Filter Integrity Test Market to Worth USD 156.97 Million by 2034

The filter integrity test market size is calculated at USD 99.72 million in 2025 and is expected to reach around USD 156.97 million by 2034, growing at a CAGR of 5.17% for the forecasted period.

Ottawa, Sept. 16, 2025 (GLOBE NEWSWIRE) -- The global filter integrity test market size was valued at USD 94.82 million in 2024 and is predicted to hit around USD 156.97 million by 2034, rising at a 5.17% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research.

The global filter integrity test market is driven by the growing demand for advanced therapies, strict regulatory requirements, expanding industries, and growing disease burden.

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Key Takeaways

North America held a major revenue of 39% share of the market.
By type, the liquid filter integrity test segment dominated the filter integrity test market.
By mode, the automated segment dominated the market.
By test method, the bubble point test segment held a 33% share in the market.
By end-use, the biopharmaceutical & pharmaceutical industry segment held a 62% share in the market.

Market Overview & Potential

Different types of sterilizing-grade membrane filtration are being used during the sterile manufacturing process. Therefore, there is a need to test the integrity of the filters to ensure the reliable and safe manufacturing of the products. This drives the use of filter integrity tests before the use of the filters, making the sterilizing grade filtration an acceptable process.

Different types of methods, such as forward-flow pressure test or bubble-point pressure test or pressure hold test, or water intrusion test, are used to verify the integrity of the filter assembly. Moreover, the filter integrity test market is expanding due to increasing infectious diseases, growing research and development, stringent regulatory standards, as well as growing technological advancements.

What are the Major Growth Drivers Filter Integrity Test Market?

The expanding pharmaceutical industry serves as the major driver to enhance the use of filter integrity testing. Their use is mandatory to meet the regulatory standards for sterile drug manufacturing. As there is a rise in the demand for vaccines, biologics, and IV fluids, their production is increasing, which is increasing their use of these materials to maintain their sterility.

At the same time, the growing development of cell and gene therapies is also enhancing their use to test sterility and to avoid contamination. They are also being used during the quality control of the products. Additionally, factors such are strict GMP regulations, increasing adoption of single-use filtration systems, growing clinical trials, and growing safety norms are some of the other market drivers.

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What are the Key Drifts in the Filter Integrity Test Market?

The market has been expanding due to the growing launches and innovations to enhance the adoption of the filter integrity testers.

In March 2024, the iProbe Plus scanning probe, which is a filter scanning probe compatible with both new and old model 2i Aerosol Photometers, was launched by Air Techniques International (ATI).
In November 2023, a HEPA filter retrofit was launched by Tesla for Model Y EVs manufactured in 2020–2021 in North America, which was able to capture 99.97% of particles with less than 0.3 micrometers diameter, along with a secondary filtering system, eliminating germs, viruses, mold spores, smells, and gases.
In March 2023, a new hydraulic filtering technology, enhancing the hydraulic fluid purity, that is the Alpha-Web® filtering medium, was launched by Donaldson Company, Inc.

What is the Significant Challenge in the Filter Integrity Test Market?

High cost serves as the major limitation in the market, as it consists of advanced FIT systems, making them expensive. At the same time, they also require regular calibration as well as validation. Training is also required for accurate interpretation of the results, as well as to comply with the standard operating procedures (SOPs).

Therefore, all these factors, along with the maintenance cost, make the filter integrity test more costly. This, in turn, decreases their adoption by the startups, as well as small or limited-resource pharmaceutical and biotechnology industries. Additionally, technical complexity, detailed documentation, and different regulatory standards depending on respective countries act as other limitations in the market growth.

Regional Analysis

Why did North America Dominate the Filter Integrity Test Market in 2023?

North America captured the biggest revenue share of the filter integrity test market in 2023. North America consisted of well-developed industries, which increased the use of filter integrity testers during the production process. The biotechnology and pharmaceutical industries used these testers due to the growth in the demand for biologics, vaccines, as well as injectables.

Similarly, growth in healthcare investments also promoted their adoption and use. At the same time, the industries also contributed to their increased innovations for developing automated filter integrity testers and digital data management and integration. This increased their early adoption in the country. Additionally, the growing research and development, as well as clinical trials, have also increased the use. Thus, all these advancements enhanced the market growth.

