Global Bioburden Testing Market by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028
Summary of the Report
Global bioburden testing market was worth USD 727.0 million in 2018. It is projected to grow at a 13.7% CAGR over the forecast period. The growth is expected to be driven by the growing pharmaceutical, medical device, food and beverage, and HTML3_ biotechnology HTML3_ industries.
The demand will rise due to increased government initiatives to encourage bioburden testing tools. The high risk of bioburden and microbial contamination during pharmaceutical and biologics manufacturing are key factors that encourage governments and private companies to adopt biological safety measures. Microbial contamination can have a significant impact on pharmaceutical and biologics manufacturing. This can lead to product variation and significant loss in potency.
Many government agencies are increasingly involved in the issuing of guidelines and microbial contamination prevention strategy, which will promote bioburden testing and contribute to market growth. The future growth prospects are also being enhanced by the publication of a variety of publications that promote safety testing tools.
Food safety standards are increasing, which has led to a high demand for microbiological bioburden tests in the food and drink industry. Key players are increasing their range of microbial testing tools in food and beverages. Merck, for example, has a ready-to-use culture media portfolio (RTU), to test microbiological bioburden in non-sterile foods and beverages.
Companies are expected to invest more in R&D and reduce their research costs to develop highly efficient biological testing tools that can counter contamination losses. Bristol-Myers Squibb, for example, invested in the production of investigational medicines to support clinical trials. Additionally, FDA (U.S. Food and Drug Administration) requires sterilization validation. This creates a need to test for bioburden in medical devices.
Product Insights
Due to the repeated use of culture media, reagents and kits, the consumables segment dominated bioburden testing in 2018. The U.S., European and Japanese Pharmacopeias have agreed to produce the solid and liquid media used for the detection of aerobic microorganisms.
The Instruments segment held a significant market share in 2018, owing to the availability advanced technologies for rapid microbiological testing. This segment can be divided into two types: automated microbial identification system and PCR instruments. The segment will continue to grow due to the advancements in PCR instruments.
Test Type Insights
The largest market share for aerobic count testing was in 2018, due to its broad application for determining total bacterial populations on samples. It is also used to inspect and check for food safety, organoleptic checks, and sanitary inspection. Anaerobic counts tests are required, since anaerobic bacteria is a common cause of infection.
There are two types of bioburden testing. The first phase consists of a quantitative analysis that identifies the total number of yeast, aerobic bacteria, and mold. The second phase consists of a qualitative analysis that determines the presence or absence specific microorganisms. Spore count tests can also be used to determine the bioburden percent recover, and are therefore an alternative to the above types of testing.
Application Insights
The market leader in raw material testing was 2018 thanks to rising standards for quality to ensure safety of final products and services. Manufacturers of pharmaceutical, biotechnology, food, and beverage products are constantly improving the quality of their finished products by rigorous bioburden testing.
In 2018, medical device testing accounted for a significant share. In 2018, medical device testing accounted for a significant share of the market. It measures the total microbial count in medical devices before they are used or implanted. On the other hand, in-process material testing are used to determine the quality, strength, or purity of products as they are being manufactured. Sterilization validation tests are used to identify the amount of bioburden in order to determine the sterilization dose.
End Use Insights
Due to the growing pharma and biotech industries and the rise in drug manufacturing, pharmaceutical and biotechnology companies are the most lucrative revenue-generating segments. The growth is expected to be driven by rising government support for the pharmaceutical and biotechnology sectors. The market will see a rise in medical device manufacturers in the coming years.
The Contract Manufacturing Organizations segment (CMOs), is expected to experience lucrative growth during the forecast period. Biotech and pharmaceutical companies are outsourcing bioburden testing services to approve products on parameters like accuracy, specificity and linearity. Food and beverage companies are increasingly outsourcing microbiological testing to detect bacteria and spores.
Regional Insights
North America accounted for the majority of 2018's revenue. This is due to increased R&D investments in the pharmaceutical and biotechnology sectors. Bioburden testing services are also in high demand due to the development of new drugs, biologics, and vaccines in the United States. Technological advancements are also driving the growth of the U.S. medical device sector. This is expected to be a positive factor for the region's future market growth.
