The global viral clearance market size was USD 403.5 Million in 2020 and is expected to register a CAGR of 21.9% during the forecast period. Rapid advancements in pharmaceutical and biotechnology sectors, growing global burden of chronic diseases, launch of novel drugs, and increasing investment in the biopharmaceutical sector are key factors expected to drive market revenue growth over the forecast period.
In addition, technological advancements and advancements in nanofiltration, rising funding and financial support for life sciences industry, and growing R&D activities worldwide are some other key factors expected to drive revenue growth of the market.
Viral clearance is the process of eliminating viral contamination though specific membranes or chromatography techniques. Virus clearance is majorly a function of the innate immune system and adheres to the rapid kinetics of viral elimination. Viruses are microscopic organisms and contagious agents that reproduce inside living hosts. Some viruses cause morphological changes to infected cells and are easy to detect while others that do not affect the cell morphology are difficult to detect. Products can be contaminated by adventitious or endogenous viruses. Adventitious viruses are those that have been accidently introduced into the manufacturing processes of biological products. Viral contamination is a common complication of all animal- and human-derived biopharmaceuticals. It significantly affects any part of bioproduction processes and so it is imperative to perform viral testing studies and incorporate viral clearance methods into the processes. Viral clearance studies are a crucial part of process validation and are vital to ensure safety of drugs. Biopharmaceutical product manufacturers and suppliers have implemented preventive measures to reduce viral contamination and adopted use of well-established and characterized cell lines and chemically derived materials. This is a key factor expected to drive revenue growth of the market going ahead.
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Viral clearance plays a critical role in the developmental processes of mAb, recombinant proteins, tissue-based products, and medical devices. During the designing of viral clearance validation studies, it becomes important to recognize which viruses can potentially contaminate a product during manufacturing processes. Increasing investment and expenditure in research and development activities to design more efficient validation processes is also expected to drive market revenue growth over the forecast period. However, high costs and labor-intensive and time-intensive processes of drug development are expected to hamper market growth to a certain extent over the forecast period.
Market Dynamics:
Driver: Increasing demand for biopharmaceutical products is key revenue growth driving factor
Rapidly rising demand for biopharmaceutical products such as vaccines, therapeutic agents, monoclonal antibodies, and recombinant products are key factors expected to drive market revenue growth over the forecast period. Increasing ability of biologics to efficiently treat chronic and rare diseases with minimal to no side effects is a key factor boosting their adoption globally. Rising burden of chronic diseases across the globe and growing investment in research and development activities in pharmaceutical and biotechnology sector to accelerate drug development processes and production of biologics has boosted demand for efficient viral-clearance validation processes. This is expected to further fuel revenue growth of the market. Viral clearance is a critical process in biopharmaceutical manufacturing and practicing virus safety and clearance studies is extremely pivotal for research studies. This is also expected to be a key factor driving revenue growth of the market over the forecast period.
Restraint: High costs and time-intensive drug development processes are key factors restraining market growth
High costs associated with drug development processes and time-intensive pipeline development processes are key factors expected to restrain market growth to a certain extent over the forecast period. In addition, increasing degree of consolidation and scarcity of skilled professionals and experts is expected to affect adoption of viral clearance practices. This is expected to further restrain market growth to a certain extent over the forecast period.
Method Outlook:
Based on method, the global viral clearance market has been segmented into viral detection, viral removal, and viral inactivation. Viral removal segment is expected to account for largest revenue share in the global market over the forecast period. Growth can be attributed to rapid growth of research and development activities in biopharmaceutical sector, increasing adoption of this method, and rising investment to develop efficient processes. In addition, attributes of this method such as accuracy, speed, and flexibility have increased the efficiency of research experiments and manufacturing processes of biologics and this is expected to further fuel revenue growth of this segment.
Application Outlook:
Based on application, the global viral clearance market has been segmented into blood & blood products, vaccines, recombinant proteins, and others. Vaccines segment is expected to register considerable revenue growth over the forecast period owing to increasing demand for vaccines and therapeutics due to growing global burden of chronic diseases and illnesses. Segment of other applications can be further divided into cell therapies, tissue-based therapies, and other treatments. The segment is expected to register significant revenue CAGR during the forecast period owing to rising awareness regarding stem cell therapies and increasing application of tissue-based therapies to treat several diseases and disorders. In addition, growing investment by public and private companies for stem cell research is also expected to drive the revenue growth of this segment over the forecast period.
End-use Outlook:
Based on end-use, the global viral clearance market has been segmented into pharmaceutical & biotechnology companies, Contract Research Organizations (CROs), and academic & research institutes. CROs segment is expected to account for largest revenue share in the global market over the forecast period. Steady growth can be attributed to increasing investment by CROs in drug discovery platforms and infrastructure and rising outsourcing activities of drug discovery services by pharmaceutical and biotechnology companies to CROs.
Regional Outlook:
Based on regional analysis, North America is expected to account for largest revenue share in the global market over the forecast period. Robust revenue share can be attributed to presence of modern healthcare and research infrastructure and increasing development of biopharmaceutical sector in the region. In addition, rising private and public funding for stem cell research, growing demand for biopharmaceuticals, increasing production of monoclonal antibodies, and major presence of key companies are some other factors expected to fuel revenue growth of the market in the region.
Asia Pacific is expected to register a rapid revenue CAGR over the forecast period owing to increasing funding and financial support to pharmaceutical and biotechnology companies, growing acceptance of viral clearance validation studies, rising demand for biologics, and increasing drug discovery and development processes. In addition, rapid growth of the biopharmaceutical sector and increasing prevalence of chronic diseases are also major factors expected to drive revenue growth of the market in the region over the forecast period. Presence of several CROs that provide preclinical and clinical research services and increasing development of generic drugs are also expected to drive market growth.
Competitive Landscape:
The global viral clearance market is consolidated, and major companies are engaged in mergers and acquisitions, collaborations, and product developments to cater to growing global demand, as well as to drive revenues, expand product portfolio, and develop and introduce new products in the market. Major companies operating in the market include Charles River Laboratories International, Inc., WuXi Biologics, Lonza Group, Merck KGaA, Sigma-Aldrich Corporation, Avance Biosciences Inc., BSL BIOSERVICE, Clean Cells, SGS S.A., Texcell, Inc., and Vironova Biosafety.
Some key developments in the market:
- In September 2020, Merck, which is a prominent leader in science and technology, announced expansion of its biosafety testing laboratory services in Singapore. The services enable customers to conduct viral clearance studies to make sure safety and quality requirements of their biological drugs are met during clinical development process.
- In January 2021, Mountain Valley MD Holdings inked a deal to conduct its Bio Safety Level 4 lab study to assess coronavirus (COVID-19) viral clearance in transgenic mice. The company announced the study is designed to ensure superiority of its solubilized Ivermectin technology against a commercially available oral form in terms of speed and efficacy of viral clearance.
Segments Covered in the Report:
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the sub-segments from 2019 to 2030. For this study, Reports and Data has segmented the global viral clearance market based on method, application, end-use, and region:
Viral Clearance Market Report Scope
Segments covered By Method Outlook, Application Outlook, Regional Outlook
By Method Outlook
Viral Removal
Chromatography
Nanofiltration
Precipitation
Viral Inactivation
Low pH
Solvent Detergent Method
Pasteurization
Other Viral Inactivation Methods
Viral Detection
By Application Outlook
Recombinant Proteins
Blood and Blood Products
Vaccines
Other Applications
By End-use Outlook
Pharmaceutical & Biotechnology Companies
Contract Research Organizations (CROs)
Academic & Research Institutes
Others
Regional scope
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
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