U.S. And Europe Cleanrooms Market Size, Share, & Trend Analysis Report By End Use (Hospitals, Compounding Pharmacies), By Region (U.S., Europe), Competitive Insights, And Segment Forecasts, 2019 - 2025

Report Overview

The U.S. and Europe cleanrooms market size was valued at USD 5,815 million in 2018 and is anticipated to grow at a CAGR of 0.2% over the forecast period. Growing government regulations for sterile & hazardous drugs compounding, especially in the U.S., and increasing incidence of Hospital-acquired Infections (HAIs) are some of the key factors boosting demand for cleanrooms in hospitals & compounding pharmacies. Moreover, technological advancements are also positively impacting the market.

In the U.S., market penetration in compounding pharmacies is high owing to the presence of regulations such as USP 797 and USP 800. According to Pharmacy Purchasing and Products report published in 2016, compounding sites reported a 73% compliance with USP 797 standards and about 48% of compounding sites were compliant with the newly proposed USP 800 standards. Thus, stringent regulations for drug compounding contribute to market growth.

Growing incidence of HAIs is one of the major factors boosting demand from hospitals. According to a report by CDC, there were nearly 722,000 HAIs in the U.S. Similarly, according to the data published by the National Institute for Health and Care Excellence, in England, about 300,000 patients contract HAIs every year as a result of care within the National Health Service. 

Currently, modular cleanrooms are replacing conventional cleanrooms owing to its advanced features, such as low cost of installation, ease of mobility, and flexibility. They provide intrinsic versatility, as they can be assembled, disassembled, and relocated.

There are several benefits associated with modular cleanroom, which include fast installations and reconfiguration based on requirement.

Recently, many prominent companies are engaging in developing modular cleanrooms. For instance, North Central Instruments (NCI) offers a range of these in softwall and hardwall configurations. Their adoption is high in compounding pharmacies as compared to the hospitals. For instance, in January 2017, the Kingspan UltraTech Precision Cleanroom System was built and designed by BAM Ireland to develop modular cleanrooms within the pharmacy department at St. James’s Hospital in Dublin, Ireland.

End-use Insights

Compounding pharmacies accounted for the largest revenue share in 2018. Pharmacies involved in compounding sterile and hazardous drugs are required to meet certain cleanliness standards. In addition, past cases of fungal infections due to cross-contamination in compounding pharmacies have led to the introduction of strict regulations. For instance, in 2012, a series of fungal meningitis cases were traced to contaminated steroids prepared at a compounding pharmacy in Massachusetts, the U.S. The abovementioned factors have led to increased penetration in compounding units. Growing demand is driving prominent players to develop cleanrooms for compounding pharmacies. Some of the U.S. and Europe cleanrooms market players are Mecart, GERMFREE, and Terra Universal, among others. For instance, Terra Universal manufactures USP 800 and USP 797 compounding types.

Hospitals segment is expected to grow at a CAGR of 1.4% over the forecast period. Hospital laboratories process biological samples such as urine, serum, plasma, & tissue. It is essential to keep these instruments contamination free for executing accurate processing of a sample. In such laboratories, the presence of clean environment is crucial. The factors such as growing cases of HIAs and increasing adoption in oncology, burn & operating units, and gene therapy departments within the hospital facilities contribute toward segment growth.

Regional Insight

In 2018, the U.S. dominated the market, accounting for 60% of share. Well-established healthcare infrastructure and large number of cleanroom providers in the country contribute toward increased market share. In addition, growing number of hospital admissions also propel the market. It is estimated that around 36.5 million hospital admission were reported in 2017. Moreover, increasing prevalence of HIAs also boosts demand. According to the CDC, HIAs account for almost 1.7 million infections each year in the U.S.

Europe is expected to witness a lucrative growth rate of 2.2% over the forecast period. Europe cleanrooms market is majorly fueled by high healthcare expenditure and presence of well-developed healthcare infrastructure, especially in Western Europe. Favorable government initiatives toward infection control and improvements in healthcare infrastructure are also among few factors responsible for increase in demand for cleanrooms. In addition, the rising prevalence of nosocomial infections is one of the major factors boosting demand among hospitals in the region.

Key Companies & Market Share Insights

Terra Universal, Nicomac Srl, Mecart, and Clean Air Products are among the major players in the U.S. and Europe cleanrooms market. Product up-gradation and new launches are some of the key strategies adopted by these players for gaining competitive edge. For instance, in 2015, Terra Universal, Inc. introduced a series of control systems to automatically control fan/filter units in modular types. With this, the company intended to expand its product offerings.

U.S. And Europe Cleanrooms Market Report Scope 

Segments Covered in the Report

This report forecasts volume and revenue growth at regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented U.S. and Europe cleanrooms market report on the basis of end-use and region:

• End-use Outlook (Volume, Unit; Revenue, USD Million, 2014 - 2025)

  • Hospitals

  • Compounding Pharmacies

• Regional Outlook (Volume, Unit; Revenue, USD Million, 2014 - 2025)

  • The U.S.

  • Europe

    • The U.K.

    • Germany

    • Spain

    • Italy

    • France