Sterile Filtration Market size is valued at $7.41Bn by 2019, and is anticipated to grow at a CAGR of 6.13% during the forecast period 2020-2025. The Sterile Filtration Market growth rate is attributed to the advantages of sterile filters over non-sterile filters, increasing adoption of single-use devices & disposables and the rising focus on the development of large-molecule biopharmaceutical drugs. Filtration is one of the major processes in several industries such as pharmaceutical, biotechnology, food & beverage, and research institutes. The filtration process ensures that the products are adequately purified and are fit for consumption. It prevents loss of valuable product. Sterile filtration can be carried out by microfiltration using membrane filtration for pharmaceutical and protein solutions in medical field. Objectives of sterile filtration are safety of patients or users; minimize risk for patients. Furthermore, sterile filters are used in drug development and other biological processes where contamination is highly lethal and has to be avoided. Sterile Filters are small pores sized to improve the filtration process, thereby making it essential biopharmaceutical applications. According to the U.S. Food and Drug Administration (FDA) and the U.S. Pharmacopoeia (USP), sterile filtration is defined as a nominal rating of 0.2 µm and 0.22 µm respectively to produce sterile effluent. From Product improvements such as reliable mechanical and thermal stability, doubling of throughput and flow rates leading to lower processing costs, faster processing times, and less down-time adopted by the market players is anticipated to propel the Sterile Filtration Market during the forecast period 2020-2025. For instance, in 2016, Sartorius Stedim Biotech (SSB), announced integration of polyethersulfone membrane (PESU) in two new, sterile Sartocon benchtop and production scale a filtration assembly, which provides rapid and safe ultrafiltration of biologics and vaccines.
- North America dominated the Sterile Filtration Market with a share of 39% in the year 2019.
- The factors such as growth in the biopharmaceutical industry, growing demand for biopharmaceutical molecules, rising incidence of diabetes & kidney failure, and increasing purity requirement in end-users are amongst the major factor projected to impel growth of Sterile Filtration Market.
- Growing number of research activities for the development of advanced fillers coupled with rising applications from emerging economies are the key factors owing to the growth in the segment during forecast period 2020-2025.
Product Type – Segment Analysis
Cartridges & Capsules segment held the largest share in the market over sterile filtration types owing 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. However, membrane filters type is anticipated to witness a market growth in the forecast period 2020-2025 as its increasing applications for sterile filtration in both pharmaceutical and biopharmaceutical laboratories is lavishing the market demands. Furthermore, there is a rise in the number of patients with kidney failure issues globally which is fueling the growth in the segmental market.
End Users- Segment Analysis
On the basis of End Users, pharmaceutical & biotechnological companies segment held the major share of the market in terms of revenue and is poised to grow with a CAGR of 4.1%. The reason is set to attribut to the utilization of sterile filtration techniques for meeting filtration and separation requirements from R&D activities to early-stage product development to full-scale manufacturing in the pharmaceutical & biotechnology companies. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), 2016, companies invested an estimated US$ 58.8 billion in research and development in 2015, which was the majority of all biopharmaceutical R&D spending in the U.S.
By Geography – Segment Analysis
North America dominated the Sterile Filtration Market with a share of 39% in 2019. The application of Sterile Filtration has grown rapidly over the last few years owing to 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 which continues to expand its market. However, Asia-Pacific is anticipated to be the fastest-growing segment during the forecast period 2020-2025. Factors such as the increasing demand for generic drugs and biosimilars, significant investments by biopharmaceutical companies and CMOs in emerging Asia Pacific countries, the increasing focus on healthcare modernization, and demand for low-cost medicines are supporting the growth of the Asia Pacific market.
Drivers – Sterile Filtration Market
- Growth of Pharmaceutical & biotechnology sectors in emerging economies and growing chronic diseases
With increasing investments in the pharmaceuticals sector and high incidence of chronic and acute diseases is set to boost growth of the global sterile filtration market. For instance, according to the Organization for Economic Co-operation and Development (OECD), investment in pharmaceuticals across OECD countries was around US$ 800 billion in 2013, which accounted for around 20% of total investment in healthcare. According to the Cancer Research U.K., around 55,122 new cases of breast cancer were registered in the U.K. in 2015. Moreover, increasing R&D of new drugs and high demand for potent medicines can be considered as a Sterile Filtration key driver of the market during the forecast period 2020-2025.
Challenges – Sterile Filtration Market
- High initial capital and maintenance cost
The major challenge for the market is the high initial capital investment required for new production plant, R&D cost and man power required add additional cost for production of pharmaceutical, biotechnological products and compliance of these Sterile Filtration products in a vast and heterogeneous market. The poor compliance with stringent government regulations to validate filtration process is set to hamper growth of the global sterile filtration market. Proper understanding and testing of the sterile filtration system according to international regulatory standards is important for both the validation and ongoing monitoring of the system prior to distribution and sales is the major problem for some of the regions in Asia-Pacific.
Sterile Filtration Industry Outlook
Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Sterile Filtration Market. In 2019, Sterile Filtration Market share is fragmented by the top ten players present in the market. Sterile Filtration Market top 10 companies are Pall Corporation, Parker Hannifin Corporation, 3M, Merck & Co., Inc., General Electric Company, Sartorius, Starlab Scientific Co., Ltd., Porvair Filtration Group, Sterlitech Corporation, Sigma Aldrich Corporation, Thermo Fisher Scientific and others.
- In 2019, Merck & Co. (Germany) launched the Stericup Quick Release 500 ml Vacuum Filtration System.
- In 2018, Pall Corporation established a Biotech Integrated Solutions Center of Excellence (CoE), advanced bioprocessing equipment, including single-use cell culture solutions, cell clarification using acoustic wave technology, chromatography using automated packing techniques, viral clearance, and tangential flow filtration, to serve bioprocess engineering consultancies for China and broader Asia.