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市场调查报告书
商品编码
1741464
生物过程验证市场（按测试类型、製程组件、最终用户和地区）Bioprocess Validation Market, By Test Type, By Process Component, By End User, By Geography |
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生物製程验证市场在 2025 年的价值估计为 5.548 亿美元，预计到 2032 年将达到 10.607 亿美元，2025 年至 2032 年的复合年增长率为 9.7%。
| 报告范围 | 报告详细信息 | ||
|---|---|---|---|
| 基准年 | 2024 | 2025年的市场规模 | 5.548亿美元 |
| 效能数据 | 从2020年到2024年 | 预测期 | 2025年至2032年 |
| 预测期：2025-2032年复合年增长率： | 9.70% | 2032年价值预测 | 10.607亿美元 |
生物製程验证是指从设计阶段到商业化生产阶段对资料进行收集和评估，以建立科学依据，确保製程能持续提供高品质产品。这是生物製药生产的一项监管要求。近年来，受生技药品和单株抗体需求成长的推动，生物製程验证市场经历了显着成长。生技药品彻底改变了各个治疗领域的病患照护和治疗。生技药品核准和生产的增加推动了验证活动的发展，以确保此类复杂分子的品质、功效和安全性。包括美国食品药物管理局(US FDA) 在内的各监管机构都对生物製程验证制定了严格的规定，从而推动了该市场的成长。
市场动态：
生物製程验证市场的成长受到塑造产业格局的多种因素的驱动。其中一个主要驱动因素是对生物製药需求的不断增长。癌症和自体免疫疾病等慢性疾病的日益普及促进了先进生技药品的开发，从而催生了对稳健的生物工艺验证策略的需求。
推动市场成长的另一个因素是美国食品药物管理局（FDA）和欧洲药品管理局（EMA）等监管机构实施的严格规定，这些规定要求生物製药製造商证明其製造流程的有效性和一致性，从而推动对生物製程验证的需求。
此外，市场参与企业收购等无机活动日益增多，预计也将在预测期内推动全球生物製程验证市场的成长。例如，2020年4月，全球生命科学和诊断创新企业丹纳赫集团从通用电气生命科学部门收购了包括层析法系统在内的生物製程业务，以增强其生技药品开发和製造解决方案。
然而，市场存在诸多限制因素。生物製程的复杂性以及缺乏标准化的验证通讯协定构成了挑战。生物製程开发和验证耗时长，需要投入大量资源和基础设施。此外，缺乏精通生物工艺验证的熟练专业人员也阻碍了市场的成长。
儘管面临诸多挑战，市场仍蕴含着许多成长机会。生物製程自动化和资料分析技术的进步有望简化验证流程，降低成本并提高效率。此外，个人化医疗日益受到重视，以及一次性技术在生物製程的日益普及，也为市场扩张提供了新的途径。
本研究的主要特点
- 本报告对全球生物製程验证市场进行了详细分析，并以 2024 年为基准年，展示了预测期 2025-2032 的市场规模和复合年增长率。
- 它还强调了各个领域的潜在商机，并说明了该市场的有吸引力的投资提案矩阵。
- 它还提供了有关市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景和主要企业采用的竞争策略的重要见解。
- 本报告的见解将使负责人和企业经营团队能够就未来的产品发布、新兴趋势、市场扩张和行销策略做出明智的决策。
- 全球生物製程验证市场报告涉及该行业的各个相关人员，例如投资者、供应商、产品製造商、经销商、新进入者和金融分析师。
- 可以透过用于分析全球生物工艺验证市场的各种策略矩阵来促进相关人员的决策。
目录
第一章 调查目的与前提条件
- 研究目标
- 先决条件
- 简称
第二章 市场展望
- 报告描述
- 市场定义和范围
- 执行摘要
- Coherent Opportunity Map（COM）
第三章市场动态、法规与趋势分析
- 市场动态
- 驱动程式
- 生物製药需求不断成长
- 限制因素
- 生物加工的复杂性
- 机会
- 生物过程自动化和数据分析的技术进步
- 影响分析
- 主要亮点
- 监管情景
- 启动/核准测试类型
- PEST分析
- 波特分析
- 併购场景
第四章 生物过程验证市场-冠状病毒（COVID-19）大流行的影响
- COVID-19流行病学
- 供需侧分析
- 经济影响
5. 2020 年至 2032 年全球生物製程验证市场（依测试类型）
- 可提取测试服务
- 微生物学检测服务
- 生理化学检测服务
- 完整性测试服务
- 其他（如相容性测试服务）
6. 全球生物製程验证市场（依製程组件划分），2020 年至 2032 年
- 滤芯
- 培养基容器和袋子
- 冻融袋
- 生物反应器
- 运输系统
- 其他（混合系统等）
7. 全球生物製程验证市场（依最终用户划分），2020 年至 2032 年
- 製药和生物技术公司
- 合约开发和製造组织
- 学术研究所
- 其他（临床研究机构等）
8. 2020 年至 2032 年全球生物製程验证市场（按地区）
- 北美洲
- 美国
- 加拿大
- 欧洲
- 德国
- 英国
- 西班牙
- 法国
- 义大利
- 俄罗斯
- 其他欧洲国家
- 亚太地区
- 中国
- 印度
- 日本
- 澳洲
- 韩国
- ASEAN
- 其他亚太地区
- 拉丁美洲
- 巴西
- 阿根廷
- 墨西哥
- 其他拉丁美洲
- 中东和非洲
- 海湾合作委员会国家
- 以色列
- 南非
- 北非
- 中部非洲
- 其他中东地区
第九章 竞争态势
- Sartorius Stedim Biotech
- Merck KGaA
- Pall Corporation
- Cobetter Filtration Equipment
- Toxikon Corporation
- DOC Srl
- Meissner Filtration Test Types
- Thermo Fisher Scientific
- SGS SA
- Eurofins Scientific
- Lonza Group
- ProBioGen AG
- Charles River Laboratories
- Pacific BioLabs
- Gibraltar Laboratories
- Nelson Laboratories
- BioProcess Technology Consultants
- CMIC HOLDINGS Co., Ltd
- Cytovance Biologics
- Wuxi Biologics
第 10 章 章节
- 调查方法
- 关于出版商
Bioprocess Validation Market is estimated to be valued at USD 554.8 Mn in 2025 and is expected to reach USD 1,060.7 Mn by 2032, growing at a compound annual growth rate (CAGR) of 9.7% from 2025 to 2032.
| Report Coverage | Report Details | ||
|---|---|---|---|
| Base Year: | 2024 | Market Size in 2025: | USD 554.8 Mn |
| Historical Data for: | 2020 To 2024 | Forecast Period: | 2025 To 2032 |
| Forecast Period 2025 to 2032 CAGR: | 9.70% | 2032 Value Projection: | USD 1,060.7 Mn |
