The WFI generation system refers to a system specially designed for the preparation of highly purified water in the field of pharmaceutical manufacturing. This water is suitable for the preparation of injections and other pharmaceutical applications that have strict sterility and purity requirements for water quality. The system includes pretreatment of raw water, deep purification steps using advanced technologies such as multiple-effect distillation and steam compression distillation, as well as aseptic storage and distribution under aseptic conditions, while integrating a comprehensive quality monitoring and management system to ensure that the generated WFI fully complies with international pharmacopoeia standards.
The global WFI Generation System market was valued at US$ 187 million in 2023 and is anticipated to reach US$ 244 million by 2030, witnessing a CAGR of 3.9% during the forecast period 2024-2030.
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 掳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.
Report Scope
This report aims to provide a comprehensive presentation of the global market for WFI Generation System, with both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding WFI Generation System.
The WFI Generation System market size, estimations, and forecasts are provided in terms of output/shipments (Units) and revenue ($ millions), considering 2023 as the base year, with history and forecast data for the period from 2019 to 2030. This report segments the global WFI Generation System market comprehensively. Regional market sizes, concerning products by Type, by Application, and by players, are also provided.
For a more in-depth understanding of the market, the report provides profiles of the competitive landscape, key competitors, and their respective market ranks. The report also discusses technological trends and new product developments.
The report will help the WFI Generation System manufacturers, new entrants, and industry chain related companies in this market with information on the revenues, production, and average price for the overall market and the sub-segments across the different segments, by company, by Type, by Application, and by regions.
Market Segmentation
By Company
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
by Type
Distillation System
Membrane System
by Application
Pharmaceutical
Biotechnology
Other
Production by Region
North America
Europe
China
Japan
Consumption by Region
North America
U.S.
Canada
Asia-Pacific
China
Japan
South Korea
China Taiwan
Southeast Asia
India
Europe
Germany
France
U.K.
Italy
Russia
Rest of Europe
Latin America, Middle East & Africa
Mexico
Brazil
Turkey
GCC Countries
Chapter Outline
Chapter 1: Introduces the report scope of the report, executive summary of different market segments (by region, by Type, by Application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter 2: Detailed analysis of WFI Generation System manufacturers competitive landscape, price, production and value market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: Production/output, value of WFI Generation System by region/country. It provides a quantitative analysis of the market size and development potential of each region in the next six years.
Chapter 4: Consumption of WFI Generation System in regional level and country level. It provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and production of each country in the world.
Chapter 5: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 6: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product production/output, value, price, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 10: The main points and conclusions of the report.
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1 WFI Generation System Market Overview
1.1 Product Definition
1.2 WFI Generation System by Type
1.2.1 Global WFI Generation System Market Value Growth Rate Analysis by Type: 2023 VS 2030
1.2.2 Distillation System
1.2.3 Membrane System
1.3 WFI Generation System by Application
1.3.1 Global WFI Generation System Market Value Growth Rate Analysis by Application: 2023 VS 2030
1.3.2 Pharmaceutical
1.3.3 Biotechnology
1.3.4 Other
1.4 Global Market Growth Prospects
1.4.1 Global WFI Generation System Production Value Estimates and Forecasts (2019-2030)
1.4.2 Global WFI Generation System Production Capacity Estimates and Forecasts (2019-2030)
