查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
全球生物製程验证市场：按最终用户、产品类型、测试类型、地区、竞争形势- 分析和预测，2024-2033 年
市场调查报告书
商品编码
1397352

全球生物製程验证市场：按最终用户、产品类型、测试类型、地区、竞争形势- 分析和预测，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个工作天内

价格

在严格的监管标准和对生物治疗药物的需求不断增长的推动下，生物製程验证市场预计将呈现显着成长。

生物製程验证符合美国FDA 指南和 cGMP 法规，涉及与生技药品和生物製药相关的程序、配合措施和证据的完整记录。这份全面的文件可确保产品测试各阶段的合规性，并专注于活性药物成分 (API) 和杂质评估。

本报告调查了全球生物製程验证市场，并提供了市场背景和概述，分析了市场成长的各种影响因素、技术和专利趋势、法律制度、市场规模趋势和预测以及各种分类。・编制了详细的区域分析，竞争形势、主要企业分析等

市场分类

细分 1：按最终用户

  • 製药和生物技术公司
  • 开发/受託製造厂商
  • 其他的

细分 2：依考试类型

  • 可萃取性和溶离度测试服务
  • 微生物检测服务
  • 物理化学测试服务
  • 完整性测试服务
  • 合格测试服务
  • 其他的

细分 3：依流程组件

  • 滤芯
  • 介质容器和介质袋
  • 冷冻/解冻加工袋
  • 生物反应器
  • 输送系统
  • 其他的

细分 4：按地区

  • 北美洲
  • 欧洲
  • 亚太地区
  • 拉丁美洲
  • 中东/非洲

目录

执行摘要

范围和定义

第一章 市场

  • 趋势：当前和未来的影响评估
  • 供应链概览
    • 价值链分析
    • 市场地图
  • 研发回顾
    • 按国家和公司分類的专利申请趋势
  • 监管状况
  • 世界重大事件的影响分析：COVID-19
  • 市场动态概览
    • 市场驱动因素
    • 市场抑制因素
    • 市场机会

第二章 应用

  • 使用分类
  • 应用概述
  • 全球生物工艺验证市场（按最终用户）
    • 製药和生物技术公司
    • 合约开发/製造组织
    • 其他的

第三章 产品

  • 产品分类
  • 产品概要
  • 全球生物製程验证市场（按产品）
    • 市场概况
  • 全球生物工艺验证市场（按测试类型）
    • 可萃取性和溶离度测试服务
    • 微生物检测服务
    • 物理化学测试服务
    • 完整性测试服务
    • 合格测试服务
    • 其他的
  • 全球生物工艺验证市场（按工艺组件）
    • 滤芯
    • 介质容器和介质袋
    • 冷冻/解冻加工袋
    • 生物反应器
    • 输送系统
    • 其他的

第四章 区域

  • 区域概况
  • 促进因素/抑制因素
  • 北美洲
  • 欧洲
  • 亚太地区
  • 拉丁美洲
  • 中东/非洲

第五章市场：竞争基准化分析/公司简介

  • 下一个前沿
  • 区域评估
    • 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

第六章调查方法

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