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U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (Outsourcing, In-house), By Product, By Test (Sterility Testing, Bioburden Testing), By Sample (Pharmaceuticals, Medical Devices), By End-use, And Segment Forecasts, 2025 - 2033- Product Image
U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (Outsourcing, In-house), By Product, By Test (Sterility Testing, Bioburden Testing), By Sample (Pharmaceuticals, Medical Devices), By End-use, And Segment Forecasts, 2025 - 2033- Product Image
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U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (Outsourcing, In-house), By Product, By Test (Sterility Testing, Bioburden Testing), By Sample (Pharmaceuticals, Medical Devices), By End-use, And Segment Forecasts, 2025 - 2033

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    Report

  • 150 Pages
  • July 2025
  • Region: United States
  • Grand View Research
  • ID: 4613461
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U.S. Pharmaceutical Sterility Testing Market Summary

The U.S. pharmaceutical sterility testing market size was estimated at USD 0.67 billion in 2024 and is projected to reach USD 1.70 billion by 2033, growing at a CAGR of 11.04% from 2025 to 2033. The market is driven by increasing R&D activities, growing drug innovations, rising focus on quality & sterility, and rising government investments in healthcare.

Besides, rising demand for biologics, personalized medicines, and stringent regulatory requirements from the FDA and USP is expected to support the market growth. In addition, the adoption of rapid microbiological methods (such as PCR and ATP bioluminescence), increased automation to minimize errors, and the use of AI-driven analytics for improved data interpretation is contributing to growing trends toward outsourcing and managing costs effectively. Also, the market is shifting towards faster and more reliable testing solutions that ensure product safety and compliance, especially as the complexity of pharmaceutical manufacturing increases and there is an increased focus on patient safety.

Moreover, the rising number of drug launches globally continues to be a significant growth driver for the pharmaceutical sterility testing industry. According to the U.S. FDA, 50 new molecular entities (NMEs) and biologics were approved by Center for Drug Evaluation and Research (CDER) in 2024 alone, the trend is expected to accelerate in 2025 due to advancements in personalized medicine, gene therapies, and novel biologics. Each newly launched sterile drug, including injectables, vaccines, and advanced therapy medicinal products (ATMPs), requires stringent sterility testing to comply with rigorous regulatory frameworks such as those from the FDA, EMA, and WHO.

The growing complexity and diversity of sterile formulations, driven by innovations in drug delivery systems and biologics, further intensify sterility testing demands. As per the research study, the pipeline of sterile injectable drugs expanded by over 15% year-on-year in 2024, reflecting sustained R&D investment and market entry of novel therapies targeting unmet medical needs. This expansion requires enhanced sterility testing capacity, adoption of rapid microbiological methods, and tailored testing protocols to ensure safety and efficacy.

Furthermore, the U.S. pharmaceutical sterility testing sector is evolving rapidly due to the adoption of innovative technologies. Emerging rapid microbiological methods, such as ATP bioluminescence and PCR, are accelerating contamination detection and shortening product release times. The increased use of automation and robotics enhances testing accuracy while reducing manual errors. In addition, artificial intelligence aids in data analysis and provides predictive insights, improving decision-making processes. These advancements align with stricter FDA and USP requirements, ensuring enhanced safety standards for complex biologics and personalized therapies.

U.S. Pharmaceutical Sterility Testing Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. pharmaceutical sterility testing market report based on type, product, test, sample, and end-use.

Type Outlook (Revenue, USD Million, 2021 - 2033)

  • In-House
  • Outsourcing

Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Kits and Reagents
  • Instruments
  • Services

Test Outlook (Revenue, USD Million, 2021 - 2033)

  • Sterility Testing
  • Membrane Filtration
  • Direct Inoculation
  • Product Flush
  • Bioburden Testing
  • Bacterial Endotoxin Testing

Sample Outlook (Revenue, USD Million, 2021 - 2033)

  • Pharmaceuticals
  • Medical Devices
  • Biopharmaceuticals

End-use Outlook (Revenue, USD Million, 2021 - 2033)

  • Compounding Pharmacies
  • Medical Device Companies
  • Pharmaceutical Companies
  • Others

Why should you buy this report?

  • Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
  • Competitive Landscape: Explore the market presence of key players worldwide.
  • Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
  • Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

  • Market intelligence to enable effective decision-making
  • Market estimates and forecasts from 2018 to 2030
  • Growth opportunities and trend analyses
  • Segment and regional revenue forecasts for market assessment
  • Competition strategy and market share analysis
  • Product innovation listing for you to stay ahead of the curve
  • COVID-19's impact and how to sustain in these fast-evolving markets

This product will be delivered within 1-3 business days.