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Segmental Insights

By type analysis

Why Did the Liquid Filter Integrity Test Segment Dominate in the Filter Integrity Test Market in 2023?

By type, the liquid filter integrity test segment led the market in 2023, driven by its increased use in biopharmaceuticals. They were used due to their enhanced accuracy and sensitivity, which helped in the detection of minor defects. They were also used for sterile filtration validation during biologic preparations. They were also used for hydrophilic filters and were used during the drug production process. Thus, this enhanced the market growth.

By mode insights analysis

Which Mode Type Segment Held the Dominating Share of the Filter Integrity Test Market in 2023?

By mode, the automated segment held the dominating share of the market in 2023, as it provided enhanced accuracy. They also provided consistent and reliable results, which increased their use. It also provided digital records as well as automatic generation of reports. This, in turn, accelerated the testing process. Additionally, the closed automated systems reduce the risk of contamination.

By test method analysis

What Made the Bubble Point Test the Dominant Segment in the Filter Integrity Test Market in 2023?

By test method, the bubble point test segment dominated the market with a 33% share in 2023, because it did not damaged or altered the filters. They were also used during the drug production as they were suitable for membrane filters and for hydrophilic and hydrophobic filters as well. It also provided an ideal pore size as well as SOPs, which enhanced their use. Moreover, they comply with the regulatory standards, which has increased their use. Thus, this promoted the market growth.

By end-user analysis

How the Biopharmaceutical & Pharmaceutical Industry Segment Dominated the Filter Integrity Test Market in 2023?

By end-use, the biopharmaceutical & pharmaceutical industry segment held the largest share of 62% in the market in 2023, as they ensured sterility during the production of the drugs, biologics, or injections. They were used in the development of sterile drug products as they were essential to maintain the product stability. Moreover, due to high testing volumes, their adoption increased. At the same time, automated filter integrity tests were also used to minimize errors and the risk of contamination.

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Recent Developments in the Filter Integrity Test Market

In April 2025, to automate the density gradient ultracentrifugation, the OptiMATE Gradient Maker, which accelerates the purification processes, as well as enhances the reproducibility and consistency, was launched by Beckman Coulter Life Sciences.
In September 2024, filtration services such as sterile air and liquid filter integrity testing, comprehensive filter management, equipment calibration, and compressed air quality measurement will be provided by Donaldson Company, Inc. in Germany, Austria, and France.
In July 2023, for precise filter integrity testing as per the latest GAMP recommendations, an integrity tester named “Dolintestor I Integrity Tester” was launched by Feature-Tec.
In May 2024, for the testing of the automated bubble point, a Filter Integrity Tester (FIT) was launched by LabLogic.

Filter Integrity Test Market Key Players

Beijing Neuronbc Laboratories Co., Ltd.
Thermo Fisher Scientific, Inc.
Meissner Filtration Products, Inc.
Surway Filter
Air Techniques International (ATI)
3M
Donaldson Company, Inc.
Parker Hannifin Corp
Pentair Ltd.
Merck KGaA
PALL Corporation
Sartorius AG

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The global bilirubin blood test market was valued at USD 1.29 billion in 2024, grew to USD 1.38 billion in 2025, and is anticipated to reach USD 2.46 billion by 2034, progressing at a CAGR of 6.67% throughout the forecast period.

Segments Covered in The Report

By Type

Liquid Filter Integrity Test
Air Filter Integrity Test

By Mode

Automated
Manual

By Test Method

Forward Flow (Diffusion) Test
Bubble Point Test
Pressure Hold Test
Water Intrusion Test
Others

By End-use

Biopharmaceutical & Pharmaceutical Industry
Food & Beverage Industry
Others

By Region

North America

U.S.
Canada

Asia Pacific

China
Japan
India
South Korea
Thailand

Europe

Germany
UK
France
Italy
Spain
Sweden
Denmark
Norway

Latin America

Brazil Mexico
Argentina

Middle East and Africa (MEA)

South Africa
UAE
Saudi Arabia
Kuwait

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About Us

Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.

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