Bioprocess Validation Market Size, Share & Trends Analysis Report By Testing Type (Extractables & Leachables Testing, Bioprocess Residuals Testing), By Stage (Process Design, Process Qualification), By Mode, By Region, And Segment Forecasts, 2025 - 2033
Description
Bioprocess Validation Market Summary
The global bioprocess validation market size was estimated at USD 485.5 million in 2024 and is projected to reach USD 1.05 billion by 2033, growing at a CAGR of 9.01% from 2025 to 2033. Growth is driven by the rising demand for biologics and biosimilars, stringent regulatory requirements for product safety and efficacy, and the increasing adoption of single-use systems in manufacturing.
Moreover, biopharmaceutical companies' shift toward outsourcing validation services to reduce costs and accelerate time-to-market is expected to support market expansion.
Rising biologics and biosimilars production
The rising production of biologics and biosimilars strongly drives the demand for bioprocess validation. Biologics such as monoclonal antibodies, recombinant proteins, vaccines, and advanced therapies like cell and gene therapies are highly complex and sensitive to manufacturing variations. To ensure product safety, efficacy, and consistency, rigorous validation of every production stage, upstream, downstream, and final fill/finish is critical. Moreover, with the rapid growth of the biosimilars market following the expiration of major biologic patents, manufacturers are under increasing pressure to validate their processes to demonstrate comparability with reference products in line with strict regulatory requirements. This growing biologic pipeline and the global push for more cost-effective therapeutic solutions have made validation an indispensable step in biomanufacturing.
Beyond product innovation, regulatory compliance, and evolving manufacturing technologies further accelerate market growth. Stringent guidelines issued by agencies such as the FDA, EMA, and PMDA require thorough validation of processes, analytical methods, and equipment to safeguard patient safety. The shift toward single-use bioprocessing systems has also intensified demand for extractables and leachable testing to ensure product purity. Moreover, outsourcing validation activities to contract research and manufacturing organizations allows companies to reduce costs, speed up production timelines, and access specialized expertise.
Global Bioprocess Validation Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global bioprocess validation market report on the basis of testing type, stage, mode, and regioN
The global bioprocess validation market size was estimated at USD 485.5 million in 2024 and is projected to reach USD 1.05 billion by 2033, growing at a CAGR of 9.01% from 2025 to 2033. Growth is driven by the rising demand for biologics and biosimilars, stringent regulatory requirements for product safety and efficacy, and the increasing adoption of single-use systems in manufacturing.
Moreover, biopharmaceutical companies' shift toward outsourcing validation services to reduce costs and accelerate time-to-market is expected to support market expansion.
Rising biologics and biosimilars production
The rising production of biologics and biosimilars strongly drives the demand for bioprocess validation. Biologics such as monoclonal antibodies, recombinant proteins, vaccines, and advanced therapies like cell and gene therapies are highly complex and sensitive to manufacturing variations. To ensure product safety, efficacy, and consistency, rigorous validation of every production stage, upstream, downstream, and final fill/finish is critical. Moreover, with the rapid growth of the biosimilars market following the expiration of major biologic patents, manufacturers are under increasing pressure to validate their processes to demonstrate comparability with reference products in line with strict regulatory requirements. This growing biologic pipeline and the global push for more cost-effective therapeutic solutions have made validation an indispensable step in biomanufacturing.
Beyond product innovation, regulatory compliance, and evolving manufacturing technologies further accelerate market growth. Stringent guidelines issued by agencies such as the FDA, EMA, and PMDA require thorough validation of processes, analytical methods, and equipment to safeguard patient safety. The shift toward single-use bioprocessing systems has also intensified demand for extractables and leachable testing to ensure product purity. Moreover, outsourcing validation activities to contract research and manufacturing organizations allows companies to reduce costs, speed up production timelines, and access specialized expertise.
