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Bioburden Testing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028
Report Format: PDF+Excel | Report ID: SR112023A3466
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Market Overview:
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:
- Consumables
- Culture Media
- Reagents
- Others
- Instruments
- Automated Microbial Identification Systems
- Polymerase Chain Reaction Systems
- Microscopes
- Others
Breakup by Test Type:
- Aerobic Count Testing
- Anaerobic Count Testing
- Fungi/Mold Count Testing
- Spores Count Testing
- Others
Breakup by Application:
- Raw Material Testing
- Medical Devices Testing
- In-process Testing
- Sterilization Validation Testing
- Others
Breakup by End User:
- Pharmaceutical and Biotechnology Companies
- Medical Device Companies
- Contract Manufacturing Organizations (CMOs)
- Food and Beverages Companies
- Others
Breakup by Region:
- North America
- United States
- Canada
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Indonesia
- Others
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Russia
- Others
- Latin America
- Brazil
- Mexico
- Others
- Middle East and Africa
Competitive Landscape:
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.
Report Coverage:
| Report Features | Details |
|---|---|
| Base Year of the Analysis | 2022 |
| Historical Period | 2017-2022 |
| Forecast Period | 2023-2028 |
| Units | US$ Billion |
| Segment Coverage | Product, Test Type, Application, End User, Region |
| Region Covered | Asia Pacific, Europe, North America, Latin America, Middle East and Africa |
| Countries Covered | United States, Canada, Germany, France, United Kingdom, Italy, Spain, Russia, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico |
| Companies Covered | 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 |
| Customization Scope | 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 | 10-12 Weeks |
| Delivery Format | PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request) |
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.
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