Sterile Filtration Market

The global sterile filtration market in terms of revenue was estimated to be worth $8.9 billion in 2023 and is poised to reach $15.3 billion by 2028, growing at a CAGR of 11.4% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The growth of this market is majorly driven by demand for sterile filtration in pharmaceutical companies and the food and beverage industries. In addition, increasing number of end users switching from Type II pure lab water to high-purity Type I pure lab water is also fuelling the demand for sterile filtration processes across all industry segments.

Sterile Filtration Market- Global Forecast to 2028

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Attractive Opportunities in the Sterile Filtration Market

Sterile Filtration Market Dynamics

DRIVER: Growing demand for sterile filtration in pharmaceutical industry

In the pharmaceutical industry, maintaining the utmost level of sterility during processing is of paramount importance. The risk of contamination is a significant concern, and effectively controlling microorganisms is a crucial objective. One of the primary causes of contamination is the use of water, steam, gases, and compressed air during the manufacturing process. These "utilities" can potentially transport oil, dirt, debris, and microorganisms into the final product unless they are suitably filtered. Therefore, the sterile filtration of these utilities is imperative to prevent any undesirable substances from compromising the quality and safety of the pharmaceutical product. Sterilizing-grade filters are widely used in many upstream and downstream steps in the manufacturing of biologics. These filters are also used widely in many intermediate steps to reduce cross-contamination risk from in-process liquids such as buffers. Such factors are driving the demand for sterile filters in the pharmaceutical industry.

RESTRAINT: Fouling of the filter membranes

The sterile filter membrane is a key component of the sterile filtration system, which is designed to trap and remove microorganisms and other impurities while allowing the desired product to pass through. However, one of the challenges of sterile filtration is the fouling of the filter membrane. The fouling of the filter membrane can have a significant impact on the efficiency of the sterile filtration process, increase the cost of operation, and lead to product contamination or loss. In some cases, it may even render the filtration system unusable and require the replacement of the filter membrane. Thus, negatively impacting the market growth.

OPPORTUNITY: Increased demand for sterile water in end-use industries

In the pharmaceutical industry, it is crucial that purified water meets the requirements for ionic and organic chemical purity and must be protected from microbial contamination. Sterile water for injection is used for extemporaneous preparation compounding and as a stenle diluent for parenteral products In addition Water for Injection is a crucial solvent used to produce pharmaceutical products, particularly those that need to maintain low endotoxin levels. It is a type of sterile, distilled water that is free from any additional substances and meets specific requirements for pyrogen and bacterial endotoxin levels Since water is a common source of microbial contamination, sterilizing is important to prevent contamination and eliminate endotoxins. This has driven the demand for sterile filtration devices, hence fuelling  the market growth.

CHALLENGE: High price sensitivity among end users

Sterilizing-grade membrane filters are widely used for the intermediate and final filtration of liquid drug products. However, these filters have experienced rapid developments and improvements during the last decade, which have resulted in enhanced thermal and mechanical resistance. This increased efficiency has also impacted the cost of these filters, and there is a surge in the price of these products. Filters undergo extensive lot-release testing to ensure their performance as per standards. For sterilizing filters, manufacturers perform 100% integrity testing, along with appropriate validation tests, to ensure compliance with established standards. Some larger manufacturers perform additional lot-release testing to measure bacteria retention in every lot. Performing these tests in-house requires expensive equipment and specially trained scientists, which increases the cost of filters. Hence, the high price sensitivity for sterile filtration is likely to pose a challenge amongst the end users in the market.

The cartridge filter sub-segment of the product segment dominated sterile filtration market

Cartridge filters are intended for large-volume sterile filtration applications in the pharma, biopharma, and food & beverage industries. Cartridge filters are quality filters that are well-packaged and cost-efficient. They are specially designed and developed for bioburden reduction, sterilization of liquids, sterile APIs, fermentation, and vaccine manufacturing. Encapsulated 10-, 20-, and 30-in cartridges are available in single-use and reusable formats. Cartridges are sometimes fitted together to provide single-use filter trains for very large-volume applications.

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Asia Pacific region of sterile filtration market estimated to register the highest CAGR during the forecast period.

The Asia Pacific market is estimated to register the highest CAGR during the forecast period. Emerging Asian countries are a hub for pharmaceutical R&D and manufacturing. Many local players in the region have plans to secure approvals in the US in the coming years. This has prompted the pharmaceutical sector to adopt international standards of manufacturing that generate approval by the US FDA. This is expected to drive the demand for sterile filtration equipment to ensure the safety and efficacy of drugs.

Key players in the Sterile filtration market include Merck KGaA (Germany), Danaher Corporation (US), Sartorius AG (Germany), Thermo Fisher Scientific Inc. (US), 3M (US), Parker Hannifin Crop. (US), Porvair PLC (UK), Alfa Laval (Sweden), Donaldson Company, Inc. (US), Corning Incorporated (US), Eaton (US), GVS S.p.A (Italy), Sterlitech Corporation (US), Meissner Filtration Products, Inc. (US), Cole-Parmer Instrument, LLC. (US), Nupore Filtration Systems Pvt. Ltd. (India), STARLAB International GmbH (Germany), Amazon Filters Ltd. (UK), AMD Manufacturing Inc. (Canada), Hangzhou Cobetter Filtration Equipment Co., Ltd. (China), Simsii, Inc. (US), CELLTREAT Scientific Products (US), Wyvern Scientific Inc. (Canada), Trinity Filtration Technologies Pvt. Ltd. (India), Filtrox AG (Switzerland).

Sterile filtration Market Report Scope

This report categorizes the sterile filtration market into the following segments and sub-segments:

By Product

• Cartridge Filters
• Capsule Filters
• Membranes
• Syringe Filters
• Bottle-top & Table-top Filtration Systems
• Accessories

By Membrane Type

• PES
• PVDF
• Nylon
• PTFE
• MCE & CA
• Other Membrane Types

By Pore Size

• 0.2–0.22 μm
• 0.45 μm
• 0.1 μm

By Application

• Final Product Processing
• Active Pharmaceutical Ingredient Filtration
• Protein Purification
• Vaccine and Antibody Processing
• Formulation and Filling Solutions
• Viral Clearance
• Raw Material Filtration
• Media Buffer Filtration
• Prefiltration
• Bioburden Testing
• Cell Separation
• Water Purification
• Air Purification

By End user

• Pharmaceutical & Biotechnology Companies
• Food & Beverage Companies
• CMOs & CROs
• Academic & Research Laboratories

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • China
  • Japan
  • India
  • Rest of Asia Pacific (RoAPAC)
• Latin America (LATAM)
  • Brazil
  • RoLATAM
• Middle East and Africa (MEA)

Recent Developments

• In November 2021, Sartorius AG (Germany) launched vacuum filters for research purposes and filtration of small volumes from 50 mL to 1 L.
• In March 2021, Pall Corporation (US) acquired Pall-Austar Lifesciences Limited to expand its manufacturing capacity for single-use technology in China.

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