Bioburden Testing Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Report Covers Bioburden Testing Market Analysis and it is segmented by Product (Consumables and Instruments), Enumeration Method (Membrane Filtration, Plate Count Method, Most Probable Number (MPN), and Other Enumeration Methods), Application (Raw Material Testing, Medical Devices Testing, In-process Testing, Equipment Cleaning Validation, and Other Applications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Market values are Provided (in USD million) for the above segments.

Bioburden Testing Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

Bioburden Testing Market Size

Bioburden Testing Market Overview
Study Period 2019 - 2030
Market Size (2025) USD 1.58 Billion
Market Size (2030) USD 2.92 Billion
CAGR (2025 - 2030) 13.05 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Low

Major Players

Global Bioburden Testing Market Major Players

*Disclaimer: Major Players sorted in no particular order

Compare market size and growth of Global Bioburden Testing Market with other markets in Healthcare Industry

Biotechnology

Pharmaceuticals

Healthcare IT

Medical Devices

Animal Health

Device Drug Combination

Bioburden Testing Market Analysis

The Global Bioburden Testing Market size is estimated at USD 1.58 billion in 2025, and is expected to reach USD 2.92 billion by 2030, at a CAGR of 13.05% during the forecast period (2025-2030).

With COVID-19, many regulatory bodies like the United States Food and Drug Administration (FDA) have deemed it necessary to maintain adequate sterilization that can facilitate the rapid turnaround of sterilized or disinfected medical devices, raw materials, and packaging to help reduce the contamination and ensure the safety of the novel diagnostic tests and drugs developed for the treatment and management of COVID-19. As per the study published in November 2021, titled "Infection prevention and surgery in the pandemic era" this article has reviewed the measures that have been implemented and have helped infection control in surgery, such as testing, patient isolation, personal protective equipment, and ventilation. Additionally, during COVID-19 pandemic, the Eurofins Medical Device Testing network of laboratories has worked to give expert assistance in examining the safety and efficacy of COVID-19-fighting technologies. Thus, during the COVID-19 pandemic, researchers and healthcare practitioners were more focused on bioburden testing, and this tendency is predicted to continue over the projected period.

The major factors boosting the market growth are the high frequency of product recall due to microbial contamination and increasing research and development investments in life sciences. The high potential of microbial contamination and bioburden during pharmaceutical and biologics manufacturing is seen as a major motivator for governments and corporate companies to implement diverse biological safety practices due to consequences like product recall. For instance, in June 2022, Green Pharmaceuticals Inc voluntarily recalled to the consumer level lot 2373/21222 of SnoreStop NasoSpray, packed in 0.3 FL OZ (9ml) bottles. The product recall happened due to microbiological contamination with Providencia rettgeri. Additionally, in March 2022, Plastikon Healthcare, LLC voluntarily recalled three lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one lot of Acetaminophen 650mg/ 20.3mL, and six lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL. The products are being recalled as a result of microbial contamination and a failure to adequately examine failed microbiological testing. Thus, with the increase in the product recall due to microbial contamination the demand for microbial testing is expected to increase over the forecast period.

Furthermore, increase in the pharmaceutical research and development is another factor which is contributing to the market growth. For instance, according to the September 2021 data from Pharmaceutical Research and Manufacturers of America (PhRMA), since 2000, PhRMA member companies have invested more than USD 1.1 trillion in the search for new treatments and cures, including USD 102.3 billion in 2021 alone. Furthermore, this R&D expenditure is further expected to increase in coming years, which is likely to contribute to the market growth. Additionally, increasing research and development in the field of life sciences, coupled with huge public and private funding in the sector boost the market growth. The Indian Ministry of Science and Technology allocated a budget of INR 35 billion for the Department of Biotechnology (DBT) of India in the Union Budget for the year 2021-2022, a 25% increase from the 2020-2021 budget, primarily for biotechnology research and development as well as industrial and entrepreneurship development in the country, which will boost the studied market. Hence, all the above-mentioned factors are contributing to the market growth.

However, the high cost of microbial enumeration instruments may restrain the market growth over the forecast period.

Bioburden Testing Industry Overview

The bioburden testing market consists of several major players such as Becton, Dickinson and Company, Charles River Laboratories Inc., Merck KGaA, Pacific BioLabs Inc., SGS SA, and others. The companies are implementing certain strategic initiatives, such as mergers, new product launches, acquisitions, and partnerships that help them strengthen their market position. For instance, Charles River Laboratories is adopting an innovative technology platform for helping streamline bioburden testing. Additionally, Merck KGaA developed the product for testing bioburden and others, called EZ Fluo Rapid Detection, Ready-to-Use Culture Media.

