Global Bioburden Testing Market is anticipated to witness value over USD 1.3 billion during the forecast period 2019 to 2026 with a CAGR of over 11%.
Bioburden tests are microbial limit tests that are used for the detection of contamination in products. The rising growth of pharmaceutical products, medical devices, food and beverage industries, etc. are the driving factors for the bioburden testing market growth.
Based on the product, the culture media and reagents are expected to be the dominating segment in the market. Culture media and reagents are vital parts of bioburden testing. The culture media selection differs depending on the type of testing method to be used. The variety and selectivity of culture media is the key factor for the increase in the bioburden testing market share.
The anaerobic type of testing method is estimated to have more demand in the market. The method is used in raw material testing in pharma companies. Since contamination in raw materials is not acceptable for further procedures, the preference for anaerobic testing is high. Raw materials are a vital part of the production process. Hence, expenditure spent on raw material testing is more and contribute to a major bioburden testing market share.
The medical device manufacturers, and pharmaceutical and biotechnology industries tend to hold a large market share compared to other end users. Contamination of medical devices is the primary reason for obtaining wrong results along with huge economic losses, so conducting appropriate bioburden tests of medical devices is a necessity which increases its market demand. Pharmaceutical companies have to perform bioburden testing at each step of production and on each type of ingredient and equipment. Expenditure assigned to bioburden testing by pharma companies is significantly contributing to bioburden testing market growth.
The massive consumption of dairy products and protein-rich meat is the key element responsible for dominating the market in North America. The investment in the bioburden testing organizations and research centres is the key factor. The Asia Pacific is estimated to hold a large share in the bioburden testing market. The rising population and demand for dairy and meat products are high in this region contributing to bioburden testing market growth.
The major companies are Charles River, Merck KGaA, SGS SA, Wuxi Apptec and so on. Merck KGaA is one of the major key players in the bioburden testing market. It has a range of testing facilities for food and beverages, pharmaceuticals, clinical and diagnostics, and so on.
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Global Bioburden Testing Market Segmentation:
By Product
● Consumables
● Instruments
By Test Type
● Aerobic count testing
● Anaerobic count testing
● Fungi/ Mold count testing
● Spore count testing
By Application
● Raw material testing
● Medical device testing
● In-process material testing
● Sterilization validation testing
● Equipment cleaning validation
By End User
● Pharmaceutical and biotechnology companies
● Medical device manufacturers
● Contract manufacturing organizations
● Manufacturers of Food & Beverage and Agricultural Products
● Microbial Testing Laboratories
By Region
● North America
● Europe
● Asia Pacific
● Rest of the world
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FutureWise Key Takeaways:
● New advancements in bioburden testing methods
● Investment in bioburden consumables products
● Collaboration bioburden testing organizations
Competitive Landscape:
● Tier 1 players- established companies in the market with a major market share
● Tier 2 players
● Emerging players which are growing rapidly
● New Entrants
Objectives of the Study:
● To provide with an exhaustive analysis on the bioburden testing market by product, by test type, by application, by end user and by region
● To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
● To evaluate and forecast micro-markets and the overall market
● To predict the market size, in key regions (along with countries)— North America, Europe, Asia Pacific, and the rest of the world
● To record evaluate and competitive landscape mapping-product launches, technological advancements, mergers and expansions
● Profiling of companies to evaluate their market shares, strategies, financials and core competencies

Table of Contents
1 Introduction
1.1 Objectives of the Study
1.2 Market Definition
1.2.1 Markets Covered
1.2.2 Years Considered for the Study
1.3 Currency
1.4 Limitations
1.5 Market Stakeholders

2 Research Methodology
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.2 Market Size Estimation
2.3 Market Breakdown and Data Triangulation
2.4 Assumptions for the Study

3 Executive Summary

4 Premium Insights
4.1 Bioburden Testing Market: Market Overview
4.2 Bioburden Testing Market, By Product, 2018 vs 2023 (USD Million)
4.3 Bioburden Testing Market, By Application, 2018 vs 2023 (USD Million)
4.4 Bioburden Testing Market, By End User
4.5 Geographic Analysis: Bioburden Testing Market
4.6 Geographical Snapshot of the Bioburden Testing Market

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Growth in the Medical Devices, Pharmaceutical, and Biotechnology Industries
5.2.1.2 Rising Safety Concerns Related to Food and Beverage Products
5.2.1.3 Increasing Number of Product Recalls Due to Microbial Contamination
5.2.2 Restraints
5.2.2.1 High Cost of Enumeration Instruments
5.2.3 Opportunities
5.2.3.1 Growth Opportunities in Emerging Economies
5.2.4 Challenges
5.2.4.1 Shortage of Skilled Professionals

6 Bioburden Testing Market, By Product
6.1 Introduction
6.2 Consumables
6.2.1 Culture Media, Reagents, and Kits
6.2.1.1 Culture Media, Reagents, and Kits to Witness the Highest Growth in the Bioburden Testing Consumables Market
6.2.2 Other Consumables
6.3 Instruments
6.3.1 Automated Microbial Identification Systems
6.3.1.1 Automated Microbial Identification Systems to Witness the Highest Growth, Primarily Due to the Ease of Use of These Systems and Their Ability to Produce Cost-Effective Results
6.3.2 Pcr Instruments
6.3.2.1 Pcr Instruments Find Applications in Molecular Biology, Recombinant Dna Technology, and Genotypic Identification
6.3.3 Microscopes
6.3.3.1 Low Cost of Microscopes has Resulted in Their Increased Adoption, Especially in Developing Countries
6.3.4 Other Instruments

