Sterile Filtration Market, by Product Type (Membrane Filters, Cartridge Filters, and Capsule Filters), by Application (Bioprocesses, Fill-finish Process, Pre-filtration, and Utilities Filtration), by Membrane Pore Size (0.1 um, 0.2 um, and 0.5 um), by End User (Pharmaceutical and Biotechnology Companies and Academic Research Institute), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : May 2019 |
  • Pages : 156 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Sterile Filtration Market – Insights

Sterile filtration is used in pharmaceutical industry to prevent microbial contamination. The process minimizes the risk of microbial contamination in patients by offering a reliable, safe, and effective way to ensure product manufacturing. An extensive range of products and formats are available from multiple vendors for a diverse range of applications. It is the most important filtration process in any pharmaceutical operation. According to the U.S. Food and Drug Administration (U.S. FDA) and the U.S. Pharmacopoeia (USP), sterile filtration is defined as a nominal rating of 0.2 µm and 0.22 µm respectively to produce sterile effluent. The objective of a sterile filtration step is the removal of any viable microorganism that may be present in the bulk product.

Sterile filtration is used for several applications such as for media with or without serum. The process supports growth of cell culture, reagents or solutions with sensitive components that may degrade when exposed to autoclave temperatures, filtering supplements, samples, buffers, and post-fermentation broths.

The global sterile filtration market size was valued at US$ 5.2 billion in 2017 and is expected to witness a CAGR of 13.3% over the forecast period (2018 – 2026).

Global Sterile Filtration Market Share (%) Analysis, By Region 2018

Source: Coherent Market Insights Analysis (2019)

Increasing investments in pharmaceuticals is expected to drive growth of the sterile filtration market

Increasing investments in pharmaceuticals and high prevalence of chronic and acute diseases are the major factors driving growth of the sterile filtration market. According to the Organisation for Economic Co-operation and Development (OECD), investment in pharmaceuticals across OECD countries was around US$ 800 billion in 2013, which accounted for around 20% of total investment in healthcare. Moreover, high demand for medicines and the introduction of new drugs are key factors responsible for increasing investments in pharmaceutical industry. According to the same source, between 2000 and 2013, the use of antidiabetic, anti-depressant, and antihypertensive medications increased double fold, while the use of cholesterol-lowering drugs tripled. These trends reflect an increasing demand for pharmaceuticals sterile filtration.

Moreover, increased prevalence of several chronic diseases such as cancer, diabetes, and mental illness has increased demand for medical treatments. For instance, according to the Cancer Research U.K., around 55,122 new cases of breast cancer were registered in the country in 2015. Furthermore, improvements in diagnosis, leading to early recognition of conditions and early treatment with medicines, along with development of novel medicines to treat common conditions have contributed to increasing consumption of medicines. Therefore, such developments in the pharmaceutical industry are driving the sterile filtration market growth.

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.

Global Sterile Filtration Market Value (US$ Mn) & Y-o-Y Growth (%)

          

 Source: Coherent Market Insights Analysis (2019)

Sterile Filtration Market - Competitive Landscape

Key players operating in the global sterile filtration market include, 3M, Merck & Co., Inc., General Electric Company, Pall Corporation, Parker Hannifin Corporation, Porvair Filtration Group, Sterlitech Corporation, Sartorius, Starlab Scientific Co., Ltd., Sigma Aldrich Corporation, and Thermo Fisher Scientific.

 

Sterile filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality. Drug sterility is important requirement in the pharmaceutical industry. Virus inactivation or removal is required for biologically derived therapeutics such as recombinant gene proteins, monoclonal antibodies, and plasma components. Moreover, membrane filtration is widely used for both bacterial removal and viral clearance.

Market Dynamics

Growth in the biopharmaceutical industry and increasing investment in research and development activities are the major factors driving the sterile filtration market growth. Moreover, high demand for biopharmaceutical molecules and increasing prevalence of diabetes and kidney failure are some of the other factors propelling growth of the market. According to a report by Pharmaceutical Research and Manufacturers of America (PhRMA), in 2015, the research-based pharmaceutical industry allots around 15% to 20% of revenue to R&D activities and invests over US$ 50 billion on R&D annually. According to the U.S Department of Commerce, the generic drug sales increased to US$ 70 billion in U.S. due to a large number of drugs going off-patent and healthcare reforms favoring generics.

However, stringent government regulations for validation of filtration process are expected to limit the sterile filtration market growth during the forecast period.

