Market Perspective

The global Sterile Filtration Market was valued at USD 5.75 billion in 2022 and is projected to reach USD 11.12 billion by 2030, growing at a CAGR of 8.77% from 2023 to 2030.

The increasing prevalence of chronic diseases, such as cancer and diabetes, as well as mental illness, has led to an increased demand for medical treatments, including sterile filtration in the pharmaceutical industry. However, it is reasonable to assume that as the demand for pharmaceutical products increases, so too does the need for effective methods of removing microbial and particulate contamination from these products. For instance, in February 2023, the New York State Department of Health stated that a significant proportion of the adult population is affected by chronic diseases, which results in a considerable burden on the healthcare system through hospitalizations and deaths. The two leading causes of mortality in the state are heart disease and cancer. However, challenges include compatibility and stability issues with the filter and the product being filtered, throughput limitations, and regulatory compliance.

Analyst’s Review on Sterile Filtration Market

Regulatory trends in the manufacturing of sterile medicinal products via filtration are also being monitored and addressed. Good manufacturing practices regulations are in place to ensure the quality and safety of sterile drug products produced through aseptic processing. The market for sterile filters is moderately competitive, as there are both global and local companies present. Research and development spending in the pharmaceutical and biotechnology industries is driving growth in the market for sterile filtration products. Going forward, the trend towards greater use of sterile filters is expected to continue, particularly in the pharmaceutical industry.

Market Definition

Sterile filtration is a method used in microbiological and chemical laboratories, as well as in industry, to remove microbial and particulate contamination from liquids or gases. It involves passing the liquid or gas through a filter with pore sizes small enough to prevent the passage of bacteria, viruses, and other microorganisms.

In the pharmaceutical industry, sterile filtration is a key step in the production of drugs and biologics, as it allows for the removal of unwanted contaminants while retaining the desired active components. Sterile filters are used in the filtration of cell culture media, buffers, and other bioprocess fluids. The filters are often made of materials such as polyethersulfone (PES) or polyvinylidene fluoride (PVDF) and may be validated for use in specific applications.

To ensure the effectiveness of the sterile filtration process, it is important to validate the filtration system and monitor the integrity of the filter. Validation activities typically include testing the filter under worst-case conditions to ensure that it can remove bacteria and viruses, and ensuring that the filter does not leach any toxic or harmful substances into the product. Regular testing of the filter integrity is also important to ensure it is not compromised during use.

Market Dynamics

The introduction of single-use devices and disposables has had a significant impact on the use of sterile filtration. Single-use devices and disposables have become increasingly popular in recent years due to their cost-effectiveness, convenience, and reduced risk of contamination. The use of single-use devices and disposables has resulted in several benefits for sterile filtration, as it eliminates the need for cleaning and sterilization of reusable equipment and reduces the risk of cross-contamination between batches. Additionally, the adoption of single-use devices and disposables can help simplify validation and testing processes, as each batch can be treated as a separate entity. However, while the use of single-use devices and disposables has many advantages, it is important to ensure that they are properly designed, manufactured, and tested to meet regulatory standards and ensure product safety. Overall, the use of single-use devices and disposables has revolutionized sterile filtration, and is likely to continue to have a significant impact on the industry in the future.

Non-compliance with strict government regulations for the validation of filtration processes is anticipated to impede the growth of the sterile filtration market. Companies need to have a proper understanding of and conduct testing on their sterile filtration systems in accordance with global regulatory standards to ensure validation and continued monitoring of the filtration system. Moreover, the cost of filtration equipment and consumables, as well as the associated validation and testing costs, can be significant. This can be especially true for small-scale operations or for products with low profit margins.

Segmentation Analysis

The global sterile filtration market is segmented based on membrane pore size, product, application, end-user and geography.

Based on membrane pore size, the sterile filtration market is bifurcated into 0.22 Microns, 0.1 Microns, and 0.45 Microns. The 0.22 Microns segment held the largest market revenue with a valuation of USD 3.10 billion in 2022. Sterile filtration with a pore size of 0.22 microns is commonly used in the pharmaceutical industry to ensure the removal of bacteria and other contaminants from products. Various sterile filtration products,, such as syringe filters and capsule filters, are available with a 0.22-micron pore size. These products are designed to provide superior results for filtration of cell culture media and feeds, as well as removal of bacterial endotoxins and other impurities.

