Bioburden Testing Market Snapshot
|Study Period:||2018 - 2026|
|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The bioburden testing market is expected to register a CAGR of nearly 9.2% during the forecast period. The major factors boosting the market growth are the high frequency of product recall due to microbial contamination and increasing R&D investments in life sciences.
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.
Increasing researches are taking place. For instance, in May 2020, the Department of Biotechnology (DBT) in India undertook a project to sequence 1,000 SARS-CoV-2 genomes from samples to understand the evolving behavior of the virus that causes COVID-19. The samples were being collected across India to study the emerging mutations in the virus and how they change the symptoms of the disease. Therefore, all these researches have helped in boosting the bioburden testing. Hence, all these factors are expected to increase the demand for proper sterilization, which is expected to boost the market growth of bioburden testing.
Bioburden testing is a process used for the assessment of cleaning processes, and packaging of products to ensure safety. One of the major factors that have a direct impact on the market studied is the rising R&D investments by companies, institutes, and other academia in life sciences. There is an increasing demand for biopharmaceuticals that has also led to the significant need for ensuring validation of the process of manufacturing. The biopharmaceuticals research for rare diseases, supported by R&D spending, offers a great opportunity.
Also, as per Pharmaprojects 2019, the United States was the largest producer of pharma R&D, contributing 46%, followed by Europe. Therefore, the increased investments by the companies and other organizations in R&D activities are expected to fuel the market studied.
Furthermore, the growth in the medical devices, pharmaceutical, and rising product recalls due to microbial contamination are also the major factors that drive the growth of the bioburden testing market. In the biotechnology and food and beverage industries, safety concerns supplement the overall growth. The increasing advancements made in membrane filtration production and module designs, capital, and operating costs are likely to continuously increase, which would boost the overall market growth.
Scope of the Report
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 products (consumables and instruments), consumables are further sub-segmented as (culture media and reagents and other consumables), instruments are further sub-segmented as (automated microbial identification systems, polymerase chain reaction systems, microscopes, and other instruments), enumeration method (membrane filtration, plate count method, most probable number, 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 report offers the value (in USD million) for the above segments.
|By Enumeration Method|
|Plate Count Method|
|Most Probable Number (MPN)|
|Other Enumeration Methods|
|Raw Material Testing|
|Medical Devices Testing|
|Equipment Cleaning Validation|
Key Market Trends
Polymerase Chain Reaction 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 delivers 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 COVID testing. The RT–PCR is found to be one of the most widely used laboratory methods for detecting the COVID-19 virus. Many countries have used real-time RT–PCR for diagnosing other diseases, boosting the adoption of these PCR systems for COVID-19 testing.
Polymerase chain reaction testing is therefore found to be one of the well-established methods for the detection, quantification of different types of microbial agents in the areas of clinical diagnostics and food safety. The PCR-based pathogen detection requires the use of appropriate controls, which aid in result interpretation by identifying adverse factors such as contamination, 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 June 2018, QIAGEN (ThermoFisher) launched the QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit. The new QIAGEN kits avoid external bias in PCR and NGS library preparation with inhibitor-resistant PCR and low bioburden reagents tested for bacterial and fungal DNA contamination. Hence, all these factors have majorly impacted the overall market growth.
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The North American Region Holds the Largest Market Share of the Bioburden Testing Market
North America holds the largest regional market in terms of revenue due to the increasing R&D 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. Many companies have launched new products to reduce the infection rate from drugs and devices.
According to the Pharmaceutical Research and Manufacturers Association (PhRMA), in 2018, the US firms conducted over half the world's R&D in pharmaceuticals. Approximately USD 79.6 billion was invested in biopharmaceutical research and development in the United States in 2018. Due to the increasing number of drugs and devices recalled, there is an emerging need for validation of the drugs and devices process of manufacturing, which is expected to boost the demand for the market studied.
Increasing R&D investments by prominent companies and research costs are expected to encourage companies to adopt highly efficient biological testing tools to counter the possible losses caused by contamination. For example, Bristol-Myers Squibb had invested in the production of investigational medicine to support clinical trials. Furthermore, regulatory bodies, such as the US FDA, require sterilization validation that helps in creating a need for bioburden testing for medical devices.
According to the US Food & Drug Administration (FDA), the United States had approximately 4,676 manufacturing sites for drugs. The government has also taken various measures to ensure the safety of the products. For instance, the government of the United States has developed a code of federal regulation under Title 21. This regulation checks upon microbial limit testing, which is used for medical devices.
Hence, the increasing investments in R&D activities in the United States are expected to fuel the growth of the market studied over the forecast period.
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The bioburden testing market consists of several major players. 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 of bioburden and others, called EZ Fluo Rapid Detection, Ready-to-Use Culture Media.
- In September 2020, Almac Sciences, a member of the Almac Group, announced the expansion of its existing suite of analytical solutions to include biologics testing.
- In January 2020, MilliporeSigma (Merck Group) launched the Milliflex Oasis System, which has 96 new features to increase result reliability and traceability while streamlining the bioburden testing workflow. The system also offers an all-in-one filtration solution with sterilized, ready-to-use filtration units and pharmacopeia-compliant media for comfort and peace of mind for water and bioburden testing.
Table of Contents
1.1 Study Deliverables
1.2 Study Assumptions
1.3 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
4.3.2 Lack of Skilled Personnel
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
5.1 By Product
188.8.131.52 Culture Media and Reagents
184.108.40.206 Other Consumables
220.127.116.11 Automated Microbial Identification Systems
18.104.22.168 Polymerase Chain Reaction (PCR) Systems
22.214.171.124 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
5.4.1 North America
126.96.36.199 United States
188.8.131.52 United Kingdom
184.108.40.206 Rest of Europe
220.127.116.11 South Korea
18.104.22.168 Rest of Asia-Pacific
5.4.4 Middle-East and Africa
22.214.171.124 South Africa
126.96.36.199 Rest of Middle-East and Africa
5.4.5 South America
188.8.131.52 Rest of South America
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
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 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
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Bioburden Testing Market market is studied from 2018 - 2026.
What is the growth rate of Global Bioburden Testing Market?
The Global Bioburden Testing Market is growing at a CAGR of 9.2% over the next 5 years.
Which region has highest growth rate in Global Bioburden Testing Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Bioburden Testing Market?
North America holds highest share in 2020.
Who are the key players in Global Bioburden Testing Market?
Becton, Dickinson and Company, Charles River Laboratories Inc., Merck KGaA, Nelson Laboratories Inc., Pacific BioLabs Inc. are the major companies operating in Global Bioburden Testing Market.