The latest market report published by Credence Research, Inc. “Global Biological Safety Testing Market– Growth, Future Prospects, Competitive Analysis, 2018 – 2026,” the global biological safety testing market was valued at US$ 3,120.8 Mn in 2017, and is expected to reach US$ 8,935.4 Mn by 2026, expanding at a CAGR of 12.5% from 2018 to 2026.
Browse the full report Biological Safety Testing Market – Growth, Future Prospects, Competitive Analysis, 2018 – 2026 report at https://www.credenceresearch.com/report/biological-safety-testing-market
Biological safety testing is an important aspect related to the sterility validation of medicinal and food products. Government healthcare agencies such as WHO, ICH and USFDA have sanctioned stringent regulatory norms in biopharmaceutical industires pertaining to product safety and efficacy in compliance with cGMP guidelines. Rising prevalence of infectious disease and influx of biologics as first line therapy for chronic illness has led to the rapid growth of cGLP certified research and clinical laboratories.
Reagents and kits are currently dominating the product segment for biological safety testing market. The key features responsible for its prominence are rising prevalence of chronic disease and rampant growth in clinical laboratories throughout the globe. Instruments have tremendous demand in research centers due to its multitasking ability of performing biological assays and result interpretation of biological sample under investigation.
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Vaccines and therapeutics is the largest and fastest growing application segment due to rising prevalence of infectious disease and increasing demand for preventive medicine and prophylaxis. Gene therapy will garner impressive growth in the near future due to increasing number of patients suffering with advanced stage cancer and need for targeted drug delivery to overcome side effects associated with chemotherapy.
Endotoxin tests are leading the test segment for biological safety testing market on account of the diverse range of endotoxin tests available and its increased adoption in biopharmaceutical industires to validate sterility during manufacturing operation. Bioburden test is gaining prominence owing to the stringent regulatory norms sanctioned by healthcare agencies to validate medicinal agent safety. Its recent integration with colorimetric method helps in quantifying the bioburden limits for biologics and medical devices.
In the current scenario North America is leading the regional segment for biological safety testing market. As per the statistics provided by Center for Disease Prevention and Control (CDC) in United States 6 in 10 adults suffer with chronic disease which is equivalent to 60% of the total adult population. Rising prevalence of chronic diseases and domicile of key players such as Charles River Laboratories International, Inc., and Merck & Co., Inc., drive the market growth in North America. In Europe the market growth is determined by the stringent regulatory norms sanctioned by European Medical Agency (EMA) and flourishing biopharmaceutical industries. Asia Pacific is set to register outstanding growth in the near future owing to the supportive regulatory scenario favoring biological safety products market growth and rapid growth in clinical laboratories.
Medical device manufacturers providing biological safety testing products are Avance Biosciences, Inc., Bsl Biosciences, Charles River Laboratories International, Inc., Cytovance Biologics, Inc., Lonza Group, Merck & Co., Inc., Sigma-Aldrich Corporation, SGS S.A., Toxikon Corporation and Wuxi Pharmatech (Cayman), Inc.
Key Market Movements:
- Rising prevalence of chronic diseases and increasing number of clinical laboratories worldwide
- Stringent regulatory norms sanctioned by healthcare agencies to ensure medicinal agent safety and efficacy
- Technological advancement in the instruments and reagents & kits employed for performing biological assays and interpretation
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- Reagents and Kits
- Gene Therapy
- Stem Cells
- Tissue & Tissue Based Products
- Blood & Blood Based Products
- Vaccines & Therapeutics
- Sterility Test
- Cell Line Authentication & Characterization Test
- Bioburden Test
- Endotoxin Test
- Adventitious Agent Detection Test
- Residual Host Contamination Detection Test
By Geography Segment
- North America
- Asia Pacific (APAC)
- Latin America
- Middle East & Africa (MEA)
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