Key features of the study:

  • This report provides in-depth analysis of the global sterile filtration market, market size (US$ Mn), and compound annual growth rate (CAGR (%)) for the forecast period: 2018 – 2026, considering 2017 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by the key players
  • It profiles key players in the global sterile filtration market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key players covered as a part of this study include, 3M, Merck & Co., Inc., General Electric Company, Pall Corporation, Parker Hannifin Corporation, Porvair Filtration Group, Sterlitech Corporation, Sartorius, Starlab Scientific Co., Ltd., Sigma Aldrich Corporation, and Thermo Fisher Scientific.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, governmental initiatives, technological up-gradation, market expansion, and marketing tactics
  • The global sterile filtration market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors and suppliers for sterile filtration market, research and consulting firms, new entrants, and financial analysts

Detailed Segmentation:

  • Global Sterile Filtration Market, By Product Type:
    • Membrane Filters
    • Cartridge Filters
    • Capsule Filters
  • Global Sterile Filtration Market, By Application:
    • Bioprocesses
    • Fill-finish Process
    • Pre-filtration
    • Utilities Filtration
  • Global Sterile Filtration Market, By Membrane Pore Size:
    • 0.1 um
    • 0.2 um
    • 0.5 um
  • Global Sterile Filtration Market, By End User:
    • Pharmaceutical and Biotechnology Companies
    • Academic Research Institute
  • Global Sterile Filtration Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
    • Europe
      • By Country:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
    • Africa
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
      • By Product Type:
        • Membrane Filters
        • Cartridge Filters
        • Capsule Filters
      • By Application:
        • Bioprocesses
        • Fill-finish Process
        • Pre-filtration
        • Utilities Filtration
      • By Membrane Pore Size:
        • 0.1 um
        • 0.2 um
        • 0.5 um
      • By End User:
        • Pharmaceutical and Biotechnology Companies
        • Academic Research Institute
  • Company Profiles
    • 3M*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Merck & Co., Inc.
    • General Electric Company
    • Pall Corporation
    • Parker Hannifin Corporation
    • Porvair Filtration Group
    • Sterlitech Corporation
    • Sartorius
    • Starlab Scientific Co., Ltd.
    • Sigma Aldrich Corporation
    • Thermo Fisher Scientific

 “*” marked represents similar segmentation in other categories in the respective section

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Overview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Product Type
      • Market Snippet, By Application
      • Market Snippet, By Membrane Pore Size
      • Market Snippet, By End User
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Market Trends
    • Key Developments
    • Technological Advancements
    • Regulatory Scenario
    • PORTER’S Five Forces
    • PEST Analysis
  4. Global Sterile Filtration Market, By Product Type, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Membrane Filters
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
      • Hydrophilic Polyvinylidene Fluoride (PVDF)
      • Polyethersulfone (PES)
      • Hydrophobic Polytetrafluoroethylene (PTFE)
    • Cartridge Filters
      • Introduction  
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Capsule Filters
      • Introduction  
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  5. Global Sterile Filtration Market, By Application, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Bioprocesses
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Fill-finish Process
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Pre-Filtration
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Utilities Filtration
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  6. Global Sterile Filtration Market, By Membrane Pore Size, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • 0.1 um
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • 0.2 um
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • 0.5 um
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  7. Global Sterile Filtration Market, By End User, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Pharmaceutical and Biotechnology Companies
      •  Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
    • Academic Research Institute
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Million)
  8. Global Sterile Filtration Market, By Region, 2016 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, By Region, 2016 – 2026
      • Regional Trends
    • North America
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • China
        • Japan
        • India
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • Northern Africa
        • Central Africa
        • South Africa
    • Middle East
      • Market Size and Forecast, By Product Type, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Application, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Membrane Pore Size, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By End User, 2016 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2016 – 2026, (US$ Million)
        • GCC Countries
        • Israel
        • Rest of Middle East
  9. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • 3M
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Merck & Co., Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • General Electric Company
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Pall Corporation
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Parker Hannifin Corporation
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Porvair Filtration Group
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Sterlitech Corporation
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Sartorius
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Starlab Scientific Co., Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Sigma Aldrich Corporation
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Thermo Fisher Scientific
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
    • Analyst Views
  10. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 47 market data tables and 36 figures on "Sterile Filtration Market” - Global forecast to 2026”.

Research Methodology

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  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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