The Market Reports

Synopsis

The global market for Water for Injection (WFI) System was estimated to be worth US$ 193 million in 2024 and is forecast to a readjusted size of US$ 252 million by 2031 with a CAGR of 4.0% during the forecast period 2025-2031.

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.

This report aims to provide a comprehensive presentation of the global market for Water for Injection (WFI) System, focusing on the total sales volume, sales revenue, price, key companies market share and ranking, together with an analysis of Water for Injection (WFI) System by region & country, by Type, and by Application.

The Water for Injection (WFI) System market size, estimations, and forecasts are provided in terms of sales volume (Unit) and sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. 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 Water for Injection (WFI) System.

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

Segment by Type

• Distillation System
• Membrane System

Segment by Application

• Pharmaceutical
• Biotechnology
• Other

Segment by Region

• North America: United States, Canada, and Mexico
• Europe: United Kingdom, Germany, France, Spain, Italy, and Rest of Europe
• Asia Pacific: China, India, Japan, Australia, South Korea, and Rest of Asia Pacific
• Middle East & Africa: Saudi Arabia, South Africa, and Rest of MEA
• Latin America: Brazil, Argentina, and Rest of Latin America

*If you need a regional or country-specific version, or customized segmentation, we can tailor the report to your requirements.