Increasing outsourcing of sterility testing services is driving the market growth. The complexity and resource-intensive nature of sterility testing, coupled with the need for specialized expertise and facilities, are driving many pharmaceutical and biotechnology companies to outsource their testing needs to specialized contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract testing laboratories.
Outsourcing allows companies to access state-of-the-art facilities, expertise, and testing capabilities while reducing operational costs, accelerating testing timelines, and maintaining flexibility in resource allocation.
Furthermore, the demand for faster, more sensitive, and efficient microbial testing solutions is driving the adoption of Rapid Microbial Methods (RMM) in sterility testing. RMMs offer advantages such as reduced time-to-result, enhanced sensitivity, and automation capabilities compared to traditional culture-based methods.
Authors:
Mariam Faizullabhoy , Gauri Wani
Frequently Asked Questions (FAQ) :
The global sterility testing market was valued at USD 1.2 billion in 2023 and is predicted to exhibit 10.6% CAGR from 2024 – 2032, attributed to the increasing focus on ensuring the safety and efficacy of pharmaceutical and biopharmaceutical products.
The kits & reagents segment accounted for 55.6% of the market share in 2023 and is expected to witness 10.5% CAGR from 2024- 2032, owing to the growing emphasis on quality control in drug manufacturing, and the rising number of pharmaceutical and biotech companies.
North America sterility testing market size was valued at USD 529.5 million in 2023 and is anticipated to grow at 10.4% CAGR between 2024 and 2032, driven by technological advancements and innovation, supported by a conducive regulatory environment.
bioMerieux SA, Charles River Laboratories International Inc., Merck KGaA, Nelson Laboratories, LLC, Pacific Biolabs, Rapid Micro Biosystems Inc., Sartorius AG, SGS SA and Thermo Fisher Scientific.