#In-Vitro Diagnostics and Cell Culture Medias Industry
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Exploring Opportunities in Fetal Bovine Serum Market
Market Overview –
The market for fetal bovine serum was estimated to be worth USD 0.9 billion in 2022 and is expected to increase to USD 1.5 billion by 2030, with a compound annual growth rate (CAGR) of 5.7% from USD 0.95 billion in 2023 to USD 1.5 billion in 2023.
The fetal bovine serum (FBS) market focuses on supplying a vital component used in cell culture media for various research and biopharmaceutical applications. FBS, derived from the blood of fetal calves, contains essential nutrients, growth factors, and hormones necessary for the growth and proliferation of cells in vitro.
Market growth is driven by the increasing demand for cell-based research, biopharmaceutical manufacturing, and regenerative medicine applications. FBS is widely used in laboratories and biotech companies for culturing cells for vaccine production, drug screening, cell therapy development, and academic research, among other applications.
Technological advancements and innovations in cell culture techniques and bioprocessing are shaping the FBS market, offering new formulations, quality control measures, and production methods to meet the diverse needs of researchers and manufacturers. From serum-free media and chemically defined supplements to animal component-free alternatives and serum replacement solutions, these advancements aim to enhance cell culture performance, reproducibility, and scalability.
Moreover, the COVID-19 pandemic has underscored the importance of reliable and sustainable sources of FBS in biopharmaceutical manufacturing, as companies ramp up production of vaccines, cell-based therapies, and diagnostic tests to combat the pandemic. Ensuring a stable supply chain of FBS remains critical to meeting the growing demand for cell culture materials and accelerating the development and production of lifesaving treatments.
However, challenges such as ethical concerns, supply chain disruptions, and regulatory constraints pose obstacles to market growth. Addressing these challenges requires collaboration between industry stakeholders, regulatory agencies, and animal welfare organizations to develop ethical sourcing practices, ensure product safety, and promote alternative cell culture technologies.
Overall, the FBS market presents significant opportunities for innovation and collaboration to support advancements in cell-based research, biopharmaceutical manufacturing, and regenerative medicine. By investing in research, technology, and sustainability initiatives, stakeholders can drive continued growth and advancement in the FBS market and contribute to scientific discoveries and medical breakthroughs.
The fetal bovine serum (FBS) market, with a spotlight on heat-inactivated FBS, is experiencing notable growth. Heat inactivation ensures sterility and safety, making it a preferred choice in cell culture applications. With expanding biomedical research and biopharmaceutical production, the demand for high-quality FBS, particularly heat-inactivated variants, is on the rise, driving market expansion.
Overall, the FBS market is expected to witness steady growth as the demand for cell-based research and biopharmaceutical production continues to expand, driving the need for high-quality and reliable FBS products to support these activities.
Segmentation –
As per the MRFR study, the end user, product type, and application segments the global market for fetal bovine serum. These market categories contain a range of components and market dynamics that are well-known for their significant contributions to the advancement of market issues. A thorough examination of these could yield a number of guidelines that businesses can use to plan their actions.
The report on the fetal bovine serum market may be divided into many product categories, such as exosome depleted, charcoal stripped, dialyzed fetal bovine serum (FBS), chromatographic, stem cell, and others. There are sub-segments within the stem cell segment, such as mesenchymal stem cell qualified and embryonic stem cell qualified.
The study on the fetal bovine serum market may be divided into many segments based on their intended use, such as cell culture media, drug discovery, in-vitro fertilization, human and animal vaccine production, diagnostics, and others. The recent shifts in market dynamics will lead to a rise in the intake of the drug discovery segment.
According to end users, the research examines the market using data from academic and research institutions, biotechnology, pharmaceutical, and other sources. It is anticipated that the pharmaceutical industry will significantly boost the global market.
Regional Analysis –
Regional analysis of the fetal bovine serum (FBS) market reveals distinct trends and dynamics across different parts of the globe. In North America, particularly in the United States, the market for FBS is significant due to factors such as advanced biotechnology research infrastructure, a large number of pharmaceutical and biotechnology companies, and stringent regulatory standards ensuring product quality.
The region witnesses a high demand for FBS in cell culture applications, including drug discovery, vaccine production, and stem cell research. Europe showcases a mature FBS market, with countries like Germany, the UK, and France leading in terms of production and consumption. The region benefits from established healthcare and biotechnology sectors, along with a strong focus on research and development. In the Asia-Pacific region, countries like China, India, and Japan are emerging as key players in the FBS market, driven by increasing investments in life sciences research, growing demand for biopharmaceuticals, and expanding biotechnology industry.
Latin America exhibits significant growth potential in the FBS market, fueled by improving healthcare infrastructure and rising investments in biotechnology and life sciences. The Middle East and Africa region also experience a steady increase in FBS demand, supported by expanding research activities and a growing focus on healthcare development. Understanding these regional variations is essential for FBS manufacturers and suppliers to tailor their strategies, ensure market access, and meet the specific needs of diverse customer bases worldwide.
Key Players –
Fetal bovine serum companies include HiMedia Laboratories, Merck KGaA, Bovogen Biologicals Pty Ltd, Atlanta Biologicals Inc., TCS Biosciences Ltd, Tissue Culture Biologicals, Rocky Mountain Biologicals, GE Healthcare, Thermo Fisher Scientific, Bio-Techne, PAN-Biotech, and Access Biologicals.
