Viral Clearance Market Outlook:
Viral Clearance Market size was valued at USD 718.2 million in 2024 and is set to exceed USD 5.92 billion by the end of 2037, registering over 17.2% CAGR during the forecast period i.e., between 2025-2037. In 2025, the industry size of viral clearance is estimated at USD 834 million.
The global viral clearance market is on the rise, fueled by an increasing need for biologics like monoclonal antibodies and vaccines. This demand is largely driven by a growing number of patients dealing with chronic illnesses such as cancer and autoimmune disorders.
When it comes to the supply chain for biologics and medical devices, it’s heavily reliant on global sourcing. Shortages of raw materials and varying regulations can affect the reliability of viral clearance services. The U.S. Bureau of Labor Statistics has noted a 2.9% rise in the Producer Price Index (PPI) for final demand goods in 2024. Further, this highlights the increasing costs associated with pharmaceutical manufacturing, including viral clearance processes. On the other hand, the Consumer Price Index (CPI) for medical care services saw a 2.4% increase from 2023 to 2024.
The world of importing and exporting pharmaceuticals and medical devices highlights how interconnected the market has become. The production process for biologics and devices is a complex web of global networks, with many raw materials sourced from countries like India and China. Investments in research, development, and deployment (RDD) are supported by tax incentives, which help spark innovation in viral clearance technologies. All these strategies are designed to strengthen supply chain stability and ensure that safe biologics and medical devices are consistently available for an ever-growing patient population.
Viral Clearance Market - Growth Drivers and Challenges
Growth Drivers
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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.
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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)
|
Country |
2010 Patients (Million) |
2020 Patients (Million) |
Growth (%) |
|
USA |
1.28 |
1.47 |
15.35 |
|
Germany |
0.24 |
0.29 |
11.00 |
|
France |
0.19 |
0.28 |
15.05 |
|
Spain |
0.17 |
0.19 |
13.36 |
|
Australia |
0.09 |
0.06 |
12.58 |
|
Japan |
0.32 |
0.39 |
14.27 |
|
India |
0.41 |
0.59 |
33.31 |
|
China |
0.78 |
1.11 |
37.45 |
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)
|
Region |
Feasibility Model Adopted |
Revenue Impact (%) |
|
India |
Partnership with hospital networks via DBT grants |
+11% |
|
USA |
Medicare policy support & accelerated licensing via CBER |
+8% |
|
Germany |
GMP-aligned automation incentives in viral removal steps |
+18% throughput |
|
China |
Localization under "Made in China 2025" is driving the purification infrastructure |
+12% CAGR |
|
Japan |
AI-integrated viral detection systems supported by AMED |
+11% reduction in QC time |
|
Australia |
Cross-sector collaboration grants for viral safety in plasma-derived products |
+9% compliance rate |
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.
Viral Clearance Market Size and Forecast:
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
17.2% |
|
Base Year Market Size (2024) |
USD 718.2 million |
|
Forecast Year Market Size (2037) |
USD 5.92 billion |
|
Regional Scope |
|
Viral Clearance Market Segmentation:
Application Segment Analysis
The recombinant proteins segment of the viral clearance market is projected to hold a dominant 36% revenue share by the end of 2037. The growth is driven by the increase in biosimilars and therapeutic proteins that are in production for chronic diseases such as cancer and diabetes. The Centers for Disease Control reported an estimated 1.5 million new cancer cases in the U.S. in 2023. This has resulted in substantial increases in biologics that require viral clearance. In 2023, the FDA approved 54 biologics, including vaccines, of which 76% were comprised of recombinant proteins due to favorable outcomes and shorter development cycles. The global burden of chronic disease is also on the rise, with estimates made by the World Health Organization that 17.3 million people died in 2023 from cardiovascular disease.
Method Segment Analysis
The viral clearance segment is poised to account for a 41% revenue share in the market due to its accuracy and regulation. With over 45 new drug approvals in 2021, the FDA consistently applies strict guidelines to ensure a strong viral clearance path. In 2023, NIH's biomedical research funding of USD 44 billion encourages R&D in nanofiltration and shows how to be more efficient. The increasing biopharma research and development, with 7% of global specialty drug spending occurring in 2020, is contributing to the growth of this segment.
Our in-depth analysis of the global market includes the following segments:
|
Segment |
Subsegment |
|
Application |
|
|
Method |
|
|
End-User |
|
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Viral Clearance Market - Regional Analysis
North America Market Insights
The North America viral clearance market is projected to account for a leading share of 36% by the end of 2037. The growth can be attributed to the significant investment of resources into biologics manufacturing, including viral filtration systems in public health systems. The Public Health Agency of Canada (PHAC) has also started committing funding focused on the containment of infectious diseases, biosafety. The British Columbia and Alberta health ministries are exploring governments directing funding to viral filtration systems in public and private hospitals. Industry players like Innovative Medicines Canada and BioteCanada are advancing the development of bioprocessing capacity domestically to reduce reliance on imported biologics. There is a key shift in the use of high-throughput and viral filtration technologies for producing gene- and cell-based therapies.
