PHARMACEUTICAL WATER MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Pharmaceutical Water Market Trends & Growth – 2025 to 2032

Pharmaceutical Water Market is estimated to be valued at USD 7.28 Bn in 2025 and is expected to reach USD 12.4 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of 7.9% from 2025 to 2032.

Key Takeaways

• On the basis of Product Type, the Highly Purified Water segment is acquiring the largest proportion of the global market share in 2025, driven by its essential role in drug manufacturing, equipment cleaning, and as a base component in various pharmaceutical applications.
• On the basis of Application, Cleaning and Purification segment is projected to acquire a significant proportion in the global share market, surpassing drug formulation in operational significance. This dominance is driven by stringent regulatory expectations for sterile production environments and the increasing frequency of product recalls due to microbial and cross-contamination issues.
• On the basis of End User, Pharmaceutical & Biotechnology Companies are projected to contribute a significant amount to the global market share in 2025, supported by the expansion of drug development pipelines and strict regulatory mandates for water purity in production processes.
• On the basis of Region, North America dominates the global pharmaceutical water market, accounting for 36% of the market share in 2025. This is attributed to the region's strong pharmaceutical manufacturing base, regulatory enforcement by agencies such as the FDA, and high adoption of water purification technologies.

Market Overview

The pharmaceutical water market refers to the market for highly purified water used in the pharmaceutical industry for drug formulation, cleaning and sterilization of equipment, purification, and other processes. Pharmaceutical grade water must meet stringent quality standards as per pharmacopeia monographs in order to be suitable for use in pharmaceutical processing and manufacturing. High purity water is critical for drug safety, quality, and efficacy. The pharmaceutical water market is driven by growth in pharmaceutical manufacturing, rising demand for generics and biologics, and stringent regulatory requirements for pharmaceutical water.

Key drivers of the pharmaceutical water market include rising demand for high quality water, increasing biologics and biosimilars production, stringent regulations, and growth in pharmaceutical manufacturing.

Current Events and Its Impact

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End User Feedback on Pharmaceutical Water

Pharmaceutical water is a critical raw material used in drug manufacturing, lab testing, and cleaning processes. End users (e.g., pharmaceutical manufacturers, quality control labs, regulatory bodies) often share feedback on various aspects:

Common Feedback Themes

• Water Quality Consistency
  • Users emphasize the importance of consistently meeting water quality standards (e.g., Purified Water, Water for Injection).
  • Feedback often highlights issues with fluctuations in microbial content, endotoxins, or conductivity.
• System Reliability & Maintenance
  • End users want water systems that minimize downtime and require less frequent maintenance without compromising water quality.
  • Problems include biofilm formation, membrane fouling, or corrosion affecting output quality.
• Monitoring and Control
  • Real-time, automated monitoring for critical parameters is highly valued.
  • Users want better integration of water system monitoring with plant-wide quality systems and electronic records.
• Regulatory Compliance
  • Feedback often revolves around ensuring water systems and testing comply with USP, EP, JP standards, and FDA expectations.
  • Users desire clear guidance on validation and routine monitoring practices.

Unmet Needs in Pharmaceutical Water

Despite advances, there are still gaps and unmet needs in pharmaceutical water systems

• Advanced Contaminant Detection
  • Faster, more sensitive detection methods for endotoxins, organic contaminants, and emerging impurities are needed.
  • Current microbial testing can be slow and reactive rather than proactive.
• Improved Biofilm Control
  • Biofilm formation remains a persistent challenge affecting water purity and system integrity.
  • More effective and less labor-intensive biofilm prevention or removal technologies are sought.

Segmental Insights

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Pharmaceutical Water Market Insights, By Product Type - Highly Purified Water Segment Anchors Market Growth

The highly purified water segment acquires the dominant global pharmaceutical water market share, driven by its essential role in drug manufacturing, equipment cleaning, and as a base component in various pharmaceutical applications. Purified water serves as a critical raw material in the production of non-parenteral pharmaceuticals, acting as a solvent and diluent in formulations. Its use extends to cleaning processes, ensuring that equipment and containers are free from contaminants that could compromise product quality. 

