PUBLISHER: Fairfield Market Research | PRODUCT CODE: 1485938
PUBLISHER: Fairfield Market Research | PRODUCT CODE: 1485938
The global market for biologics safety testing is projected to witness substantial growth during the forecast period 2024-2031, driven by the increasing demand for safe biologics in drug development. According to a new report by Fairfield Market Research, untested and unsafe biologics pose severe risks to global health, potentially causing new abnormalities in patients and complicating existing health conditions.
Critical Role of Safety Testing in Biologics
Biologics, complex molecules produced from the genes of living organisms using advanced DNA technologies, play a crucial role in developing new medicines and improving existing drugs. Ensuring the safety of these biologics is paramount, prompting stringent regulations by government authorities worldwide. These regulations oversee the complex processes of drug development, product testing, and efficacy evaluation to prevent the inclusion of unknown entities in the drug manufacturing system.
"Safety testing for biologics is not just a regulatory requirement but a critical component in ensuring the overall safety and efficacy of new and existing medicines," said a spokesperson for Fairfield Market Research. "The rigorous testing protocols in place are designed to protect public health and ensure that biologics can be safely integrated into therapeutic practices."
Regional Insights: North America and APEJ Lead Market Growth
North America is anticipated to be the most lucrative market for biologics safety testing, bolstered by the presence of the FDA and robust healthcare marketplaces in the US and Canada. The regulatory landscape in North America is highly developed, providing a conducive environment for the growth of the biologics safety testing market.
Additionally, the Asia-Pacific excluding Japan (APEJ) region is expected to reflect robust growth due to favorable industrial regulations, low labor wages, and ample resource availability. The region's burgeoning biopharmaceutical industry, supported by government initiatives and investments, is set to drive market expansion.
"The growth in the APEJ region is indicative of the global nature of the biologics safety testing market," the spokesperson added. "With increasing industrial activity and regulatory support, this region is poised to become a key player in the global market."
Market Segmentation Highlights
The report highlights several key segments within the biologics safety testing market, providing a detailed analysis of growth prospects by test type and product type, as well as applications.
Endotoxin Tests: Expected to register the highest growth, accounting for nearly one-third of global market revenues and showing significant market leadership.
Sterility and Residual Host Contamination Tests: Both are anticipated to show parallel growth with similar steady growth rates.
Cell Line Authentication and Characterization Tests: Demand for these tests is expected to gain traction.
Bioburden Tests: Projected to create substantial incremental opportunities in the market.
Adventitious Agent Detection Tests: Expected to exhibit a relatively low growth rate, indicating limited demand in the near future.
Kits & Reagents: Nearly half of the global market revenues are expected to come from sales of kits and reagents, driven by the continuous need for reliable testing tools.
Testing Services: Testing services are anticipated to record higher traction compared to products, with an expected strong growth rate over the forecast period 2024-2031.
Applications: Vaccine and therapeutics development will remain the largest application for biologics safety testing. The application of biologics safety testing in cellular and gene therapy is anticipated to witness a gradual increase, contributing significantly to market revenues.
Driving Factors and Market Trends
Several factors are driving the growth of the biologics safety testing market. The increasing complexity of biologics and the growing number of biologics being developed necessitate comprehensive safety testing protocols. Additionally, advancements in DNA technology and the rise of personalized medicine are contributing to the expansion of the market.
"The demand for biologics safety testing is also being fueled by the need to comply with international regulatory standards," the spokesperson noted. "As biopharmaceutical companies expand their operations globally, adherence to these standards is crucial for market entry and acceptance."
Key Players in the Market
Leading companies in the biologics safety testing market, 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 expected to maintain active roles throughout the forecast period. These companies combine industry-leading expertise and operational excellence to ensure the success of critical drug development programs and manufacturing processes.
Biologics Safety Testing Market Segmentation
By Product Type
By Test Type
By Application
By Region