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全球生物製程驗證市場：按最終用戶、產品類型、測試類型、地區、競爭形勢- 分析和預測，2024-2033 年
市場調查報告書
商品編碼
1397352

全球生物製程驗證市場：按最終用戶、產品類型、測試類型、地區、競爭形勢- 分析和預測，2024-2033 年

Global Bioprocess Validation Market: Focus on End Users, Product, Test Type, Region and Competitive Landscape - Analysis and Forecast, 2024-2033
出版日期: | 出版商: BIS Research | 英文 147 Pages | 商品交期: 1-5個工作天內

價格

在嚴格的監管標準和對生物治療藥物的需求不斷成長的推動下，生物製程驗證市場預計將呈現顯著成長。

生物製程驗證符合美國FDA 指南和 cGMP 法規，涉及與生技藥品和生物製藥相關的程序、配合措施和證據的完整記錄。這份全面的文件可確保產品測試各階段的合規性，並專注於活性藥物成分 (API) 和雜質評估。

本報告調查了全球生物製程驗證市場，並提供了市場背景和概述，分析了市場成長的各種影響因素、技術和專利趨勢、法律制度、市場規模趨勢和預測以及各種分類。,編制了詳細的區域分析，競爭形勢、主要企業分析等

市場分類

細分 1：按最終用戶

  • 製藥和生物技術公司
  • 開發/受託製造廠商
  • 其他

細分 2：依考試類型

  • 可萃取性和溶離度測試服務
  • 微生物檢測服務
  • 物理化學測試服務
  • 完整性測試服務
  • 合格測試服務
  • 其他

細分 3：依流程組件

  • 濾芯
  • 介質容器和介質袋
  • 冷凍/解凍加工袋
  • 生物反應器
  • 輸送系統
  • 其他

細分 4：按地區

  • 北美洲
  • 歐洲
  • 亞太地區
  • 拉丁美洲
  • 中東/非洲

目錄

執行摘要

範圍和定義

第1章 市場

  • 趨勢：當前和未來的影響評估
  • 供應鏈概覽
    • 價值鏈分析
    • 市場地圖
  • 研發回顧
    • 按國家和公司分類的專利申請趨勢
  • 監管狀況
  • 世界重大事件的影響分析：COVID-19
  • 市場動態概覽
    • 市場促進因素
    • 市場抑制因素
    • 市場機會

第2章 應用

  • 使用分類
  • 應用概述
  • 全球生物程序驗證市場（按最終用戶）
    • 製藥和生物技術公司
    • 合約開發/製造組織
    • 其他

第3章 產品

  • 產品分類
  • 產品概要
  • 全球生物製程驗證市場（按產品）
    • 市場概況
  • 全球生物程序驗證市場（按測試類型）
    • 可萃取性和溶離度測試服務
    • 微生物檢測服務
    • 物理化學測試服務
    • 完整性測試服務
    • 合格測試服務
    • 其他
  • 全球生物程序驗證市場（按工藝組件）
    • 濾芯
    • 介質容器和介質袋
    • 冷凍/解凍加工袋
    • 生物反應器
    • 輸送系統
    • 其他

第4章 區域

  • 區域概況
  • 促進因素/抑制因素
  • 北美洲
  • 歐洲
  • 亞太地區
  • 拉丁美洲
  • 中東/非洲

第5章市場：競爭基準化分析/公司簡介

  • 下一個前沿
  • 區域評估
    • Merck KGgA
    • Sartorius AG
    • Eurofins Scientific
    • Thermo Fisher Scientific Inc.
    • Hangzhou Cobetter Filtration Equipment Co.,Ltd
    • Meissner Filtration Products, Inc.
    • Almac Group
    • Danaher Corporation
    • SGS Societe Generale de Surveillance SA.
    • Charles River Laboratories
    • Lonza
    • Labcorp Drug Development
    • BIOZEEN
    • WuXi Biologics
    • Pacific Biolabs

第6章調查方法

Product Code: BHL1662SA

“The bioprocess validation market is poised for significant growth, fueled by stringent regulatory standards and an increasing need for biotherapeutics.”