Table of Contents

Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Market Definitions
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. Internal Database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Information Or Data Analysis
1.5.1. Data Analysis Models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Value chain based analysis (Model 2)
1.7.3. Multivariate Analysis (Model 3)
1.8. List Of Secondary Sources
1.9. List Of Abbreviations
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. U.S. Pharmaceutical Sterility Testing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Supportive Government Investment in Healthcare Industry
3.2.1.2. Increasing R&D Activities
3.2.1.3. Increasing Number of Drug Launches
3.2.1.4. Increasing Focus on Quality and Sterility
3.2.2. Market Restraint Analysis
3.2.2.1. Compliance Issues While Outsourcing
3.2.2.2. Third Party Performance
3.3. Pricing Model Analysis
3.4. Technology Landscape
3.5. Market Analysis Tools
3.5.1. Porter’s Five Force Analysis
3.5.2. PESTEL by SWOT Analysis
3.5.3. COVID-19 Impact Analysis
Chapter 4. U.S. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis
4.1. U.S. Pharmaceutical Sterility Testing Market, By Type: Segment Dashboard
4.2. U.S. Pharmaceutical Sterility Testing Market, By Type: Movement Analysis
4.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Type, 2021-2033 (USD Million)
4.4. In-House
4.4.1. In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5. Outsourcing
4.5.1. Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. Pharmaceutical Sterility Testing Market: Product Estimates & Trend Analysis
5.1. U.S. Pharmaceutical Sterility Testing Market, By Product: Segment Dashboard
5.2. U.S. Pharmaceutical Sterility Testing Market, By Product: Movement Analysis
5.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Product, 2021-2033 (USD Million)
5.4. Kits and Reagents
5.4.1. Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Instruments
5.5.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Services
5.6.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. Pharmaceutical Sterility Testing Market: Test Estimates & Trend Analysis
6.1. U.S. Pharmaceutical Sterility Testing Market, By Test: Segment Dashboard
6.2. U.S. Pharmaceutical Sterility Testing Market, By Test: Movement Analysis
6.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Test, 2021-2033 (USD Million)
6.4. Sterility Testing
6.4.1. Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.4.2. Membrane Filtration
6.4.2.1. Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.4.3. Direct Inoculation
6.4.3.1. Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.4.4. Product Flush
6.4.4.1. Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.5. Bioburden Testing
6.5.1. Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
6.6. Bacterial Endotoxin Testing
6.6.1. Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis
7.1. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Segment Dashboard
7.2. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Movement Analysis
7.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By End-Use, 2021-2033 (USD Million)
7.4. Compounding Pharmacies
7.4.1. Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
7.5. Medical Device Companies
7.5.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
7.6. Pharmaceutical Companies
7.6.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
7.7. Others
7.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis
8.1. U.S. Pharmaceutical Sterility Testing Market, By Sample: Segment Dashboard
8.2. U.S. Pharmaceutical Sterility Testing Market, By Sample: Movement Analysis
8.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Sample, 2021-2033 (USD Million)
8.4. Pharmaceuticals
8.4.1. Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.5. Medical Devices
8.5.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
8.6. Biopharmaceuticals
8.6.1. Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 9. Competitive Landscape
9.1. Market Participant Categorization
9.2. Company Market Share/Assessment Analysis, 2024
9.3. Company Profiles
9.3.1. Pacific Biolabs
9.3.1.1. Company overview
9.3.1.2. Financial performance
9.3.1.3. Service benchmarking
9.3.1.4. Strategic initiatives
9.3.2. Steris Plc
9.3.2.1. Company overview
9.3.2.2. Financial performance
9.3.2.3. Service benchmarking
9.3.2.4. Strategic initiatives
9.3.3. Boston Analytical
9.3.3.1. Company overview
9.3.3.2. Financial performance
9.3.3.3. Service benchmarking
9.3.3.4. Strategic initiatives
9.3.4. Nelson Laboratories, LLC (Sotera Health)
9.3.4.1. Company overview
9.3.4.2. Financial performance
9.3.4.3. Service benchmarking
9.3.4.4. Strategic initiatives
9.3.5. Sartorius AG
9.3.5.1. Company overview
9.3.5.2. Financial performance
9.3.5.3. Service benchmarking
9.3.5.4. Strategic initiatives
9.3.6. SOLVIAS AG
9.3.6.1. Company overview
9.3.6.2. Financial performance
9.3.6.3. Service benchmarking
9.3.6.4. Strategic initiatives
9.3.7. SGS SA
9.3.7.1. Company overview
9.3.7.2. Financial performance
9.3.7.3. Service benchmarking
9.3.7.4. Strategic initiatives
9.3.8. Labcorp
9.3.8.1. Company overview
9.3.8.2. Financial performance
9.3.8.3. Service benchmarking
9.3.8.4. Strategic initiatives
9.3.9. Pace Analytical
9.3.9.1. Company overview
9.3.9.2. Financial performance
9.3.9.3. Service benchmarking
9.3.9.4. Strategic initiatives
9.3.10. Charles River Laboratories
9.3.10.1. Company overview
9.3.10.2. Financial performance
9.3.10.3. Service benchmarking
9.3.10.4. Strategic initiatives
9.3.11. Thermo Fisher Scientific, Inc.
9.3.11.1. Company overview
9.3.11.2. Financial performance
9.3.11.3. Service benchmarking
9.3.11.4. Strategic initiatives
9.3.12. Rapid Micro Biosystems
9.3.12.1. Company overview
9.3.12.2. Financial performance
9.3.12.3. Service benchmarking
9.3.12.4. Strategic initiatives
9.3.13. Almac Group
9.3.13.1. Company overview
9.3.13.2. Financial performance
9.3.13.3. Service benchmarking
9.3.13.4. Strategic initiatives
Chapter 10 Key Recommendations
List of Tables
Table 1. List of Tables
Table 2. List of Secondary Sources
Table 3. List of Abbreviations
Table 4. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Type, 2021 - 2033 (USD Million)
Table 5. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
Table 6. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Test, 2021 - 2033 (USD Million)
Table 7. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sterility Testing, 2021 - 2033 (USD Million)
Table 8. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by End-Use, 2021 - 2033 (USD Million)
Table 9. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sample, 2021 - 2033 (USD Million)
List of Figures
Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Market formulation & validation
Fig. 6 Commodity flow analysis
Fig. 7 Value-chain-based sizing & forecasting
Fig. 8 QFD model sizing & forecasting
Fig. 9 Bottom-up approach
Fig. 10 Market snapshot
Fig. 11 Segment snapshot 1
Fig. 12 Segment snapshot 2
Fig. 13 Competitive landscape snapshot
Fig. 14 Parent market outlook, 2024 (USD Billion)
Fig. 15 Ancillary market outlook, 2024 (USD Billion)
Fig. 16 U.S. Pharmaceutical Sterility Testing Market Dynamics
Fig. 17 Porter’s five forces analysis
Fig. 18 PESTEL analysis
Fig. 19 U.S. Pharmaceutical Sterility Testing Market: Type outlook and key takeaways
Fig. 20 U.S. Pharmaceutical Sterility Testing Market: Type movement analysis
Fig. 21 In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 22 Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 23 U.S. Pharmaceutical Sterility Testing Market: Product outlook and key takeaways
Fig. 24 U.S. Pharmaceutical Sterility Testing Market: Product movement analysis
Fig. 25 Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 26 Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 27 Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 28 U.S. Pharmaceutical Sterility Testing Market: Test outlook and key takeaways
Fig. 29 U.S. Pharmaceutical Sterility Testing Market: Test movement analysis
Fig. 30 Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 31 Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 32 Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 33 Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 34 Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 35 Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 36 U.S. Pharmaceutical Sterility Testing Market: End-Use outlook and key takeaways
Fig. 37 U.S. Pharmaceutical Sterility Testing Market: End-Use movement analysis
Fig. 38 Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 39 Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 40 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 41 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 42 U.S. Pharmaceutical Sterility Testing Market: Sample outlook and key takeaways
Fig. 43 U.S. Pharmaceutical Sterility Testing Market: Sample movement analysis
Fig. 44 Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 45 Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 46 Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Fig. 47 Key company categorization
Fig. 48 Service heat map analysis
Fig. 49 Strategic framework

