New York, United States, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Bioprocess validation comprises several activities that occur throughout the bioproduct manufacturing cycle. An essential component of bioprocess validation is the evaluation of active medicinal components and other possible contaminants.
“The global bioprocess validation market size is envisioned to reach USD 475 million growing at a CAGR of 5.82% during the forecast period.” stated by Research Manager at Straits Research P. Ltd.
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Key Drivers
The production techniques for bioproducts are intended to yield products with uniform quality attributes. It is eliminating impurities and contaminants from chromatographic media, including endotoxins, viruses, cell membranes, nucleic acids, proteins, culture medium components, process chemicals, ligands, and product changes, aggregates, and inactive forms. The Food and Drug Administration (FDA) document Guideline on General Principles of Process Validation defines process validation as the construction of documented evidence that provides a high level of assurance that a particular process will consistently produce a product that meets its predetermined specifications and quality attributes.
Bioprocess validation is an integrated process in the pharmaceutical industry, as FDA and EMA national and international requirements must be met. Pharmaceutical production is currently outsourced to third-party service providers to boost manufacturing yields. In addition, pharmaceutical businesses outsource their research to universities and corporate contract research organizations (CROs) to remain competitive and flexible in a rapidly expanding information, advancing technology, and an unpredictable economy. Consequently, market growth for bioprocess validation.
Growth Opportunities
In developing countries, untapped markets for bioprocess validation services may emerge due to an increase in disposable income and the implementation of new testing services regulations. India and China are becoming new industrial hubs due to their lower manufacturing costs and increased output. Rapid industrialization and economic expansion in Asia are anticipated to substantially impact the global bioprocess validation market and create potential prospects.
Regional Insights
North America will command the market with the largest share while growing at a CAGR of 4.9%. The bioprocess validation market in North America is developing consistently due to increased demand for outsourcing bioprocess validation, growth in life science research related to biologics, and increased investments by pharmaceutical and biotechnology companies. In addition, the North American market for bioprocess validation is well-established, and the U.S. government has expanded financing for validation services in response to increased testing by pharmaceutical and biotechnology companies across the country. The strong presence of prominent businesses in North America, such as Danaher Corporation, Thermo Fisher Scientific, Inc., Toxikon Corporation, Eurofins, Meissner Filtration Products, Inc., and others, boosts the market expansion in this area. Moreover, there seems to be a rise in the presence of essential players in the region, driving the development of the North American bioprocess validation market.
Europe will grow at a CAGR of 5.8% during the forecast period. The Europe market is increasing significantly due to a boost in the number of new testing services, the growth of healthcare infrastructure in nations such as the United Kingdom, France, and Germany, and an increase in bioprocess validation. Increases in regulatory approvals, product launches, and services, together with the availability of government funding in critical areas, are expected to boost the global bioprocess validation market. A strong presence of bioprocess validation companies, such as Almac Group, Sartorius, Porvair Plc, and Merck KGaA, will continue to impact the market expansion of bioprocess validation.
Key Highlights
- The filter elements division is projected to advance at a CAGR of 6.5% and hold the largest market share.
- Based on test type, the extractable testing services division is projected to advance at a CAGR of 4.8% and hold the largest market share.
- Based on end-user, the pharmaceutical & biotechnology company’s division is projected to advance at a CAGR of 6% and hold the largest market share.
- Based on regional analysis, North America will command the market with the largest share while growing at a CAGR of 4.9%.
Competitive Players in the Market
- Almac Group
- Biozeen
- Cobetter Filtration Equipment Co., Ltd
- Danaher Corporation (Pall Corporation)
- Merck KGaA
- Meissner Filtration Products, Inc
- Porvair Plc
- Sartorius
- Thermo Fisher Scientific, Inc
- Toxikon Corporation
Market News
- In 2022 Thermo Fisher Scientific, Inc and Moderna, Inc. revealed a 15-year strategic collaboration deal to permit dedicated large-scale manufacturing of Spikevax®, Moderna's COVID-19 vaccine, and additional investigational mRNA therapies in its pipeline in the United States.
- In 2022, Thermo Fisher Scientific acquired PeproTech.
Global Bioprocess Validation Market: Segmentation
By Test Type
- Extractables Testing Services
- Microbiological Testing Services
- Physiochemical Testing Services
- Integrity Testing Services
- Compatibility Testing Services
- Other Testing Services
By Process Component
- Filter Elements
- Bioreactors
- Other Process Component
By end-user
- Pharmaceutical & Biotechnology Companies
- Contract Development & Manufacturing Organizations
By Region
- North America
- Europe
- Asia Pacific
- LAMEA
About Straits Research Pvt Ltd.
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