The global bioburden testing market is expected to exhibit a growth rate (CAGR) of 12% during 2023-2028.
Bioburden testing assists in measuring the total viable count of microbial contamination in a product. It is widely used in the pharmaceutical industry to understand the different types and amounts of microorganisms in sterile medical devices throughout the production process. Prior to the test, a suitability experiment is usually conducted to ensure the effectiveness of the testing method while recovering the microorganisms present on the device.
Bioburden Testing Market Trends:
At present, the governing authorities of numerous countries are implementing stringent regulatory norms to validate the sterilization process of medical devices. This represents one of the leading factors escalating the demand for bioburden testing to meet microbial quality and sterilization requirements of medical devices. Moreover, bioburden testing can be performed on devices as a part of the routine quality control process. Apart from this, major pharmaceutical manufacturers are focusing on producing safe products and achieving sterility assurance. This, in confluence with the rising utilization of single-use medical items, is influencing the market positively. Furthermore, as bioburden testing is an integral part of the microbiological monitoring program while manufacturing sterile products, it is gaining recognition in the cosmetics industry for maintaining the overall safety and performance of the packaged goods. Additionally, the surge in coronavirus disease (COVID-19) cases is escalating the need for bioburden reduction systems that utilize dry heat to support the reuse of particulate filtering facepiece respirators (FFRs). This, along with the growing food safety standards, is anticipated to drive the market further.
Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the global bioburden testing market report, along with forecasts at the global, regional and country level from 2023-2028. Our report has categorized the market based on product, test type, application and end user.
Breakup by Product:
Automated Microbial Identification Systems
Polymerase Chain Reaction Systems
Breakup by Test Type:
Aerobic Count Testing
Anaerobic Count Testing
Fungi/Mold Count Testing
Spores Count Testing
Breakup by Application:
Raw Material Testing
Medical Devices Testing
Sterilization Validation Testing
Breakup by End User:
Pharmaceutical and Biotechnology Companies
Medical Device Companies
Contract Manufacturing Organizations (CMOs)
Food and Beverages Companies
Breakup by Region:
Middle East and Africa
The competitive landscape of the industry has also been examined along with the profiles of the key players being Becton Dickinson and Company, Biomérieux SA (Compagnie Merieux Alliance), Charles River Laboratories Inc, Merck KGaA, Nelson Laboratories LLC (Sotera Health LLC), North American Science Associates Inc., Pacific BioLabs Inc., SGS SA, Thermo Fisher Scientific Inc and Wuxi Apptec.
Base Year of the Analysis
Product, Test Type, Application, End User, Region
Asia Pacific, Europe, North America, Latin America, Middle East and Africa
United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico
Becton Dickinson and Company, Biomérieux SA (Compagnie Merieux Alliance), Charles River Laboratories Inc, Merck KGaA, Nelson Laboratories LLC (Sotera Health LLC), North American Science Associates Inc., Pacific BioLabs Inc., SGS SA, Thermo Fisher Scientific Inc and Wuxi Apptec
10% Free Customization
Report Price and Purchase Option
Single User License: US$ 2499
Five User License: US$ 3499
Corporate License: US$ 4499
Post-Sale Analyst Support
PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)
Key Questions Answered in This Report
We expect the global bioburden testing market to exhibit a CAGR of 12% during 2023-2028
The increasing demand for bioburden testing as a routine quality control process for medical devices, along with the growing focusing on producing safe products and achieving sterility assurance, is primarily driving the global bioburden testing market.
The sudden outbreak of the COVID-19 pandemic has led to the rising demand for bioburden testing to meet the sterilization requirement of medical devices for ensuring the safety of testing kits and drugs that are being developed to treat the coronavirus infection.
Based on the product, the global bioburden testing market has been segmented into consumables and instruments, where consumables currently hold the majority of the total market share.
Based on the test type, the global bioburden testing market can be divided into aerobic count testing, anaerobic count testing, fungi/mold count testing, spores count testing, and others. Currently, aerobic count testing exhibits a clear dominance in the market.
Based on the application, the global bioburden testing market has been categorized into raw material testing, medical devices testing, in-process testing, sterilization validation testing, and others. Among these, raw material testing currently accounts for the majority of the global market share.
Based on the end user, the global bioburden testing market can be segregated into pharmaceutical and biotechnology companies, medical device companies, Contract Manufacturing Organizations (CMOs), food and beverages companies, and others. Currently, Contract Manufacturing Organizations (CMOs) hold the largest market share.
On a regional level, the market has been classified into North America, Asia Pacific, Europe, Latin America, and Middle East and Africa, where North America currently dominates the global market.
Some of the major players in the global bioburden testing market include Becton Dickinson and Company, Biomérieux SA (Compagnie Merieux Alliance), Charles River Laboratories Inc, Merck KGaA, Nelson Laboratories LLC (Sotera Health LLC), North American Science Associates Inc., Pacific BioLabs Inc., SGS SA, Thermo Fisher Scientific Inc, and Wuxi Apptec.
Need more help?
Speak to our experienced analysts for insights on the current market scenarios.
Include additional segments and countries to customize the report as per your requirement.
Gain an unparalleled competitive advantage in your domain by understanding how to utilize the report and positively impacting your operations and revenue.
For further assistance, please connect with our analysts.
Gain a deeper dive into a specific application, geography, customer, or competitor
Any level of personalization
Get in Touch With Us
IMARC made the whole process easy. Everyone I spoke with via email was polite, easy to deal with, kept their promises regarding delivery timelines and were solutions focused. From my first contact, I was grateful for the professionalism shown by the whole IMARC team. I recommend IMARC to all that need timely, affordable information and advice. My experience with IMARC was excellent and I can not fault it.
The IMARC team was very reactive and flexible with regard to our requests. A very good overall experience. We are happy with the work that IMARC has provided, very complete and detailed. It has contributed to our business needs and provided the market visibility that we required
We were very happy with the collaboration between IMARC and Colruyt. Not only were your prices competitive, IMARC was also pretty fast in understanding the scope and our needs for this project. Even though it was not an easy task, performing a market research during the COVID-19 pandemic, you were able to get us the necessary information we needed. The IMARC team was very easy to work with and they showed us that it would go the extra mile if we needed anything extra
The figures of market study were very close to our assumed figures. The presentation of the study was neat and easy to analyse. The requested details of the study were fulfilled. My overall experience with the IMARC Team was satisfactory.
I agree the report was timely delivered, meeting the key objectives of the engagement. We had some discussion on the contents, adjustments were made fast and accurate. The response time was minimum in each case. Very good. You have a satisfied customer.
We would be happy to reach out to IMARC for more market reports in the future. The response from the account sales manager was very good. I appreciate the timely follow ups and post purchase support from the team. My overall experience with IMARC was good.