Medical Device Testing Services Market Size

Medical Device Testing Services Market Growth Projections and Opportunities

The sterility testing market encompasses a diverse array of products, with global segmentation based on product type into instruments, consumables, and services. Within the services category, key offerings include sterility assurance tests, sterilization validations, cleaning and disinfection, stability testing, and more. The sterility assurance tests, primarily used to determine the Sterility-Assurance Level (SAL) of pharmaceutical products with a limited shelf life, held the largest market share in 2016. This segment is anticipated to witness substantial growth, reaching USD 151.6 million by 2023 from its 2016 valuation of USD 67.1 million.
The market further stratifies based on test type, encompassing membrane filtration sterility testing, direct transfer sterility testing, product flush sterility testing, among others. Membrane filtration sterility testing, recognized as a regulatory method for filterable pharmaceutical samples containing preservatives and bacteriostatic compounds, inhibits microbial growth. This method involves retaining microorganisms through a 0.45-micron pore size filter, rinsing inhibitory compounds, selecting a suitable solution for microbial growth, and obtaining results post a 14-day incubation period. The advantages of this method, including its applicability to large volume samples and the removal of inhibitory substances, contribute to its dominance in the market. The membrane filtration sterility testing segment is projected to hold the largest market share, reaching USD 348.6 million by 2023 at a CAGR of 12.1% from 2017 to 2023.

End-users play a significant role in market segmentation, with categories such as pharmaceutical companies, hospitals and clinics, academic and research laboratories, among others. Pharmaceutical companies emerge as the dominant force in the global market, driven by the escalating demand for sterile injectables to treat chronic diseases like cancer and cardiovascular conditions. The pharmaceutical companies segment is forecasted to achieve a valuation of USD 428.0 million by the conclusion of 2023, exhibiting a CAGR of 12.1% from 2017 to 2023.

The sterility testing market showcases a range of products and services, with the services segment, particularly sterility assurance tests, holding a prominent position. Membrane filtration sterility testing stands out as the leading test type, owing to its regulatory acceptance and advantageous features. Furthermore, pharmaceutical companies spearhead the end-user segmentation, reflecting the substantial demand for sterile injectables in treating chronic diseases. The market dynamics indicate robust growth, propelled by technological advancements and the increasing need for stringent quality control in pharmaceutical and healthcare sectors.