Moreover, advancements in water purification technologies, such as reverse osmosis and distillation, have enhanced the accessibility and reliability of purified water systems, supporting their widespread adoption across pharmaceutical manufacturing facilities. In line with the growing demand for high-purity water in pharmaceutical applications. CN Water, a key player in ultrapure water solutions, has extended its expertise beyond the pharmaceutical sector to support semiconductor manufacturing. The company’s expansion reflects the increasing reliance on ultrapure and purified water across precision-driven industries. In the pharmaceutical domain, CN Water has been instrumental in providing high-grade purified water systems essential for drug manufacturing, cleaning protocols, and quality assurance processes. This cross-sectoral demand reinforces the critical role of purified water and highlights the need for stringent contamination control, further driving innovation and investment in water purification technologies.

Pharmaceutical Water Market Insights, By Application - Cleaning and Purification Segment Takes the Lead Amid Heightened Regulatory and Contamination Concerns

The Cleaning and Purification segment is increasingly dominating the pharmaceutical water market, owing to its pivotal role in safeguarding product integrity and ensuring regulatory compliance across the global pharmaceutical manufacturing landscape. Unlike other applications, cleaning and purification underpin every operational layer of pharmaceutical production from sterilizing critical equipment to maintaining aseptic processing environments. Pharmaceutical-grade water, such as Water for Injection (WFI) and Purified Water (PW), is essential for cleaning vessels, production pipelines, and manufacturing surfaces, as these are potential hotspots for microbial growth and particulate contamination. In an industry where even trace residues can compromise entire batches, the emphasis on water-based cleaning systems has grown exponentially. Regulatory agencies such as the U.S. FDA and EMA have intensified inspections on cleaning validation, especially after notable incidents of cross-contamination. In India, guidelines from the Central Drugs Standard Control Organization (CDSCO) mandate stringent water quality protocols in cleaning processes, especially in sterile manufacturing zones. Violations are met with production halts or license suspensions, as seen in the 2022 shutdown of several contract manufacturing units across Himachal Pradesh, where waterborne contamination was a key factor.

Pharmaceutical Water Market Insights, By End User - Pharmaceutical & Biotechnology Companies Lead Due to Stringent Quality Requirements

Pharmaceutical & biotechnology companies are projected to contribute a significant amount to the global market share in 2025, supported by the expansion of drug development pipelines and strict regulatory mandates for water purity in production processes. These companies rely heavily on high-purity water for various applications, including drug formulation, equipment cleaning, and quality control testing. The adherence to Good Manufacturing Practices (GMP) and other regulatory standards necessitates the implementation of advanced water purification systems to ensure consistent water quality. The increasing complexity of pharmaceutical products, such as biologics and cell therapies, further underscores the need for ultrapure water in manufacturing processes. Additionally, the globalization of pharmaceutical supply chains and the establishment of manufacturing facilities in emerging markets have prompted companies to invest in robust water purification infrastructure to meet international quality standards and regulatory requirements.

Veolia Water Technologies has unveiled the latest version of its Polaris system, a high-capacity steam generation and water distillation solution designed to meet the rigorous quality and safety requirements of pharmaceutical manufacturers. Polaris systems are engineered to ensure compliance with global pharmacopeial standards while delivering consistent, high-quality water for injection (WFI) and clean steam, which are essential for equipment sanitization, and maintaining contamination-free environments. This innovation reflects the ongoing investment by pharmaceutical companies in advanced water purification infrastructure to uphold product integrity and meet evolving regulatory mandates, further propelling the pharmaceutical water market share.

Pharmaceutical Water Market Regional Insights

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North America Pharmaceutical Water Market Trends

North America is expected to be the largest market for pharmaceutical water during the forecast period, accounting for over 38.6% of the market share in 2025. The growth of the market in North America is attributed to the well-established pharmaceutical industry, growing biopharmaceutical sector, and strong regulatory landscape in the region. This leadership is driven by a well-established pharmaceutical manufacturing base, increasing biopharmaceutical developments, and the presence of strict regulatory frameworks such as those imposed by the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP). These agencies mandate stringent water quality specifications for drug formulation, compounding, and sterilization processes. Moreover, the expansion of biomanufacturing facilities such as Thermo Fisher Scientific’s USD 650 million investment to grow its biologics and sterile manufacturing capacity in North Carolina illustrates the continued demand for ultrapure water systems in the region.

Asia Pacific Pharmaceutical Water Market Trends

Asia Pacific is expected to be the fastest-growing market for pharmaceutical water, with a CAGR of over 9.2% during the forecast period. The growth of the market in Asia Pacific is attributed to the rising pharmaceutical manufacturing, increasing investments, and growing healthcare expenditure in the region. Countries such as India and China are central to this growth. India, recognized as the “pharmacy of the world,” has significantly upgraded its pharmaceutical water infrastructure in response to WHO and USFDA audit expectations. The Indian government Promotion of Bulk Drug Parks scheme, underscores the nation's commitment to bolstering pharmaceutical manufacturing infrastructure. By approving bulk drug parks in Gujarat, Himachal Pradesh, and Andhra Pradesh, the initiative aims to reduce dependency on imports for Active Pharmaceutical Ingredients (APIs) and enhance self-reliance in the pharmaceutical sector. These parks are envisioned to be equipped with state-of-the-art facilities, including advanced water treatment and purification systems, essential for maintaining the stringent quality standards required in pharmaceutical production. Such developments are poised to significantly impact the pharmaceutical water market in the Asia Pacific region, positioning India as a pivotal player in global pharmaceutical manufacturing.

United States Pharmaceutical Water Market Trends

The United States pharmaceutical water market is experiencing significant advancements driven by stringent regulatory standards, technological innovations, and a focus on sustainability. Moreover, the rising drug launch is also acting as one of the major growth-inducing factor. Glenmark Pharmaceuticals Inc, USA has announced the launch of its bioequivalent version of Adderall® a mixed-salts amphetamine product in multiple composition strengths. This development addresses the ongoing shortage of ADHD medications in the U.S. market, enhancing accessibility for patients. The production of such high-precision oral solid dosage forms necessitates stringent water quality standards, particularly for processes like granulation and tablet coating. Consequently, this underscores the critical role of purified water systems in pharmaceutical manufacturing, highlighting the importance of the pharmaceutical water market demand in ensuring product quality and compliance with regulatory standards.

Pharmaceutical Water Market Trends

India's pharmaceutical water market is experiencing significant growth, driven by the expansion of the pharmaceutical sector, increased demand for chronic therapies, and substantial investments in water infrastructure. According to an IBEF article, India’s pharmaceutical sector meets over 50% of global vaccine demand, 40% of US generic medicine demand, and 25% of all medicines in the UK. The industry comprises around 3,000 drug companies and approximately 10,500 manufacturing units. This growth underscores the increasing need for high-quality pharmaceutical water, essential for manufacturing processes, especially in chronic therapy segments such as cardiac, anti-diabetic, and central nervous system treatments. Ensuring the availability of high-quality water is pivotal for sustaining the pharmaceutical industry's expansion and meeting global quality standards.

Pharmaceutical Water Market Drivers

Advances in Water Purification Technologies

The pharmaceutical water market is benefitting from continuous advances in water purification technologies such as UV oxidation, reverse osmosis, electrodeionization, ultrafiltration, and distillation among others. Pharma companies are increasingly adopting advanced technologies capable of reliably producing water as per rigorous pharmacopeia quality requirements. The integration of novel technologies for online TOC (Total Organic Carbon) monitoring, remote system access, data analytics for predictive maintenance, and automation are key features boosting technology adoption. Thus, continuous advances are supporting the transition to newe- generation pharmaceutical water systems. In July 2022, SUEZ - Water Technologies & Solutions, a water technology company, launched DataShare Elite Software for Sievers Total Organic Carbon (TOC) Analyzers. The newly launched software will help enable centralized water quality data management across the pharmaceutical industry

Increasing Focus on Quality and Regulatory Compliance

The pharmaceutical industry is highly regulated with stringent guidelines around quality and safety. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) mandate the use of pharmaceutical-grade purified water meeting quality standards outlined in pharmacopeias. This has led to an increased focus on water quality compliance amongst pharmaceutical companies. The use of contaminated water can pose significant risks and lead to substandard drug products resulting in regulatory action. To mitigate these risks, pharma companies are proactively adopting pharmaceutical-grade water purification technologies and testing regimes. The growing regulatory burden is compelling companies to utilize high-quality water, driving the growth of the pharmaceutical water market.

