Adventitious agents, as defined by the World Health Organization, are organisms such as virus, parasites, and fungi which are unintentionally introduced into the manufacturing process of biological medicinal products. Biotechnological products such as vaccines are vital health medicinal products, thus their safety and quality are of utmost importance for public health. Production of vaccine or other biotechnological products bears the risk of getting contaminated due to adventitious agents.
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Therefore, detection of adventitious agents during the manufacturing of biotechnological products is essential for the protection of the patient. Furthermore, it is a regulatory requirement. Testing of adventitious agents can be done using various methods such as in-vivo tests, in-vitro tests, nucleic acid based methods, etc.
The global adventitious agent testing market is estimated to expand at a significant rate during the forecast period. Rise in concern about the quality and safety of vaccines is a key driver of the global adventitious agent testing market during the forecast period. Surge in manufacturing of biological products from animal origin possesses the risk of contamination with adventitious agents. Thus, demand for adventitious agent testing is high which, in turn, is expected to boost the global adventitious agent testing market. Furthermore, increase in vaccine production for different infectious diseases, improved funding from government, increase in R&D, etc. are some other factors that are projected to boost the growth of the global adventitious agent testing market during the forecast period. However, issues regarding harmonization with different regulatory authorities is anticipated to restrain the growth of the global adventitious agent testing market.
The global adventitious agent testing market can be segmented based on test type, end-user, and region. In terms of test type, the global adventitious agent testing market can be divided into molecular-based tests, in vitro tests, in vivo tests, and electron microscopy detection. Molecular-based tests are expected to constitute a significant share of the global adventitious agent testing market due to their efficient results and high specificity, coupled with lesser time as compared to the in vivo or in vitro testing which requires days to show cytopathic effects. Based on end-user, the global adventitious agent testing market can be classified into biopharmaceuticals, CROs, research institutes, and others. Biopharmaceuticals are expected to constitute the dominant share of the adventitious agent testing market in 2025 due to increase in the number of companies and large scale manufacturing.
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Geographically the adventitious agent testing market can be divided into North America, Asia Pacific, Latin America, Europe, and Middle East & Africa. North America is anticipated to dominate the global adventitious agent testing market with the leading share. Major contribution in production of biological medicinal products, in the region, is one of the important factor driving the growth of the adventitious agent testing market in the region. Furthermore, technological advancement and increased government support in the region are contributing to the growth of the adventitious agent testing market in North America. Europe is also expected to hold a significant share of the global market after North America due high R&D investment, government funding, etc. The adventitious agent testing market in Asia Pacific is anticipated to register a rapid growth rate during the forecast. Asia Pacific is a highly attractive market for adventitious agent testing due to rise in prevalence of infectious diseases, entry of new market players, upsurge in government funding for R&D, increase in concern of safety and quality, since it is an attractive market for vaccines there is increase in number of contract research organizations in the region etc.
Many players operating in the global adventitious agent testing market are focusing on strategies such as geographical expansion and collaboration and partnership. Some of the prominent players operating in the global adventitious agent testing market are Thermo Fisher Scientific Inc., Molecular Diagnostic Services, Inc., Sigma-Aldrich Co. LLC, Charles River Laboratories International, Inc., and GENEWIZ.
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