Filter Integrity Test Market Size, Share & Trend Analysis Report By Test Method (Bubble Point), By Mode (Automated), By Type (Air Filter), By End-use (Biopharmaceutical), And Segment Forecasts, 2019 - 2026

Report Overview

The global filter integrity test market size was valued at USD 58.79 million in 2018 and is expected to grow at a compound annual growth rate (CAGR) of 4.31% from 2019 to 2026. Continuous and controlled performance of the filter elements is one of the critical parameters for the process of bioproduction. Sterilizing grade filter integrity test is usually carried out after the process of filtration however few users run the test before the filter sterilization and before the filtration process as well. Introduction of several regulatory guidelines for the recommended use of the integrity tests pre/post sterilization and filtration are expected to drive the growth to a considerable extent.

The presence of the stringent and well-defined regulatory guidelines for validation of the filtration process in the quality control and quality assurance departments of the and filter assembly products has augmented the use of these testing techniques. In January 2017, the European regulatory authorities have included the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) as a requirement in Annex 1 that covers guidelines on the manufacturing of sterile medicinal products for assurance to filter’s quality.

Furthermore, the gradual shift of the pharmaceutical industry towards biopharmaceutical manufacturing due to rapid advancements in bioprocess engineering has also driven the filter integrity test market. These advancements in biopharmaceutical manufacturing that have positively impacted this market include the advent of single-use technology, growth of contract service providers, and the emergence of nano-biocatalysts that tends to improve the bioproduction.

Biopharmaceutical & pharmaceutical firms are increasingly focusing on the integrity testing of sterilized-grade filters to prevent financial damages and delays in the market launch of biotherapeutics. The documented results of the tests play an essential role in the manufacturing audit trail for the release of biopharmaceuticals in the market.

Moreover, key suppliers are undertaking continuous efforts to raise awareness about sterile filtration in biomanufacturing practices, thereby increasing the adoption rate of filter integrity test products. For instance, in June 2019, Parker Hannifin hosted a free webinar that focused on optimizing filtration processes in biomanufacturing and examining the advantages of sterile filtration, along with guidance on filter integrity testing.

Test Method Insights

Bubble point test serves as a simple, cost-effective, and non-destructive method, which can be applied to any filter at any time without the risk of contamination. These factors have resulted in its extensive application in the pharmaceutical and medical device manufacturing workflows, thereby accounting for the maximum revenue share in 2018.

However, the bubble point test is based on a visual assessment of the bubbling rate, which can be affected by the diffusive gas flows. To combat this, the pressure hold test is recommended as an alternative to the bubble point test that has attributed to its projected growth rate for the forecast period. Therefore, this method is highly applicable to filter integrity testing in radiopharmaceuticals manufacturing.

Mode Insights

Automated systems captured the largest revenue share in 2018 because automated testing is not affected by downstream interventions, manages the track record, eliminates the operator errors, and allows multiple validations. The automated system also facilitates the post-sterilization integrity tests without causing downstream contamination.

The availability of a substantial number of automated filter integrity tests in the market and constant improvements in the design of these systems have boosted the segment revenue. Furthermore, the high usage of automated instruments in industrial settings for the measurement of flow rate on the upstream side of the filter has also benefitted the segment in the past years.

On the other hand, manual testing systems accounted for the low penetration with respect to revenue share, yet it is expected to grow at a considerable pace throughout the forecast period. The small and mid-sized end-users usually adopt manual testing systems. Factors attributive for the adoption of these systems include simple designing and direct measurement or observation of gas flow.

Type Insights

Liquid filter integrity tests have accounted for the largest revenue share in 2018 owing to the high usage of hydrophilic filters, particularly for aqueous solutions. High penetration of forward flow (diffusion) test and bubble point test has resulted in the dominance of this segment. Furthermore, a liquid filtration system offers numerous advantages such as reduce process downtime, reduce waste disposal costs, and minimize maintenance time along with the expense. Thus, high usage of liquid filtration test has positively impacted its adoption.

