Bioprocess Validation Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Bioprocess Validation Market Report is Segmented by Test Type (Extractables Testing Services, Microbiological Testing Services, and More), Process Component (Filter Elements, and More), End User (Pharmaceutical & Biotechnology Companies, and More), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Bioprocess Validation Market Size and Share

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Compare market size and growth of Bioprocess Validation Market with other markets in Healthcare Industry

Bioprocess Validation Market Analysis by Mordor Intelligence

The bioprocess validation market stood at USD 412.70 million in 2025 and is projected to reach USD 817.18 million by 2030, representing a 14.64% CAGR. Growth is anchored in three inter-locking forces: stricter global regulatory guidance, greater volumes of commercial and clinical biologics, and the steady migration of validation work to contract development and manufacturing organizations (CDMOs). Demand has broadened as biologics account for around 50% of all drug candidates, which magnifies the number of facilities, processes, and analytical procedures that must be formally qualified. The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) updated viral safety, analytical procedure, and contamination-control expectations in 2024, creating new compliance milestones that most producers must meet before batch release[1]U.S. Food and Drug Administration, “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines,” fda.gov. Digital validation frameworks—built around electronic batch records, data-integrity checkpoints, and audit-ready data trails—are now a major differentiator because they shorten inspection cycles and reduce the risk of compliance findings[2]Rapid Microbiology, “EMA Annex 1: Key Changes and Validation Implications,” rapidmicrobiology.com.

Key Report Takeaways

  • By test type, extractables testing led with 38.43% of bioprocess validation market share in 2024, while integrity testing is forecast to expand at a 16.45% CAGR through 2030.
  • By process component, filter elements accounted for 26.53% share of the bioprocess validation market size in 2024; bioreactors are projected to grow at a 14.45% CAGR between 2025-2030.
  • By end user, pharmaceutical and biotechnology companies held 57.54% of the bioprocess validation market share in 2024, whereas CDMOs are advancing at a 17.43% CAGR through 2030.
  • By geography, North America captured 48.65% of the bioprocess validation market size in 2024; Asia-Pacific is the fastest-growing region at a 15.76% CAGR to 2030.

Segment Analysis

By Test Type: Extractables Testing Dominates Complex Validation Landscape

Extractables testing captured 38.43% of the bioprocess validation market in 2024, underlining the acute focus on material-derived impurities that could jeopardize drug safety. Regulatory expectations for single-use systems require full chemical profiling, with the FDA’s April 2024 draft on ANDA submissions laying out tightly scripted protocols. Suppliers and manufacturers jointly map polymer compositions, solvents, and potential leachables, then translate these findings into risk assessments before commercial batches can run. Integrity testing services, positioned to grow at a 16.45% CAGR through 2030, benefit from EMA mandates for pre-use/post-sterilization assessments. The shift toward closed processing gives integrity testing extra weight, because even minute filter compromise invites contamination.

Accelerating demand for rapid methods reshapes microbiological and physicochemical testing. Platforms such as the BACT/ALERT 3D system cut sterility timelines to six days, freeing warehouse space and cash that would otherwise sit in quarantine. Physicochemical assays remain essential for routine release, but automation upgrades deliver higher throughput with fewer analysts, mitigating the labor pinch. Compatibility studies for novel excipients, combination devices, and high-concentration formulations add fresh revenue pockets. Non-growth-based sterility testing—such as SCANRDI, which gives results in under four hours—emerges as a differentiator for producers chasing rapid release in competitive therapeutic classes.

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Note: Segment shares of all individual segments available upon report purchase

By Process Component: Filter Elements Lead Amid Bioreactor Innovation

Filter elements controlled 26.53% of the bioprocess validation market size in 2024 and remain central to any contamination-control strategy. Regulators demand documented proof of retention, pressure endurance, and integrity across the life cycle of each filter, whether stainless steel or single-use. Annex 1 adds compulsory point-of-use integrity checks, swelling demand for high-accuracy test rigs and trained operators. Viral-clearance claims further multiply analytical runs because filters must prove log-reduction values under worst-case loads and flow rates.