Global Bioprocess Validation Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global bioprocess validation market report on the basis of testing type, stage, mode, and regioN
- Testing Type Outlook (Revenue, USD Million, 2021 - 2033)
- Extractables & Leachables Testing
- Bioprocess Residuals Testing
- Viral Clearance Testing
- Filtration & Fermentation Systems Testing
- Others
- Stage Outlook (Revenue, USD Million, 2021 - 2033)
- Process Design
- Process Qualification
- Continued Process Verification
- Mode Outlook (Revenue, USD Million, 2021 - 2033)
- In house
- Outsourced
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia Pacific
- China
- Japan
- India
- Australia
- Thailand
- South Korea
- Latin America
- Brazil
- Argentina
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Table of Contents
130 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Market Definitions
- 1.2.1. Testing Type
- 1.2.2. Stage
- 1.2.3. Mode
- 1.3. Information analysis
- 1.4. Market formulation & data visualization
- 1.5. Data validation & publishing
- 1.6. Information Procurement
- 1.6.1. Primary Research
- 1.7. Information or Data Analysis
- 1.8. Market Formulation & Validation
- 1.9. Market Model
- 1.10. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
- Chapter 3. Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Ancillary Market Outlook
- 3.2. Market Trends and Outlook
- 3.3. Market Dynamics
- 3.3.1. Market Driver Impact Analysis
- 3.3.1.1. Rising biologics and biosimilars production
- 3.3.1.2. Stringent regulatory requirements
- 3.3.2. Market Restraint Impact Analysis
- 3.3.2.1. Cost associated with validation process
- 3.4. Business Environment Analysis
- 3.4.1. PESTLE Analysis
- 3.4.2. PORTER’S Five Forces Analysis
- Chapter 4. Testing Type Business Analysis
- 4.1. Testing Type Segment Dashboard
- 4.2. Global Bioprocess Validation Market Testing Type, Movement Analysis
- 4.3. Global Bioprocess Validation Market Size & Trend Analysis, by Testing Type, 2021 to 2033 (USD Million)
- 4.4. Extractable & Leachables Testing
- 4.4.1. Global extractable & leachables testing market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.5. Bioprocess Residuals Testing
- 4.5.1. Global bioprocess residuals testing media market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.6. Viral Clearance Testing
- 4.6.1. Global viral clearance testing market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.7. Filtration & Fermentation Systems Testing
- 4.7.1. Global filtration & fermentation systems testing market estimates and forecasts, 2021 - 2033 (USD Million)
- 4.8. Others
- 4.8.1. Global others market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 5. Stage Business Analysis
- 5.1. Stage Segment Dashboard
- 5.2. Global Bioprocess Validation Market Stage, Movement Analysis
- 5.3. Global Bioprocess Validation Market Size & Trend Analysis, by Stage, 2021 to 2033 (USD Million)
- 5.4. Process Design
- 5.4.1. Global process design market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.5. Process Qualification
- 5.5.1. Global process qualification market estimates and forecasts, 2021 - 2033 (USD Million)
- 5.6. Continued Process Verification
- 5.6.1. Global continued process verification market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 6. Mode Business Analysis
- 6.1. Mode Segment Dashboard
- 6.2. Global Bioprocess Validation Market Application, Movement Analysis
- 6.3. Global Bioprocess Validation Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
- 6.4. In House
- 6.4.1. Global in-house market estimates and forecasts, 2021 - 2033 (USD Million)
- 6.5. Outsourced
- 6.5.1. Global outsourced market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 7. Bioprocess Validation Market: Regional Estimates and Trend Analysis, by By Testing Type, By Stage, & Mode
- 7.1. Regional Dashboard
- 7.2. Market Size & Forecasts and Trend Analysis, 2021 to 2033
- 7.3. North America
- 7.3.1. North America bioprocess validation market, 2021 - 2033 (USD Million)
- 7.3.2. U.S.
