Sterile Filtration Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Sterile Filtration Market is Segmented by Product (Cartridge Filters, Capsule Filters, and More), Membrane Material (PES, PVDF, and More), Filtration Technique (Microfiltration, and More), Application (Final Fill/Finish, Buffer, and More), End User (Pharmaceutical and Biopharmaceutical Companies, and More), and Geography (North America, Europe, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Sterile Filtration Market Size and Share

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Compare market size and growth of Sterile Filtration Market with other markets in Healthcare Industry

Sterile Filtration Market Analysis by Mordor Intelligence

In 2025, the sterile filtration market stands at USD 9.1 billion and is forecast to reach USD 14.0 billion by 2030, advancing at a 9.5% CAGR. Rising contamination-control standards for advanced therapy medicinal products, together with the European Medicines Agency’s revised Annex 1 guidelines that require rigorous pre-use post-sterilization integrity testing, keep capital and validation spending on an upward trajectory. Demand scales further as chronic diseases spur sterile injectable volumes and single-use manufacturing gains wider acceptance. Contract development and manufacturing organizations (CDMOs) boost regional capacity, helping biopharma companies de-risk supply chains while maintaining speed to clinic. Cartridge filters remain the volume workhorse, yet capsule filters grow fastest on the back of small-batch gene and cell therapy requirements. Polyethersulfone (PES) membranes lead current installations, although looming PFAS restrictions are pushing producers to diversify away from polyvinylidene fluoride (PVDF).

Key Report Takeaways

  • By product type, cartridge filters held 31.8% of the sterile filtration market share in 2024, while capsule filters are projected to register a 10.4% CAGR through 2030. 
  • By membrane material, PES led with 25.2% share of the sterile filtration market size in 2024; PVDF membranes are set to expand at 10.2% CAGR between 2025-2030. 
  • By filtration technique, microfiltration accounted for 29.5% revenue in 2024, whereas ultrafiltration is expected to grow at 12.5% CAGR to 2030. 
  • By application, final fill/finish secured 20.0% share of the sterile filtration market size in 2024, and ATMP small-batch filtration is forecast to advance at a 13.3% CAGR through 2030. 
  • By end user, pharmaceutical and biopharmaceutical firms captured 40.2% revenue in 2024, while CDMOs are poised to expand at 12.9% CAGR to 2030.
  • By geography, North America led with 38.4% revenue share in 2024, while Asia Pacific is forecast to expand at a 9.1% CAGR to 2030.

Segment Analysis

By Product: Capsule Filters Drive Innovation

Cartridge filters dominated 2024 with 31.8% revenue, confirming their incumbency in high-volume plant operations. Capsule filters, however, are forecast to log a 10.4% CAGR owing to flexible batch scalability for personalized therapies. This momentum anchors the sterile filtration market size expansion for ATMP producers that need rapid changeovers without re-cleaning. Cytiva’s Emflon II gamma-compatible modules exemplify single-use advances that eliminate CIP validation burdens. 

Syringe filters keep laboratory and clinical trial workflows moving even though their growth remains modest. Accessories such as holders, vent filters, and assemblies provide incremental gains as manufacturers emphasize closed-system integration to limit contamination events. This is a critical concern for regulators enforcing Annex 1 clarity on aseptic connections.

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Note: Segment shares of all individual segments available upon report purchase

By Membrane Material: PES Dominance Faces PVDF Pressure

Polyethersulfone membranes held a 25.2% share in 2024 due to low protein binding and robust throughput, cementing their status for final fill/finish lines. PVDF variants are projected to grow 10.2% annually until 2030, driven by chemical resistance, yet pending PFAS restrictions in Europe threaten long-term accessibility. PES suppliers invest in next-generation grades to capture capacity migrating from PVDF. 

PTFE, nylon, and mixed cellulose ester membranes fill application niches spanning gas filtration to low-cost buffer prep. The sterile filtration market is expected to witness accelerated R&D in fluoropolymer-free chemistries as customers look to de-risk material compliance and avoid costly system re-validation.