Bioburden Testing Market Leaders

  1. Becton, Dickinson and Company

  2. Charles River Laboratories Inc.

  3. Merck KGaA

  4. Pacific BioLabs Inc.

  5. Sotera Health (Nelson Laboratories Inc.)

  6. *Disclaimer: Major Players sorted in no particular order
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Bioburden Testing Market News

  • In August 2022, Lonza introduced the Nebula Multimode Reader, the first multimode reader certified for use with Lonza's turbidimetric, chromogenic, and recombinant endotoxin detection methodologies.
  • In July 2022, Merck launched the first Microbiology Application and Training (MAT) Lab in Bengaluru's Jigani neighborhood. It would provide facilities and technical skills to help the Indian life science community enhance microbiological quality control capabilities. The MAT Centre, which cost EUR 200,000, covers an area of 1,100 square feet.

Bioburden Testing Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 High Frequency of Product Recall Due to Microbial Contamination
    • 4.2.2 Increasing R&D Investments in Life Sciences
  • 4.3 Market Restraints
    • 4.3.1 High Costs of Microbial Enumeration Instruments
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD Million)

  • 5.1 By Product
    • 5.1.1 Consumables
    • 5.1.1.1 Culture Media and Reagents
    • 5.1.1.2 Other Consumables
    • 5.1.2 Instrument
    • 5.1.2.1 Automated Microbial Identification Systems
    • 5.1.2.2 Polymerase Chain Reaction (PCR) Systems
    • 5.1.2.3 Microscopes
    • 5.1.2.4 Other Instruments
  • 5.2 By Enumeration Method
    • 5.2.1 Membrane Filtration
    • 5.2.2 Plate Count Method
    • 5.2.3 Most Probable Number (MPN)
    • 5.2.4 Other Enumeration Methods
  • 5.3 By Application
    • 5.3.1 Raw Material Testing
    • 5.3.2 Medical Devices Testing
    • 5.3.3 In-process Testing
    • 5.3.4 Equipment Cleaning Validation
    • 5.3.5 Other Applications
  • 5.4 Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle-East and Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Becton, Dickinson and Company
    • 6.1.2 Charles River Laboratories Inc.
    • 6.1.3 Merck KGaA
    • 6.1.4 Sotera Health (Nelson Laboratories Inc.)
    • 6.1.5 Pacific BioLabs Inc.
    • 6.1.6 SGS SA
    • 6.1.7 Thermo Fisher Scientific Inc.
    • 6.1.8 WuXi AppTec Co. Ltd
    • 6.1.9 North American Science Associates Inc.
    • 6.1.10 Biomérieux SA
    • 6.1.11 STERIS Laboratories
    • 6.1.12 Sartorius AG
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Bioburden Testing Industry Segmentation

As per the scope of the report, bioburden testing is an integral part of validation and revalidation of sterilization processes, assessment of the efficiency of cleaning processes, routine monitoring of manufacturing processes, monitoring of raw materials, components, or packaging, and overall environmental monitoring programs. The Bioburden Testing Market is segmented by Product (Consumables and Instruments), Enumeration Method (Membrane Filtration, Plate Count Method, Most Probable Number (MPN), and Other Enumeration Methods), Application (Raw Material Testing, Medical Devices Testing, In-process Testing, Equipment Cleaning Validation, and Other Applications), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Product Consumables Culture Media and Reagents
Other Consumables
Instrument Automated Microbial Identification Systems
Polymerase Chain Reaction (PCR) Systems
Microscopes
Other Instruments
By Enumeration Method Membrane Filtration
Plate Count Method
Most Probable Number (MPN)
Other Enumeration Methods
By Application Raw Material Testing
Medical Devices Testing
In-process Testing
Equipment Cleaning Validation
Other Applications
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa GCC
South Africa
Rest of Middle-East and Africa
South America Brazil
Argentina
Rest of South America
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Bioburden Testing Market Research FAQs

How big is the Global Bioburden Testing Market?

The Global Bioburden Testing Market size is expected to reach USD 1.58 billion in 2025 and grow at a CAGR of 13.05% to reach USD 2.92 billion by 2030.

What is the current Global Bioburden Testing Market size?

In 2025, the Global Bioburden Testing Market size is expected to reach USD 1.58 billion.

Who are the key players in Global Bioburden Testing Market?

Becton, Dickinson and Company, Charles River Laboratories Inc., Merck KGaA, Pacific BioLabs Inc. and Sotera Health (Nelson Laboratories Inc.) are the major companies operating in the Global Bioburden Testing Market.

Which is the fastest growing region in Global Bioburden Testing Market?

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Which region has the biggest share in Global Bioburden Testing Market?

In 2025, the North America accounts for the largest market share in Global Bioburden Testing Market.

What years does this Global Bioburden Testing Market cover, and what was the market size in 2024?

In 2024, the Global Bioburden Testing Market size was estimated at USD 1.37 billion. The report covers the Global Bioburden Testing Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Bioburden Testing Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

Bioburden Testing Industry Report

Statistics for the 2025 Global Bioburden Testing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Bioburden Testing analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.