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This report studies the global Biological Safety Testing market size, industry status and forecast, competition landscape and growth opportunity. This research report categorizes the global Biological Safety Testing market by companies, region, type and end-use industry.
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.
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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.
Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations.
Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth. Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years.
High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices. Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools.
Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.
The Americas will be the major revenue contributor to the biosafety testing services market till 2021. The region has the presence of several NPOs and regulatory organizations that promote biological safety testing.
Additionally, the focus of organizations such as the FDA, the CDC, and the American Biological Safety Association (ABSA) towards promoting biological safety in several industries such as pharmaceutical and biotechnology, will also drive the growth of the market in this region.
This report focuses on the global top players, covered
- Thermo Fisher Scientific
- Charles River Laboratories International
- Lonza Group
- Avance Biosciences
Market segment by Regions/Countries, this report covers
- United States
- Southeast Asia
Market segment by Type, the product can be split into
- Kits & Reagents
Market segment by Application, split into
- Vaccine Development
- Blood Products
- Stem Cell Research
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