NEWS RELEASE April 2022
Most Profitable Market for Cleanroom Product and Service Suppliers
Driven by semiconductors and biopharmaceuticals the demand for cleanroom, hardware, consumables and services will grow at a high single digit rate over the next five years. Some components will grow faster and at the expense of others. The more isolators used, the less class 100 space, garments, mops, wipes, and ceiling filters.
Applications are rapidly evolving. The semiconductor needs today with wafer pods and 5 nm line sizes are greatly different than they were a decade ago.
Cell and gene therapy with limited product runs prior to cleaning provides unique challenges. The product is often worth its weight or more in gold. The potential costs of contamination are therefore very high.
Nanotechnology has found its way into medical devices and to other products which now need to be better protected.
Growing cannabis is an exact science. Achieving optimal potency and consistency, researching differing strains, navigating different vegetative cycles, and producing cannabis in general all require unique and precise controls. Many growers successfully resolve these challenges by basing operations in cleanrooms.
Cleanroom science is changing. To some extent the regulations drive the science and vice vera. Cleanroom classes are defined in regulations but do not necessarily reflect the latest science. A class 100 cleanroom is rated based on filtered air flow. However, movement of objects or people in a room will change the particulate levels in the room.
Garments are typically rated upon their filter efficiency when not in motion. Two garments which prove equally efficient at rest can behave differently when the wearer is in motion.
Filter efficiency is generally rated on 0.3 micron efficiency with the assumption that smaller particles are captured at higher efficiency due to Brownian motion. This assumption is being challenged by suppliers of membrane media which have higher efficiencies on particles less than 0.3 microns than do microglass fiber media. Other examples relative to filters and media are shown at http://home.mcilvainecompany.com/images/Products_and_Services/IFN_HVAC_TCO_Factors_06-25-21.pdf
Measurement criteria are changing with the science. The continuous measurement of viable particles as opposed to the delayed results from periodic sampling could change regulatory policy. The usefulness will rest on the ability to distinguish between live and microorganisms.
Product evolution. Microfibers are changing the performance of wipes, mops, filters, garments and other media based products. Anti-microbial coatings are another ongoing development.
Variable speed fan drives offer the potential for lower energy consumption. Male and female valve connections which avoid product exposure to the room environment during transfer have many advantages.
Geographic Distribution. Forecasts for new semiconductor investment changed instantaneously with the Russian invasion of Ukraine and announcements of the closer ties between Russia and China.
The huge expansion of vaccine manufacture in the last two years was unexpected. The need for additional facilities in Asia and Africa is greater due to efficacy as low as 50% for the Chinese COVID vaccines. When this is combined with the high rate of transmission for the latest COVID variant the market dynamics are changed.
The dynamic aspects of the cleanroom market make it challenging to find the most profitable niches.
McIlvaine company can support the efforts in three areas
- market forecasts
- predicate evidence
- disputed evidence
Market Forecasts. Suppliers want to pursue the most profitable markets (MPM). McIlvaine can identify the specific opportunities for a particular design of filter, garment, or isolator.
Predicate Evidence. Market forecasts need to focus on opportunities where a product with the lowest total cost of ownership (LTCOV) can be supplied. This is determined in part by predicate evidence such as regulations, processes, product sensitivity to contaminants, value per unit of product, operating hours, and energy costs. No credible claim for lowest total cost of ownership can be made without all the predicate evidence
Disputed Evidence. The supplier needs to convince purchasers that his product will have the lowest total cost of ownership. This entails analysis of competitors. McIlvaine identifies competitors and the claims they are making relative to the cost of ownership for their products.
McIlvaine has market reports which can be used as the basis for the forecasts. However, it is important to identify the most profitable market opportunity. This requires analysis of the predicate and disputed evidence. This is best accomplished in a consulting contract.