Global Bioprocess Validation Market: Overview
Rigorous safety and quality laws thatcontrol the entire process of product certification and testing acrosspharmaceutical and biopharmaceutical industries are prognosticated to spell growth forglobal bioprocess validation market over the timeframe of stipulation.
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In addition to that, numerous regulatory mandates in the healthcare sector, coupled with increasing trend of outsourcing the services of bioprocess validation, are expected to stimulate growth for the global bioprocess validation market. Services in the healthcare sector need to be in line with Good Manufacturing Practices (GMPs), which is setting the standard for the healthcare industry, thereby driving the market growth.
Global bioprocess validation market is segmented on the basis of test type, process component, end-user, and region.
Global Bioprocess Validation Market: Notable Developments
The below-mentioned strategic moves in the global bioprocess validationmarket reveal the key aspects of the dynamic:
- In 2018, Meissner Filtration Products made an announcement that it has completed the process of acquisition of PDC Aseptic Filling Systems. The latter suppliessealers and advanced aseptic filling systems to the pharmaceutical sector. Following the acquisition, it is expected that the products of PDC Aseptic Filling Systems would complement Meissner’spresent portfolio of process solutions. These comprise unit processing offerings, single-use systems fluid handling, and filtration.
- In 2019, Thermo Fisher Scientific Inc., a leading developer of biotechnology product, and Brammer Bio, famed maker of viral vectorfor cell and gene therapies, entered into a definitive agreement. Honoring the agreement, Thermo Fisher made an acquisition ofBrammer Bio.
Some of the most prominent competitors operating in the competitive landscape of global bioprocess validation market include –
- Filtration Products Inc.
- Thermo Fisher Scientific Inc.
- Sartorius Stedim Biotech
- Cobetter Filtration Equipments Co., Ltd.
- Eurofins Scientific
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Global Bioprocess Validation Market: Growth Drivers
Stringent Safety Measures for Product Certification Accelerates Growth
Global bioprocess validation market is expected to be fuelled by the strict quality and safety rules that govern product testing and certification process across the pharmaceutical and biopharmaceutical sectors. The World Health Organization (WHO) asserts that quality management in the drug industry is an essential element, and validation is an essential part of GMP. According to the WHO, licensed pharmaceutical products must always be made strictly by the licensed manufacturers only. The agencyfurther mandates that the activities of those manufacturers need to be regularly scrutinized from time to time by competent nationalauthorities.
Furthermore, increased expenditure on research and development activities in the area of life sciences together with the rising demand for outsourcing the services of bioprocess validation are likely to propel the global bioprocess validation market towards growth.
Global Bioprocess Validation Market: Regional Outlook
Considering geographies of the global bioprocess validation market, North America is likely to hold lion’s share throughout the assessment period of 2018 – 2028. Europe is likely to trail North America in the coming years.
The North America bioprocess validation market is likely to gain traction fromthe concentration of a large number of key service providers of bioprocess validation in the region. In addition to that, strict regulations pertaining to the production of biopharmaceutical products are adding impetus to the demand for bioprocess validation systems in the region.
Asia Pacific is expected to emerge as a rapidly expanding region in the global bioprocess validation market during the period of assessment. This can be attributed primarily to the expanding capacities of numerous biopharmaceutical manufacturers and increased spending on research and development activities in life sciencesin the region.
The global bioprocess validation market is segmented as:
- Extractables and Leachables
- Integrity Testing
- Microbiology Testing
- Filter Element
- Biotechnology Companies
- Pharmaceutical Companies