It is believed that the increase in awareness about the benefits of biosafety testing tools has led to the lucrative growth in the Asia Pacific market for bioburden test. Other factors contributing to the growth are rising healthcare spending, increased demand for better infrastructure in laboratory research and clinical research, as well as the adoption of low-cost and compact clinical research techniques.
Bioburden Testing Market Share Insights
Charles River Laboratories International, Inc., Merck KGaA, Merck KGaA, Becton, Dickinson and Company, Wuxi Apptec, North American Science Associates Inc., Nelson Laboratories, LLC, Biomerieux SA, Thermo Fisher Scientific, and Pacific Biolabs are some of the market leaders.
Strategic initiatives are undertaken by key companies, including geographic expansion, product development and mergers and acquisitions. The demand is also driven by technologically advanced products made by key players. Milliflex Quantum from Merck Millipore is an advanced filter for quick bioburden detection. These methods are more reliable and faster than traditional bioburden testing methods.
Bioburden Testing Market Report Scope
Report Attribute |
More Details |
2020 Market Size Value |
USD 923.0 Million |
Forecast revenue in 2026 |
USD 2.0 billion |
Growth Rate |
CAGR of 13.7% between 2019 and 2026 |
Estimation base year |
2018 |
Historical data |
2015 - 2017 |
Forecast period |
2019 - 2026 |
Quantitative units |
From 2019 to 2026, revenue in USD million and CAGR |
Report coverage |
Forecast revenue, company share, competitive landscape and growth factors and trends |
Segments covered |
Product, test type and application. End use. Region |
Regional scope |
North America; Europe; Asia Pacific, Latin America; MEA |
Country coverage |
U.S.; Canada; U.K.; Germany; France; Italy; Spain; Russia; Japan; India; China; South Korea; Singapore; Australia; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE |
Key companies profiled |
Charles River Laboratories International, Inc., SGS SA, Merck KGaA, Becton, Dickinson and Company, Wuxi Apptec, North American Science Associates Inc., Nelson Laboratories, LLC, Biomerieux SA, Thermo Fisher Scientific, Pacific Biolabs. |
The scope of customization |
With purchase, you get free report customization (equivalent to up to 8 analysts working day) You can add or modify country, region and segment scope. |
Prices and purchase options |
You can get customized purchase options that meet your research needs. Explore your purchase options |
The Report Covers Certain Segments
This report predicts revenue growth at the global, regional and country level and offers an analysis of industry trends and opportunities for each sub-segment between 2015 and 2026. Grand View Research has divided the global bioburden market report by product, test type and application.
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Product Outlook (Revenue USD Million, 2015-2026)
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Consumables
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Culture Media
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Reagents & Kits
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Instruments
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Automated Microbial Identification Systems
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PCR Instruments
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Type Outlook Test (Revenue, USD million, 2015-2026)
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Aerobic Count Testing
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Anaerobic Count Test
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Fungi/Mold Count Testing
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Spore Count Testing
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Application Outlook (Revenue USD Million, 2015-2026)
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Test of raw material
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Medical Device Testing
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Material Testing During Production
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Sterilization Validation Testing
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Equipment Cleaning Validation
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End Use Outlook (Revenue USD Million, 2015-2026)
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Companies in Pharmaceutical & Biotechnology
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Manufacturers of Medical Devices
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Contract Manufacturing Organizations
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Manufacturers of Food & Beverage and Agricultural Products
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Microbial Testing Laboratories
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Regional Outlook (Revenue USD Million, 2015-2026)
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North America
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U.S.
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Canada
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Europe
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Germany
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U.K.
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France
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Italy
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Spain
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Russia
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Asia Pacific
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Japan
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China
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India
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South Korea
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Australia
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Singapore
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Latin America
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Brazil
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Mexico
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Argentina
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MEA
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South Africa
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Saudi Arabia
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UAE
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These are the most frequently asked questions about this report
What is the market for bioburden testing?b. Global bioburden testing market was valued at USD 818.3 Million in 2019, and is forecast to grow to USD 923.0 in 2020.
