Your Market Analysis: Expanded role for life sciences cleanrooms
By Robert McIlvaine
Cleanroom technology developed for traditional applications such as aseptic filling in pharmaceutical plants is increasingly being applied to distinctly 21st Century problems. The result is an expanded role for suppliers of rooms, filters, wipes and clothing to address problems such as SARS and bio-terrorism which did not exist previously.
By 2010 the traditional market for life sciences cleanrooms is forecast at $1.22 billion. The market for nontraditional cleanrooms is $950 million, expanding the total life sciences cleanroom market to $2.17 billion (see Fig. 1).
There is a large market developing for protection of both military and civilian sites from bio-terrorism. A number of U.S. embassies may have been secretly equipped with bio-terrorism protection.
A number of key government buildings have been identified as qualifying for investments to provide isolation from bio-weapons. By creating a positive pressure within the building and providing a way to destroy microbes in the intake air, the occupants of the building can be protected against exposure.
The U.S. EPA’s National Homeland Security Research Center recently completed performance verifications of ten indoor air filters designed to protect occupants of large buildings from biological attack from terrorists. The filters are designed to remove bacterial or viral warfare agents from outside air entering the building and also re-circulated indoor air.
The performance verification, conducted by the EPA’s Environmental Technology Verification Program (ETV), addressed the efficiency of very fine particle removal down to a size of 0.03 micron, which is characteristic of bacteria and viruses. Also addressed was the efficacy of each filter in removing selected biological agents, irrespective of particle size, including selected bacteria and viruses.
The filters tested were:
AAF International: BioCel I (Type SH) and DriPak 90/95%;
Aeolus Corporation: Synthetic Minipleat Panel, SMP-M12-24244;
Synthetic Minipleat V-Cell, SMV-M13-2424 and Synthetic Minipleat V-Cell, SMV-M14-2424;
Airflow Products: AFP30;
Columbus Industries: High Efficiency Mini Pleat and SL-3 Ring Panel;
Filtration Group: AeroStar “C-Series” Polyester Panel Filter and;
AeroStar FP-98 Minipleat V-Bank Filter.
Better protection for tanks, tents, and other military equipment is a high priority. A great deal of U.S. Defense Department funds are being expended to research ways to provide this protection. As a result even the “research” market will be significant.
Private companies that have reason to believe they might be targets, e.g., Haliburton, also are a substantial market.
Post offices initially appeared to be a substantial market after the anthrax attack in the U.S. However, the high level of concern has now diminished and there are few ongoing programs to provide protection. It should be remembered, though, that it would only take one more incident to create that market.
The bulk of the market (75 percent) would initially be in the U.S. or for U.S. personnel and installations abroad. However, depending on the pattern of future attacks, the markets in other countries could suddenly develop.
This market, which includes items such as HEPA-filtered tents, in total will be $400 million worldwide.
Air quality in many hospitals has deteriorated to a point that airborne transmission of infectious disease has become a significant problem. Given the fact that many infections are transmitted via the airborne route, adequate ventilation becomes more critical than ever. Newly discovered strains of antibiotic-resistant bacteria make infection control one of the top priorities for healthcare providers. The SARS epidemic and more recent bird flu incidences are prime examples. The ever-increasing numbers of orthopedic replacement procedures and organ transplants make sterile operating room, isolation room and general patient room air quality critical issues in patient care.
To minimize the risk of airborne infections during orthopedic surgery, practitioners have demanded laminar flow operating rooms. Also, many surgeons operate in fully encapsulated suits with HEPA-filtered breathing air and filtered inhaled air. In essence, these operating rooms are cleanrooms with efficiencies as low as the Class 10 range. Interestingly, surgeons are increasing their use of encapsulated suits out of concern for their own well-being, as well as for their patients’ benefit. The high-speed cutting tools used in orthopedic surgery create significant aerosols from blood and fluids at the wound site. Therefore, any blood-borne pathogens present in these fluids could be inhaled, infecting the operating room staff.
Airborne infectious particles are a potential source of hospital infections. Control of airborne microorganisms depends on measures consistent with aseptic technique as well as on contamination control connected with ventilation. Infectious contaminants transmitted by the airborne route are most commonly fungal, bacterial, and viral. Although infections acquired by the airborne route make up a relatively small portion of nosocomial, or hospital-acquired, infections, the outcome to the patient of these infections can be grave.
In addition to traditional applications, there is a whole range of new applications in healthcare. The biggest opportunity is to expand the use of local cleanroom concepts to patient rooms. Also nursing homes, dental facilities, and other health-related facilities will need to consider investing in cleanoom technology.
