Market Challenges And Opportunities
- Product Recalls
- Intense competition among major providers
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.
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