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)
Adventitious Agent Testing Market: Drivers and Restraints
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.
Get To Know Sample of Report @ https://www.persistencemarketresearch.com/samples/15445
Adventitious Agent Testing Market: Segmentation
Segmentation based on Type
- Specific Method
- Non-Specific Method
- In-Vivo (Animal)
- In-Vitro (Cell Cultures)
Segmentation based on End User
- Biotechnology Companies
- Research Institutes
- Research Laboratories
Adventitious Agent Testing Market: Market Overview
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.
Adventitious Agent Testing Market: Region-wise Overview
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.
Adventitious Agent Testing Market: Key Participants
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.
The report covers exhaustive analysis on:
- Market Segments
- Market Dynamics
- Historical Actual Market Size, 2014 – 2016
- Market Size & Forecast 2017 to 2025
- Supply & Demand Value Chain
- Market Current Trends/Issues/Challenges
- Competition & Companies involved
- Value Chain
- Aircraft Refurbishing Market Drivers and Restraints
Regional analysis for Market includes
- North America
- Latin America
- Asia Pacific & Japan
- The Middle East and Africa
- Shifting Industry dynamics
- In-depth market segmentation
- Historical, current and projected industry size Recent industry trends
- Key Competition landscape
- Strategies of key players and product offerings
- Potential and niche segments/regions exhibiting promising growth
- A neutral perspective towards market performance
Access Full Report @ https://www.persistencemarketresearch.com/checkout/15445
Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.
To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.
Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMR’s collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.
Persistence Market Research
Address – 305 Broadway, 7th FloorNew York City,
NY 10007 United States
U.S. Ph. – +1-646-568-7751
USA-Canada Toll-free – +1 800-961-0353
Sales – [email protected]
Website – https://www.persistencemarketresearch.com