Bioprocess validation, aligning with US FDA guidelines and cGMP regulations, involves meticulous documentation of procedures, activities, and evidence related to the production of biological and biopharmaceutical products. This comprehensive documentation ensures compliance across all stages of product testing, emphasizing the assessment of active pharmaceutical ingredients (APIs) and impurities.

This comprehensive report provides a detailed analysis of market trends, key players, and growth opportunities within the bioprocessing validation sector.

With insights into market drivers, challenges, and opportunities, this report serves as a valuable resource for industry participants, investors, and decision-makers seeking to navigate the dynamic landscape of the global bioprocessing validation market.

Market Segmentation:

Segmentation 1: by End User

  • Pharmaceutical and Biotechnology Companies
  • Contract Development & Manufacturing Organizations
  • Others

Segmentation 2: by Test Type

  • Extractable and Leachable Testing Services
  • Microbiological Testing Services
  • Physiochemical Testing Services
  • Integrity Testing Services
  • Compatibility Testing Services
  • Others

Segmentation 3: by Process Component

  • Filter Elements
  • Media Containers and Bags
  • Freezing And Thawing Process Bags
  • Bioreactors
  • Transfer Systems
  • Others Process Component

Segmentation 4: by Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa

Key Questions Answered in this Report:

  • 1. What constitutes the market share of bioprocess validation, and which industry is anticipated to experience growth in the next decade?
  • 2. What opportunities are prevalent for producers in the bioprocess validation market share within North America?
  • 3. Which factors serve as constraints impacting the expansion of the bioprocess validation market share market in North America?
  • 4. How is the consumption of bioprocess validation market share influenced by emerging trends in production?
  • 5. What end-user sector is propelling the growth in demand for bioprocess validation market share?
  • 6. Which specific application of bioprocess validation market share is expected to maintain its significance?
  • 7. What lies within the future scope and evolving trends of technologies in the global market?
  • 8. Who are the prominent companies leading the global bioprocess validation market share?

Table of Contents

Executive Summary

Scope and Definition

1. Markets

  • 1.1. Trends: Current and Future Impact Assessment
    • 1.1.1. Sample Text
    • 1.1.2. Trend 1
    • 1.1.3. Trend 2
    • 1.1.4. Trend 3
  • 1.2. Supply Chain Overview
    • 1.2.1. Value Chain Analysis
    • 1.2.2. Market Map
  • 1.3. Research and Development Review
    • 1.3.1. Patent Filing Trend (by Country, Company)
  • 1.4. Regulatory Landscape
  • 1.5. Impact Analysis for Key Global Events- COVID- 19
  • 1.6. Market Dynamics Overview
    • 1.6.1. Market Drivers
    • 1.6.2. Market Restraints
    • 1.6.3. Market Opportunities

2. Application

  • 2.1. Application Segmentation
  • 2.2. Application Summary
  • 2.3. Global Bioprocess Validation Market (by End User)
    • 2.3.1. Pharmaceutical and Biotechnology Companies
    • 2.3.2. Contract Development & Manufacturing Organizations
    • 2.3.3. Others

3. Products

  • 3.1. Product Segmentation
  • 3.2. Product Summary
  • 3.3. Global Bioprocess Validation Market- (by Product)
    • 3.3.1. Market Overview
      • 3.3.1.1. Analyst View
  • 3.4. Global Bioprocess Validation Market (by Test Type)
    • 3.4.1. Extractable and Leachable Testing Services
    • 3.4.2. Microbiological Testing Services
    • 3.4.3. Physiochemical Testing Services
    • 3.4.4. Integrity Testing Services
    • 3.4.5. Compatibility Testing Services
    • 3.4.6. Others
  • 3.5. Global Bioprocess Validation Market (by Process Component)
    • 3.5.1. Filter Elements
    • 3.5.2. Media Containers and Bags
    • 3.5.3. Freezing And Thawing Process Bags
    • 3.5.4. Bioreactors
    • 3.5.5. Transfer Systems
    • 3.5.6. Others Process Component