Based on product, the sterile filtration market is divided into cartridges & capsules, syringe filters, bottle-top vacuum filters, filter funnels & holders, and others. The cartridges & capsules segment is anticipated to be the fastest-growing segment, depicting a CAGR of 10.10% over the forecast period. Cartridge filters are a type of tubular filtration equipment that effectively removes unwanted impurities, pollutants, and chemicals from liquids. They are utilized in the pre-filtration and self-cleaning of RO and other membranes, as well as in the filtration of industrial and pool water. In petrochemicals and refineries, they are used for oil removal and particle filtration. The small, cost-effective, and low-maintenance nature of cartridge filters makes them highly practical for a wide range of applications. The broad range of uses and practical advantages of cartridge filters is expected to drive the growth of this market.

By application, the sterile filtration market is divided into bioprocesses, utilities filtration, pre-filtration, fill-finish process, and virus filtration. The bioprocesses segment accounted for the largest market share of 38.86% in 2022. Sterile filtration is an essential operation in bioprocessing for controlling bioburden and ensuring product safety.

Based on end-user, the sterile filtration market is divided into pharmaceutical & biotechnology companies, food & beverage industry, academic institutes & research laboratories, and water filtration companies. The pharmaceutical & biotechnology companies segment achieved the largest market share of 42.98% in 2022. Pharmaceutical and biotechnology companies are one of the largest end-users of sterile filtration products. Sterile filtration plays a critical role in ensuring the safety and quality of pharmaceutical products, particularly during the production of vaccines and therapeutics.

Geographical Analysis

Based on region, the global sterile filtration market is classified into North America, Europe, Asia Pacific, MEA and Latin America.

North America dominated the market with a 36.55% share of 36.55% in 2022 owing to the escalating demand for sterilized products in the pharmaceutical industry. A noteworthy example is the United States Postal Service, which uses irradiation to sterilize mail in Washington, D.C. The industry's growth is attributed to a multitude of factors, including the need for sterilized products in pharmaceuticals, biotechnology, and medical device industries. The regional market expansion is also propelled by the advent of advanced technological solutions, product safety standards, cost-effectiveness, and environmental sustainability practices. Additionally, the rising prevalence of chronic diseases in the region is expected to further fuel the growth of this industry in the upcoming years.

Competitive Landscape

The global sterile filtration industry study report will provide valuable insights with an emphasis on the fragmented nature of the global market. Prominent players are focusing on several key business strategies such as partnerships, mergers & acquisitions, product innovations, and joint ventures to expand their product portfolio and increase their respective market shares across different regions. Expansion & investments involve a range of strategic initiatives including investments in R&D activities, new manufacturing facilities, and supply chain optimization. The major manufacturers in the sterile filtration market are:

• 3M
• Merck KGaA
• Sartorius AG
• Danaher Corporation (Pall)
• Porvair Filtration Group
• Sterlitech Corporation
• Starlab Scientific Co.
• Thermo Fisher Scientific Inc.
• Meissner Filtration Products, Inc.
• PARKER HANNIFIN CORP

Key Developments

• April 2023 (Launch): Porvair Filtration Group has introduced its latest range of filtration products for sterile liquid filtration, known as Biofil 3 and Biofil 3 Plus. These products are available with sizes ranging from 0.2µm to 0.45m. The filters are designed using a membrane that is easily wettable, allowing them to be used in a broader range of applications that were not previously suitable for PES.
• January 2023 (Collaboration): Sartorius has signed a strategic collaboration partnership agreement with RoosterBio to tackle purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. The collaboration will also focus on developing downstream purification methods. Sartorius will utilize its scalable filtration equipment, Sartoflow Smart and Sartoflow Advanced, for clarification, concentration, and formulation of exosomes in conjunction with column chromatography unit operations.
• January 2022 (Launch): Pall Corporation, an operating company of Danaher, recently unveiled its latest product offering, SupralonTM hydraulic and lube oil filter element range. The SupralonTM line serves as a direct upgrade from Pall's existing Coralon, Ultipor, and Red1000 series filters.

The global Sterile Filtration Market is segmented as:

By Membrane Pore Size

• 0.22 Microns
• 0.1 Microns
• 0.45 Microns

By Product

• Cartridges & Capsules
• Syringe Filters
• Bottle-Top Vacuum Filters
• Filter Funnels & Holders
• Others

By Application

• Bioprocesses
• Utilities Filtration
• Pre-Filtration
• Fill-Finish Process
• Virus Filtration

By End-User

• Pharmaceutical & Biotechnology Companies
• Food & Beverage Industry
• Academic Institutes & Research Laboratories
• Water Filtration Companies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • France
  • UK
  • Spain
  • Germany
  • Italy
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific
• Middle East & Africa
  • GCC
  • North Africa
  • South Africa
  • Rest of Middle East & Africa
• Latin America
  • Brazil
  • Argentina
  • Rest of Latin America