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Viral clearance market (testing services) was estimated to be USD 545 million in 2023 and is anticipated to grow at a CAGR of 10% during the forecast period. Viral clearance testing refers to the detection and elimination of viral contaminants, using a wide array of methods, to ensure the product’s safety for human use. Over the past few years, viral clearance testing has emerged as one of the key pre-requisites for biopharmaceutical regulatory approvals.
It is worth mentioning that, till date, over 630 biologics have already been approved by the Food and Drug Administration (FDA), while more than 8,000 biopharmaceuticals are in the clinical evaluation process. This increased number of approvals and ongoing clinical trials in the biopharmaceutical industry has resulted in a rise in the demand for such studies. However, virus removal, viral inactivation and virus detection requires specialized expertise as it is a complex, cost intensive, and time consuming process. Therefore, innovators are actively exploring avenues that would enable them to overcome the existing challenges. Among other alternatives, outsourcing these studies to service providers having FDA accredited laboratories has emerged as a preferred option for most of the biopharmaceutical manufacturers. Presently, a number of service providers across the globe are actively engaged in providing efficient viral clearance testing services throughout the research and development process. Further, as more biologics enter into the development pipeline, the viral clearance market size (services) is anticipated to witness a healthy CAGR during the forecast period.
The Viral Clearance Market - Distribution by Scale of Operation (Discovery Phase, Preclinical Phase and Clinical Phase), Method of Viral Clearance Testing (Viral Detection, Viral Inactivation and Viral Removal), End User (Biotechnology and Pharmaceutical Companies and Academic / Research Institutes) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunity for the laboratories involved in offering viral clearance testing services. The report answers many key questions related to this industry.
Viral clearance studies have emerged as a mandatory step for regulatory submissions of biologics for commercial applications. These studies result in streamlined manufacturing of contamination free / safe products and on-time delivery of biologics. Owing to this, the demand for these services has increased significantly. It is worth highlighting that, with the continuous revision of the regulatory guidelines, viral clearance studies are already amongst the most essential steps in the manufacturing of biologics, including antibodies, blood products, cell and gene therapies, hormones, recombinant proteins, therapeutic proteins and vaccines.
The rise of biologics has resulted in an increasing demand for viral clearance testing services. However, these studies are quite cost intensive, time-consuming and follow stringent regulatory guidelines. In addition, they require specialized technical skills and good scientific expertise. This has prompted the biopharmaceutical developers to outsource the viral clearance studies to the service providers, which have aseptic laboratories, GMP-certified facilities and specialized equipment in accordance with the requirements of regulatory authorities.
The viral clearance testing service providers landscape features a mix of large, mid-sized and small companies, which have the required expertise to offer various services for the viral clearance and testing of biologics, across the manufacturing and purification n stages. It is worth highlighting that majority of the service providers are large companies. Recent developments in this segment of the biopharmaceutical industry indicate that the service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for these services.
Since the onset of the COVID-19 pandemic, viral clearance testing services for biopharmaceuticals have garnered significant attention. In addition, the success of next generation sequencing in efficiently detecting a wide variety of viruses has created an enormous need for the consistent usage of such advanced tools / methods in viral clearance and testing studies. In the coming decade, several promising techniques, specifically those exhibiting enhanced efficacy, are anticipated to develop at a faster rate. Moreover, considering the active involvement of large players as well as the new entrants, the viral clearance testing services market is likely to witness healthy growth during the forecast period.
Further, to address the growing demand for these services, various large players have undertaken several initiatives, including strengthening their respective service portfolios, entering into strategic deals, and expanding their facility and capacity. The most recent collaboration was signed between France based GTP Bioways and Texcell in March 2023. The former is a CDMO for biologic manufacturing and Texcell is a CRO specializing in viral testing, viral clearance and bioassays. The partnership has created a one-stop solution for their clients, specifically biopharmaceutical companies for testing and manufacturing support during clinical development.
Viral clearance market for testing services was estimated to be USD 545 million in 2023. Driven by the rising interest in research and development activities and the demand for viral clearance testing services, the future opportunities and growth associated with this market are anticipated to witness a noteworthy growth in the foreseen future. The global market is anticipated to grow at a CAGR of 10% during the forecast period. Specifically, in terms of end users, the market is anticipated to be driven by biotechnology and pharmaceutical companies. In addition, presently, more than 60% of the market is captured by laboratories based in North America and Europe. Asia-pacific is being looked at as a growth market for the viral clearance testing services, as the development and manufacturing of biologics and biosimilars is picking up in countries such as China and India. MilliporeSigma opened a biologics testing center in Shanghai, China in September 2022. The center has a viral clearance laboratory, set-up with the aim to meet the growing local demand for viral clearance testing services.
Presently, viral removal dominates the viral clearance testing services market. This can be attributed to the ongoing innovations and advancements in viral removal techniques, such as chromatography, filtration, and precipitation. Viral inactivation involves the inactivation of viruses using physical or chemical methods. A number of laboratory supply companies are developing novel medium and reagents for inactivation of virus, supporting the viral inactivation methods. Additionally, the growing number of marketed and pipeline biologics such as cell and gene therapy, tissue and tissue products and vaccines, will continue to support the demand for viral inactivation service market.
Examples of key companies engaged in this industry (which have also been captured in this report) include Charles River Laboratories, Creative Biolabs, Eurofins Scientific, Microbac Laboratories, MilliporeSigma, Nelson Labs, Syngene International, Texcell, Vironova and WuXi Biologics.
Several recent developments have taken place in the field of viral clearance market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined in the below table:
|Key Report Attributes
Market Size 2023
Scale of Operation
|Discovery Phase, Preclinical Phase, Clinical Phase
Method of Viral Clearance and Testing
Viral Detection, Viral Inactivation, Viral Removal
|Biotechnology and Pharmaceutical Companies, Academic / Research Institutes
|Key Geographical Regions
|North America, Europe, Asia-Pacific, Rest of the World
|Key Companies Profiled
Charles River Laboratories, Eurofins Scientific, Microbac Laboratories, Nelson Labs, Pall, Syngene International, Texcell
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|Market Landscape Analysis, Company Competitiveness Analysis, Patent Analysis, Recent Developments, Market Forecast and Opportunity Analysis
The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this market, across different geographies. Amongst other elements, the market report includes:
One of the key objectives of the market report was to estimate the current opportunity and the future growth potential of the viral clearance testing services market over the forecast period. We have provided informed estimates on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as scale of operation (discovery phase, preclinical phase and clinical phase), method of viral clearance and testing (viral detection, viral inactivation and viral removal), end user (biotechnology and pharmaceutical companies and academic / research institutes), and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.