1.4.3 Global WFI Generation System Production Estimates and Forecasts (2019-2030)
1.4.4 Global WFI Generation System Market Average Price Estimates and Forecasts (2019-2030)
1.5 Assumptions and Limitations
2 Market Competition by Manufacturers
2.1 Global WFI Generation System Production Market Share by Manufacturers (2019-2024)
2.2 Global WFI Generation System Production Value Market Share by Manufacturers (2019-2024)
2.3 Global Key Players of WFI Generation System, Industry Ranking, 2022 VS 2023
2.4 Global WFI Generation System Market Share by Company Type (Tier 1, Tier 2, and Tier 3)
2.5 Global WFI Generation System Average Price by Manufacturers (2019-2024)
2.6 Global Key Manufacturers of WFI Generation System, Manufacturing Sites & Headquarters
2.7 Global Key Manufacturers of WFI Generation System, Product Type & Application
2.8 Global Key Manufacturers of WFI Generation System, Date of Enter into This Industry
2.9 Global WFI Generation System Market Competitive Situation and Trends
2.9.1 Global WFI Generation System Market Concentration Rate
2.9.2 Global 5 and 10 Largest WFI Generation System Players Market Share by Revenue
2.10 Mergers & Acquisitions, Expansion
3 WFI Generation System Production by Region
3.1 Global WFI Generation System Production Value Estimates and Forecasts by Region: 2019 VS 2023 VS 2030
3.2 Global WFI Generation System Production Value by Region (2019-2030)
3.2.1 Global WFI Generation System Production Value Market Share by Region (2019-2024)
3.2.2 Global Forecasted Production Value of WFI Generation System by Region (2025-2030)
3.3 Global WFI Generation System Production Estimates and Forecasts by Region: 2019 VS 2023 VS 2030
3.4 Global WFI Generation System Production by Region (2019-2030)
3.4.1 Global WFI Generation System Production Market Share by Region (2019-2024)
3.4.2 Global Forecasted Production of WFI Generation System by Region (2025-2030)
3.5 Global WFI Generation System Market Price Analysis by Region (2019-2024)
3.6 Global WFI Generation System Production and Value, Year-over-Year Growth
3.6.1 North America WFI Generation System Production Value Estimates and Forecasts (2019-2030)
3.6.2 Europe WFI Generation System Production Value Estimates and Forecasts (2019-2030)
3.6.3 China WFI Generation System Production Value Estimates and Forecasts (2019-2030)
3.6.4 Japan WFI Generation System Production Value Estimates and Forecasts (2019-2030)
4 WFI Generation System Consumption by Region
4.1 Global WFI Generation System Consumption Estimates and Forecasts by Region: 2019 VS 2023 VS 2030
4.2 Global WFI Generation System Consumption by Region (2019-2030)
4.2.1 Global WFI Generation System Consumption by Region (2019-2030)
4.2.2 Global WFI Generation System Forecasted Consumption by Region (2025-2030)
4.3 North America
4.3.1 North America WFI Generation System Consumption Growth Rate by Country: 2019 VS 2023 VS 2030
4.3.2 North America WFI Generation System Consumption by Country (2019-2030)
4.3.3 U.S.
4.3.4 Canada
4.4 Europe
4.4.1 Europe WFI Generation System Consumption Growth Rate by Country: 2019 VS 2023 VS 2030
4.4.2 Europe WFI Generation System Consumption by Country (2019-2030)
4.4.3 Germany
4.4.4 France
4.4.5 U.K.
4.4.6 Italy
4.4.7 Netherlands
4.5 Asia Pacific
4.5.1 Asia Pacific WFI Generation System Consumption Growth Rate by Country: 2019 VS 2023 VS 2030
4.5.2 Asia Pacific WFI Generation System Consumption by Region (2019-2030)
4.5.3 China
4.5.4 Japan
4.5.5 South Korea
4.5.6 China Taiwan
4.5.7 Southeast Asia
4.5.8 India
4.6 Latin America, Middle East & Africa
4.6.1 Latin America, Middle East & Africa WFI Generation System Consumption Growth Rate by Country: 2019 VS 2023 VS 2030
4.6.2 Latin America, Middle East & Africa WFI Generation System Consumption by Country (2019-2030)
4.6.3 Mexico
4.6.4 Brazil
4.6.5 Turkey
4.6.6 GCC Countries
5 Segment by Type
5.1 Global WFI Generation System Production by Type (2019-2030)
5.1.1 Global WFI Generation System Production by Type (2019-2024)
5.1.2 Global WFI Generation System Production by Type (2025-2030)
5.1.3 Global WFI Generation System Production Market Share by Type (2019-2030)
5.2 Global WFI Generation System Production Value by Type (2019-2030)
5.2.1 Global WFI Generation System Production Value by Type (2019-2024)
5.2.2 Global WFI Generation System Production Value by Type (2025-2030)