4. Regions

  • 4.1. Regional Summary
  • 4.2. Drivers and Restraints
  • 4.3. North America
    • 4.3.1. Regional Overview
    • 4.3.2. Driving Factors for Market Growth
    • 4.3.3. Factors Challenging the Market
    • 4.3.4. Application
    • 4.3.5. Product
    • 4.3.6. U.S.
    • 4.3.7. U.S. Bioprocess Validation Market by Application
    • 4.3.8. Canada
    • 4.3.9. Canada Bioprocess Validation Market by Application
  • 4.4. Europe
    • 4.4.1. Regional Overview
    • 4.4.2. Driving Factors for Market Growth
    • 4.4.3. Factors Challenging the Market
    • 4.4.4. Application
    • 4.4.5. Product
    • 4.4.6. Germany
    • 4.4.7. Germany Bioprocess Validation Market by Application
    • 4.4.8. U.K.
    • 4.4.9. U.K. Bioprocess Validation Market by Application
    • 4.4.10. France
    • 4.4.11. France Bioprocess Validation Market by Application
    • 4.4.12. Italy
    • 4.4.13. Italy Bioprocess Validation Market by Application
    • 4.4.14. Spain
    • 4.4.15. Spain Bioprocess Validation Market by Application
    • 4.4.16. Rest of Europe
    • 4.4.17. Rest of Europe Bioprocess Validation Market by Application
  • 4.5. Asia Pacific
    • 4.5.1. Regional Overview
    • 4.5.2. Driving Factors for Market Growth
    • 4.5.3. Factors Challenging the Market
    • 4.5.4. Application
    • 4.5.5. Product
    • 4.5.6. China
    • 4.5.7. China Bioprocess Validation Market by Application
    • 4.5.8. Japan
    • 4.5.9. Japan Bioprocess Validation Market by Application
    • 4.5.10. South Korea
    • 4.5.11. South Korea Bioprocess Validation Market by Application
    • 4.5.12. Australia
    • 4.5.13. Australia Bioprocess Validation Market by Application
    • 4.5.14. India
    • 4.5.15. India Bioprocess Validation Market by Application
    • 4.5.16. Rest-of-Asia-Pacific
    • 4.5.17. Rest-of-Asia-Pacific Bioprocess Validation Market by Application
  • 4.6. Latin America
    • 4.6.1. Regional Overview
    • 4.6.2. Driving Factors for Market Growth
    • 4.6.3. Factors Challenging the Market
    • 4.6.4. Application
    • 4.6.5. Product
    • 4.6.6. Brazil
    • 4.6.7. Brazil Bioprocess Validation Market by Application
    • 4.6.8. Mexico
    • 4.6.9. Mexico Bioprocess Validation Market by Application
    • 4.6.10. Rest-of-Latin America
    • 4.6.11. Rest-of-Latin America Bioprocess Validation Market by Application
  • 4.7. Middle East & Africa
    • 4.7.1. Regional Overview
    • 4.7.2. Driving Factors for Market Growth
    • 4.7.3. Factors Challenging the Market
    • 4.7.4. Application
    • 4.7.5. Product