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#Fetal Bovine Serum Market#Fetal Bovine Serum Market Size#Fetal Bovine Serum Market Share#Fetal Bovine Serum Market Growth#Fetal Bovine Serum Market Trends
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Fetal Bovine Serum Market Share and Demand Analysis with Size, Growth Drivers and Forecast to 2030
The latest market report published by Credence Research, Inc. “Global Fetal Bovine Serum Market: Growth, Future Prospects, and Competitive Analysis, 2016 – 2028. The global Fetal Bovine Serum Market has grown steadily in recent years and is predicted to expand at a CAGR of 5.60% between 2023 and 2030. In 2022, the market was worth USD 849.8 million, and it is predicted to grow to USD 1314.0 million by 2030.
Introduction: Unveiling the Significance of Fetal Bovine Serum
Fetal bovine serum is a vital component in cell culture, primarily due to its rich composition of growth factors, hormones, and other essential nutrients. It serves as a nutritional source for cultured cells, enabling their growth, proliferation, and maintenance. Researchers rely on FBS to cultivate a wide range of cell types, making it indispensable in various fields, including pharmaceuticals, biotechnology, and academic research.
Market Dynamics: Exploring Growth Factors
1. Increased Demand for Biopharmaceuticals
The pharmaceutical industry has witnessed a paradigm shift towards biopharmaceuticals. This shift can be attributed to the rising prevalence of chronic diseases and the need for innovative therapies. As a result, the demand for FBS has surged, as it plays a pivotal role in the production of biopharmaceuticals, including vaccines, monoclonal antibodies, and cell-based therapies.
2. Advancements in Cell-based Research
Cell-based research is at the forefront of scientific innovation. FBS serves as the cornerstone of cell culture, enabling scientists to conduct experiments and develop new treatments for various diseases. Its applications extend to cancer research, regenerative medicine, and drug discovery, driving the market's growth.
Fetal Bovine Serum Market Major Challenges and Risks
Supply Chain Vulnerabilities: The primary source of FBS is the blood of unborn calves, which makes it susceptible to supply chain disruptions due to factors like disease outbreaks in cattle, regulatory changes, or natural disasters. These disruptions can lead to shortages and price volatility.
Ethical Concerns: There are ethical concerns related to the use of FBS, as it involves the collection of blood from unborn calves, which raises animal welfare and cruelty issues. These concerns can result in regulatory restrictions or push for alternative serum-free culture media.
Regulatory Changes: Regulations surrounding the collection and use of FBS can vary between countries and regions. Changes in regulatory requirements can impact the availability and cost of FBS, as well as necessitate costly adjustments for producers and users to comply with new standards.
Contamination and Quality Control: Ensuring the quality and safety of FBS is crucial in cell culture applications. Contamination with pathogens, mycoplasma, or other undesirable elements can pose a significant risk to experiments and processes. Quality control and testing are essential but can be costly.
Browse 247 pages report Fetal Bovine Serum Market By Grade (Cell Culture Biopharmaceuticals Production Vaccine Production In Vitro Fertilization (IVF Diagnostics and Research) By Distribution Channel (Research Institutes and Laboratories Biotechnology Companies Pharmaceutical Companies Academic Institutions) By Grade (Premium Superior Standard)- Growth, Future Prospects & Competitive Analysis, 2016 – 2030- https://www.credenceresearch.com/report/fetal-bovine-serum-market
Market Trends
1. Advent of Serum Alternatives
While Fetal Bovine Serum has been a cornerstone of cell culture, there is a growing trend towards the development of serum alternatives. These alternatives aim to address ethical concerns and reduce the risk of contamination, which can be advantageous in specific research scenarios.
2. Asia-Pacific Emerging as a FBS Hub
The Asia-Pacific region is witnessing remarkable growth in the FBS market. Factors such as the increasing number of research institutions, availability of skilled labor, and cost-effective production have made the region a key player in the global FBS industry.
Some of the major players in the market and their market share are as follows: Danaher (Cytiva), Merck KGaA (Sigma Aldrich), HiMedia Laboratories Pvt. Ltd, Bio-Techne, Sera Scandia (Biowest), Sartorius (Biological Industries), Atlas Biologicals, Rocky Mountain Biologicals, PAN-Biotech.
Key Segments
By Grade
Cell Culture
Biopharmaceuticals Production
Vaccine Production
In Vitro Fertilization (IVF)
Diagnostics and Research
By Distribution Channel
Research Institutes and Laboratories
Biotechnology Companies
Pharmaceutical Companies
Academic Institutions
Why to Buy This Report-
The report provides a qualitative as well as quantitative analysis of the global Fetal Bovine Serum Market by segments, current trends, drivers, restraints, opportunities, challenges, and market dynamics with the historical period from 2016-2020, the base year- 2021, and the projection period 2022-2028.
The report includes information on the competitive landscape, such as how the market's top competitors operate at the global, regional, and country levels.
Major nations in each region with their import/export statistics
The global Fetal Bovine Serum Market report also includes the analysis of the market at a global, regional, and country-level along with key market trends, major players analysis, market growth strategies, and key application areas.
