Bioburden Testing Market Snapshot
2018 - 2026
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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 that are found boosting the market growth are the high frequency of product recall due to microbial contamination and increasing R&D investments in life sciences.
With the rising of the COVID-19, there are many regulatory bodies like the United States Food and Drug Administration (FDA) that have deemed it necessary to maintain adequate sterilization that can facilitate the rapid turnaround of sterilized or disinfected medical devices, raw materials, and packaging and that help reduce the contamination, to ensure the safety of the novel diagnostic tests and drugs that are being developed for the treatment and management of COVID 19.
There are also increasing researches taking place for instance, in May 2020, The Department of Biotechnology (DBT) in India had undertaken a project to sequence 1,000 SARS-CoV-2 genomes from samples to understand the evolving behaviour of the virus that causes the coronavirus disease (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 increasing 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 that is 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 it. 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 is 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 biotechnology and food and beverage industries, safety concerns supplement the overall growth. The increasing advancements are made in membrane filtration production and module designs, capital and operating costs that are likely to continuously increase that helps in boosting 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 is 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 the COVID testing. The RT–PCR is found to be one of the most widely used laboratory methods for detecting the COVID-19 virus. While many countries have used real time RT–PCR for diagnosing other diseases therefore this has boosted the adoption of these PCR systems in the COVID-19 testing.
Polymerase chain reaction testing is therefore found to be one of the well-established method for the detection, quantification of different types of the 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) had 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 has majorly impacted the overall market growth.
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North America Region Holds the Largest Market Share of Bioburden Testing Market
North America hold the largest regional market in terms of revenue due to the increasing R&D expenditures, increased number of product recalls, and the 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 that has raised the demand for bioburden testing. Many companies have launched new products to reduce the infection rate from the drugs and devices
According to the Pharmaceutical Research and Manufacturers Association (PhRMA), 2018, the United States firms conducted over half the world's R&D in pharmaceuticals. Approximately 79.6 billion had been invested in biopharmaceutical research and development in the United States in the year 2018. Due to the increasing number of drugs and devices recalled, there is an emerging need for validation of drugs and devices process of manufacturing that is expected to boost the demand in 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 U.S. FDA requires sterilization validation that helps in creating a need for bioburden testing for medical devices.
According to the United States 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 the microbial limit testing, which is used for medical devices.
Hence, the increasing investments in research and development 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 a merger, new product launch, acquisition, and partnerships that help them in strengthening their market position. For instance, Charles River Laboratories is adopting an innovative technology platform for helping in streamline bioburden testing. Additionally, one of the players, Merck KGaA., developed the product for testing of bioburden and others, called EZ Fluo Rapid Detection, Ready-to-Use Culture Media.
- In Sep 2020, Almac Sciences, a member of the Almac Group, has announced the expansion of its existing suite of analytical solutions to include biologics testing.
- In Jan 2020, MilliporeSigma (Merck Group) has launched the Milliflex Oasis System that 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 pharmacopoeia-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 Force 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
18.104.22.168 Culture Media and Reagents
22.214.171.124 Other Consumables
126.96.36.199 Automated Microbial Identification Systems
188.8.131.52 Polymerase Chain Reaction (PCR) Systems
184.108.40.206 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
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
5.4.3 Asia Pacific
126.96.36.199 South Korea
188.8.131.52 Rest of Asia-Pacific
5.4.4 Middle East and Africa
184.108.40.206 South Africa
220.127.116.11 Rest of Middle East and Africa
5.4.5 South America
18.104.22.168 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.