How is the growth of the bioburden market for testing?b. Global bioburden testing markets are expected to expand at a compound annual rate of 13.7% between 2019 and 2026, reaching USD 2.0 billion in 2026.
Which segment had the largest share of the bioburden testing market?b. With a 36.7% share in 2019, North America was the dominant market for bioburden testing. This can be attributed to the rise in R&D investments made by the pharmaceutical and biotechnology sectors, as well as development of new biologics and vaccines in U.S. and technological advances.
What are the major players in the bioburden market?b. b.
What are the driving factors for the bioburden market?b. The market growth is driven by the growing pharmaceutical, medical device and food and drink industries as well as government initiatives to support bioburden testing tools.
Up Market Research published a new report titled “Bioburden Testing Market research report which is segmented by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing), By Players/Companies Charles River Laboratories International, LLC; Biom©rieux SA; Thermo Fisher Scientific; and Pacific Biolabs, Inc; SGS SA; Merck KGaA; Becton, Dickinson and Company; Wuxi Apptec; North American Science Associates Inc; Nelson Laboratories”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.
Report Scope
Report Attributes | Report Details |
Report Title | Bioburden Testing Market Research Report |
By Test Type | Anaerobic Count, Aerobic Count |
By Application | Medical Device Testing, Raw Material Testing |
By Companies | Charles River Laboratories International, LLC; Biom©rieux SA; Thermo Fisher Scientific; and Pacific Biolabs, Inc; SGS SA; Merck KGaA; Becton, Dickinson and Company; Wuxi Apptec; North American Science Associates Inc; Nelson Laboratories |
Regions Covered | North America, Europe, APAC, Latin America, MEA |
Base Year | 2020 |
Historical Year | 2018 to 2019 (Data from 2010 can be provided as per availability) |
Forecast Year | 2028 |
Number of Pages | 230 |
Number of Tables & Figures | 161 |
Customization Available | Yes, the report can be customized as per your need. |
The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.
Global Bioburden Testing Market Report Segments:
The market is segmented by Test Type (Anaerobic Count, Aerobic Count), by Application (Medical Device Testing, Raw Material Testing).
Bioburden Testing Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.
Key Benefits for Industry Participants & Stakeholders:
- Industry drivers, restraints, and opportunities covered in the study
- Neutral perspective on the market performance
- Recent industry trends and developments
- Competitive landscape & strategies of key players
- Potential & niche segments and regions exhibiting promising growth covered
- Historical, current, and projected market size, in terms of value
- In-depth analysis of the Bioburden Testing Market
Overview of the regional outlook of the Bioburden Testing Market:
Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.
Highlights of The Bioburden Testing Market Report:
- The market structure and projections for the coming years.
- Drivers, restraints, opportunities, and current trends of Bioburden Testing Market.
- Historical data and forecast.
- Estimations for the forecast period 2028.
- Developments and trends in the market.
1. Anaerobic Count
2. Aerobic Count
7. By Application:1. Medical Device Testing
2. Raw Material Testing
- Market scenario by region, sub-region, and country.
- Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
- Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
- Government Policies, Macro & Micro economic factors are also included in the report.
We have studied the Bioburden Testing Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.
How you may use our products:
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Reasons to Purchase the Bioburden Testing Market Report:
- The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
- Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
- Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
- The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
- Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.
