Bioburden Testing Market by Product (Consumables, Instrument (PCR, Microscope)), Test (Anerobic, Mold/Fungi, Aerobic, Spore), Application (Raw Material, Medical Devices, Sterility Testing), End User (Pharma, Biotechnology, CMO) - Global Forecast to 2023

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Date: 06-Dec-2018
No. of pages: 129
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“Growth in the medical devices, pharmaceutical, and biotechnology industries to drive the growth of the bioburden testing market”

The bioburden testing market is projected to reach USD 1,103 million by 2023 from USD 614 million in 2018, at a CAGR of 12.4% during the forecast period. A number of factors, such as the growth in the medical devices, pharmaceutical, and biotechnology industries; rising safety concerns related to food and beverage products; and the increasing number of product recalls due to microbial contamination are expected to drive the growth of this market during the forecast period. However, the high cost of enumeration instruments is expected to restrain market growth in the coming years.

“Consumables segment to witness the highest CAGR in the bioburden testing products market during the forecast period”

Based on product, the bioburden testing market is segmented into consumables and instruments.

The consumables market is further segmented into culture media, reagents, and kits, and other consumables, while the market for instruments is further categorized as automated microbial identification systems, PCR instruments, microscopes, and other instruments. In 2018, the consumables segment is expected to register the highest CAGR during the forecast period, majorly due to the recurrent purchase of kits and reagents, as opposed to instruments which are considered as a one-time investment.

“Aerobic count segment to account for the largest share of the bioburden testing market, by test type”

Based on test type, the bioburden testing market is segmented into aerobic count, anaerobic count, fungi/mold count, and spore count. In 2018, the aerobic count segment is expected to account for the largest share of the bioburden testing market, by test type. This segment is also expected to witness the highest CAGR during the forecast period. Growth in this segment can be attributed to the necessity of performing aerobic count tests in order to ensure the safety of pharmaceutical and biotechnology products.

“North America to dominate the bioburden testing market during the forecast period”

North America is expected to account for the largest share of the bioburden testing market in 2018. The large size of the North American biotechnology industry will aid in the growth of the bioburden testing market in this region. However, the Asian market is expected to grow at the highest CAGR during the forecast period. Strong investments and rapid growth in the pharmaceutical and biotechnology industries will drive the growth of the bioburden testing market in this region.

The primary interviews conducted for this report can be categorized as follows:


  • By Company Type: Tier 1: 37%, Tier 2: 22%,and Tier 3: 41%

  • By Designation: C-level: 25%, D-level: 20%, and Others: 55%

  • By Region: North America: 40%, Europe: 27%, Asia: 20%, and the RoW: 13%


List of Companies Profiled in the Report


  • Charles River (US)

  • Merck KGaA (Germany)

  • SGS SA (Switzerland)

  • WuXi AppTec (China)

  • Becton, Dickinson and Company (US)

  • NAMSA (US)

  • Nelson Laboratories, LLC (US)

  • Thermo Fisher Scientific, Inc. (US)

  • biomérieux SA (France)

  • Pacific BioLabs (US)


Research Coverage

This report provides a picture of the global bioburden testing market. It aims at estimating the size and future growth potential of the market across different segments, such as product, application, test type, end user, and region. The report also includes an in-depth competitive analysis of the key market players, along with their company profiles, recent developments, and key market strategies.

Key Benefits of Buying the Report

The report will help market leaders/new entrants by providing them the closest approximations of the revenue numbers for the overall bioburden testing market and its sub segments. Also, this report will help stakeholders to better understand the competitive landscape and gain more insights to better position their business and make suitable go-to-market strategies. It will also enable stakeholders to understand the pulse of the market and provide them with information on key market drivers, restraints, challenges, and opportunities.

