Bioprocess Validation Market Size, Share, and COVID-19 Analysis, By Test Type (Extractable and Leachable Testing, Microbiological Testing, Physicochemical Testing, Integrity Testing, Compatibility Testing, and Others), By Process Component (Filter Elements, Bioreactors, Media Containers and Bags, and Others), By End User (Pharmaceutical & Biotechnology Companies, Contract Development & Manufacturing Organizations, and Others), and Regional Forecast, 2024-2032

Bioprocess validation is a process of collecting and evaluating the data obtained from the design stage to the final production. It provides scientific evidence that a process can consistently deliver quality products. During product development, assessing the potential sources of variability becomes crucial, and working on them minimizes the chances of batch failure. Any process involved in producing the bio/pharmaceutical product significantly impacts the end product. Hence, regulatory agencies require testing to monitor and validate the manufacturing process's performance to mark the product's safety, uniformity, and effectiveness.

The growing demand for outsourcing bioprocess validation services and rising R&D investment by key players is expected to drive market growth.

• For instance, in February 2020, SGS in Glasgow pioneered a rapid and safe testing strategy for a COVID-19 vaccine. Also, SGS increased its capacity for biosafety testing, backed with a USD 12.3 million investment.

However, process development and validation costs even more than manufacturing, and such high costs are affecting its adoption. Thus, restricting the market expansion across the globe.

Impact of COVID-19 on the Bioprocess Validation Market

The COVID-19 pandemic has affected almost every market and has caused a rapid, unexpected evolution in the industry over the last few years. The excessive demand for biopharmaceuticals, vaccines, and immediate regulatory approval requirements for products and devices had positively impacted the bioprocess validation market. Emphasis on system and raw material characterization has gained importance.

• For instance, according to an article published by Outsourcing Pharma in 2021, the development and manufacturing and contract development and manufacturing organizations (CDMOs) had no significant impact on COVID-19. There are certain growth opportunities for bioprocessing and process intensification during a pandemic.

Key Insights

The report will cover the following key insights:

• Overview of the Bioprocess Validation Market.


• Key Industry Developments.


• Technological Advancements in Bioprocess Validation.


• Regulatory Scenario, By Key Regions/ Countries.


• Impact of COVID-19 on Global Bioprocess Validation Market.

Analysis by Type

Based on test type, the global market is segmented into extractable and leachable testing, microbiological testing, physiochemical testing, integrity testing, compatibility testing, and others. Extractable and leachable testing holds the maximum share in the bioprocess validation market. The data obtained from these testing helps assess process performance, product quality, and patient safety. The extractable and leachable testing studies determine whether harmful organic and inorganic impurities altered the product safety or effectiveness of the finished product. Robust utilization and several developments by key players contribute to segmental growth.

• For instance, in December 2022, Sartorius AG. developed a mechanistic digital twin representing a cell and gene therapy (CGT) perfusion bioreactor. This model simulates the process of equipment-related leachable (PERLs) exposure from single-use system components. With this, they could replicate the CGT production environment and easily predict how the concentration of potential PERLs compounds would affect over time in both the liquid phase and adsorbed to the cells.

Regional Analysis

Asia Pacific is anticipated to have the fastest CAGR in the forecast period. The vast increase in the biopharmaceutical manufacturing capabilities, booming research and development, specifically by pharmaceutical and biotechnological companies, and increasing investments and partnerships of key players with Asian industries is expected to drive the market growth.

• For instance, in January 2023, Eurofins Scientific expanded its presence in India (Hyderabad) to complement its existing operations in India. This investment by Eurofins Advinus further reinforces Hyderabad's position as a world-class drug discovery location.

Key Players Covered

The report will include the profiles of key players such as Merck KGaA, Eurofins Scientific, SGS Société Générale de Surveillance, Sartorius AG, Pall Corporation (Danaher), METTLER TOLEDO, Thermo Fisher Scientific Inc., Lonza, Charles River Laboratories, Almac Group, and Others.

Segmentation

Key Industry Developments

• June 2022: Merck KGaA collaborated with Agilent Technologies, Inc. intending to bridge the gap in process analytical technologies (PAT) for downstream processing. PAT is encouraged strongly by regulatory authorities worldwide as it enables real-time bioprocessing.


• June 2022: NorthX Biologics is expanding its services in cell therapy with the support of Alder Therapeutics. This will increase the investments, manufacturing facilities, and GMP laboratories in Sweden.


• May 2022: Qosino launched a new bioprocess resource center as a one-stop information source for the bioprocess industry.


• April 2022: Merck KGaA acquired Lonza's modular automated sampling technology (MAST) platform and added completely automated sampling to its bioprocessing portfolio. It became the first company that offers a completely integrated ecosystem for advanced process technologies.