Quality control measures for drug development are of utmost importance as inadvertent presence of unknown pharmaceutical ingredients can further complicate health conditions of the patients. Government authorities are closely watching over pharmaceutical companies and regulating their drug manufacturing processes by compelling them to undertake safety tests. Large and complex molecules such as biologics, which are produced from genes of living organisms through advanced DNA technologies, are also being tested for their safety in biopharmaceutical production.
Biotechnological companies and pharmaceutical manufacturers continue to give high regards for biologics safety testing products and services. The efficacy of biologics safety testing ensures that tested medicine and drugs are not containing any extra ingredient, thereby preventing patients from experiencing adverse reactions upon intake. A recently published report by Persistence Market Research projects that the global market for biologics safety testing will soar at a robust CAGR of 8.8% over the forecast period, 2017-2022. The report anticipates that approx. US$ 4.36 Bn worth of biologics safety testing products & services will be utilized globally by the end of 2022.
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According to the report, North America will remain at the forefront of global expansion of biologics safety testing market. Throughout the forecast period, North America is anticipated to remain the largest market for biologics safety testing products & services. Key drug regulatory bodies such as the FDA are based in North America. Moreover, the overall healthcare infrastructure in the US and Canada is robust, and exhibits a high uptake for new and improved safety tests on biologics.
The biologics safety testing market in Europe is also expected to witness impressive growth. Global leaders in biopharmaceutical production are expanding their presence in European countries such as Germany and the UK. Moreover, the European region continues to showcase a scientifically- and technologically-advanced healthcare marketplace for biologics safety testing.
Likewise, Japan’s biologics safety testing market is also anticipated to incur rapid growth at a CAGR of 9.3%. Meanwhile the Asia-Pacific excluding Japan (APEJ) region is anticipated to witness stellar growth, particularly with respect to manufacturing of biologics safety testing products. Low wages and favorable industrial regulations are expected to bolster the manufacturing of biologics safety testing products in the APEJ region. Between 2017 and 2022, the APEJ biologics safety testing market is estimated to create over US$ 270 Mn in absolute dollar opportunity.
Key insights on the future of global biologics safety testing market
The report also projects that,
- In 2017, endotoxin tests will account for nearly one-third share on global revenues
- The demand for adventitious agent detection tests will incur a relatively sluggish growth towards the latter half of the forecast period
- While kits and reagents will remain top-selling products, the global market for biologics safety testing will register higher traction for services, revenues from which are slated to grow at a CAGR of 9%
- Vaccine and therapeutics development, the largest application for biologics safety testing, will be bringing in revenues worth over US$ 1.68 Bn by the end of 2022
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Wuxi Apptec, Lonza Group Ltd., Toxikon Corporation, BioMerieux SA, Pace Analytical Services Inc., Thermo Fisher Scientific Inc., Genscript Biotech Corp., Eurofins Scientific Se, SGS S.A., Sigma-Aldrich Corporation (Merck KGaA), and Charles River Laboratories International, Inc. are profiled as key players in the global market for biologics safety testing. These companies are anticipated to remain active in the expansion of global biologics safety testing market through 2022.