Bioburden Testing Market by Product (Consumables, Instrument (PCR, Microscope)), Test (Anerobic, Mold/Fungi, Aerobic, Spore), Application (Raw Material, Medical Devices, Sterility Testing), End User (Pharma, Biotechnology, CMO) - Global Forecast to 2023

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 MnM View
12.2 Merck KGaA
12.2.1 Business Overview
12.2.2 Products and Services
12.2.3 Recent Developments
12.2.4 MnM View
12.3 SGS SA
12.3.1 Business Overview
12.3.2 Services Offered
12.3.3 Recent Developments
12.3.4 MnM View
12.4 Wuxi Apptec
12.4.1 Business Overview
12.4.2 Services Offered
12.4.3 Recent Developments
12.4.4 MnM View
12.5 BD
12.5.1 Business Overview
12.5.2 Products/Services Offered
12.5.3 MnM 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 Appendix
13.1 Insights From Industry Experts
13.2 Discussion Guide
13.3 Knowledge Store: Marketsandmarkets’ Subscription Portal
13.4 Available Customizations
13.5 Related Reports
13.6 Author Details

List of Tables

Table 1 Product Recalls During 2017–2018
Table 2 Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 3 Bioburden Testing Consumables Market, By Type, 2016–2023 (USD Million)
Table 4 Bioburden Testing Consumables Market, By Region, 2016–2023 (USD Million)
Table 5 Culture Media, Reagents, and Kits Market, By Region, 2016–2023 (USD Million)
Table 6 Other Consumables Market, By Region, 2016–2023 (USD Million)
Table 7 Bioburden Testing Instruments Market, By Type, 2016–2023 (USD Million)
Table 8 Bioburden Testing Instruments Market, By Region, 2016–2023 (USD Million)
Table 9 Automated Microbial Identification Systems Market, By Region, 2016–2023 (USD Million)
Table 10 Pcr Instruments Market, By Region, 2016–2023 (USD Million)
Table 11 Microscopes Market, By Region, 2016–2023 (USD Million)
Table 12 Other Instruments Market, By Region, 2016–2023 (USD Million)
Table 13 Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 14 Aerobic Count Testing Market, By Region, 2016–2023 (USD Million)
Table 15 Anaerobic Count Testing Market, By Region, 2016–2023 (USD Million)
Table 16 Bioburden Testing Market for Fungi/Mold Count Testing, By Region, 2016–2023 (USD Million)
Table 17 Bioburden Testing Market for Spore Count Testing, By Region, 2016–2023 (USD Million)
Table 18 Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 19 Bioburden Testing Market for Raw Material Testing, By Region, 2016–2023 (USD Million)
Table 20 Bioburden Testing Market for Medical Device Testing, By Region, 2016–2023 (USD Million)
Table 21 Bioburden Testing Market for In-Process Material Testing, By Region, 2016–2023 (USD Million)
Table 22 Bioburden Testing Market for Sterilization Validation Testing, By Region, 2016–2023 (USD Million)
Table 23 Bioburden Testing Market for Equipment Cleaning Validation, By Region, 2016–2023 (USD Million)
Table 24 Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 25 Bioburden Testing Market for Pharmaceutical & Biotechnology Companies, By Region, 2016–2023 (USD Million)
Table 26 Bioburden Testing Market for Medical Device Manufacturers, By Region, 2016–2023 (USD Million)
Table 27 Bioburden Testing Market for Contract Manufacturing Organizations, By Region, 2016–2023 (USD Million)
Table 28 Bioburden Testing Market for Manufacturers of Food & Beverage and Agricultural Products, By Region, 2016–2023 (USD Million)
Table 29 Bioburden Testing Market for Microbial Testing Laboratories, By Region, 2016–2023 (USD Million)
Table 30 Bioburden Testing Market, By Region, 2016–2023 (USD Million)
Table 31 North America: Bioburden Testing Market, By Country, 2016–2023 (USD Million)
Table 32 North America: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 33 North America: Bioburden Testing Consumables Market, By Type, 2016–2023 (USD Million)
Table 34 North America: Bioburden Testing Instruments Market, By Type, 2016–2023 (USD Million)
Table 35 North America: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 36 North America: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 37 North America: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 38 US: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 39 US: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 40 US: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 41 US: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 42 Canada: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 43 Canada: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 44 Canada: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 45 Canada: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 46 Europe: Bioburden Testing Market, By Country, 2016–2023 (USD Million)
Table 47 Europe: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 48 Europe: Bioburden Testing Consumables Market, By Type, 2016–2023 (USD Million)
Table 49 Europe: Bioburden Testing Instruments Market, By Type, 2016–2023 (USD Million)
Table 50 Europe: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 51 Europe: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 52 Europe: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 53 Germany: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 54 Germany: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 55 Germany: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 56 Germany: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 57 UK: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 58 UK: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 59 UK: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 60 UK: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 61 France: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 62 France: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 63 France: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 64 France: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 65 RoE: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 66 RoE: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 67 RoE: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 68 RoE: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 69 Asia: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 70 Asia: Bioburden Testing Consumables Market, By Type, 2016–2023 (USD Million)
Table 71 Asia: Bioburden Testing Instruments Market, By Type, 2016–2023 (USD Million)
Table 72 Asia: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 73 Asia: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 74 Asia: Bioburden Testing Market, By End User, 2016–2023 (USD Million)
Table 75 RoW: Bioburden Testing Market, By Product, 2016–2023 (USD Million)
Table 76 RoW: Bioburden Testing Market, By Test Type, 2016–2023 (USD Million)
Table 77 RoW: Bioburden Testing Market, By Application, 2016–2023 (USD Million)
Table 78 RoW: Bioburden Testing Market, By End User, 2016–2023 (USD Million)

