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Biologics Safety Testing Market: Global Market Estimation, Dynamics, Regional Share, Trends, Competitor Analysis 2013 to 2016 and Forecast 2017 to 2024
Biologics Safety Testing Market
Biologics are pharmaceutical medical products which are synthesized from biological sources. These biologics are complex molecules such as recombinant proteins and monoclonal antibodies among others. Biologics are commonly used in the treatment of chronic diseases such as rheumatoid arthritis, cancer, and other chronic diseases. Biologics safety testing is carried to ensure the patient safety and the tests include sterility tests, endotoxins test, residual host contamination detection tests, and bioburden tests among others.
Growing biologic products launches, rise R&D activities by pharmaceutical and biotechnology companies, technological advancements of biologics safety testing methods, stringent regulatory guidelines for product approval, and rise in funding from public and private sectors for the development of newer biologics are expected to boost the biologics safety testing market. However, high cost of biologics safety testing, and lack of well-developed healthcare in underdeveloped countries are hamper the market growth.
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The global Biologics safety testing market is divided into following categories-
1. Product type
• Reagents and Kits
• Instruments
• Services
2. Test type
• Sterility Tests
• Bioburden Tests
• Endotoxin Tests
• Residual Host Contamination detection Tests
• Cell Line Authentication and Characterization Tests
• Others
3. Application
• Cellular and Gene Therapy
• Vaccine and Therapeutics Development
• Tissue and Tissue-related Products Testing
• Blood and Blood-related Products Testing
• Stem Cell Research
4. End-users
• Pharmaceutical Companies
• Biotechnology Companies
And lastly, on the basis of the geographical regions, the global biologics safety testing market have five major regions- North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America biologics safety testing market dominant share owing to increase in R&D activities by the market players, presence of huge number of market players, and well-developed healthcare infrastructure. Europe biologics safety testing market has a significant share owing to adoption of newer technologies, expansion of business by market players in Germany and UK, and increase in funding for R&D activities for the development of newer biologics. Asia Pacific biologics safety testing market is projected to grow due to rise in awareness about biologics safety testing, favorable regulatory policies, and increase in healthcare expenditure.
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Some of the key players in the global biologics safety testing market include Charles River Laboratories (U.S.), Pace Analytical Services Inc. (U.S.), Thermo Fisher Scientific Inc. (U.S.), WuXi Apptec (China), Sartorius AG (Germany), Toxikon Corporation (U.S.), Cytovance Biologics, Inc. (U.S.), SGS SA (Switzerland), Merck KGaA (Germany), Sterigenics International, LLC (U.S.). Some of the market developments include Sterigenics International LLC acquiring Toxikon’s European laboratory business including biologics testing business in 2017.
Acquisitions and mergers, collaborations, and launching of newer tests by market players also immensely boost to the biologics safety testing market. For instance, in 2016, Charles River Laboratories acquired Blue Stream laboratories to strengthen its capabilities in biologics development and safety assessments. In addition in 2016, Abreos Biosciences collaborated with True Diagnostics to develop the point-of-care tests for biologics.
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