Overview

Bioburden Testing Market Introduction

Global Bioburden Testing Market is anticipated to witness value over USD 1.3 billion during the forecast period 2020 to 2027 with a CAGR of over 11%.

Bioburden testing is the study of the microbial count present on the surface of any material or product. The term is used for testing the contamination in pharmaceutical products, food and beverages, medical devices, etc. Bioburden testing is mandatory as per ICH (International Conference on Harmonization) guidelines for the manufacturing and distribution of food and drugs along with medical devices.

For an FDA ( Food and Drug Administration) approval the bioburden testing as per ICH guidelines must be followed. This is the key factor driving the bioburden testing market. 

Growth in the pharmaceutical products, food and beverages, medical devices across the globe are factors contributing to bioburden market growth and are positively influencing the CAGR. The risk of microbial contamination in healthcare products and hence the related safety concerns can not be ignored. It is the key factor driving the market.

The consumables like culture media and reagents are estimated to contribute as a major part of the market growth across the globe. Culture media and reagents are basic ingredients used for bioburden testing. Any negligence in the safety and sterility conditions of the product creates severe health problems and a huge loss in the market. To avoid such consequences, bioburden testing is the key.

The contamination in raw materials is detected by anaerobic count testing. The safety and economic concerns related to raw materials have driven the preference for anaerobic count testing in the market. The rising demand for anaerobic count testing is one of the key elements driving its contribution to the market. 

Pharmaceutical and biotechnology companies contribute to the large share of the bioburden testing market worldwide. Pharma companies involve bioburden testing at every step of manufacturing starting from raw materials to finished products. This is the major feature that drives the growth of the market.

North America is estimated to hold a large share in the  market. The rise in research and development activities and massive investments in these activities play a major role in market growth. The increasing scope for pharma industries in Asia Pacific s one of the dominating factors responsible for the market to grow.

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.

FutureWise Key Takeaways:

●    New advancements in bioburden testing methods

●    Investment in bioburden consumables products

●    Collaboration bioburden testing organization

 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

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  By Product, 2018 vs 2024 (USD Million) 

    4.3  By Application, 2018 vs 2024 (USD Million) 

    4.4  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 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 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  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 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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