PHARMACEUTICAL WATER MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

The pharmaceutical water market size is expected to reach US$ 10.66 billion by 2030, from US$ 6.26 billion in 2023, growing at a CAGR of 7.9% during the forecast period.

Pharmaceutical water is purified water used for various applications in the pharmaceutical industry, such as drug formulation, cleaning and purification, and cell culture production, among others. The high purity of pharmaceutical grade water makes it suitable for use in sensitive pharmaceutical manufacturing operations where impurities can impact drug safety and efficacy. 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.

The pharmaceutical water market is segmented by product type, application, end user, distribution channel, and region. By product type, the market is segmented into highly purified water, water for injection, water for inhalation, pure steam, pretreated water, and others. The highly purified water segment is estimated to account for the largest market share in 2023. The growing focus on high-quality standards in pharmaceutical manufacturing is driving the demand for highly purified water.

Pharmaceutical Water Market Regional Insights

• 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 2023. 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.
• Europe is expected to be the second-largest market for pharmaceutical water, accounting for over 24.9% of the market share in 2023. The growth is attributed to stringent regulations regarding water quality, increasing R&D investments and clinical trials, and investments by leading players in the region.
• 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.

Figure 1. Global Pharmaceutical Water Market Share (%), by Region, 2023

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Pharmaceutical Water Market – Analyst View

The pharmaceutical water market is expected to grow significantly over the forecast period owing to rising importance of water quality in pharmaceutical manufacturing. Strict regulations around water quality will drive increased investments in advanced water purification systems globally. Asia Pacific region is anticipated to remain the fastest growing regional market driven by expanding pharmaceutical industry in countries like India and China.

The use of purified water is essential across many areas in drug production from initial synthesis to tablet coating. Stringent guidelines stipulating endotoxin and particle limits will boost demand for high-purity water technologies. New drug development focused on biologics will further augment the need for highly purified and controlled water systems. However, high costs associated with setting up and maintaining water purification plants could hamper market growth to some extent.

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.
• Biologic Drug Product Development: The adoption of pharmaceutical water is expected to rise significantly in bioprocessing applications for the development and manufacturing of drug products such as monoclonal antibodies, recombinant proteins, vaccines, etc. Water is extensively used in downstream purification and final fill-finish operations during biologic drug product preparation. The current bioprocessing manufacturing paradigm is transitioning to single-use technologies. Pharma water systems compatible with single-use bioprocessing equipment and compliant with drug product manufacturing will provide new market prospects.

Pharmaceutical Water Market Trends

• Integration with Single-Use Technologies: Pharmaceutical companies are increasing integrating single-use disposable technologies into their manufacturing operations including the use of pre-sterilized plastic bags, tubing, connectors, bioreactors, etc. Advantages such as reduced cross-contamination risks, operational flexibility, and lower capital costs are driving the shift. Pharmaceutical water system manufacturers are focusing on developing water purification solutions compatible with single-use assemblies and equipment. Integration capabilities allowing direct water dispensing into single-use components is an emerging trend.
• Rising Adoption of Remote System Monitoring: Cloud-based remote monitoring platforms are emerging as an essential feature of pharmaceutical water purification systems. IoT-enabled capabilities allow access to real-time system performance data and operational metrics through online software and mobile apps. This allows manufacturers to identify and resolve any process deviations or equipment issues proactively. Remote access provides tangible benefits such as near 24x7 monitoring, reduced site visits, and predictive maintenance capabilities. These advantages are fueling the adoption of remote monitoring.
• Automation & Connectivity with Smart Factory: The pharmaceutical manufacturing sector is gradually transitioning into a smart factory environment enabled by automation, IoT, analytics, and AI. Pharmaceutical water systems are also evolving to offer digital automation, allowing seamless integration and data exchange with production equipment, ERP, and quality management systems. Automated regulation of system operation coupled with connectivity will help minimize manual errors and enhance compliance. The shift towards automation will hence become more prevalent.
• Multi-parameter Water Quality Testing: Pharma companies are adopting a quality-by-design approach with a focus on building quality into the manufacturing process rather than by testing the final product. This demands a thorough assessment of raw material quality attributes to minimize risks. In line with this trend, there is a greater emphasis on multi-parameter testing of pharmaceutical water quality covering microbiological, chemical, physical, and elemental parameters. Regular validation of water quality will enable bespoke purification system design and robust process control.

Pharmaceutical Water Market Restraints

• Product Recalls: Product recalls have been a cause of concern hampering the growth momentum of the pharmaceutical water market, which is essential for the production of medicines and medical solutions. Pharmaceutical water acts as a raw material as well as a medium of formulation in the drug-making process, so any impurity or contamination in its purity can negatively impact the safety and efficacy of the end product. In May 2022, Pfizer, Inc., a global biopharmaceutical company voluntarily recalled one lot of sterile water for injection due to the potential presence of visible particulate.
• Intense Competition among Major Providers: The pharmaceutical water purification technologies and systems segment is dominated by prominent companies such as Sartorius, Merck KGaA, Veolia Water Technologies, Thermo Fisher Scientific and Danaher Corporation. These players have a strong market foothold based on their proven product portfolios and long-standing industry presence. Moreover, competitors are focused on launching newer products with advanced features to garner market share. The intense competition among major providers limits the entry and expansion of newer and smaller participants. This can constrain the overall pharmaceutical water market growth.

Recent Developments

• 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.

Figure 2. Global Pharmaceutical Water Market Share (%), by Application, 2023

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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.

Definition: 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. The market is segmented by product type, application, end-user, and region. Key players operating in the pharmaceutical water market provide a range of technologies, systems, and services to pharmaceutical companies to help ensure access to reliable, high-quality water.

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