The biopharmaceutical industries highly adapt a Viral Clearance to remove viral contamination using chromatography or specialized membranes. The ultimate goal of viral clearance in the healthcare field is to ensure that therapeutic drugs derived from specific sources are getting rid of any viral contamination; these protein solutions undergo viral clearance to inactivate or remove viral materials. Viral clearance is essential in developing monoclonal antibodies, glycoproteins & recombinant proteins, blood & tissue-derived products, and medical devices. Viral clearance can be performed by several methods depending on product type or technique for production, such as PCR, qRT-PCR, western blotting, and ELISA.
The global viral clearance market size was valued at USD 449.2 million in 2019 and projected to reach USD 1059.78 million by 2027, growing at a CAGR of 12.21% during the forecast period, 2020-2027. The major factors are the growing demand for viral clearance by the biopharmaceutical industries to manufacture therapeutics and biologics. The increasing clinical usage of viral clearance in pharmacology to protect cell culture processes, raw materials, bioreactor contamination, and downstream processing will propel the demand for viral clearance over the coming years. Additionally, the increasing utilization of viral clearance to remove virus at an early stage of drug development and increase R&D investments will spur the global viral clearance industry in the future periods. Furthermore, the growing public-private funding for novel drug development activities and rising advances in nanofiltration technology are expected to witness remarkable growth of the viral clearance industry.
Moreover, the increasing demand for new drug launches positively impacts the market for viral clearance in the healthcare industry. Furthermore, the rapidly expanding customer base, rise in the extensive R&D activities at the academic and industrial level, and increasing scope of biomedical applications are fueling the demand for the viral clearance market. The growing demand for virus inactivation and increasing demand for biopharmaceutical products & vaccines to treat numerous chronic diseases will bolster the growth of the global viral clearance market share. Additionally, the growing geriatric population and increasing healthcare infrastructure in the developing world propelling the revenue of the viral clearance market across the globe.
Viral clearance is used to maintain the high standard of purity in biopharmaceutics, including cell- & gene-based therapeutic products, plasma products, recombinant protein therapeutics, and vaccines, which can effectively reduce the risk of contamination and prevention of drug failures. Traditionally, In-vitro methods have been used to test the presence of contaminating viruses in the product stream. Moreover, next-generation sequencing (NGS) holds great promise in the quick and accurate detection of known and unknown contaminating viruses due to the advent of technology. It allows sensitive and specific testing of a wide range of viral contaminants instead of detecting only specific viruses allowed by current methods. However, the high cost associated with the viral removal techniques can be a restraint to the growth of the viral clearance market.
Based on the method, the global viral clearance market is categorized into viral removal and viral inactivation. Furthermore, the viral removal method is sub-segmented into chromatography, nanofiltration, and precipitation. The viral inactivation is further sub-segmented into low PH, solvent detergent method, pasteurization, and other viral inactivation. The viral removal segment held for a significant market share in 2019 and will gain maximum market revenue by 2027. It is attributable to the availability of advanced filtration technology with large adaptation by the biopharmaceutical& food industries, effective in the downstairs purification process, and easy removal of large viruses through filters.
The viral inactivation segment is poised to witness significant growth over the forecast period as it is relatively simple, robust, and effective against the enveloped virus.
The global viral clearance market is added into recombinant proteins, blood, vaccines, and other applications based on the application. The segment’s revenue is primarily attributed to the rising demand for antiviral vaccines, rising prevalence of infectious diseases, and increasing demand for the detection of viral contaminants to innovate novel drugs &vaccines. The vaccines are expected to be the highest revenue share for viral clearance during the forecast period.
The Recombinant Protein will witness a lucrative growth rate in the estimated period due to rising research on the ground of proteomics and increasing demand for protein therapeutics.
Based on the end-user, the global viral clearance market is segmented into pharmaceutical and biotechnology companies, academic research institutes, contract research organizations, and other end users.
The pharmaceutical & biotechnology companies segment will dominate the global viral clearance market by 2027. It is due to the rising demand for biopharmaceuticals to treat chronic illnesses such as cancer and diabetes, increasing investments in drug development activities, and increasing use of viral clearance methods in the clinical trial setting.
The CROs accounted for the largest share of the viral clearance market in 2019 because of the rising demand for viral clearance studies by the biopharmaceutical industries for their biological drugs and the increasing demand for pharmaceutical purification services.
The global viral clearance market is segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa by geography. North America is estimated to project considerable growth over 2020-2026. It is due to the rise in the number of drug launches, the growing incidence of chronic illness, and leading industry players offering innovative products.
The Asia Pacific will produce a prominent share of the viral clearance market by 2027. Due to the increasing awareness towards the health and safety of medicinal treatments, we are continually improving healthcare infrastructure in the region and mounting health care expenditures in developing countries such as India and China.
Merck KGaA, Charles River Laboratories International, Texcell, Wuxi Biologics, Lonza Group, Kedrion, Vironova Biosafety, BslBioservice, and Virusure GmbH are the key players in the global viral clearance market.
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Global Viral Clearance Market
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