Global Bioprocess Validation Market Size & Outlook

The global bioprocess validation market size was estimated at USD 485.6 million in 2024 and is projected to reach USD 1,052.5 million by 2033, growing at a CAGR of 9% from 2025 to 2033.
Revenue, 2024 (US$M)
$485.6
Forecast, 2033 (US$M)
$1,052.5
CAGR, 2025 - 2033
9%
Report Coverage
Worldwide

Global bioprocess validation market, 2021-2033 (US$M)

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Global bioprocess validation market highlights

  • The global bioprocess validation market generated a revenue of USD 485.5 million in 2024 and is expected to reach USD 1,052.5 million by 2033.
  • The market is expected to grow at a CAGR (2025 - 2033) of 9% by 2033.
  • In terms of segment, bioprocess residuals testing accounted for a revenue of USD 153.8 million in 2024.
  • Extractables & Leachables Testing is the most lucrative testing type segment registering the fastest growth during the forecast period.
  • In terms of region, North America was the largest revenue generating market in 2024.
  • Country-wise, China is expected to register the highest CAGR from 2025 to 2033.

Global data book summary

Market revenue in 2024USD 485.5 million
Market revenue in 2033USD 1,052.5 million
Growth rate9% (CAGR from 2025 to 2033)
Largest segmentBioprocess residuals testing
Fastest growing segmentExtractables & Leachables Testing
Historical data covered2021 - 2023
Base year for estimation2024
Forecast period covered2025 - 2033
Quantitative unitsRevenue in USD million
Market segmentationExtractables & Leachables Testing, Bioprocess Residuals Testing, Viral Clearance Testing, Filtration & Fermentation Systems Testing

Other key industry trends

  • In terms of revenue, the North America accounted for 40.5% of the global bioprocess validation market in 2024.
  • By country, the U.S. is projected to lead the global market in terms of revenue in 2033.
  • By country, China is the fastest growing regional market and is projected to reach USD 82.6 million by 2033.

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Bioprocess Validation Market Companies

Name Profile # Employees HQ Website
Cobetter Filtration View profile - Hangzhou, Zhejiang, China, Asia https://www.cobetterfiltration.com/
SGS AG View profile 103193 1 Place des Alpes, P.O. Box 2152, Geneva, Switzerland, CH-1211 https://www.sgs.com
Labcorp Holdings Inc View profile 67000 358 South Main Street, Burlington, NC, United States, 27215 https://www.labcorp.com
Charles River Laboratories International Inc View profile 21400 251 Ballardvale Street, Wilmington, MA, United States, 01887 https://www.criver.com
Eurofins Scientific SE View profile 61798 23 Val Fleuri, Luxembourg, Luxembourg, L-1526 https://www.eurofins.com
Sartorius AG View profile 14338 Otto-Brenner-Strasse 20, Gottingen, NI, Germany, 37079 https://www.sartorius.com
Danaher Corp View profile 63000 2200 Pennsylvania Avenue, N.W., Suite 800W, Washington, DC, United States, 20037-1701 https://www.danaher.com
Thermo Fisher Scientific Inc View profile 122000 168 Third Avenue, Waltham, MA, United States, 02451 https://www.thermofisher.com
Lonza Group Ltd View profile 18000 Muenchensteinerstrasse 38, Basel, Switzerland, CH-4002 https://www.lonza.com
Merck KGaA View profile 62345 Frankfurter Strasse 250, Darmstadt, HE, Germany, 64293 https://www.emdgroup.com

Global bioprocess validation market outlook

The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to bioprocess validation market will help companies and investors design strategic landscapes.


Bioprocess residuals testing was the largest segment with a revenue share of 31.68% in 2024. Horizon Databook has segmented the Global bioprocess validation market based on extractables & leachables testing, bioprocess residuals testing, viral clearance testing, filtration & fermentation systems testing covering the revenue growth of each sub-segment from 2021 to 2033.


  • Global Bioprocess Validation Testing Type Outlook (Revenue, USD Million, 2021-2033)
    • Extractables & Leachables Testing
    • Bioprocess Residuals Testing
    • Viral Clearance Testing
    • Filtration & Fermentation Systems Testing
    • Others
  • Global Bioprocess Validation Stage Outlook (Revenue, USD Million, 2021-2033)
    • Process Design
    • Process Qualification
    • Continued Process Verification
  • Global Bioprocess Validation Mode Outlook (Revenue, USD Million, 2021-2033)
    • In house
    • Outsourced

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Target buyers of Global bioprocess validation market databook

  • Our clientele includes a mix of bioprocess validation market companies, investment firms, advisory firms & academic institutions.
  • 30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
  • Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
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Horizon Databook provides a detailed overview of global-level data and insights on the Global bioprocess validation market , including forecasts for subscribers. This global databook contains high-level insights into Global bioprocess validation market from 2021 to 2033, including revenue numbers, major trends, and company profiles.

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Global bioprocess validation market size, by regions, 2021-2033 (US$M)

Top 10 countries: Bioprocess validation market size, 2024 (US$M)

Global bioprocess validation market share, by testing type, 2024 & 2033 (%, US$M)

Bioprocess validation market: Opportunity assessment by country

Global bioprocess validation market, by region, 2024 (US$M)

Global bioprocess validation market size, by regions, 2021-2033 (US$M)

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