Biologics are products manufactured from different biological sources comprising complex combination of substances that may be composed of living entities such as cells and tissues. It includes a wide range of products such as blood components, tissues, gene therapy, and recombinant therapeutic proteins. The wide-ranging applications of this market include the detection of virus contaminants in products that hold a high commercial value and pose a potential health risk to the target population.
Biological safety testing methods are highly preferred and are incorporated as a consequence of high requirement of product safety and quality of biopharmaceutical products. They are commonly included in process validation of virus inactivation, evaluation of clearance capability during biopharmaceutical production, and quality testing to ensure purity, genetic stability, and sterility.
"Addressable biological safety testing market"
Biological safety testing holds utmost importance due to the high probability of contamination during the production of biologics and medical devices. It is being increasingly incorporated in response to the formulation of stringent guidelines and recommendations laid down by the regulatory organizations due to the increasing clinical burden and the high need to curb it.
The growth of this vertical is also due to the employment of these testing tools in contract testing laboratories, performing tests on behalf of numerous drug developers, thus contributing to an upsurge in the demand for these biological safety testing tools. Biological safety testing alternatives are adopted by medical device manufacturers, microbial testing laboratories, contract manufacturing organizations, and manufacturers of food & beverage and agricultural products. Furthermore, these tools have high growth scope in the testing and evaluation of radiopharmaceuticals as these formulations possess a limited shelf-life requiring a high level of safety monitoring.
The biological safety testing market is competitive in nature and is dominated by major players such as Charles River Laboratories International, Inc., Lonza Group, Wuxi Pharmatech (Cayman), Inc., and Sigma Aldrich Corporation. The sector participants are attaining consistent growth through geographical expansions, new product development initiatives, and mergers & acquisitions. In July 2015, Charles River Laboratories completed the acquisition of Celsis International Ltd. This acquisition was carried out to enhance quality control testing of its biopharmaceutical and consumer products.
"Biological safety testing market outlook"
Rapid growth in the number of biotechnology and pharmaceutical companies, soaring prevalence of chronic diseases, and the rising number of innovative product launches are primary factors presumed to engender a heightened demand for the biological safety testing products. In addition, government and private funding in clinical research, increasing R&D investment in life sciences, and heightening healthcare awareness, are some of the significant factors driving the growth of the global biological safety testing market.
In-depth report on global biological safety testing market by Grand View Research: