Virus elimination and inactivation continue to emerge as an important factor in overall bioprocess safety. As bioprocesses, products, and unit operations flourish, viral clearance will become more customized to industrial and individual situations. At the same time, the global viral clearance market will keep extending its purview. Viral clearance is also called viral safety. For example, in case of inactivation of reagents such as monoclonal antibodies and recombinant proteins, companies, CROs, and diagnostic testing labs need to evaluate the removal of specific viral strains or viral copy number in samples.
Viral clearance can be performed by numerous methods depending on product type, technique for production, and whether it is a medical device or not. Examples of the techniques used in viral clearance are qRT-PCR, PCR, real time PCR, ELISA (EIA), western blot, and transmission EM. Viral clearance is vital for final confirmation about the acceptable level of safety which can be taken in for a final product. The success ratio of viral clearance depends on the selection of suitable methods that make sure the removal or demolition of any viruses without disturbing the target protein. A number of factors must be considered when making this choice: the regulatory requirements, characteristics of the target protein, the mechanism(s) of clearance method(s), and the impact of process parameters.
The major driver of the global viral clearance market is increasing demand in the pharmaceutical and biotechnological industries. Rise in the number of new drug launches in various segments and associated drug approval processes are also boosting market growth. The global viral clearance market has been segmented based on technique, end-user, application, and region. Based on technique, the viral clearance market has been divided into viral detection method, viral removal method, and viral inactivation method. The viral detection method segment is estimated to account for the largest share of the global viral clearance market.
In terms of application, the market has been segmented into blood & blood products, cellular & gene therapy products, stem cell products, tissue & tissue products, and vaccines and therapeutics. The vaccines and therapeutics segment is projected to hold the largest market share. Based on end-user, the viral clearance market has been segmented into pharmaceutical and biotechnology companies, contract research organizations, academics and research institutes, and others. The others segment constitutes medical device companies, cell banks, small cell culture laboratories and consultants, microbiology laboratories, and toxicology laboratories.
Geographically, the global viral clearance market has been divided into North America, Europe, Asia Pacific, and Rest of the World (Latin America, Middle East, and Africa). In terms of region, North America accounted for the largest share of the viral clearance market, followed by Europe, and Asia. North America and Europe are likely to witness high demand for viral clearance assays as a result of technological advancement, rise in number of new drug launches, and patent expiry of popular branded drugs. Other factors driving the market in these regions are rapidly aging population, growing incidence of associated disease, and increased obesity rates.
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The market in Asia Pacific is expected to expand at the highest growth rate during the forecast period. The considerable growth of the market in the region is attributable to growing public and private initiatives to increase awareness related to health and safety of medicinal treatment and constant growth in health care expenditure. Presence of a large chronically ill population, increasing number of private sector hospitals, rising affluence, advancements in technology, and expansion to rural health care infrastructure are also likely to drive the market.
Major companies operating in the viral clearance market are Avance Biosciences, Inc., BSL Bioservice, Charles River Laboratories International, Inc., Clean Cells, Inc., Lonza Group, Merck Millipore – Sigma-Aldrich, Texcell, Inc., and Wuxi Pharmatech (Cayman), Inc., among others.
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