The viral clearance market is expected to reach USD 554 million in 2023 anticipated to grow at a CAGR of 10% during the forecast period 2023-2035.

Viral clearance testing plays a pivotal role in ensuring the safety of biopharmaceutical products by identifying and eliminating viral impurities. This process has become increasingly crucial for securing regulatory approvals, particularly with the Food and Drug Administration (FDA) having already approved over 630 biologics and more than 8,000 undergoing clinical evaluation. The growing number of approved products and ongoing trials in this field has heightened the demand for comprehensive viral clearance studies. However, the methods employed for virus removal, inactivation, and detection are intricate, demanding specialized expertise, resources, and time. Consequently, there’s a keen interest among innovators to overcome these challenges. One popular solution is outsourcing these studies to service providers equipped with FDA-accredited laboratories. This trend has gained traction among biopharmaceutical manufacturers seeking efficient solutions.

Currently, several global service providers are actively engaged in offering robust viral clearance testing services across the entire research and development phase. With a surge in biologics entering the development pipeline, the market for viral clearance services is anticipated to witness significant growth with a robust Compound Annual Growth Rate (CAGR) during the forecasted period.

Report Coverage

  • The report examines the viral clearance market, focusing on operational scale, testing methods, end-user demographics, and key geographic regions.
  • An analysis is conducted to evaluate factors such as drivers, restraints, opportunities, and challenges impacting market growth.
  • It assesses potential advantages and challenges within the market landscape, providing insights into the competitive environment for leading market players.
  • Revenue forecasts for market segments are provided concerning four major regions.
  • The research comprehensively evaluates companies offering viral clearance testing services, covering aspects like establishment year, company size, headquarters and testing facility locations, identified virus types, key services offered, types of biologics analyzed, viral clearance methods employed, and types of testing services provided.
  • A detailed comparative analysis of viral clearance testing service providers across North America, Europe, and Asia-Pacific is conducted, focusing on their strengths based on supplier and service capabilities. Factors such as experience, company size, key offerings, detected virus types, clearance methods, types of biologics analyzed, and additional services are considered.
  • Comprehensive profiles of major players in North America, Europe, and Asia-Pacific engaged in viral clearance testing services are presented. These profiles encompass company overviews, financial details (if available), information about viral clearance and testing services, recent developments, and future prospects.
  • An in-depth analysis of patents filed or granted for viral clearance testing since 2017 is carried out. This analysis considers parameters such as patent types, publication and application years, involved organizations, emerging focus areas, geographical locations, patent characteristics, valuation analysis, and leading patents based on citations.
  • The recent industry developments section covers partnerships, mergers, acquisitions, service agreements, and expansions among stakeholders since 2015. It evaluates these deals by year, type, purpose, involved organizations, geographical locations, and active market players. Additionally, it assesses expansion initiatives by service providers to augment viral clearance testing capabilities, highlighting the most active providers in this domain.


Key Market Companies

  • Charles River Laboratories
  • Eurofins Scientific
  • Microbac Laboratories
  • Nelson Labs
  • Pall
  • Syngene International
  • Texcell