥）日益成長的需求以及全球衛生監管機構日益嚴格的監管要求的驅動，這些要求促使企業必須嚴格遵守品質和安全規程。

主要市場促進因素

主要市場挑戰

這些高昂的程序成本會直接阻礙市場成長，因為它們可能會減緩新型生物製藥的研發和市場推廣速度。

主要市場趨勢

目錄

第1章：產品概述

第2章：研究方法

第3章：執行概要

第4章：顧客之聲

第5章：全球生物製程驗證市場展望

• 市場規模及預測
  • 按價值
• 市佔率及預測
  • 按測試類型（萃取物和浸出物測試、生物製程殘留物測試、病毒清除測試、過濾和發酵系統測試、其他）
  • 依階段分類（製程設計、製程確認、持續製程驗證）
  • 按模式（內部開發、外包）
  • 按地區
  • 按公司（2024 年）
• 市場地圖

第6章：北美生物製程驗證市場展望

• 市場規模及預測
• 市佔率及預測
• 北美洲：國家分析
  • 美國
  • 加拿大
  • 墨西哥

第7章：歐洲生物製程驗證市場展望

• 市場規模及預測
• 市佔率及預測
• 歐洲：國家分析
  • 德國
  • 法國
  • 英國
  • 義大利
  • 西班牙

第8章：亞太地區生物製程驗證市場展望

• 市場規模及預測
• 市佔率及預測
• 亞太地區：國家分析
  • 中國
  • 印度
  • 日本
  • 韓國
  • 澳洲

第9章：中東和非洲生物製程驗證市場展望

• 市場規模及預測
• 市佔率及預測
• 中東和非洲：國家分析
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 南非

第10章：南美洲生物製程驗證市場展望

• 市場規模及預測
• 市佔率及預測
• 南美洲：國家分析
  • 巴西
  • 哥倫比亞
  • 阿根廷

第11章：市場動態

• 促進要素
• 挑戰

第12章：市場趨勢與發展

• 併購（如有）
• 產品發布（如有）
• 最新進展

第13章：全球生物製程驗證市場：SWOT分析

第14章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商議價能力
• 顧客的力量
• 替代產品的威脅

第15章：競爭格局

• 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16章：策略建議

第17章調查會社について,免責事項

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