The global bioprocess integrity testing systems market is anticipated to witness substantial growth, projecting an increase from US$ 74.2 million in 2022 to US$ 136.6 million by 2032, at a compound yearly growth rate (CAGR) of 5.7%. This significant expansion is primarily attributed to the escalating accessibility to fully automated integrity test solutions. Bioprocess integrity testing systems play a pivotal role in ensuring product quality by detecting errors resulting from improper control and filling procedures.
The market’s expansion aligns with the rising demand for advanced solutions across various industries, including biopharmaceuticals and biotechnology. These systems empower users to verify the integrity of their products, thus bolstering confidence in their quality and safety.
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In the manufacturing of sterile drug products, it is critical to access filter integrity testing as regulated by regulatory bodies. The filter in the bioprocess is subjected to wear owing to particle load, fluctuations in pressure and temperature changes in pH, and other factors. The performance of filter elements is crucial in any bioprocess.
Bioprocess Integrity Testing Systems Market: Overview
In a process, a filter can have irreparable blockage of the filter membrane, cracks, and changes in the filter, with variations in the pore structure. Such blockages are easily detected cracks, however, variations in the pore are challenging to detect, and it is crucial to test the bioprocess integrity. Filter integrity testing varies from process to process such as for solutions it is preferred that the integrity test is performed during the final membrane filtration step and also before and after the use of filters in the process.
Bioprocess Integrity Testing Systems Market: Drivers and Restraints
Bioprocess integrity testing systems market would grow during the forecast years as many multi-national companies are focusing towards new product innovations and are required to follow the GMP guidelines which are the most critical factor in bioprocess integrity testing systems. Also, in the United States, there are stringent regulations for evaluation of materials and container closure systems the United States Pharmacopeia (USP) and Food and Drug Administration (FDA) have enforced stringent requirements for bioprocess integrity testing and Container Closure Integrity Testing (CCIT).
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Also, the integrity testing is highly recommended and adopted by leading biopharmaceutical players and biotechnology companies owing to the reliability of the systems, portability, and ease of implementation which is leading to a massive gain of market share in the bioprocess integrity testing systems market. Other factors contributing to bioprocess integrity testing systems market are increasing the availability of fully automated integrity test systems. The market for bioprocess integrity testing systems would be accelerated due to the accelerated testing capabilities of the systems.
Bioprocess Quality Assurance is used in the biopharmaceutical industry to ensure the quality and purity of biologics produced through bioprocessing. These systems are designed to detect any microbial contamination, impurities, or other irregularities that may compromise the quality and efficacy of the final product.
Bioprocess Integrity Testing Systems Market: Key Players
- Merck Millipore
- Eurofins Scientific
- Pall Corporation
- Sartorius Group
- Viet Anh Scientific Co. Ltd.
Key Segments Profiled in the Bioprocess Integrity Testing System Industry Survey:
Bioprocess Integrity Testing System Market by Product Type:
- Bioprocess Integrity Destructive Testing System
- Bioprocess Integrity Non-Destructive Testing System
- Bioprocess Integrity Bubble Point Testing System
- Bioprocess Integrity Diffusion Testing System
- Bioprocess Integrity Pressure Hold Testing System
Bioprocess Integrity Testing System Market by Process Type:
- Particle-based Bioprocess Integrity Testing System
- Liquid Property Based Bioprocess Integrity Testing System
Bioprocess Integrity Testing System Market by End User:
- Bioprocess Integrity Testing System for Biopharmaceutical Industry
- Bioprocess Integrity Testing System for Biotechnology Industry
- Bioprocess Integrity Testing System for Other End Users
Bioprocess Integrity Testing System Market by Region:
- North America Bioprocess Integrity Testing System Market
- Latin America Bioprocess Integrity Testing System Market
- Europe Bioprocess Integrity Testing System Market
- Asia Pacific Bioprocess Integrity Testing System Market
- Middle East and Africa Bioprocess Integrity Testing System Market
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