The Report “Sterility Testing Market” is segmented by Product (Kits and Reagents, Instruments, Services), by type (Membrane Filtration, Direct Inoculation, Other Sterility Tests), By Application (Pharmaceutical and Biological Manufacturing, Medical Devices Manufacturing, Others Applications), Region (North America, Europe, APAC and LAMEA). In 2020, the Global Sterility Testing Market share was USD 143.15. It is predicted to reach USD 2193.8 million by 2028, representing a CAGR of 12.6 percent throughout the forecasted period.
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Key Factors Augmenting The Market Growth
In order to limit the probability of product contamination, sterility testing is widely conducted in the pharmaceutical and biopharmaceutical industries. As a result, the growth of this end-use sector will dramatically boost the overall use of sterility testing during the next few years. Due to strict regulatory limits, process monitoring and quality control are carried out for the entire production chain of pharmaceutical and biopharmaceutical items. This step includes raw material sterility testing, bulk lot release testing, and final product release testing.
By Product- (Kits and Reagent Segment is dominating the market)
The market for reagents and kits is expected to increase significantly by 2028. This rise is due to the availability of a number of technologies that help to lower the risk of false-negative and positive outcomes. There are also sterility testing pumps available, which are designed to fit easily into any testing facility and aid in maximizing safety and streamlining productivity. Rising demand for similar items is predicted to boost segmental growth throughout the forecasted period.
By Type- (Membrane Filtration is dominating the testing market)
Membrane filtration dominated the testing market as a result of technological breakthroughs in membrane filtration design and operation, which improved filtration efficiency and allowed filtration processes to operate at low temperatures and with low energy consumption.
By Application- (Over the forecast period, the Pharmaceutical and Biological Manufacturing segment is expected to grow)
The pharmaceutical and biological production industry is predicted to account for a large percentage of the sterility testing market by 2028. As the importance of sterility testing methodologies in the pharmaceutical manufacturing process develops, this growth can be attributed to growing regulatory intervention. Several regulators have devised a number of scientifically sound and product-specific standards to ensure that these harmonized techniques are followed, and that unnecessary risk is avoided, leading to future segmental expansion.
By Region- (North America dominates the sterility testing market, and this trend is expected to continue during the forecast period)
Due to increased research, North America currently dominates the sterility testing market and is anticipated to do so for the duration of the projection period. It is due to innovation in the biotechnology and pharmaceutical industries, increased investment in life sciences and medical technology research, and the development of favorable government initiatives.
Competitive Analysis: -
With numerous big rivals and others, the market for sterility testing is moderately competitive, and the Fastest Growing Market is Sterility Testing. As the biopharmaceutical industry's prospects improve, several new companies are expected to enter the market. Some of the market's major competitors are BioMérieux, Charles River Laboratories, Inc., Merck KGaA, Sartorius AG, SGS S.A., Sotera Health LLC, and Thermo Fisher Scientific.
Sterility Testing Market: Recent Developments
On May 17, 2021, Charles River Laboratories International, Inc. announced a definitive agreement to acquire Vigene Biosciences, Inc., a leading gene therapy contract development and manufacturing organization (CDMO) in the United States specializing in viral vector-based gene delivery solutions.
On April 6, 2021, Charles River Laboratories International, Inc. and Valence Discovery signed a strategic collaboration to allow clients to use Valence's artificial intelligence platform for molecular property prediction, generative chemistry, and multiparameter optimization.