by The 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 and providing documented evidence that bioprocesses consistently yield results within required parameters. It helps ensure the quality attributes and performance of biopharmaceutical products manufactured using specific processes remain consistent over time. It involves validation activities for facilities, utilities, equipment, and processes. Key products include instruments, services, and consumables used for filter validation, bioreactor validation, chromatography process validation, and wet analytical validation among others.
Market Dynamics:
The bioprocess validation market is expected to witness significant growth over the forecast period owing to several factors. Rising demand for monoclonal antibodies, recombinant proteins, and gene and cell therapies has increased the focus on continuous bioprocessing which aims to improve efficiency and reduce costs. This is expected to drive the need for validation of new and improved bioprocessing techniques. Additionally, stringent regulatory guidelines regarding process validation have made it mandatory for biopharmaceutical companies to validate their bioprocesses. This is anticipated to boost demand for bioprocess validation products and services.
Segment Analysis
The bioprocess validation market can be segmented based validation type, types of process, end user and region. Validation type segment is further divided into process validation, equipment validation, cleaning validation and others. Process validation segment dominates the market as it is essential for biopharmaceutical manufacturing. It ensures that the manufacturing process creates a product as expected and offers reproducible results.
PEST Analysis
Political: Stringent regulations regarding bioprocess validation from regulatory bodies such as FDA drives the market. Economic: Increasing R&D investments in biopharmaceutical industry and growing demand for biosimilars boost the market growth. Social: Rising prevalence of chronic diseases and growing geriatric population fuel the demand for cost-effective biologics manufactured through validation processes. Technological: Advancements in single-use technologies for biopharmaceutical manufacturing aid the bioprocess validation market.
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 demand for monoclonal antibodies and recombinant proteins.
Regional analysis: North America dominates the market and is expected to remain the highest revenue generating region over the forecast period. This can be attributed to presence of large biopharma companies, rising biologics manufacturing and strict regulatory framework.
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.
Key players related content: Key players focus on new product launches, expansions and partnerships for business growth in the bioprocess validation market. For instance, in 2022, Sartorius Stedim Biotech launched single-use connectors to streamline single-use bioprocessing operations across phases of the validation lifecycle from development to commercial production.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
