Biologics are the advanced drugs used in the treatment of rheumatoid arthritis, cancer and other dieses. Biological safety is carried out by the manufacturer to detect the contamination like viruses, toxic mycoplasma, and bacteria. It is the mandatory process in these companies to quality control of the product as well as the raw material. It is also use for process control and validation of the end product. Biologic drugs are formed from living organisms, which includes tissues, recombinant proteins, genes, cells, allergens, vaccines, and blood components. The global biologics safety testing market size was valued at USD 3.8 billion in 2020 and it expected to reach USD 11.7 billion by 2030, register the CAGR of 11.80% during the forecast period.

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On the basis of product & services, the global biologics safety testing market is categorized into kits & reagents services, and instruments. On the basis of test type, the market is segmented into sterility test, endotoxin tests, cell line authentication and characterization tests, bio burden test, residual host contamination detection tests, adventitious agent detection tests, and others. On the basis of application, the market is categorized into vaccine development, blood product testing, cellular & gene therapy, tissue & tissue related product testing, and stem cell research. By geography basis, the biologics safety testing market is divided into North America, Asia Pacific, Europe, and RoW.

Increasing the biotechnology and pharmaceutical industry, increasing drugs launches and government activity to promote the biological safety that to boost the market growth. Moreover, high rate of microbial contamination, and bio burden while manufacturing the pharmaceutical & biologics are the factor that help biologics safety testing market growth. Furthermore, presence of regulatory authorities to apply significant safety standards is expected to boost adoption of testing tools. High cost of product, stringent government regulations and regulatory body norms for approval of biosimilars may hamper the biologics safety testing market growth. Government provides fund for biological development that has opportunity in the biologics safety testing market.

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North America dominating the biologics safety testing market, as increase adaptation in cancer research, and development of biological vaccine in this region. Increase development in R&D department, and pharmaceutical industry help North America to grow. The market is growing with 11.9% CAGR. Followed by North America, Asia Pacific dominating the biologics safety testing market, as developing pharmaceutical infrastructure, and development in R&D in this region. Furthermore, favorable industrial regulations, coupled with low labor wages and ample resource availability, are anticipated to factor the growth of biologics safety testing market in the region.

The major players in, the global biologics safety testing industry are Lonza Group LTD., Sigma Aldrich Corporation, Toxikon Corporation, Charles River Laboratories, Merck KGaA, SGS SA, WuXi pharmatech, Inc., WuXi AppTec Co., Ltd., Advanced Bio Science, Inc., Sartorius AG, Cytovance Biologics, Inc., Bsl Bio services, Pace Analytical Services Inc., Thermo Fisher Scientific Inc., and others.