Sterile Filtration Market

Global Sterile Filtration Market Size (2024 to 2032)

The size of the global sterile filtration market was worth USD 7.21 billion in 2023. The global market is expected to grow at a CAGR of 12.5% from 2024 to 2032 and be worth USD 20.81 billion by 2032 from USD 8.11 billion in 2024.

Filtration makes the products purified adequately and suitable for consumption, helps optimize process economics, and avoids the loss of valuable products. Therefore, it is an essential operation in the pharmaceutical industry. Fluids such as drug products damaged by heat, chemical sterilization, or irradiation can be sterilized by microfiltration using different membrane filters. This method is commonly used for protein solutions in medical drug processing and labile pharmaceuticals.

MARKET DRIVERS

The growing investments from pharmaceutical companies and the high prevalence of acute diseases are other significant factors driving the growth of the sterile filtration market.

According to data from the Organization for Economic Cooperation and Development (OECD), in 2013, pharmaceutical investment in OECD countries was approximately $ 800 billion, accounting for about 20% of total healthcare investment. Also, the high demand for medicines and the introduction of new drugs are the key factors leading to increased investment in the pharmaceutical industry. According to the same source, the number of people using antidiabetics, antidepressants, and antihypertensive drugs tripled, and the number of people using cholesterol-lowering drugs tripled between 2000 and 2013. These trends reflect the growing demand for the sterile filtration of drugs.

The growing prevalence of chronic diseases fuels the growth rate of the sterile filtration market.

Chronic diseases, such as cancer, diabetes, and mental illness, have increased medical care demand. For instance, according to the British "Cancer Research" report, the country registered 55.122 new breast cancer cases in 2015. Also, there is an increase in diagnosis, identification of diseases, early treatment of drugs, and the development of new medicines. In addition, the treatment of common diseases leads to increased drug consumption. Using sterile techniques, microorganisms can be removed during the upstream and downstream drug development, and final drug sterility can be assured using absolute drug sterility. Therefore, mass production of these drugs increases sterile processes, which is more likely to boost market growth.

Sterile filtration is an essential application in the biopharmaceutical industry to develop quality products, which is anticipated to boost the sterile filtration market. The rise in support from private and public organizations through investments in pharmaceutical industries creates chances for the market to grow. Besides, the emergence of Nano filters for removing microorganisms is accelerating the demand for the sterile filtration market. Increasing incidences of various health disorders due to lifestyle changes are also expected to accelerate the market's growth. Adopting the latest technologies and launching innovative products in favor of the end-users will surge growth opportunities for the market. The growing biopharmaceutical industry strongly drives the growth of the global sterile filtration market. In addition, an increase in R&D spending, growing production of large molecules and biologics, the rise of the generic drugs market, rising incidence of diabetes & kidney failure, increasing demand for biopharmaceutical molecules, and increasing purity requirements in the end-user market are further propelling the sterile filtration market.

MARKET RESTRAINTS

Stringent government regulations for validating the filtration process are one of the major factors hampering the sterile filtration market growth.

High initial capital investment required to establish sterile filtration infrastructure, Complex and time-consuming validation processes, risk of filter fouling and clogging during filtration and limited compatibility with sensitive products, such as biologics and vaccines hinder the growth of the sterile filtration market. Technological limitations such as filter lifespan or flow rate constraints, rapid adoption of single-use systems in the biopharmaceutical industry, lack of skilled workforce with expertise in sterile filtration techniques, environmental concerns related to the disposal of used filtration materials and regional disparities in healthcare infrastructure, regulatory frameworks and economic conditions further inhibit the growth rate of the sterile filtration market.

REPORT COVERAGE

SEGMENTAL ANALYSIS

Global Sterile Filtration Market Analysis By Product

The membrane filter segment is estimated to hold the dominating share of the global sterile filtration market during the forecast period. The growing demand for effective particulate removal and sterilization in pharmaceutical and biotechnology industries and an increasing number of advancements in membrane technology that offer improved filtration efficiency and selectivity majorly drive the growth of the membrane filter segment in the global market. The rising emphasis on quality control and regulatory compliance in the healthcare and food industries further contributes to the growth rate of the segment.