Companies Mentioned

  • Pacific Biolabs
  • Steris Plc
  • Boston Analytical
  • Sotera Health Company (Nelson Labs)
  • Sartorius Ag
  • Solvias Ag
  • SGS SA
  • Labcorp
  • Pace Analytical
  • Charles River Laboratories
  • Thermo Fisher Scientific, Inc.
  • Rapid Micro Biosystems, Inc.
  • Almac Group

Table Information

Report AttributeDetails
No. of Pages150
PublishedJuly 2025
Forecast Period2024 - 2033
Estimated Market Value ( USD ) in 2024 $ 0.67 Billion
Forecasted Market Value ( USD ) by 2033 $ 1.7 Billion
Compound Annual Growth Rate11.0%
Regions CoveredUnited States
No. of Companies Mentioned13

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About the Sterility Testing Market

The Sterility Testing market within the Healthcare Services sector is a specialized field of testing that is used to detect the presence of microorganisms in a product or environment. Sterility testing is used to ensure that products are free from contamination and are safe for use. It is an important part of the quality control process for medical devices, pharmaceuticals, and other healthcare products. Sterility testing is also used to detect the presence of microorganisms in the environment, such as in hospitals and other healthcare facilities. Sterility testing is conducted by a variety of companies, including those specializing in laboratory testing, medical device manufacturers, and contract research organizations. These companies provide services such as microbial identification, environmental monitoring, and sterility assurance testing. They also provide consulting services to help healthcare organizations develop and implement sterility testing protocols. Some companies in the Sterility Testing market include Merck KGaA, SGS SA, Charles River Laboratories, Eurofins Scientific, and WuXi AppTec. Show Less Read more

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