Bioreactors, slated for a 14.45% CAGR, echo the broader movement toward intensified and continuous processing. Perfusion, single-use reactors, and automated feeding loops require validation plans that blend classical parameters (agitation, temperature, pH) with software validations for control logic. Lonza’s Vacaville purchase showcases how legacy stainless infrastructure and next-gen single-use modules coexist in mega-plants, each with unique validation dossiers. Media containers, bags, and mixing systems maintain steady mid-single-digit growth because closed processing pushes fluid handling into disposable formats that still demand chemical compatibility and extractables proof. Transfer systems ride a similar curve, propelled by multi-suite facilities that prefer modular skids and sterile connectors over hard-piped loops.

Bioprocess Validation Market
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Note: Segment shares of all individual segments available upon report purchase

By End User: CDMOs Drive Outsourcing Transformation

Pharmaceutical and biotechnology firms supplied 57.54% of overall revenue in 2024 as they financed lot-specific tests, method transfers, and facility re-qualifications tied to pipeline progression. Internal quality groups still run core studies, but they increasingly ration their bandwidth to products in late-stage or commercial phases. CDMOs, posting a 17.43% CAGR through 2030, win the rest through bundled validation packages that span extractables, microbiology, viral clearance, and data-migration services. Eurofins’ multiyear track record—closing H1 2024 at EUR 3.419 billion BioPharma revenue—confirms the model’s global pull.

CDMOs also convert scale economies into favorable pricing, absorbing peak workloads during facility upgrades or expedited regulatory filings. Charles River Laboratories faced near-term revenue pressure in 2025 yet preserved its biotherapeutic-testing pipeline by reallocating resources to higher-margin cell and gene therapy programs. Academic centers, non-profit institutes, and government labs hold modest shares but remain critical for early-stage methods and regulatory science. Virtual biotech start-ups, often outsourcing 100% of CMC tasks, represent a consistent inflow of project-based validation business for CDMOs equipped with flexible capacity.

Geography Analysis

North America retained 48.65% of the bioprocess validation market in 2024, powered by the FDA’s leadership on global GMP norms and a dense cluster of commercial biologics producers. U.S. laboratories pioneer rapid-microbiology innovations, such as real-time viable-particle counters used in environmental monitoring, which translate into additional validation work for early adopters. SGS, for instance, achieved a zero-483 outcome in a 2024 FDA audit of its North American biologics center, underscoring the region’s high compliance bar. Canada expands through biologics corridor incentives in Québec and Ontario, whereas Mexico attracts fill-finish projects that channel validation fees into local service providers.

Asia-Pacific is set to outpace all regions at a 15.76% CAGR during 2025-2030. China’s five-year biotech roadmap funds capacity additions alongside domestic regulatory upgrades that increasingly mirror ICH standards. Surveys show 90% of Chinese plant managers aim for full global GMP alignment within ten years[3]International Society for Pharmaceutical Engineering, “2024 Biopharmaceutical Survey Highlights GMP Alignment Goals,” ispe.org. India pushes forward through policy reforms that simplify import permits for reference standards and encourage third-party validation labs. Singapore partners with Charles River Laboratories to offer master cell-banking services that require CGMP-level validation, signalling a regional move toward advanced therapy production.

Europe commands mature demand shaped by the EMA’s Annex 1 and the continent’s strong biosimilar pipeline. Germany anchors the region with clusters in Bavaria and North Rhine-Westphalia running high-capacity stainless and single-use suites. France and Spain add modular facilities built for flexible campaigns, each calling for concurrent validation plans. Brexit generates dual-submission obligations for products sold in both the EU and United Kingdom, effectively doubling some validation documentation. The Middle East & Africa and South America lag in absolute size but gain from rising generic and biosimilar ambitions, notably in Brazil where ANVISA fortifies GMP inspections that elevate local demand for accredited validation labs.

