Towards Healthcare
Filter Integrity Test Market Size | Shares Report

Filter Integrity Test Market Size (USD 149.26 Mn by 2033) - 5.17% CAGR Growth

The report covers Filter Integrity Test Market Segment Analysis including Liquid Filter Integrity Tests and Air Filter Integrity Tests, differentiated by Automated and Manual modes of testing. Test methods encompass Forward Flow (Diffusion) Test, Bubble Point Test, Pressure Hold Test, Water Intrusion Test and other methods. The report focuses on key end-use sectors such as the Biopharmaceutical & Pharmaceutical Industry, Food & Beverage Industry and other industrial applications. The report offers the value (in USD Million) for the above segments.

Filter Integrity Test Market Size, Manufacturers and Segments Outlook Report

The filter integrity test market size was valued at US$ 90.16 million in 2023 and is projected to reach US$ 149.26 million by 2033, registering a CAGR of 5.17% from 2024 to 2033. The growing healthcare, pharmaceutical, and biotechnology industries are increasing the use of filters that promote the growth of the market.

Filter Integrity Test Market Revenue 2023 - 2033

Unlock Infinite Advantages: Subscribe to Annual Membership

Key Takeaways

  • North America has contributed more than 39% of revenue share in 2023.
  • By type, the liquid filter integrity test segment dominated the market in 2023.
  • By mode insights, the automated segment dominated the filter integrity market in 2023.
  • By test method, the bubble point test segment has held a major revenue share of 33% in 2023.
  • By end-use, the biopharmaceutical & pharmaceutical industry segment has held the largest revenue share of 62% in 2023.

Industry at a Glance

The filter integrity test market encompasses tests done to guarantee a filter is free of contamination. This involves checking the integrity of the cartridges/capsules, disk filters, and filter membranes. A filter integrity machine is the name of the device that carries out this function. Specifically, this test equipment can generate reports and handle data thanks to an integrated data description management unit.

A process's use of a filter may result in a number of damaging phenomena. The filter integrity test is a technique for monitoring these filter element attributes as the process progresses. Suppliers offering absolute-rated membrane cartridge filters for the microbiological reduction or elimination of yeast and mold are required to conduct integrity testing.

A certificate attesting to the filter's quality is supplied with every product, and test results are verified for the removal of certain species. For crucial process filtering applications in the pharmaceutical sector, integrity testing sterilizing filters is a basic necessity. Industry rules in the bioprocessing and pharmaceutical industries require Integrity Testing at certain stages of a process. The food and beverage sector is becoming more involved with the filter integrity test market as a result of the strategic decision to use integrity testing, even when it is not required, to guarantee product safety and quality.

Top Companies in the Filter Integrity Test Market

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

Recent Innovation by ATI in the Filter Integrity Test Market

Company Name ATI
Headquarters Maryland, U.S.
Recent Development In March 2024, the new photometer product from Air Techniques International (ATI), a leading global authority in the development and production of specialist testing apparatus for HEPA filters and protective masks, became available. The new device's name is the iProbe Plus scanning probe. The most sophisticated filter scanning probe on the market, the iProbe Plus is "plug and play" compatible with both new and old model 2i Aerosol Photometers and comes with a number of additional capabilities and advantages over the original iProbe.

Recent Innovation by Donaldson Company Inc. in the Filter Integrity Test Market

Company Name Donaldson Company Inc.
Headquarters Minneapolis, U.S.
Recent Development In March 2023, the Alpha-Web® filtering medium was released by Donaldson Company, Inc., a prominent global provider of cutting-edge filtration technologies. With the use of this revolutionary hydraulic filtering technology, hydraulic fluid purity may be greatly increased, resulting in longer-lasting hydraulic components, less downtime, and cheaper equipment ownership.

