Virus elimination and inactivation continue to emerge as a vital aspect in overall bioprocess safety. Viral clearance testing is a process which is obligatory by regulatory authorities for the investigational new drug (IND) submission and it is required mostly in the critical process development for biologicals such as antibodies (monoclonal), recombinant proteins and glycoproteins, tissue and blood-derived product etc. As bioprocesses, products, and unit operations are developing, viral clearance will become more customized to individual situations. For instance, in case of inactivation of reagents such as recombinant proteins and monoclonal antibodies, companies, diagnostic testing labs and, CROs need to evaluate the elimination of specific viral strains or viral copy number in samples.
VIRAL CLEARANCE MARKET OUTLOOK
The factors that propel the growth of the global Viral Clearance Market include a growth in the pharmaceutical and biotechnology industries, increasing number of new drug launches, the rising government funding for the pharmaceutical and biotechnology industries, innovation of novel drugs, and rise in RD activities. Additionally, high incidence and large economic burden of chronic disease coupled with the increasing aging population boost the growth of the global Viral Clearance Market. On the contrary, the high cost of technology and the time-consuming process of drug development is likely to hamper the market growth. Rising demand for contract research organizations for pharmaceutical outsourcing coupled with the potential emerging markets are likely to offer the growth opportunities for the viral clearance market in the upcoming years.
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VIRAL CLEARANCE MARKET SEGMENTAL OVERVIEW
The report analyses the global a viral clearance market based on application, method, end user and geography.
VIRAL CLEARANCE MARKET BY METHOD
Viral clearance can be performed by numerous methods depending on product type technique for production etc. Viral Removal (Chromatography, Nanofiltration and Precipitation) and Viral Inactivation (Low Ph, Solvent Detergent Method, Pasteurization and other Viral Inactivation Methods) are the methods used for the virus clearance. In viral removal method all viruses are removed from the sample completely. In Viral Inactivation, viruses remain in the final product, but in a non-infective form. Viral inactivation is used widely in the blood plasma industry. The viral removal method is also expected to observe lucrative market growth attributed to the factors such as RD activities by biopharmaceutical companies, high acceptance of this method, and the speed, accuracy, flexibility provided by the method in life sciences research.
VIRAL CLEARANCE MARKET BY APPLICATION
Viral Clearance market finds application in recombinant proteins, blood and blood products, vaccines, and others (stem cell products, cellular and gene therapy products, tissue and tissue products etc.) Recombinant proteins are used in development of novel therapies for severe chronic diseases such as cancer and other rare diseases. Recombinant proteins have high potency and lesser side effects. Thus, the growth is observed in the biopharmaceutical research and development field. The segmental growth is attributed to the increased production and use of biosimilars and other therapeutic proteins for treating life-threatening diseases, such as cancer, diabetes, etc., globally.
VIRAL CLEARANCE MARKET BY END USER
The various end users of vial clearance products in this report are pharmaceutical biotechnology companies, CROs, academic research institutes, and others. The contract research organizations segment is observing lucrative growth owing to the factors including rising outsourcing of drug discovery services to CROs by pharmaceutical companies, academic institutes, small biotechnology companies and ability of CROs to invest in extensive drug discovery infrastructure.
VIRAL CLEARANCE MARKET BY GEOGRAPHY
North America, Europe, Asia Pacific and Rest of the World are key regions covered for the global Viral Clearance Market. North America is dominated the viral clearance market in 2018. Th largest share of the market is attributed to the increasing biopharmaceutical RD activities in this region coupled with the rapidly growing life science research related to stem cell products, gene, and cellular therapy for cancer treatment, tissue-based therapies for heart, and liver, lung, and kidney disorders. Further, huge RD investments made by biotechnology and pharmaceutical companies coupled with the favourable research grant/fund and ongoing cell culture research activities in academic research institute contribute toward the progress of the viral clearance market in this region. However, Asia Pacific is expected to witness the highest growth over the forecast period. The highest growth of the market is attributed to the factors such as growth in generics development and manufacturing, growth in funding for medical research and the presence of many CROs to provide preclinical and clinical research services in China. Further, increasing aging population, rise in pharmaceutical RD expenditures, and the increasing pharmaceutical manufacturing in this region is likely to propel the growth of the market in this region.
VIRAL CLEARANCE MARKET KEY PLAYERS
The key companies which led this industry verticals includes, Wuxi Biologics (Cayman) (Subsidiary of Wuxi Apptec), Merck KGaA, Charles River Laboratories International, Kedrion, Vironova Biosafety, Texcell, Clean Cells, Bsl Bioservice, Virusure GmbH, Avance Biosciences Inc, SGS S.A, Sigma-Aldrich Corporation and Lonza group among others.
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