Bioprocess Validation Market
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Competitive Landscape

The bioprocess validation market shows moderate fragmentation. Merck KGaA, SGS, Eurofins Scientific, and Thermo Fisher Scientific field global networks that handle volume spikes and specialized assays. Thermo Fisher’s USD 4.1 billion purchase of Solventum’s purification and filtration arm in February 2025 deepens its downstream and validation bench strength, with management projecting USD 1 billion in incremental revenue from the deal. Danaher merged Cytiva and Pall into a USD 7.5 billion bioprocess unit that bundles filtration, chromatography, and single-use hardware, presenting customers with an integrated validation roadmap.

Technology leadership matters more each year. Firms investing in automated sample prep, cloud-native data lakes, and AI-driven trend analytics trim lot release time, making them preferred partners for speed-sensitive launches. Providers wielding six-day sterility tests capture share over labs that still rely on 14-day compendial methods. Smaller regional specialists carve profitable niches in extractables for novel polymers, cell and gene therapy assays, and digital-validation consulting. Market consolidation will likely continue as full-service players pick up niche labs to round out portfolios and secure local regulatory relationships.

Geographical white spaces persist, chiefly in fast-growing Asia-Pacific markets where validation capacity remains below projected manufacturing output. International firms use joint ventures and strategic site openings to close those gaps and lock in early customers. Competition also centers on workforce development; multinationals with in-house academies for validation science stand apart in hiring and retention, enabling them to sustain throughput even as project loads climb.

Bioprocess Validation Industry Leaders

  1. Merck KGaA

  2. Eurofins Scientific

  3. SGS S.A.

  4. Sartorius AG

  5. Pall Corporation

  6. *Disclaimer: Major Players sorted in no particular order
Bioprocess Validation Market
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Recent Industry Developments

  • February 2025: Thermo Fisher Scientific finalized the acquisition of Solventum’s purification and filtration business for USD 4.1 billion, broadening its bioproduction and validation service scope.
  • October 2024: Lonza completed the USD 1.2 billion acquisition of Roche’s Vacaville, California biologics site, adding 330,000 L of capacity that requires extensive re-validation.
  • October 2024: Lonza announced a new bioconjugation suite in Visp, Switzerland to support antibody-drug conjugate supply from 2027, with validation protocols tailored to highly potent compounds.
  • September 2024: Eurofins Scientific acquired Infinity Laboratories, adding eight U.S. sites focused on microbiology, chemistry, and sterilization testing to strengthen its validation offering.
  • September 2024: Lonza Walkersville began expanding its endotoxin-assay production facility to meet higher validation testing demand while embedding energy-efficient technologies.

Table of Contents for Bioprocess Validation Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Expanding Global Biopharmaceutical Production Volume
    • 4.2.2 Stringent Regulatory Compliance Requirements
    • 4.2.3 Rising Outsourcing of Validation Services to CDMOs
    • 4.2.4 Transition Toward Integrated Continuous Manufacturing Lines
    • 4.2.5 Adoption of Advanced Process Analytical Technology Tools
    • 4.2.6 Emergence of Data-Driven Lifecycle Validation Frameworks
  • 4.3 Market Restraints
    • 4.3.1 High Capital and Operational Costs of Validation Testing
    • 4.3.2 Complexity of Extractables and Leachables Assessments
    • 4.3.3 Limited Availability of Skilled Validation Workforce
    • 4.3.4 Data Integrity and Cybersecurity Challenges in Digital Validation
  • 4.4 Regulatory Landscape
  • 4.5 Porter's Five Forces Analysis
    • 4.5.1 Threat of New Entrants
    • 4.5.2 Bargaining Power of Buyers
    • 4.5.3 Bargaining Power of Suppliers
    • 4.5.4 Threat of Substitutes
    • 4.5.5 Intensity of Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Test Type
    • 5.1.1 Extractables Testing Services
    • 5.1.2 Microbiological Testing Services
    • 5.1.3 Physicochemical Testing Services
    • 5.1.4 Integrity Testing Services
    • 5.1.5 Compatibility Testing Services
    • 5.1.6 Other Testing Services
  • 5.2 By Process Component
    • 5.2.1 Filter Elements
    • 5.2.2 Media Containers & Bags
    • 5.2.3 Freezing & Thawing Process Bags
    • 5.2.4 Mixing Systems
    • 5.2.5 Bioreactors
    • 5.2.6 Transfer Systems
    • 5.2.7 Other Process Components
  • 5.3 By End User
    • 5.3.1 Pharmaceutical & Biotechnology Companies
    • 5.3.2 Contract Development & Manufacturing Organizations
    • 5.3.3 Other End Users
  • 5.4 Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
    • 6.3.1 Merck KGaA
    • 6.3.2 SGS S.A.
    • 6.3.3 Eurofins Scientific
    • 6.3.4 Sartorius AG
    • 6.3.5 Pall Corporation
    • 6.3.6 Thermo Fisher Scientific
    • 6.3.7 Lonza Group
    • 6.3.8 Charles River Laboratories
    • 6.3.9 Catalent Inc.
    • 6.3.10 Cytiva
    • 6.3.11 Intertek Group
    • 6.3.12 Element (VR Analytical)
    • 6.3.13 Aizon
    • 6.3.14 ValGenesis
    • 6.3.15 Cobetter Filtration Equipments
    • 6.3.16 DOC S.r.l
    • 6.3.17 Meissner Filtration Products
    • 6.3.18 Almac Group
    • 6.3.19 Labcorp
    • 6.3.20 Cytiva Fast-Trak Services
    • 6.3.21 US Validation

