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Europe Sterility Testing Companies

Sterility testing is a critical aspect of quality control in industries such as pharmaceuticals, biotechnology, and medical devices. It ensures that products are free from viable microorganisms, including bacteria, fungi, and viruses. Companies specializing in sterility testing typically offer services that adhere to regulatory standards and guidelines to guarantee the safety and efficacy of the products they test.

EMEA Sterility Testing Key CompaniesLatest Sterility testing Companies Update

July 2023: Ten23 Health recently introduced quality control (QC) services in Switzerland, which are designed to conduct stability and release testing of sterile commercial and clinical drug products in accordance with international cGMP standards. Two locations of ten23 will house the new quality control division in order to accommodate a variety of testing needs and to ensure that each location is in optimal harmony with our other offerings. In Basel ten23 Health, physico-chemical testing, including identity, purity, and content, will be provided in accordance with pharmacopeial standards to assure the stability and release of sterile pharmaceutical drug products intended for clinical and commercial use. Ten23 will incorporate these services with the pharmaceutical development service it offers in Basel. The pharmaceutical industry's partner headquartered in Basel has established a new quality control (QC) division to assist in the release and stability testing of sterile drug products for commercial and clinical use, in accordance with international cGMP standards.


November 2023: MilliporeSigma, a life science enterprise of Merck KGaA, Darmstadt, operating in the United States and Canada, introduced ChemisTwinTM, the first digital reference materials platform capable of employing calibrated algorithm-based digital references for automated analysis of sample purity, identification, and degradation of compounds. By utilizing digital signatures for over 1,500 reference materials, this automation and calibration instrument aids scientists in guaranteeing the safety and quality of pharmaceuticals throughout the entire research and development process, including quality control and assurance testing. Life sciences are being disrupted by the expanding use of digital technologies that are supported by high-quality data. The ability to digitize reference materials represents an enormous advance in the protection of consumer goods and medications around the globe. The user-friendly and intuitive nature of ChemisTwinâ„¢ facilitates the progression of scientific inquiry, product innovation, quality assurance, and adherence to regulatory standards.


List of Sterility testing Key companies in the market

  • Merck KGaA (Germany)

  • bioMérieux SA (France)

  • SGS SA (Switzerland)

  • Sartorius AG (Germany)

  • Thermo Fisher Scientific Inc. (U.S.)

  • Toxikon, Inc. (U.S.)

  • Charles River (U.S.)

EMEA Sterility Testing Market Overview


The EMEA Sterility Testing Market is projected to reach USD 153.66 Million by 2030 at 13.20% CAGR during the forecast period 2022-2030.Sterilisation is any process that effectively eradicates any surface, equipment or article from the presence of viable microorganisms. Sterility testing is one of the important aspects of the healthcare sector which ensures the purity and safety of a product or a substance. Increasing prevalence of chronic diseases like cancer and HIV which can be easily transferred from the patient to the healthy adults through the use of the contaminated articles is one of the major drivers for the EMEA sterility testing market growth. In 2015, according to the Centers for Disease Control and Prevention, 9,250 out of every 10,000 exposures to infected blood transfusion resulted in the transmission of the HIV. Similar, results were estimated by the use of infected needle during the parenteral intake of the drugs, 63 out of every 10,000 such exposures led to HIV. Moreover, expanding pharmaceutical and biotech industries, the rise in the approval of the drugs, growth in R&D investments in life science research along with rising healthcare and government support is expected to boost the market growth during the forecast period. However, precise regulatory and time-consuming approval processes along with the lack of skilled labor will restrain the EMEA sterility testing market growth during the forecast period. 

Intended Audience



  • Pharmaceutical companies

  • Biotechnological institutes

  • Research and Development (R&D) Companies

  • Medical Research Laboratories

  • Market Research and Consulting Service Providers 


Figure 1:- EMEA sterility testing market share, by region EMEA sterility testing market


Sources: WHO, annual reports, press release, white paper, and company presentation


EMEA Sterility Testing Market Segment Insights


The EMEA sterility testing market is segmented on the basis of product, test, application and end users.


EMEA Sterility Testing Product Insights


The EMEA sterility testing market is segmented into kits & reagents, services, instruments, and others.


EMEA Sterility Testing Test Insights


The market is segmented into membrane filtration, direct inoculation sterility testing, and others. The membrane filtration segment is sub-segmented into membrane type which is further segmented into synthetic organic polymers and inorganic materials. The synthetic organic polymers, by membrane type, is sub-segmented into polysulfone, cellulose acetate, and others. The inorganic materials, by membrane type, is sub-segmented into ceramic membranes, metal membranes, others.


EMEA Sterility Testing Application Insights


The market is segmented into pharmaceutical industries, biotechnology industries, and others.


EMEA Sterility Testing End Users Insights


The market is segmented into hospitals & clinics, academic institutes, research organization, and others. 


EMEA Sterility Testing Regional Insights


Europe is the largest sterility testing market. High healthcare expenditures, government support for research & development and huge patient population drives the European market. Moreover, growing biotechnology and pharmaceutical industries is boosting the market growth. Additionally, the presence of the developed economies within the region like the U.K and France is fuelling the market growth during the forecast period. Regionally Europe is divided into Western Europe and Eastern Europe. Western Europe leads the market within the region. On the other hand, there are huge opportunities for the market growth in Eastern Europe. 


Asia Pacific is the fastest growing region in EMEA market due to the presence of a huge patient population and continuously developing economies like India and China which have a growing healthcare industry. According to the Indian Brand Equity Foundation, in 2017, the Indian healthcare sector is one of the fastest growing industries and is expected to advance at a CAGR of 22.8% and reach USD 280 billion by 2020. Additionally, favorable government policies like reduced excise and customs duty followed by the exemptions in service tax in India boosts the regional market growth. 


The Middle East & Africa holds the least share in the EMEA sterility testing market due to the presence of poor economies in the African region owing to the low per capita income and stringent government policies within the region. A majority of the Middle East & Africa market is held by the Middle East due to huge healthcare expenditures and presence of developed economies like Kuwait, Saudi Arabia, Dubai, and Qatar.  


Research Methodology Europe Sterility Testing Market


Sources: WHO, annual reports, press release, white paper, and company presentation


Key players for EMEA sterility testing market


Some of the major players in the EMEA sterility testing market are Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), Sartorius AG (Germany), Thermo Fisher Scientific Inc. (U.S.), Toxikon, Inc. (U.S.), Charles River (U.S.), and others.

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