Bioburden Testing Market

Market Overview:

The global bioburden testing market exhibited strong growth during 2015-2020. Bioburden testing assists in measuring the total viable count of microbial contamination in a product. It is widely used in the pharmaceutical industry to understand the different types and amounts of microorganisms in sterile medical devices throughout the production process. Prior to the test, a suitability experiment is usually conducted to ensure the effectiveness of the testing method while recovering the microorganisms present on the device.

At present, the governing authorities of numerous countries are implementing stringent regulatory norms to validate the sterilization process of medical devices. This represents one of the leading factors escalating the demand for bioburden testing to meet microbial quality and sterilization requirements of medical devices. Moreover, bioburden testing can be performed on devices as a part of the routine quality control process. Apart from this, major pharmaceutical manufacturers are focusing on producing safe products and achieving sterility assurance. This, in confluence with the rising utilization of single-use medical items, is influencing the market positively. Furthermore, as bioburden testing is an integral part of the microbiological monitoring program while manufacturing sterile products, it is gaining recognition in the cosmetics industry for maintaining the overall safety and performance of the packaged goods. Additionally, the surge in coronavirus disease (COVID-19) cases is escalating the need for bioburden reduction systems that utilize dry heat to support the reuse of particulate filtering facepiece respirators (FFRs). This, along with the growing food safety standards, is anticipated to drive the market further. Looking forward, IMARC Group expects the global bioburden testing market to grow at a CAGR of around 12% during the forecast period (2021-2026).

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global bioburden testing market report, along with forecasts for growth at the global, regional and country level from 2021-2026. Our report has categorized the market based on region, product, test type, application and end user.

Breakup by Product:

• Consumables
  • Culture Media
  • Reagents
  • Others
• Instruments
  • Automated Microbial Identification Systems
  • Polymerase Chain Reaction Systems
  • Microscopes
  • Others
     

Breakup by Test Type:

• Aerobic Count Testing
• Anaerobic Count Testing
• Fungi/Mold Count Testing
• Spores Count Testing
• Others
   

Breakup by Application:

• Raw Material Testing
• Medical Devices Testing
• In-process Testing
• Sterilization Validation Testing
• Others
   

Breakup by End User:

• Pharmaceutical and Biotechnology Companies
• Medical Device Companies
• Contract Manufacturing Organizations (CMOs)
• Food and Beverages Companies
• Others
   

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players being Becton Dickinson and Company, Biomérieux SA (Compagnie Merieux Alliance), Charles River Laboratories Inc, Merck KGaA, Nelson Laboratories LLC (Sotera Health LLC), North American Science Associates Inc., Pacific BioLabs Inc., SGS SA, Thermo Fisher Scientific Inc and Wuxi Apptec.

Key Questions Answered in This Report:

• How has the global bioburden testing market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the global bioburden testing market?
• What are the key regional markets?
• What is the breakup of the market based on the product?
• What is the breakup of the market based on the test type?
• What is the breakup of the market based on the application?
• What is the breakup of the market based on the end user?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the industry?
• What is the structure of the global bioburden testing market and who are the key players?
• What is the degree of competition in the industry?