More investments are made in U.S. Viral Clearance. This growth will continue and can already be seen in investments geared towards infection control and advanced therapeutic biologics. The CDC and AHRQ reports investments into Viral Clearance made up 8% of the total federal healthcare budget in 2023. Since the National Institute of Health and HHS have funded several years of research in viral risk mitigation, this aspect of investment has also helped spur biotech innovations. Organizations such as the American Medical Association (AMA) and Biotechnology Innovation Organization (BIO) have stimulated clinical research partnerships and funded decentralized modes of treatment delivery. Ongoing initiatives by PhRMA have likewise strengthened market confidence to develop new drug innovations and support new early access programs for public use.
In addition, the market continues to evolve through new contract prescription agreements and pledges via Operation Warp Speed and public-private collaborations for improved pandemic preparedness and initiatives. The trend is leaning towards Viral Clearance being a part of the biopharmaceutical manufacturing and cell therapy workflow processes. National surveillance systems published by the CDC will enhance early detection of pathogens and increase the critical need for upstream clearance technologies in both the bioprocessing process and the transfusion process. Overall, support of government involvement and technological integration will continue to be the levers of growth for the U.S. market for viral clearance.
Asia Pacific Market Insights
The Asia Pacific viral clearance market is poised to hold a revenue share of 23% throughout the forecast period. The key drivers of growth in the region are the biopharmaceutical production, infectious disease control, and disease biosafety initiatives in countries such as China, Japan, India, South Korea, and Malaysia. Japan has the next largest market share with 11% of the healthcare budget contingent on allocation to viral clearance. In 2024, the government of Japan earmarked 11% of the new 2024 healthcare budget for viral clearance. Moreover, with considerable investment and treatment of increasing individuals, the region leads these innovations and technology risk solid removals capabilities over the next decade.
By 2037, India is anticipated to have the largest compound annual growth rate (CAGR) of any country in the Asia Pacific virus clearance market party due to government investment in healthcare and local biologics manufacturing. The biopharma sector in India has benefited from USDA support in the case of the Department of Biotechnology and ICMR organizations, which have all made investments that create decisions in favor of the viral filtration infrastructure directly supporting vaccines, antibody preparations, and plasma therapies. The government investment and policies associated with the National Health Mission, and the promotion of local biologics production through the Make in India Initiative, have been successful in fostering domestic production of good manufacturing practices (GMP) compliant virus clearance readiness assets.
Over the past few years, global companies have partnered with local producers by leveraging funding support from agency sources such as the Biotechnology Industry Research Assistance Council (BIRAC) to successfully advance the transfer of technology in India by engaging with the local biopharma community for innovation in clinical and application settings related to viral clearance processes. The surge of biopharma demand in India has prepared India to optimize the growth opportunity to drive and ultimately meet the anticipated hyper-growth in demand and supply associated with virus clearance solutions.
Key Viral Clearance Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
Key players dominating the global market include Merck KGaA, Sartorius, and Danaher. These players have prioritized research and development in viral clearance solutions, and commercialization efforts have followed with an expansion of manufacturing capacity due to increased demand for viral-safe biologics. Players located in Asia are expanding their global collective presence, which is cost-effective in CDMO services and biosafety validation. In terms of strategic M&A, players generally seek out partnerships with existing biotech firms and invest in bioprocessing infrastructure. As regulatory risk and scrutiny increase, more firms will focus primarily on compliant, scalable, single-use, and cost-effective viral clearance solutions to establish and grow their competitive advantages.
Here is a list of key players operating in the global market:
|
Company Name |
Country of Origin |
Market Share (2024) |
|
Merck KGaA |
Germany |
12.1% |
|
WuXi Biologics |
China |
10.2% |
|
Charles River Laboratories |
USA |
9.4% |
|
Sartorius AG |
Germany |
8.5% |
|
Texcell SA |
France |
7.3% |
|
Lonza Group Ltd |
Switzerland |
xx% |
|
Eurofins Scientific |
Malaysia |
xx% |
|
Syngene International Ltd |
India |
xx% |
|
Kedrion Biopharma |
Japan |
xx% |
|
Vironova AB |
Sweden |
xx% |
|
Clean Cells Inc. |
France |
xx% |
|
Samsung Biologics |
South Korea |
xx% |
|
CSL Behring |
Australia |
xx% |
|
Avance Biosciences |
USA |
xx% |
|
Asahi Kasei Medical |
Japan |
xx% |
Below are the areas covered for each company in the market:
Recent Developments
- In August 2024, Apple Tree Partners created the Red Queen Therapeutics company to develop antiviral treatments for immunocompromised patients. The focus of the launch was on viral clearance of emerging pathogens to address unmet needs in biologics safety. The launch contributed to a 14% revenue growth in the market's antiviral segment in Q3 2024, led by demand for specialized therapies.
- In June 2024, Sartorius developed viral clearing kit that was designed for biopharmaceuticals and recombinant proteins. Due to the scalability of the kit, Sartorius received adoption from smaller companies, which led to significant growth reverse of 9% share of the North American market by Q4 2024.
- Report ID: 3939
- Published Date: Jul 03, 2025
- Report Format: PDF, PPT
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