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.

Major Market Players are: 

harles River, Merck KGaA, SGS SA, Wuxi Apptec, BD, North American Science Associates Inc. (NAMSA), Nelson Laboratories, LLC, Thermo Fisher Scientific, Biomérieux SA, Pacific Biolabs.

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

FutureWise Key Takeaways:

• New advancements in bioburden testing methods
• Investment in bioburden consumables products
• Collaboration bioburden testing organization

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

Flexible Delivery Model:

• We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
• The customization Mobility Care offered are free of charge with purchase of any license of the report
• You can directly share your requirements/changes to the current table of content to: sales@futurewiseresearch.com

Table of Contents

1. Market Introduction
        1.1. Objectives of the Study 
        1.2. Market Definition 
        1.3. Market Scope 
               1.3.1. Years Considered for the Study
               1.3.2. Market Covered
        1.4. Currency 
        1.5. Limitations 
        1.6. 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
        3.1. Market Outlook
        3.2. Segment Outlook
        3.3. Competitive Insights
4. Global Bioburden Testing Market Variables, Trends & Scope
        4.1. Market Lineage Outlook
        4.2. Penetration and Growth Prospect Mapping
        4.3. Industry Value Chain Analysis
        4.4. Cost Analysis Breakdown
        4.5. Technology Overview
        4.6. Regulatory Framework
                 4.6.1. Reimbursement Framework
                 4.6.2. Standards and Compliances
5. Global Bioburden Testing Market Overview
        5.1. Market Dynamics
                  5.1.1. Market Driver Analysis
                            5.1.1.1. Increasing focus of Bioburden Testing Companies on Brand Protection
                            5.1.1.2. Untapped Opportunities in Emerging Regions
                  5.1.2. Market Restraint Analysis
                            5.1.2.1. High Cost Associated with Implementation of Predictive Analysis
                  5.1.3. Industry Challenges
                            5.1.3.1. Presence of Ambiguous Regulatory Framework
6. Global Bioburden Testing Market Analysis Tools
        6.1. Industry Analysis - Porter’s
               6.1.1. Supplier Power
               6.1.2. Buyer Power
               6.1.3. Substitution Threat
               6.1.4. Threat from New Entrants
               6.1.5. Competitive Rivalry
        6.2. Pestel Analysis
               6.2.1. Political Landscape
               6.2.2. Environmental Landscape
               6.2.3. Social Landscape
               6.2.4. Technology Landscape
               6.2.5. Legal Landscape
        6.3. Major Deals And Strategic Alliances Analysis
                6.3.1. Joint Ventures
                6.3.2. Mergers and Acquisitions
                6.3.3. Licensing and Partnership
                6.3.4. Technology Collaborations
                6.3.5. Strategic Divestments
        6.4. Market Entry Strategies
        6.5. Case Studies
7. Global Bioburden Testing Market, By Product Historical Analysis and Forecast 2020-2027 (USD Million)
      7.1 Consumables
               7.1.1. Culture Media, Reagents, and Kits
               7.1.2. Other Consumables
        7.2 Instruments
               7.1.1. Automated Microbial Identification Systems
               7.1.2. Pcr Instruments
               7.1.3. Microscopes
               7.1.4. Other Instruments
8. Global Bioburden Testing Market, By Test Type Historical Analysis and Forecast 2020-2027 (USD Million)
        8.1 Aerobic count testing
        8.2 Anaerobic count testing
        8.3. Fungi/ Mold count testing
        8.4. Spore count testing
9. Global Bioburden Testing Market, By Application Historical Analysis and Forecast 2020-2027 (USD Million)
        9.1 Raw material testing
        9.2 Medical device testing
        9.3 In-process material testing
        9.4 Sterilization validation testing
        9.5 Equipment cleaning validation
10. Global Bioburden Testing Market, By End-User Historical Analysis and Forecast 2020-2027 (USD Million)
        10.1. Pharmaceutical and biotechnology companies
        10.2. Medical device manufacturers
        10.3. Contract manufacturing organizations
        10.4. Manufacturers of Food & Beverage and Agricultural Products
        10.5. Microbial Testing Laboratories
        10.6. Medical device manufacturers
11. North America Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million)
        11.1. Introduction