- 7.3.2.1. Key Country Dynamics
- 7.3.2.2. Competitive Scenario
- 7.3.2.3. Regulatory Framework
- 7.3.2.4. U.S. bioprocess validation market, 2021 - 2033 (USD Million)
- 7.3.3. Canada
- 7.3.3.1. Key Country Dynamics
- 7.3.3.2. Competitive Scenario
- 7.3.3.3. Regulatory Framework
- 7.3.3.4. Canada bioprocess validation market, 2021 - 2033 (USD Million)
- 7.3.4. Mexico
- 7.3.4.1. Key Country Dynamics
- 7.3.4.2. Competitive Scenario
- 7.3.4.3. Regulatory Framework
- 7.3.4.4. Mexico bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4. Europe
- 7.4.1. Europe bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.2. UK
- 7.4.2.1. Key Country Dynamics
- 7.4.2.2. Competitive Scenario
- 7.4.2.3. Regulatory Framework
- 7.4.2.4. UK bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.3. Germany
- 7.4.3.1. Key Country Dynamics
- 7.4.3.2. Competitive Scenario
- 7.4.3.3. Regulatory Framework
- 7.4.3.4. Germany bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.4. France
- 7.4.4.1. Key Country Dynamics
- 7.4.4.2. Competitive Scenario
- 7.4.4.3. Regulatory Framework
- 7.4.4.4. France bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.5. Italy
- 7.4.5.1. Key Country Dynamics
- 7.4.5.2. Competitive Scenario
- 7.4.5.3. Regulatory Framework
- 7.4.5.4. Italy bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.6. Spain
- 7.4.6.1. Key Country Dynamics
- 7.4.6.2. Competitive Scenario
- 7.4.6.3. Regulatory Framework
- 7.4.6.4. Spain bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.7. Denmark
- 7.4.7.1. Key Country Dynamics
- 7.4.7.2. Competitive Scenario
- 7.4.7.3. Regulatory Framework
- 7.4.7.4. Denmark bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.8. Sweden
- 7.4.8.1. Key Country Dynamics
- 7.4.8.2. Competitive Scenario
- 7.4.8.3. Regulatory Framework
- 7.4.8.4. Sweden bioprocess validation market, 2021 - 2033 (USD Million)
- 7.4.9. Norway
- 7.4.9.1. Key Country Dynamics
- 7.4.9.2. Competitive Scenario
- 7.4.9.3. Regulatory Framework
- 7.4.9.4. Norway bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5. Asia Pacific
- 7.5.1. Asia Pacific bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.2. Japan
- 7.5.2.1. Key Country Dynamics
- 7.5.2.2. Competitive Scenario
- 7.5.2.3. Regulatory Framework
- 7.5.2.4. Japan bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.3. China
- 7.5.3.1. Key Country Dynamics
- 7.5.3.2. Competitive Scenario
- 7.5.3.3. Regulatory Framework
- 7.5.3.4. China bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.4. India
- 7.5.4.1. Key Country Dynamics
- 7.5.4.2. Competitive Scenario
- 7.5.4.3. Regulatory Framework
- 7.5.4.4. India bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.5. Australia
- 7.5.5.1. Key Country Dynamics
- 7.5.5.2. Competitive Scenario
- 7.5.5.3. Regulatory Framework
- 7.5.5.4. Australia bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.6. Thailand
- 7.5.6.1. Key Country Dynamics
- 7.5.6.2. Competitive Scenario
- 7.5.6.3. Regulatory Framework
- 7.5.6.4. Thailand bioprocess validation market, 2021 - 2033 (USD Million)
- 7.5.7. South Korea
- 7.5.7.1. Key Country Dynamics
- 7.5.7.2. Competitive Scenario
