Bioburden Testing Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 1.40 Billion |
| Market Size (2029) | USD 2.59 Billion |
| CAGR (2024 - 2029) | 13.05 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Bioburden Testing Market Analysis
The Global Bioburden Testing Market size is estimated at USD 1.40 billion in 2024, and is expected to reach USD 2.59 billion by 2029, growing at a CAGR of 13.05% during the forecast period (2024-2029).
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 Market Trends
This section covers the major market trends shaping the Bioburden Testing Market according to our research experts:
Polymerase Chain Reaction (PCR) Systems are Expected to Hold the Large Share of the Market
The molecular methods of identifying pathogens are becoming progressively popular, as they offer precise detection at a fraction of the time and effort invested in traditional, culture-based methods. Both the real-time and end-point PCR provide the rapid, sensitive, and highly specific detection of nucleic acids from bacteria, viruses, fungi, and other microbial organisms. There is a positive impact on the segment due to the increasing demand for bioburden testing as the research and development activity for COVID-19 vaccines has increased.
Polymerase chain reaction testing is therefore found to be one of the well-established methods for the detection, and quantification of different types of microbial agents in the areas of clinical diagnostics and food safety. PCR-based pathogen detection requires the use of appropriate controls, which aid in result interpretation by identifying adverse factors such as contamination, and inhibition of the amplification reaction.
Moreover, the market players are also adopting various growth strategies, such as frequent product launches, partnerships, and merger and acquisition activities, to gain a competitive edge in the market. For instance, in March 2021 the UgenTecand Hamann Lab entered into a partnership venture for the PCR middleware landscape. Such partnerships by the market players to develop PCR System and strengthen their position in the market is boosting the growth of the market. Hence, all these factors have majorly impacted the overall market growth.
The North American Region Dominates Bioburden Testing Market Over the Forecast Period
North America is the largest market in terms of revenue due to the increasing research and development expenditures, increased number of product recalls, and government initiatives related to the accuracy of the safety process of drugs and devices. The recent outbreak of COVID -19 has also created a huge demand for drug discovery and medical devices, increasing the demand for bioburden testing.
Due to the increasing number of drugs and devices recalled, the emerging need for validation of the manufacturing process for drugs and devices is expected to boost the demand for the market studied. For instance, in June 2022, Buzzagogo voluntarily recalled one lot of Allergy Bee Gone for Kids Nasal Swab Remedy due to microbial contamination identified by the FDA as Bacillus cereus, a gram-positive bacterium, as well as high levels of yeast and mold.
According to the data published by the National Center for Biotechnology Information (NCBI), biotechnology funding by the National Institute of Health (NIH), and increasing R&D investments by prominent companies are expected to encourage companies to adopt highly efficient biological testing tools to counter the possible losses caused by contamination. According to the data published in May 2022 by the National Center for Biotechnology Information (NCBI), the National Institutes of Health (NIH) invested around USD 7.77 billion in biotechnology, during the fiscal year 2020. Furthermore, according to figures supplied by the Federation of American Scientists, federal funding for research and development increased 5.9% in 2020 compared to 2019, totaling to USD 138.9 billion. Thus, with growing research and development spending it is expected that the research and development activity is going to increase over the forecast period, thereby boosting the market growth in the region.
Thus, all the above-mentioned factors are expected to boost the market growth in the North American region.
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
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Becton, Dickinson and Company
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Charles River Laboratories Inc.
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Merck KGaA
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Pacific BioLabs Inc.
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Sotera Health (Nelson Laboratories Inc.)
*Disclaimer: Major Players sorted in no particular order
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
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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
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4.3 Market Restraints
- 4.3.1 High Costs of Microbial Enumeration Instruments
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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)
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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
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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
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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
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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
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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 AvailablityBioburden 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 | ||
| By Product | 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 | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle-East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Bioburden Testing Market Research FAQs
How big is the Global Bioburden Testing Market?
The Global Bioburden Testing Market size is expected to reach USD 1.40 billion in 2024 and grow at a CAGR of 13.05% to reach USD 2.59 billion by 2029.
What is the current Global Bioburden Testing Market size?
In 2024, the Global Bioburden Testing Market size is expected to reach USD 1.40 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 (2024-2029).
Which region has the biggest share in Global Bioburden Testing Market?
In 2024, 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 2023?
In 2023, the Global Bioburden Testing Market size was estimated at USD 1.24 billion. The report covers the Global Bioburden Testing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Bioburden Testing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Bioburden Testing Industry Report
Statistics for the 2023 Bioburden Testing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Bioburden Testing analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