1    Preface
2    Scope and Methodology
    2.1    Objectives of the Study
    2.2    Stakeholders
    2.3    Data Sources
        2.3.1    Primary Sources
        2.3.2    Secondary Sources
    2.4    Market Estimation
        2.4.1    Bottom-Up Approach
        2.4.2    Top-Down Approach
    2.5    Forecasting Methodology
3    Executive Summary
4    Introduction
    4.1    Overview
    4.2    Key Industry Trends
5    Global Bioburden Testing Market
    5.1    Market Overview
    5.2    Market Performance
    5.3    Impact of COVID-19
    5.4    Market Forecast
6    Market Breakup by Product
    6.1    Consumables
        6.1.1 Market Trends
        6.1.2 Major Types
           6.1.2.1 Culture Media
           6.1.2.2 Reagents
           6.1.2.3 Others
        6.1.3 Market Forecast
    6.2    Instruments
        6.2.1 Market Trends
        6.2.2 Major Types
           6.2.2.1 Automated Microbial Identification Systems
           6.2.2.2 Polymerase Chain Reaction Systems
           6.2.2.3 Microscopes
           6.2.2.4 Others
        6.2.3 Market Forecast
7    Market Breakup by Test Type
    7.1    Aerobic Count Testing
        7.1.1 Market Trends
        7.1.2 Market Forecast
    7.2    Anaerobic Count Testing
        7.2.1 Market Trends
        7.2.2 Market Forecast
    7.3    Fungi/Mold Count Testing
        7.3.1 Market Trends
        7.3.2 Market Forecast
    7.4    Spores Count Testing
        7.4.1 Market Trends
        7.4.2 Market Forecast
    7.5    Others
        7.5.1 Market Trends
        7.5.2 Market Forecast
8    Market Breakup by Application
    8.1    Raw Material Testing
        8.1.1 Market Trends
        8.1.2 Market Forecast
    8.2    Medical Devices Testing
        8.2.1 Market Trends
        8.2.2 Market Forecast
    8.3    In-process Testing
        8.3.1 Market Trends
        8.3.2 Market Forecast
    8.4    Sterilization Validation Testing
        8.4.1 Market Trends
        8.4.2 Market Forecast
    8.5    Others
        8.5.1 Market Trends
        8.5.2 Market Forecast
9    Market Breakup by End User
    9.1    Pharmaceutical and Biotechnology Companies
        9.1.1 Market Trends
        9.1.2 Market Forecast
    9.2    Medical Device Companies
        9.2.1 Market Trends
        9.2.2 Market Forecast
    9.3    Contract Manufacturing Organizations (CMOs)
        9.3.1 Market Trends
        9.3.2 Market Forecast
    9.4    Food and Beverages Companies
        9.4.1 Market Trends
        9.4.2 Market Forecast
    9.5    Others
        9.5.1 Market Trends
        9.5.2 Market Forecast
10    Market Breakup by Region
    10.1    North America
        10.1.1 United States
           10.1.1.1 Market Trends
           10.1.1.2 Market Forecast
        10.1.2 Canada
           10.1.2.1 Market Trends
           10.1.2.2 Market Forecast
    10.2    Asia-Pacific
        10.2.1 China
           10.2.1.1 Market Trends
           10.2.1.2 Market Forecast
        10.2.2 Japan
           10.2.2.1 Market Trends
           10.2.2.2 Market Forecast
        10.2.3 India
           10.2.3.1 Market Trends
           10.2.3.2 Market Forecast
        10.2.4 South Korea
           10.2.4.1 Market Trends
           10.2.4.2 Market Forecast
        10.2.5 Australia
           10.2.5.1 Market Trends
           10.2.5.2 Market Forecast
        10.2.6 Indonesia
           10.2.6.1 Market Trends
