by 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:
The bioprocess validation market involves various products and services required for validating the manufacturing processes of biopharmaceuticals and biologics. This includes tools, equipment, consumables and validation documentation & support services. Validation ensures that a bioprocess consistently operates within predetermined acceptance criteria or quality standards. It is critical for biopharmaceutical manufacturers to validate their production processes to comply with regulations and deliver safe and effective products to patients. The validation process helps identify potential issues during production that could impact drug safety, efficacy or quality. This gives biopharmaceutical companies assurance in meeting stringent quality standards set by regulatory agencies.
Market key trends:
One of the major trends in the bioprocess validation market is increasing outsourcing of validation activities to contract service providers. Most biopharma companies prefer to outsource validation services to focus internal resources on core drug development work. Leading contract validation organizations offer end-to-end validation services from planning, execution to documentation. This has boosted their market share. Another key trend is the growing adoption of continuous bioprocessing over batch processing. Continuous systems have potential advantages of improved productivity, reduced contamination risk and greater process understanding. However, validating continuous bioprocessing poses unique technical challenges. Equipment manufacturers are addressing this through novel sensor technologies and advanced analytics platforms for continuous online monitoring and validation of processes.
Porter’s Analysis
Threat of new entrants: The bioprocess validation market requires high R&D investment and strict regulatory approvals which pose barriers for new entrants.
Bargaining power of buyers: Large pharmaceutical companies have significant bargaining power over bioprocess validation service providers and solution developers.
Bargaining power of suppliers: Few technology developers hold proprietary technologies providing them stronger position in negotiations.
Threat of new substitutes: No viable substitute exists presently for bioprocess validation services.
Competitive rivalry: The market is dominated by large players intensifying competition.
Key Takeaways
The Global Bioprocess Validation Market Size is expected to witness high growth, exhibiting CAGR of 11% over the forecast period, due to increasing regulatory mandates to validate bioprocessing steps.
Regional analysis: North America dominates the bioprocess validation market owing to presence of large pharmaceutical companies and favorable regulations. Asia Pacific exhibits fastest growth in bioprocess validation market driven by expanding biopharma industry and growing generics market in the region.
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.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc.
