Global Sterility Testing Market Size, Share, Growth Analysis, By Test(Membrane filtration sterility testing and direct inoculation sterility testing), By End user(Pharmaceutical & biotechnology and medical devices), By Product(Instruments, Services) - Industry Forecast 2024-2031

Sterility Testing Market size was valued at USD 161.18 million in 2019 and is poised to grow from USD 181.36 million in 2023 to USD 469 million by 2031, growing at a CAGR of 12.6% in the forecast period (2024-2031).

The global sterility testing market is fragmented and highly competitive with the presence of local as well as global companies. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of global sterility testing market. 'Merck KGaA', 'Charles River Laboratories International, Inc.', 'SGS S.A.', 'WuXi AppTec Inc.', 'Thermo Fisher Scientific Inc.', 'bioMérieux SA', 'Sartorius AG', 'Pacific Biolabs', 'Nelson Laboratories, LLC', 'Bio-Rad Laboratories, Inc.', 'Becton, Dickinson and Company', 'Sigma-Aldrich Corporation', 'Pace Analytical Services LLC', 'Eurofins Scientific SE', 'ATS Labs, Inc.', 'MilliporeSigma', 'Cytovance Biologics, Inc.', 'North American Science Associates, Inc. (NAMSA)', 'Toxikon Corporation', 'Nelson Laboratories (Europe) B.V.'

The demand for sterility tests will increase with the improvement in the pharmaceutical and medical sectors. Global biotechnology industry growth is one factor that will support the expansion of the sterility testing market in the coming years. Concerns about the safety of biological pharmaceutical products are also increasing. In the coming years, these factors will drive the market for sterility testing. Sterility testing has benefited from the advancement of new technologies that have increased the efficiency of the process, thereby fueling market expansion. For filterable pharmaceutical items, the method of choice for sterility testing is membrane filtration.

Players in the pharmaceutical and biopharmaceutical industry are ensuring that environmental monitoring (EM) programs are in place to prevent future sterility test failures. The product is sterilized to ensure safety and identify any problems at the earliest. It helps businesses position themselves in the service sector as effectively as possible. 

By region, market is segmented into North America, Europe, Asia Pacific and MEA. In 2021, North America accounted for the largest market share of 49.6%. This may be due to the growing number of pharmaceutical industries in the US and Canada. The presence of numerous major market players in this sector is expected to have a significant impact on the expansion of the market. The global sterility testing market in this region is expanding as a result of stringent regulatory requirements for sterility testing of drugs and medical devices. The United States is currently the largest sterility testing market in North America and is expected to continue its dominance during the forecast period. The United States holds a major market share for sterility testing due to the presence of various global pharmaceutical and biopharmaceutical companies as well as significant funding for R&D from both the public and commercial sectors in the country. For example, in 2019, Canadian businesses spent a record USD 21.7 billion on in-house R&D, according to the Government of Canada, Industrial Research and Development, 2019 (Actual), 2020 (Intended), and 2021 (Intended) reports. , which is an increase of 3.8% compared to the expenditure in 2018. The Government of Canada's Pharmaceutical Industry Profile shows that from 2011 to 2020, pharmaceutical exports and imports to Canada and the rest of the world increased by 143% and 58%, respectively.