Global Pharmaceutical Sterility Testing Market Size & Outlook

The global pharmaceutical sterility testing market size was estimated at USD 1,750.3 million in 2024 and is projected to reach USD 4,639.4 million by 2033, growing at a CAGR of 11.6% from 2025 to 2033.
Revenue, 2024 (US$M)
$1,750.3
Forecast, 2033 (US$M)
$4,639.4
CAGR, 2025 - 2033
11.6%
Report Coverage
Worldwide

Global pharmaceutical sterility testing market, 2021-2033 (US$M)

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Global pharmaceutical sterility testing market highlights

  • The global pharmaceutical sterility testing market generated a revenue of USD 1,750.3 million in 2024 and is expected to reach USD 4,639.4 million by 2033.
  • The market is expected to grow at a CAGR (2025 - 2033) of 11.6% by 2033.
  • In terms of segment, outsourcing accounted for a revenue of USD 1,136.3 million in 2024.
  • Outsourcing is the most lucrative 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, India is expected to register the highest CAGR from 2025 to 2033.

Global data book summary

Market revenue in 2024USD 1,750.3 million
Market revenue in 2033USD 4,639.4 million
Growth rate11.6% (CAGR from 2025 to 2033)
Largest segmentOutsourcing
Fastest growing segmentOutsourcing
Historical data covered2021 - 2023
Base year for estimation2024
Forecast period covered2025 - 2033
Quantitative unitsRevenue in USD million
Market segmentationIn-House, Outsourcing

Other key industry trends

  • In terms of revenue, the North America accounted for 52.9% of the global pharmaceutical sterility testing market in 2024.
  • By country, the U.S. is projected to lead the global market in terms of revenue in 2033.
  • By country, India is the fastest growing regional market and is projected to reach USD 185.5 million by 2033.

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Pharmaceutical Sterility Testing Market Scope

Pharmaceutical sterility testing market segmentation & scope
In-House
Outsourcing
Kits and Reagents
Instruments
Services
Bioburden Testing
Bacterial Endotoxin Testing
Membrane Filtration
Direct Inoculation
Product Flush
Compounding Pharmacies
Medical Device Companies
Pharmaceutical Companies
Others
Pharmaceuticals
Medical Devices
Biopharmaceuticals

Pharmaceutical Sterility Testing Market Companies

Name Profile # Employees HQ Website
Labor LS View profile 501-1000 Bad Bocklet, Bayern, Germany, Europe https://www.labor-ls.de/en/
Boston Analytical View profile 101-250 Salem, New Hampshire, United States, North America http://bostonanalytical.com
Pacific BioLabs, Inc. View profile 101-250 Hercules, California, United States, North America http://pacificbiolabs.com
Rapid Micro Biosystems Inc Class A View profile 193 1001 Pawtucket Boulevard West, Suite 280, Lowell, MA, United States, 01854 https://www.rapidmicrobio.com
Solvias View profile 501-1000 Kaiseraugst, Aargau, Switzerland, Europe http://www.solvias.com/en/home/
Almac Group View profile 1001-5000 Craigavon, Craigavon, United Kingdom, Europe https://www.almacgroup.com
Pace Analytical Services View profile 11-50 Woburn, Massachusetts, United States, North America https://www.pacelifesciences.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
Sartorius AG View profile 14338 Otto-Brenner-Strasse 20, Gottingen, NI, Germany, 37079 https://www.sartorius.com
Thermo Fisher Scientific Inc View profile 122000 168 Third Avenue, Waltham, MA, United States, 02451 https://www.thermofisher.com
Sotera Health Co Ordinary Shares View profile 3000 9100 South Hills Boulevard, Suite 300, Broadview Heights, OH, United States, 44147 https://investors.soterahealth.com
Steris PLC View profile 17100 5960 Heisley Road, Mentor, OH, United States, 44060 https://www.steris-ir.com

Global pharmaceutical sterility testing 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 pharmaceutical sterility testing market will help companies and investors design strategic landscapes.


Outsourcing was the largest segment with a revenue share of 64.92% in 2024. Horizon Databook has segmented the Global pharmaceutical sterility testing market based on in-house, outsourcing covering the revenue growth of each sub-segment from 2021 to 2033.


  • Global Pharmaceutical Sterility Testing Type Outlook (Revenue, USD Million, 2021-2033)
    • In-House
    • Outsourcing
  • Global Pharmaceutical Sterility Testing Product Outlook (Revenue, USD Million, 2021-2033)
    • Kits and Reagents
    • Instruments
    • Services
  • Global Pharmaceutical Sterility Testing Test Type Outlook (Revenue, USD Million, 2021-2033)
    • Bioburden Testing
    • Bacterial Endotoxin Testing
    • Sterility Testing
      • Membrane Filtration
      • Direct Inoculation
      • Product Flush
  • Global Pharmaceutical Sterility Testing End Use Outlook (Revenue, USD Million, 2021-2033)
    • Compounding Pharmacies
    • Medical Device Companies
    • Pharmaceutical Companies
    • Others
  • Global Pharmaceutical Sterility Testing Sample Outlook (Revenue, USD Million, 2021-2033)
    • Pharmaceuticals
    • Medical Devices
    • Biopharmaceuticals

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Target buyers of Global pharmaceutical sterility testing market databook

  • Our clientele includes a mix of pharmaceutical sterility testing 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 pharmaceutical sterility testing market , including forecasts for subscribers. This global databook contains high-level insights into Global pharmaceutical sterility testing market from 2021 to 2033, including revenue numbers, major trends, and company profiles.

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Global pharmaceutical sterility testing market size, by regions, 2021-2033 (US$M)

Top 10 countries: Pharmaceutical sterility testing market size, 2023 (US$M)

Global pharmaceutical sterility testing market share, by product, 2023 & 2030 (%, US$M)

Pharmaceutical sterility testing market: Opportunity assessment by country

Global pharmaceutical sterility testing market, by region, 2024 (US$M)

Global pharmaceutical sterility testing market size, by regions, 2021-2033 (US$M)

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