Bioprocess Validation of mAbs is fastest growing segment fueling the growth of Bioprocess Validation Market

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posted on 9 months ago — updated on 2 seconds ago

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Bioprocess Validation of mAbs is fastest growing segment fueling the growth of Bioprocess Validation Market

Bioprocess validation involves confirming that bioprocessing equipment, processes, analytical test methods, facilities as well as utility systems can consistently deliver products with intended quality attributes.It helps to ensure that the manufacturing process is capable of producing a consistent drug product

The global Bioprocess Validation Market is estimated to be valued at US$ 356.8 Mn in 2023 and is expected to exhibit a CAGR of 11.% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Overview:
Bioprocess validation involves confirming that bioprocessing equipment, processes, analytical test methods, facilities as well as utility systems can consistently deliver products with intended quality attributes.It helps to ensure that the manufacturing process is capable of producing a consistent drug product.

Market key trends:
One of the key trends in the bioprocess validation market is increased adoption of single-use bioprocessing technologies. Single-use bioprocessing offers advantages such as reduced risk of cross-contamination, lower capital expenditure, improved flexibility and shorter turnaround times. Rapid implementation of QbD (Quality by Design) and process analytical technology (PAT) among biopharmaceutical companies is another major trend driving the market growth. QbD approach aims to build quality into process design and development. It helps to gain better understanding of manufacturing processes. PAT uses real-time measurements, modeling and process understanding to facilitate process control and quality assurance.

Segment Analysis
The global bioprocess validation market is dominated by upstream and downstream process validation subsegments. The upstream process validation subsegment held the largest market share in 2022 owing to increasing stringent regulatory requirements for biologics and biosimilars manufacturing. Upstream process validation ensures product quality and verifies process parameters during cell line development, cell banking, and fermentation stages of bioprocessing.

Key Takeaways
The Global Bioprocess Validation Market Size is expected to witness high growth, exhibiting a CAGR of 11% over the forecast period, due to increasing regulatory requirements for process validation in the biopharmaceutical industry.

Regional analysis
North America dominated the global bioprocess validation market in 2022 owing to presence of large biopharmaceutical companies and contract manufacturing organizations in the region. Europe is expected to be the fastest growing market during the forecast period due to increasing outsourcing of bioprocessing activities to contract manufacturing organizations in countries like Germany and UK.

Key players
Key players operating in the bioprocess validation market are Sartorius Stedim Biotech, Merck KGaA, Pall Corporation, Cobetter Filtration Equipment, Toxikon Corporation, DOC S.r.l., MEISSNER FILTRATION PRODUCTS, Thermo Fisher Scientific, SGS SA, Eurofins Scientific, Lonza Group, ProBioGen AG, Charles River Laboratories, Pacific BioLabs, Gibraltar Laboratories, Nelson Laboratories, BioProcess Technology Consultants, CMIC HOLDINGS Co., Ltd, Cytovance Biologics, Wuxi Biologics.

The global bioprocess validation market size for 2023 is estimated to be US$ 356.8 million. The market is anticipated to grow at a CAGR of 11% during the forecast period of 2023 to 2030.