Global Viral Clearance Market Report and Forecast 2024-2032

Global Viral Clearance Market Outlook

The global viral clearance market would likely grow at a CAGR of 9.6% during 2024-2032. Viral contamination poses a common but significant threat to human and animal-derived biopharmaceuticals. Such contamination may affect any phase of a bioproduction process, and biomanufacturers must carry out viral testing studies and include viral clearance methods into their procedures.

Viral clearance refers to removal of viral contamination with the help of specialized membranes (generally proteins) or chromatography. To ensure that therapeutic drugs drawn from particular sources are free of viral contamination, protein solutions go through viral clearance to remove or inactivate viral material. Asia Pacific, North America and Europe are likely to be key markets. 

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Global Market Likely to be Driven by Need to Ensure Biopharmaceutical Product Safety

Viral clearance studies are important to manufacturers’ programs to ensure product safety. Producers of biopharmaceutical products or auxiliary material drawn from human or animal tissue are needed to exhibit the capability of their purification and production processes to inactivate or remove viruses or TSE agents and ascertain product safety. 

Most viral contaminations associated with raw materials are linked with the use of materials drawn from animals. Materials like trypsin, serum, plasma proteins, and tissue and protein extracts may possibly carry viral contaminants. Among non-animal raw materials, glucose has the greatest risk of viral contamination in the upstream process, if a chemically defined medium is employed. 

Examples of human or animal tissue-driven products include recombinant proteins, blood products, polyclonal antibodies, hormones, enzymes, and medical devices that carry animal or human blood-derived elements.

Leading Companies Offer Sophisticated Solutions to Meet Client Needs

Leading companies hold significant databases of thousands of studies conducted for clients that guide their ability to execute, develop, and assess the viral/TSE clearance studies that best fulfil client requirement.

Companies like Syngene offer viral testing and clearance services catering to client needs to fulfil the viral safety requirements of their Biologics programs. Such services are expected to boost the global viral clearance market.

Texcell provides diverse alternatives for quality data for regulatory submissions. The company defines investigational Viral Clearance studies as For Information Only or “FIO”, and customizes them to be quick, economical, and offer the most vital info required to design a robust GLP Viral Clearance. Viral Clearance products experience include, among others, recombinant proteins, monoclonal antibodies, ortho biologics, gene therapy products, bone, tissues, and collagen, blood products, nanoparticles, and vaccines.

Organizations like Eurofins BioPharma offer Viral Clearance Services that include several types of validated and well characterized viral stocks to support animal and human-derived products.

In 2020, Merck expanded BioReliance® Viral Clearance offering in Singapore to save customers’ time. The services would enable customers to carry out viral clearance studies that ensured the quality and safety of their biological drugs during the clinical development process. Such services are expected to boost the global viral clearance market.

Market Segmentation

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By method, the market is divided into:

• Viral Removal Method

• Viral Inactivation Method

By application, the market is segmented into:

• Recombinant Proteins

• Vaccines

• Blood and Blood Products

• Cellular and Gene Therapy Products

• Others

By end use, the global viral clearance market is classified into;

• Contract Research Organisation (CRO)

• Pharmaceutical and Biotech Industry

• Academic Research Institutes

• Others

By region, the market is segmented into:

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East and Africa

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Key Industry Players in the Market

The report offers an extensive assessment of major players in the global viral clearance market; it evaluates their capability, observes latest occurrences such as mergers and acquisitions, capacity expansions, and plant turnarounds:

• Merck KGaA

• WuXi AppTec Co., Ltd

• Charles River Laboratories International, Inc.

• Texcell SA

• Vironova AB

• Sartorius AG

• Syngene International Limited

• Creative Biogene

• Eurofins Scientific

• Others

Using SWOT analysis and Porter’s Five Forces model, the EMR report offers deep insights into the industry.

Key Highlights of the Report