Sterility testing is performed for the occurrence or lack of feasible microorganisms skilled of escalating and growing under favorable conditions. It is used to guarantee the lack of impurities in biologics and medical devices.
The global sterility testing market is growing at a significant rate due to the evolution of pharmaceutical & biotechnology companies, a mounting number of drug introductions. Different products such as instruments, kits & reagents, and services contributed to the sterility testing market size. The market has witnessed high demand for kits & reagents in the coming years due to a mounting inclination for kit-based testing and requirement of the frequent consumption of these products.
Insight by Product
On the basis of product, the market is subdivided into instruments, kits & reagents, and services. Of all products, kits & reagents segment accounted the largest share in the market, due to the requirement of the frequent consumption of these products, the mounting contribution of the Institute for research and development activity, effortless product affordability, and escalating inclination for kit-based testing. Moreover, strict regulation of cGMP and cGLP and escalating reports of drug-related adverse events in regard to product contamination are also facilitating the growth of the kits & reagents segment in the market.
In addition, the instrument segment is the fastest growing segment in the market, due to technological development in the membrane filtration device and design proposing essential features such as energy consumption, and extremely effectual at the low-pressure drop.
Insight by Test
On the basis of the test, the market is subdivided into membrane filtration, direct inoculation, and others. Speedy progress in the pharmaceutical and biotechnology industry, mounting filtration efficiency, and technological improvement in membrane filtration design and operations are the major factors responsible for the growth of the membrane filtration. Of all the tests, the membrane filtration accounted foremost share in the sterility testing market. Moreover, the direct inoculation segment is expected to grow at fastest rate in the market due to its use in execution of sterility testing of products which are not filterable or deformable and smaller volumes of test items can be used.
Insight by Application
On the basis of application, the market is subdivided into pharmaceutical and biological manufacturing, medical device manufacturing, and others. Speedy progress in the pharmaceutical and biotechnology industry is the factor responsible for the growth of the pharmaceutical and biological manufacturing application. Among all applications, the pharmaceutical and biological manufacturing application accounted the largest share in the sterility testing market.
Evolution of pharmaceutical & biotechnology companies, a mounting number of drug introductions, escalating occurrence of chronic diseases, government assistance for pharmaceutical and biotechnology industries, and expanding research and development assets in life sciences are the primary growth drivers for sterility testing market. For instance, according to the Centers for Disease Control and Prevention (CDC) in 2012, approximately 117 million people in the U.S. had one or the more chronic conditions.
Mounting pharmaceutical outsourcing, intensifying healthcare expenditure, and technological improvement in rapid sterility test are also facilitating the growth for the sterility testing market.
Strict regulatory frameworks, time exhausting sanction processes, and scarcity of expert professionals are the major challenges for the growth of sterility testing market.
Globally, the manufacturing companies trying to enter the sterility testing market are required to maintain stringent regulatory standards. Moreover, the high level of capital requirement also poses a major barrier to the entry of new players. This offers an edge to the established players in the industry competition.
Geographically, North America is the largest sterility testing market as in the region the new biopharmaceutical companies are established, and pharmaceutical and biotechnology industries occupied in vigorous research and development activities. In addition, intensifying need for sterility testing, mounting healthcare expenditure, the presence of active healthcare system, and primary acceptance for advanced technology are also up surging growth of the North American sterility testing market.
Asia-Pacific is observed to witness the fastest growth in the market, due to mounting expenditure on life science research, and growing biopharmaceutical manufacturers. In addition, intensifying occurrence of chronic diseases, a supportive regulatory environment, and the budding inclination of pharmaceutical outsourcing are also creating a positive impact on the sterility testing market growth in the region.
Key players in the sterility testing market are catering to the demand of these devices by investing in technologically advanced products in their product portfolio across the globe. Merck KGaA, SGS S.A, Pacific Biolabs, Thermo Fisher Scientific Inc., Charles River Laboratories International, Inc., Sartorius AG, Biomérieux SA, and Wuxi Apptec are the key players offering sterility testing products.