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The U.S. viral clearance market size was worth USD 187.5 million in 2022 and is projected to grow at a CAGR of 17.8% during the forecast period.
Viral clearance studies are used to assess and remove the presence of viruses from a downstream process. Biological products derived from human or animal sources must undergo viral removal to ensure the drug's safety. The increasing pharma and biotech companies’ emphasis on developing and manufacturing biological drugs and vaccines has been fueling the U.S. viral clearance market growth.
Moreover, the increasing government initiative for viral safety and the rising number of clinical studies involving biologics has fueled the market growth of viral clearance.
Due to the sudden outbreak of COVID-19, the market experienced slower growth in 2020. The manufacturing capacity of the pharmaceutical and biotechnological companies slowed, and many research studies other than that on COVID-19 vaccine development were put on hold. This led to the slow growth of the U.S. market in 2020.
Adoption of Advanced Technology, such as Next Generation Sequencing (NGS) in Validation of Viral Clearance, has been Increasing Significantly
Certain limitations are associated with the in-vitro adventitious virus assays of viral removal studies. For instance, these methods can only detect viral families that cause cytopathic effects, hemadsorption, or hemagglutination. Thus, viral species that do not cause these effects would go undetected by this methodology.
The use of Next Generation Sequencing (NGS) can overcome this limitation. NGS uses the notion of sequencing millions of DNA fragments simultaneously.
The significant advantage of NGS is that its detection does not require prior knowledge of potential adventitious viral agents, as it can detect a broad range of viral contaminations of both novel and unknown viral sequences.
The utilization of NGS for adventitious virus testing is a new approach in viral testing, as this methodology can detect novel or unknown viruses without prior knowledge of potential viral targets. Moreover, advances in nucleic assay detection technologies have enabled the capability to generate hundreds of mega-bases to several giga-bases worth of sequences in hours, days, or weeks.
Such advantages associated with the NGS have increased its adoption for viral detection and removal studies.
Increasing R&D investment by Pharmaceutical and Biotechnological Companies in the U.S is Fueling the Market Growth
It is mandatory for the drug molecule being derived from the human or animal source to go through a viral detection and removal study to validate its safety. Therefore, the increasing investment by life science companies in R&D activities for new drug development has been fueling the U.S. viral clearance market growth.
The increasing R&D expenditure by these companies increased the new drug development, fueling the demand for these studies.
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Lack of Skilled the Workforce Tends to Limit the Viral Clearance Market Growth
Demand for viral detection and removal studies has increased with the increasing R&D in the biotech and pharmaceutical industry. However, it is challenging for the market players to find and maintain qualified scientists with experience in the life science sector.
Despite the increasing demand for viral detection and removal studies in manufacturing biological drugs, the industry lacks the presence of an experienced workforce.
The limited availability of experienced technicians tends to hamper the efficacy of the viral removal procedure, thereby negatively impacting the market growth.
In 2022, around 9,901 new clinical trials were registered in the U.S., experiencing a growth of 7.4% from 2016.
Based on method, the market is fragmented into viral removal method, viral inactivation method, and viral detection method.
The viral removal method dominated the market in 2022. The segment's dominance is attributed to the growing investments in R&D by key viral clearance players in the market and the increasing demand for vaccines and other biopharmaceuticals in the region.
On the basis of application, the market is segmented into blood and blood products, recombinant proteins, cellular & gene therapy, vaccines, and others.
The cellular & gene therapy products segment is expected to grow at the highest CAGR during the forecast period owing to increasing drug development and approval of cellular & gene therapy products.
Based on end-user, the market is segmented into pharmaceutical and biotechnology companies, academic & research institutes, Contract Research Organizations (CRO), and others.
The CRO segment is expected to grow significantly during the forecast period. The growth of the segment is attributed to the increased collaboration between the market players to enhance their service offerings and research outputs.
The market includes significant players such as WuXi Biologics, Merck KGaA, and Charles River Laboratories. These players together accounted for a significant U.S. viral clearance market share. The growth of these players in the market was due to their focus on expanding their presence in the U.S.
Other players operating in the U.S. market, such as Vironova, Kedrion, Sartorius AG, Texcell, and Clean Cells, have been focusing on mergers and acquisitions to expand their presence in the market.
An Infographic Representation of U.S. Viral Clearance Market
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The U.S. market research report provides a detailed analysis of the market. The research report includes key points such as an overview of technological advancements and others. Additionally, it includes the increased use of viral removal services in the U.S., new service launches, key industry developments such as mergers, collaborations, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market in recent years.
CAGR of 17.8% from 2023 to 2030
Value (USD Million)
Fortune Business Insights says the U.S. market was worth USD 187.5 million in 2022.
The market is expected to exhibit a CAGR of 17.8% during the forecast period (2023-2030).
By method, viral removal method accounts for a considerable proportion of the market.
WuXi Biologics, Merck KGaA, and Charles River Laboratories are the top players in the U.S. market.
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