The future of this market is majorly driven by the rising demand for sterilized pharmaceutical formulations, increasing demand for medical devices. The technological advancements in cleanroom technology along with the increasing demand for cleanroom technologies in developing economies are expected to offer significant opportunities for market growth in the coming years.
The technical limitations associated with their operational costs and technical challenges associated with the customization of cleanroom designs in developing economies are hindering the growth of this market to a certain extent.
The use and maintenance of a cleanroom is a complex process. Usually, the cost of construction of standard cleanrooms for pharmaceutical and medical device manufacturing may range between USD 100 to more than USD 1,000 per square foot.
Also, the price per square foot is not the same for ISO 6 and ISO 8 cleanrooms. This is because the amount of air supplied is different in both classes of cleanrooms. The air is 100 times cleaner in an ISO 6 cleanroom than in an ISO 8 cleanroom, thereby doubling the air conditioning capacity of the HVAC systems.
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Cleanrooms are mostly designed according to customer requirements based on product specifications and customer-specific design requirements. However, there are no specific guidelines for cleanroom designs for different application areas or product types. This leads to several challenges for cleanroom manufacturers, as they need to follow different designs every time.
Furthermore, regulations do not provide requirements regarding the environmental, product, or facility parameters that are to be controlled. Instead, they only provide standards that a company needs to meet after it decides to manufacture a product using a cleanroom environment.
The high and growing number of pharmaceutical, biotech, and medical device companies facilitating the use of disposable protective clothing has resulted in the increased adoption of the consumables in the cleanroom technologies market. Also, the large number of R&D activities in the healthcare industry is resulting in a stable demand for cleanroom consumables among end users.
The pharmaceutical industry end-user segment accounted for the largest share of the market in 2019. This is attributed to the industrial growth in this sector, the robust pipeline of injectable formulations, and rising focus on ensuring the quality of healthcare products.