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Global Adult Bovine Serum Market Is Estimated To Witness High Growth Owing To Increasing Demand for Cell Culture Applications
The global adult bovine serum market is estimated to be valued at US$ 119.3 million in 2022 and is expected to exhibit a CAGR of 5.6% over the forecast period 2022-2030, as highlighted in a new report published by Coherent Market Insights. Market Overview: Adult bovine serum is a high-quality supplement used in various cell culture applications. It provides essential nutrients, growth factors, and hormones required for cell growth and proliferation. The increasing demand for adult bovine serum can be attributed to its advantages such as better cell attachment, faster cell growth rate, and higher cell yield. These serum products are extensively used in academic research, pharmaceutical and biotechnology industries, and in vitro diagnostics. Market Key Trends: One key trend in the global adult bovine serum market is the growing adoption of serum-free culture media. Serum-free culture media eliminates potential contamination issues associated with traditional serum-based cultures. It also allows for increased control over the specific components used in the media, resulting in more consistent and reproducible results. The use of serum-free culture media is particularly beneficial in applications that require high precision and accuracy, such as drug discovery and development. For example, Thermo Fisher Scientific offers Gibco™ AIM V® Medium, a proprietary serum-free culture medium, designed for the expansion of multiple cell types including T-cells and dendritic cells. This medium enables robust cell growth and function without the use of animal-derived serum. PEST Analysis: - Political: The use of animal-derived products, including bovine serum, is subject to regulations and guidelines set by government bodies. Regulatory compliance plays a crucial role in the market dynamics of adult bovine serum. - Economic: The adult bovine serum market is driven by the increasing investment in research and development activities by pharmaceutical and biotechnology companies. - Social: The growing focus on personalized medicine and regenerative therapies is fueling the demand for advanced cell culture applications, driving the growth of the adult bovine serum market. - Technological: Advancements in cell culture technologies and the development of serum-free culture media are shaping the market landscape of adult bovine serum. Key Takeaways: 1: The global Adult Bovine Serum Market Growth is expected to witness high growth, exhibiting a CAGR of 5.6% over the forecast period, due to increasing demand for cell culture applications. The advantages of adult bovine serum, such as better cell attachment, faster cell growth rate, and higher cell yield, are driving its adoption in various industries. 2: Regionally, North America is the fastest-growing and dominating region in the global adult bovine serum market. The presence of key players and the high investment in research and development activities are contributing to the market growth in this region. 3: Key players operating in the global adult bovine serum market include HiMedia Laboratories, Sartorius AG, Thermo Fisher Scientific, Auckland BioSciences Ltd., Moregate Biotech, Bovogen Biologicals, Merck KGaA, Capricorn Scientific GmbH, Gemini Bio, ROCKY MOUNTAIN BIOLOGICALS, Otto Chemie Pvt. Ltd, CellSera Australia, Serana Europe GmbH, TRINA BIOREACTIVES AG, and WISENT BIOPRODUCTS. These companies are focusing on product development and strategic collaborations to strengthen their market presence. In conclusion, the global adult bovine serum market is projected to experience significant growth in the coming years due to the increasing demand for cell culture applications. The adoption of serum-free culture media and advancements in cell culture technologies are expected to contribute to the market expansion. However, regulatory compliance and the emergence of alternative cell culture techniques may pose challenges to market growth.
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In-Vitro Diagnostics and Cell Culture Medias Market 2022 | Industry Size, Share, Demand And Growth Analysis Report Till 2028
The study on In-Vitro Diagnostics and Cell Culture Medias Market with its type and application sales analysis is very essential for all the decision-makers or strategists operating in this industry. The report is made by analysts with deep industry knowledge and experience. The global, regional, and country annual sales and revenue has been studied for the historical years and estimated for the current year. With the help of analytical tools, primary interviews, and data triangulation the report is enriched with quality data. The qualitative data on the upcoming industry trends with market triggers and risks are covered as a separate section in this comprehensive report.
As understood and analyzed in the global In-Vitro Diagnostics and Cell Culture Medias market report the growth CAGR in the year 2022 to 2028 is showing a promising inclination. The macro and microeconomic conditions are studied and forecast data is anticipated.
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As per this report analysis, the In-Vitro Diagnostics and Cell Culture Medias market is expected to show a CAGR (revenue) of xx% between the forecast years and the global market size can cross USD XX million by the end of 2028, growing from USD XX million in the year 2022. This report specifically covers the global market share (sales as well as revenue) of key companies in the In-Vitro Diagnostics and Cell Culture Medias business, as mentioned in a separate Chapter 3.
Regionally, the In-Vitro Diagnostics and Cell Culture Medias market data is studied under the below-mentioned regions and countries – Americas covering (United States, Canada, Mexico, Brazil), APAC covering (China, Japan, Korea, Southeast Asia, India, Australia), Europe covering (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa covering (Egypt, South Africa, Israel, Turkey, and other GCC Countries).
This research study gives a comprehensive overview of market share and growth opportunities of the In-Vitro Diagnostics and Cell Culture Medias market as per type and application. The report also covers key manufacturers’ profiles with sales and gross margin data.
The key manufacturers covered in this report: Breakdown data in Chapter 3.
FUJIFILM Irvine Scientific
Nidacon International AB
Genea Biomedx
FertiPro
Kitazato Corporation
Vitrolife AB
Microm Ltd
City Fertility
Corning Incorporated
Gynemed
Others
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This study considers the In-Vitro Diagnostics and Cell Culture Medias value and volume generated from the sales of the following segments:
Segmentation by type: breakdown data from 2017 to 2022, in Section 2.3; and forecast to 2028 in section 11.7.
Reagent
Medium
Segmentation by application: breakdown data from 2017 to 2022, in Section 2.4; and forecast to 2028 in section 11.8.
Hospital
IVF Research Center
Others
The latest developments of the industry and the sales channel, manufacturing process along with the manufacturing cost study is covered in the report.
Key Questions Answered –
What will be the In-Vitro Diagnostics and Cell Culture Medias market CAGR and size between 2022-2028?
Who are the top/leading players of the In-Vitro Diagnostics and Cell Culture Medias market?
What changes are expected in the In-Vitro Diagnostics and Cell Culture Medias market in the next six years?
