Global Water for Injection (WFI) System Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2031
Description
According to our (Global Info Research) latest study, the global Water for Injection (WFI) System market size was valued at US$ 199 million in 2024 and is forecast to a readjusted size of USD 258 million by 2031 with a CAGR of 3.9% during review period.
A Water for Injection (WFI) System is a critical component in pharmaceutical and biotechnology manufacturing, producing high-quality purified water that meets the stringent standards required for injectable drugs, sterile formulations, and other critical applications in the industry. The WFI system typically includes processes like reverse osmosis, distillation, and filtration to remove impurities and microorganisms, ensuring the water’s purity and quality. This purified water is a key ingredient in drug formulation and is used for cleaning, sterilization, and various other pharmaceutical processes.
Biologic drugs, including mAbs and peptides, have seen tremendous growth over the past two decades, resulting in an increase in the number of injectable drug formulations. While standard tap water is purified to a level sufficient for drinking, water standards for ingredient water are very high as drugs are injected directly into the bloodstream. WFI requires high purity water that has highly controlled endotoxin levels and minimal microbial contamination.
Water for Injection (WFI) is considered a critical utility in the biopharm industry and is produced in bulk classifications described in detail within various Pharmacopeia, including the United States (USP), European (Ph. Eur.), Japanese (JP) and Chinese Pharmacopeias.
The quality specifications for WFI have long been harmonized across the United States, Europe, Japan, and China. The conductivity of WFI must be less than 1.3 microSiemens per centimeter (mS/cm) at 25 °C. All require bacterial levels to be less than 10 colony-forming units per 100 milliliters (cfu/100 mL) and endotoxin to be less than 0.25 international units (IU)/mL. Total organic carbon (TOC) must be less than 0.5 mg/L in all three compendia Europe and China require an additional maximum specification for nitrates of 0.2 ppm, which is not currently required by the United States and Japan.
WFI is used in the pharmaceutical industry to formulate parenteral drugs and for cleaning and other manufacturing operations. Because WFI can be incorporated into final drug formulations, the quality requirements are extremely high.
The most widely used WFI method is distillation; however, this method is highly capital intensive and incurs high energy costs for heating the water. To address these barriers, many pharmacopeias have allowed or are evaluating alternative technologies, and in the United States and Japan, pharmacopeia monographs have allowed other methods, as long as the same quality can be achieved. For example, reverse osmosis (RO) tend to have lower operating costs than distillation techniques, lower total capital costs, and require a smaller footprint in the facility. Following the publication of its new monograph on WFI in April 2017, the European Pharmacopoeia was brought in alignment. Reverse osmosis followed by a polishing step can be a more efficient and cost-effective solution for WFI production. However, in China, only distillation is currently allowed for the production of WFI.
This report is a detailed and comprehensive analysis for global Water for Injection (WFI) System market. Both quantitative and qualitative analyses are presented by manufacturers, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Water for Injection (WFI) System market size and forecasts, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market size and forecasts by region and country, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market size and forecasts, by Type and by Application, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market shares of main players, shipments in revenue ($ Million), sales quantity (Unit), and ASP (K US$/Unit), 2020-2025
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Water for Injection (WFI) System
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Water for Injection (WFI) System market based on the following parameters - company overview, sales quantity, revenue, price, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Stilmas, BWT, MECO, STERIS, Veolia Water Technologies, BRAM-COR, Syntegon, Aqua-Chem, Evoqua Water Technologies, Truking Technology, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market Segmentation
Water for Injection (WFI) System market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for consumption value by Type, and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
Distillation System
Membrane System
Market segment by Application
Pharmaceutical
Biotechnology
Other
Major players covered
Stilmas
BWT
MECO
STERIS
Veolia Water Technologies
BRAM-COR
Syntegon
Aqua-Chem
Evoqua Water Technologies
Truking Technology
Shenzhen Carryclean
Shanghai GenTech
Puretech Process Systems
Fabtech Technologies
Organo
NGK Filtech
TSA Process Equipments
Nihon Rosuiki Kogyo
Nomura Micro Science
Haedong Technology
JUNGHYUN PLANT
Market segment by region, regional analysis covers
North America (United States, Canada, and Mexico)
Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
South America (Brazil, Argentina, Colombia, and Rest of South America)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)
The content of the study subjects, includes a total of 15 chapters:
Chapter 1, to describe Water for Injection (WFI) System product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top manufacturers of Water for Injection (WFI) System, with price, sales quantity, revenue, and global market share of Water for Injection (WFI) System from 2020 to 2025.
Chapter 3, the Water for Injection (WFI) System competitive situation, sales quantity, revenue, and global market share of top manufacturers are analyzed emphatically by landscape contrast.
Chapter 4, the Water for Injection (WFI) System breakdown data are shown at the regional level, to show the sales quantity, consumption value, and growth by regions, from 2020 to 2031.
Chapter 5 and 6, to segment the sales by Type and by Application, with sales market share and growth rate by Type, by Application, from 2020 to 2031.
Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value, and market share for key countries in the world, from 2020 to 2025.and Water for Injection (WFI) System market forecast, by regions, by Type, and by Application, with sales and revenue, from 2026 to 2031.
Chapter 12, market dynamics, drivers, restraints, trends, and Porters Five Forces analysis.
Chapter 13, the key raw materials and key suppliers, and industry chain of Water for Injection (WFI) System.
Chapter 14 and 15, to describe Water for Injection (WFI) System sales channel, distributors, customers, research findings and conclusion.
