Sterilization Services

Sterilization Services Global Market Outlook

MARKET OVERVIEW

Global market size – $4.5 billion (2022)

Expected to grow at a CAGR of ~5-6 percent Y-o-Y

• Most of the medical device manufacturers use contract sterilization service providers for there sterilization requirements. Sterilization supply market is highly dominated (Takes major part ~>70% of outsourced market) with very few major players namely Sterigenics and Steris.

• Due to increasing regulations, decreased EtO supply /capacity and increasing demand for medical products across regions, companies are under pressure in exploring alternative sterilization service providers & techniques (which might provide reliable, safer, cost effective and flexible or lesser lead time opportunities/solutions).

• Approximately 50% of the single use medical devices are sterilized using ethylene oxide sterilization techniques, 40% of the devices using gamma, and 4-5% of the devices using E-beam technique.

Sterilization Services Market Drivers/Constraints

Drivers

• Introduction  of new biological products and advanced medical equipment's in the market increases the demand for new & better technologies for sterilization.

• Trend towards the increase of Minimally Invasive Surgery (MIS) which uses complex, expensive & delicate devices drives the necessity for low temperature sterilization.

• Increasing practice of reprocessing medical devices in order to decrease healthcare costs spurs the demand for advanced sterilization technologies.

Constraints

• Medical Sterilization technology is subjected to stringent regulations associated with harmful gases (ex. Ethylene Oxide & Formaldehyde) and strict medical safety and infection prevention norms.

• Risk involved in inventing new sterilization technologies is its compatibility with delicate medical device instruments.

• High cost incurred in maintenance and replacement part of sterilization equipment increases the overall functional costs.

Cost Structure Analysis : Sterilization Services

• The average price for the large volume of medical devices in South Europe could be between 110-150 Euros/pallet if sterilization is done via contract, and in-house implant could cost 90-140 Euros/Pallet.

• However, the price depends on factors such as the volume of product, dose uniformity (maximum dose that the products can absorb) etc.

• Availability and pricing of cobalt 60 are the concerns with the raw material. Cobalt-60 price is anticipated to increase by 5% in the market. Nordion (subsidiary of Sterigenics) is the major supplier of cobalt 60.

• In Feb 2019, Nordion is involved in the development of new reactor technology for expanded supply to meet the growing demand.

• The technical key personnel involved in this work are trained and certified by the regulatory bodies along with one Radiation Safety Officer and Quality Control Officer Rest of the people involved are for loading and unloading the materials.

• Electricity represents a small % which is needed for running conveyor and it varies with each region.