What is the global market size of the Sterility Testing Market?

Global Sterility Testing Market size was valued at USD 161.18 million in 2021 and is poised to grow from USD 181.36 million in 2022 to USD 469 million by 2030, growing at a CAGR of 12.6% in the forecast period (2023-2030).

Who are the key vendors in the Global Sterility Testing Market?

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.'

What is the key driver of the Global Sterility Testing Market?

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.

What is the key market trend for the Global Sterility Testing Market?

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.

Which region accounted for the largest share in the Global Sterility Testing Market?

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.

Sterility Testing Market Size, Share, Growth Analysis, By Product & Services(Kits & Reagents, Services, Instruments ), By Test Type(Membrane Filtration, Direct Inoculation, Other Tests), By Application(Pharmaceuticals and Biologicals, Medical Devices, Other Applications), By End User(Pharmaceutical Companies, Biotechnology Companies, and Others), By Region - Industry Forecast 2024-2031

Report ID: SQMIG35A2169 | Region: Global | Published Date: September, 2024
Pages: 219 | Tables: 86 | Figures: 76

Sterility Testing Market News

In October 2024, LGM Pharma, leading service provider for drug development lifecycle added endotoxin and rapid sterility testing capabilities to its Analytical Testing Services (ATS) offering. LGM made these new services available at its Irving facility after installing new equipment for sterility testing.
In May 2024, Sartorius, a renowned developer and supplier of life science and analytical tools and instruments announced the launch of its new pump for sterility testing use. The novel 4th generation Sterisart® Universal pump is designed to comply with modern safety standards and redefine sterility testing in this connected era of healthcare.
In January 2024, Rapid Micro Biosystems, a leading name in the quality control space announced its plans to launch its new Growth Direct® Rapid Sterility System in mid 2024. The new system is capable of delivering sterility testing results in as little as 1 to 3 days' time.

Sterility Testing Market Report Snapshots

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Global Sterility Testing Market size was valued at around USD 1.1 billion in 2022 and is expected to rise from USD 1.2 billion in 2023 to reach a value of USD 2.7 billion by 2031, at a CAGR of 10.5% over the forecast period (2024–2031).

Developing sterility testing procedures that take less time and provide accurate results will be the prime focus of all sterility testing companies. Targeting developing and underdeveloped countries could help sterility testing providers maximize their revenue generation and global sterility testing market share as well. Market players should also launch training programs to address the issue of absence of skilled professionals to perform sterility testing. 'Merck KGaA ', 'Charles river laboratories ', 'bioMérieux SA ', 'Sgs s.a. ', 'Sartorius ag ', 'Thermo fisher scientific inc. ', 'Wuxi apptec ', 'Samsung biologics ', 'Genscript ', 'Pacific biolabs ', 'Nelson laboratories, llc ', 'Pace analytical ', 'Rapid micro biosystems, inc. ', 'Tentamus ', 'Singota solutions ', 'Neopharm labs inc. ', 'Lexamed ', 'Astell scientific ltd ', 'Himedia laboratories ', 'Pall corporation (part of danaher corporation) ', 'Boston analytical ', 'Solvias ag ', 'BD'

Increasing emphasis on keeping healthcare products free from contamination is pushing governments and regulatory bodies such as the U.S. FDA and the European Medicines Agency (EMA) to impose strict regulations for sterility testing. Maintaining compliance with these regulations is essential and thereby promotes adoption of sterility testing around the world.

Use of Automation: Sterility testing companies should focus on developing automated solutions and services to streamline the sterility testing workflow and improve accuracy and efficiency as well. Integration of artificial intelligence and machine learning could help sterility testing companies achieve the desired automation and also help them stand out in the global sterility testing industry landscape going forward.

North America is predicted to spearhead the demand for sterility testing in the world. Growing healthcare research activity, presence of a strict regulatory framework mandating use of sterility testing, and the presence of key sterility testing companies are helping North America lead the global sterility testing market growth. Targeting the United States and Canada will offer good returns on investment for almost all sterility testing providers operating in this region. Rising incidence of infectious diseases in this region is also expected to create new opportunities for sterility testing providers going forward. Supportive government initiatives to promote safety in healthcare will also benefit sterility testing market forecast in North America.

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What is the global market size of Sterility Testing Market?

Who are the key vendors in the Sterility Testing Market?

What is the key driver of Sterility Testing Market?

What is the key market trend for Sterility Testing Market?

Which region accounted for the largest share in Sterility Testing Market?

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