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, 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, 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 accounted 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 Market during the forecast period, accounting for over 35% 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.
• The Asia Pacific market is expected to be the second-largest market for Pharmaceutical Water Market, accounting for over 25% of the market share in 2023. The growth is attributed to expanding generics and biologics manufacturing, increasing pharmaceutical R&D expenditure, and investments by leading players in the region.
• The Latin America market is expected to be the fastest-growing market for Pharmaceutical Water Market, with a CAGR of over 9% during the forecast period. The growth of the market in Latin America 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

Pharmaceutical Water Market Drivers

• 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 FDA and 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 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 is thus fueling the demand for pharmaceutical grade water.
• 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 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 newer generation pharmaceutical water systems.
• 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

• 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.
• Point-of-use Systems: Pharmaceutical water systems for point-of-use supply at individual steps in the manufacturing process are gradually gaining adoption. Conventional centralized pharmaceutical pure water generation followed by storage and distribution via loops often leads to recontamination. Point-of-use water systems overcome this by supplying water directly to unit operations as per application needs. Advancements in point-of-use technologies is enhancing convenience and minimizing risks. The demand for decentralized point-of-use systems is thus on the rise.
• Rising Adoption of Remote Monitoring: With the availability of IoT-enabled pharmaceutical water purification systems, manufacturers can gain significant value from cloud-based remote monitoring platforms. Remote monitoring allows real-time system data access to track critical water quality parameters and operational performance. Predictive analytics help accurately forecast maintenance needs, minimizing system downtime. These benefits offered by remote system monitoring provide capabilities to ensure compliance and enhance reliability, driving adoption in the pharmaceutical industry.

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 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

• High Capital Investment and Maintenance Costs: Pharmaceutical water purification systems require substantial initial capital investments and have considerable maintenance costs. Installation costs are high as these systems are customized to meet specific water type & quality requirements. The systems incorporate high-end purification technologies such as reverse osmosis, distillation, UV oxidation etc. Also, regular consumables replacement, energy consumption and manpower expenses add to operational costs. High capital and maintenance costs especially for small & mid-sized players limits widespread adoption.
• Technical Expertise Requirements: Pharmaceutical water systems require specialized technical expertise for system design, installation, commissioning, operation, monitoring and maintenance. Personnel must have a thorough understanding of stringent pharma water quality norms, applicable purification technologies, validation protocols and regulatory compliance. Lack of adequately trained personnel especially in emerging markets poses a major restraint to technology penetration and after-sales support. This also necessitates pharma companies to provide substantial training for ensuring smooth system functioning.
• 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 overall pharmaceutical water market growth.

Recent Developments

New product launches

• In January 2022, Sartorius launched a new pharmaceutical-grade water system Arium Pro UV optimized for cell and gene therapy applications. The product launch strengthened Sartorius' product portfolio for the biopharma market.
• In June 2021, Thermo Fisher Scientific launched the Thermo Scientific Barnstead GenPure Pro UV-TOC Pharmaceutical-Grade Water Purification System designed for modern pharmaceutical manufacturing. The new system provides reliable TOC reduction.
• In April 2022, Merck announced the introduction of the Milli-Q IQ 7000 system, an advanced pharmaceutical water purification system with remote services enabled by TRIOTM, real-time predictive maintenance and analytics software.

Acquisition and partnerships

• In September 2022, Danaher acquired Aldevron, a manufacturer of plasmid DNA, mRNA and proteins, for around $9.6 billion. The acquisition will expand Danaher's capabilities in biologics development and manufacturing.
• In June 2021, Thermo Fisher Scientific acquired PPD, a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion. The acquisition enhanced Thermo Fisher's capabilities.
• In April 2020, Sartorius entered into a partnership with DataHow, a Chinese digital startup to leverage DataHow's big data platform combined with Sartorius’ single-use bioprocessing know-how to accelerate biomanufacturing in China.

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

Top companies in Pharmaceutical Water Market

• Sartorius
• Merck KGaA
• Thermo Fisher Scientific Inc.
• GENERAL ELECTRIC
• Danaher Corporation
• SUEZ Water Technologies & Solutions
• Veolia Water Solutions and Technologies
• Evoqua Water Technologies LLC
• Aqua Solutions, Inc.
• Baxter International Inc

*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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