Adventitious agents are microorganisms that have unintentionally introduced into the manufacturing of biological products. They mainly include fungi, mycoplasmas, rickettsia, protozoa, bacteria, parasites, and viruses. Adventitious agents testing is a process of detection by a combination of methods at various stages of biologics production. Adventitious agents are a major concern while using mammalian cell lines for the production of biologics. They are two types of testing methods namely Specific and Non-specific methods. In the Specific method, the adventitious agents are known e.g. PCR. In the Non-specific method, the adventitious agents are known and unknown, and it is subdivided into three types. A) In Vivo (Animals) b) In Vitro (Cell Cultures) c) Molecular/Biochemical. In In-vivo methods, various animal species are used, like a guinea pig, rabbits, adult mice and suckling mice, etc. In-Vivo methods are used because they detect viruses not readily possible with other systems. The in-vitro method is based on the ability of culture to grow a wide array of pathogens and also based on their extensive use in detection of human pathogens. Others Non-specific methods include Transmission Electron Microscopy and Reverse Transcriptase (RT) Assay for Retroviruses. (Source: FDA)
Rising concerns of contamination in biological products and the need for improvement of quality control measures for biologicals are drivers boosting the burgeoning growth of the adventitious agent testing market. Adventitious agent testing methods are continuously evolving and represent the improvement in technology, including throughput and sensitivity. These technological advancements have potential to support safe biologicals developments, all these factors boosting the growth of the adventitious agent testing market. Manufacturers of a large class biologicals products, including vaccines and cell therapy products, often require cell substrates from animal origin. There is a high potential risk that cell substrates and raw materials of biologicals products can contaminated with adventitious agents. So, there is a high need for adventitious agent testing to assure quality and safety of biological substances. This demand fuels the growth of the adventitious agent testing market.
Evaluation of risk associated with new viruses by using present evolving technology limits the application of present adventitious agents testing. Issues in uses of assays and various national regulatory authorities harmonization act as a restraint on the growth of the adventitious agent testing market.
Selection of cell substrate influence purity and safety of the biologics manufactured in it. The evaluation is specifically tailored to the vaccine product and cell substrate to be developed to assure purity and safety. Because of increasing vulnerability to microbial contamination of biological products, there is a high demand for adventitious agent testing which is expected to boost the growth of the market. The market has witnessed robust growth due to increasing adventitious agents and vaccines is pertinent in the context of day-by-day emerging infectious diseases. Improving government funding and increasing research institution contribution in innovation are expected to fuel the growth. The future of Adventitious Agent Testing Market anticipated with double CAGR during the forecasted period.
Global Adventitious Agent Testing Market segmented into North America, Europe, Asia -Pacific & Japan, The Middle East and Africa regions and Latin America by region wise. North America dominates the global Adventitious Agent Testing Market due to increasing research contribution in new biological product development, and in North America, USA is a major shareholder. Europe and Asia-pacific are the fastest growing market in Adventitious Agent Testing Market due to increasing support of the government and funding organizations in these regions. The Middle East and Africa regions and Latin America are also showing least growth comparatively during the forecasted period.
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The key participants in Adventitious Agent Testing Market are Charles River Laboratories International, Inc., Sigma-Aldrich Co. LLC, Thermo Fisher Scientific Inc, etc. The companies are mainly focusing on collaboration and partnership to keep up the pace of the competitiveness and to acquire new markets.
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