Global Sterile Filtration Market – Insights
Sterile filtration is used to prevent contamination via microorganisms. The process is majorly used in the pharmaceutical sector in product manufacturing. Sterile filtration is used for several applications such as for media with or without serum. 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. The objective of a sterile filtration step is the removal of any viable microorganism that may be present in the bulk product.
Sterile filtration 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).
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Global Sterile Filtration Market Share (%) Analysis, By Region 2018
Source: Coherent Market Insights Analysis (2019)
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Global Sterile Filtration Market: Drivers
Increasing investments in the pharmaceuticals sector and high incidence of chronic and acute diseases is expected 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 is also expected to boost growth of the market. For instance, according to OECD, between 2000 and 2013, the use of antidiabetic, anti-depressant, and antihypertensive medications increased double fold, while the use of cholesterol-lowering drugs tripled. Increasing development in diagnosis that facilitates early recognition of disorders and early treatment is also expected to boost growth of the market.
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Global Sterile Filtration Market: Restraints
Poor compliance with stringent government regulations to validate filtration process is expected 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. 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.
Global Sterile Filtration Market: Regional Analysis
Increasing development in nanofibers, high production of large molecules and biologics, and regulatory mandates for cleanrooms in pharmaceutical production are some of the factors boosting growth of the market in Europe.
The market in Asia Pacific is driven by lower pharmaceutical R&D cost compared to developed regions.
Global Sterile Filtration Market Value (US$ Mn) & Y-o-Y Growth (%)
Source: Coherent Market Insights Analysis (2019)
Global Sterile Filtration Market – Competitive Landscape
Major players operating in the global sterile filtration market include, 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, and Thermo Fisher Scientific.
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Detailed Segmentation:
- Global Sterile Filtration Market, By Product Type:
- Membrane Filters
- Cartridge Filters
- Capsule Filters
- Global Sterile Filtration Market, By Application:
- Bioprocesses
- Fill-finish Process
- Pre-filtration
- Utilities Filtration
- Global Sterile Filtration Market, By Membrane Pore Size:
- 0.1 um
- 0.2 um
- 0.5 um
- Global Sterile Filtration Market, By End User:
- Pharmaceutical and Biotechnology Companies
- Academic Research Institute
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