Viral Clearance Market

Viral Clearance Market - Distribution by Scale of Operation (Discovery, Preclinical and Clinical), Method of Viral Clearance Testing, End User and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

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Viral Clearance Market Overview

The viral clearance market size is estimated to grow from USD 0.55 billion in 2023 to USD 1.7 billion by 2035, representing a CAGR of 10% during the forecast period 2023-2035. 

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.

Viral Clearance Market, By Method of Viral Clearance and Testing, 2024-2035 (USD Million)


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.

Key Viral Clearance Market Insights

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.

Benefits and Growing Demand for Viral Clearance Studies 

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.

Need for Outsourcing Viral Clearance Testing

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.

Current Market Landscape of Viral Clearance Testing Service Providers

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. 

Key Drivers in the Viral Clearance Testing Services Market

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 Size

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.

Viral Removal Segment Currently Holds the Largest Market Share; Viral Inactivation to Demonstrate Strong Market Growth

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. 

Key Viral Clearance Testing Services Providers

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.

Recent Developments in Viral Clearance Market

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.

  • In June 2023, Cytiva along with BioCentriq received a funding of USD 15.8 million from National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) with an aim to strengthen the creation of a viral and exotoxin clearance platform for adeno-associated virus (AAV) manufacturing process. 
  • In June 2023, Texcell announced the opening of a testing facility in North America with an aim to improve the viral safety of biotherapeutics and medical devices. 
  • In June 2023, Valo Therapeutics entered into a collaboration with Texcell in order to investigate immune responses to PeptiCRAd-1 in its Phase 1 clinical study.

Scope of the Viral Clearance Market Report

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 Details

Base Year

2022

Forecast Period

2023-2035

Market Size 2023

$545 million

CAGR 2023-2035

10%

Scale of Operation

Discovery Phase, Preclinical Phase, Clinical Phase

Method of Viral Clearance and Testing

Viral Detection, Viral Inactivation, Viral Removal

End-User

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
(Full list of 30+ companies captured in the market landscape analysis of the report)

Customization Scope

15% Free Customization Option (equivalent to 5 analysts working days)

PowerPoint Presentation (Complimentary) Available
Excel Data Packs (Complimentary)  Market Landscape Analysis, Company Competitiveness Analysis, Patent Analysis, Recent Developments, Market Forecast and Opportunity Analysis

 

The image provides context of Viral Clearance Testing Services Market. Owing to the technical and operational challenges associated with the in-house viral clearance and testing procedures, players in the biopharmaceutical industry are increasingly relying on the viral clearance and testing service providers This image provides a list of companies / service providers in viral clearance market who provide a variety of viral clearance studies employing various methods such as viral inactivation, viral removal, chromatography and others The infographic provides viral clearance market landscape distribution. Currently, the market is highly fragmented, featuring the presence of both new entrants and well-established players


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:

  • An executive summary of the insights captured during our research. It offers a high-level view on the current state of viral clearance market and its likely evolution in the mid-long term.
  • A general overview of the viral clearance studies, highlighting details on viral contamination in biologics and the need for viral clearance testing. It also presents information on the process of viral clearance testing, and regulatory guidelines related to viral contamination. Additionally, it features a discussion on the future perspectives of the viral clearance testing industry.
  • A detailed assessment of the overall market landscape of the companies offering viral clearance testing services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of viral clearance testing facilities, type of virus detected (by envelope - RNA enveloped, RNA non-enveloped, DNA enveloped and DNA non-enveloped), type of virus detected (by class - retrovirus, adenovirus, lentivirus, adeno-associated virus (AAV), herpesvirus and others), key offerings (viral clearance services, viral testing services and viral clearance products), type of biologic(s) analyzed (antibodies, cell and gene therapies, vaccines, recombinant proteins, blood and blood products, hormones and others), method(s) of viral clearance (inactivation - pH treatment, solvent detergent, heat pasteurization and others), method(s) of viral clearance (removal - chromatography, filtration, precipitation and others) and type of viral testing service(s) offered (cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing).
  • A detailed competitiveness analysis of viral clearance testing service providers based in North America, Europe and Asia-Pacific. The analysis compares the service providers based on supplier strength (in terms of years of experience and company size) and service strength (considering key offerings, type of virus detected (by envelope), type of virus detected (by class), method(s) of viral clearance (removal), method(s) of viral clearance (inactivation), viral testing service(s) offered, type of biologic(s) analyzed and additional services offered). 
The image highlights distribution of viral clearance and testing service facilities. Majority of these players are based in Europe, primarily in countries, such as the UK, Germany and France This image provides viral inactivation market company compeititveness analysis. In pursuit of building a competitive edge, stakeholders are actively upgrading their existing capabilities and enhancing their respective service offerings to comply with the evolving industry benchmarks The infographic highlights recent expansions that have taken up by viral clearance testing service provides for their respective testing services

