The global bioprocess validation market was estimated at USD 295.02 million in 2022 and it is expected to surpass around USD 971.74 million by 2032, poised to grow at a CAGR of 12.66% from 2023 to 2032.
The global bioprocess validation market was estimated at USD 295.02 million in 2022 and it is expected to surpass around USD 971.74 million by 2032, poised to grow at a CAGR of 12.66% from 2023 to 2032.
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Bioprocess Validation is documenting all the evidence of the procedure and activity of the testing and production of biopharmaceutical and other biological products. It also ensures that the compliance of the product tested is maintained at all the stages of processing. This method was proposed by FDA. Evaluation of the APIs, and contaminants (bacteria, endotoxin, mycoplasma) is the essential part of the process validation. An efficient bioprocess validation method assures the quality, safety, and efficacy of the product. In the biopharmaceutical sector, it is conducted in the compliance with FDA and EMA. The steps involved in the bioprocess validation are as follows:
- Planning
- Installation Qualification
- Operational Qualification
- Process or Product Qualification
- Process Monitoring
- Revalidate.
Bioprocess validation procedures adhere to worldwide standards and CGMP requirements. Bioprocess validation is important to set the manufacturing process protocol for bioproducts. It is essential in process development, engineering, analytical technique development, statistics, regulatory affairs, quality control, and quality assurance. The demand for this process has increased after the COVID-19 pandemic as it is required in all the stages of clinical trials of vaccine development. This has been a key driver to boost the market. For instance, in November 2020, the company SGS invested in the Biosafety Centre of Excellence located in Glasglow. SGS will support the scientific research and manufacturing capacity for the development of the vaccine, cell therapies, gene therapies, and other medicine.
The high demand for bioprocess activity by the biopharmaceutical and biotechnology industries has increased for developing safe and effective regulatory-governed certified products. This spurs the market stake. Drug safety and efficacy guidelines have become stringent which enhances the bioprocess market. The process is cost-effective and economic which is the major key driver for the bioprocess verification market. Moreover, the prevalence of the outsourcing of validation processes in hospitals and clinics has been increased to maintain conformance with GMP which spurs market growth. The rise in the expenditure on R&D in the life science sector for developing efficient products has a positive impact on the market.
| Report Coverage | Details |
| Market Size in 2022 | USD 295.02 million |
| Revenue Forecast by 2032 | USD 971.74 million |
| Growth rate from 2023 to 2032 | CAGR of 12.66% |
| Base Year | 2022 |
| Forecast Period | 2023 to 2032 |
| Segmentation | Type, Application, End user, Region |
| Companies Covered | Thermo Fisher Scientific, Inc., Merck KGaA, Sartorius AG, Toxikon Corporation, Eurofins Scientific, Pall Corporation, Danaher Corporation, Cobetter Filtration Equipment Co. Ltd., Porvair Plc, Biozeen, SGS among other |
The market is segmented based on type, process component, application, end-user, and region. The type segment is divided into extractable and leachable testing services, microbiological testing services, integrity testing services, physiochemical testing services, compatibility testing services, and others. The process component segment is divided into filter assemblies, bioreactors, media containers and bags, freezing and thawing process bags, mixing systems, and transfer systems. The application segment is divided into biopharmaceuticals, specialty products, industrial chemicals, and environment management aid. The end-use segment is divided into pharmaceutical companies, biotechnology companies, CDMO, and CRO. The region segment is divided into North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Based on the regional analysis North America leads the global bioprocess validation market. This is due to the presence of a large number of outsourcing service providers for the validation process in this region. Moreover, North America has a large number of key biotechnology and pharmaceutical industries operating in the R&D sector. Europe also has a significant share and will lead the market in the upcoming forecast. Asia-Pacific also has growing biopharmaceutical manufacturing capabilities which will spur the forecast market.
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Key Players
- Thermo Fisher Scientific, Inc.
- Merck KGaA
- Sartorius AG
- Toxikon Corporation
- Eurofins Scientific
- Pall Corporation
- Danaher Corporation
- Cobetter Filtration Equipment Co. Ltd.
- Porvair Plc
- Biozeen
- SGS
Market Segmentation
- By Type
- Extractable and Leachable Testing Services
- Microbiological Testing Services
- Integrity Testing Services
- Physiochemical Testing Services
- Compatibility Testing Services
- Others
- By Application
- Biopharmaceuticals
- Specialty Products
- Industry Chemicals
- Others
- By End user
- Pharmaceutical Companies
- Biotechnology Companies
- Contract Development and Manufacturing Organizations
- Contract Research Organizations
- Others
- By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East And Africa
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