Biologics Safety Testing Market

Introduction

Large and complex molecules produced from genes of living organisms by using advanced DNA technologies are collectively identified as biologics. Theses biologics are actively incorporated in development of new medicines as well as improvement of existing drugs. Testing the safety of these biologics is critical for avoiding the inadvertent inclusion of unknown entities in drug manufacturing system.

Untested and unsafe biologics can cause a greater harm to global population as drugs derived from them can create new abnormalities for patients, and further complicate their health conditions. Hence, government authorities from around the world are watchfully regulating these complex manufacturing processes, which include drug development, product testing, and efficacy evaluation.

According to Persistence Market Research, the global market for biologics safety testing is poised to grow at a robust pace during the forecast period, 2017-2022. Safety of biologics will continue to play a pivotal role in future drug developments, and products facilitating these tests will witness a significant uptake in the global pharmaceuticals industry. The report projects that by the end of 2022, the global biologics safety testing market will have reached a value of US$ 4,360 Mn.

The report anticipates North America as the most lucrative market for biologics safety testing. Presence of the FDA and robust healthcare marketplaces in the US and Canada will continue to bolster the presence of North America in the global market. The Asia-Pacific excluding Japan (APEJ) region is also expected to reflect robust growth in its biologics safety testing market. Favorable industrial regulations, coupled with low labor wages and ample resource availability, are anticipated to factor the growth of biologics safety testing market in the APEJ region.

Market Analysis by Test-Type

The report anticipates that on the basis of safety tests, endotoxin tests will register high upturns in the global biologics safety testing market. Currently, endotoxin tests are estimated to account for nearly one-third share of global market revenues, and are anticipated to procure more than US$ 1,400 Mn by the end 2022. During the forecast period, endotoxin tests will record largest revenue share as well as the fastest revenue growth in the overall biologics safety testing market.

Sterility tests and residual host contamination tests will register parallel growth by reflecting similar CAGRs through 2022. The demand for cell line authentication and characterization tests is also anticipated to gain traction, while bioburden tests are anticipated to create an incremental opportunity of over US$ 100 Mn between 2017 and 2022. Compared to the above, adventitious agent detection tests will exhibit a relatively low CAGR, indicating their limiting demand in the near future.

Market Analysis by Product-type & Applications

• In 2017, nearly half of the revenues procured in the global market will be procured from sales of kits & reagents
• Compared to products, testing services will record higher traction, and are expected to exhibit 9% CAGR over the forecast period
• The report projects that vaccine and therapeutics development will remain the largest application for biologics safety testing
• Application of biologics safety testing in cellular and gene therapy is anticipated to witness a gradual uptick, revenues from which are likely to touch US$ 710 Mn value by the end of 2022

Biological Safety Testing Market: Key Companies

Companies developing solutions on assessing the safety of biologics are anticipated to combine industry-leading expertise and operational excellence, which will ensure that critical drug development programs and manufacturing processes become successful. Companies such as Wuxi Apptec, Toxikon Corporation, Lonza Group Ltd., Pace Analytical Services Inc., BioMerieux SA, Genscript Biotech Corp., Thermo Fisher Scientific Inc., SGS S.A., Eurofins Scientific Se, Sigma-Aldrich Corporation (part of Merck KGaA), and Charles River Laboratories International, Inc.are observed to remain active in the global biologics safety testing market throughout the forecast period.

Market Taxonomy

A concise taxonomy on the global market for biologics safety testing has been summarized in the table below:

Attribute	Details
Region	North Americ Latin America Europe Japan APEJ MEA
Product Type	Kits & Reagents Instruments Services
Test Type	Endotoxin Tests Sterility Tests Cell Line Authentication and Characterization Tests Adventitious Agent Detection Tests Bioburden Tests Other Tests
Application	Vaccine and Therapeutics Development Blood and Blood-related Products Testing Cellular and Gene Therapy Tissue-related Products Testing Stem Cell Research

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