The cartridges and capsules segment is anticipated to account for a substantial share of the global market during the forecast period. Factors such as high-throughput filtration needs in large-scale pharmaceutical and biopharmaceutical manufacturing processes and growing demand for reliable and efficient filtration solutions for critical applications in the healthcare and biotechnology sectors primarily propel the growth of the cartridges and capsules segment in the global market. Ease of use, scalability and compatibility with existing filtration systems further boost the growth rate of the segment.

The syringe filters segment is predicted to witness a healthy CAGR during the forecast period. Factors such as the rising need for precise and sterile filtration of small sample volumes in research and laboratory settings and the expansion of pharmaceutical research and development activities drive the growth of the syringe filters segment in the global market. The growing demand for analytical and diagnostic testing in healthcare and life sciences industries supports the growth rate of the segment.

Global Sterile Filtration Market Analysis By Application

The bioprocess segment is anticipated to account for the major share of the global sterile filtration market during the forecast period owing to factors such as the growing demand to produce large molecules and biologics and rising awareness of the process in almost every end-user industry. Stringent regulatory requirements for product safety and quality in the biopharmaceutical industry and increasing number of advancements in bioprocess technologies and the growing adoption of single-use systems further propel the growth of the bioprocess segment.

The fill-finish process segment is another lucrative segment and is estimated to register a healthy CAGR during the forecast period. The growing pharmaceutical production, increasing need for reliable sterile filtration to maintain product integrity during the fill-finish process, rising emphasis on patient safety and the prevention of contamination in drug products and technological advancements in aseptic processing and container closure systems propel the growth of the fill-finish segment in the global market.

The virus filtration segment is projected to register a healthy CAGR during the forecast period. Factors such as the rising demand for vaccines, gene therapies, and biopharmaceutical products, necessitating effective virus removal during manufacturing, regulatory guidelines mandating virus filtration to ensure product safety and minimize the risk of viral contamination and continuous research and development in virus filtration technologies to enhance filtration efficiency and capacity contribute to the growth rate of the virus filtration segment.

Global Sterile Filtration Market Analysis By Membrane Pore Size

The 0.22 microns segment is estimated to lead the global sterile filtration market during the forecast period. Stringent sterility requirements drive the adoption of the 0.22-micron pore size for effectively removing bacteria and ensuring sterility in critical processes and driving the growth of the 0.22 microns segment. Mitigating microbial contamination risk and ensuring product safety in pharmaceutical, biotechnology, and healthcare industries and compliance with regulatory standards and quality assurance requirements necessitates the use of the 0.22-micron pore size to further fuel the growth rate of the 0.22-micron segment.

On the other hand, the 0.45 microns segment is estimated to hold a considerable share of the global market during the forecast period. The growing number of applications of 0.45 microns across industries for general particulate removal and maintaining cleanliness in liquids and gases is one of the key factors propelling segmental growth. The rising need to address regulatory compliance and product integrity by capturing larger microorganisms and particulate matter and the versatility in diverse sectors such as pharmaceuticals, food and beverage, electronics, and water treatment drives the demand for the 0.45-micron pore size and boost the segmental growth.

Global Sterile Filtration Market Analysis By End-User

The pharmaceutical and biotechnology companies segment is predicted to capture the leading share of the global market during the forecast period. Stringent regulatory standards and compliance requirements drive the adoption of sterile filtration in the pharmaceutical and biotechnological industries to ensure product safety and meet regulatory guidelines, which is one of the major factors propelling the growth of the pharmaceutical and biotechnological segment in the global market. The growing demand for biologics and advanced therapies fuels the need for sterile filtration in the production process to maintain product purity and sterility and this is fuelling the segmental growth further. Ongoing research and development activities in the pharmaceutical and biotechnology sectors require sterile filtration for laboratory settings and sterile environments, which also boosts the growth rate of the segment.

The F&B segment is predicted to account for a substantial share of the global market during the forecast period. The rising emphasis on product quality and safety to remove contaminants and microorganisms to ensure the purity and extended shelf life of food and beverage products drives the adoption of sterile filtration in the F&B industry and fuels the growth rate of the F&B segment in the global market. The compliance with food safety regulations and standards mandates the use of sterile filtration in various processes further contributes to the growth rate of the F&B segment.