- 7.5.7.3. Regulatory Framework
- 7.5.7.4. South Korea bioprocess validation market, 2021 - 2033 (USD Million)
- 7.6. Latin America
- 7.6.1. Latin America bioprocess validation market, 2021 - 2033 (USD Million)
- 7.6.2. Brazil
- 7.6.2.1. Key Country Dynamics
- 7.6.2.2. Competitive Scenario
- 7.6.2.3. Regulatory Framework
- 7.6.2.4. Brazil bioprocess validation market, 2021 - 2033 (USD Million)
- 7.6.3. Argentina
- 7.6.3.1. Key Country Dynamics
- 7.6.3.2. Competitive Scenario
- 7.6.3.3. Regulatory Framework
- 7.6.3.4. Argentina bioprocess validation market, 2021 - 2033 (USD Million)
- 7.7. MEA
- 7.7.1. MEA bioprocess validation market, 2021 - 2033 (USD Million)
- 7.7.2. South Africa
- 7.7.2.1. Key Country Dynamics
- 7.7.2.2. Competitive Scenario
- 7.7.2.3. Regulatory Framework
- 7.7.2.4. South Africa bioprocess validation market, 2021 - 2033 (USD Million)
- 7.7.3. Saudi Arabia
- 7.7.3.1. Key Country Dynamics
- 7.7.3.2. Competitive Scenario
- 7.7.3.3. Regulatory Framework
- 7.7.3.4. Saudi Arabia bioprocess validation market, 2021 - 2033 (USD Million)
- 7.7.4. UAE
- 7.7.4.1. Key Country Dynamics
- 7.7.4.2. Competitive Scenario
- 7.7.4.3. Regulatory Framework
- 7.7.4.4. UAE bioprocess validation market, 2021 - 2033 (USD Million)
- 7.7.5. Kuwait
- 7.7.5.1. Key Country Dynamics
- 7.7.5.2. Competitive Scenario
- 7.7.5.3. Regulatory Framework
- 7.7.5.4. Kuwait bioprocess validation market, 2021 - 2033 (USD Million)
- Chapter 8. Competitive Landscape
- 8.1. Company Categorization
- 8.2. Strategy Mapping
- 8.3. Company Market Position Analysis, 2024
- 8.4. Company Profiles/Listing
- 8.4.1. Eurofins Scientific, Inc.
- 8.4.1.1. Overview
- 8.4.1.2. Financial Performance
- 8.4.1.3. Product Benchmarking
- 8.4.1.4. Strategic Initiatives
- 8.4.2. Sartorius AG
- 8.4.2.1. Overview
- 8.4.2.2. Financial Performance
- 8.4.2.3. Product Benchmarking
- 8.4.2.4. Strategic Initiatives
- 8.4.3. Thermo Fisher Scientific Inc.
- 8.4.3.1. Overview
- 8.4.3.2. Financial Performance
- 8.4.3.3. Product Benchmarking
- 8.4.3.4. Strategic Initiatives
- 8.4.4. Lonza
- 8.4.4.1. Overview
- 8.4.4.2. Financial Performance
- 8.4.4.3. Product Benchmarking
- 8.4.4.4. Strategic Initiatives
- 8.4.5. Charles River Laboratories
- 8.4.5.1. Overview
- 8.4.5.2. Financial Performance
- 8.4.5.3. Product Benchmarking
- 8.4.5.4. Strategic Initiatives
- 8.4.6. SGS S.A
- 8.4.6.1. Overview
- 8.4.6.2. Financial Performance
- 8.4.6.3. Product Benchmarking
- 8.4.6.4. Strategic Initiatives
- 8.4.7. Toxikon Corporation
- 8.4.7.1. Overview
- 8.4.7.2. Financial Performance
- 8.4.7.3. Product Benchmarking
- 8.4.7.4. Strategic Initiatives
- 8.4.8. Danaher
- 8.4.8.1. Overview
- 8.4.8.2. Financial Performance
- 8.4.8.3. Product Benchmarking
- 8.4.8.4. Strategic Initiatives
- 8.4.9. Cobetter Filtration Equipment Co., Ltd.
- 8.4.9.1. Overview
- 8.4.9.2. Financial Performance
- 8.4.9.3. Product Benchmarking
- 8.4.9.4. Strategic Initiatives
- 8.4.10. Merck KGaA
- 8.4.10.1. Overview
- 8.4.10.2. Financial Performance
- 8.4.10.3. Product Benchmarking
- 8.4.10.4. Strategic Initiatives
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