The sterility testing method demonstrates the presence of microorganisms in sterile products to ensure safety. Sterility testing is done in different industries such as food, beverages, pharmaceuticals, medical sectors, etc. The pharmaceuticals and medical sectors are said to be the major industry for this method. The sterility of any device or material is measured through the sterility assurance level.
The global sterility market size in 2021 was $161.18 million, and by 2030 it is expected to reach $469.0, with a CAGR of 12.6% 2021-2030.
Segmentation Analysis of the Market
The sterility testing market is segmented into products type, test types, and applications. The market is divided into kits, reagents, instruments, and services based on product type. The kits and reagents segments were the market dominators in 2021 and held the largest market share. The market is fragmented into membrane filtration, direct injection, and other tests by test type. The membrane filtration method held the largest market share in 2021 because of the technological advancements in operations. By application, the industry is fragmented into pharmaceutical and biological manufacturing, medical devices manufacturing, bioburden testing, and other applications. The pharmaceutical and biological manufacturing segment is expected to hold a great position due to the increased intervention in this segment.
The sterility testing market is accounted for the rising population, technological advancements in rapid sterility testing, increase in healthcare expenses, and rise in the number of rare diseases. Development of new products, technological innovation, and advancements in research and development will fuel the global sterility testing market. Technological advancements and the development of new testing methods have enabled an accurate result in half time. With the advancements in the medical field and pharmaceuticals, the demand for sterility testing will also increase. With the rise in the biotechnology industry, safety concerns regarding medical products are also rising, and these factors will boost the sterility testing market in the coming years. Sterility testing is now carried out at all levels in the pharmaceutical and biopharmaceutical industry to minimize the risk of contamination.
Positive Impact of COVID-19
The healthcare industry is expected to have a positive impact due to COVID-19. With the rise in cases worldwide, innovations and technological advancements have also been boosted, directly affecting the growth of other medical sectors. Growth in the pharmaceutical and biotechnology industry, new drug launches, and increased research and development in life science contribute to the growth of the sterility testing market. New trials and drug launch Key players in the sterility testing market are nelson laboratories, Charles River, Wuxi AppTec, Merck, and others. These companies are majorly adopting acquisition, partnerships, collaboration, and product development to build their market position. The industry is focusing more on research and development and is investing a huge revenue for better outcomes in the pharmaceutical and biotech industry which is likely to boost the market at high speed and create opportunities for the new industry players to invest.
However, time-consuming clinical trials and a lack of skilled professionals to handle the new high technology machinery and operating system can hamper the market's growth and is one of the major challenging factors in the sterility testing market.
Advancements and Research in the Market
The sterility testing market will see a huge surge in the coming year because of the new advancements and research in the pharmaceutical and biotechnology industry. In the coming years, sterility testing will be done with more trained and skilled professionals with new and safer methods.