바이오프로세스 밸리데이션 시장 : 시험 유형별, 프로세스 컴포넌트별, 최종사용자별, 지역별

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.

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