5.2.3 Global WFI Generation System Production Value Market Share by Type (2019-2030)
5.3 Global WFI Generation System Price by Type (2019-2030)
6 Segment by Application
6.1 Global WFI Generation System Production by Application (2019-2030)
6.1.1 Global WFI Generation System Production by Application (2019-2024)
6.1.2 Global WFI Generation System Production by Application (2025-2030)
6.1.3 Global WFI Generation System Production Market Share by Application (2019-2030)
6.2 Global WFI Generation System Production Value by Application (2019-2030)
6.2.1 Global WFI Generation System Production Value by Application (2019-2024)
6.2.2 Global WFI Generation System Production Value by Application (2025-2030)
6.2.3 Global WFI Generation System Production Value Market Share by Application (2019-2030)
6.3 Global WFI Generation System Price by Application (2019-2030)
7 Key Companies Profiled
7.1 Stilmas
7.1.1 Stilmas WFI Generation System Company Information
7.1.2 Stilmas WFI Generation System Product Portfolio
7.1.3 Stilmas WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.1.4 Stilmas Main Business and Markets Served
7.1.5 Stilmas Recent Developments/Updates
7.2 BWT
7.2.1 BWT WFI Generation System Company Information
7.2.2 BWT WFI Generation System Product Portfolio
7.2.3 BWT WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.2.4 BWT Main Business and Markets Served
7.2.5 BWT Recent Developments/Updates
7.3 MECO
7.3.1 MECO WFI Generation System Company Information
7.3.2 MECO WFI Generation System Product Portfolio
7.3.3 MECO WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.3.4 MECO Main Business and Markets Served
7.3.5 MECO Recent Developments/Updates
7.4 STERIS
7.4.1 STERIS WFI Generation System Company Information
7.4.2 STERIS WFI Generation System Product Portfolio
7.4.3 STERIS WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.4.4 STERIS Main Business and Markets Served
7.4.5 STERIS Recent Developments/Updates
7.5 Veolia Water Technologies
7.5.1 Veolia Water Technologies WFI Generation System Company Information
7.5.2 Veolia Water Technologies WFI Generation System Product Portfolio
7.5.3 Veolia Water Technologies WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.5.4 Veolia Water Technologies Main Business and Markets Served
7.5.5 Veolia Water Technologies Recent Developments/Updates
7.6 BRAM-COR
7.6.1 BRAM-COR WFI Generation System Company Information
7.6.2 BRAM-COR WFI Generation System Product Portfolio
7.6.3 BRAM-COR WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.6.4 BRAM-COR Main Business and Markets Served
7.6.5 BRAM-COR Recent Developments/Updates
7.7 Syntegon
7.7.1 Syntegon WFI Generation System Company Information
7.7.2 Syntegon WFI Generation System Product Portfolio
7.7.3 Syntegon WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.7.4 Syntegon Main Business and Markets Served
7.7.5 Syntegon Recent Developments/Updates
7.8 Aqua-Chem
7.8.1 Aqua-Chem WFI Generation System Company Information
7.8.2 Aqua-Chem WFI Generation System Product Portfolio
7.8.3 Aqua-Chem WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.8.4 Aqua-Chem Main Business and Markets Served
7.8.5 Aqua-Chem Recent Developments/Updates
7.9 Evoqua Water Technologies
7.9.1 Evoqua Water Technologies WFI Generation System Company Information
7.9.2 Evoqua Water Technologies WFI Generation System Product Portfolio
7.9.3 Evoqua Water Technologies WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.9.4 Evoqua Water Technologies Main Business and Markets Served
7.9.5 Evoqua Water Technologies Recent Developments/Updates
7.10 Truking Technology
7.10.1 Truking Technology WFI Generation System Company Information
7.10.2 Truking Technology WFI Generation System Product Portfolio
7.10.3 Truking Technology WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.10.4 Truking Technology Main Business and Markets Served
7.10.5 Truking Technology Recent Developments/Updates
7.11 Shenzhen Carryclean
7.11.1 Shenzhen Carryclean WFI Generation System Company Information
7.11.2 Shenzhen Carryclean WFI Generation System Product Portfolio
7.11.3 Shenzhen Carryclean WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.11.4 Shenzhen Carryclean Main Business and Markets Served
7.11.5 Shenzhen Carryclean Recent Developments/Updates
7.12 Shanghai GenTech
7.12.1 Shanghai GenTech WFI Generation System Company Information
