U.S. Filter Integrity Test Market Size, Share & Trends Analysis Report By Test Method (Forward Flow (Diffusion) Test, Bubble Point Test, Pressure Hold Test, Water Intrusion Test), By Mode, By Type, By End-use, And Segment Forecasts, 2025 - 2033

PUBLISHED: September 11, 2025

PAGES: 150 Pages

DELIVERY TIME: 2-10 business days

SELECT AN OPTION

The U.S. filter integrity test market size was estimated at USD 32.12 million in 2024 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.

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, Grand View Research 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

Product Code: GVR-4-68040-737-7

Chapter 1. Methodology and Scope

1.1. Data for primary interviews in Latin America
1.2. Data for Primary interviews in MEA
1.3. Information or Data Analysis
- 1.3.1. Data analysis models
1.4. Market Formulation & Validation
1.5. Model Details
- 1.5.1. Commodity flow analysis (Model 1)
- 1.5.2. Approach 1: Commodity flow approach
- 1.5.3. Volume price analysis (Model 2)
- 1.5.4. Approach 2: Volume price analysis
1.6. List of Secondary Sources
1.7. List of Primary Sources
1.8. Objectives

Chapter 2. Executive Summary

2.1. Market Outlook
2.2. Segment Outlook
- 2.2.1. Test Method
- 2.2.2. Mode
- 2.2.3. Type
- 2.2.4. End Use
- 2.2.5. Regional outlook
2.3. Competitive Insights

Chapter 3. U.S. Filter Integrity Test 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. Rising demand for biopharmaceuticals
  - 3.2.1.2. Presence of stringent safety regulatory guidelines
  - 3.2.1.3. Growing awareness with respect to product purity and stability requirements across several industries
  - 3.2.1.4. Higher Spending in R&D Activities
- 3.2.2. Market restraint analysis
  - 3.2.2.1. Occurrence of failures in U.S. filter integrity testing
  - 3.2.2.2. High cost of integrity testing
3.3. U.S. Filter Integrity Test Market Analysis Tools
- 3.3.1. Industry Analysis - Porter's
  - 3.3.1.1. Supplier power
  - 3.3.1.2. Buyer power
  - 3.3.1.3. Substitution threat
  - 3.3.1.4. Threat of new entrant
  - 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
  - 3.3.2.1. Political landscape
  - 3.3.2.2. Technological landscape
  - 3.3.2.3. Economic landscape
- 3.3.3. Pricing Analysis
- 3.3.4. Volume Analysis (Instruments)

Chapter 4. U.S. Filter Integrity Test Market: Test Method Estimates & Trend Analysis

4.1. U.S. Filter Integrity Test Market: Test Method Dashboard
4.2. U.S. Filter Integrity Test Market: Test Method Movement Analysis
4.3. U.S. Filter Integrity Test Market by Test Method, Revenue 2021 - 2033 (USD Million)
4.4. Forward Flow (Diffusion) Test
- 4.4.1. Forward Flow (Diffusion) Test market estimates and forecasts 2021 to 2033 (USD Million)
4.5. Bubble Point Test
- 4.5.1. Bubble Point Test market estimates and forecasts 2021 to 2033 (USD Million)
4.6. Pressure Hold Test
- 4.6.1. Pressure Hold Test market estimates and forecasts 2021 to 2033 (USD Million)
4.7. Water Intrusion Test
- 4.7.1. Water Intrusion Test market estimates and forecasts 2021 to 2033 (USD Million)
4.8. Others
- 4.8.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 5. U.S. Filter Integrity Test Market: Mode Estimates & Trend Analysis

5.1. U.S. Filter Integrity Test Market: Mode Dashboard
5.2. U.S. Filter Integrity Test Market: Mode Movement Analysis
5.3. U.S. Filter Integrity Test Market by Mode, Revenue 2021 - 2033 (USD Million)
5.4. Automated
- 5.4.1. Automated market estimates and forecasts 2021 to 2033 (USD Million)
5.5. Manual
- 5.5.1. Manual market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 6. U.S. Filter Integrity Test Market: Type Estimates & Trend Analysis

6.1. U.S. Filter Integrity Test Market: Type Dashboard
6.2. U.S. Filter Integrity Test Market: Type Movement Analysis
6.3. U.S. Filter Integrity Test Market by Type, Revenue 2021 - 2033 (USD Million)
6.4. Liquid Filter Integrity Test
- 6.4.1. Liquid Filter Integrity Test market estimates and forecasts 2021 to 2033 (USD Million)
6.5. Air Filter Integrity Test
- 6.5.1. Air Filter Integrity Test market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. U.S. Filter Integrity Test Market: End Use Estimates & Trend Analysis

7.1. U.S. Filter Integrity Test Market: End Use Dashboard
7.2. U.S. Filter Integrity Test Market: End Use Movement Analysis
7.3. U.S. Filter Integrity Test Market by End Use, Revenue 2021 - 2033 (USD Million)
7.4. Biopharmaceutical & Pharmaceutical Industry
- 7.4.1. Biopharmaceutical & Pharmaceutical Industry market estimates and forecasts 2021 to 2033 (USD Million)
7.5. Food & Beverage Industry
- 7.5.1. Food & Beverage Industry market estimates and forecasts 2021 to 2033 (USD Million)
7.6. Others
- 7.6.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. Competitive Landscape

