Biologics are substance or products extracted or manufactured from biological sources such as living organisms, proteins, nucleic acid, or a complex combination of these substances. It includes a wide range of products such as gene therapy, somatic cells, tissues, recombinant therapeutic proteins, and blood components. Virus contamination of commercially valued cell culture may pose a health risk to the population and a financial burden to the manufacturing and biopharmaceuticalcompanies. In addition, safety testing for biologics is difficult and requires specialized evaluation.
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Biological safety testing is carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. It is a major step towards the launch of innovative biopharmaceutical products. Biological safety testing is essential to ensure product safety, and ensure the quality of biopharmaceutical products. It is conducted to ensure that the drug-producing microbes or cells are free from microbial or viral pathogens, for process validation of virus inactivation, clearance capability during biopharmaceutical production, and to test these biological materials during biopharmaceutical production for verifying the identity and characteristics. In addition, it is also used to ensure the purity, sterility, and genetic stability of the production cell bank. Bioburden testing, sterility testing, adventitious agent’s detection test, cell line authentication and characterization tests, endotoxin tests, and residual host contaminant detection tests are the major biological safety tests. Biological safety testing is used in vaccine, cellular, and gene therapy products, blood and blood products, tissue and tissue products, and stem cell products. It is performed by contract testing laboratories on the behalf of drug developers. These laboratories are confronted with a number of ethical issues and tasked with maintaining confidentiality in handling the results.
North America dominates the global market for biological safety testing due to increasing prevalence of chronic diseases, and rising R&D investment in life sciences in the region. Asia Pacific is expected to show high growth rate in the next five years in the global biological safety testing market with China and India being the fastest growing markets in the Asia Pacific region. The key driving forces for the biological safety testing market in developing countries are the large pool of patients, increasing healthcare awareness, rising burden of chronic diseases, improving healthcare awareness, rising government initiatives, and increasing healthcare expenditure in the region.
Rapid growth in biotechnology and pharmaceutical industries, rise in population, increasing prevalence of chronic diseases, increasing number of innovative product launches, rise in government and private funding for life science research, rise in R&D investment in life sciences, growing healthcare expenditure, improving healthcare awareness, and increasing government support for pharmaceutical and biotechnology industries are some key factors driving the growth of the global biological safety testing market. However, factor such as strict regulatory requirements and time-consuming approval process act as major restraints for the growth of the global biological safety testing market.
Increasing pharmaceutical outsourcing would pose an opportunity for the global biological safety testing market.
Key segments covered in this report are:
- By application
- Vaccines and therapeutics
- Blood and blood products
- Tissue and Tissue products
- Cellular and gene therapy products
- Stem cell products
- By tests
- Endotoxin tests
- Cell line authentication and characterization tests
- Bioburden tests
- Residual host contaminant detection tests
- Adventitious agent detection tests
- Sterility tests
- By products
- Kits and reagents
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Top companies profiled in this report are:
- Charles River Laboratories International, Inc.
- Lonza Group
- Sigma-Aldrich Corporation
- Wuxi Pharmatech (Cayman), Inc.
- Merck & Co., Inc.
- SGS S.A.
- Avance Biosciences, Inc.
- Toxikon Corporation
- Cytovance Biologics, Inc.
- Bsl Bioservice.
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