Dublin, Aug. 22, 2025 (GLOBE NEWSWIRE) -- The "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" report has been added to ResearchAndMarkets.com's offering.
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.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 150 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value (USD) in 2024 | $0.67 Billion |
| Forecasted Market Value (USD) by 2033 | $1.7 Billion |
| Compound Annual Growth Rate | 11.0% |
| Regions Covered | United States |
Key Topics Covered:
Chapter 1. Research Methodology and Scope
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
3.2. 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
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
4.5. Outsourcing
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
5.4. Kits and Reagents
5.5. Instruments
5.6. Services
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
6.4.2. Membrane Filtration
6.4.3. Direct Inoculation
6.4.4. Product Flush
6.5. Bioburden Testing
6.6. Bacterial Endotoxin Testing
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
7.4. Compounding Pharmacies
7.5. Medical Device Companies
7.6. Pharmaceutical Companies
7.7. Others
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
8.4. Pharmaceuticals
8.5. Medical Devices
8.6. Biopharmaceuticals
Chapter 9. Competitive Landscape
9.1. Market Participant Categorization
9.2. Company Market Share/Assessment Analysis, 2024
9.3. Company Profiles
- Pacific Biolabs
- Steris
- Boston Analytical
- Sotera Health Company (Nelson Labs)
- Sartorius
- Solvias
- SGS SA
- Labcorp
- Pace Analytical
- Charles River Laboratories
- Thermo Fisher Scientific, Inc.
- Rapid Micro Biosystems, Inc.
- Almac Group
For more information about this report visit https://www.researchandmarkets.com/r/76b77g
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Attachment