Bioprocess validation is the collection and evaluation of data, from the design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. It is a regulatory requirement for biopharmaceuticals manufacturing. The bioprocess validation market has been witnessing significant growth in recent years driven by the increasing demand for biologics and monoclonal antibodies. Biologics have revolutionized patient care and treatments across various therapeutic areas. Rising biologics approvals and production have been propelling validation activities to guarantee the quality, efficacy, and safety of such complex molecules. Various regulatory agencies including the U.S. Food and Drug Administration (U.S. FDA) have stringent regulations for bioprocess validation, facilitating the growth of this market.
Market Dynamics:
The bioprocess validation market growth is driven by various factors that are shaping the industry landscape. One of the primary drivers is the increasing demand for biopharmaceutical products. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, has led to the development of advanced biologics, thereby creating a need for robust bioprocess validation strategies.
Another factor contributing to market growth is the stringent regulations imposed by regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations require biopharmaceutical manufacturers to demonstrate the effectiveness and consistency of their manufacturing processes, driving the demand for bioprocess validation.
Moreover, the increasing adoption of inorganic activities such as acquisition by the market players is expected to drive the growth of the global bioprocess validation market over the forecast period. For instance, in April 2020, Danaher Corporation, a global life sciences and diagnostic innovator, acquired the bioprocessing business from General Electric's life sciences division, including chromatography systems, to enhance biologics development and manufacturing solutions.
However, the market does face some restraints. The complex nature of bioprocessing and the lack of standardized validation protocols pose challenges. The development and validation of bioprocesses are time-consuming and require substantial investments in terms of resources and infrastructure. Additionally, the scarcity of skilled professionals with expertise in bioprocess validation further impedes market growth.
Despite these challenges, the market experiences several opportunities for growth. Technological advancements in bioprocess automation and data analytics are anticipated to streamline the validation process, reducing costs and enhancing efficiency. Furthermore, the increasing focus on personalized medicine and the rising adoption of single-use technologies in bioprocessing offer new avenues for the market expansion.
Key features of the study:
- This report provides in-depth analysis of the global bioprocess validation market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period 2025-2032, considering 2024 as the base year
- It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
- This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
- Key companies covered as a part of this study include Sartorius Stedim Biotech, Merck KGaA, Pall Corporation, Cobetter Filtration Equipment, Toxikon Corporation, DOC S.r.l., MEISSNER FILTRATION PRODUCTS, Thermo Fisher Scientific, SGS SA, Eurofins Scientific, Lonza Group, ProBioGen AG, Charles River Laboratories, Pacific BioLabs, Gibraltar Laboratories, Nelson Laboratories, BioProcess Technology Consultants, CMIC HOLDINGS Co., Ltd, Cytovance Biologics, and Wuxi Biologics.
- Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
- The global bioprocess validation market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
- Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global bioprocess validation market.
Bioprocess Validation Market Segmentation:
- By Test Type
- Extractable Testing Services
- Microbiological Testing Services
- Physiochemical Testing Services
- Integrity Testing Services
- Others (Compatibility Testing Services and Others)
- By Process Component
- Filter Elements
- Media containers and bags
- Freezing And Thawing Process Bags
- Bioreactors
- Transfer Systems
- Others (Mixing Systems and Others)
- By End User
- Pharmaceutical & Biotechnology Companies
- Contract Development & Manufacturing Organizations
- Academic and Research Institutes
- Other (Clinical Research Organizations and Others)
- By Region
- North America
- Latin America
- Europe
- Asia Pacific
- Middle East
- Africa
- Company Profiles
- Sartorius Stedim Biotech
- Merck KGaA
- Pall Corporation
- Cobetter Filtration Equipment
- Toxikon Corporation
- DOC S.r.l.
- MEISSNER FILTRATION PRODUCTS
- Thermo Fisher Scientific
- SGS SA
- Eurofins Scientific
- Lonza Group
- ProBioGen AG
- Charles River Laboratories
- Pacific BioLabs
- Gibraltar Laboratories
- Nelson Laboratories
- BioProcess Technology Consultants
- CMIC HOLDINGS Co., Ltd
- Cytovance Biologics
- Wuxi Biologics
Table of Contents
1. Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
2. Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Bioprocess Validation, By Test Type
- Market Bioprocess Validation, By Process Component
- Market Bioprocess Validation, By End User
- Market Bioprocess Validation, By Region
- Coherent Opportunity Map (COM)
3. Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Increasing demand for biopharmaceutical products
- Restraints
- Complex nature of bioprocessing
- Opportunities
- Technological advancements in bioprocess automation and data analytics
- Impact Analysis
- Key Highlights
- Regulatory Scenario
- Test Type launch/Approvals
- PEST Analysis
- PORTER's Analysis
- Merger and Acquisition Scenario
4. Bioprocess Validation Market - Impact of Coronavirus (COVID-19) Pandemic
- COVID-19 Epidemiology
- Supply Side and Demand Side Analysis
- Economic Impact
5. Global Bioprocess Validation Market, By Test Type, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021 - 2032
- Segment Trends
- Extractable Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Microbiological Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Physiochemical Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Integrity Testing Services
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Others (Compatibility Testing Services and Others)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
6. Global Bioprocess Validation Market, By Process Component, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021- 2032
- Segment Trends
- Filter Elements
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Media containers and bags
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Freezing And Thawing Process Bags
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Bioreactors
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Transfer Systems
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Others (Mixing Systems and Others)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
7. Global Bioprocess Validation Market, By End User, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, 2021- 2032
- Segment Trends
- Pharmaceutical & Biotechnology Companies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Contract Development & Manufacturing Organizations
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Academic and Research Institutes
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
- Other (Clinical Research Organizations and Others)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2020-2032,(US$ Mn)
8. Global Bioprocess Validation Market, By Region, 2020-2032, (US$ Mn)
- Introduction
- Market Share Analysis, By Country, 2025 and 2032 (%)
- Y-o-Y Growth Analysis, For Country 2021-2032
- Country Trends
- North America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
- U.S.
- Canada
- Europe
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Latin America
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Middle East & Africa
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, By Test Type, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Process Component, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By End User, 2020-2032,(US$ Mn)
- Market Size and Forecast, and Y-o-Y Growth, By Country, 2020-2032,(US$ Mn)
- GCC Countries
- Israel
- South Africa
- North Africa
- Central Africa
- Rest of Middle East
9. Competitive Landscape
- Sartorius Stedim Biotech
- Company Highlights
- Test Type Portfolio
- Key Developments
- Financial Performance
- Strategies
- Merck KGaA
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Pall Corporation
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Cobetter Filtration Equipment
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Toxikon Corporation
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- DOC S.r.l.
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Meissner Filtration Test Types
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Thermo Fisher Scientific
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- SGS SA
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Eurofins Scientific
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Lonza Group
- Company Highlights
- Test Type Portfolio
- Key Developments
- Financial Performance
- Strategies
- ProBioGen AG
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Charles River Laboratories
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Pacific BioLabs
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Gibraltar Laboratories
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Nelson Laboratories
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- BioProcess Technology Consultants
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- CMIC HOLDINGS Co., Ltd
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Cytovance Biologics
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Wuxi Biologics
- Company Highlights
- Test Type Portfolio
- Key Highlights
- Financial Performance
- Strategies
- Analyst Views
10. Section
- Research Methodology
- About us
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