The global Water for Injection (WFI) System market size is predicted to grow from US$ 195 million in 2025 to US$ 248 million in 2031; it is expected to grow at a CAGR of 4.1% from 2025 to 2031.
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.
The “Water for Injection (WFI) System Industry Forecast” looks at past sales and reviews total world Water for Injection (WFI) System sales in 2024, providing a comprehensive analysis by region and market sector of projected Water for Injection (WFI) System sales for 2025 through 2031. With Water for Injection (WFI) System sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Water for Injection (WFI) System industry.
This Insight Report provides a comprehensive analysis of the global Water for Injection (WFI) System landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyzes the strategies of leading global companies with a focus on Water for Injection (WFI) System portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms’ unique position in an accelerating global Water for Injection (WFI) System market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Water for Injection (WFI) System and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Water for Injection (WFI) System.
This report presents a comprehensive overview, market shares, and growth opportunities of Water for Injection (WFI) System market by product type, application, key manufacturers and key regions and countries.
Segmentation by Type:
Distillation System
Membrane System
Segmentation by Application:
Pharmaceutical
Biotechnology
Other
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analysing the company's coverage, product portfolio, its market penetration.
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
Key Questions Addressed in this Report
What is the 10-year outlook for the global Water for Injection (WFI) System market?
What factors are driving Water for Injection (WFI) System market growth, globally and by region?
Which technologies are poised for the fastest growth by market and region?
How do Water for Injection (WFI) System market opportunities vary by end market size?
How does Water for Injection (WFI) System break out by Type, by Application?
Please Note - This is an on demand report and will be delivered in 2 business days (48 hours) post payment.
1 Scope of the Report
1.1 Market Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 Market Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 Market Estimation Caveats
2 Executive Summary
2.1 World Market Overview
2.1.1 Global Water for Injection (WFI) System Annual Sales 2020-2031
2.1.2 World Current & Future Analysis for Water for Injection (WFI) System by Geographic Region, 2020, 2024 & 2031
2.1.3 World Current & Future Analysis for Water for Injection (WFI) System by Country/Region, 2020, 2024 & 2031
2.2 Water for Injection (WFI) System Segment by Type
2.2.1 Distillation System
2.2.2 Membrane System
2.3 Water for Injection (WFI) System Sales by Type
2.3.1 Global Water for Injection (WFI) System Sales Market Share by Type (2020-2025)
2.3.2 Global Water for Injection (WFI) System Revenue and Market Share by Type (2020-2025)
2.3.3 Global Water for Injection (WFI) System Sale Price by Type (2020-2025)
2.4 Water for Injection (WFI) System Segment by Application
2.4.1 Pharmaceutical
2.4.2 Biotechnology
2.4.3 Other
2.5 Water for Injection (WFI) System Sales by Application
2.5.1 Global Water for Injection (WFI) System Sale Market Share by Application (2020-2025)
2.5.2 Global Water for Injection (WFI) System Revenue and Market Share by Application (2020-2025)
2.5.3 Global Water for Injection (WFI) System Sale Price by Application (2020-2025)
3 Global by Company
3.1 Global Water for Injection (WFI) System Breakdown Data by Company
3.1.1 Global Water for Injection (WFI) System Annual Sales by Company (2020-2025)
3.1.2 Global Water for Injection (WFI) System Sales Market Share by Company (2020-2025)
3.2 Global Water for Injection (WFI) System Annual Revenue by Company (2020-2025)
3.2.1 Global Water for Injection (WFI) System Revenue by Company (2020-2025)
3.2.2 Global Water for Injection (WFI) System Revenue Market Share by Company (2020-2025)
3.3 Global Water for Injection (WFI) System Sale Price by Company
3.4 Key Manufacturers Water for Injection (WFI) System Producing Area Distribution, Sales Area, Product Type
3.4.1 Key Manufacturers Water for Injection (WFI) System Product Location Distribution
3.4.2 Players Water for Injection (WFI) System Products Offered
3.5 Market Concentration Rate Analysis
3.5.1 Competition Landscape Analysis
3.5.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.6 New Products and Potential Entrants
3.7 Market M&A Activity & Strategy
4 World Historic Review for Water for Injection (WFI) System by Geographic Region
4.1 World Historic Water for Injection (WFI) System Market Size by Geographic Region (2020-2025)
4.1.1 Global Water for Injection (WFI) System Annual Sales by Geographic Region (2020-2025)
4.1.2 Global Water for Injection (WFI) System Annual Revenue by Geographic Region (2020-2025)
