The global sterile filtration market is projected to grow from USD 4.7 billion in 2019 to USD 7.4 billion by 2025, at a CAGR of 8.0% from 2019 to 2025. The major factors driving the growth of this market are the advantages of sterile filters over non-sterile filters, the growing demand for pure water in end-use industries, increasing adoption of single-use devices & disposables, and the rising focus on the development of large-molecule biopharmaceutical drugs. However, the high price sensitivity among end users is a major challenge for the growth of this market.
By product, the cartridge filters segment is segment is expected to account for the largest share of the sterile filtration market.
On the basis of product, the market is segmented into cartridge filters, capsule filters, membranes, syringe filters, bottle-top & table-top filtration systems, and accessories. The cartridge filters segment accounted for the largest market share. This can primarily be attributed to the increasing use of different types of cartridges filters for larger processes requiring more filtration area and/or lower unit operating cost and high flow rates & high throughput.
By end user, the biopharmaceutical company segment is expected to witness the highest growth in the sterile filtration market during the forecast period.
The biopharmaceutical company segment is expected to show the highest growth in the forecast period due to its increasing demand in cell separation. In biopharmaceutical manufacturing, the volume of feed is relatively low, but the degree of difficulty with filter plugging is considerably high, and sterile filters are used throughout the process. Sterile filters find extensive applications in the biopharmaceutical industry as biopharmaceutical products and their intermediates are susceptible to degradation due to heat and chemical treatment and are difficult to separate using other techniques.
By application, the fill-finish processes segment is expected to witness the highest growth in the sterile filtration market during the forecast period.
The fill-finish processes segment is expected to show the highest growth in the forecast period owing to use of sterile filters in the fill-finish process of manufacturing of sterile products and demands the highest level of quality and reliability. The aseptic filling of sterile drugs, also known as sterile filling/finish, remains one of the most critical processes in biopharmaceutical manufacturing. This will drive the demand for sterile filters for fill-finish process during the forecast period.
By membrane type, the PES segment is expected to grow at the highest CAGR during the forecast period.
The PES segment is projected to register the highest growth during the forecast period due to the hydrophilic nature of PES, its low protein-binding properties, and a wide range of applications.
By membrane pore size, the 0.2–0.22 μm segment is expected to grow at the highest CAGR during the forecast period.
The 0.2–0.22 μm segment is projected to register the highest growth during the forecast period due to its use in wide range of pharmaceutical and biological liquid applications, including the filtration of therapeutics, vaccines, antibiotics, blood fractionations, bulk pharmaceuticals, and other downstream biotechnology processing solutions, where protein binding must be minimized.
The sterile filtration market is divided into five major regions—Europe, North America, Asia Pacific, LATAM, and the MEA. North America accounted for the largest share of the global market, closely followed by Europe. Factors such as the strong presence of sterile product manufacturers in the region, well-established biopharmaceutical industry, significant R&D spending by pharmaceutical and biotechnology companies, and the presence of a well-established intellectual property system for innovative biologics production are driving the growth of the market in North America.
The Asia Pacific region is estimated to grow at the highest CAGR during the forecast period, mainly due to the growing contract-manufacturing base in this region. Several small and medium-scale CMOs set up in the APAC have obtained US FDA approval for their operations and completed GMP certification, which shall most likely drive the demand for sterile filters.
Key Market Players
The major companies in the tangential flow filtration market include Merck KGaA (Germany), Danaher Corporation (US), Sartorius AG (Germany), 3M (US), and Parker Hannifin Corporation (US).