Growth of Biopharmaceuticals and Biosimilars

Biopharmaceuticals including monoclonal antibodies, recombinant proteins, vaccines, and cell & gene therapies require the use of high-quality water meeting stringent purity standards at various stages of manufacturing. Further, the rising number of approved biosimilars which are the biologic equivalents of approved biologics is also contributing to market growth. Pharmaceutical water is an essential raw material used in the development and manufacturing of biologics and biosimilars. The escalating biopharma sector and subsequent increase in production capacities are thus fueling the demand for pharmaceutical-grade water.

Outsourcing of Pharmaceutical Manufacturing

An emerging trend in the pharmaceutical industry is the increased outsourcing of both clinical and commercial manufacturing to contract manufacturing organizations (CMOs) and contract development & manufacturing organizations (CDMOs). As pharmaceutical companies focus on core areas, there is substantial outsourcing of manufacturing operations including drug substances, drug products, and packaging services to third parties. CMOs/CDMOs involved in providing integrated services utilize pharmaceutical-grade water across production processes. The growth of the pharmaceutical outsourcing sector provides significant room for pharmaceutical water market expansion.

Pharmaceutical Water Market Opportunities

Increase in the Acquisitions

The market players are focused on strategies such as company acquisitions and this will create the opportunity for the market to grow in near future. For instance, in April 2022, Evoqua Water Technologies, a water treatment company serving pharmaceutical, beverage, and other industries, entered into a definitive agreement to acquire the assets of the renal business from STERIS Plc., a medical technology company. The acquisition will expand Evoqua Water Technologies' service footprint and further its reach into the healthcare vertical market.

Rising Demand in Emerging Markets

The pharmaceutical water market presents attractive growth opportunities in emerging countries such as China, India, Brazil, and Southeast Asia among others. These countries have a fast-growing pharmaceutical sector driven by expanding generic drug manufacturing coupled with large biotechnology sectors, investments in R&D infrastructure, and increasing healthcare access. Local as well as multinational pharmaceutical companies are setting up new facilities in emerging markets to cater to growing domestic and export demand. This will spur the adoption of pharmaceutical water treatment systems, providing substantial growth opportunities to manufacturers.

Market Report Scope

Pharmaceutical Water Market Report Coverage

Recent Developments

• In May 2025, Researchers at IIIT-Allahabad developed a cost-effective device capable of separating plasma from blood and purifying water, filtering contaminants as small as 2 nanometers. Priced at approximately ₹1,000, it offers an accessible solution for rural healthcare settings.
• In March 2025, ANGEL unveiled the AIMS (ANGEL Ionic Microsensor) for real-time water quality monitoring and the Long-lasting Reverse Osmosis Membrane 2.0, enhancing water purification efficiency and longevity.
• In July 2023, Nexus Pharmaceuticals, a pharmaceutical company, announced that the company’s Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials received U.S. FDA approval
• In February 2023, Evoqua Water Technologies, a water treatment company serving pharmaceutical, beverage and other industries, acquired Texas-based industrial water treatment service business of the former Bob Johnson & Associates from Kemco Systems for the expansion of the company’s presence in Texas market.
• In November 2022, Merck KGaA, a global biopharmaceutical company, announced the launch of Milli-Q EQ 7008/16 ultrapure and pure water purification system. The new Milli-Q EQ 7008/16 system produces consistent ultrapure (Type 1) water quality directly from a tap water source and includes an option to obtain reverse osmosis (RO, Type 3) quality water.
• In July 2022, Evoqua Water Technologies, a water treatment company serving pharmaceutical, beverage, and other industries announced the opening of new manufacturing facility in Singapore for expanding its presence in the Asia Pacific region. The new facility contributes to efforts to localise production in order to better satisfy the region's expanding need for ultrapure water solutions, namely in the microelectronics and pharmaceutical industries.