7 Bioburden Testing Market, By Test Type
7.1 Introduction
7.2 Aerobic Count Testing
7.2.1 These Tests Check for the Most Frequently Found Contaminants That Can Affect Finished Products
7.3 Anaerobic Count Testing
7.3.1 Need to Test for Anaerobic Microorganisms in Raw Materials and Canned Food Will Drive Market Growth
7.4 Fungi/Mold Count Testing
7.4.1 Used to Detect Bioburden Affecting Paint, Glass, Electrical Equipment
7.5 Spore Count Testing
7.5.1 Resistance to Sterilizers Makes It Important to Check for Spores

8 Bioburden Testing Market, By Application
8.1 Introduction
8.2 Raw Material Testing
8.2.1 Raw Materials Can Be Major Contributors to the Bioburden Count of the Finished Product
8.3 Medical Device Testing
8.3.1 Favorable Regulations for Medical Device Manufacturing Have Sustained the Demand for Bioburden Testing
8.4 In-Process Material Testing
8.4.1 Recommendations for In-Control Material Testing for Bioburden Contribute to the Growth of the Market
8.5 Sterilization Validation Testing
8.5.1 Sterility Validation is Mandated for Biologics
8.6 Equipment Cleaning Validation
8.6.1 to Avoid Contamination From the Final Product, Manufacturing Equipment Must Be Cleaned Enough to Use

9 Bioburden Testing Market, By End User
9.1 Introduction
9.2 Pharmaceutical & Biotechnology Companies
9.2.1 Growing Number of Drug Recalls Due to Microbial Contamination—Key Driver for This End-User Segment
9.3 Medical Device Manufacturers
9.3.1 Growth in the Medical Device Industry is Driving the Demand for Bioburden Testing Among Medical Device Manufacturers
9.4 Contract Manufacturing Organizations
9.4.1 Contract Manufacturing Organizations to Witness the Highest Growth in the Forecast Period
9.5 Manufacturers of Food & Beverage and Agricultural Products
9.5.1 Rising Concerns Related to the Safety of Food & Beverage Products is Driving the Growth of the Bioburden Testing Market
9.6 Microbial Testing Laboratories
9.6.1 Microbial Testing Laboratories are Equipped With Advanced Automated Tools to Carry Out Complex, Specialized, and Obscure Tests

10 Bioburden Testing Market, By Region
10.1 Introduction
10.2 North America
10.2.1 US
10.2.1.1 Increasing Food Imports Into the US Will Contribute to Market Growth
10.2.2 Canada
10.2.2.1 R&D Activity is Increasing in Canada, Supported By Rising Expenditure
10.3 Europe
10.3.1 Germany
10.3.1.1 Strong Infrastructural Base and Increasing Public-Private Collaboration Will Favor Market Growth
10.3.2 UK
10.3.2.1 One-Third of the Uk’s Biotech Companies are Engaged in Drug R&D
10.3.3 France
10.3.3.1 High Consumption of Pharma Products has Drawn Attention to Generics, to Cut Costs
10.3.4 Rest of Europe
10.4 Asia
10.4.1 Growth of the Pharma Industry in China and India Will Drive Bioburden Testing Activity
10.5 Rest of the World

11 Competitive Landscape
11.1 Overview
11.2 Market Ranking Analysis
11.3 Competitive Situation and Trends
11.3.1 Expansions
11.3.2 Acquisitions
11.3.3 Agreements, Partnerships, and Collaborations
11.3.4 Product Launches

12 Company Profiles
12.1 Charles River
12.1.1 Business Overview
12.1.2 Services Offered
12.1.3 Recent Developments
12.1.4 FutureWise Perspective View
12.2 Merck KGaA
12.2.1 Business Overview
12.2.2 Products and Services
12.2.3 Recent Developments
12.2.4 FutureWise Perspective View
12.3 SGS SA
12.3.1 Business Overview
12.3.2 Services Offered
12.3.3 Recent Developments
12.3.4 FutureWise Perspective View
12.4 Wuxi Apptec
12.4.1 Business Overview
12.4.2 Services Offered
12.4.3 Recent Developments
12.4.4 FutureWise Perspective View
12.5 BD
12.5.1 Business Overview
12.5.2 Products/Services Offered
12.5.3 FutureWise Perspective View
12.6 North American Science Associates Inc. (NAMSA)
12.6.1 Business Overview
12.6.2 Services Offered
12.7 Nelson Laboratories, LLC
12.7.1 Business Overview
12.7.2 Services Offered
12.8 Thermo Fisher Scientific
12.8.1 Business Overview
12.8.2 Products Offered
12.8.3 Recent Developments
12.9 Biomérieux SA
12.9.1 Business Overview
12.9.2 Products Offered
12.9.3 Recent Developments
12.10 Pacific Biolabs
12.10.1 Business Overview
12.10.2 Services Offered
13. Research Finding and Conclusion
14. Appendix
15.1 Research Methodology
15 .2 Research Data Source
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