5. Markets - Competitive Benchmarking & Company Profiles

  • 5.1. Next Frontiers…..
  • 5.2. Geographic Assessment
    • 5.2.1. Merck KGgA
      • 5.2.1.1. Overview
      • 5.2.1.2. Top Products / Product Portfolio
      • 5.2.1.3. Top Competitors
      • 5.2.1.4. Target Customers
      • 5.2.1.5. Key Personnel
      • 5.2.1.6. Analyst View
      • 5.2.1.7. Market Share
    • 5.2.2. Sartorius AG
      • 5.2.2.1. Overview
      • 5.2.2.2. Top Products / Product Portfolio
      • 5.2.2.3. Top Competitors
      • 5.2.2.4. Target Customers
      • 5.2.2.5. Key Personnel
      • 5.2.2.6. Analyst View
      • 5.2.2.7. Market Share
    • 5.2.3. Eurofins Scientific
      • 5.2.3.1. Overview
      • 5.2.3.2. Top Products / Product Portfolio
      • 5.2.3.3. Top Competitors
      • 5.2.3.4. Target Customers
      • 5.2.3.5. Key Personnel
      • 5.2.3.6. Analyst View
      • 5.2.3.7. Market Share
    • 5.2.4. Thermo Fisher Scientific Inc.
      • 5.2.4.1. Overview
      • 5.2.4.2. Top Products / Product Portfolio
      • 5.2.4.3. Top Competitors
      • 5.2.4.4. Target Customers
      • 5.2.4.5. Key Personnel
      • 5.2.4.6. Analyst View
      • 5.2.4.7. Market Share
    • 5.2.5. Hangzhou Cobetter Filtration Equipment Co.,Ltd
      • 5.2.5.1. Overview
      • 5.2.5.2. Top Products / Product Portfolio
      • 5.2.5.3. Top Competitors
      • 5.2.5.4. Target Customers
      • 5.2.5.5. Key Personnel
      • 5.2.5.6. Analyst View
      • 5.2.5.7. Market Share
    • 5.2.6. Meissner Filtration Products, Inc.
      • 5.2.6.1. Overview
      • 5.2.6.2. Top Products / Product Portfolio
      • 5.2.6.3. Top Competitors
      • 5.2.6.4. Target Customers
      • 5.2.6.5. Key Personnel
      • 5.2.6.6. Analyst View
      • 5.2.6.7. Market Share
    • 5.2.7. Almac Group
      • 5.2.7.1. Overview
      • 5.2.7.2. Top Products / Product Portfolio
      • 5.2.7.3. Top Competitors
      • 5.2.7.4. Target Customers
      • 5.2.7.5. Key Personnel
      • 5.2.7.6. Analyst View
      • 5.2.7.7. Market Share
    • 5.2.8. Danaher Corporation
      • 5.2.8.1. Overview
      • 5.2.8.2. Top Products / Product Portfolio
      • 5.2.8.3. Top Competitors
      • 5.2.8.4. Target Customers
      • 5.2.8.5. Key Personnel
      • 5.2.8.6. Analyst View
      • 5.2.8.7. Market Share
    • 5.2.9. SGS Societe Generale de Surveillance SA.
      • 5.2.9.1. Overview
      • 5.2.9.2. Top Products / Product Portfolio
      • 5.2.9.3. Top Competitors
      • 5.2.9.4. Target Customers
      • 5.2.9.5. Key Personnel
      • 5.2.9.6. Analyst View
      • 5.2.9.7. Market Share
    • 5.2.10. Charles River Laboratories
      • 5.2.10.1. Overview
      • 5.2.10.2. Top Products / Product Portfolio
      • 5.2.10.3. Top Competitors
      • 5.2.10.4. Target Customers
      • 5.2.10.5. Key Personnel
      • 5.2.10.6. Analyst View
      • 5.2.10.7. Market Share
    • 5.2.11. Lonza
      • 5.2.11.1. Overview
      • 5.2.11.2. Top Products / Product Portfolio
      • 5.2.11.3. Top Competitors
      • 5.2.11.4. Target Customers
      • 5.2.11.5. Key Personnel
      • 5.2.11.6. Analyst View
      • 5.2.11.7. Market Share
    • 5.2.12. Labcorp Drug Development
      • 5.2.12.1. Overview
      • 5.2.12.2. Top Products / Product Portfolio
      • 5.2.12.3. Top Competitors
      • 5.2.12.4. Target Customers
      • 5.2.12.5. Key Personnel
      • 5.2.12.6. Analyst View
      • 5.2.12.7. Market Share
    • 5.2.13. BIOZEEN
      • 5.2.13.1. Overview
      • 5.2.13.2. Top Products / Product Portfolio
      • 5.2.13.3. Top Competitors
      • 5.2.13.4. Target Customers
      • 5.2.13.5. Key Personnel
      • 5.2.13.6. Analyst View
      • 5.2.13.7. Market Share
    • 5.2.14. WuXi Biologics
      • 5.2.14.1. Overview
      • 5.2.14.2. Top Products / Product Portfolio
      • 5.2.14.3. Top Competitors
      • 5.2.14.4. Target Customers
      • 5.2.14.5. Key Personnel
      • 5.2.14.6. Analyst View
      • 5.2.14.7. Market Share
    • 5.2.15. Pacific Biolabs
      • 5.2.15.1. Overview
      • 5.2.15.2. Top Products / Product Portfolio
      • 5.2.15.3. Top Competitors
      • 5.2.15.4. Target Customers
      • 5.2.15.5. Key Personnel
      • 5.2.15.6. Analyst View
      • 5.2.15.7. Market Share

