Report Overview

The global viral clearance market was pegged at US$ 489.23 million in 2021 and is expected to witness a CAGR of 15.90% during the forecast period. 

Market Fundamentals 

Viral clearance refers to the removal and/or inactivation of unwanted viruses during manufacturing. It is an essential procedure that is followed by all biotechnology and pharmaceutical companies as part of maintaining the standard, quality, and safety of products. Viral clearance is also one of the standard tests done to demonstrate safety in Phase I/II clinical trials and it is mandatory for Phase III studies and commercial release. There are numerous routes through which viruses may contaminate manufacturing processes and raw materials, cell cultures, and manufacturing units. Viral clearance is essential to keep the product free from pyrogen and viruses which may induce the diseases. Viral contaminations are rare events in biopharmaceutical manufacturing, and regulatory agencies expect all biologics to undergo viral clearance testing to mitigate the risk of contamination.  Typical viral clearance methods include filtration, chromatography, and inactivation using high or low pH, heat, or detergents. 

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Market Dynamics

The global viral clearance market is mainly driven by increasing demand for biosimilars, investment in the biotechnology industry, and rising initiatives for the manufacturing of vaccines and biologics. Additionally, the increasing prevalence of chronic & viral diseases and the imposing of new safety regulations by regulatory bodies are fueling the global viral clearance market. The introduction of novel methodologies for viral testing and clearance methods is also contributing to the growth of the global viral clearance market. However, the high costs of viral clearance methods may restrain the market growth.

Market Ecosystem

The global viral clearance market has been analyzed from five perspectives: method, application, end user, and region. 

Viral Clearance Market by Method

Based on the method, the global viral clearance market has been segmented into viral removal method (chromatography, nanofiltration, and precipitation), viral inactivation method (low pH, solvent detergent method, pasteurization, and other), and viral detection method. Viral removal methods are leading the global viral clearance market owing to their affordability, high viral clearance yield, and quick turnaround time compared to other processes. Chromatographic viral clearance is a combination of ion exchange, hydrophobic interaction, affinity, and size exclusion. Chromatography and nanofiltration and precipitation methods help in the reduction of viral and can be applied to both enveloped and non-enveloped viruses and increase product purity.

Viral Clearance Market by Application

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Based on the application, the global viral clearance market is segmented into blood and blood products, recombinant proteins, cellular & gene therapy products, vaccines, and others. The vaccines segment is at present leading the global viral clearance market owing to increasing vaccine research & development, favorable government initiatives for uptake of vaccines, and growing scale of vaccine production due to outbreaks of diseases such as COVID-19, H1N1, etc. Additionally, increasing regulations for safety and quality standards by pharmaceutical and biotechnology regulatory bodies are contributing to the global viral clearance market in vaccines application.

Viral Clearance Market by End User

Based on end user, the global viral clearance market has been segmented into the pharmaceutical and biotech industry, academic and research institutes, contract research organizations, and others. The pharmaceutical and biotech industry dominates the market with the largest share owing to increasing regulation and safety majors for production, emerging biotech & pharma industry in developing countries, and increasing investment in research & development. Additionally, the introduction of novel biosimilars and parenteral products is contributing to the growth of the viral clearance market in the pharmaceuticals and biotechnology industry.

Viral Clearance Market by Region

Based on region, the global viral clearance market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World. North America dominated the global viral clearance market in terms of revenue share. The large share of North America in the global market can be attributed to increasing regulation for drug safety and expanding novel drug approvals in the region. Additionally, the presence of prominent players and their high R&D spending indicates intense R&D activity in the region which fuels the growth of the North America viral clearance market. The Asia Pacific is expected to show the highest growth during the forecast period owing to the merging of the biotechnology and pharmaceutical industry and increasing generic & biosimilar manufacturing facilities.

Competitive Landscape

Some of the prominent players operating in the global viral clearance market are 

• Charles River Laboratories International, Inc.
• Clean Cells 
• Eurofins Scientific SE
• Kedrion S.p.A.
• Merck KGaA 
• Sartorius AG
• Texcell SA
• Vironova AB
• ViruSure GmbH 
• WuXi Biologics, among others

Strategic Developments

• In October 2019, Asahi Kasei Medical acquired Virusure Forschung und Entwicklung GmbH (ViruSure), an Austrian company of biosafety testing services. The investment is part of Asahi Kasei Medical's business expansion and encouragement of its bioprocess business, which is focused on PlanovaTM virus removal filters used in the manufacturing process for biotherapeutics like plasma derivatives and biopharmaceuticals. It exemplifies Asahi Kasei Medical's ongoing strategic efforts to develop businesses that contribute to the safety and efficiency of biotherapeutic manufacturing.
• In November 2020, PathoQuest SAS and strategic partner Charles River Laboratories International launched a United States subsidiary, PathoQuest, Inc. PathoQuest, Inc. will strengthen the two companies’ strategic partnership while also expanding Charles River's and PathoQuest's capacity to satisfy client requirements. It will deliver a fully integrated and reliable solution for rapid viral safety testing of biologics, particularly advanced therapeutic medicinal products (ATMPs) and vaccines.

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