Which are the top product and leading applications of the In-Vitro Diagnostics and Cell Culture Medias market?
What are the leading market drivers and major risks factors for the In-Vitro Diagnostics and Cell Culture Medias market?
Which region/country leads and foresees highest growth in the next six years?
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The fetal bovine serum market is expected to witness market growth at a rate of 6.50% in the forecast period of 2021 to 2028, and is estimated to reach the value of USD 1,088.31 million by 2028
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The fetal bovine serum market is expected to witness market growth at a rate of 6.50% in the forecast period of 2021 to 2028, and is estimated to reach the value of USD 1,088.31 million by 2028.
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Fetal Bovine Serum Market Research to Expand at a Higher CAGR During Forecast | Top Players Thermo Fisher Scientific Inc., Merck KGaA, Atlanta Biologicals Inc.
Fetal Bovine Serum Market Summary 2022-2030
Straits Research's latest report on, Fetal Bovine Serum Market - Global Industry Overview and Forecast 2022-2030, highlights potential, risk factor analyses, and enhanced with strategic and tactical decision-making assistance. The growth and regulatory factors impacting information consumption, the availability of highly dependable items in the market, and the improvement in operating efficiency of Fetal Bovine Serum industry players.The fetal bovine serum (FBS) market size was valued at USD 879.9 million in 2021 and is expected to generate USD 1,401.23 million by 2030. The market is projected to grow at a CAGR of 5.69% during the forecast period (2021–2030). Fetal Bovine Serum Market Research covers market trends and development, drivers, capacities, technologies, and the changing dynamics of the Fetal Bovine Serum Market.
Competitive Landscape
Some of the prominent players operating in the Fetal Bovine Serum market are Thermo Fisher Scientific Inc., Merck KGaA, Atlanta Biologicals Inc., Tissue Culture Biologicals, HiMedia Laboratories, Bovogen Biologicals Pty Ltd., Rocky Mountain Biologicals, TCS Biosciences Ltd., PAN-Biotech and GE Healthcare.
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Studies explore the effects of COVID-19 on the upstream, midstream, and downstream sectors of the industry. In addition, this analysis provides extensive market estimations by putting an emphasis on data covering numerous factors that encompass market dynamics such as market drivers, market barriers, market opportunities, market risks, and industry news and trends.
This research also provides a dashboard view of prominent organisations, highlighting their effective marketing tactics, market share and most recent advances in both historical and current settings.
Global Fetal Bovine Serum Market: Segmentation
As a result of the Fetal Bovine Serum market segmentation, the market is divided into sub-segments based on product type, application, as well as regional and country-level forecasts. By Product, Charcoal Stripped, Chromatographic, Dialyzed Fetal Bovine Serum (FBS), Exosome Depleted, Stem Cell, Embryonic Stem Cells Qualified, Mesenchymal Stem Cell Qualified, Others By Application, Drug Discovery, Cell Culture Media, In vitro Fertilization, Human and Animal Vaccine production, Diagnostics, Others By End-Users, Research & Academic Institutes, Industry, Pharma, Biotech, Others
The report forecasts revenue growth at all the geographic levels and provides an in-depth analysis of the latest industry trends and development patterns from 2020 to 2030 in each of the segments and sub-segments. Some of the major geographies included in the market are given below:
North America (U.S., Canada)
Europe (U.K., Germany, France, Italy)
Asia Pacific (China, India, Japan, Singapore, Malaysia)
Latin America (Brazil, Mexico)
Middle East & Africa
You may buy this document on Buy Fetal Bovine Serum Market Report
The following are the report's key features:
It gives useful information on the Global Fetal Bovine Serum Market.
Information for the years 2022-2030 is provided.
Market-related important factors are highlighted.
The latest technological innovations, government restrictions, and developments are presented.
This paper investigates advertising and marketing techniques, market trends, and analysis.
Growth projections and analyses by forecast 2030.
The statistical analysis of the market's leading competitors is emphasised.
Fetal Bovine Serum Market summary based on extensive study.
Other aspects of the report include:
Provides a complete review of important tactics in numerous firms, with an emphasis on corporate structure, R&D processes, localization strategies, manufacturing capabilities, sales, and performance.
Provides essential product portfolio information, including product planning, development, and positioning.
Analyzes the role of significant market participants, as well as their collaborations, mergers, and acquisitions.
The Table of Contents and Figures of the Full Report are available for your perusal Fetal Bovine Serum Market Report with TOC
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#Fetal Bovine Serum Market#Fetal Bovine Serum Market Share#Fetal Bovine Serum Market Size#Fetal Bovine Serum Market Research#Fetal Bovine Serum Industry#What is Fetal Bovine Serum?
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For decades, laboratory testing on human serum samples has been an essential tool for clinical diagnosis, therapeutic monitoring, and biomedical research. Human serum refers to the supernatant fluid extracted from whole blood samples by coagulation and subsequent removal of blood cells by centrifugation. It is composed of proteins, antibodies, electrolytes, minerals, vitamins, antigens, hormones, etc. Sometimes, human serum samples contain drugs, toxins, and pathogens. It is a highly specific and sensitive matrix for assessing an individual’s health status.
Uses of human serum samples
In modern medical research, investigation on human serum samples is a vital resource in gaining deeper insights into human physiology and disease biology. Especially in the in-vitro diagnostic (IVD) industries, studies on human serum samples guide the development of next-generation diagnostic tests or equipment. On the other hand, in clinical practice, laboratory testing's on human serum samples enable treatment by measuring the drug concentration in blood. Therapeutic drug monitoring on patient serum helps to prevent expected adverse effects and drug toxicities of narrow therapeutic index drugs. Furthermore, it allows the assessment of the patient’s response to the drug therapy. Also, nowadays human serum is widely used as media for human cell culture for genomic and immunological research.
