Biologics or biological products are medical products derived from various natural sources such as humans, microorganisms, and/or animals. The biological products are either extracted from sources such as proteins, sugar, and nucleic acids of living organisms, or produced by biotechnology techniques and/or other technologies. The various biological products are used to treat diseases or to prevent or diagnose diseases. Biological products include blood and blood components, vaccines, gene therapy, allergenics, somatic cells, tissues, and recombinant therapeutic proteins. The structure of different biological products are complex and difficult to identify.
Biologics produced through biotechnology methods are heat liable and more susceptible to microorganism contamination. Therefore, it is essential to use aseptic methods from primary manufacturing stage, in contrast to most conventional drugs. Biological products offer most effective treatment options for various medical conditions that currently have no other treatment availability. Biological safety testing is a process or method to check or ensure non-contamination of vaccines and other biological products. Biological testing is a major step in drug development to ensure quality, sterility, purity, stability, and safety of products to produce non-contaminated products. Detection, authentication, and characterization are the major steps of biological safety testing to check the biological products are whether free from bacteria, fungi, yeasts, mycoplasma, viruses, and other potential contaminants or not.
The biological safety testing market can be segmented based on product type, application, test type, end-user, and region. In terms of product type, the market can be segmented into instruments, kits & reagents, and services. Rising advancement and availability of various kits and reagents for testing are likely to drive the biological safety testing market. Based on test type, the biological safety testing market can be segmented into sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contaminant detection tests, adventitious agent detection tests, bioburden tests, and other tests such as toxicity tests, stability tests, etc.
In terms of application, the biological safety testing market can be segmented into vaccines and therapeutics, blood and blood products, tissue and tissue products, cellular and gene therapy products, and stem cell products. Vaccines is expected to be the fastest growing segment of the biological safety testing market, as these are used to prevent diseases. Increasing prevalence of chronic diseases is expected to drive the biological safety testing market during the forecast period.
Based on end-user, the biological safety testing market can be segmented into pharmaceutical companies, biotechnology companies, and contract research organizations. Pharmaceutical and biotechnology companies are expected to be the fastest growing segments of the market due to increasing R&D spending in pharmaceutical and biotechnology sectors globally. Other factors such as rapid growth in the pharmaceutical and biotechnology industries, new product launches in the biologics category, and rising government support for the development to new drugs are anticipated to fuel the market during the forecast period.
In terms of region, the biological safety testing market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America and Europe are projected to account for the largest share of the market owing to presence of key players in these regions. Moreover, rising research and development investment by market players for development of new biological products will drive the biological safety testing market during the forecast period. Asia Pacific is the fastest growing market for biological safety testing. Growing awareness about biological products, increasing health care spending, and rising medical tourism is likely to drive the market in Asia Pacific during the forecast period.
Key players operating in the biological safety testing market are Charles River Laboratories, International, Inc., Merck Millipore, SGS S.A., B&V Testing, Avance Biosciences, and WuXi AppTec.
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