Air filter integrity test is expected to witness the fastest growth rate during the forecast period due to an increase in the adoption rate of hydrophobic membrane filters for gas filtration. Moreover, high usage of automated test instruments, such as Integritest Exacta and Sartocheck 3, which incorporate several options for water-based testing of hydrophobic filters, result in rise in revenue generation from this segment.  

End-use Insights

Driven by the high demand for biopharmaceuticals, usage of filter integrity testing is maximum in biopharmaceutical & pharmaceutical industries. Biopharma manufacturers are engaged in boosting their organic revenue through the establishment of new facilities or capacity expansion projects, both resulting in an increase in the use of single-use filtration technologies.

Moreover, currently, a substantial number of conventional pharmaceutical firms have shifted towards developing biologics and biosimilars due to technological advances in bioprocessing technology. These factors have resulted in the higher penetration of filter integrity tests in this end-use segment.

With government regulations becoming more stringent towards the standardization of food products, the food & beverage industry is anticipated to emerge as the lucrative source of revenue. Implementation of advanced microfiltration technology ensures aseptic production and packaging of perishable food products. Thus, with the expanding use of filtration systems in this segment, the implementation of filter integrity tests is anticipated to expand.

Regional Insights

North America held the largest revenue share in 2018. A substantial number of biopharmaceutical manufacturers in the U.S. have attributed to the estimated share of North America. Furthermore, key OEMs are engaged in partnerships with biopharmaceutical manufacturers to accelerate the industrialization of their disposable filtration businesses.

The presence of global suppliers that provide services in the U.S. has boosted revenue growth. For example, Provantage Validation Specialists, is a service provided by Europe-based company EMD Millipore for product and water integrity testing of filters. Validation and testing services are provided by the company in the U.S.

On the other hand, global companies are undertaking strategies to grow awareness pertaining to integrity testing in Asian countries. For example, in May 2017, the Singapore division of Merck KGaA released an article titled ‘Introduction to Integrity Testing Theory’ which elaborated various aspects of integrity tests. Such initiatives are anticipated to result in the surging growth of Asia Pacific market.

Key Companies & Market Share Insights

The market players are undertaking several strategic growth initiatives to strengthen their filter integrity test portfolio and increase their business footprint in the marketplace. Constant innovations and improvements in filtration products have prompted the key suppliers to introduce advancements in their test portfolio.

For example, in April 2018, Merck introduced Millipak Final Fill Filter with an aseptic single multi-purpose port for sampling, venting and integrity testing. Such improvements in filtration designing are anticipated to accelerate the product launch by key suppliers in this market. Some of the prominent players in the filter integrity test market include:

• Merck KGaA

• Sartorius AG

• Parker Hannifin Corp

• PALL Corporation

• Donaldson Company, Inc.

• Pentair Ltd.

• 3M

• MEISSNER FILTRATION PRODUCTS, INC.

• Beijing Neuronbc Laboratories Co., Ltd.

• Surway Filter

• Analytical Technologies Limited

• Thermo Fisher Scientific, Inc.

Filter Integrity Test Market Report Scope

Segments covered in the report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis of the industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global filter integrity test market report on the basis of the test method, mode, type, end-use, and region:

• Test Method Outlook (Revenue, USD Million; 2015 - 2026)

  • Forward Flow (Diffusion) Test

  • Bubble Point Test

  • Pressure Hold Test

  • Water Intrusion Test

  • Others

• Mode Outlook (Revenue, USD Million; 2015 - 2026)

  • Automated

  • Manual

• Type Outlook (Revenue, USD Million; 2015 - 2026)

  • Liquid Filter Integrity Test 

  • Air Filter Integrity Test 

• End-use Outlook (Revenue, USD Million; 2015 - 2026)

  • Biopharmaceutical & Pharmaceutical Industry

  • Food & Beverage Industry

  • Others

• Regional Outlook (Revenue, USD Million; 2015 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • France

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

  • Latin America

    • Brazil

  • Middle East and Africa (MEA)

    • South Africa