6. Research Methodology

  • 6.1. Data Sources
    • 6.1.1. Primary Data Sources
    • 6.1.2. Secondary Data Sources
    • 6.1.3. Data Triangulation
  • 6.2. Market Estimation and Forecast

List of Figures

  • Figure 1: Global Bioprocess Validation Market, By Region, 2022, 2026, and 2033
  • Figure 2: Global Bioprocess Validation Market, Pricing/Cost Analysis
  • Figure 3: Global Bioprocess Validation Market, by Stage, 2022, 2026, and 2033
  • Figure 4: Global Bioprocess Validation Market, by Mode, 2022, 2026, and 2033
  • Figure 5: Global Bioprocess Validation Market, by End User, 2022, 2026, and 2033
  • Figure 6: Global Bioprocess Validation Market, by Test Type, 2022, 2026, and 2033
  • Figure 7: Global Bioprocess Validation Market, by Process Component, 2022, 2026, and 2033
  • Figure 8: Global Bioprocess Validation Market, Recent Developments
  • Figure 9: Supply chain and Identifying Risks within the Supply Chain
  • Figure 10: Global Bioprocess Validation Market, January 2020-December 2023
  • Figure 11: Global Bioprocess Validation Market, January 2020-December 2023
  • Figure 12: Impact Analysis of Market Navigating Factors
  • U.S. Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 13: Canada Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 14: Germany Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 15: U.K. Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 16: France Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 17: Italy Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 18: Spain Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 19: Rest of Europe Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 20: China Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 21: Japan Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 22: South Korea Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 23: Australia Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 24: India Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 25: Rest-of-Asia-Pacific Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 26: Brazil Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 27: Mexico Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 28: Rest-of-Latin America Bioprocess Validation Market, By End User ($ Million), 2022, 2026 and 2033
  • Figure 29: Strategic Initiatives, 2020 - 2023
  • Figure 30: Share of Strategic Initiatives
  • Figure 31: Data Triangulation
  • Figure 32: Top-Down and Bottom-Up Approach
  • Figure 33: Assumptions and Limitations

List of Tables

  • Table 1: Market Snapshot
  • Table 2: Global Bioprocess Validation Market, Opportunities
  • Table 3: Global Bioprocess Validation Market, by Test Type, $Million, 2022-2033
  • Table 4: Global Bioprocess Validation Market, by Process Component, $Million, 2022-2033
  • Table 5: Global Bioprocess Validation Market, By Region, ($ Million), 2022-2033
  • Table 6: North America Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 7: North America Bioprocess Validation Market, By Test Type ($ Million), 2022-2033
  • Table 8: U.S. Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 9: Canada Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 10: Europe Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 11: Europe Bioprocess Validation Market, By Test Type ($ Million), 2022-2033
  • Table 12: Germany Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 13: U.K. Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 14: France Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 15: Italy Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 16: Spain Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 17: Rest of Europe Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 18: Asia Pacific Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 19: Asia Pacific Bioprocess Validation Market, By Test Type ($ Million), 2022-2033
  • Table 20: China Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 21: Japan Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 22: South Korea Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 23: Australia Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 24: India Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 25: Rest-of-Asia-Pacific Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 26: Latin America Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 27: Latin America Bioprocess Validation Market, By Test Type ($ Million), 2022-2033
  • Table 28: Brazil Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 29: Mexico Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 30: Rest-of-Latin America Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 31: Middle East & Africa Bioprocess Validation Market, By End User ($ Million), 2022-2033
  • Table 32: Middle East & Africa Bioprocess Validation Market, By Test Type ($ Million), 2022-2033
  • Table 33: Market Share