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Bovine Blood Plasma Derivatives Market Detailed in New Research Report 2017-2025
Bovine Blood Plasma Derivatives Market: Overview
Development in the healthcare sector has also been of the key focus in North American region. A similar growth and development is seen in the bovine blood plasma derivatives market that made North America a leading region. Presence of key players that are making constant efforts through research and development activities in this region is the major reason for the growth of this region in the global bovine blood plasma derivatives market. Apart from investment made in R&D, leading players are also establishing relationship by initiating mergers and acquisition with other companies mainly to extend their geographical presence.
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On the other hand, Asia Pacific is also expected to offer lucrative growth opportunities for the stakeholder in the global bovine blood plasma derivatives market. Rising initiative taken by governments in different regions is giving approvals to export products such as serum and cattle protein is considered as key factor behind Asia Pacific bovine blood plasma derivatives market growth. Demand for bovine blood plasma derivatives is high in India, China, and from countries in Southeast Asia that made this region a key market.
Besides, geographical growth of the global bovine blood plasma derivatives market, the revenue generation in this market is also expected to rise significantly in the coming years. Based on the Transparency Market Research on the global bovine blood plasma derivatives market, revenue generation is expected to reach US$2.19 billion by the end of 2025. This figure is substantially high that the revenue earned in 2016 that is US$1.33 billion, thus creating an incremental opportunity of nearly US$ 0.86 billion over the forecast period between 2017 and 2025.
Development of New Drugs through R&D – A Key Strategy Used by Players
Players operating in the global bovine blood plasma derivatives market are focusing on various business development strategies to increase their shareholding in the market. In terms of market structure, this market is fragmented in nature due to the presence of large number of players. Prominent players analyzed in this report include Rocky Mountain Biologicals Inc., Thermo Fisher Scientific, Inc., Proliant Inc., Auckland BioSciences Ltd., Sigma-Aldrich Co. (Merck KGaA), Bovogen Biologicals Pty Ltd., and Lake Immunogenics, Inc. Besides, the leading players, presence of large number of small players are also seen in the global market. For example, LAMPIRE Biological Laboratories acquired about 180+ acre corporate dairy farms in Bedford County, Pennsylvania. After this initiative, LAMPIRE Biological Laboratories planned to offer valuable biological raw materials to research and diagnostic companies across the globe.
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Increasing Application of Thrombin Due To High R&D Likely to Benefit Market’s Growth
In terms of derivatives types, the demand for thrombin is comparatively higher than fibrinogen, immunoglobulin, new born calf serum, fetal bovine serum, serum albumin, transferrin, and others including BGG. According to the report, the thrombin segment held larger share in 2017, as compared to other derivatives types. This rise was mainly because of its increasing usage during surgeries and diagnostic purposes. Increasing research and development activities including as medical research, in vitro study, protein structure analysis, biochemical, coagulation research has augmented application of thrombin. Moreover, there are high chances of growth of bovine serum albumin in the coming years and stand at the second position by the end of forecast period. Applications of bovine serum albumin are seen in the drug formulation, food industry, and as a component of media for cell culture. Its use is also seen in the manufacturing several vaccines and in cell culture related work, comprising effective washing of cells and cryopreservation.
The study presented here is based on a report by Transparency Market Research (TMR) titled “Bovine Blood Plasma Derivatives Market (Derivatives Type - Immunoglobulin, Fibrinogen, Bovine Serum Albumin, Fetal Bovine Serum, Thrombin, Transferrin, New Born Calf Serum, and BGG; Application - Pharmaceutical Industry, Diagnostic Industry, Cell Culture or Biotechnology, Research and Development, Food Industry, Cosmetic Industry, and Nutrition Supplements) - Global Industry Analysis, Size, Share, Growth, Trends, & Forecast 2017 - 2025”.
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Fetal Bovine Serum Market : Emerging Trends, Business Growth Opportunities, Major Driving Factors
Transparency Market Research (TMR) has published a new report titled, ‘Fetal Bovine Serum Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027’. According to the report, the global Fetal Bovine Serum Market was valued at US$ 910.6 Mn in 2018 and is projected to expand at a CAGR of 5.8% from 2019 to 2027.
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Overview
· Fetal bovine serum (FBS) is used as a supplement to basal growth medium in cell culture because of its high content of embryonic growth promoting factors.
· The serum provides a wide variety of macromolecular proteins, low molecular weight nutrients, carrier proteins for water insoluble components, and other compounds necessary for in vitro growth of cells, such as hormones and attachment factors and also adds buffering capacity to the medium and binds or neutralizes toxic components.
· Fetal bovine serum (FBS)-based media remains the gold standard for MSC isolation and expansion for both basic research and clinical application and has been defined as common protocol by the Developmental Committee of the European Group for Blood and Marrow Transplantation (EBMT).
· North America dominated the global Fetal Bovine Serum Market in 2018 and the trend is anticipated to continue during the forecast period. Highly development of biopharmaceuticals and funding available from the government are expected to drive the market in North America.
· Asia Pacific is likely to be a highly lucrative market because of the research and development in the region and it is expected to expand at a high CAGR during the forecast period
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Rising consumption of fetal bovine serum in emerging markets drive the market
· There is a demand in emerging countries such as China, India, South Korea, and countries of the Middle East for fetal bovine serum market and it is increasing. China imported fetal bovine serum from the U.S. to fulfill the domestic demand.
