STERILE FILTRATION MARKET ANALYSIS

Market Challenges And Opportunities

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.