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Bioprocess validation is a process of collecting and evaluating the data obtained from the design stage to the final production. It provides scientific evidence that a process can consistently deliver quality products. During product development, assessing the potential sources of variability becomes crucial, and working on them minimizes the chances of batch failure. Any process involved in producing the bio/pharmaceutical product significantly impacts the end product. Hence, regulatory agencies require testing to monitor and validate the manufacturing process's performance to mark the product's safety, uniformity, and effectiveness.
The growing demand for outsourcing bioprocess validation services and rising R&D investment by key players is expected to drive market growth.
However, process development and validation costs even more than manufacturing, and such high costs are affecting its adoption. Thus, restricting the market expansion across the globe.
The COVID-19 pandemic has affected almost every market and has caused a rapid, unexpected evolution in the industry over the last few years. The excessive demand for biopharmaceuticals, vaccines, and immediate regulatory approval requirements for products and devices had positively impacted the bioprocess validation market. Emphasis on system and raw material characterization has gained importance.
The report will cover the following key insights:
Based on test type, the global market is segmented into extractable and leachable testing, microbiological testing, physiochemical testing, integrity testing, compatibility testing, and others. Extractable and leachable testing holds the maximum share in the bioprocess validation market. The data obtained from these testing helps assess process performance, product quality, and patient safety. The extractable and leachable testing studies determine whether harmful organic and inorganic impurities altered the product safety or effectiveness of the finished product. Robust utilization and several developments by key players contribute to segmental growth.
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Asia Pacific is anticipated to have the fastest CAGR in the forecast period. The vast increase in the biopharmaceutical manufacturing capabilities, booming research and development, specifically by pharmaceutical and biotechnological companies, and increasing investments and partnerships of key players with Asian industries is expected to drive the market growth.
The report will include the profiles of key players such as Merck KGaA, Eurofins Scientific, SGS Société Générale de Surveillance, Sartorius AG, Pall Corporation (Danaher), METTLER TOLEDO, Thermo Fisher Scientific Inc., Lonza, Charles River Laboratories, Almac Group, and Others.
By Test Type | By Process Component | By End User | By Geography |
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