By Filtration Technique: Ultrafiltration Gains Momentum

Microfiltration sustained 29.5% revenue in 2024 as the default microbial barrier in bulk drug manufacturing. Ultrafiltration, growing at 12.5% CAGR, is increasingly chosen for virus clearance and protein concentration, serving the surge in monoclonal antibody and gene therapy pipelines. Toray’s hollow-fiber development, which marries selectivity with high flux, illustrates technical progress that shortens processing cycles. 

Nanofiltration and reverse osmosis continue to underpin water-for-injection and buffer concentration schemes, though their higher energy and capital intensity keep them in specialized roles rather than broad adoption across the sterile filtration market.

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Note: Segment shares of all individual segments available upon report purchase

By Application: ATMP Small-Batch Drives Growth

Final fill/finish retained 20.0% share of the sterile filtration market in 2024 because regulations require terminal filtration immediately before container closure. The ATMP small-batch niche is on track for 13.3% CAGR as gene and cell therapy pipelines commercialize and require validated, low-hold-up volume capsules.[2]Nature Reviews Drug Discovery, “Advanced Therapies Require Sterile Manufacturing Innovation,” nature.com

Buffer/media prep and water-for-injection filtration move in lock-step with overall capacity additions, whereas air and gas sterilization rise as single-use systems demand validated venting for blow-fill-seal lines and closed processing steps.

By End User: CDMOs Accelerate Adoption

Pharmaceutical and biopharmaceutical companies produced 40.2% of 2024 sales, yet CDMOs will advance faster at 12.9% CAGR as sponsors outsource production and expect plug-and-play validation files. The sterile filtration market share gains for service providers mirror their rising stake in global biologic capacity, forecast to reach 54% by 2028. 

Academic and government labs sustain steady bench-scale demand, while food and beverage processors adopt pharmaceutical-style sterility assurance mainly in high-risk liquids such as dairy concentrates and probiotic beverages.

Geography Analysis

North America and Europe command the lion’s share of 2024 revenue owing to entrenched biopharmaceutical clusters, advanced regulatory oversight, and a strong pipeline of injectable therapeutics. U.S. capacity expansions from Novo Nordisk’s USD 4.1 billion site in North Carolina to Eli Lilly’s USD 2 billion Concord investment embed long-run demand for filtration hardware and validation services. Europe’s Annex 1 revisions, now the global contamination-control benchmark, compel every drug maker exporting into the region to align filtration strategies. 

Asia Pacific, led by South Korea, delivers the fastest-growing sterile filtration market through 2030 because of major greenfield projects such as Cytiva’s USD 326 million Incheon plant and Samsung Biologics’ multi-billion-dollar campus. China and India scale facilities that meet FDA and EMA standards, while Japan’s materials expertise buttresses membrane R&D, reinforcing regional self-sufficiency goals. MilliporeSigma’s EUR 300 million Daejeon center underlines incumbent suppliers’ commitment to localizing production. 

Middle East & Africa and South America remain emerging but strategic territories. Brazil and Argentina advance fill/finish lines to curb import reliance, and GCC nations embed pharmaceutical manufacture within diversification plans. Technology transfer initiatives and government incentives ease skills gaps and build the regulatory foundations needed for future sterile filtration market penetration.

Sterile Filtration Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The sterile filtration market demonstrates moderate concentration. Danaher, Sartorius, and Merck KGaA leverage broad portfolios, validation toolkits, and global supply chains to safeguard their share as Annex 1 rules tighten. Danaher reported USD 5.74 billion revenue for Q1 2025 with sustained bioprocessing order growth over seven quarters, reflecting resilient demand for filtration and single-use assemblies. 

Thermo Fisher’s USD 4.1 billion purchase of Solventum’s purification and filtration line intensifies competition, extending its reach into high-growth biologics workflows. AI-driven predictive maintenance, disposable system integration, and PFAS-free membrane alternatives are becoming decisive differentiators. Smaller innovators thrive in niches—virus filters with superior flux or regional servicing—but higher compliance hurdles encourage strategic partnerships or bolt-on deals with larger multinationals. 