4.2 World Historic Water for Injection (WFI) System Market Size by Country/Region (2020-2025)
4.2.1 Global Water for Injection (WFI) System Annual Sales by Country/Region (2020-2025)
4.2.2 Global Water for Injection (WFI) System Annual Revenue by Country/Region (2020-2025)
4.3 Americas Water for Injection (WFI) System Sales Growth
4.4 APAC Water for Injection (WFI) System Sales Growth
4.5 Europe Water for Injection (WFI) System Sales Growth
4.6 Middle East & Africa Water for Injection (WFI) System Sales Growth
5 Americas
5.1 Americas Water for Injection (WFI) System Sales by Country
5.1.1 Americas Water for Injection (WFI) System Sales by Country (2020-2025)
5.1.2 Americas Water for Injection (WFI) System Revenue by Country (2020-2025)
5.2 Americas Water for Injection (WFI) System Sales by Type (2020-2025)
5.3 Americas Water for Injection (WFI) System Sales by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Water for Injection (WFI) System Sales by Region
6.1.1 APAC Water for Injection (WFI) System Sales by Region (2020-2025)
6.1.2 APAC Water for Injection (WFI) System Revenue by Region (2020-2025)
6.2 APAC Water for Injection (WFI) System Sales by Type (2020-2025)
6.3 APAC Water for Injection (WFI) System Sales by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
6.10 China Taiwan
7 Europe
7.1 Europe Water for Injection (WFI) System by Country
7.1.1 Europe Water for Injection (WFI) System Sales by Country (2020-2025)
7.1.2 Europe Water for Injection (WFI) System Revenue by Country (2020-2025)
7.2 Europe Water for Injection (WFI) System Sales by Type (2020-2025)
7.3 Europe Water for Injection (WFI) System Sales by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Water for Injection (WFI) System by Country
8.1.1 Middle East & Africa Water for Injection (WFI) System Sales by Country (2020-2025)
8.1.2 Middle East & Africa Water for Injection (WFI) System Revenue by Country (2020-2025)
8.2 Middle East & Africa Water for Injection (WFI) System Sales by Type (2020-2025)
8.3 Middle East & Africa Water for Injection (WFI) System Sales by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 Market Drivers, Challenges and Trends
9.1 Market Drivers & Growth Opportunities
9.2 Market Challenges & Risks
9.3 Industry Trends
10 Manufacturing Cost Structure Analysis
10.1 Raw Material and Suppliers
10.2 Manufacturing Cost Structure Analysis of Water for Injection (WFI) System
10.3 Manufacturing Process Analysis of Water for Injection (WFI) System
10.4 Industry Chain Structure of Water for Injection (WFI) System
11 Marketing, Distributors and Customer
11.1 Sales Channel
11.1.1 Direct Channels
11.1.2 Indirect Channels
11.2 Water for Injection (WFI) System Distributors
11.3 Water for Injection (WFI) System Customer
12 World Forecast Review for Water for Injection (WFI) System by Geographic Region
12.1 Global Water for Injection (WFI) System Market Size Forecast by Region
12.1.1 Global Water for Injection (WFI) System Forecast by Region (2026-2031)
12.1.2 Global Water for Injection (WFI) System Annual Revenue Forecast by Region (2026-2031)
12.2 Americas Forecast by Country (2026-2031)
12.3 APAC Forecast by Region (2026-2031)
12.4 Europe Forecast by Country (2026-2031)
12.5 Middle East & Africa Forecast by Country (2026-2031)
12.6 Global Water for Injection (WFI) System Forecast by Type (2026-2031)
12.7 Global Water for Injection (WFI) System Forecast by Application (2026-2031)
13 Key Players Analysis
13.1 Stilmas
13.1.1 Stilmas Company Information
13.1.2 Stilmas Water for Injection (WFI) System Product Portfolios and Specifications
13.1.3 Stilmas Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.1.4 Stilmas Main Business Overview
13.1.5 Stilmas Latest Developments
13.2 BWT
13.2.1 BWT Company Information
13.2.2 BWT Water for Injection (WFI) System Product Portfolios and Specifications
13.2.3 BWT Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.2.4 BWT Main Business Overview
13.2.5 BWT Latest Developments
13.3 MECO
13.3.1 MECO Company Information
13.3.2 MECO Water for Injection (WFI) System Product Portfolios and Specifications
13.3.3 MECO Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.3.4 MECO Main Business Overview
13.3.5 MECO Latest Developments
13.4 STERIS
13.4.1 STERIS Company Information
13.4.2 STERIS Water for Injection (WFI) System Product Portfolios and Specifications
13.4.3 STERIS Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.4.4 STERIS Main Business Overview
13.4.5 STERIS Latest Developments
13.5 Veolia Water Technologies
13.5.1 Veolia Water Technologies Company Information
13.5.2 Veolia Water Technologies Water for Injection (WFI) System Product Portfolios and Specifications
13.5.3 Veolia Water Technologies Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.5.4 Veolia Water Technologies Main Business Overview
13.5.5 Veolia Water Technologies Latest Developments
13.6 BRAM-COR
13.6.1 BRAM-COR Company Information
13.6.2 BRAM-COR Water for Injection (WFI) System Product Portfolios and Specifications
13.6.3 BRAM-COR Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.6.4 BRAM-COR Main Business Overview
13.6.5 BRAM-COR Latest Developments
13.7 Syntegon
