Summary

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, Grand View Research 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
o Membrane Filtration
o Direct Inoculation
o 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

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Table of Contents

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. GVR’s 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