Demand for Filters from Various Industries Drives the Filter Integrity Test Market

In industrial and clinical settings, HEPA filtration devices are commonly utilized. HEPA systems are used in clinics, medical institutions, veterinary hospitals, nursing homes, and pharmaceutical production plants. There are many different types of industrial workplace settings where HEPA filtration is utilized. The other is precision optics for the military and commercial markets. Particles of tiny dust produced during the manufacture of precision components are reduced and eliminated using HEPA systems. To guarantee quality and safety while packing and processing food-grade items, HEPA systems are employed to maintain a clean room environment. For both alcoholic and non-alcoholic beverage bottling, these systems are very crucial. Last but not least, automakers use HEPA filtering systems in their paint and coatings R&D centers.

For instance,

  • In November 2023, Tesla is proposing a HEPA filter retrofit for Model Y EVs manufactured in 2020–2021 in North America. 99.97% of particles with a diameter of less than 0.3 micrometers may be captured by the High-Efficiency Particulate Air (HEPA) filter, which is part of the HEPA filter. To eliminate smells, gasses, germs, viruses, pollen, and mold spores, a secondary filtering system equipped with activated carbon filters is utilized.

High Operational Costs Can Restraint the Growth of the Market

The filter integrity test market faces challenges due to the high costs of tests. Preciseness and rigorous adherence to standards necessitate a substantial financial commitment. The cost components mostly include purchasing and maintaining specialist testing apparatus, such as diffusive flow, bubble point, and water intrusion testers. The intricate nature of these instruments needs regular calibration and maintenance to provide accurate outcomes, hence augmenting operational expenses. Consumables like integrity test filters and sterilized solutions that are used during the testing procedure also have an impact on continuous costs. The cost of labor is further increased by the highly skilled individuals who perform these exams. The technicians must train in the special filter integrity testing techniques, which calls for ongoing education and certification. Consequently, high operating costs hinder the filter integrity test market expansion.

Technological Advancements Create Opportunity for Market’s Growth

The accuracy and dependability of these evaluations are consistently improved by technological and methodological advancements, which propels market expansion. The filter integrity test market is growing as a result of advances in membrane integrity testing methodologies, such as quicker and more accurate procedures. These developments enable producers to maintain strict quality control guidelines, guaranteeing the efficacy and safety of their goods. Technological developments in integrity test equipment are enhancing industries' capacity to carry out accurate and effective testing, guaranteeing the integrity of their filtering systems. The need for advanced filter integrity testing is anticipated to increase as long as companies maintain their emphasis on quality and safety. Businesses in this industry are spending money on R&D to improve and reinvent their product offerings and make sure they satisfy the changing demands of their clientele.

Report Highlights

Type Insights

By type, the liquid filter integrity test segment dominated the filter integrity test market in 2023. The rise in this segment is due to the use of filters designed for liquid sterilization in different industries. The filters designed for liquid materials are highly essential due to their demand in pharmaceuticals, healthcare, and food and beverages. The filters are essential for liquids that are sensitive to heat, such as serums, antibodies, and active ingredients in medicines. With time, the use of filters has increased due to quality improvement, continuous demand from the pharma and healthcare industry, and utilization of filters for liquid filtration. Two of the very common methods used for liquid filter integrity tests are the forward flow (Diffusion) test and the bubble hold test.

Mode Insights

By mode insights, the automated segment dominated the filter integrity market in 2023. A further advancement is the automation of integrity testing. Although the bulk of laboratory filtration products are still validated using the manual bubble-point method, there is a trend toward speedier, more automated techniques that reduce human error and boost productivity. Thanks to automated technology, filter integrity testing may now be done quickly, precisely, repeatedly, traceably and auditably. It is one of the most important tools for producing biopharmaceutical components for medications efficiently.

Test Method Insights

By test method, the bubble point test segment dominated the filter integrity test market in 2023. The test is the most widely used for integrating filters. Hydrophobic filters, which are frequently used in pharmaceutical applications, provide several benefits for evaluating the integrity and performance of filters when using the bubble point test. Finding the biggest holes in the filter matrix with accuracy is one of its main advantages. The test displays the pore size distribution of the filter and its capacity to hold particles of certain sizes by watching the development of a continuous stream of bubbles at the bubble point pressure. The bubble point test method is also a helpful way for regular quality control evaluations since it is extremely simple to do and can be completed quickly. It also provides a non-destructive method of assessing filter performance, enabling tests on filters without sacrificing their structural integrity.

