The U.S. filter integrity test market size was estimated at USD 33.47 Million in 2025 and is projected to reach USD 47.36 million by 2033, growing at a CAGR of 4.44% from 2025 to 2023. The market is primarily driven by the rapid growth of the biopharmaceutical industry. Increasing demand for biologics, monoclonal antibodies, and advanced therapies has heightened reliance on sterile filtration processes, where integrity testing is essential for maintaining product quality and regulatory compliance. With strict FDA oversight and sterility assurance requirements across every stage of biologics production, companies are making significant investments in advanced manufacturing facilities and filtration systems, creating strong demand for integrity testing solutions nationwide.
A recent example underscores this trend. In April 2025, UCB, a biopharmaceutical company committed to treating severe diseases, announced plans to establish a new, state-of-the-art biologics manufacturing facility in the U.S. This expansion highlights the growing biomanufacturing footprint in the country and underscores the importance of U.S. filter integrity testing systems to support compliance and ensure product safety. As more organizations invest in biologics capacity and cutting-edge production capabilities, demand for FIT solutions is expected to rise further.
The market is also being propelled by technological innovation and evolving regulatory expectations. As the U.S. strengthens its position as a leader in biologics, vaccines, and cell and gene therapies, integrity testing-particularly Pre-Use Post-Sterilization Integrity Testing (PUPSIT)-is gaining traction as a critical quality measure. These tests help manufacturers meet global standards while minimizing contamination risks and avoiding costly recalls. The integration of automated testing solutions into Good Manufacturing Practice (GMP) environments further ensures efficiency, compliance, and reliability.
For instance, in May 2025, Parker Bioscience Filtration, a division of Parker Hannifin, launched the SciLog NFF+ PF, a compact, multipurpose normal flow filtration system equipped with onboard PUPSIT functionality. By addressing the complexities of PUPSIT-such as reducing manual handling, operator errors, and product waste-this system supports safer and more streamlined biopharmaceutical production. Such innovations are setting new industry benchmarks, positioning the U.S. FIT market for sustained growth in the years ahead.
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A recent example underscores this trend. In April 2025, UCB, a biopharmaceutical company committed to treating severe diseases, announced plans to establish a new, state-of-the-art biologics manufacturing facility in the U.S. This expansion highlights the growing biomanufacturing footprint in the country and underscores the importance of U.S. filter integrity testing systems to support compliance and ensure product safety. As more organizations invest in biologics capacity and cutting-edge production capabilities, demand for FIT solutions is expected to rise further.
The market is also being propelled by technological innovation and evolving regulatory expectations. As the U.S. strengthens its position as a leader in biologics, vaccines, and cell and gene therapies, integrity testing-particularly Pre-Use Post-Sterilization Integrity Testing (PUPSIT)-is gaining traction as a critical quality measure. These tests help manufacturers meet global standards while minimizing contamination risks and avoiding costly recalls. The integration of automated testing solutions into Good Manufacturing Practice (GMP) environments further ensures efficiency, compliance, and reliability.
For instance, in May 2025, Parker Bioscience Filtration, a division of Parker Hannifin, launched the SciLog NFF+ PF, a compact, multipurpose normal flow filtration system equipped with onboard PUPSIT functionality. By addressing the complexities of PUPSIT-such as reducing manual handling, operator errors, and product waste-this system supports safer and more streamlined biopharmaceutical production. Such innovations are setting new industry benchmarks, positioning the U.S. FIT market for sustained growth in the years ahead.
U.S. Filter Integrity Test Market Report Segmentation
This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, the analyst has segmented the U.S. filter integrity test market report based on test method, mode, type, and end-use:Test Method Outlook (Revenue, USD Million, 2021-2033)
- Forward Flow (Diffusion) Test
- Bubble Point Test
- Pressure Hold Test
- Water Intrusion Test
- Others
Mode Outlook (Revenue, USD Million, 2021-2033)
- Automated
- Manual
Type Outlook (Revenue, USD Million, 2021-2033)
- Liquid Filter Integrity Test
- Air Filter Integrity Test
End-use Outlook (Revenue, USD Million, 2021-2033)
- Biopharmaceutical & Pharmaceutical Industry
- Food & Beverage Industry
- Others
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the 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
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Filter Integrity Test Market Variables, Trends & Scope
Chapter 4. U.S. Filter Integrity Test Market: Test Method Estimates & Trend Analysis
Chapter 5. U.S. Filter Integrity Test Market: Mode Estimates & Trend Analysis
Chapter 6. U.S. Filter Integrity Test Market: Type Estimates & Trend Analysis
Chapter 7. U.S. Filter Integrity Test Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this U.S. Filter Integrity Test market report include:- erck KGaA
- artorius AG
- arker Hannifin Corp
- ALL Corporation (Danaher)
- onaldson Company, Inc.
- entair Ltd.
- M
- eissner Filtration Products, Inc.
- eijing Neuronbc Laboratories Co., Ltd.
- rother Filtration
- nalytical Technologies Limited
- hermo Fisher Scientific, Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 33.47 Million |
| Forecasted Market Value ( USD | $ 47.36 Million |
| Compound Annual Growth Rate | 4.4% |
| Regions Covered | United States |
| No. of Companies Mentioned | 12 |
