The global bioburden testing market is projected to grow at a CAGR of 12.7%, in terms of value, from 2016 to reach USD 1,611.8 Million by 2028.
The global bioburden testing market is projected to grow at a CAGR of 12.7%, in terms of value, from 2016 to reach USD 1,611.8 Million by 2028. Bioburden testing, or total viable count checking, is the monitoring of microbial contamination levels on or in a medical device or drug. Bioburden contamination can derive from the raw materials used in the manufacturing process, or be introduced via the workforce or manufacturing operation. The market is anticipated to grow due to factors such as the increase in government initiatives to encourage bioburden analysis tools. Moreover, the high risk of microbial contamination and bioburden during pharmaceutical and biological processing is deliberated to be a key factor encouraging the implementation of various biological safety practices by governments and private organizations.
Simultaneously, the growth in the medical device, pharmaceutical, and biotechnology industries would directly impact the growth of the bioburden testing market. The rising number of product recalls due to contamination of microbial would also propel the market growth significantly. However, the expensive nature of enumeration instruments would cause hindrance to the expansion of target industry.
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Leading players in the industry are focused on bringing in new products with modified technologies for faster and reliable testing. For instance, in October 2020, SGS SA acquired IBR Inc., an organization for non-clinical contract research (CRO). IBR Inc. focuses on essential services for the production of biologics, biosimilars and vaccines in biopharmaceutical research and offers a range of filter testing and particle counting services.
It is expected that increasing awareness of bioburden testing in emerging economies will provide the global market with a significant escalation. Developing countries in the region of Asia-Pacific and Latin American countries such as China, India and Brazil are anticipated to propel the growth of bioburden testing. For instance, China is the world’s second-largest R&D investor in the industry. Similarly, Brazil is a pioneer in industrial biotechnology research and investment, particularly in cellulosic sugars and agri-business.
Further key findings from the report suggest
- Autofluorescence II type test method is expected to grow with a CAGR of 10.0% during the forecast period. Autofluorescence I remain the chief revenue generating segment in the global Bioburden testing market.
- Automated growth detection culture instruments are commonly used in clinical laboratories to detect a wide array of microorganisms. The use of this technology allows for more rapid detection of microbial growth while decreasing laboratory workload. For instance, bioMérieux has launched EviSight Compact, which utilizes algorithmic technology to detect the microbial growth.
- In August 2020, Nelson Labs acquired New Jersey-based Gibraltar Laboratories. The acquisition was intended to extend the company’s outsourced testing capabilities to serve the pharmaceutical and medical device industries better. Gibraltar is known for USP compendial microbiology, sterility assurance and analytical chemistry testing.
- North America remains the key revenue generating geographical segment in the target industry. The geographical segment accounted for USD 193.1 million in 2020. Presence of key market players in the region, favorable reimbursements, and rising focus on precision medicine are among the key factors driving the market growth for bioburden testing in this region.
The ongoing pandemic is significantly changing the dynamics of the pharma and healthcare sector. Various countries are facing challenges such as shortage of medicines, vaccines, healthcare devices in hospitals. This is expected to open lucrative growth opportunities for market players in the coming years.
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Competitive Landscape:
The global market comprises various market players operating at regional and global levels. These key players are adopting various strategies such as R&D investments, license agreements, partnerships, merger and acquisitions, collaborations, and joint ventures to gain robust footing in the market.
Top Companies Profiled in the Report:
Charles River Laboratories, Merck KGaA, SGS SA, Thermo Fisher Scientific, Biomérieux SA, Pacific Biolabs, Wuxi Apptec, STERIS Laboratories, Nelson Laboratories LLC, and Sartorius AG
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Bioburden Testing Market Segmentation:
Test Method Outlook (Revenue in Million USD; 2020–2028)
- Automated Detection of Growth
- Staining
- Autofluorescence I
- Autofluorescence II
- ATP-Bioluminescence
- Cytometry
- Other
Application Outlook (Revenue in Million USD; 2020–2028)
- Raw Materials
- Process Water
- Pharmaceutical Ingredients
- Process Equipment
- Manufacturing Personnel
- Manufacturing Environmental Monitoring
- Heating System
- Ventilation System
- Air-Conditioning System
- Packaging/Bulk Finished Products
Regional Outlook:
- North America (U.S., Canada, Mexico)
- Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe)
- Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
- Latin America (Brazil, Rest of LATAM)
- Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
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This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth.
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