A Water for Injection (WFI) System is a critical component in pharmaceutical and biotechnology manufacturing, producing high-quality purified water that meets the stringent standards required for injectable drugs, sterile formulations, and other critical applications in the industry. The WFI system typically includes processes like reverse osmosis, distillation, and filtration to remove impurities and microorganisms, ensuring the water’s purity and quality. This purified water is a key ingredient in drug formulation and is used for cleaning, sterilization, and various other pharmaceutical processes.
Biologic drugs, including mAbs and peptides, have seen tremendous growth over the past two decades, resulting in an increase in the number of injectable drug formulations. While standard tap water is purified to a level sufficient for drinking, water standards for ingredient water are very high as drugs are injected directly into the bloodstream. WFI requires high purity water that has highly controlled endotoxin levels and minimal microbial contamination.
Water for Injection (WFI) is considered a critical utility in the biopharm industry and is produced in bulk classifications described in detail within various Pharmacopeia, including the United States (USP), European (Ph. Eur.), Japanese (JP) and Chinese Pharmacopeias.
The quality specifications for WFI have long been harmonized across the United States, Europe, Japan, and China. The conductivity of WFI must be less than 1.3 microSiemens per centimeter (mS/cm) at 25 °C. All require bacterial levels to be less than 10 colony-forming units per 100 milliliters (cfu/100 mL) and endotoxin to be less than 0.25 international units (IU)/mL. Total organic carbon (TOC) must be less than 0.5 mg/L in all three compendia Europe and China require an additional maximum specification for nitrates of 0.2 ppm, which is not currently required by the United States and Japan.
WFI is used in the pharmaceutical industry to formulate parenteral drugs and for cleaning and other manufacturing operations. Because WFI can be incorporated into final drug formulations, the quality requirements are extremely high.
The most widely used WFI method is distillation; however, this method is highly capital intensive and incurs high energy costs for heating the water. To address these barriers, many pharmacopeias have allowed or are evaluating alternative technologies, and in the United States and Japan, pharmacopeia monographs have allowed other methods, as long as the same quality can be achieved. For example, reverse osmosis (RO) tend to have lower operating costs than distillation techniques, lower total capital costs, and require a smaller footprint in the facility. Following the publication of its new monograph on WFI in April 2017, the European Pharmacopoeia was brought in alignment. Reverse osmosis followed by a polishing step can be a more efficient and cost-effective solution for WFI production. However, in China, only distillation is currently allowed for the production of WFI.
This report is a detailed and comprehensive analysis for global Water for Injection (WFI) System market. Both quantitative and qualitative analyses are presented by manufacturers, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Water for Injection (WFI) System market size and forecasts, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market size and forecasts by region and country, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market size and forecasts, by Type and by Application, in consumption value ($ Million), sales quantity (Unit), and average selling prices (K US$/Unit), 2020-2031
Global Water for Injection (WFI) System market shares of main players, shipments in revenue ($ Million), sales quantity (Unit), and ASP (K US$/Unit), 2020-2025
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Water for Injection (WFI) System
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Water for Injection (WFI) System market based on the following parameters - company overview, sales quantity, revenue, price, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include Stilmas, BWT, MECO, STERIS, Veolia Water Technologies, BRAM-COR, Syntegon, Aqua-Chem, Evoqua Water Technologies, Truking Technology, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market Segmentation
Water for Injection (WFI) System market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for consumption value by Type, and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
Distillation System
Membrane System
Market segment by Application
Pharmaceutical
Biotechnology
Other
Major players covered
Stilmas
BWT
MECO
STERIS
Veolia Water Technologies
BRAM-COR
Syntegon
Aqua-Chem
Evoqua Water Technologies
Truking Technology
Shenzhen Carryclean
Shanghai GenTech
Puretech Process Systems
Fabtech Technologies
Organo
NGK Filtech
TSA Process Equipments
Nihon Rosuiki Kogyo
Nomura Micro Science
Haedong Technology
JUNGHYUN PLANT
Market segment by region, regional analysis covers
North America (United States, Canada, and Mexico)
Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
South America (Brazil, Argentina, Colombia, and Rest of South America)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)
The content of the study subjects, includes a total of 15 chapters:
Chapter 1, to describe Water for Injection (WFI) System product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top manufacturers of Water for Injection (WFI) System, with price, sales quantity, revenue, and global market share of Water for Injection (WFI) System from 2020 to 2025.
Chapter 3, the Water for Injection (WFI) System competitive situation, sales quantity, revenue, and global market share of top manufacturers are analyzed emphatically by landscape contrast.
Chapter 4, the Water for Injection (WFI) System breakdown data are shown at the regional level, to show the sales quantity, consumption value, and growth by regions, from 2020 to 2031.
Chapter 5 and 6, to segment the sales by Type and by Application, with sales market share and growth rate by Type, by Application, from 2020 to 2031.
Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value, and market share for key countries in the world, from 2020 to 2025.and Water for Injection (WFI) System market forecast, by regions, by Type, and by Application, with sales and revenue, from 2026 to 2031.
Chapter 12, market dynamics, drivers, restraints, trends, and Porters Five Forces analysis.
Chapter 13, the key raw materials and key suppliers, and industry chain of Water for Injection (WFI) System.
Chapter 14 and 15, to describe Water for Injection (WFI) System sales channel, distributors, customers, research findings and conclusion.
Table of Contents
162 Pages
- 1 Market Overview
- 2 Manufacturers Profiles
- 3 Competitive Environment: Water for Injection (WFI) System by Manufacturer
- 4 Consumption Analysis by Region
- 5 Market Segment by Type
- 6 Market Segment by Application
- 7 North America
- 8 Europe
- 9 Asia-Pacific
- 10 South America
- 11 Middle East & Africa
- 12 Market Dynamics
- 13 Raw Material and Industry Chain
- 14 Shipments by Distribution Channel
- 15 Research Findings and Conclusion
- 16 Appendix
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