According to the latest report published by Credence Research, Inc. “Biological Safety Testing Market – (Product Type – Reagents & Kits, Instruments and Services); (Test Type – Sterility Tests, Endotoxin Tests, Cell Line Authentication and Characterization Tests, Residual Host Contaminant Detection Tests, Bioburden Tests, Adventitious Agent Detection Tests, Others Tests); (Application – Gene and Cellular Therapy, Tissue & tissue-based products, Vaccines & therapeutics, Stem Cell Research, and Others): Market Growth, Future Prospects and Competitive Analysis, 2017-2025,” the market was valued at USD 2.15 Bn in 2016, and is expected to reach USD 6.17 Bn by 2025, expanding at a CAGR of 12.3% from 2017 to 2025.
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Biological safety testing is a mandatory process in pharmaceutical and biotechnology companies for quality control measure for biological and drug manufacturing process. On the basis of products and services the biological safety testing market is segmented into reagents & kits, instruments and services. The reagents & kits held the largest market in the product segment due to repeated use of necessary reagents in the biological safety process. Hence, leading to the higher purchase of reagents and kits. Moreover, introduction of more advanced and modified reagents formulations serving the purpose better are further driving the market. The manufacturing companies are introducing the kits for particular application which has increased the better adaptability of these products in the laboratory setting and toxicology testing making it a more organized market. The most common tests elucidated in this study include sterility tests, endotoxin tests, cell line authentication and characterization tests, residual host contaminant detection tests, bioburden tests, adventitious agent detection tests and others. Sterility testing held the largest market in the overall biological safety testing market due to its wide application in pharmaceutical and biotechnology process. The constant efforts for ensuring drug product quality and safety, health authorities in many countries have implemented, or are considering implementing, quality control (QC) testing requirements for pharmaceuticals, biological/biotechnology, and/or vaccine products entering the market which would drive the biological safety testing market during the forecast period.
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The applications mentioned in the biological safety testing market are gene and cellular therapy, tissue & tissue-based products, vaccines & therapeutics, stem cell research and other. Vaccines & therapeutics held the largest share in the application segment. Vaccines and therapeutics administered by the parenteral route are required to be tested for sterility at the final container and also at various stages during manufacture according to the guidelines issued by the FDA and respective authority to prevent toxicity and contaminations. Thus, defined guidelines ensuring the safety of developed vaccines with unaltered therapeutic value and reduced toxicity, which may result from constituent materials and pharmacodynamic action of the vaccine, are presumed to be responsible for the heightened demand of this segment during the forecast period.
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Geographically, North America dominated the global biological safety testing market which was followed by Europe. The major factors leading to the dominance of North America are the presence of prominent players in the region with continuous market expansion and evolution. Heightened R&D activities undertaken by the companies with the initiatives by the government further drive the market. Asia Pacific is anticipated to be the fastest growing region the biological safety testing market due to growing healthcare infrastructure resulting in growing R&D investments from the major pharmaceutical giants. Moreover, lower cost of contract research has led to the paradigm shift towards Asia Pacific. In addition, favourable regulatory policies enforced by the healthcare organizations to improve safety, as well as the improving healthcare infrastructure quality is further expected to widen the growth opportunities in the future.
Market Competition Assessment:
The biological safety testing market currently have comprises number of companies such as Thermo Fisher Scientific, Lonza Group, Sigma Aldrich Corporation, Charles River Laboratories International, Inc., and Wuxi Pharmatech, and others currently operating in the market.
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