Viral Clearance Market Report 2025

The viral clearance market size has grown rapidly in recent years. It will grow from $0.82 billion in 2024 to $0.96 billion in 2025 at a compound annual growth rate (CAGR) of 16.9%. The growth in the historic period can be credited to the increase in biopharmaceutical production, heightened regulatory focus on viral safety, rising prevalence of chronic and infectious diseases, expansion in plasma-derived product manufacturing, growing outsourcing to CROs and CDMOs, and broader adoption of monoclonal antibodies and recombinant proteins.

The viral clearance market size is expected to see rapid growth in the next few years. It will grow to $1.77 billion in 2029 at a compound annual growth rate (CAGR) of 16.6%. The growth in the forecast period can be attributed to increasing demand for cell and gene therapies, heightened focus on biosafety in biomanufacturing, more stringent regulatory validation requirements, expansion of biologics production facilities, rising outsourcing of viral safety testing, and greater adoption of single-use systems in bioprocessing. Major trends during this period include the integration of high-throughput analytical technologies, widespread adoption of single-use systems, advancements in filtration and chromatography methods, progress in continuous bioprocessing, and growth in contract research and manufacturing services.

The increasing prevalence of chronic diseases is expected to drive growth in the viral clearance market in the coming years. Chronic diseases are long-term health conditions that develop over time and often require ongoing care or management. Their prevalence is rising globally, largely due to aging populations, as improvements in healthcare and living standards allow people to live longer, resulting in a higher incidence of age-related conditions such as cardiovascular diseases, diabetes, arthritis, and cancer. Viral clearance plays a critical role in the development of biologics and gene therapies for treating chronic diseases, ensuring these treatments are safe and effective. For example, in June 2023, the Institute for Health Metrics and Evaluation, a US-based public health research institute, reported that over half a billion people worldwide were living with diabetes, a number projected to exceed 1.3 billion by 2050. Thus, the rising prevalence of chronic diseases is fueling demand in the viral clearance market.

Companies in the viral clearance market are increasingly focusing on capacity expansion strategies, such as large-scale viral vector manufacturing facilities, to meet the growing demand for gene therapies and biologics. Large-scale viral vector manufacturing facilities are advanced bioproduction sites equipped to produce viral vectors used in cell and gene therapies, ensuring high purity, safety, and adherence to viral clearance standards. For instance, in August 2022, Thermo Fisher Scientific, a US-based biotechnology company, opened a 300,000-square-foot commercial viral vector manufacturing facility in Plainville, Massachusetts. This facility doubles the company’s global capacity, supports end-to-end manufacturing including viral clearance and analytical testing, and enables the rapid, safe commercialization of gene therapies, vaccines, and advanced biologics.

In August 2024, Merck Group, a Germany-based healthcare company, acquired Mirus Bio LLC for $600 million. This acquisition strengthens Merck’s viral vector manufacturing capabilities by incorporating Mirus Bio’s leading transfection technology, enhancing its ability to provide integrated solutions for the growing gene therapy market. Mirus Bio LLC, based in the US, specializes in transfection reagents used in viral clearance processes.

Major players in the viral clearance market are F Hoffmann-La Roche Ltd., Merck Group, Thermo Fisher Scientific Inc., Asahi Kasei Corporation, SGS SA, Eurofins Scientific Inc., Lonza Group AG, WuXi AppTec, Catalent Biologics, Charles River Laboratories, Kedrion Biopharma, Nelson Labs, Pall Corporation, Sartorius AG, Syngene International, Microbac Laboratories, Creative Biolabs, Texcell SA, GTP Bioways, and Vironova AB.

North America was the largest region in the viral clearance market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in viral clearance market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the viral clearance market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Viral clearance is the process of detecting, removing, or inactivating viruses from biological products to ensure they are free from viral contamination. This involves steps such as filtration, chemical treatment, or heat inactivation, with the primary goal of ensuring product safety and purity by minimizing the risk of viral transmission.

The primary approaches to viral clearance include viral removal, viral inactivation, and viral detection. These techniques are designed to eliminate potential viral contaminants from biological products. They are applied across various areas, including vaccines and therapeutics, blood and blood products, cellular and gene therapy products, and tissue-based products, serving end users such as pharmaceutical and biotechnology companies, contract research organizations (CROs), academic research institutes, and others.

The viral clearance market research report is one of a series of new reports that provides viral clearance market statistics, including the viral clearance industry's global market size, regional shares, competitors with the viral clearance market share, detailed viral clearance market segments, market trends and opportunities, and any further data you may need to thrive in the viral clearance market. This viral clearance market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The viral clearance market consists of revenues earned by entities by providing services such as viral removal and inactivation testing, validation studies, and regulatory consulting. The market value includes the value of related goods sold by the service provider or included within the service offering. The viral clearance market also includes sales of viral filters, reagents, and specialized clearance equipment. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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