The basic market is limited to orthopedic operating rooms, laboratories, isolation rooms, burn treatment centers and 5 percent of central air delivery systems.
The expanded market potential is much larger and involves the full range of applications where virus destruction would be cost effective (i.e., cost of patient care exceeds cost of system installation.) In addition to the orthopedic operating rooms, it includes 50 percent of all operating rooms, 50 percent of intensive care units, dental surgeries, blood transfusion centers, maternity wards and 25 percent of central air delivery systems.
Food processing, storage and transportation
Improving air quality to enhance product safety and shelf life has been receiving more emphasis in the food-processing industry. Air can serve as a transportation medium for microorganisms with the help of dust particles and water spray suspended in air. Surface contamination from airborne bio-aerosols can result in shortened shelf life of high quality products. Poor quality air is caused by contamination from sources in and around the plant.
Consumer demand for fresh foods with few preservatives is driving the need for clean air in production facilities. Fresher foods are more vulnerable to airborne contaminants. In many foods, packaging a pure product to obtain longer product shelf life is directly related to controlling these microrganisms; at the same time, tight control on the air and gases involved in the food processes and packaging is required.
There is a market in the fresh fruit and vegetable industry, especially in tropical climates where inventory losses due to ethylene-induced premature ripening, mold attack and decay are often enormous and are, therefore, a significant factor in determining final profit.
The markets for fruit and vegetables are becoming global. Over the last two decades, major expansions have occurred in international shipments. For example, overseas producers in New Zealand, Australia, Chile and South Africa are now supplying their in-season produce to North America during the winter months. This creates a need for systems to protect food shipments in on-route warehouses, containers, ships and trucks.
The expanded role for cleanroom technology will cause a market in 2010 which is twice the size of the traditional market of $200 million.
Pharmaceutical and biotechnology
This market is considered traditional. But the biotechnology segment will show robust growth.
This industry requires cleanrooms not only to protect the product, but also to protect the worker. About 5 percent of biotechnology plants currently utilize cells or products known to be pathogenic or derived from genetic engineering techniques.
Biotechnology is not new; microorganisms have been used for thousands of years to produce foods, beverages, and other fermented substances. Over the past 100 years, they have been used to produce antibiotics, enzymes, vitamins and amino acids. The potential value of biological processes has been greatly enhanced in the past 10 to 15 years through the development of recombinant DNA technology (sometimes referred to as genetic engineering), cell fusion (including monoclonal antibody production technology), protein engineering and new bioprocesses. These advances have provided powerful new tools to manipulate organisms at the molecular and cellular level in order to create new products, produce larger quantities of rare products, improve the quality and safety of existing products, and improve the speed and efficiency of manufacturing based on biological processes.
Firms in biotechnology fall into two basic groups: small, new companies that were started to exploit discoveries made in the 1970s in recombinant DNA and monoclonal antibody technologies; and manufacturing firms, predominantly pharmaceutical, chemical and agribusiness. Like the biopharmaceutical business itself, contract manufacturing of biotech drugs also holds strong growth potential. These groups are sometimes linked as an “industry” because they share such common concerns as regulations, patent protection, and research and development needs.
With continued steady growth in traditional pharmaceutical applications and more dynamic growth in the biotechnology sector, the market for cleanrooms will grow to $600 million per year worldwide by 2010. The U.S. will still be the largest purchaser but Asia will be closing the gap.
The Medical Device market is composed of myriad market segments devoted to the diagnosis and treatment of virtually every disease or disorder that can affect the human body. The United States is among the top three markets for medical devices, followed by Europe and Japan. Several emerging sectors in this market, such as molecular diagnostics and nucleic acid probes, blood glucose monitors, and point-of-care tests, are forecast to show solid growth.
Contamination concerns in the manufacturing of medical devices are very similar to those in the pharmaceutical and biotechnology industries.
The market for new medical device cleanrooms is considered traditional and will grow to $150 million per year by 2010.
The investment in protection from bio-terrorism will have a profound effect on the cleanroom industry. As shown in Figure 2, the market for bio-terrorism protection cleanrooms will grow to 30 percent of the total market by 2010. Nontraditional applications will represent 50 percent of the total $2.2 million spent for new life sciences cleanrooms in 2010. III
Robert McIlvaine is president and founder of the McIlvaine Company, Northfield, Ill. The company first published “Cleanrooms: World Markets” in 1984 and has since continued to publish market and technical information for the cleanroom industry.