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Sterile, Single-Use Lab Supplies: Why Are They So Expensive?

An overview of how lab supplies are delivered sterile 

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Single-use lab supplies are critical in supporting good science. Consistently manufactured and sterile lab supplies help labs eliminate variables that can adversely affect their research in a cost-effective and scalable manner. These advantages are why billions of sterile, single-use devices are consumed by commercial and research labs each year.

Cotton swabs are a good example of the cost delta between sterile and non-sterile products. A 6”-long cotton-tipped non-sterile applicator sells for about 2 cents. The identical sterile product costs 7 cents—3.5x more. 

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It wasn’t always this way. In recent years, the cost of sterilization has increased, and there has been a consequent increase in the pricing of sterile medical, laboratory, and other products. 

An overview of the contract sterilization industry

Single-use medical device manufacturers (MDMs) have long been the dominant customers of the contract sterilization industry. The medical device industry is a $200B annual market in the US alone. Additionally, around 40 billion devices are sterilized annually. 

Though lab supply is a significant market at around $40B worldwide, its smaller scale means  it often competes with the larger medical device sector for sterilization capacity.

Over the past decade, the contract sterilization industry has become dominated by two companies, Steris and Sterigenics, which are products of years of industry consolidation. Together they control approximately two-thirds of the market, and they offer the three-most common sterilization modalities: ethylene oxide (EO), gamma irradiation, and Electron Beam (E-Beam) irradiation.

So, what’s happening In the industry?

With the consolidation of the past 20 years, as well as a somewhat margin-insensitive (and very quality-sensitive) major industry customer, contract sterilizers have traditionally enjoyed relatively comfortable pricing power in their industry , resulting in increasing sterilization prices over time (typically around five percent per year). However, two additional factors have shaped the market consistently over the past decade.

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EO, representing 50 percent of the contract market, is a modality that has become embroiled in scandal, with multiple facilities closing because their environmental controls were not sufficient. Allegedly these facilities caused elevated rates of cancer in surrounding communities, and defendants in many lawsuits have to date paid out nearly $1 billion in settlement fees. Additionally, the EPA has recently implemented new regulations that will increase the cost of compliance, making EO, which has traditionally been inexpensive, considerably more costly. To date, we have seen 10 facilities close (> 10% of market) in the US and it is likely that more will close in the future. All of this is causing and will continue to cause more upward pressure on EO pricing.

Gamma irradiation, representing 40 percent of the contract market, requires a supply of radioactive cobalt-60 isotope. This isotope is made in a limited set of nuclear reactors across the world, and supply has been limited for the better part of a decade now. With continued demand growth and no reason to believe that more cobalt-60 will be available, we expect the price of gamma irradiation will continue to increase.

With 90 percent of the market seeing price increases for the above reasons, the cost of sterilizing or bioreducing any products has increased —in some cases by two to three times over the past five years.

What are accelerator-based modalities?

E-Beam sterilization technology dates to the 1950s and is well understood by the FDA (it is categorized as equivalently mature to gamma sterilization). E-Beam, and X-ray—a derivative accelerator-based technology, involve large, multi-million-dollar machines that accelerate electrons to >99.9 percent the speed of light. These electrons, which are directed at products to be sterilized, disrupt the DNA of any pathogens living on the device itself.

Over the last decade, E-Beam has matured significantly, making it capable of much higher processing volumes. Formerly expensive, E-Beam now has cost and speed advantages over both Gamma and EO, depending on the details of the product that must be sterilized.  All modalities can be used to produce the same sterility assurance level (SAL) result, if desired, though EO, gamma, and E-Beam all have different material compatibility requirements.

Outlook: Why should I care as a lab manager?

If your products are sterilized in either EO or gamma, you should expect sterilization, and thus product costs to continue to increase  in the near term. E-Beam costs, however, are in a much better position to remain consistent over time. They neither require a cornered resource (as gamma does), nor do they have environmental or litigation concerns (as does EO).

Thus, E-Beam is a mature and sustainable  solution for many industries, including lab supply, as it can be operated on renewable grid power. The materials commonly used in lab supply are especially well-suited to E-Beam because they are typically both radiation-compatible and relatively lightweight—two factors that suggest strong compatibility with this sterilization modality.

Single-use products that are sterilized/bioreduced with E-Beam are likely to have better long-term price stability and consistent availability, a useful thing to consider when planning for future lab supply needs.

About the Author

  • Andrew Patton

    Andrew is an executive and entrepreneur who has held engineering and business leadership roles in aerospace and technology companies. After extensively researching the US contract irradiation and sterilization industries, Andrew founded NextBeam in 2020 with the vision of creating a new irradiator that would closely collaborate with customers to help solve their most challenging irradiation and sterilization problems. He believes that we are in the process of a long-term industry shift toward clean forms of irradiation, like E-Beam, and that there is a tremendous opportunity to help companies optimize their radiation processing activities.

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