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生技設備生物工藝

生物製程驗證市場規模、佔有率和成長分析（按測試類型、製程組件、階段、模式、最終用戶和地區分類）－2026-2033年產業預測

市場調查報告書

商品編碼

1897790

生物製程驗證市場規模、佔有率和成長分析（按測試類型、製程組件、階段、模式、最終用戶和地區分類）－2026-2033年產業預測

Bioprocess Validation Market Size, Share, and Growth Analysis, By Test Type (Extractables/Leachables Testing Services, Microbiological Testing Services), By Process Component, By Stage, By Mode, By End User, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月16日 | 出版商:

SkyQuest | 英文 197 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

全球生物製程驗證市場規模預計到 2024 年將達到 3.591 億美元，到 2025 年將達到 3.9681 億美元，到 2033 年將達到 8.8202 億美元，預測期（2026-2033 年）的複合年成長率為 10.5%。

生物製程驗證市場的發展動力源自於確保生物製藥（例如抗體和疫苗）的生產流程符合既定品質標準的需求。推動市場成長的關鍵因素包括日益嚴格的監管要求、對生物製藥日益成長的興趣以及生物製造技術的進步。此外，生物程序複雜性的增加和個人化醫療的興起也推動了市場的發展。儘管面臨工藝變異性和合規性問題等挑戰，該行業預計仍將實現顯著成長。生物製藥的不斷發展和創新數位解決方案的整合為市場提供了擴張機遇，預示著該市場在不久的將來有望取得重大進展。

全球生物製程驗證市場促進因素

感染疾病和慢性病的日益普及推動了對高品質生物製藥（包括疫苗、抗體和基因療法）的需求。隨著生物製藥研發日趨複雜且規模化，健全的驗證流程對於確保這些產品的有效性和安全性至關重要。對驗證的日益重視體現了業界致力於提供可靠有效的治療方法，以滿足公共衛生領域的嚴格要求。因此，實施能增強相關人員與病患信心的完善驗證通訊協定，是全球生物製程驗證市場的主要驅動力。

限制全球生物製程驗證市場的因素

由於生物製造技術的進步，全球生物製程驗證市場面臨許多限制因素。這些創新引入了新的複雜性，對現有的驗證方法構成挑戰。確保創新技術有效運作需要高水準的專業知識和技能。此外，生物製程固有的可變性也為建立一致的驗證標準帶來了額外的挑戰，尤其是在處理定製或新型產品時。因此，這些因素會阻礙市場驗證流程的進展和效率，持續的調整和改進對於滿足不斷變化的生物製造需求至關重要。

全球生物製程驗證市場趨勢

全球生物製程驗證市場的一個顯著趨勢是採用「品質源自於設計 (QbD)」通訊協定，該方案強調在生物製程的各個階段整合品質控制。這種轉變涉及以預定義品質屬性為中心的驗證流程，從而提高了生物產品的可靠性。企業正致力於了解敏感的程式參數及其對產品品質的影響，並建立穩健的驗證標準。這種積極主動的方法不僅加強了對監管要求的遵守，還促進了生物製程開發的創新和效率提升，從而推動市場成長，並確保生物製藥生產中產品的完整性和安全性得到改善。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2023-2025年營收年比比較

主要企業簡介

Thermo Fisher Scientific, Inc.
Merck KGaA
Danaher Corporation（Pall Corporation）
Sartorius Stedim Biotech SA
SGS SA
Eurofins Scientific SE
Cobetter Filtration Equipment Co., Ltd.
LabCorp Holdings Inc.
Meissner Corporation
Porvair PLC
Bangalore Biotech Labs Pvt. Ltd
McClay Foundation（Almac Group）
Doc SRL
Charles River Laboratories International, Inc.
Lonza Group AG
WuXi AppTec
Samsung Biologics
AGC Inc.
Repligen Corporation
Bio-Rad Laboratories, Inc.

結論與建議

簡介目錄

Product Code: SQMIG35H2319

Global Bioprocess Validation Market size was valued at USD 359.1 Million in 2024 and is poised to grow from USD 396.81 Million in 2025 to USD 882.02 Million by 2033, growing at a CAGR of 10.5% during the forecast period (2026-2033).