End-use Insights

By end-use, the biopharmaceutical & pharmaceutical industry segment dominated the filter integrity test market in 2023. The biopharmaceutical & pharmaceutical industry needs filter integration the most due to the continuous use of filters for sterilizing medicines and air in laboratories. Apart from this, filters are used in various steps during the upstream and downstream processes. The medicines go through strict regulatory standards as they should be safe for medical use. Therefore, continuous integrity tests are done in the pharma industries, which promotes the growth of the filter integrity test market.

Regional Insights

By region, North America dominated the filter integrity test market in 2023. Robust filter integrity testing processes are necessary due to several factors, including the pharmaceutical, biotechnology, and food and beverage sectors, which have strict regulatory requirements and quality standards. In order to guarantee product safety and efficacy, the region's sophisticated pharmaceutical production skills and healthcare infrastructure fuel the need for high-quality filter integrity testing. Furthermore, filtration technology advances and technical advancements drive market expansion in North America. During the projected time frame, increased demand for the market is anticipated due to the expanding need for high-purity, high-quality goods from the biotechnology and pharmaceutical sectors, as well as rising production volumes. In particular, the rising demand for various pharmaceuticals, medications, and other food and beverage goods, together with the growing number of ailments and growing concern for purity, have driven the market's burgeoning expansion in North America.

Recent Developments

  • In July 2023, a new integrity tester called “Dolintestor I Integrity Tester” was launched. The high-quality Dolintestor TM Integrity tester was created by Feature-Tec to carry out precise filter integrity testing in compliance with the most recent GAMP recommendations. It contains features for electronic records and signatures and can save testing time. Both online and offline filter tests may be conducted using the Dolintestor TM in a dust-free area to test hydrophobic or hydrophilic membrane filters.
  • In May 2024, LabLogic introduced a Filter Integrity Tester (FIT) for automated bubble point testing. Filters up to 42 mm in diameter, both vented and non-vented, can be tested with the FIT. Gas pressure is measured by the unit's calibrated pressure sensors to provide precise bubble point testing. Test results are shown on the integrated touchscreen with a clear pass/fail indicator. All of the tests are kept on the FIT, but they may also be transferred by USB as a PDF or CSV file to another device.

Segments Covered in Filter Integrity Test Market Report

Type

  • Liquid Filter Integrity Test
  • Air Filter Integrity Test

Mode

  • Automated
  • Manual

Test Method

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

End-use

  • Biopharmaceutical & Pharmaceutical Industry
  • Food & Beverage Industry
  • Others

Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Denmark
    • Sweden
    • Norway
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Thailand
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • Saudi Arabia
    • Kuwait
    • UAE

Proceed To Buy

USD 5400
USD 3800
USD 2100
USD 2100
USD 7500

About The Author

Deepa has certified the degree of Master’s in Pharmacy in the Pharmaceutical Quality Assurance department from Dr D.Y. Patil College of Pharmacy. Her research is focused on the healthcare industry. She is the author or co-author of four Review Articles, which include Solid dispersion a strategic method for poorly soluble drugs and solubility improvement techniques for poorly soluble drugs, Herbal Drugs Used In Treatment Of Cataracts, Nano sponges And Their Application in Cancer Prevention and Ayurvedic Remedies of Peptic ulcer. She has also published a Research Article on the Formulation and Evaluation of Mucoadhesive Tablets of Miconazole cocrystal which was published in GIS Science Journal Volume 9 Issue 8. Her passion for secondary research and desire to take on the challenge of solving unresolved issues is making her flourish is the in the research sector.

FAQ's

Bubble point test, diffusion test, pressure hold test, diffusive flow test and pressure decay test.

The permissible limit for leaks is set at 0.01%.

The filter integration test ensures that the filters are working properly and that safety standards are maintained, which may otherwise lead to contamination and become a health hazard.

U.S. Environmental Protection Agency, National Institute of Health, Parental Drug Association, FDA.