8.1. Recent Developments & Impact Analysis, By Key Market Participants
8.2. Company/Competition Categorization
8.3. Vendor Landscape
- 8.3.1. List of key distributors and channel partners
- 8.3.2. Key customers
- 8.3.3. Key company market share analysis, 2023
- 8.3.4. Merck KGaA
  - 8.3.4.1. Company overview
  - 8.3.4.2. Financial performance
  - 8.3.4.3. Product benchmarking
  - 8.3.4.4. Strategic initiatives
- 8.3.5. Sartorius AG
  - 8.3.5.1. Company overview
  - 8.3.5.2. Financial performance
  - 8.3.5.3. Product benchmarking
  - 8.3.5.4. Strategic initiatives
- 8.3.6. Parker Hannifin Corp
  - 8.3.6.1. Company overview
  - 8.3.6.2. Financial performance
  - 8.3.6.3. Product benchmarking
  - 8.3.6.4. Strategic initiatives
- 8.3.7. PALL Corporation
  - 8.3.7.1. Company overview
  - 8.3.7.2. Financial performance
  - 8.3.7.3. Product benchmarking
  - 8.3.7.4. Strategic initiatives
- 8.3.8. Donaldson Company, Inc.
  - 8.3.8.1. Company overview
  - 8.3.8.2. Financial performance
  - 8.3.8.3. Product benchmarking
  - 8.3.8.4. Strategic initiatives
- 8.3.9. Pentair Ltd.
  - 8.3.9.1. Company overview
  - 8.3.9.2. Financial performance
  - 8.3.9.3. Product benchmarking
  - 8.3.9.4. Strategic initiatives
- 8.3.10. 3M
  - 8.3.10.1. Company overview
  - 8.3.10.2. Financial performance
  - 8.3.10.3. Product benchmarking
  - 8.3.10.4. Strategic initiatives
- 8.3.11. Meissner Filtration Products, Inc.
  - 8.3.11.1. Company overview
  - 8.3.11.2. Financial performance
  - 8.3.11.3. Product benchmarking
  - 8.3.11.4. Strategic initiatives
- 8.3.12. Beijing Neuronbc Laboratories Co., Ltd.
  - 8.3.12.1. Company overview
  - 8.3.12.2. Financial performance
  - 8.3.12.3. Product benchmarking
  - 8.3.12.4. Strategic initiatives
- 8.3.13. Brother Filtration
  - 8.3.13.1. Company overview
  - 8.3.13.2. Financial performance
  - 8.3.13.3. Product benchmarking
  - 8.3.13.4. Strategic initiatives
- 8.3.14. Analytical Technologies Limited
  - 8.3.14.1. Company overview
  - 8.3.14.2. Financial performance
  - 8.3.14.3. Product benchmarking
  - 8.3.14.4. Strategic initiatives
- 8.3.15. Thermo Fisher Scientific, Inc.
  - 8.3.15.1. Company overview
  - 8.3.15.2. Financial performance
  - 8.3.15.3. Product benchmarking
  - 8.3.15.4. Strategic initiatives

Product Code: GVR-4-68040-737-7

List of Tables

Table 1 List of abbreviation
Table 2 U.S. filter integrity test market, by test method, 2021 - 2033 (USD Million)
Table 3 U.S. filter integrity test market, by mode, 2021 - 2033 (USD Million)
Table 4 U.S. filter integrity test market, by type, 2021 - 2033 (USD Million)
Table 5 U.S. filter integrity test market, by end use, 2021 - 2033 (USD Million)

List of Figures

Fig. 1 Market research process
Fig. 2 Data triangulation techniques
Fig. 3 Primary research pattern
Fig. 4 Primary interviews in North America
Fig. 5 Primary interviews in Europe
Fig. 6 Primary interviews in APAC
Fig. 7 Primary interviews in Latin America
Fig. 8 Primary interviews in MEA
Fig. 9 Market research approaches
Fig. 10 Value-chain-based sizing & forecasting
Fig. 11 QFD modeling for market share assessment
Fig. 12 Market formulation & validation
Fig. 13 U.S. Filter Integrity Test market: market outlook
Fig. 14 U.S. Filter Integrity Test competitive insights
Fig. 15 Parent market outlook
Fig. 16 Related/ancillary market outlook
Fig. 17 Filter integrity test market driver impact
Fig. 18 Filter integrity test market restraint impact
Fig. 19 Filter integrity test market: Test Method movement analysis
Fig. 20 Filter integrity test market: Test Method outlook and key takeaways
Fig. 21 Forward flow (Diffusion) test market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 22 Bubble point test estimates and forecast, 2021 - 2033 (USD Million)
Fig. 23 Pressure hold test market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 24 Water intrusion test estimates and forecast, 2021 - 2033 (USD Million)
Fig. 25 Others market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 26 Filter integrity test market: Mode movement analysis
Fig. 27 Filter integrity test market: Mode outlook and key takeaways
Fig. 28 Automated market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 29 Manual estimates and forecast, 2021 - 2033 (USD Million)
Fig. 30 Filter integrity test market: Type movement analysis
Fig. 31 Filter integrity test market: Type outlook and key takeaways
Fig. 32 Liquid integrity test market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 33 Air filter integrity test market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 34 Filter integrity test market: End Use movement analysis
Fig. 35 Filter integrity test market: End Use outlook and key takeaways
Fig. 36 Biopharmaceutical & pharmaceutical industry market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 37 Food & beverage industry market estimates and forecast, 2021 - 2033 (USD Million)
Fig. 38 Others market estimates and forecast, 2021 - 2033 (USD Million)