List of Figures

Figure 1 Research Design
Figure 2 Market Size Estimation: Bottom-Up Approach
Figure 3 Market Size Estimation: Top-Down Approach
Figure 4 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 5 Data Triangulation Methodology
Figure 6 Bioburden Testing, By Product, 2018 vs 2023 (USD Million)
Figure 7 Bioburden Testing Market, By Test Type, 2018 vs 2023 (USD Million)
Figure 8 Bioburden Testing Market, By Application, 2018 vs 2023 (USD Million)
Figure 9 Bioburden Testing Market, By End User, 2018–2023 (USD Million)
Figure 10 Geographical Snapshot of the Bioburden Testing Market
Figure 11 Rising Safety Concerns Related to Food and Beverage Products —A Key Factor Driving Market Growth
Figure 12 Consumables to Dominate the Bioburden Testing Products Market Between 2018 & 2023
Figure 13 Raw Material Testing Segment to Dominate the Bioburden Testing Market During the Forecast Period
Figure 14 Contract Manufacturing Organizations to Register the Highest CAGR During 2018–2023
Figure 15 Aerobic Count Segment to Account for the Largest Market Share in 2018
Figure 16 Asia to Witness the Highest Growth During the Forecast Period (2018–2023)
Figure 17 Bioburden Testing Market: Drivers, Restraints, Opportunities, and Challenges
Figure 18 Consumables Segment to Dominate the Bioburden Testing Products Market During the Forecast Period
Figure 19 Aerobic Count Segment to Command Largest Share of the Market in 2018
Figure 20 Raw Materials Testing Segment to Command Largest Share of the Market in 2018
Figure 21 Pharmaceutical & Biotechnology Companies Segment to Dominate the Bioburden Testing Market During the Forecast Period
Figure 22 Asia to Witness Highest Growth During the Forecast Period (2018–2023)
Figure 23 North America: Market Snapshot
Figure 24 Europe: Market Snapshot
Figure 25 Key Developments in the Bioburden Testing Market From 2015 to 2018
Figure 26 Market Evolution Framework
Figure 27 Bioburden Testing Market Ranking, By Key Player, 2017
Figure 28 Charles River: Company Snapshot (2017)
Figure 29 Merck KGaA: Company Snapshot (2017
Figure 30 SGS SA: Company Snapshot (2017)
Figure 31 BD: Company Snapshots (2017)
Figure 32 Thermo Fisher Scientific, Inc.: Company Snapshots (2017)
Figure 33 Biomérieux SA: Company Snapshots (2017)

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