 

  • Tabulated profiles of key players based in North America, Europe and Asia-Pacific that are engaged in providing services related to viral clearance testing (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, financial information (if available), information on viral clearance and testing related services, recent developments and an informed future outlook. 
  • An in-depth analysis of various patents that have been filed / granted for viral clearance testing, since 2017, based on various relevant parameters, such type of patent, publication year, application year, type of organization, emerging focus areas, geographical location, CPC symbols, leading players (in terms of number of patents granted / filed), patent benchmarking (in terms of CPC symbols and leading players), patent characteristics and patent age. It also includes an insightful patent valuation analysis and list of leading patents by number of citations.
  • A detailed analysis of recent developments taking place in this industry. This chapter includes the partnerships inked between stakeholders engaged in this market, since 2015, covering instances of mergers and acquisitions, service agreements, service alliances, technology assessment agreements and other agreements. Further, it comprises of analysis of the deals inked based on year of partnership, type of partnership, purpose of partnership, type of organization, location of facility, and geographical region. It also highlights the most active players (in terms of number of partnerships) in the market. In addition, this chapter also includes a detailed assessment of the recent expansion initiatives undertaken by various service providers to enhance viral clearance testing capabilities, based on various parameters, including year of expansion, type of expansion, focus of expansion, type of service(s) offered, type of biologic(s) involved, and geography. It also highlights the most active service providers (in terms of number of expansions) in the market.
The image highlights intellectual property landscape generated within viral clearance and viral testing field, both industry and non-industry players have filed / were granted more than 260 patents in the past five years This image provides details on viral clearance market size. The market is projected to grow at a CAGR of 9.9%, till 2035; the forecasted opportunity is likely to be distributed across different scales of operation, methods of viral clearance and testing, end users, and geographical regions


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.

Frequently Asked Questions

Question 1: Why is viral clearance important?

Answer: Viral contamination is a serious threat to the biopharmaceutical industry; it occurs when the biologics are infected by the endogenous and adventitious viruses, during the production process. The potential sources of these viruses include cell lines, blood, hormones and other animal or human derived unprocessed material.

Question 2: What is viral clearance testing?

Answer: 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.

Question 3: How many companies are providing viral clearance testing services?

Answer: Presently, more than 30 companies offer various services related to viral clearance and testing, including viral testing services (such as cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing) and viral clearance services (such as several virus inactivation and removal methods). In addition, few service providers offer services for the specialized detection and removal of prions and transmissible spongiform encephalopathies (TSE).

Question 4: How many patents, related to viral clearance testing, have been filed / granted in the last few years?

Answer: More than 260 patents, related to viral clearance and testing, have been filed / granted in the last few years. It is worth mentioning that most of the patents have been filed by industry players and are focused on viral removal methods and techniques. 

Question 5: What is the partnership and collaboration trend in viral clearance market?

Answer: Currently, mergers and acquisitions are the most preferred type of partnership models adopted by the stakeholders in this industry. This is followed by service agreements, service alliances and technology assessment agreements.

Question 6: What is the most important method for viral clearance?

Answer: 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.

Question 7: What are the recent developments in the viral clearance testing services market?

Answer: Viral clearance testing service providers have made significant investments to expand their respective capabilities through the incorporation of advanced methods, technologies, and platforms; this is required for attracting a client base across different geographies. In addition, players have also inked a number of partnerships to enhance their expertise, technology and operations portfolio.

Question 8: Which geographical segment has the highest growth rate in viral clearance market?

Answer: Europe is likely to grow at the highest CAGR, during the period 2023- 2035.

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