Biologics Safety Testing Market to Receive Favors from the Biopharmaceutical Sector | New Research by MRFR


Biopharmaceutical products, which include drugs and vaccines, can carry contaminants. In the longer run, if not handled carefully, these products can trouble patients. But the rising demand has also set manufacturers on a track where they are now focusing more on the manufacturing process. This process includes improved productivity, cost efficiency, and deviations. But along with it comes safety testing measures. These measures are of utmost importance as only they can ensure clearance from governments for a widespread market. MRFR report on the same market includes several aspects such as segmentation, competitive scenario, and factors that can influence the market in performing better.

Market Research Future (MRFR) in their latest report of the biologics safety testing market revealed that the market can achieve 13.6% CAGR during the forecast period (2018-2023). The biologics safety testing market can scale far better market valuation than its previous USD 2.79 billion by the end of 2023. The biopharmaceutical industry is rapidly increasing as the global need for drugs based on life science-related products are increasing.

Increasing regulations introduced by governments to create safer drugs are one of the major factors that can thrust the biologics safety testing market forward. As a square impact, this is forcing the biopharmaceutical companies to introduce latest technologies in their manufacturing sector. This is also creating more space for the biologics safety testing market expansion.


The global biologics safety testing market, as per the reports of MRFR, has been segmented into the product, test type, and application.

Product-wise, the biologics safety testing market can be segmented into kits and reagents, services, and instruments. The kits and reagents segment has the maximum market penetration as of 2017. The instruments segment is expected to experience an uptick in the coming years.

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Based on the test type, the biologics safety testing market includes sterility tests, bioburden tests, cell line authentication, and characterization tests, endotoxin tests, adventitious agent detection tests, residual host contamination detection tests, and others. The endotoxin test segment is garnering accolades from biopharmaceuticals. The bioburden tests segment is also deemed to prosper in the coming years.

Application-wise, the biologics safety testing market includes cellular and gene therapy, vaccine and therapeutics development, tissue & tissue-related products testing, blood and blood-related products testing, and stem cell research.

Regional Analysis:

MRFR, regionally, segments the global biologics safety testing market by the Americas, Europe, Asia Pacific (APAC), and the Middle East & Africa (MEA).

The Americas is leading the market from the front and is gaining substantial market revenue. All credit goes to the U.S. The robust infrastructure in the healthcare sector and research industry and their interconnected workflow are things boosting the regional market further ahead. In addition, the presence of FDA in the region has strict control over the quality which is making sure that the products that come out are of the highest quality.

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Europe has the second biggest market and it can rely mostly on the investment made by governments to promote safety of the product launched and innovations to steer clear of any danger. The APAC market has several well-performing nations such as China, Japan, Republic of Korea, India, and Australia, investing substantially in enriching the quality of such drugs. The region is deemed to be the fastest growing one due to the revamped pharmaceutical and biotech industries.

Competitive Landscape:

Notable contributors of the global biologics safety testing market are Charles River Laboratories, Lonza Group Ltd., Sartorius AG, Merck KGaA, Thermo Fisher Scientific Inc, SGS S.A., Wuxi Apptec, Avance Biosciences Inc., Cytovance Biologics, Inc., and Eurofins Scientific.

In 2018, Sartorius Stedim Biotech launched FlexAct BT that can detect any possible leak in the Flexboy 2D bags that could take place during handling of it or transportation. It does it by using ASTM F2095-01 pressure decay test to maintain the safety standard of the bags.

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