Bioprocess Validation Market Overview With Detailed Analysis, Competitive Landscape, Forecast To 2027

The bioprocess validation market size was valued at $0.26 billion in 2019 and is projected to reach $0.41 billion by 2027, registering a CAGR of 5.5% from 2020 to 2027.

Bioprocess validation is a method of building documentary evidence demonstrating a process, activity or procedure, carried out in production or testing maintains the desired level of compliance at all stages. Validation is an act of documenting and demonstrating that any process, procedure, and activity will consistently produce the required results. The production process within the pharmaceutical industry undergoes a series of recalls, reworks, and product failures. This factor necessitates the presence of a system to evaluate the viability of an experiment or product development channel.

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Furthermore, pharmaceutical manufacturing is now being outsourced to third party service providers for higher production yields. Disposable technology is being widely used in drug development for bringing down production costs. Disposable technology is facilitating the full integration of pharmaceutical production for consistent products while consuming fewer resources. This has made it necessary to establish an ongoing monitoring process that ensures strict adherence to regulatory compliance. In addition, Pharmaceutical companies are increasingly outsourcing research activities to academic and private contract research organizations (CROs) as a strategy to stay competitive and flexible in a world of exponentially growing knowledge, increasingly sophisticated technologies and an unstable economic environment.

The bioprocess validation market is positively impacted by the COVID-19 pandemic. Several pharmaceutical and & biotechnological companies use validation services for at least some of their bioprocessing. The bioprocessing sector is experiencing operational and personnel-related problems, but often these are related to increased activity. Essentially, all bioprocessing-related industrial activities are continuing largely unaffected in terms of operations and output. Many bioprocessing processes are being leveraged for the development of vaccines against coronaviruses. For instance, many companies, including developers and suppliers of services are increasing their pandemic-related R&D and manufacturing. Many suppliers of both equipment and services have begun increasing their activities in response to this increase, and to projected demand. The coronavirus disease could affect the global economy through three channels such as direct impact on production, supply chain & market disruption, and financial impact on firms & financial markets. In addition, this pandemic has affected the effect on production and import & export of finished goods, due to shutdown in various COVID-19-affected countries.

The bioprocess validation market witnesses rapid growth due to stringent safety & quality regulations, increase in demand for biopharmaceuticals, and surge in demand for outsourcing bioprocess validation. In addition, increase in life science R&D expenditure is expected to fuel the bioprocess validation market growth. However, issues related to extractables are expected to impede this growth. On the contrary, patent expiry of bio-product is expected to present various opportunities for the market expansion.

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In terms of test type, the extractables testing services segment dominated the bioprocess validation market in 2019. The large share of this segment can be attributed to the presence of regulatory mandates and guidelines regarding the testing of extractables; increasing outsourcing of testing services by biopharmaceutical manufacturers; growing requirement for product safety, identity, purity, and quality; and increasing risk of product adulteration.

The pharmaceutical & biopharmaceutical companies segment is projected to grow at the highest CAGR of 5.8% during the forecast period, owing to increase in production of biopharmaceuticals & consistent increase in the number of impurities to be checked along with the stringency of standards & regulations regarding the quality and validity of bioprocesses involved in the production.

The Major Key Players Are:

Cobetter Filtration Equipment Co., Ltd, Danher Corporation, Merck KGaA, Porvair Plc, Sartorius, Thermo Fisher Scientific, Inc., Meissner Filtration Products, Inc, Toxikon Corporation, Almac Group, and Biozeen.

Key findings of the study:

• By test type, the extractables testing services segment occupied 39.7% share of the bioprocess validation market in 2019.
• By end user, the pharmaceutical & biotechnology companies segment occupied 69.0% share of the bioprocess validation market in 2019.
• By region, Asia Pacific is anticipated to experience growth at 7.1% CAGR during the forecast period.

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