Viral clearance testing is a process used to demonstrate the ability of a manufacturing process to detect, remove, and inactivate viruses that may be present in biological products, including vaccines, gene therapy vectors, monoclonal antibodies, and recombinant proteins. This testing is performed to ensure the safety of the final product by minimizing the risk of viral contamination & transmission to patients.
Market Insights & Analysis: Global Viral Clearance Testing Market (2023-28)
The Global Viral Clearance Testing market is projected to grow at a CAGR of around 20.10% during the forecast period, i.e., 2023-28. With expanding consumer appetite for biopharmaceutical products, strict regulatory control, and a surge in viral infection rates globally, the market has grown significantly in the past decade, and this trend is expected to continue in the coming year. The prevalence of several viral infections, such as Coronavirus, H1N1, and others, is growing globally, causing companies to manufacture & develop drugs. Due to the government's stringent regulations, this testing is an essential step to ensure the safety & efficacy of biopharmaceutical products, which may be contaminated with viruses, driving demand for this testing & propelling its market expansion.
Furthermore, the development of advanced technologies, like, PCR, next-generation sequencing (NGS), etc., has significantly improved the efficiency & accuracy of this testing. This has led to the inflated adoption of these technologies by biopharmaceutical companies, which increases the resulting efficiency of testing & drives market expansion. Viral Clearance Testing has emerged as one of the key prerequisites for biopharmaceutical products for regulatory approvals to ensure product safety for human consumption.
|Study Period||Historical Data: 2018-21|
|Base Year: 2022|
|Forecast Period: 2023-28|
|Regions Covered||North America: US, Canada, Mexico|
|Europe: Germany, The UK, France, Spain, Italy, Rest of Europe|
|Asia-Pacific: China, India, Japan, South Korea, Australia, Rest of Asia-Pacific|
|South America: Brazil, Rest of South America|
|Middle East & Africa: GCC, South Africa, Egypt, Rest of MEA|
|Key Companies Profiled||Merck KGaA , Charles River Laboratories, 3P Biopharmaceuticals, Eurofins Scientific, Wuxi Biologics, Kedrion S.p.A, Virusure Gmbh, Texcell SA, Samsung Biologics, Syngene International Limited, Creative Biolab, Creative Biogene, Sartorius AG, Nelson Laboratories LLC, Others|
|Unit Denominations||USD Million/Billion|
For instance, in the manufacturing of the HPV vaccine, Bovine serum is used, including bovine viral diarrhea virus (BVDV) & bovine parvovirus (BPV), which can contaminate the vaccine product. Therefore, to ensure the safety of the HPV vaccine, the regulatory agencies required the manufacturers to perform this testing to demonstrate that the manufacturing process effectively removes or inactivates these potential viral contaminants.
Moreover, virus detection, inactivation, and removal require a skilled workforce & high-tech instruments due to the complexity of testing, which is time-consuming & cost-intensive. Therefore, numerous biopharmaceutical companies such as Takeda Pharmaceutical, Pfizer, Novartis, and others are turning to alternatives such as outsourcing these testing services to FDA-accredited laboratories as the preferred choice to overcome the discrepancy in the test result. Hence, the testing service provider's growth potential in the market has risen.
Global Viral Clearance Testing Market Key Drivers:
Stringent Regulations for Biopharmaceutical Products Necessitates the Demand for Viral Clearance Testing - The presence of viral contaminants in biopharmaceutical products can pose significant health risks to patients, including the transmission of infectious diseases. Therefore, regulatory agencies, such as the US Food and Drug Administration (FDA) & the European Medicines Agency (EMA), mandated this testing to be performed as part of the approval process for these products. This process is an essential step in the development & approval of biopharmaceutical products, such as vaccines, monoclonal antibodies, gene therapies, etc., to ensure that the products are safe for human use.
Additionally, the emergence of several novel viral diseases, which require vaccines to control the incidence among humans, necessitates this testing in their process of commercialization, hence, driving the demand.
Global Viral Clearance Testing Market Possible Restraint:
Lack of Skilled Professionals to Hamper the Adoption of New Technology - The scarcity of highly competent experts in the field of analytical testing is one of the significant challenges faced by the market. This is due to intense competition for qualified & experienced scientists in the market between viral clearance service providers, pharmaceutical & biotechnology companies, and academic & research institutions. Due to this, this testing service providers struggle to attract & maintain highly competent experts, who are essential for carrying out accurate & reliable testing.
Therefore, to attract & retain these experts, companies may have to offer higher compensation & other incentives, which can impact their finances & operational outcomes, particularly for small-scale analytical testing providers. Thus, the scarcity of qualified scientists can also hinder the adoption of new technology & procedures, limiting the ascension of the market in the upcoming years.
