Bioburden Testing Market, By Products (Consumables (Culture Media and Reagents, and Others), and Instruments (Automated microbial, Identification Systems, PCR, Microscopes, and Others)), By Enumeration Method (Membrane Filtration, Plate Count Method, Most probable Number, and Others), By Application (Raw Material Testing, Medical Devices Testing, In-Process Testing, Equipment Cleaning Validation, and Others), and By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Trends, Analysis and Forecast till 2030

Report Code: PMI388020 | Publish Date: May 2023 | No. of Pages: 169

Global Bioburden Testing Market By Overview

Introduction :

Bioburden testing is a process of measuring viable microorganisms on medical devices, raw material, or package. The process helps in determining parameters for its sterilization process to ensure safety and effectiveness of medical devices. It further aids in routine monitoring of raw material, components, and assembly processes in manufacturing process. The bio burden testing is used for assessment of cleaning processes and packaging of products is conducted to ensure safety. Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized.The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products proves that these requirements have been met The bioburden testing market accounted for US$ 911.363 million in 2020 and is estimated to be US$ 3091.69 million by 2030 and is anticipated to register a CAGR of 13.1%.

Global Bioburden Testing Market By Dynamics

                                           

Quality purpose for medical

The global bioburden testing market is anticipated to take positive strides toward successful growth because of its role in achieving quality purposes for medical, biotechnological, and pharmaceutical products. The application of measuring the count of viable microorganisms on a product using instruments and consumables could provide a good boost to the target market. However, the demand in the market is expected to be negatively impacted with the regularity of lengthy approval procedures owing to time-consuming and complex regulatory standards and the expensive cost of instruments. With that mentioned, rising awareness about bioburden testing in emerging economies and swelling count of product recalls because of microbial contamination are predicted to provide a fillip to the global market. The world bioburden testing market could gain impetus from the growing trend of research and development investment in life sciences.

Rising food safety concerns bringing microbial identification into the limelight is envisaged to bode well for the growth of the global market in the coming years. The opportunities for the global bioburden market are significant improvement in the healthcare facilities, rising number of products and recalls and advertisements because of the increased microbial contamination.

Global Bioburden Testing Market By Segmentation

                                

The global bioburden testing market is segmented based on product, enumeration method, application, and region.

Based on product, the global bioburden testing market is segmented into consumables (culture media and reagents, and others) and instruments (automated microbial, identification systems, PCR, microscopes, and others).  The consumables segment is expected to account for the largest share of the global bioburden testing market. The large share of this segment majorly attributed to the requirement of repeat purchase of kits and reagents, unlike instruments which are considered as a one-time investment. Based on the enumeration method, the target market is segmented into membrane filtration, plate count method, most probable number, and others. Based on application, the target market is bifurcated into raw material testing, medical devices testing, in-process testing, equipment cleaning validation, and others. The raw materials testing segment is expected to grow at the highest CAGR during the forecast period. Growth in this segment is likely to be driven by the rising quality standards to ensure safety of finished products.

Regional Insights:

                                          

Based on the region the global bioburden testing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in North America accounts highest revenue share to the global bioburden testing market due to growing demand for advanced medical technologies and increasing geriatric population. Asia Pacific Bioburden testing market is projected to register a high CAGR over the forecast period owing to the growing trend of medical devices, pharma and biotechnology industries, rising concerns of safety and health related to food and beverage products; and rising number of incidences of microbial contamination.