           10.2.6.2 Market Forecast
        10.2.7 Others
           10.2.7.1 Market Trends
           10.2.7.2 Market Forecast
    10.3    Europe
        10.3.1 Germany
           10.3.1.1 Market Trends
           10.3.1.2 Market Forecast
        10.3.2 France
           10.3.2.1 Market Trends
           10.3.2.2 Market Forecast
        10.3.3 United Kingdom
           10.3.3.1 Market Trends
           10.3.3.2 Market Forecast
        10.3.4 Italy
           10.3.4.1 Market Trends
           10.3.4.2 Market Forecast
        10.3.5 Spain
           10.3.5.1 Market Trends
           10.3.5.2 Market Forecast
        10.3.6 Russia
           10.3.6.1 Market Trends
           10.3.6.2 Market Forecast
        10.3.7 Others
           10.3.7.1 Market Trends
           10.3.7.2 Market Forecast
    10.4    Latin America
        10.4.1 Brazil
           10.4.1.1 Market Trends
           10.4.1.2 Market Forecast
        10.4.2 Mexico
           10.4.2.1 Market Trends
           10.4.2.2 Market Forecast
        10.4.3 Others
           10.4.3.1 Market Trends
           10.4.3.2 Market Forecast
    10.5    Middle East and Africa
        10.5.1 Market Trends
        10.5.2 Market Breakup by Country
        10.5.3 Market Forecast
11    SWOT Analysis
    11.1    Overview
    11.2    Strengths
    11.3    Weaknesses
    11.4    Opportunities
    11.5    Threats
12    Value Chain Analysis
13    Porters Five Forces Analysis
    13.1    Overview
    13.2    Bargaining Power of Buyers
    13.3    Bargaining Power of Suppliers
    13.4    Degree of Competition
    13.5    Threat of New Entrants
    13.6    Threat of Substitutes
14    Price Analysis
15    Competitive Landscape
    15.1    Market Structure
    15.2    Key Players
    15.3    Profiles of Key Players
        15.3.1    Becton Dickinson and Company
           15.3.1.1 Company Overview
           15.3.1.2 Product Portfolio
           15.3.1.3 Financials
           15.3.1.4 SWOT Analysis
        15.3.2    Biomérieux SA (Compagnie Merieux Alliance)
           15.3.2.1 Company Overview
           15.3.2.2 Product Portfolio
           15.3.2.3 Financials
           15.3.2.4 SWOT Analysis
        15.3.3    Charles River Laboratories Inc
           15.3.3.1 Company Overview
           15.3.3.2 Product Portfolio
           15.3.3.3 Financials
           15.3.3.4 SWOT Analysis
        15.3.4    Merck KGaA
           15.3.4.1 Company Overview
           15.3.4.2 Product Portfolio
           15.3.4.3 Financials
           15.3.4.4 SWOT Analysis
        15.3.5    Nelson Laboratories LLC (Sotera Health LLC)
           15.3.5.1 Company Overview
           15.3.5.2 Product Portfolio
        15.3.6    North American Science Associates Inc.
           15.3.6.1 Company Overview
           15.3.6.2 Product Portfolio
        15.3.7    Pacific BioLabs Inc.
           15.3.7.1 Company Overview
           15.3.7.2 Product Portfolio
        15.3.8    SGS SA
           15.3.8.1 Company Overview
           15.3.8.2 Product Portfolio
           15.3.8.3 Financials
        15.3.9    Thermo Fisher Scientific Inc
           15.3.9.1 Company Overview
           15.3.9.2 Product Portfolio
           15.3.9.3 Financials
           15.3.9.4 SWOT Analysis
        15.3.10    Wuxi Apptec
           15.3.10.1 Company Overview
           15.3.10.2 Product Portfolio

