Sterile Filtration Market – Insights
Sterile filtration is used in pharmaceutical industry to prevent microbial contamination. The process minimizes the risk of microbial contamination in patients by offering a reliable, safe, and effective way to ensure product manufacturing. An extensive range of products and formats are available from multiple vendors for a diverse range of applications. It is the most important filtration process in any pharmaceutical operation. According to the U.S. Food and Drug Administration (U.S. 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. The objective of a sterile filtration step is the removal of any viable microorganism that may be present in the bulk product.
Sterile filtration is used for several applications such as for media with or without serum. The process supports growth of cell culture, reagents or solutions with sensitive components that may degrade when exposed to autoclave temperatures, filtering supplements, samples, buffers, and post-fermentation broths.
The global sterile filtration market size was valued at US$ 5.2 billion in 2017 and is expected to witness a CAGR of 13.3% over the forecast period (2018 – 2026).
Global Sterile Filtration Market Share (%) Analysis, By Region 2018
Source: Coherent Market Insights Analysis (2019)
Increasing investments in pharmaceuticals is expected to drive growth of the sterile filtration market
Increasing investments in pharmaceuticals and high prevalence of chronic and acute diseases are the major factors driving growth of the sterile filtration market. According to the Organisation 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. Moreover, high demand for medicines and the introduction of new drugs are key factors responsible for increasing investments in pharmaceutical industry. According to the same source, between 2000 and 2013, the use of antidiabetic, anti-depressant, and antihypertensive medications increased double fold, while the use of cholesterol-lowering drugs tripled. These trends reflect an increasing demand for pharmaceuticals sterile filtration.
Moreover, increased prevalence of several chronic diseases such as cancer, diabetes, and mental illness has increased demand for medical treatments. For instance, according to the Cancer Research U.K., around 55,122 new cases of breast cancer were registered in the country in 2015. Furthermore, improvements in diagnosis, leading to early recognition of conditions and early treatment with medicines, along with development of novel medicines to treat common conditions have contributed to increasing consumption of medicines. Therefore, such developments in the pharmaceutical industry are driving the sterile filtration market growth.
Sterile Filtration Market Restraints
However, poor compliance with stringent government regulations for validation of filtration process is expected to hinder growth of the 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. There are two major, global guidance documents for sterile products manufacture: the Food and Drugs Administration (FDA) guidance and EU Good Manufacturing Practice (GMP). For instance, according to American Society for Testing and Materials (ASTM) standard, a sterilizing-grade filter must completely retain Brevundimonas diminuta microorganisms when challenged with 107 bacteria per cm square of filtration area.
Sterile Filtration Market - Regional Insights
On the basis of region, the global sterile filtration market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe sterile filtration market is expected to witness significant growth, owing to technological advancements in nanofibers, increasing production of large molecules and biologics, growth in the generics market, and regulatory mandates for cleanrooms in pharmaceutical production.
Moreover, low pharmaceutical research and development cost in Asia Pacific in comparison to developed regions is expected to increase investment of key players in the region.
Global Sterile Filtration Market Value (US$ Mn) & Y-o-Y Growth (%)
Source: Coherent Market Insights Analysis (2019)
Sterile Filtration Market - Competitive Landscape
Key players operating in the global sterile filtration market include, 3M, Merck & Co., Inc., General Electric Company, Pall Corporation, Parker Hannifin Corporation, Porvair Filtration Group, Sterlitech Corporation, Sartorius, Starlab Scientific Co., Ltd., Sigma Aldrich Corporation, and Thermo Fisher Scientific.
Sterile filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality. Drug sterility is important requirement in the pharmaceutical industry. Virus inactivation or removal is required for biologically derived therapeutics such as recombinant gene proteins, monoclonal antibodies, and plasma components. Moreover, membrane filtration is widely used for both bacterial removal and viral clearance.
Growth in the biopharmaceutical industry and increasing investment in research and development activities are the major factors driving the sterile filtration market growth. Moreover, high demand for biopharmaceutical molecules and increasing prevalence of diabetes and kidney failure are some of the other factors propelling growth of the market. According to a report by Pharmaceutical Research and Manufacturers of America (PhRMA), in 2015, the research-based pharmaceutical industry allots around 15% to 20% of revenue to R&D activities and invests over US$ 50 billion on R&D annually. According to the U.S Department of Commerce, the generic drug sales increased to US$ 70 billion in U.S. due to a large number of drugs going off-patent and healthcare reforms favoring generics.
However, stringent government regulations for validation of filtration process are expected to limit the sterile filtration market growth during the forecast period.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section