Viral Clearance Market Trends

Growth Drivers

• Growing incidence of chronic and infectious diseases: The rising number of patients dealing with chronic illnesses like cancer, diabetes, and infectious diseases such as hepatitis and HIV is fueling the demand for biologics. In North America, the CDC noted that there were 1.7 million new cancer cases in 2023. In Germany, the estimated prevalence of hepatitis C, a significant condition that requires viral clearance for biologics, was around 200,000 cases in 2025. Manufacturers need to focus on scalable viral clearance solutions for biologics to keep up with the rising demand in oncology and infectious disease treatments.

• Strict regulatory requirements and government spending on healthcare and biologics: Regulatory bodies such as the FDA and EMA are exercising increased control over the process with stringent requirements of broad-based viral clearance studies for biologics. In 2021, there were 47 new drug approvals by the FDA and many of those would have required some level of validation for viral clearance. Companies are investing into complying with the changing standard and speeding up drug approvals with compliance-driven technologies like nanofiltration. In addition, government spending on healthcare is giving a useful push to the viral clearance development space.

Opportunities in the Global Viral Clearance Market

Patient Pool Impact on Market Expansion

The global viral clearance marketplace is forecasted to reach USD 5927.5 million by 2037, primarily because of the increasing patient population requiring biologics for chronic and infectious medical conditions. From 2010 to 2020, the growth in patient numbers in regions like the USA, Germany, and China was facilitated by the increasing prevalence of cancer, hepatitis, and autoimmune diseases, all of which require significant viral clearance processes for the safety of biologics. For instance, in 2010, there were around 34 million cancer patients in the USA. By 2020, the CDC cited 14% growth, which is expected to increase demand for monoclonal antibodies. The historical growth we witnessed in the number of patients created the market environment we see today. The current increase in patient numbers has resulted in many investments in viral clearance technologies. Future growth in the marketplace will depend on paying attention to areas of unmet need in emerging markets like India. The table below highlights the patient growth, which underpins the opportunities in the marketplace.

Historical Patient Growth (2010-2020)

Manufacturer Strategies for Market Growth

The growth of the viral clearance market will be primarily attributed to proactive initiatives made by the manufacturers to help secure their position within the market. Companies invested heavily in the R&D space. Companies are forming strategic partnerships with contract research organizations (CROs), like the recent one in 2023 involving Charles River and CENTOGENE. Recent innovations, like the use of targeted subsets of nanofiltration products which are noted by AHRQ to reduce contamination risks by about 29%, will help improve compliance and effectiveness. The FDA has approved a record 54 biologics in 2023, which drives regulatory-initiated demand. Overall, the emergence of these three strategies – investment in and support of R&D, strategic collaborations, investments in innovations - should position the manufacturers were tipped in a position where they can expect to take advantage of new opportunities as they appear.

Feasibility Models for Market Expansion (2022–2024)

Challenges

• Increasing regulatory burden: Regulatory agencies like the FDA and EMA require lengthy viral safety validation, resulting in extensive compliance costs and delays.  As per the Organisation for Economic Co-operation and Development, in 2022, the PMDA in Japan mandated stricter rules governing new biologics, requiring additional documentation and expanding timelines by 5 months. Smaller manufacturers, who are disproportionately affected by the high compliance costs, see potential barriers to market entry and decreased innovation potential.

• High costs of treatment with limited access for patients: The high costs of the viral clearance requirements make it difficult for patients to access biologics.  High costs represent a barrier to entry for many patients who may benefit from biologics, limiting the market growth opportunity in cost-sensitive areas.