7.12.2 Shanghai GenTech WFI Generation System Product Portfolio
7.12.3 Shanghai GenTech WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.12.4 Shanghai GenTech Main Business and Markets Served
7.12.5 Shanghai GenTech Recent Developments/Updates
7.13 Puretech Process Systems
7.13.1 Puretech Process Systems WFI Generation System Company Information
7.13.2 Puretech Process Systems WFI Generation System Product Portfolio
7.13.3 Puretech Process Systems WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.13.4 Puretech Process Systems Main Business and Markets Served
7.13.5 Puretech Process Systems Recent Developments/Updates
7.14 Fabtech Technologies
7.14.1 Fabtech Technologies WFI Generation System Company Information
7.14.2 Fabtech Technologies WFI Generation System Product Portfolio
7.14.3 Fabtech Technologies WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.14.4 Fabtech Technologies Main Business and Markets Served
7.14.5 Fabtech Technologies Recent Developments/Updates
7.15 Organo
7.15.1 Organo WFI Generation System Company Information
7.15.2 Organo WFI Generation System Product Portfolio
7.15.3 Organo WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.15.4 Organo Main Business and Markets Served
7.15.5 Organo Recent Developments/Updates
7.16 NGK Filtech
7.16.1 NGK Filtech WFI Generation System Company Information
7.16.2 NGK Filtech WFI Generation System Product Portfolio
7.16.3 NGK Filtech WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.16.4 NGK Filtech Main Business and Markets Served
7.16.5 NGK Filtech Recent Developments/Updates
7.17 TSA Process Equipments
7.17.1 TSA Process Equipments WFI Generation System Company Information
7.17.2 TSA Process Equipments WFI Generation System Product Portfolio
7.17.3 TSA Process Equipments WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.17.4 TSA Process Equipments Main Business and Markets Served
7.17.5 TSA Process Equipments Recent Developments/Updates
7.18 Nihon Rosuiki Kogyo
7.18.1 Nihon Rosuiki Kogyo WFI Generation System Company Information
7.18.2 Nihon Rosuiki Kogyo WFI Generation System Product Portfolio
7.18.3 Nihon Rosuiki Kogyo WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.18.4 Nihon Rosuiki Kogyo Main Business and Markets Served
7.18.5 Nihon Rosuiki Kogyo Recent Developments/Updates
7.19 Nomura Micro Science
7.19.1 Nomura Micro Science WFI Generation System Company Information
7.19.2 Nomura Micro Science WFI Generation System Product Portfolio
7.19.3 Nomura Micro Science WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.19.4 Nomura Micro Science Main Business and Markets Served
7.19.5 Nomura Micro Science Recent Developments/Updates
7.20 Haedong Technology
7.20.1 Haedong Technology WFI Generation System Company Information
7.20.2 Haedong Technology WFI Generation System Product Portfolio
7.20.3 Haedong Technology WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.20.4 Haedong Technology Main Business and Markets Served
7.20.5 Haedong Technology Recent Developments/Updates
7.21 JUNGHYUN PLANT
7.21.1 JUNGHYUN PLANT WFI Generation System Company Information
7.21.2 JUNGHYUN PLANT WFI Generation System Product Portfolio
7.21.3 JUNGHYUN PLANT WFI Generation System Production, Value, Price and Gross Margin (2019-2024)
7.21.4 JUNGHYUN PLANT Main Business and Markets Served
7.21.5 JUNGHYUN PLANT Recent Developments/Updates
8 Industry Chain and Sales Channels Analysis
8.1 WFI Generation System Industry Chain Analysis
8.2 WFI Generation System Key Raw Materials
8.2.1 Key Raw Materials
8.2.2 Raw Materials Key Suppliers
8.3 WFI Generation System Production Mode & Process
8.4 WFI Generation System Sales and Marketing
8.4.1 WFI Generation System Sales Channels
8.4.2 WFI Generation System Distributors
8.5 WFI Generation System Customers
9 WFI Generation System Market Dynamics
9.1 WFI Generation System Industry Trends
9.2 WFI Generation System Market Drivers
9.3 WFI Generation System Market Challenges
9.4 WFI Generation System Market Restraints
10 Research Findings and Conclusion
11 Methodology and Data Source
11.1 Methodology/Research Approach
11.1.1 Research Programs/Design
11.1.2 Market Size Estimation
11.1.3 Market Breakdown and Data Triangulation
11.2 Data Source
11.2.1 Secondary Sources
11.2.2 Primary Sources
11.3 Author List
11.4 Disclaimer
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
听
听
*If Applicable.