The global biologics safety testing market is expected to reach USD 4.90 billion by 2022 from USD 2.75 billion in 2017, at a CAGR of 12.2%. Globally, the biologics safety testing market is witnessing a high growth due to factors such as growth in the pharmaceutical and biotechnology industry driven by government support, positive trend of R&D investment in the life science industry, and increasing drug launches.
Over the last few decades, key players operating in this market focus on offering products & services to help the pharmaceutical and biotechnology industry maintain product safety and quality. For instance, Merck KGaA (Germany) introduced the steritest symbio pumps system, which is used in sterility testing. SGS SA (Switzerland) introduced the stability testing services. This service provides stability testing for biologics product.
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Based on product & service, the biologics safety testing market is segmented into kits and reagents, services, and instruments. The kits and reagents segment is expected to register the highest CAGR during the forecast period. This growth can be attributed to the increasing adoption of kits-based biological safety testing and repeating purchase of kits and reagents compared to instruments.
By test type, the market is segmented into endotoxin tests, sterility tests, cell line authentification and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and other tests. The endotoxin tests segment is expected to register the highest growth rate during the forecast period. The endotoxin test is the most widely used test method in the biologics safety testing market, and is also expected to grow at the highest rate amongst all test segments in this market. Endotoxin testing is used for the detection of bacterial toxins in products intended for human use. Limulus amebocyte lysate (LAL) assays are the most widely used endotoxin tests.
North America is expected to account for the largest share of the global biologics safety testing market in 2017. Asia is expected to grow at the highest CAGR in the forecast period for this report (2017–2022), and represents new revenue pockets for the biologics safety testing market. Asia is expected to witness a steady year-on-year growth, owing to the trend of outsourcing drug discovery research activities to countries in this geography. An increase in government support for the pharmaceutical and biotechnology industry in this region will further fuel the demand for products offered in the biologics safety testing market. For instance, beginning in 2014, the Indian government plans to invest up to USD 5 billion a year for the next five years, to boost the biotechnology sector in the country and make it a USD 100 billion industry by 2025. Similarly, the Chinese government is also taking various initiatives to promote life science research. These funding activities help in increasing the purchasing power of major research institutes, which in turn is driving the market for biologics safety testing products.
In the coming years, emerging markets and increasing pharmaceutical outsourcing are expected to offer growth opportunities for players in the biologics safety testing market. CROs act as outsourcing partners for pharmaceutical & biotechnology companies and academic institutes. Through outsourcing various functions to CROs, pharmaceutical and biotechnology companies can reduce their operational costs and R&D budgets. Cost savings, commercial sustainability, and optimal staffing are some of the key advantages driving the outsourcing of biologics safety testing and clinical trial services for large companies. In addition, expanding pipelines of pharmaceutical and biopharmaceutical companies is further expected to drive the outsourcing of biologics safety testing to CROs.