PUBLISHER: Grand View Research | PRODUCT CODE: 1842097
PUBLISHER: Grand View Research | PRODUCT CODE: 1842097
The global bioprocess validation market size was estimated at USD 485.5 million in 2024 and is projected to reach USD 1.05 billion by 2033, growing at a CAGR of 9.01% from 2025 to 2033. Growth is driven by the rising demand for biologics and biosimilars, stringent regulatory requirements for product safety and efficacy, and the increasing adoption of single-use systems in manufacturing.
Moreover, biopharmaceutical companies' shift toward outsourcing validation services to reduce costs and accelerate time-to-market is expected to support market expansion.
Rising biologics and biosimilars production
The rising production of biologics and biosimilars strongly drives the demand for bioprocess validation. Biologics such as monoclonal antibodies, recombinant proteins, vaccines, and advanced therapies like cell and gene therapies are highly complex and sensitive to manufacturing variations. To ensure product safety, efficacy, and consistency, rigorous validation of every production stage, upstream, downstream, and final fill/finish is critical. Moreover, with the rapid growth of the biosimilars market following the expiration of major biologic patents, manufacturers are under increasing pressure to validate their processes to demonstrate comparability with reference products in line with strict regulatory requirements. This growing biologic pipeline and the global push for more cost-effective therapeutic solutions have made validation an indispensable step in biomanufacturing.
Beyond product innovation, regulatory compliance, and evolving manufacturing technologies further accelerate market growth. Stringent guidelines issued by agencies such as the FDA, EMA, and PMDA require thorough validation of processes, analytical methods, and equipment to safeguard patient safety. The shift toward single-use bioprocessing systems has also intensified demand for extractables and leachable testing to ensure product purity. Moreover, outsourcing validation activities to contract research and manufacturing organizations allows companies to reduce costs, speed up production timelines, and access specialized expertise.
Global Bioprocess Validation Market Report Segmentation
This report forecasts revenue growth at the global, regional, and country levels and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global bioprocess validation market report on the basis of testing type, stage, mode, and regioN