Regulators also spur innovation; FDA patent activity around real-time integrity analytics indicates a future where automated systems can flag contamination risks as batches run, rewarding suppliers equipped with sensor-rich cartridges and data platforms.[3]U.S. Food and Drug Administration, “Q5A(R2) Viral Safety Evaluation of Biotechnology Products,” fda.gov As customers prioritize risk mitigation over unit cost, technology leadership and global support networks outweigh simple price competition.

Sterile Filtration Industry Leaders

  1. Merck KGaA

  2. Danaher Corporation

  3. ThermoFisher Scientific Inc.

  4. Sartorius AG

  5. GE Healthcare

  6. *Disclaimer: Major Players sorted in no particular order
Sterile Filtration Market Concentration
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Recent Industry Developments

  • February 2025: Thermo Fisher Scientific closed the USD 4.1 billion acquisition of Solventum’s Purification & Filtration business, adding roughly USD 1 billion in 2024 revenue to its bioprocessing division.
  • February 2025: Resilience received USD 17.5 million from the U.S. Department of Health and Human Services to expand domestic sterile filtration capability.
  • January 2025: DuPont introduced FilmTec LiNE-XD nanofiltration elements for lithium brine purification, underscoring membrane innovation that can translate back into pharmaceutical filtration workflows.
  • November 2024: Cytiva inaugurated a 6,100 m² Incheon plant focused on sterile filtration production, projected to add 150 jobs

Table of Contents for Sterile Filtration Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Burden Of Chronic & Rare Diseases
    • 4.2.2 Expansion Of Global Biopharmaceutical Manufacturing Capacity
    • 4.2.3 Shift Toward Single-Use And Modular Production Facilities
    • 4.2.4 Stricter Global GMP & Annex 1 Revisions Tightening Filter Validation
    • 4.2.5 Surge In Advanced-Therapy Medicinal Products (ATMPs) Needing Low-Volume Sterile Runs
    • 4.2.6 AI-Driven Predictive Maintenance Reducing Filtration Failure Risk
  • 4.3 Market Restraints
    • 4.3.1 High Total Cost Of Ownership Of Validated Sterile Filters
    • 4.3.2 Membrane Fouling & Integrity Test Failures Causing Downtime
    • 4.3.3 Long Lead-Times For Regulatory Re-Validation After Filter Or Process Change
    • 4.3.4 Emerging PFAS Regulations Threatening PTFE/PVDF Membrane Supply
  • 4.4 Supply Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter's Five Forces Analysis
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Bargaining Power of Buyers
    • 4.7.3 Bargaining Power of Suppliers
    • 4.7.4 Threat of Substitutes
    • 4.7.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value)

  • 5.1 By Product
    • 5.1.1 Cartridge Filters
    • 5.1.2 Capsule Filters
    • 5.1.3 Syringe Filters
    • 5.1.4 Other Membrane Filters
    • 5.1.5 Accessories
  • 5.2 By Membrane Material
    • 5.2.1 PES
    • 5.2.2 PVDF
    • 5.2.3 PTFE
    • 5.2.4 Nylon & MCE
    • 5.2.5 Others (PP, RC, etc.)
  • 5.3 By Filtration Technique
    • 5.3.1 Microfiltration
    • 5.3.2 Ultrafiltration
    • 5.3.3 Nanofiltration & Reverse Osmosis
  • 5.4 By Application
    • 5.4.1 Final Fill / Finish
    • 5.4.2 Buffer & Media Preparation
    • 5.4.3 Water-for-Injection & Utilities
    • 5.4.4 Air & Gas Sterilization
    • 5.4.5 Others
  • 5.5 By End User
    • 5.5.1 Pharmaceutical & Biopharmaceutical Companies
    • 5.5.2 Contract Development & Manufacturing Organizations (CDMOs)
    • 5.5.3 Academic & Government Research Labs
    • 5.5.4 Food & Beverage Manufacturers
  • 5.6 Geography
    • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
    • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
    • 5.6.3 Asia Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia Pacific
    • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
    • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.3.1 3M
    • 6.3.2 Danaher (Pall & Cytiva)
    • 6.3.3 Sartorius AG
    • 6.3.4 Merck KGaA (MilliporeSigma)
    • 6.3.5 Thermo Fisher Scientific
    • 6.3.6 GE Healthcare
    • 6.3.7 Eaton Corporation
    • 6.3.8 Cole-Parmer Instrument Company
    • 6.3.9 Porvair Filtration Group
    • 6.3.10 Sterlitech Corporation
    • 6.3.11 Koch Separation Solutions
    • 6.3.12 Prominent GmbH
    • 6.3.13 Donaldson Company
    • 6.3.14 Parker Hannifin (Bioscience Division)
    • 6.3.15 Saint-Gobain Life Sciences
    • 6.3.16 Repligen Corporation
    • 6.3.17 Meissner Filtration Products
    • 6.3.18 Advantec MFS
    • 6.3.19 GVS Group
    • 6.3.20 Cytiva (see Danaher)
    • 6.3.21 Alfa Laval
    • 6.3.22 Donaldson Ultrafilter
    • 6.3.23 W. L. Gore & Associates
    • 6.3.24 Amazon Filters
    • 6.3.25 Cobetter Filtration