 

                                          

Report Scope:

Attribute

Details

Base year for estimation

2020

Forecast period

2020 – 2029

Market representation

Revenue in USD Million & CAGR from 2020 – 2029

Market Segmentation

By Product Type- Consumables (Culture Media And Reagents, And Others) And Instruments (Automated Microbial, Identification Systems, PCR, Microscopes, And Others)

By Enumeration Method- Membrane Filtration, Plate Count Method, Most Probable Number, And Others

By Application- Raw Material Testing, Medical Devices Testing, In-Process Testing, Equipment Cleaning Validation, And Others

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

 

Detailed Segmentation:

Global Bioburden Testing Market, By Product:

  • Consumables
    • Culture Media and Reagents,
    • Others
  • Instruments
    • Automated microbial
    • Identification Systems
    • PCR
    • Microscopes
    • Others

Global Bioburden Testing Market, By Enumeration Method:

  • Membrane Filtration
  • Plate Count Method
  • Most probable Number
  • Others

Global Bioburden Testing Market, By Application:

  • Raw Material Testing
  • Medical Devices Testing
  • In-Process Testing
  • Equipment Cleaning Validation
  • Others

Global Bioburden Testing Market, By Region:

      • North America
        • North America Bioburden Testing Market, By Product
        • North America Bioburden Testing Market, By Enumeration Method
        • North America Bioburden Testing Market, By Application
        • North America Bioburden Testing Market, By Country
          • U.S.
          • Canada
      • Europe
        • Europe Bioburden Testing Market, By Product
        • Europe Bioburden Testing Market, By Enumeration Method
        • Europe Bioburden Testing Market, By Application
        • Europe Bioburden Testing Market, By Country
          • Germany
          • UK
          • France
          • Russia
          • Italy
          • Rest of Europe
      • Asia Pacific
        • Asia Pacific Bioburden Testing Market, By Product
        • Asia Pacific Bioburden Testing Market, By Enumeration Method
        • Asia Pacific Bioburden Testing Market, By Application
        • Asia Pacific Bioburden Testing Market, By Country
          • China
          • India
          • Japan
          • South Korea
          • Rest of Asia Pacific
      • Latin America
        • Latin America Bioburden Testing Market, By Product
        • Latin America Bioburden Testing Market, By Enumeration Method
        • Latin America Bioburden Testing Market, By Application
        • Latin America Bioburden Testing Market, By Country
          • Brazil
          • Mexico
          • Rest of Latin America
      • Middle East & Africa
        • Middle East & Africa Bioburden Testing Market, By Product
        • Middle East & Africa Bioburden Testing Market, By Enumeration Method
        • Middle East & Africa Bioburden Testing Market, By Application
        • Middle East & Africa Bioburden Testing Market, By Country
          • GCC
          • Israel
          • South Africa
          • Rest of Middle East & Africa

Global Bioburden Testing Market By Key Players

The key players operating the global bioburden testing market involves Becton, Dickinson And Company, Charles River Laboratories, Inc., Merck KGaA, Nelson Laboratories Inc., Pacific Bio labs, Inc., SGS S.A., WuXi AppTec,  North American Science Associates Inc., Dynatec Labs, and Thermo Fisher Scientific. In April 2018, Charles River, the beast of bioburden testing, has completely acquired MPI Research, a premier nonclinical contract research organization (CRO). With this purchase Charles River would enrich and expand it client base, by mastering its expertise drug discovery and development continuum. In October 2018, SGS SA acquired INTER-BASIC RESOURCES, INC. (IBR), a non-clinical contract research organization (CRO). IBR Inc. is a leader in state-of-art testing and biopharma analytics for the construction of biologics, biosimilars and vaccines, and delivers various filter testing and particle counting services. With this acquisition, SGS SA would broaden its filtration services, thereby expand its customer base and customer services.

Global Bioburden Testing Market By Company Profile

      • Becton, Dickinson And Company
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Charles River Laboratories, Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Merck KGaA
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Nelson Laboratories Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Pacific Bio labs, Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • SGS S.A.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • WuXi AppTec
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • North American Science Associates Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Dynatec Labs
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance
      • Thermo Fisher Scientific
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Performance

