29 July 2020
Visiongain has launched a new report Pharmaceutical Sterility Testing Market Report 2020-2030: Forecasts by Type (In-house, Outsourcing), Test Type (Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing), by Sample (Sterile Drugs, Biologics & Therapeutics), End-use (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, Others), and by Region (North America, Europe, Asia Pacific, Latin America & MEA), Including Forecasts by Major Developed Countries and Developing Countries, Plus Profiles of Leading Companies.
Pharmaceutical sterility tests are conducted to ensure the absence of viable microorganisms in the product. These tests include fungistasis and bacteriostasis testing that help to ensure the sterility of the product and are safe for human use. These tests are extremely difficult to perform and require clean environment as there is need to reduce the risk of false positive results caused laboratory contamination or any manual error. Pharmaceutical companies is the dominant segment owing to the regulatory requirement to follow GMP and ICH standards before every drug launch and approval, thereby ensuring product safety.
The relaxation of regulatory guidelines by the FDA has motivated contract labs and manufacturers to use modern and sophisticated techniques for sterility testing. Outsourcing of sterility testing is dominant segment of the pharmaceutical sterility testing market as it helps to save time and reduce costs required for purchase of sterility testing equipment. In addition, the lack of sophisticated infrastructure required to conduct quality sterility testing lead to an increased demand for outsourcing these tests.
The increase in the R&D activities in pharmaceutical companies is expected to increase the development of disease-specific drugs. As per the data by UNESCO, the US, Japan, China, and Germany were among the top countries to have high R&D expenditures annually. The increase in the number of product development is expected to increase the demand for sterility tests. The rise in demand for medications have motivated many developing countries to accelerate the launch of new drugs by streamlining the timelines for regulatory approval. The increase in number of drug launches and growing demand for better quality and sterility further drives the growth of global pharmaceutical sterility testing market. However, the third party performance and stringent regulations are expected to hamper the market growth.
The Visiongain report analyst commented “the initiative by governments in developing countries to offer cost-effective medications, increase in launch of advanced drug, rise in R&D investments for better quality of products, and the large number of pipeline products are expected to boost the growth of the pharmaceutical sterility testing market”.
The report covers a detailed competitive outlook that includes market share and company profiles of key players operating in the global market. Key players profiled in the report include Pacific Biolabs, Steris Corporation, Boston Analytical, Gibraltar Laboratories, Sartorius AG, Solvias AG, SGS SA, Toxikon, Inc., Pace Analytical Services, and Charles River Laboratories International, Inc.
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