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Global Sterile Filtration Market Report Scope

As per the scope of the report, sterile filtration is a technique used in manufacturing drugs to avoid contamination by filtering the micro-organisms without degrading product quality. The sterile filtration market is segmented by product (cartridge filter, capsule filter, syringe filter, other membrane filters, accessories), end user (pharmaceutical and biopharmaceutical companies, contract research organizations, research laboratories), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions. The report offers the value of market sizes and forecasts in USD million for the above segments.

By Product Cartridge Filters
Capsule Filters
Syringe Filters
Other Membrane Filters
Accessories
By Membrane Material PES
PVDF
PTFE
Nylon & MCE
Others (PP, RC, etc.)
By Filtration Technique Microfiltration
Ultrafiltration
Nanofiltration & Reverse Osmosis
By Application Final Fill / Finish
Buffer & Media Preparation
Water-for-Injection & Utilities
Air & Gas Sterilization
Others
By End User Pharmaceutical & Biopharmaceutical Companies
Contract Development & Manufacturing Organizations (CDMOs)
Academic & Government Research Labs
Food & Beverage Manufacturers
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia Pacific China
Japan
India
South Korea
Australia
Rest of Asia Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
By Product
Cartridge Filters
Capsule Filters
Syringe Filters
Other Membrane Filters
Accessories
By Membrane Material
PES
PVDF
PTFE
Nylon & MCE
Others (PP, RC, etc.)
By Filtration Technique
Microfiltration
Ultrafiltration
Nanofiltration & Reverse Osmosis
By Application
Final Fill / Finish
Buffer & Media Preparation
Water-for-Injection & Utilities
Air & Gas Sterilization
Others
By End User
Pharmaceutical & Biopharmaceutical Companies
Contract Development & Manufacturing Organizations (CDMOs)
Academic & Government Research Labs
Food & Beverage Manufacturers
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia Pacific China
Japan
India
South Korea
Australia
Rest of Asia Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
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Key Questions Answered in the Report

What is the current size of the sterile filtration market?

The sterile filtration market is valued at USD 9.1 billion in 2025 and is projected to grow to USD 14.0 billion by 2030.

Which product type leads the sterile filtration market?

Cartridge filters lead with 31.8% share in 2024, while capsule filters are growing fastest at a 10.4% CAGR.

Why is Asia Pacific the fastest-growing region?

Large-scale investments by Samsung Biologics, Cytiva, and others are boosting biopharmaceutical capacity and driving filtration demand.

How are Annex 1 revisions affecting filtration suppliers?

The new guidelines increase integrity-testing frequency and validation documentation, favoring suppliers with advanced monitoring and compliance services.

Which end-user group is expanding the quickest?

CDMOs are forecast to rise at 12.9% CAGR as pharmaceutical companies outsource more manufacturing activities.

Page last updated on: July 1, 2025

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