List of Figures

Figure 1: Global: Bioburden Testing Market: Major Drivers and Challenges
Figure 2: Global: Bioburden Testing Market: Sales Value (in Billion US$), 2015-2020
Figure 3: Global: Bioburden Testing Market Forecast: Sales Value (in Billion US$), 2021-2026
Figure 4: Global: Bioburden Testing Market: Breakup by Product (in %), 2020
Figure 5: Global: Bioburden Testing Market: Breakup by Test Type (in %), 2020
Figure 6: Global: Bioburden Testing Market: Breakup by Application (in %), 2020
Figure 7: Global: Bioburden Testing Market: Breakup by End User (in %), 2020
Figure 8: Global: Bioburden Testing Market: Breakup by Region (in %), 2020
Figure 9: Global: Bioburden Testing (Consumables) Market: Sales Value (in Million US$), 2015 & 2020
Figure 10: Global: Bioburden Testing (Consumables) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 11: Global: Bioburden Testing (Instruments) Market: Sales Value (in Million US$), 2015 & 2020
Figure 12: Global: Bioburden Testing (Instruments) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 13: Global: Bioburden Testing (Aerobic Count Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 14: Global: Bioburden Testing (Aerobic Count Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 15: Global: Bioburden Testing (Anaerobic Count Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 16: Global: Bioburden Testing (Anaerobic Count Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 17: Global: Bioburden Testing (Fungi/Mold Count Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 18: Global: Bioburden Testing (Fungi/Mold Count Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 19: Global: Bioburden Testing (Spores Count Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 20: Global: Bioburden Testing (Spores Count Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 21: Global: Bioburden Testing (Other Test Types) Market: Sales Value (in Million US$), 2015 & 2020
Figure 22: Global: Bioburden Testing (Other Test Types) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 23: Global: Bioburden Testing (Raw Material Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 24: Global: Bioburden Testing (Raw Material Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 25: Global: Bioburden Testing (Medical Devices Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 26: Global: Bioburden Testing (Medical Devices Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 27: Global: Bioburden Testing (In-process Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 28: Global: Bioburden Testing (In-process Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 29: Global: Bioburden Testing (Sterilization Validation Testing) Market: Sales Value (in Million US$), 2015 & 2020
Figure 30: Global: Bioburden Testing (Sterilization Validation Testing) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 31: Global: Bioburden Testing (Other Applications) Market: Sales Value (in Million US$), 2015 & 2020
Figure 32: Global: Bioburden Testing (Other Applications) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 33: Global: Bioburden Testing (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million US$), 2015 & 2020
Figure 34: Global: Bioburden Testing (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 35: Global: Bioburden Testing (Medical Device Companies) Market: Sales Value (in Million US$), 2015 & 2020
Figure 36: Global: Bioburden Testing (Medical Device Companies) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 37: Global: Bioburden Testing (Contract Manufacturing Organizations- CMOs) Market: Sales Value (in Million US$), 2015 & 2020
Figure 38: Global: Bioburden Testing (Contract Manufacturing Organizations- CMOs) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 39: Global: Bioburden Testing (Food and Beverages Companies) Market: Sales Value (in Million US$), 2015 & 2020
Figure 40: Global: Bioburden Testing (Food and Beverages Companies) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 41: Global: Bioburden Testing (Other End Users) Market: Sales Value (in Million US$), 2015 & 2020
Figure 42: Global: Bioburden Testing (Other End Users) Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 43: North America: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 44: North America: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 45: United States: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 46: United States: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 47: Canada: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 48: Canada: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 49: Asia-Pacific: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 50: Asia-Pacific: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 51: China: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 52: China: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 53: Japan: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 54: Japan: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 55: India: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 56: India: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 57: South Korea: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 58: South Korea: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 59: Australia: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 60: Australia: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 61: Indonesia: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 62: Indonesia: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 63: Others: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 64: Others: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 65: Europe: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 66: Europe: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 67: Germany: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 68: Germany: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 69: France: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 70: France: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 71: United Kingdom: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 72: United Kingdom: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 73: Italy: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 74: Italy: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 75: Spain: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 76: Spain: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 77: Russia: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 78: Russia: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 79: Others: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 80: Others: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 81: Latin America: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 82: Latin America: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 83: Brazil: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 84: Brazil: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 85: Mexico: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 86: Mexico: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 87: Others: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 88: Others: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 89: Middle East and Africa: Bioburden Testing Market: Sales Value (in Million US$), 2015 & 2020
Figure 90: Middle East and Africa: Bioburden Testing Market: Breakup by Country (in %), 2020
Figure 91: Middle East and Africa: Bioburden Testing Market Forecast: Sales Value (in Million US$), 2021-2026
Figure 92: Global: Bioburden Testing Industry: SWOT Analysis
Figure 93: Global: Bioburden Testing Industry: Value Chain Analysis
Figure 94: Global: Bioburden Testing Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Bioburden Testing Market: Key Industry Highlights, 2020 and 2026
Table 2: Global: Bioburden Testing Market Forecast: Breakup by Product (in Million US$), 2021-2026
Table 3: Global: Bioburden Testing Market Forecast: Breakup by Test Type (in Million US$), 2021-2026
Table 4: Global: Bioburden Testing Market Forecast: Breakup by Application (in Million US$), 2021-2026
Table 5: Global: Bioburden Testing Market Forecast: Breakup by End User (in Million US$), 2021-2026
Table 6: Global: Bioburden Testing Market Forecast: Breakup by Region (in Million US$), 2021-2026
Table 7: Global: Bioburden Testing Market: Competitive Structure
Table 8: Global: Bioburden Testing Market: Key Players