· The consumption of fetal bovine serum imported from the U.S. by South Korea in 2015 stood at 20,000 liters, which is expected to increase in the next few years
· The increasing number of contract research organizations in Asia, especially China and India, is driving the demand for fetal bovine serum in the region. This, in turn, is expected to drive the global fetal bovine serum market during the forecast period.
Cell Culture Media Segment to Dominate Market
· Based on Application, the global Fetal Bovine Serum Market has been divided into Drug Discovery, Cell Culture Media, In vitro Fertilization, Human and Animal Vaccine production, Diagnostics and Others
· The Cell Culture Media segment dominated the global Fetal Bovine Serum Market in 2018 and the trend is projected to continue during the forecast period. Increase in use of Cell Culture Media to accelerate the growth of the segment.
· The research and development carried out in various region boost the Cell Culture Media segment market during the forecast period.
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Industry (pharma, biotech, etc.) to be Highly Lucrative Segment
· In terms of end user, the global Fetal Bovine Serum Market has been classified into Research & Academic Institutes and Industry (pharma, biotech, etc.).
· The Industry (pharma, biotech, etc.) segment dominated the Fetal Bovine Serum Market due to increased R&D and production of vaccines and rise in biopharmaceutical industry.
North America to Dominate Global Market
· In terms of region, the global Fetal Bovine Serum Market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global Fetal Bovine Serum Market in 2018, followed by Europe.
· North America dominated the global Fetal Bovine Serum Market in 2018 and the trend is anticipated to continue during the forecast period. Highly development of biopharmaceuticals and funding available from the government are expected to drive the market in North America.
· The Fetal Bovine Serum Market in Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. This can be attributed to rapid economic growth in developing economies such as India, China, Indonesia, Vietnam, South Korea, and the Philippines.
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Competitive Landscape
· The global Fetal Bovine Serum Market is fragmented in terms of number of players. Key players in the global market include Merck KGaA, GE Healthcare, Thermo Fisher Scientific Inc., TCS Biosciences Ltd., HiMedia Laboratories, Atlanta Biologicals, Inc., PAN-Biotech, Rocky Mountain Biologicals, Bovogen Biologicals Pty Ltd., Tissue Culture Biologicals among others
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Cell Culture Media Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2025
The report on the global cell culture media market provides qualitative and quantitative analysis for the period from 2017 to 2025. The report predicts the global cell culture media market to grow with a CAGR of 8.1% over the forecast period from 2019-2025. The study on cell culture media market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and RoW for the period of 2017 to 2025. The report on cell culture media market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global cell culture media market over the period of 2017 to 2025. Moreover, the report is a collective presentation of primary and secondary research findings.
Get More Information Here: https://www.sdki.jp/sample-request-103964 Porter's five forces model in the report provides insights into the competitive rivalry, supplier and buyer positions in the market and opportunities for the new entrants in the global cell culture media market over the period of 2017 to 2025. Further, IGR- Growth Matrix gave in the report brings an insight into the investment areas that existing or new market players can consider. Report Findings 1) Drivers • Increasing research and development activities for biological drug development • Increasing manufacturing of biopharmaceuticals 2) Restraints • High cost of the culture media and their maintenance 3) Opportunities • Increasing funding and new innovations can provide better opportunities to the market in forecast period Research Methodology A) Primary Research Our primary research involves extensive interviews and analysis of the opinions provided by the primary respondents. The primary research starts with identifying and approaching the primary respondents, the primary respondents are approached include 1. Key Opinion Leaders associated with Infinium Global Research 2. Internal and External subject matter experts 3. Professionals and participants from the industry Our primary research respondents typically include 1. Executives working with leading companies in the market under review 2. Product/brand/marketing managers 3. CXO level executives 4. Regional/zonal/ country managers 5. Vice President level executives. B) Secondary Research Secondary research involves extensive exploring through the secondary sources of information available in both the public domain and paid sources. At Infinium Global Research, each research study is based on over 500 hours of secondary research accompanied by primary research. The information obtained through the secondary sources is validated through the crosscheck on various data sources. The secondary sources of the data typically include 1. Company reports and publications 2. Government/institutional publications 3. Trade and associations journals 4. Databases such as WTO, OECD, World Bank, and among others. 5. Websites and publications by research agencies Segment Covered The global cell culture media market is segmented on the basis of product type, application, and end user. The Global Cell Culture Media Market by Product Type • Serum-free Media • Chemically Defined Media • Lysogeny Broth • Classical Media • Stem Cell Media • Specialty Media • Other Product The Global Cell Culture Media Market by Application • Biopharmaceuticals • Biological Drug Discovery • Cancer Research • Tissue Engineering • Stem Cell Technologies • Other Applications The Global Cell Culture Media Market by End User • Academic Institute • Research And Development Laboratory • Biotechnology Industry • Other End User Company Profiles The companies covered in the report include • Becton • Dickinson and Company (BD) • Bio-Rad Laboratories Inc. • GE Healthcare • Merck & Co., Inc. • Thermo Fisher Scientific Inc. • Vitro Diagnostics, Inc. • Avantor Performance Materials • Sartorius AG • HiMedia Laboratories Pvt., Ltd • Other companies What does this report deliver? 1. Comprehensive analysis of the global as well as regional markets of the cell culture media market. 2. Complete coverage of all the segments in the cell culture media market to analyze the trends, developments in the global market and forecast of market size up to 2025. 3. Comprehensive analysis of the companies operating in the global cell culture media market. The company profile includes analysis of product portfolio, revenue, SWOT analysis and latest developments of the company. 4. IGR- Growth Matrix presents an analysis of the product segments and geographies that market players should focus to invest, consolidate, expand and/or diversify.