Global Viral Clearance Testing Market Growth Opportunities
Emergence of Novel Viral Infection Creates a New Market Opportunity - The growing prevalence of viral infection globally, in humans, animals, and birds due to adverse environmental conditions & rising genetic mutation in the viruses would create a prospect for the market during the forthcoming period. For instance, during the pandemic at the time of vaccine development, the market has expanded its capabilities & shown huge potential.
Similarly, when the new viral mutation of COVID-19 emerged in 2021, Charles River announced the expansion of its virus clearance testing services to introduce a new assay for detecting novel COVID-19 virus variants. Hence, the advent of new viral infections and mutations in old viral illnesses would provide a market opportunity in the following year, as this service is required before commercializing any drug in the market.
Global Viral Clearance Testing Market Key Trends:
Rising Manufacturing of Biosimilar Products - Biologics became a vital medicine for treating chronic diseases such as diabetes, autoimmune disorder, and cancers. However, the high price tag of these has encouraged the development of another low-cost option, i.e., biosimilar. The low cost of biosimilar manufacturing and R&D, along with the less time required for the development are some of the key factors for the increased adoption of biosimilar products which require viral clearance testing before commercializing. Moreover, the evolution of the regulatory framework in countries such as the US, China, and Japan has provided more opportunities to adopt biosimilars.
Several regulatory bodies which actively regulate the development & commercialization of biosimilars include European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the World Health Organization (WHO). Hence, the growing inclination of companies towards the development & production of biosimilars would strongly contribute to the market in the forthcoming period,
Global Viral Clearance Testing Market (2023-28): Segmentation Analysis
Global Viral Clearance Testing Market report by Markntel Advisors includes segmentation analysis based on End-User, and Operation. This breakdown allows businesses to identify specific market segments and tailor their marketing and product strategies accordingly, maximizing their chances of success in the Global Viral Clearance Testing Market.
Based on End User:
The Pharmaceutical & Biotechnology Companies dominated the market in the past few years & this trend is expected to continue during the forecast period as well, owing to the increased utilization of the viral clearance testing process during biopharmaceutical production. Along with this, businesses like Merck, Charles River, etc., that are participating in the market are adopting different key tactics such as investing for expanding their business, and increased R&D investment for the drug development process is driving the need for this testing in the market. Aside from that, contract research organizations are also predicted to flourish significantly throughout the forecast period due to an upsurging number of medication makers outsourcing their product testing studies.
Based on Scale of Operation:
Of them, the Clinical Phase witnessed significant growth, owing to the large-scale studies involving an enormous number of patient samples that are tested to confirm the safety & efficacy of the biopharmaceutical product. At this stage, biopharmaceutical companies are preparing to submit their product for regulatory approval, and they need to demonstrate that the product is safe & free from any viral contaminants.
Additionally, clinical trials typically involve large-scale production of the biopharmaceutical product, which increases the risk of viral contamination. Therefore, it is essential to perform this testing at this stage to ensure the protection & effectiveness of the product before it is approved for use by patients.
Global Viral Clearance Testing Market Regional Projection
Geographically, the market expands across:
Of all the regions across the globe, North America witnessed significant growth in the Viral Clearance Services market. This is primarily due to a surge in demand for biopharmaceuticals & a rise in the development of advanced technologies in the purification of recombinant proteins produced by animal cell cultures. This results in the advancement of high-value modern biotechnology products requiring this testing in the country.
Besides this, Asia-Pacific is also expected to experience significant market enlargement during the forecast period due to a spike in R&D activities for biopharmaceuticals, rising investment by the companies, and increasing government support. Furthermore, factors such as a growing biopharmaceutical industry and a highly skilled workforce are assisting in the expansion of the market in this region.
Global Viral Clearance Testing Industry Recent Developments
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Frequently Asked Questions
A. The CAGR of the Viral Clearance Testing Market during 2023-28 is projected to be around 20.10%.
A. The stringent regulatory policy for ensuring the safety of biopharmaceutical products is the prominent factor expected to drive the Viral Clearance Testing Market during 2023-28
A. The top players in the Viral Clearance Testing Market are Merck KgaA, Charles River Laboratories, 3P Biopharmaceutical, Eurofins Scientific, Wuxi Biologics, Kedrion S.p.A, Virusure Gmbh, Texcell SA, Samsung Biologics, Syngene International Limited, Creative Biolab, Creative Biogene, Sartorius AG, Nelson Laboratories LLC, etc.
A. The pharmaceutical & biotechnology companies are the leading end-user in the Viral Clearance Testing Market during 2023-28
A. North America, would present growth prospects in the Viral Clearance Testing Market during 2023-28
A. The rise in manufacturing for biosimilar products is a key trend shaping the Viral Clearance Testing Market during 2023-28
A. The high equipment cost is the possible restraint affecting the Viral Clearance Testing Market expansion during 2023-28
Global Viral Clearance Testing Market Research Report (2023-2028) - Table of Contents