Pharmaceutical Water Market – Analyst View

• The pharmaceutical water market is at a pivotal juncture where regulatory stringency and technological innovation are driving unprecedented transformation. In my view, the sector’s evolution hinges less on volume growth and more on qualitative enhancements in water purification and monitoring systems.
• A critical trend is the shift toward real-time water quality analytics powered by IoT and AI-driven sensors. For instance, companies like Pall Corporation and Evoqua Water Technologies have pioneered inline monitoring systems that drastically reduce contamination risks by providing continuous verification—addressing a major industry challenge where water quality deviations have led to costly batch rejections and compliance failures.
• Moreover, the increasing complexity of biologics and advanced therapies demands ultrapure water with tighter specifications. The USP’s recent updates to Water for Injection (WFI) standards now emphasize microbial control through vapor compression distillation or equivalent techniques, underscoring the necessity for manufacturers to upgrade beyond traditional systems. This shift directly challenges legacy infrastructure and favors firms that invest aggressively in modular, scalable purification units capable of rapid validation.
• Geographically, India’s pharmaceutical water market exemplifies this trend. With over 10,000 manufacturing units producing vaccines and generics for global markets, adherence to stringent water standards is no longer optional but a critical differentiator. Companies such as Biocon and Serum Institute of India have publicly committed to implementing cutting-edge water treatment technologies, highlighting a competitive edge driven by quality assurance.

Market Segmentation

• By Product Type
  • Highly Purified Water
  • Water for Injection
  • Water for Inhalation
  • Deionized water
  • Distilled Water
  • Others
• By Application
  • Drug Formulation
  • Cleaning and Purification
  • Cell Culture Production
  • Equipment Cleaning
  • Buffers and Solutions
  • Others
• By End User
  • Pharmaceutical & Biotechnology Companies
  • Contract Research & Manufacturing Organizations
  • Academics & Research Laboratories
  • Hospitals & Healthcare Facilities
  • Diagnostic Laboratories
  • Others
• Region
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Top Companies in Pharmaceutical Water Market
• • Sartorius
  • Merck KGaA
  • GENERAL ELECTRIC
  • Danaher Corporation
  • SUEZ Water Technologies & Solutions
  • Veolia Water Solutions and Technologies
  • Evoqua Water Technologies LLC
  • Aqua Solutions, Inc.
  • Baxter International Inc
  • Nexus Pharmaceuticals, LLC
  • Hikma Pharmaceuticals
  • Dow
  • Lenntech B.V.

Sources

Primary Research Interviews

• Facility managers and validation officers at pharmaceutical manufacturing plants
• Water system engineers from global pharma utilities teams
• Quality assurance professionals and GMP compliance officers
• Researchers and production heads in biotechnology labs

Databases

• PubMed – Water Quality in Pharmaceutical Applications
• ScienceDirect – Pharmaceutical Process Engineering
• ClinicalTrials.gov – Water-Based Sterilization & Bioprocess Trials
• U.S. FDA Database – Drug Manufacturing Water System Approvals

Magazines & News Articles

• Pharmaceutical Technology Magazine
• The Hindu BusinessLine – Pharma & Health Infrastructure Reports
• PharmTech.com – Equipment and Process Water Innovation
• FiercePharma – Facilities and Manufacturing Updates
• Chemical & Engineering News – Water Technologies in Pharma

Journals

• Journal of Pharmaceutical Sciences
• International Journal of Pharmaceutics
• PDA Journal of Pharmaceutical Science and Technology
• Journal of Water Process Engineering
• Journal of Validation Technology

Newspapers & Reports

• The Economic Times – Pharma Section
• Times of India – Health and Manufacturing News
• The Wall Street Journal – Healthcare Innovations
• Financial Express – Indian Pharma Investments & Policy Reports

Associations

• International Society for Pharmaceutical Engineering (ISPE)
• Parenteral Drug Association (PDA)
• Indian Pharmaceutical Alliance (IPA)
• U.S. Pharmacopeia (USP)
• World Health Organization (WHO) – GMP and Water Standards

Public Domain Sources

• Ministry of Chemicals and Fertilizers – Government of India
• European Medicines Agency (EMA)
• U.S. Food and Drug Administration (FDA) – Water System Guidelines
• Central Pollution Control Board (CPCB) – Water Quality Norms
• WHO – Water Quality Standards for Pharmaceutical Use

Proprietary Elements

• CMI Data Analytics Tool, Proprietary CMI Existing Repository of information for last 8 years