Global Bioburden Testing Market By Table of Contents

  1. Research Objective and Assumption
    • Preface
    • Research Objectives
    • Study Scope
    • Years considered for the study
    • Assumptions
    • Abbreviations
  2. Research Methodology
    • Research data
    • Primary Data
      • Primary Interviews
      • Primary Breakdown
      • Key data from Primary Sources
      • Key Industry Insights
    • Secondary Data
      • Major Secondary Sources
      • Secondary Sources
    • Market Estimation
    • Top-Down Approach
      • Approach for estimating Market Share by Top-Down Analysis (Supply Side)
    • Bottom-Up Approach
      • Approach for estimating market share by Bottom-up Analysis (Demand Side)
    • Market Breakdown and Data Triangulation
    • Research Assumptions
  3. Market Purview
    • Executive Summary
    • Key Findings—Global Outlook for Bioburden Testing Strategies
      • Key Questions this Study will Answer
      • Market Snippet, By Products
      • Market Snippet, By Enumeration Method
      • Market Snippet, By Application
      • Market Snippet, By Region
    • Opportunity Map Analysis
    • Executive Summary—3 Big Predictions
  4. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
      • Market Trends
    • DR Impact Analysis
    • PEST Analysis
    • Porter’s Five Forces Analysis
    • Opportunity Orbit
    • Market Investment Feasibility Index
    • Macroeconomic Factor Analysis
  5. Global Bioburden Testing Market, By Products, 2020 – 2030, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
      • Y-o-Y Growth Analysis (%), 2020 – 2030
      • Segment Trends
    • Consumables
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
        • Culture Media and Reagents
        • Others
    • Instruments
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
        • Automated microbial
        • Identification Systems
        • PCR
        • Microscopes
        • Others
  6. Global Bioburden Testing Market, By Enumeration Method, 2020 – 2030, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
      • Y-o-Y Growth Analysis (%), 2020 – 2030
      • Segment Trends
    • Membrane Filtration
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Plate Count Method
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Most probable Number
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Others
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
  7. Global Bioburden Testing Market, By Application, 2020 – 2030, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
      • Y-o-Y Growth Analysis (%), 2020 – 2030
      • Segment Trends
    • Raw Material Testing
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Medical Devices Testing
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • In-Process Testing
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Equipment Cleaning Validation
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
    • Others
      • Overview
      • Market Size and Forecast (US$ Mn), and Y-o-Y Growth (%), 2020 – 2030
  8. Global Bioburden Testing Market, By Region, 2020 – 2030, (US$ Mn)
    • Overview
      • Market Value and Forecast (US$ Mn), and Share Analysis (%), 2020 – 2030
      • Y-o-Y Growth Analysis (%), 2020 – 2030
      • Regional Trends
    • North America
      • Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Enumeration Method, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Enumeration Method, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
        • Germany
        • UK
        • France
        • Russia
        • Italy
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Enumeration Method, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
        • China
        • India
        • Japan
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Enumeration Method, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East & Africa
      • Market Size and Forecast (US$ Mn), By Products, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Enumeration Method, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Application, 2020 – 2030
      • Market Size and Forecast (US$ Mn), By Country, 2020 – 2030
        • GCC
        • Israel
        • South Africa
        • Rest of Middle East
  9. Competitive Landscape
    • Heat Map Analysis
    • Market Presence and Specificity Analysis
  10. Company Profiles
      • Becton, Dickinson And Company
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Charles River Laboratories, Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Merck KGaA
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Nelson Laboratories Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Pacific Bio labs, Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • SGS S.A.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • WuXi AppTec
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • North American Science Associates Inc.
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Dynatec Labs
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
      • Thermo Fisher Scientific
        • Company Overview
        • Product Portfolio
        • Key Highlights
        • Financial Overview
  11. The Last Word
    • Future Impact
    • About Us
    • Contact

FAQs

The global bioburden testing market accounted for US$ 911.363 million in 2020 and is estimated to be US$ 3091.69 million by 2030 and is anticipated to register a CAGR of 13.1%.

The Global Bioburden Testing Market is projected to increase at a CAGR of 13.1% during the forecast.

The global bioburden testing market is segmented based on product, enumeration method, application, and region.

The global bioburden testing market is anticipated to take positive strides toward successful growth because of its role in achieving quality purposes in various fields.