Augmentation in government initiatives, rising number of product recalls, due to microbial contamination, increasing demand of bioburden testing for quality check in biotechnological, medical and pharmaceutical products are key factors contributing to the high CAGR of bioburden testing market during the forecast period.
Market Size – USD 496.9 million in 2018, Market Growth – CAGR of 12.7 %, Market Trends–Increasing mergers and acquisitions for product developments.
The global Bioburden Testing Market is projected to grow at a CAGR of 12.7%, in terms of value, from 2016 to reach USD 1.28 billion by 2026. 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.
Leading players in the industry are focused on bringing in new products with modified technologies for faster and reliable testing. For instance, in October 2018, 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.
Furthermore, the report is furnished with the latest impact of the COVID-19 pandemic on the market. The pandemic has affected every segment of the market, along with bringing disruption in the supply chain, demands & trends, and financial difficulties. The report covers the initial and future assessment of the COVID-19 impact on the market.
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The report covers the market dynamics analysis, company profiles, production and manufacturing capacity, product specifications, product value, and key players. The report also offers an insight into the growth prospects during the forecast period. The Bioburden Testing Market report also offers detailed data on the key market players to impart a deeper understanding of the competitive landscape. The report focuses on the key market elements to ensure the readers gain a competitive advantage and maximum benefit of the market data to assist them in achieving substantial growth and an advantageous position in the global market.
Key findings of the report:
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 2018, 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 2018. 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 global bioburden testing market is slightly fragmented with major players such as Charles River Laboratories, Merck KGaA, SGS SA, Thermo Fisher Scientific, Biomérieux SA, Pacific Biolabs, Wuxi Apptec, STERIS Laboratories, Nelson Laboratories LLC, and Sartorius AG, collectively constituting a competitive market.
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For the purpose of this study, the global Bioburden Testing market has been segmented on the basis of disease type, application, distribution channel, and region:
Test Method Outlook (Revenue in Million USD; 2016–2026)
- Automated Detection of Growth
- Staining
- Autofluorescence I
- Autofluorescence II
- ATP-Bioluminescence
- Cytometry
- Other
Application Outlook (Revenue in Million USD; 2016–2026)
- Raw Materials
- Process Water
- Pharmaceutical Ingredients
- Process Equipment
- Manufacturing Personnel
- Manufacturing Environmental Monitoring
- Packaging/Bulk Finished Products
End Use Outlook (Revenue in Million USD; 2016–2026)
- Biopharmaceutical & Pharmaceutical Companies
- Contract Research Organization (CRO)
- Contract Manufacturing Organization (CMO)
- Cell Banks
- Academic Research Institutes
By Region (Revenue, USD Million; 2017-2027)
North America
- U.S.
- Canada
Europe
- Germany
- U.K.
- France
- BENELUX
- Rest of Europe
Asia Pacific
- China
- Japan
- South Korea
- Rest of Asia Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa
- Saudi Arabia
- U.A.E.
- Rest of Middle East & Africa
Table Of Contents:
Chapter 1. Market Synopsis
1.1. Market Definition
1.2. Research Scope & Premise
1.3. Methodology
1.4. Market Estimation Technique
Chapter 2. Executive Summary
2.1. Summary Snapshot, 2018 – 2026
Chapter 3. Indicative Metrics
Chapter 4. Bioburden Testing Segmentation & Impact Analysis
4.1. Bioburden Testing Segmentation Analysis
4.2. Bioburden Testing Market Value Chain Analysis, 2016-2026
4.3. Regulatory framework
4.4. Bioburden Testing Market Impact Analysis
4.4.1. Market driver analysis
4.4.1.1. Augmentation in government initiatives
4.4.1.2. Increasing number of product recalls due to microbial contamination
4.4.2. Market restraint analysis
4.4.2.1. Expensive nature of enumeration instruments
4.5. Key opportunities prioritized
4.6. Bioburden Testing Pricing Analysis
4.7. Industry analysis – Porter’s Five Forces Analysis
4.8. Bioburden Testing PESTEL Analysis
Continued…
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