Chapter 2 Assumptions and Acronyms Used
Chapter 3 Research Methodology
Chapter 4 Bioburden Testing Market Overview
4.1 Introduction
4.1.1 Market Taxonomy
4.1.2 Market Definition
4.1.3 Macro-Economic Factors Impacting the Market Growth
4.2 Bioburden Testing Market Dynamics
4.2.1 Market Drivers
4.2.2 Market Restraints
4.2.3 Market Opportunity
4.3 Bioburden Testing Market - Supply Chain Analysis
4.3.1 List of Key Suppliers
4.3.2 List of Key Distributors
4.3.3 List of Key Consumers
4.4 Key Forces Shaping the Bioburden Testing Market
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Buyers
4.4.3 Threat of Substitution
4.4.4 Threat of New Entrants
4.4.5 Competitive Rivalry
4.5 Global Bioburden Testing Market Size & Forecast, 2018-2028
4.5.1 Bioburden Testing Market Size and Y-o-Y Growth
4.5.2 Bioburden Testing Market Absolute $ Opportunity
Chapter 5 Global Bioburden Testing Market Analysis and Forecast by Test Type
5.1 Introduction
5.1.1 Key Market Trends & Growth Opportunities by Test Type
5.1.2 Basis Point Share (BPS) Analysis by Test Type
5.1.3 Absolute $ Opportunity Assessment by Test Type
5.2 Bioburden Testing Market Size Forecast by Test Type
5.2.1 Anaerobic Count
5.2.2 Aerobic Count
5.3 Market Attractiveness Analysis by Test Type
Chapter 6 Global Bioburden Testing Market Analysis and Forecast by Application
6.1 Introduction
6.1.1 Key Market Trends & Growth Opportunities by Application
6.1.2 Basis Point Share (BPS) Analysis by Application
6.1.3 Absolute $ Opportunity Assessment by Application
6.2 Bioburden Testing Market Size Forecast by Application
6.2.1 Medical Device Testing
6.2.2 Raw Material Testing
6.3 Market Attractiveness Analysis by Application
Chapter 7 Global Bioburden Testing Market Analysis and Forecast by Region
7.1 Introduction
7.1.1 Key Market Trends & Growth Opportunities by Region
7.1.2 Basis Point Share (BPS) Analysis by Region
7.1.3 Absolute $ Opportunity Assessment by Region
7.2 Bioburden Testing Market Size Forecast by Region
7.2.1 North America
7.2.2 Europe
7.2.3 Asia Pacific
7.2.4 Latin America
7.2.5 Middle East & Africa (MEA)
7.3 Market Attractiveness Analysis by Region
Chapter 8 Coronavirus Disease (COVID-19) Impact
8.1 Introduction
8.2 Current & Future Impact Analysis
8.3 Economic Impact Analysis
8.4 Government Policies
8.5 Investment Scenario
Chapter 9 North America Bioburden Testing Analysis and Forecast
9.1 Introduction
9.2 North America Bioburden Testing Market Size Forecast by Country
9.2.1 U.S.
9.2.2 Canada
9.3 Basis Point Share (BPS) Analysis by Country
9.4 Absolute $ Opportunity Assessment by Country
9.5 Market Attractiveness Analysis by Country
9.6 North America Bioburden Testing Market Size Forecast by Test Type
9.6.1 Anaerobic Count
9.6.2 Aerobic Count
9.7 Basis Point Share (BPS) Analysis by Test Type
9.8 Absolute $ Opportunity Assessment by Test Type
9.9 Market Attractiveness Analysis by Test Type
9.10 North America Bioburden Testing Market Size Forecast by Application
9.10.1 Medical Device Testing
9.10.2 Raw Material Testing
9.11 Basis Point Share (BPS) Analysis by Application
9.12 Absolute $ Opportunity Assessment by Application
9.13 Market Attractiveness Analysis by Application
Chapter 10 Europe Bioburden Testing Analysis and Forecast
10.1 Introduction
10.2 Europe Bioburden Testing Market Size Forecast by Country
10.2.1 Germany
10.2.2 France
10.2.3 Italy
10.2.4 U.K.
10.2.5 Spain
10.2.6 Russia
10.2.7 Rest of Europe
10.3 Basis Point Share (BPS) Analysis by Country
10.4 Absolute $ Opportunity Assessment by Country
10.5 Market Attractiveness Analysis by Country
10.6 Europe Bioburden Testing Market Size Forecast by Test Type
10.6.1 Anaerobic Count
10.6.2 Aerobic Count
10.7 Basis Point Share (BPS) Analysis by Test Type
10.8 Absolute $ Opportunity Assessment by Test Type
