Sterile Filtration Market Overview
The Sterile Filtration Market size is estimated to reach $8.8 billion by 2027, growing at a CAGR of 7.3% during the forecast period 2022-2027. Sterile filtration is the technique of eliminating microorganisms from a fluid stream without unfavorably influencing the product. Bioburden testing is carried out on numerous pharmaceutical and medical products for quality control. If a sterile filtered bulk solution is not suffused into the concluding product containers within 24 hours, the sterile filtration should, unless justified, be repeated immediately prior to suffusing. An added bioburden testing needs to be carried out prior to any further bioburden minimization step subsequent to the holding time. The holding time needs to be sufficiently substantiated. Sterile syringe filters are utilized to sterilize solutions or clarify sterile solutions. Syringe filters are classified by two important typical features membrane and filter housing. Millipore Filters Sterile filtration tools are utilized to filter-sterilize aqueous solutions and make ready culture media.
The increasing predominance of incessant ailments is set to drive the Sterile Filtration Market. The benefits of sterile filters like syringe filters over non-sterile filters, boost in acceptance of single-use devices & disposables, and the increasing focus on the advancement of large-molecule biopharmaceutical medications are set to propel the growth of the Sterile Filtration Market during the forecast period 2022-2027. This represents the Sterile Filtration Industry Outlook.
Sterile Filtration Market Segment Analysis – By Product
The Sterile Filtration Market based on the product can be further segmented into Membrane Filters, Cartridges & Capsules, Syringe Filters, Filtration Accessories, and Others. The Membrane Filters Segment held the largest market share in 2021. This growth is owing to the increasing acceptance of biologics and cell-culture-based vaccines resulting in soaring demand for filtration which is driving the growth of the membrane filters segment. Syringe filter membranes like 0.45um Millex HV syringe filters (Cat. SLHV033RS) can be utilized to clarify lentivirus and 0.2um Millex GV syringe filters (Cat. SLGV033RS) for sterilizing. The increasing utilization of membranes for cell separation and elimination of cell debris in clarification techniques including centrifugation, microfiltration, and harvesting of the culture are further propelling the growth of this segment.
Furthermore, the Syringe Filters segment is estimated to grow with the fastest CAGR of 7.9% during the forecast period 2022-2027 owing to the increased application of syringe filter with benefits like filtration of tiny samples of 1ml or less.
Sterile Filtration Market Segment Analysis – By End User:
The Sterile Filtration Market based on end-user can be further segmented into Pharmaceutical And Biotechnological Companies, Food And Beverage Companies, Academic Institutes And Research Laboratories and Others. The Pharmaceutical And Biotechnological Companies Segment held the largest market share in 2021. This growth is owing to the proliferating application of sterile filtration methods ranging from filtration and segregation needs pertaining to R&D activities to early-stage product development to full-scale production in the pharmaceutical & biotechnology firms. The increased application of sterile filtration products like syringe filters in the pharmaceutical and biotechnological sector is further propelling the growth of this segment.
Furthermore, the Food And Beverage Companies segment is estimated to grow with the fastest CAGR of 8.2% during the forecast period 2022-2027 owing to the increasing count of innovative product launches by key players involving sterile filtration and syringe filter pertaining to the food and beverage sector.
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Sterile Filtration Market Segment Analysis – By Geography:
The Sterile Filtration Market based on geography can be further segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World. North America (Sterile Filtration Market) held the largest share with 34% of the overall market in 2021. The growth of this region is owing to the soaring count of Active Pharmaceutical Ingredients (API) production facilities employing syringe filters and boost in investment by firms into R&D activities in the North American region. The expanded concentration of key players like Thermo Fisher Scientific Inc and the well-entrenched biopharmaceutical industry is further propelling the growth of the Sterile Filtration Market in the North American region.
Furthermore, the Asia-Pacific region is estimated to be the region with the fastest CAGR rate over the forecast period 2022-2027. This growth is owing to factors like heightening demand for generic drugs and biosimilars and considerable investments by biopharmaceutical firms. The burgeoning attention on healthcare modernization with sterile filtration products like syringe filters and demand for affordable medications is fuelling the progress of the Sterile Filtration Market in the Asia-Pacific region.
