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生技設備生物工藝

市場調查報告書

商品編碼

1741464

生物過程驗證市場（按測試類型、製程組件、最終用戶和地區）

Bioprocess Validation Market, By Test Type, By Process Component, By End User, By Geography

出版日期: 2025年03月27日 | 出版商:

Coherent Market Insights | 英文 130 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

生物製程驗證市場在 2025 年的價值估計為 5.548 億美元，預計到 2032 年將達到 10.607 億美元，2025 年至 2032 年的年複合成長率為 9.7%。

報告範圍		報告詳細資訊
基準年	2024	2025年的市場規模	5.548億美元
效能數據	從2020年到2024年	預測期	2025年至2032年
預測期：2025-2032年年複合成長率：	9.70%	2032年價值預測	10.607億美元

生物製程驗證是指從設計階段到商業化生產階段對資料進行收集和評估，以建立科學依據，確保製程能持續提供高品質產品。這是生物製藥生產的一項監管要求。近年來，受生技藥品和單株抗體需求成長的推動，生物製程驗證市場經歷了顯著成長。生技藥品徹底改變了各個治療領域的病患照護和治療。生技藥品核准和生產的增加推動了驗證活動的發展，以確保此類複雜分子的品質、功效和安全性。包括美國食品藥物管理局(US FDA) 在內的各監管機構都對生物製程驗證制定了嚴格的規定，從而推動了該市場的成長。

市場動態：

生物製程驗證市場的成長受到塑造產業格局的多種因素的驅動。其中一個主要促進因素是對生物製藥需求的不斷成長。癌症和自體免疫疾病等慢性疾病的日益普及促進了先進生技藥品的開發，從而催生了對穩健的生物程序驗證策略的需求。

推動市場成長的另一個因素是美國食品藥物管理局（FDA）和歐洲藥品管理局（EMA）等監管機構實施的嚴格規定，這些規定要求生物製藥製造商證明其製造流程的有效性和一致性，從而推動對生物製程驗證的需求。

此外，市場參與企業收購等無機活動日益增多，預計也將在預測期內推動全球生物製程驗證市場的成長。例如，2020年4月，全球生命科學和診斷創新企業丹納赫集團從通用電氣生命科學部門收購了包括層析法系統在內的生物製程業務，以增強其生技藥品開發和製造解決方案。

然而，市場存在諸多限制因素。生物製程的複雜性以及缺乏標準化的驗證通訊協定構成了挑戰。生物製程開發和驗證耗時長，需要投入大量資源和基礎設施。此外，缺乏精通生物程序驗證的熟練專業人員也阻礙了市場的成長。

儘管面臨諸多挑戰，市場仍蘊含著許多成長機會。生物製程自動化和資料分析技術的進步有望簡化驗證流程，降低成本並提高效率。此外，個人化醫療日益受到重視，以及一次性技術在生物製程的日益普及，也為市場擴張提供了新的途徑。

本研究的主要特點

本報告對全球生物製程驗證市場進行了詳細分析，並以 2024 年為基準年，展示了預測期 2025-2032 的市場規模和年複合成長率。
它還強調了各個領域的潛在商機，並說明了該市場的有吸引力的投資提案矩陣。
它還提供了有關市場促進因素、限制因素、機會、新產品發布和核准、市場趨勢、區域前景和主要企業採用的競爭策略的重要見解。
本報告的見解將使負責人和企業經營團隊能夠就未來的產品發布、新興趨勢、市場擴張和行銷策略做出明智的決策。
全球生物製程驗證市場報告涉及該行業的各個相關人員，例如投資者、供應商、產品製造商、經銷商、新進入者和金融分析師。
可以透過用於分析全球生物程序驗證市場的各種策略矩陣來促進相關人員的決策。

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 章章節

調查方法
關於出版商

簡介目錄

Product Code: CMI6287

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

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