U.S. And Europe Cleanrooms Market Summary

The U.S. and Europe cleanrooms market size was estimated at USD 6.37 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 2.7% from 2023 to 2030. This anticipated growth is primarily driven by the increasing implementation of government regulations aimed at ensuring sterile and safe drug compounding environments, particularly in the U.S., along with the rising prevalence of Hospital-acquired Infections (HAIs). These factors are generating a strong demand for cleanroom facilities in hospitals and compounding pharmacies. Additionally, continual advancements in cleanroom technology are further contributing to the market’s positive outlook during the forecast period.

In the United States, cleanroom usage is significantly high in compounding pharmacies due to strict compliance standards established by regulatory frameworks such as USP 797 and USP 800. According to a report published in 2022 by Pharmacy Purchasing and Products, approximately 75% of compounding facilities reported compliance with USP 797 standards, while around 47% had met the requirements under the newly proposed USP 800 standards. These rigorous regulations around the preparation and handling of sterile and hazardous drugs are among the major drivers accelerating the adoption of cleanroom environments in the country’s pharmaceutical sector.

Key Market Trends & Insights

• The compounding pharmacies segment accounted for the largest share of market revenue in 2022, contributing 92.9% and is also expected to register the fastest CAGR of 2.8% throughout the forecast period. Pharmacies that handle the compounding of sterile and hazardous medications must operate under stringent cleanliness guidelines to avoid contamination, hence the increasing reliance on advanced cleanroom solutions. The demand from this segment remains consistently high due to the critical need for regulatory adherence and safety in pharmaceutical preparation processes.
• The hospital segment also captured a substantial share of the market in 2022. Within hospitals, laboratories regularly process various biological samples including serum, plasma, urine, and tissue. The necessity to maintain contamination-free environments in these settings is crucial to ensure accuracy and reliability in test results. Consequently, the implementation of cleanroom technologies within hospital laboratories plays a vital role in minimizing sample contamination and upholding testing standards.
• The U.S. held the largest market share in 2022, accounting for 58.8% of the total revenue, and it is also anticipated to register the fastest CAGR of 2.7% over the forecast period. This dominance is largely due to the presence of a highly developed healthcare system, well-established infrastructure, and a significant number of cleanroom manufacturers and service providers operating within the country. These factors collectively enable easier access to cleanroom installations across a variety of medical and pharmaceutical settings.
• Europe is anticipated to experience a promising CAGR throughout the forecast period. The region’s cleanroom market growth is mainly fueled by high levels of healthcare expenditure and the strong presence of modern healthcare infrastructure, particularly across countries in Western Europe. These attributes are helping to drive the integration of cleanroom facilities into more healthcare institutions and laboratories across the region.

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Market Size & Forecast

• 2022 Market Size: USD 6.37 billion
• 2030 Projected Market Size: USD 7.93 billion
• CAGR (2023 - 2030): 2.7%

Key Companies & Market Share Insights

The cleanroom market features a wide array of participants who command a major portion of the market share. To maintain competitive advantage, companies are actively pursuing strategies such as product innovation, launching new facilities, expanding their geographic presence, and engaging in mergers and acquisitions. For example, in November 2022, Mecart announced the launch of a new manufacturing facility in Greenville, South Carolina, strengthening its U.S. operations. Additionally, in May 2022, G-CON delivered cleanroom infrastructure to CytoImmune Therapeutics, Inc., and in January 2022, Angstrom Technology acquired UK-based Connect 2 Cleanrooms, supporting the firm’s expansion into international markets.

Key Players

• ISOLTECH Srl
• ALLIED CLEANROOMS
• Angstrom Technology
• Nicomac Srl
• Terra Universal, Inc.
• MECART
• Clean Room Depot
• Clean Air Products
• Asgatech Holding Ltd.

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Conclusion

In conclusion, the U.S. and Europe cleanrooms market is poised for steady growth, driven by strict regulatory frameworks, rising infection control awareness, and ongoing advancements in cleanroom technologies. The U.S. leads due to a robust healthcare system and high regulatory compliance, while Europe is gaining traction with strong infrastructure and increased healthcare investments. Dominance by compounding pharmacies and hospitals underscores the importance of contamination-free environments. The market's competitive landscape is shaped by continuous innovation, geographic expansion, and strategic acquisitions, ensuring dynamic development. These trends collectively strengthen the market’s foundation, supporting its evolution to meet emerging healthcare and pharmaceutical demands globally.