The dynamic nature of business environment in the current global economy is raising the need amongst business professionals to update themselves with current situations in the market. To cater such needs, Shibuya Data Count provides market research reports to various business professionals across different industry verticals, such as healthcare & pharmaceutical, IT & telecom, chemicals and advanced materials, consumer goods & food, energy & power, manufacturing & construction, industrial automation & equipment and agriculture & allied activities amongst others.
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Global Fetal Bovine Serum Market 2019 By Segment Forecasts 2026
Growth of the Fetal Bovine Serum Market is due to proper concentration use which can fulfill specific metabolic requirements for the cell culture. Furthermore, the market growth is attributed to the use of high content of hormones, carrier proteins, and macromolecular proteins in biotechnological research.
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The Major Players Covered in this Report: Thermo Fisher Scientific Inc., Merck KGaA, Atlanta Biologicals Inc., Tissue Culture Biologicals, HiMedia Laboratories, Bovogen Biologicals Pty Ltd., Rocky Mountain Biologicals, TCS Biosciences Ltd., PAN-Biotech and GE Healthcare., & more....
Fetal Bovine Serums Market Segmentation: By Product
Charcoal Stripped
Chromatographic
Dialyzed Fetal Bovine Serum (FBS)
Exosome Depleted
Stem Cell
Others
Embryonic Stem Cells Qualified
Mesenchymal Stem Cell Qualified
By Application
Drug Discovery
Cell Culture Media
In vitro Fertilization
Human and Animal Vaccine production
Diagnostics
Others
By End-Users
Research & Academic Institutes
Industry
Pharma
Biotech
Others
Growing Domestic Demand and Expanding Pharmaceutical Sector to Drive the Demand for Fetal Bovine Serum in the APAC Region Asia-Pacific region is anticipated to hold the largest market share in the global Fetal Bovine Serum market during the forecast period 2017-2026. The growth in this region can be attributed to the presence of emerging economies like India, China, Japan, Vietnam, and Indonesia, which account for the largest share in this region. India is one of the largest producers of Fetal Bovine Serum and a major exporter of the product to various countries across the globe. India accounts for around 80% of the world’s exports of Fetal Bovine Serum. The favorable climatic conditions and growth of agricultural inputs and allied services like cold storage and warehousing in India are prompting higher production.
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Why buy this report?
Historical inferences, findings & analysis of the market from 2016 to 2018
Projections and performance forecast analysis for the future from 2019 to 2026
Production and consumption point of view (POV) analysis
Market drivers, restraint and opportunity analysis, to define market dynamics covering industry, regulatory, innovation, technological & pricing trends
Comprehensive competitive landscape mapping with recent development covering market leadership, competency, sustainability, and prospects.
#fetal bovine serum#healthcare#pharma#fbs#market growth#market analysis#market research#straits research
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Fetal Bovine Serum Market Research Reports 2021 | Global Industry Size
Fetal Bovine Serum Market Research Report Show the Huge Information By Product Type Charcoal Stripped, Exosome Depleted, Stem Cell, by Application Drug Discovery, Cell Culture Media, In-Vitro Fertilization, by End User Pharmaceutical, Biotechnology – Global Forecast Till 2023
Key Players:
Some of the key players in the global fetal bovine serum market are HiMedia Laboratories, Merck KGaA, Bovogen Biologicals Pty Ltd, Atlanta Biologicals Inc., TCS Biosciences Ltd, Tissue Culture Biologicals, Rocky Mountain Biologicals, GE Healthcare, Thermo Fisher Scientific, Bio-Techne, PAN-Biotech, Access Biologicals, Animal Technologies Inc., Nucleus Biologics, Biological Industries, Corning Incorporated, J R Scientific Inc., Moregate Biotech, Wisent Inc, Zhejiang Tianhang Biotechnology Co. Ltd., among others.
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Segmentation:
The global fetal bovine serum market is segmented on the basis of product type, application, and end user.
Currently, the global fetal bovine serum market is dominated by numerous players. The major players in this market are involved in new product launches, strategic partnerships and collaborations to increase their product portfolio. For instance, In January 2018, Bio-Techne announced the acquisition of Atlanta Biologicals, with the acquisition aimed at expanding the product portfolio of the company and service capabilities.
Fetal Bovine Serum Market – Highlights
It is estimated that the global fetal bovine serum market is expected to register a CAGR ~ 8% during the forecast period of 2018–2023. Fetal bovine serum is a key feedstock in pharmaceutical, diagnostics, biotechnology, diagnostic, and veterinary industries.
The global fetal bovine serum market is expected to witness tremendous growth owing to the increase in demand from traditional users of serum is also expected to drive the market. Other key factors such as the untapped market opportunities in emerging countries, growing investments by government organizations are contributing towards the growth of the market. However, in the previous years, the serum industry is witnessing product shortage due to uncertain climatic conditions along with rising demand for beef and dairy product that has led to a radical drop in cattle herd population are few factors restraining the growth of the market.
Regional Analysis:
On the regional basis, the fetal bovine serum market in the Americas is predicted to dominate the market during the forecast period. The North American region holds substantial share in the global market. This owes to the high consumption and pricing of fetal bovine serum in the region. Also, numerous major players are based in the US, owing to this the country has become a center for innovation in the fetal bovine serum market.
