Bioprocess validation refers to the collection and evaluation of data, from the design stage through routine production, which establishes scientific evidence that a process is capable of consistently delivering quality product. The increasing demand for monoclonal antibodies and recombinant proteins have accelerated the adoption of continuous manufacturing techniques in bioprocessing. This has augmented the need for validating such complex production processes to ensure safety, efficacy and quality of biotherapeutics.

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 key trends:

Continuous bioprocessing is gaining popularity as it offers benefits such as higher product yields, reduced contamination risk, and seamless production scaling. Validating such continuous systems is more complex compared to traditional batch processing. This has driven increased investments by biopharma companies in advanced analytical technologies such as in-line sensors and real-time data monitoring systems. Implementation of digital tools for process modeling and data analytics further aids in designing validation protocols and securing regulatory approvals for novel continuous bioproduction workflows. Continuous process verification also helps maintain consistent performance of biomanufacturing equipment over their lifespan. These factors are expected to further fuel growth in the bioprocess validation market during the forecast period.

Segment Analysis

The global bioprocess validation market is expected to be dominated by downstream processing sub-segment. Downstream processing holds a major share in the market owing to its wide applications in various purification and recovery processes involved in bioprocessing. Downstream processing helps in isolating and purifying the desired product from culture media by methods such as filtration, chromatography, and centrifugation.

Key Takeaways

The Global Bioprocess Validation Market Size is expected to witness high growth during the forecast period of 2023 to 2030. Regional analysis:

Europe accounted for the largest share in the global market in 2023. Stringent regulatory framework, presence of major biologics manufacturers, and increasing R&D investments are some key factors responsible for Europe's dominance in the market. Asia Pacific is projected to witness the fastest growth over the forecast period owing to growing manufacturing facilities for biologics in developing countries like China, India, and Singapore.

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.
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