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.
Bioprocess validation involves confirming and providing documented evidence that ensures any process, procedure, or system works as intended. It helps to assess the performance of an assay and identify possible sources of variation. The growing adoption of single-use technologies in bioprocessing has boosted the demand for bioprocess validation activities. Single-use technologies help reduce capital costs and provide flexibility to biopharmaceutical manufacturers. However, they require extensive validation to prove their integrity and comparable performance to stainless-steel based equipment.
Market key trends:
The increasing adoption of single-use technologies is a major trend propelling the growth of the bioprocess validation market. Single-use bioprocessing significantly reduces capital expenditure, validation requirements, and turnaround times compared to traditional stainless steel based biomanufacturing facilities. It allows for flexible operations,faster process development cycles, and enables manufacturing of smaller batches of biologics. However, extensive validation is required to prove the performance and integrity of single-use systems, processes, and equipment. This has increased the demand for validation activities from biopharmaceutical manufacturers adopting single-use technologies. Various regulatory guidelines have also been established for validating the performance of single-use bioprocessing units. This growing need for validation and qualification of single-use technologies is expected to drive significant growth of the bioprocess validation market over the forecast period.
SWOT Analysis
Strength: The bioprocess validation market is witnessing high growth due to rising biopharmaceutical production. Validation techniques ensure safety, efficacy and product quality of biologics.
Weakness: High setup and maintenance costs of validation equipments limits its adoption by small and mid-sized bioprocessors. Stringent regulatory guidelines also increase compliance burdens.
Opportunity: Emerging economies offer significant opportunities owing to improving healthcare infrastructures and demand for biologic drugs. Novel validation methods present opportunities to accelerate bioprocessing operations.
Threats: Security threats to automated systems and data risks due to digitalization. Delays in new product approvals can threaten returns on investment.
Key Takeaways
The Global Bioprocess Validation Market Size is expected to witness high growth. Regional analysis comprises: North America dominates currently due to presence of major players and stringent regulatory environment promoting adoption of validation solutions. Asia Pacific is expected to grow at fastest rate aided by expansion of biologics industry in China, India and South Korea coupled with efforts to boost local bioprocessing capabilities.
Key players analysis comprises: 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. Companies are focusing on developing integrated solutions and single-use technologies to drive operational efficiencies.