REGIONAL ANALYSIS

North America led the market worldwide in 2023 and the domination of the North American region in the global market is likely to continue throughout the forecast period. The presence of numerous companies in the pharmaceutical, biotechnology and food and beverage industries in North America, a well-established healthcare sector, and strict laws for the pharmaceutical industry majorly drive the North American market. The growing number of Active Pharmaceutical Ingredients (API) production facilities using syringe filters and increasing investments in R&D activities in the North American region boost the growth rate of the North American market. The U.S. Food and Drug Administration (FDA) and the U.S. Pharmacopoeia (USP) define sterile filtration as producing sterile effluent with nominal ratings of 0.22 m and 0.2 m, respectively. The acquisition of RIS Facility Management GmbH was announced by American Air Filter Company, Inc. and its affiliate, AAF Lufttechnik GmbH. The acquisition's goal is to increase the operations and global reach of American Air Filter Company, Inc.

Asia-Pacific is anticipated to have the highest CAGR in the global market during the forecast period. Factors such as the rapid expansion of the pharmaceutical industry in the Asia-Pacific region, growing population, increasing healthcare expenditure and growing access to medical treatments primarily boost the growth rate of the APAC market. The growing focus of the Asia-Pacific region on the production of biologics, biosimilars, and generic drugs and the increasing use of sterile filtration technologies to meet quality and safety standards to ensure the production of safe and efficacious therapies further contribute to the growth rate of the APAC market. The growing number of improvements in the healthcare infrastructure in the APAC countries and regulatory frameworks drive the adoption of sterile filtration and boost regional market growth. China and India are estimated to account for the leading share of the APAC market during the forecast period.

Europe is anticipated to account for a considerable share of the global market during the forecast period. The growing pharmaceutical industry in Europe is accelerating the need for sterile filtration solutions to maintain product integrity and comply with stringent regulatory requirements is driving the European market growth. The growing biotechnology sector in Europe, rising emphasis on the production of biologics and increasing demand for sterile filtration technologies to ensure the sterility and purity of these complex therapies drive the European market growth. Favorable government initiatives supporting research and development, innovation and healthcare infrastructure further the growth rate of the European market. Germany and the UK is estimated to hold the major share of the European market during the forecast period owing to the well-established pharmaceutical manufacturing sector and rising focus on research and development activities in the biotechnology sector.

Latin America is expected to grow at a healthy CAGR during the forecast period. The growing investments in healthcare infrastructure, the increasing number of advanced healthcare facilities, the rising pharmaceutical and biotechnology sectors in the Latin American region, the rising emphasis on research and development and the increasing adoption of sterile filtration technologies to meet regulatory standards and maintain product integrity drive the Latin American market growth. Brazil and Mexico had the largest share of the Latin American market in 2022.

The market in MEA is predicted to account for a moderate share of the global market during the forecast period.

KEY PLAYERS IN THE STERILE FILTRATION MARKET

Some noteworthy companies dominating the global sterile filtration market profiled in the report are Merck & Co Inc., 3M, General Electric Company, Pall Corporation, Parker Hannifin Corporation, Sartorius Stedim Biotech Group, Porvair Filtration Group, Sterlitech Corporation, and Starlab Scientific Co., Ltd.

Leading companies offer a wide range of products and continue to expand their existing product portfolio. Most of these participants have an enhanced distribution network in a wide geographical area. Secure distribution channels, a vast product portfolio, and the launch of new products have led to fierce competition among suppliers. It puts tremendous pressure on pricing strategies and affects supplier margins. Leading players participate in collaboration, new product development, mergers and acquisitions, and regional expansion to gain a larger share of the global sterile filtration market. Mergers and acquisitions help companies increase their existing product portfolio and geographic reach. In August 2015, Danaher completed Pall's acquisition and entered the field of filtration, separation, and purification solutions.

DETAILED SEGMENTATION OF THE GLOBAL STERILE FILTRATION MARKET INCLUDED IN THIS REPORT

This research report on the global sterile filtration market has been segmented and sub-segmented based on product, application, membrane pore size, end-user, and region.

By Product

• Membrane Filters
  • MCR
  • Coated Cellulose Acetate
  • PTFE
  • PVDF
  • PES
  • Nylon Filter Membranes
• Bottle-Top Vacuum Filters
• Cartridges & Capsules
• Syringe Filters
• Filtration Accessories
• Filter Holders

By Application

• Bioprocesses
• Cell Culture Growth Media
• Fill-Finish Process
• Virus Filtration
• Utility Filtration
• Pre-Filtration

By Membrane Pore Size

• 0.22 Microns
• 0.45 Microns
  • Microns

By End-user

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

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• The Middle East and Africa