The sterile filtration market is projected to grow at a rate of 7.7% in terms of value, from USD 4,670.1 Million in 2021 to reach USD 8,488.1 Million by 2030. Sterile filtration finds usage in the removal of contaminants and particulates from fluids comprising media with or without buffers, serum, reagents, biologic or proteinaceous samples, or other types of fluids. Filtration through a pore size of 0.2 µm is essential to get a sterile filtrate by filtering particles and germs from fluids (liquids and gases) to prevent them from contaminating the end-products. As per the GMP guidelines and the guidelines by the (FDA), producers are required to perform a filter integrity test at the pre and post-production cycle. The test confirms that the filter is completely functional and that no undesirable components got through it.
The sterile filtration is witnessing an increasing demand, attributed to the growth of the biopharmaceutical industry. The worldwide pharmaceutical market is estimated to surpass USD 1.50 trillion by the year 2023, increasing from USD 1.20 trillion in the years 2018, at an AGR of about 3.0%-6.0%. This increase is likely to be in parallel with the increase in the number of launched products that are estimated to be 54 in the year 2023.
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Growing innovations in the production of biopharmaceuticals, including the launch of nano-biocatalysts and growth in contract service providers, are causative of the growth of the market. The companies in the pharmaceutical and biopharmaceutical industry have been focusing on the sterile filtration to prevent delays and damages in the market introduction of bio-therapeutics and unveiling of bio-pharma products.
However, the cost-prohibitive sterile filtration process may create hindrances in the growth of the market in the upcoming years.
Membrane Type Outlook:
Polyethersulfone (PES) membranes held the largest market size in 2019. PES membranes are considered appropriate for cell culture media filtration. It possesses both very low protein binding and extractables, as well as provides faster flow rates as compared to nylon or cellulosic membranes.
Nylon membranes possess the hydrophilic property and are considered for applications demanding very low extractable as these membranes do not possess any wetting agents, surfactants, or detergents. The superior chemical resistance of nylon membranes makes them a better option for the filtration of aggressive solutions, like alcohol.
Biopharmaceuticals products normally cannot be terminally sterilized, and thus it is crucial to use sterile grade filters in aseptic processing. Application of heat sterilization or any other process in biopharmaceutical drug products results in unwanted degradation of the product. Sterilizing membrane filtration frequently necessitated reducing the levels of bioburden within process streams to prevent the potential formation of biofilm.
The biopharmaceutical industry is witnessing considerable growth in the past couple of years. The overall yearly revenue generation has risen from approximately USD 4.40 billion in the year 1990 to around USD 275.00 billion in the year 2018, experiencing growth of 6,250.0%, with industry contributing to more than 25.0% of the overall pharmaceutical market.
In the food & beverage, brewing, and dairy industries, effective sterile filtration is an eminent part of the production process to avert contamination, damage, and product loss. Sterile filtration systems offer 100.0% contamination-free filtration of air, CO2, compressed air, and other gases. Recent researches uphold the use of sterile filtration as the most appropriate method for brewers for controlling microbial hazards. Even though beer is alcoholic, acidic, anaerobic, and comprises hop compounds that ply the role of preservatives, certain microorganisms can survive in the chemical environment and thrive on rich nutrients present in beer. These kinds of microorganisms may result in beer spoilage forming a haze or sedimentation, a rancid/sour flavor, and over-carbonation, thus requiring the need for sterile filtration.
The market in North America dominated the market in 2019 and is expected to grow at a rate of 7.3% in the forecast period. The market dominance of the region is attributed to the growing investments in the R&D activities in the pharmaceuticals and biopharmaceuticals sector. As per the European Federation of Pharmaceutical Industries and Associations, the R&D spending was about USD 52,418 million in the US in 2016.
The market in the European region is likely to grow at a rate of 7.6% in the forecast period.
- By type, cartridge filters held a substantial sterile filtration market share in 2019 and are projected it witness the fastest growth rate of 7.6% in the forecast period.
- By membrane type, polyvinylidene difluoride (PVDF) is likely to grow at a rate of 7.9% in the forecast period.
- By end-user, pharmaceutical & biopharmaceutical firms held the largest sterile filtration market share in 2019.
- The market in the Asia Pacific region is projected to grow at the fastest rate of 8.7% in the forecast period.
Key participants include Thermo Fisher Scientific, Parker Hannifin Corporation, GE Healthcare, Steriletech Corporation, 3M, Corning Incorporated, Danaher Corporation, Eaton Corporation, Alfa Laval Corporate AB, and Merck KGaA, among others.
The players operating in the sterile filtration market have undertaken a number of strategies related to the market in the period 2022-2020. Some of the key highlights are:
- In November 2018, Thermo Fisher Scientific, a leading market player, made an announcement about the commencement of its first Bioprocess Design Center in Shanghai, China. The bioprocess center is aimed at setting up a center of excellence to connect and work together with biologic developers for designing optimum bioprocessing solutions.
The industry offers numerous growth opportunities. Thus, a number of startups providing innovative products and technologies have been entering the market. The sterile filtration industry poses a significant amount of opportunities for small producers and startups to come up with cost-effective solutions. Many innovative startups are growing remarkably and have been profiled in the report with all their innovative techniques and developments. There is a continuous growth in demand from the end-users, which can encourage several startups to launch innovative products in this sterile filtration market.
Mergers and Acquisitions are an integral part of the sterile filtration industry. Along with the companies operating in the market, other key market players have also been entering the industry.
- In January 2018, American Air Filter Company, Inc., with its affiliate company AAF Lufttechnik GmbH made an announcement about the acquisition of RIS Facility Management GmbH. The acquisition is intended to expand the American Air Filter Company, Inc. operations, as well as their presence in various geographies.
Reports and Data forecasts promising developments for increased adoption of sterile filtration. According to industry experts, the use of the procedure in the cell culture media preparation and water purification is garnering significant traction in the market. New companies entering the industry would emphasize designing and developing innovative products, thereby catering to the increasing requirement of end-use industries.
Segments covered in the report:
This report forecasts revenue growth at a global, regional & country level, and provides an analysis of the industry trends in each of the sub-segments from 2022 to 2030. The scope of the report can be defined as:
For the purpose of this study, Reports and Data have segmented global sterile filtration market on the basis of type, membrane type, application, end-user, and region:
For the purpose of this study, have segmented global sterile filtration market on the basis of type, membrane type, application, end-user, and region:
Type Outlook (Revenue, USD Million; 2022-2030)
- Cartridge Filters
- Angioplasty Balloons
- Capsule Filters
- Syringe Filters
Membrane Type Outlook (Revenue, USD Million; 2022-2030)
- Polyvinylidene Difluoride (PVDF)
- Polyethersulfone (PES)
- Polytetrafluoroethylene (PTFE)
Application Outlook (Revenue, USD Million; 2022-2030)
- Fill-Finish Process
- Buffer Filtration & Cell Culture Media Preparation
- Bioburden Reduction
- Water Purification
- Air Filtration
End-User Outlook (Revenue, USD Million; 2022-2030)
- Pharmaceutical & Biopharmaceutical Firms
- Food & Beverage Firms
- Contract Research Organizations
- Academic Institutes & Research Laboratories
Regional Outlook (Revenue, USD Million; 2022-2030)
- North America
- Rest of Europe
- Asia Pacific
- South Korea
- Rest of Asia Pacific
- Latin America
- Rest of Latin America
- Saudi Arabia
- Rest of the Middle East and Africa
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