Sterile Filtration Market Drivers
Outstanding Practices Of Sterile Filtration For Food, Beverage And Pharma Are Projected To Drive The Growth Of Sterile Filtration Market:
Most manufacturing facilities that utilize compressed air in an assortment of techniques like direct injection or blanket/purge tanks have the compressed air make direct contact with the product. Though most of these applications need the air to conform to the ISO 8573.1 quality standard, the elimination of bacteria is frequently neglected, regardless of the fact that this added degree of filtration is accessible and effortless to acquire, set up and accomplish. Sterilized compressed air may boost shelf life, minimize product spoilage, raise the quality and integrity of the end product, and considerably minimize the hazard of recalls. A syringe filter is one class of sterile filtration products. An ultrafilter is one of the most ingenious producers of high-performance filters and treatment components for compressed air, technical gases, and liquids. In nearly all manufacturing facilities, a standard two-stage compressed air filter system (with a pre and after filter installed on either side of an air dryer) is utilized to generate minimal particulate retention of 0.1 microns and oil carryover of 0.01 ppm. But point-of-use applications are best safeguarded when the sterile filter assembly is established as near as feasible to where the direct compressed air connects with the product or packaging. The inclusion of Ultrafilter sterile filtration increases the compressed air quality to an absolute retention rate of 99.9% related to 0.2 microns. This destroys bacteria and microorganism infection from the downstream compressed airflow. Nearly all factories need the set-up of a single high-quality sterile filter assembly. Expanded product shelf life and the peace of mind that Ultrafilter sterile filtration offers to an end user are further improved by the fact that all Ultrafilter sterile filter elements may be recreated between 100 and 200 times, relying on the kind of element bought. These finest practices of sterile filtration for food, beverage, and pharma are propelling the growth of the Sterile Filtration Market during the forecast period 2022-2027.
Technological Innovations Are Expected To Boost The Demand Of Sterile Filtration:
Apart from the increased application of syringe filters, technological innovations are driving the growth of the Sterile Filtration market. Sartorius offers the most progressive sterile filters. Sartopore® Platinum is the high-performance polyethersulfone (PES) filter platform developed by Sartorius Stedim Biotech. The ingenious surface alteration of the membrane results in superior wettability. This filter family is thus superbly suited for contemporary single-use applications, making techniques greatly affordable, user-friendly, and secure. The utilization of Sartopore® Platinum brings the advantages of this leading-edge membrane technology to the user. For demanding techniques like fill & finish, a special filter type with an elevated Bubble Point: Sartopore® Platinum HB has been developed. These kinds of technological innovations are driving the growth of the Sterile Filtration Market during the forecast period 2022-2027.
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Sterile Filtration Market Challenges
Sterile Filtration Of Complex Fluids Like Liposomes Is Challenging:
Complex fluids like liposomes are being utilized more and more as a vehicle for drug delivery, but owing to their quality, effective and large-scale production can be demanding. One challenge is sterile filtration, both from the point of view of throughput and bacterial retention. Generating liposomes with accurately regulated particle size and delivery guarantees an effective downstream sterile filtration technique. To beat sterile filtration issues, suitable decisions must be made at the time of the selection, assessment, and validation of filters planned for the sterilization of liposome-based drugs. Sterilization of liposomal preparations is a challenge, with every technique displaying its own drawbacks. As per U.S. Food And Drug Administration (FDA), “the physical and chemical complexity of liposome drug products present unique challenges to the sterilizing filtration process”. For example, constituents of liposomes could communicate with the filter matrix and congest it. Hence, approved product-particular purification and sterilization techniques need to display the capability of the microbial sterilizing filters to operate correctly, without jeopardizing the integrity and design of liposomes. These issues are hampering the growth of the Sterile Filtration Market.
Sterile Filtration Market Landscape:
Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the Sterile Filtration Market. Key companies of this market include:
Merck KGaA
Danaher
Thermo Fisher Scientific Inc.
Sartorius
GE Healthcare
Antylia Scientific
3M
Sterlitech Corporation
Porvair Filtration Group
Parker Hannifin Corporation
Acquisitions/Product Launches:
In May 2021, the Industrial Gas Filtration and Generation Division of Parker Hannifin Corporation declared the introduction of its novel Parker PoleStar Smart-E (PSE) Series cycling refrigerated compressed air dryer with lesser global warming potential (GWP) refrigerant, R513A.
In February 2021, Porvair introduced its 2021 Filtration Catalogue, highlighting a wide series of products. The catalog highlights numerous novel products, inclusive of 14 high-purity chemical filters, GIANT bag housing, and complimentary housings.
Key Takeaways
Geographically, North America Sterile Filtration Market accounted for the highest revenue share in 2021 and it is poised to dominate the market over the period 2022-2027 owing to the massive count of pharmaceutical and biotechnology, and food and beverages firms which may utilize sterile filtration products like syringe filter in the North American region.
Sterile Filtration Market growth is being driven by the heightening investments in research and development activities and increased utilization of sterile filtration products like syringe filters. However, the rigorous rules and regulations and the great capital funding are the major factors hampering the growth of the Sterile Filtration Market.
Sterile Filtration Market Detailed Analysis on the Strength, Weakness, and Opportunities of the prominent players operating in the market will be provided in the Sterile Filtration Market report.
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