Sterilization market a vibrant, active segment

by Curt Werner

The mélange of products and personnel that combine to produce surgical instruments that can be used safely and effectively in patients is only as strong as its weakest point. A range of products is available for sterilization, and these disposables generally do an outstanding job. Washers and sterilizers today are well constructed, well conceived and do their jobs relentlessly. But regardless of the products, two other links in the sterilization chain play an equally important, though somewhat less concrete and consistent role. Those factors are the measurements that are used to determine whether a surgical instrument is ready for use, and the personnel who not only handle the sterilization products and equipment, but make those sometimes hair-splitting determinations.

“The number one issue in sterilization is determining the efficacy of the cleaning process. It’s still the greatest challenge, and the reality is that the cleaning process is difficult to measure,” says Ray Taurasi, a longtime central service consultant who was recently named to head business development for Case Medical, a Ridgefield, NJ-based manufacturer of products used in sterilization. Taurasi says that even as technology continues to make advances that increase the effectiveness of the products used in the process in response to the introduction of new and more complex scopes that present new dilemmas that confound effective cleaning. He cites new scopes with long, narrow lumens, tiny mechanical pieces, hinged areas and sliding parts, all of which make life difficult for sterilization personnel, apart from the new, more sophisticated products used.

Taurasi alludes to the ever-present element of costs driving the sterilization process. But beyond sheer dollars devoted to products, the skill levels of the people who operate the equipment and apply the products make the difference between an item that is safe for use and one that could do potential harm to a patient. “Everything goes back to user competence,” says Taurasi. “It’s just as important as the indicators. You have to have a high degree of assurance that a unit is properly sterilized. Checkpoints must go all the way down the line. No single bell or whistle gives complete assurance. Everything must check out — packaging, loading, cool-down, drying time — the entire process must work.”

Taurasi suspects that the use of biological and chemical indicators could be overrated. “People utilize indicators as crutches,” he says. “There is some expensive overkill in the use of certain types of equipment. Departments use chemical indicators, biological indicators, mechanical and process indicators and administrative and process controls, but they need to look at everything else, too. There is still a lot of misunderstanding in the field. It’s so important that the departments have good quality, professional people at the helm in positions of management. Too often we see sterile processing departments that are under the jurisdiction of overburdened operating room supervisors and not strong CS people.”

Market report

Frost & Sullivan, Mountain View, CA-based market researchers, estimate the disinfection and sterilization market at $647 million in 2001 and expect it to grow at a compound annual growth rate of approximately 5 percent during the next five years. The researchers anticipate the market will generate more than $900 million in revenues in 2008. Sterilization supplies account for roughly 58 percent of the total revenues, with its contribution expected to go up one percent by 2008. Central sterilization equipment and sterilants accounts for nearly 20 percent of the total market, according to an October 2002 report titled “Strategic Analysis of the U.S. Disinfection and Sterilization Market.” 

St. Paul, MN-based 3M and STERIS, Mentor, OH, hold the lion’s share of the total disinfection and sterilization market. Kimberly-Clark Corp., Roswell, GA, a major player in the sterilization wraps market, enjoys share of roughly 17 percent of the total market. While Advanced Sterilization Products, the Irvine, CA-based Johnson & Johnson unit, accounts for approximately 9 percent market share, a number of small and medium companies are responsible for the remaining 30 percent of the total disinfection and sterilization market.

Dhiraj Ajmani, an analyst with Frost & Sullivan, reports an increase in the number of companies as well as in the awareness of sterilization and its validation. Further, she says that new technologies are being developed to cater to the increasing need of disinfection and sterilization in the healthcare sector.

According to Ajmani, plasma sterilization offered by ASP’s Sterrad system has been gaining popularity over ethylene oxide sterilization, traditionally used low temperature sterilization technique. A future ban on HCFC propellants and long sterilization cycle are the key factors for decline of ethylene oxide sterilization, she says. Rapid turnaround time with Sterrad system has been instrumental in its acceptance by hospitals and surgical centers. 

And with Rochester, NY-based Getinge exiting the ethylene oxide market, Ajmani says 3M and STERIS are now the major players in that segment. STERIS leads with an estimated 42 percent market share. Advanced Sterilization Products is the only company marketing plasma sterilizers in the U.S., has a 27 percent market share. New technologies in low temperature sterilization are expected to be available in the coming years. An ozone sterilizer from TSO3, which is already approved for marketing in Canada, is expected to gain the FDA clearance in the coming months.

Sterilization supplies market

Sterilization supplies account for more than 50 percent of the total sterilization market revenues, a market consisting of sterilization containers, wraps, pouches and trays, plus chemical and biological indicators. One or two players dominate most of these segments, a development that Frost & Sullivan says is a result of growing power of group purchasing organizations.

In the last couple of years the trend has been slowly shifting toward using sterilization containers in place of wraps. Through the next five years, the containers market is expected to grow at a faster rate than wraps, providing tough competition to wraps. Kimberly-Clark dominates the wraps market and has diversified to sterilization pouches in order to increase its revenues. Chemical and biological indicators are used to respectively a validate sterilization cycle and the working of a sterilizer, a market led in this country by 3M. 

Sterilization wraps today account for approximately 30 percent of the sterilization supplies market. But through 2008, Frost & Sullivan believes the share of wraps will decrease while that of biological indicators will grow. The increasing need of sterilization validation is expected to grow the usage of biological indicators and the segment is expected to be responsible for more than 32 percent of the total sterilization supplies market by 2008. The share of containers, pouches, and trays are expected to remain almost stable over the next five years. While Aesculap, the B.Braun unit based in this country in Center Valley, PA, dominates the sterilization containers market, Cardinal/Allegiance, McGaw Park, IL, is leading player in containers and pouches. 

Liquid disinfectants and sterilants

Glutaraldehyde has been the unquestioned disinfectant/sterilant of choice for past three decades. But more recent health and environmental concerns with glutaraldehyde have resulted in the acceptance of alternatives in a number of hospitals and surgical centers. Consequently, manufacturers have worked to develop alternate and safe sterilization technology for reprocessing endoscopes. Turnaround time is a crucial factor in choosing the liquid disinfectant/sterilant. New liquid agents with fast turnaround time are being developed and will likely be launched in the coming years. 

Prion deactivation

Hurdles remain in the search for better and more complete sterilization performance. Among them is the issue of prions, and whether specific strains of highly resistant organisms can be eradicated and the process measured for effectiveness. Taurasi calls prion deactivation, “a real challenge,” while Ajmani calls it “the biggest opportunity for disinfection and sterilization companies.” Prions are extremely resistant to heat and chemicals, rendering most existing technology ineffective in their deactivation. “The effective technology is expected to be a combination of new methods in existing product lines, incorporating additional technology,” Ajmani says.

The challenge for companies developing prion deactivation technologies is that there is no appropriate standard by which a company can measure the effectiveness of sterilization technique against prions.

HPN

February