Viral Clearance Market to reach USD 1.95 Billion by 2032

The global viral clearance market, valued at USD 0.99 billion in 2025, is on a trajectory of rapid expansion. Projections indicate a USD 1.95 billion valuation by 2032, exhibiting a CAGR of 10.2% during the forecast period. Increasing demand for biopharmaceuticals, stringent regulatory requirements for virus removal in biologics, and rising R&D investments in biotechnology are key driving forces boosting the viral clearance market growth.

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The global viral clearance market growth is driven primarily by the need for biologics, gene therapies, and vaccines with assurance of high-level viral safety and regulatory compliance. The increasing prevalence of chronic disorders and infectious diseases has promoted the production of biopharmaceuticals, stimulating the need for efficient viral clearance solutions.

Notably, extensive investments in large-scale biomanufacturing capacity underscore this trend. For instance, in December 2024, Eli Lilly invested US$ 3 billion to expand its Wisconsin manufacturing facility to meet the growing demand for its weight-loss drug Zepbound and diabetes drugs. Zepbound has accumulated over 5.2 million prescriptions since its introduction in the U.S. in late 2023, reflecting the growing global reliance on biologics in chronic disease treatment.

Moreover, regulatory agencies such as the U.S. FDA and EMA continue to enforce stringent safety testing guidelines, further increasing the adoption of viral clearance advanced technologies. An example is the FDA's final guidance Q5A(R2), released in January 2024, which is titled "Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin." The guidance encourages a risk-based approach to viral detection, inactivation, and removal with an emphasis on the need for validated clearance studies and robust supporting data in regulatory submissions. These developments are cumulatively empowering the position of viral clearance solutions in product safety assurance and market expansion enhancement.

Biopharmaceutical manufacturers are increasingly adopting advanced technologies such as nanofiltration, chromatography-based virus removal, and next-generation inactivation methods to strengthen viral safety protocols. These innovations offer improved efficiency, scalability, and compliance with regulatory standards. For instance, in January 2021, MilliporeSigma’s Natrix Q—a single-use, high-capacity chromatography membrane—demonstrated high viral clearance efficacy for both enveloped and non-enveloped viruses under diverse operating conditions. Such technological progress supports more robust and flexible viral clearance workflows, ensuring product safety while accelerating production timelines.

To rationalize cost, gain access to specialist knowledge, and reduce time-to-market, biopharma companies are increasingly outsourcing viral clearance activities to Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). The action simplifies the development and regulatory stages, especially in the new science of advanced biologics and gene therapy. For example, Charles River Laboratories entered into partnership with South Korea's Rznomics Inc. in January 2023 to provide viral vector CDMO services to support an RNA-based anticancer gene therapy treatment for liver cancer.

The use of artificial intelligence (AI) and automation in viral clearance testing is a game-changing possibility in the biopharmaceutical sector. With predictive modeling and automation filtration technologies, manufacturers can now achieve high accuracy and make regulatory compliance easier. For instance, in 2024, researchers presented an automated system that leveraged deep learning algorithms for the detection of virus-induced cytopathic effects in cell cultures. This technology substantially improves the precision and velocity of virus detection in clearance testing, facilitating more effective and reliable quality assurance workflows.

The growing investments in biopharmaceutical manufacturing in emerging markets, particularly the Asia Pacific and Latin America regions, offer huge opportunity for service providers in viral clearance. The regions are experiencing fantastic growth in pharmaceutical manufacturing as well as increased focus on following global regulatory standards. For instance, drug and biotechnology firms in these markets are looking to partner with global leaders in viral clearance services to establish the safety and performance of their biologics, vaccines, and gene therapies. This shift provides the chance for viral clearance service providers to enter these new markets and form strategic alliances with regional drug makers, driving market growth in these emerging markets.

“The viral clearance market is expanding rapidly, fueled by the growing demand for biopharmaceuticals and the increasing complexity of biologic drug development,” states Ms. Komal Dighe, a research consultant. “As regulatory bodies enforce more rigorous viral safety standards, particularly in the wake of updated guidance like the FDA’s Q5A(R2), manufacturers are compelled to integrate advanced detection and clearance technologies into their production pipelines.”

“The rise of outsourcing to CROs and CMOs, combined with automation and artificial intelligence in clearance testing, is fundamentally transforming the viral safety landscape. Additionally, emerging markets in Asia-Pacific and Latin America present lucrative expansion opportunities, especially for companies offering scalable and compliant viral clearance solutions. Players that prioritize strategic partnerships, AI-driven innovations, and regulatory alignment are best positioned to capitalize on the market’s accelerating trajectory.”