10.9 Market Attractiveness Analysis by Test Type
10.10 Europe Bioburden Testing Market Size Forecast by Application
10.10.1 Medical Device Testing
10.10.2 Raw Material Testing
10.11 Basis Point Share (BPS) Analysis by Application
10.12 Absolute $ Opportunity Assessment by Application
10.13 Market Attractiveness Analysis by Application
Chapter 11 Asia Pacific Bioburden Testing Analysis and Forecast
11.1 Introduction
11.2 Asia Pacific Bioburden Testing Market Size Forecast by Country
11.2.1 China
11.2.2 Japan
11.2.3 South Korea
11.2.4 India
11.2.5 Australia
11.2.6 South East Asia (SEA)
11.2.7 Rest of Asia Pacific (APAC)
11.3 Basis Point Share (BPS) Analysis by Country
11.4 Absolute $ Opportunity Assessment by Country
11.5 Market Attractiveness Analysis by Country
11.6 Asia Pacific Bioburden Testing Market Size Forecast by Test Type
11.6.1 Anaerobic Count
11.6.2 Aerobic Count
11.7 Basis Point Share (BPS) Analysis by Test Type
11.8 Absolute $ Opportunity Assessment by Test Type
11.9 Market Attractiveness Analysis by Test Type
11.10 Asia Pacific Bioburden Testing Market Size Forecast by Application
11.10.1 Medical Device Testing
11.10.2 Raw Material Testing
11.11 Basis Point Share (BPS) Analysis by Application
11.12 Absolute $ Opportunity Assessment by Application
11.13 Market Attractiveness Analysis by Application
Chapter 12 Latin America Bioburden Testing Analysis and Forecast
12.1 Introduction
12.2 Latin America Bioburden Testing Market Size Forecast by Country
12.2.1 Brazil
12.2.2 Mexico
12.2.3 Rest of Latin America (LATAM)
12.3 Basis Point Share (BPS) Analysis by Country
12.4 Absolute $ Opportunity Assessment by Country
12.5 Market Attractiveness Analysis by Country
12.6 Latin America Bioburden Testing Market Size Forecast by Test Type
12.6.1 Anaerobic Count
12.6.2 Aerobic Count
12.7 Basis Point Share (BPS) Analysis by Test Type
12.8 Absolute $ Opportunity Assessment by Test Type
12.9 Market Attractiveness Analysis by Test Type
12.10 Latin America Bioburden Testing Market Size Forecast by Application
12.10.1 Medical Device Testing
12.10.2 Raw Material Testing
12.11 Basis Point Share (BPS) Analysis by Application
12.12 Absolute $ Opportunity Assessment by Application
12.13 Market Attractiveness Analysis by Application
Chapter 13 Middle East & Africa (MEA) Bioburden Testing Analysis and Forecast
13.1 Introduction
13.2 Middle East & Africa (MEA) Bioburden Testing Market Size Forecast by Country
13.2.1 Saudi Arabia
13.2.2 South Africa
13.2.3 UAE
13.2.4 Rest of Middle East & Africa (MEA)
13.3 Basis Point Share (BPS) Analysis by Country
13.4 Absolute $ Opportunity Assessment by Country
13.5 Market Attractiveness Analysis by Country
13.6 Middle East & Africa (MEA) Bioburden Testing Market Size Forecast by Test Type
13.6.1 Anaerobic Count
13.6.2 Aerobic Count
13.7 Basis Point Share (BPS) Analysis by Test Type
13.8 Absolute $ Opportunity Assessment by Test Type
13.9 Market Attractiveness Analysis by Test Type
13.10 Middle East & Africa (MEA) Bioburden Testing Market Size Forecast by Application
13.10.1 Medical Device Testing
13.10.2 Raw Material Testing
13.11 Basis Point Share (BPS) Analysis by Application
13.12 Absolute $ Opportunity Assessment by Application
13.13 Market Attractiveness Analysis by Application
Chapter 14 Competition Landscape
14.1 Bioburden Testing Market: Competitive Dashboard
14.2 Global Bioburden Testing Market: Market Share Analysis, 2019
14.3 Company Profiles (Details – Overview, Financials, Developments, Strategy)
14.3.1 Charles River Laboratories International
14.3.2 LLC; Biom©rieux SA; Thermo Fisher Scientific; and Pacific Biolabs
14.3.3 Inc; SGS SA; Merck KGaA; Becton
14.3.4 Dickinson and Company; Wuxi Apptec; North American Science Associates Inc; Nelson Laboratories