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Bioprocess Validation Market Trends

Report ID: GMI12192
Published Date: Nov 2024
Report Format: PDF

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Bioprocess Validation Market Trends

The increasing use of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) by biopharmaceutical companies to optimize production and reduce costs is driving the need for outsourced bioprocess validation services.
This trend allows companies to ensure compliance without expanding their in-house capabilities. The National Institutes of Health (NIH) reports a growing number of partnerships between biopharmaceutical companies and CMOs/CDMOs, indicating a rising demand for external validation expertise and services.
Emerging bioprocessing technologies, including single-use systems, continuous biomanufacturing, and automation, necessitate adapted validation processes. The increasing complexity and diversity of bioprocessing methods make validation crucial for maintaining consistent product quality and manufacturing efficiency.
In 2021, the FDA released guidance on the use of digital health technologies for remote data acquisition in clinical investigations, emphasizing the importance of validating these new technologies in bioprocessing. As bioprocessing technologies continue to evolve, validation processes will play an increasingly vital role in ensuring the safety and efficacy of biopharmaceutical products, ultimately benefiting patients worldwide.

Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

The global bioprocess validation industry was valued at approximately USD 416.5 million in 2023 and is estimated to grow at a 10.7% CAGR from 2024 to 2032, driven by stringent regulatory standards in biopharmaceutical manufacturing.

The microbiological testing segment led the market with USD 126.2 million in revenue in 2023, underscoring its importance in ensuring product safety and compliance with regulatory standards.

The U.S. market was valued at USD 174.5 million in 2023 and is projected to grow at a 10.8% CAGR over the forecast period, driven by stringent FDA guidelines and GMP standards.

Key players in the industry include Asahi Kasei Corporation, Bio-Rad Laboratories, Charles River Laboratories, Danaher Corporation, Eurofins Scientific, Lonza Group, Meissner Filtration Products, Merck KGaA, Pace Analytical Services, and Repligen Corporation.