The bioprocess validation market is driven by the need to ensure that production methods for biologics, such as antibodies and vaccines, adhere to established quality standards. Key factors fueling market growth include escalating regulatory demands, heightened interest in biological products, and advancements in biomanufacturing technologies. Furthermore, the complexity of bioprocesses and the rise of personalized medicine contribute to market momentum. Despite facing challenges related to process variability and compliance issues, the sector is expected to experience significant growth. Opportunities for expansion lie in the increasing development of biopharmaceuticals, along with the integration of innovative digital solutions, positioning the market for considerable advancement in the foreseeable future.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Bioprocess Validation market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Bioprocess Validation Market Segments Analysis

Global Bioprocess Validation Market is segmented by Test Type, Process Component, Stage, Mode, End User and region. Based on Test Type, the market is segmented into Extractables/Leachables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Bioprocess Residuals Testing Services, Compatibility Testing Services and Others. Based on Process Component, the market is segmented into Filter Elements, Media Containers and Bags, Freezing and Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems and Others. Based on Stage, the market is segmented into Process Design, Process Qualification and Continued Process Verification. Based on Mode, the market is segmented into In House and Outsourced. Based on End User, the market is segmented into Pharmaceutical Companies, Contract Development & Manufacturing Organizations, Biotechnology Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Bioprocess Validation Market

The growing prevalence of infectious diseases and chronic conditions has intensified the need for high-quality biologics, including vaccines, antibodies, and gene therapies. As the development of biologics becomes increasingly sophisticated and large-scale, the necessity for robust validation processes emerges as crucial to ensure the efficacy and safety of these products. This heightened focus on validation reflects the industry's commitment to delivering reliable and effective therapies that can meet the rigorous demands of public health. Consequently, there is a significant drive within the Global Bioprocess Validation market to implement thorough validation protocols that instill confidence in the healthcare community and patients alike.

Restraints in the Global Bioprocess Validation Market

The Global Bioprocess Validation market faces several constraints stemming from advancements in biomanufacturing technologies, which introduce new complexities that can challenge existing validation practices. Ensuring that innovative techniques operate effectively requires a high level of expertise and specialized skills. Furthermore, the inherent variability in bioprocesses adds another layer of difficulty in establishing consistent validation standards, particularly when working with customized or novel products. Consequently, these factors can hinder the progression and efficiency of validation processes within the market, necessitating ongoing adaptation and refinement to meet the evolving demands of biomanufacturing.

Market Trends of the Global Bioprocess Validation Market

The Global Bioprocess Validation market is witnessing a significant trend towards the adoption of Quality by Design (QbD) protocols, which emphasize integrating quality at every stage of the bioprocess. This shift involves validation processes centered around predefined quality attributes, enhancing the reliability of bioproducts. With a concentrated effort on understanding sensitive process parameters and their impact on product quality, companies are establishing robust validation standards. This proactive approach not only boosts compliance with regulatory requirements but also fosters innovation and efficiency in bioprocess development, thereby driving market growth and ensuring higher product integrity and safety in biopharmaceutical manufacturing.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2025
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Technology Analysis
Case Studies

Global Bioprocess Validation Market Size by Test Type & CAGR (2026-2033)

Market Overview
Extractables/Leachables Testing Services
Microbiological Testing Services
- Large-Scale Eukaryotic Cell Culture Testing Services
- Virus Production & Purification Testing Services
- Electron Microscopy Testing Services
Physiochemical Testing Services
Integrity Testing Services
Bioprocess Residuals Testing Services
Compatibility Testing Services
Others

Global Bioprocess Validation Market Size by Process Component & CAGR (2026-2033)

Market Overview
Filter Elements
Media Containers and Bags
Freezing and Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Others

Global Bioprocess Validation Market Size by Stage & CAGR (2026-2033)

Market Overview
Process Design
Process Qualification
Continued Process Verification

Global Bioprocess Validation Market Size by Mode & CAGR (2026-2033)

Market Overview
In House
Outsourced

Global Bioprocess Validation Market Size by End User & CAGR (2026-2033)

Market Overview
Pharmaceutical Companies
Contract Development & Manufacturing Organizations
Biotechnology Companies
Others

Global Bioprocess Validation Market Size & CAGR (2026-2033)

North America (Test Type, Process Component, Stage, Mode, End User)
- US
- Canada
Europe (Test Type, Process Component, Stage, Mode, End User)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Test Type, Process Component, Stage, Mode, End User)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Test Type, Process Component, Stage, Mode, End User)
- Brazil
- Rest of Latin America
Middle East & Africa (Test Type, Process Component, Stage, Mode, End User)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

Thermo Fisher Scientific, Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Danaher Corporation (Pall Corporation)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius Stedim Biotech S.A.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SGS S.A.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Eurofins Scientific SE
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Cobetter Filtration Equipment Co., Ltd.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
LabCorp Holdings Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Meissner Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Porvair PLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bangalore Biotech Labs Pvt. Ltd
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
McClay Foundation (Almac Group)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Doc S.R.L.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories International, Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza Group AG
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Biologics
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
AGC Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Repligen Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Bio-Rad Laboratories, Inc.
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments