The biologics safety testing market has been growing in recent years due to the increasing demand for biologics and biosimilars. Biologics are complex molecules that are derived from living cells and used to treat various diseases such as cancer, autoimmune disorders, and infectious diseases. Biologics safety testing is a crucial step in the development and manufacturing of biologics to ensure their safety and efficacy. The safety testing of biologics is required by regulatory authorities before the products can be approved for commercial use.
Market Size:
According to Persistence Market Research, the global market for biologics safety testing is poised to grow at a robust pace during the forecast period, 2017-2022. Safety of biologics will continue to play a pivotal role in future drug developments, and products facilitating these tests will witness a significant uptake in the global pharmaceuticals industry. The report projects that by the end of 2022, the global biologics safety testing market will have reached a value of US$ 4,360 Mn.
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Market Segmentation:
The global biologics safety testing market is segmented based on product type, test type, application, and region.
Based on product type, the market is segmented into instruments, services, and reagents & kits. Services accounted for the largest share of the market in 2020 due to the increasing outsourcing of biologics safety testing services by pharmaceutical and biotechnology companies.
Based on test type, the market is segmented into endotoxin tests, sterility tests, cell line authentication and characterization tests, bioburden tests, residual host contamination detection tests, adventitious agent detection tests, and others. Endotoxin tests held the largest share of the market in 2020 due to their high sensitivity and specificity in detecting endotoxins in biologics.
Based on application, the market is segmented into vaccine development, blood products testing, cellular and gene therapy, tissue and tissue-related products testing, and stem cell research. Vaccine development accounted for the largest share of the market in 2020 due to the increasing demand for vaccines to prevent infectious diseases.
Regional Analysis:
The global biologics safety testing market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America held the largest share of the market in 2020 due to the increasing investment in biologics research and development, the presence of major market players, and the well-established healthcare infrastructure. Asia Pacific is expected to grow at the highest CAGR during the forecast period due to the increasing demand for biologics and biosimilars, the rising prevalence of chronic diseases, and the growing investment in healthcare infrastructure.
Key Players:
The global biologics safety testing market is highly competitive, with the presence of several market players. Some of the key players in the market are Lonza Group Ltd., SGS S.A., Charles River Laboratories International, Inc., Merck KGaA, Thermo Fisher Scientific Inc., Eurofins Scientific SE, Catalent, Inc., WuXi AppTec Group, Inc., and bioMérieux SA.
Conclusion:
In conclusion, the global biologics safety testing market is expected to grow at a significant rate during the forecast period due to the increasing demand for biologics and biosimilars, the rising prevalence of chronic diseases, and the increasing investment in biologics research and development. Services and endotoxin tests are the major segments of the market. North America held the largest share of the market in 2020, while Asia Pacific is expected to grow at the highest CAGR during the forecast period. The market is highly competitive, with the presence of several market players.