13.7.1 Syntegon Company Information
13.7.2 Syntegon Water for Injection (WFI) System Product Portfolios and Specifications
13.7.3 Syntegon Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.7.4 Syntegon Main Business Overview
13.7.5 Syntegon Latest Developments
13.8 Aqua-Chem
13.8.1 Aqua-Chem Company Information
13.8.2 Aqua-Chem Water for Injection (WFI) System Product Portfolios and Specifications
13.8.3 Aqua-Chem Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.8.4 Aqua-Chem Main Business Overview
13.8.5 Aqua-Chem Latest Developments
13.9 Evoqua Water Technologies
13.9.1 Evoqua Water Technologies Company Information
13.9.2 Evoqua Water Technologies Water for Injection (WFI) System Product Portfolios and Specifications
13.9.3 Evoqua Water Technologies Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.9.4 Evoqua Water Technologies Main Business Overview
13.9.5 Evoqua Water Technologies Latest Developments
13.10 Truking Technology
13.10.1 Truking Technology Company Information
13.10.2 Truking Technology Water for Injection (WFI) System Product Portfolios and Specifications
13.10.3 Truking Technology Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.10.4 Truking Technology Main Business Overview
13.10.5 Truking Technology Latest Developments
13.11 Shenzhen Carryclean
13.11.1 Shenzhen Carryclean Company Information
13.11.2 Shenzhen Carryclean Water for Injection (WFI) System Product Portfolios and Specifications
13.11.3 Shenzhen Carryclean Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.11.4 Shenzhen Carryclean Main Business Overview
13.11.5 Shenzhen Carryclean Latest Developments
13.12 Shanghai GenTech
13.12.1 Shanghai GenTech Company Information
13.12.2 Shanghai GenTech Water for Injection (WFI) System Product Portfolios and Specifications
13.12.3 Shanghai GenTech Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.12.4 Shanghai GenTech Main Business Overview
13.12.5 Shanghai GenTech Latest Developments
13.13 Puretech Process Systems
13.13.1 Puretech Process Systems Company Information
13.13.2 Puretech Process Systems Water for Injection (WFI) System Product Portfolios and Specifications
13.13.3 Puretech Process Systems Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.13.4 Puretech Process Systems Main Business Overview
13.13.5 Puretech Process Systems Latest Developments
13.14 Fabtech Technologies
13.14.1 Fabtech Technologies Company Information
13.14.2 Fabtech Technologies Water for Injection (WFI) System Product Portfolios and Specifications
13.14.3 Fabtech Technologies Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.14.4 Fabtech Technologies Main Business Overview
13.14.5 Fabtech Technologies Latest Developments
13.15 Organo
13.15.1 Organo Company Information
13.15.2 Organo Water for Injection (WFI) System Product Portfolios and Specifications
13.15.3 Organo Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.15.4 Organo Main Business Overview
13.15.5 Organo Latest Developments
13.16 NGK Filtech
13.16.1 NGK Filtech Company Information
13.16.2 NGK Filtech Water for Injection (WFI) System Product Portfolios and Specifications
13.16.3 NGK Filtech Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.16.4 NGK Filtech Main Business Overview
13.16.5 NGK Filtech Latest Developments
13.17 TSA Process Equipments
13.17.1 TSA Process Equipments Company Information
13.17.2 TSA Process Equipments Water for Injection (WFI) System Product Portfolios and Specifications
13.17.3 TSA Process Equipments Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.17.4 TSA Process Equipments Main Business Overview
13.17.5 TSA Process Equipments Latest Developments
13.18 Nihon Rosuiki Kogyo
13.18.1 Nihon Rosuiki Kogyo Company Information
13.18.2 Nihon Rosuiki Kogyo Water for Injection (WFI) System Product Portfolios and Specifications
13.18.3 Nihon Rosuiki Kogyo Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.18.4 Nihon Rosuiki Kogyo Main Business Overview
13.18.5 Nihon Rosuiki Kogyo Latest Developments
13.19 Nomura Micro Science
13.19.1 Nomura Micro Science Company Information
13.19.2 Nomura Micro Science Water for Injection (WFI) System Product Portfolios and Specifications
13.19.3 Nomura Micro Science Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.19.4 Nomura Micro Science Main Business Overview
13.19.5 Nomura Micro Science Latest Developments
13.20 Haedong Technology
13.20.1 Haedong Technology Company Information
13.20.2 Haedong Technology Water for Injection (WFI) System Product Portfolios and Specifications
13.20.3 Haedong Technology Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.20.4 Haedong Technology Main Business Overview
13.20.5 Haedong Technology Latest Developments
13.21 JUNGHYUN PLANT
13.21.1 JUNGHYUN PLANT Company Information
13.21.2 JUNGHYUN PLANT Water for Injection (WFI) System Product Portfolios and Specifications
13.21.3 JUNGHYUN PLANT Water for Injection (WFI) System Sales, Revenue, Price and Gross Margin (2020-2025)
13.21.4 JUNGHYUN PLANT Main Business Overview
13.21.5 JUNGHYUN PLANT Latest Developments
14 Research Findings and Conclusion
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*If Applicable.