Bioprocess Validation Market Size Expected To Gain Traction By $ 0.41 Billion, Growth Opportunities By 2027


Bioprocess validations

Increased demand for outsourcing of bioprocess validation. In addition, increasing R&D spending in life sciences is expected to fuel the growth of the market.

PORTLAND, OR, UNITED STATES, September 27, 2021 / – The validation of bioprocesses is a method of constructing documentary evidence demonstrating that a process, activity or procedure, carried out in production or in test, 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, rework and product failures. This factor requires the presence of a system to assess the viability of an experimentation or product development channel.

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

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The bioprocess validation market is positively impacted by the COVID-19 pandemic. Several pharmaceutical and biotechnology companies use validation services for at least part of their bioprocesses. The bioprocess industry faces operational and personnel issues, but these are often linked to increased activity. Essentially, all industrial activities related to bioprocesses continue largely unaffected in terms of operations and production. Numerous bioprocessing processes are exploited for the development of vaccines against coronaviruses. For example, many companies, including developers and service providers, are increasing their R&D and manufacturing related to the pandemic. Many equipment and service providers have started to scale up their businesses in response to this increase and expected demand. Coronavirus disease could affect the global economy through three channels such as the direct impact on production, supply chain and market disruption, and the financial impact on businesses and financial markets. In addition, this pandemic has affected the effect on the production and import and export of finished products, due to the shutdowns in various countries affected by COVID-19.

In addition, pharmaceutical manufacturing is now outsourced to third party service providers for higher production yields. Disposable technology is widely used in drug development to reduce production costs. Disposable technology facilitates the full integration of pharmaceutical production for consistent products while consuming fewer resources. This made it necessary to put in place a continuous monitoring process that ensures strict compliance with regulatory compliance. In addition, pharmaceutical companies are increasingly outsourcing their research activities to academic and private contract research organizations (CROs) in order to remain competitive and flexible in a world of exponentially growing knowledge, more and more technologies. sophisticated and unstable economic environment.

The market for bioprocess validation is growing rapidly due to strict safety and quality regulations, increasing demand for biopharmaceuticals and increasing demand for outsourcing of bioprocess validation . In addition, increasing R&D spending in life sciences is expected to fuel the growth of the bioprocess validation market. However, extractables issues are expected to hamper this growth. On the contrary, the expiration of the bioproduct patent is expected to present various opportunities for the expansion of the market.

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In terms of test type, the extractables testing services segment dominated the bioprocess validation market in 2019. The significant share of this segment can be attributed to the presence of regulatory mandates and guidelines regarding the testing of extractables. ; increased outsourcing of testing services by biopharmaceutical manufacturers; the growing demand for product safety, identity, purity and quality; and the increased risk of product adulteration.
Pharmaceuticals and Biopharmaceuticals segment is expected to grow at the highest CAGR of 5.8% during the forecast period, driven by increased production of biopharmaceuticals and steadily increasing number of impurities to verify as well as the rigor of the standards and regulations concerning the quality and validity of the bioprocesses involved in the production.

The main 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.

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Main conclusions of the study:

• By type of test, the extractables testing services segment occupied 39.7% of the bioprocess validation market in 2019.
• By end user, the pharmaceutical and biotechnology companies segment occupied 69.0% of the bioprocess validation market in 2019.
• By region, Asia-Pacific is expected to grow 7.1% CAGR during the forecast period.

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