by The bioprocess validation market involves biological products including vaccines, plasma-derived therapies, recombinant proteins, among others. Bioprocess validation is essential to ensure biopharmaceutical products meet required standards of quality, safety, and efficacy. It helps identify any issues in manufacturing processes that could potentially impact product quality. Bioprocess validation plays a key role in risk management and compliance with stringent regulatory guidelines. 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:
One of the key trends in the bioprocess validation market is the shift towards continuous bioprocessing. Continuous bioprocessing offers advantages such as increased productivity, reduced production time and costs, improved product quality, and flexibility in manufacturing operations. Leading pharmaceutical companies are adopting single-use technologies and modular facilities to enable continuous bioprocessing. For instance, in 2021 Merck KGaA started operations at its modular and flexible bioprocessing plant in Molsheim, France to produce critical raw materials for pharmaceutical and biotech applications. The plant uses single-use technologies and digital solutions to enable flexible and continuous manufacturing. This trend is expected to continue and drive growth of the bioprocess validation market during the forecast period.
Porter’s Analysis
Threat of new entrants: The bioprocess validation market requires high capital investment, established distribution channels, and technical expertise which makes the threat of new entrants moderate.
Bargaining power of buyers: The bargaining power of buyers is moderate as the market has several established players providing validation tools and services.
Bargaining power of suppliers: The bargaining power of suppliers is low as there are numerous component and instrumentation suppliers present in the market.
Threat of new substitutes: There are no close substitutes available for bioprocess validation as it helps ensure product quality and safety.
Competitive rivalry: The competitive rivalry in the market is high owing to the presence of leading global players such as Sartorius Stedim Biotech, Merck KGaA, and Pall Corporation.
Key Takeaways
The Global Bioprocess Validation Market Size is expected to witness high growth over the forecast period of 2023 to 2030.
Regional analysis: North America is expected to dominate the bioprocess validation market during the forecast period owing to increasing adoption of advanced technologies and presence of major players in the US. Europe is also expected to hold a significant share in the market due to rising R&D investments in biopharmaceuticals in Germany, UK, and Italy.
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 bioprocess validation market is expected to be driven by factors such as growing demand for biopharmaceuticals, rising R&D expenditure, and stringent regulatory requirements for product approvals. However, high costs associated with validation solutions may hamper market growth.
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