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-Need Assessment
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Global Bioprocess Validation Market Report Scope

Bioprocess validation is the process of documenting all the procedures, activities, and evidence of the process of biological and biopharmaceutical product formation. Precisely, data are collected, evaluated, and documented from every stage of a specific project at all desired levels. In this way, bioprocess validation establishes the scientific evidence that a process is capable of consistently delivering quality products.

The Bioprocess Validation Market is Segmented by Test Type (Extractables Testing Services, Microbiological Testing Services, Physiochemical Testing Services, Integrity Testing Services, Compatibility Testing Services, and Other Testing Services), Process Component (Filter Elements, Media containers and bags, Freezing And Thawing Process Bags, Mixing Systems, Bioreactors, Transfer Systems, and Other Process Components), End-User (Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments. The report offers the value (in USD million) for the above segments.

By Test Type Extractables Testing Services
Microbiological Testing Services
Physicochemical Testing Services
Integrity Testing Services
Compatibility Testing Services
Other Testing Services
By Process Component Filter Elements
Media Containers & Bags
Freezing & Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Other Process Components
By End User Pharmaceutical & Biotechnology Companies
Contract Development & Manufacturing Organizations
Other End Users
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Test Type
Extractables Testing Services
Microbiological Testing Services
Physicochemical Testing Services
Integrity Testing Services
Compatibility Testing Services
Other Testing Services
By Process Component
Filter Elements
Media Containers & Bags
Freezing & Thawing Process Bags
Mixing Systems
Bioreactors
Transfer Systems
Other Process Components
By End User
Pharmaceutical & Biotechnology Companies
Contract Development & Manufacturing Organizations
Other End Users
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current value of the bioprocess validation market?

The market is valued at USD 412.70 million in 2025 and is forecast to grow to USD 817.18 million by 2030.

Which test type holds the largest share?

Extractables testing dominates with 38.43% of 2024 revenue, driven by single-use system adoption and regulatory focus on patient safety.

Why are CDMOs growing faster than other end users?

Pharmaceutical companies outsource validation to CDMOs for cost savings and specialized expertise, giving CDMOs a 17.43% projected CAGR through 2030.

Which region is expanding the fastest?

Asia-Pacific leads with a 15.76% CAGR thanks to capacity additions in China and India and closer alignment with global GMP standards.

How are new regulations affecting validation workloads?

Updated FDA and EMA guidance adds more stringent viral safety, analytical method, and contamination-control requirements, increasing the volume and complexity of validation studies.

What technologies are transforming validation practices?

Process analytical technology tools such as real-time spectroscopy, digital twins, and machine-learning models enable continuous monitoring and shorten release timelines.

Bioprocess Validation Market Report Snapshots