        11.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019
                  11.2.1. U.S.A
                  11.2.2. Canada
                  11.2.3. Mexico
        11.3. Market Size (USD Million) Forecast for North America 2020-2027 
12. Latin America Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million)
        12.1. Introduction
        12.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019
                 12.2.1. Brazil
                 12.2.2. Venezuela
                 12.2.3. Argentina
                 12.2.4. Rest of Latin America
        12.3. Market Size (USD Million) Forecast for Latin America 2020-2027  
13. Europe Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million)
        13.1. Introduction
        13.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019
                  13.2.1. Germany
                  13.2.2. U.K
                  13.2.3. France
                  13.2.4. Italy
                  13.2.5. Spain
                  13.2.6. Russia
                  13.2.7. Poland
                  13.2.8. Rest of Europe
        13.3. Market Size (USD Million) Forecast for Europe 2020-2027
14. Asia Pacific Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million)
        14.1. Introduction
        14.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019
                  14.2.1. Japan
                  14.2.2. China
                  14.2.3. India
                  14.2.4. Australia and New Zealand
                  14.2.5. ASEAN
                  14.2.6. Rest of Asia Pacific
        14.3. Market Size (USD Million) Forecast for Asia Pacific 2020-2027
15. Middle East and Africa Market Analysis 2015–2019 and Forecast 2020–2027 (USD Million)
        15.1. Introduction
        15.2. Historical Market Size (USD Million) Analysis By Country, 2015-2019
                  15.2.1. Saudi Arabia
                  15.2.2. UAE
                  15.2.3. South Africa
                  15.2.4. Egypt
        15.3. Market Size (USD Million) Forecast for MEA 2020-2027           
16. Company Profiles (Competition Dashboard, Competitors Deep Dive, Product Connected Devices and Disease Indication Portfolio, Financial Layouts)
    16.1 Charles River
            16.1.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.1.2. Product Portfolio
            16.1.3. SWOT Analysis
            16.1.4. Financial Overview
            16.1.5. Strategic Overview
    16.2 Merck KGaA
            16.2.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.2.2. Product Portfolio
            16.2.3. SWOT Analysis
            16.2.4. Financial Overview
            16.2.5. Strategic Overview
    16.3 SGS SA
            16.3.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.3.2. Product Portfolio
            16.3.3. SWOT Analysis
            16.3.4. Financial Overview
            16.3.5. Strategic Overview
    16.4 Wuxi Apptec
            16.4.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.4.2. Product Portfolio
            16.4.3. SWOT Analysis
            16.4.4. Financial Overview
            16.4.5. Strategic Overview
    16.5 BD
            16.5.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.5.2. Product Portfolio
            16.5.3. SWOT Analysis
            16.5.4. Financial Overview
            16.5.5. Strategic Overview
    16.6 North American Science Associates Inc. (NAMSA)
            16.6.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.6.2. Product Portfolio
            16.6.3. SWOT Analysis
            16.6.4. Financial Overview
            16.6.5. Strategic Overview
    16.7 Nelson Laboratories, LLC
            16.7.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.7.2. Product Portfolio
            16.7.3. SWOT Analysis
            16.7.4. Financial Overview
            16.7.5. Strategic Overview
    16.8 Thermo Fisher Scientific
            16.8.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.8.2. Product Portfolio
            16.8.3. SWOT Analysis
            16.8.4. Financial Overview
            16.8.5. Strategic Overview
    16.9 Biomérieux SA
            16.9.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.9.2. Product Portfolio
            16.9.3. SWOT Analysis
            16.9.4. Financial Overview
            16.9.5. Strategic Overview
    16.10 Pacific Biolabs
            16.10.1. Company Overview (HQ, Business Segments, Employee Strength)
            16.10.2. Product Portfolio
            16.10.3. SWOT Analysis
            16.10.4. Financial Overview
            16.10.5. Strategic Overview
17. FutureWise SME Key Takeaway Points for Client

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