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Culture Media Market COVID 19 Impact & In-Depth Analysis till 2025
Facto Market Insights as of late distributed statistical surveying report on the worldwide Culture Media Market to its assortment of statistical surveying reports. The exploration report covers point by point examination of market measuring and anticipating of the market covering the market drivers, challenges, opportunity investigation, and patterns, alongside different key bits of knowledge in the worldwide market. The examination report additionally incorporates the investigation of territorial producers and new market players, covering all the data reasonable for the customers to settle on essential business choices in the business.
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The report covers PESTLE examination and watchman's five powers investigation which exhibits the five powers including purchasers bartering power, providers haggling power, the danger of new participants, the danger of substitutes, and level of rivalry in the worldwide culture media market. In the investigation, the system of watchman's five powers examination clarifies the technique for breaking down the opposition of the business covering the business structure and the degree of rivalry in the market. Along with this, the exploration report additionally covers current realities and figures identified with the macroeconomic patterns that are expected to affect the development of the general market.
Following are the Main Features of Global Culture Media Market Report:
- Market Overview, Industry Development, Market Maturity, PESTLE Analysis, Value Chain Analysis
- Growth Drivers and Barriers, Market Trends & Market Opportunities
- Market Segments by Geographies and Countries
- Porter’s Five Forces Analysis & Trade Analysis
- Market Segment Trend and Forecast
- Market Forecast Analysis for 2021-2025
- Key Market Driving Factors
- Market Analysis and Recommendations
- Price Analysis
- Culture Media Market Company Analysis: Company Market Share & Market Positioning, Company Profiling, Recent Industry Developments etc.
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Market Segmentation:
The exploration offers an extensive investigation of worldwide culture media market concerning following sub-markets:
By Type o Lysogeny Broth o Chemically Defined Media o Classical Media o Serum-free Media o Specialty Media o Stem Cell Media o Custom Media Formulation o Others
By Application o Cancer Research o Biopharmaceuticals o Regenerative Medicine & Tissue Engineering o Stem Cell Technologies o Drug Discovery o Others • By Research Type o Cytogenetics o Cell Therapy o Others
By End User o Biotechnology & Pharmaceutical Industry o Academic Institute o Research Laboratory o Others
Regional Insights:
The report investigations the market by geologies for example North America, Europe, Asia Pacific, Latin America and Middle East and Africa. Further, the regions are fragmented into the country and regional groupings:
- North America (U.S. & Canada)
- Europe (Germany, United Kingdom, France, Italy, Spain, Russia, and Rest of Europe)
- Asia Pacific (China, India, Japan, South Korea, Indonesia, Taiwan, Australia, New Zealand, and Rest of Asia Pacific)
- Latin America (Brazil, Mexico, and Rest of Latin America)
- Middle East & Africa (GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, and Rest of Middle East & Africa)
Competitive Landscape
The report includes profiles of leading companies in the global culture media market. Some of the key players profiled include:
o Avantor Performance Materials, LLC (VWR International, LLC) o Becton, Dickinson and Company (BD) o Bio-Rad Laboratories Inc. (Bio-Rad) o Caisson Laboratories, Inc. (Caisson Labs) o Cell Culture Technologies LLC (Cell Culture Technologies) o Corning Incorporated (Corning) o Fujifilm Holdings Corporation (Fujifilm) o GE Healthcare o HiMedia Laboratories Pvt., Ltd. (HiMedia) o Lonza Group Ltd (Lonza) o Merck & Co., Inc. (Merck) o Sartorius AG (Sartorius) o Sera Scandia A/S (Sera Scandia) o Thermo Fisher Scientific Inc. (Thermo Fisher) o Vitro Diagnostics, Inc. The other players included in the value chain analysis (and not included in the report) include: o Takara Bio, Inc. o Cyagen Biosciences
Reasons to purchase the report:
- Identify possible investment areas based on a comprehensive trend analysis of the global culture media Market over the next few years.
- Gain in-depth knowledge of the underlying factors that drive demand for culture media and recognize the opportunities provided by them.
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- Strengthen the business knowledge in terms of industry dynamics, demand drivers, and the latest technological advances among others.
- Channelize funds by concentrating on the ongoing initiatives pursued by the numerous countries in the global culture media market.
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Biomed Grid | How Do We Clean Up This Mess? - A Review of The Testing Methodologies Used for Detection of Live Bacteria in Healthcare Environments
Abstract
In light of the increasing numbers of disinfectant resistant bacterial species, and the proven direct link between disinfectant resistance and antibiotic resistance, the detection of live bacteria in high risk environments within healthcare, is of increasing importance. The benefits of accurate identification, and in some cases quantification, is paramount in indicating the effectiveness of cleaning products, protocols and therefore safety to practice for patients and staff. A review of the currently available environmental testing methods, highlighting those tests most appropriate for the different areas of our healthcare services has been explored. Looking at the latest technological advances in surface and microbiological testing, to determine their efficiency in adequately detecting organisms of potential significance, and therefore informing us of the most appropriate ways in which to treat areas that have been potentially contaminated. The outcome of using the correct testing methods can determine the true impact of surface contamination in primary and cross infection. Moreover, informing us of the effectiveness of cleaning interventions in the hope of decreasing potential causes of infection (including staff behaviours) and subsequently improving patient outcomes.
Keywords: Disinfectant resistance; Bacterial detection; live bacteria; hospital environments; surface detection
Historical Perspective
We have been aware of microorganisms and their impact on human health for over 150 years. Anton Van Leeuwenhoek was the first person to document microscopic observations of bacteria in 1676 (although a Jesuit priest, Athanasius Kircher is also credited by some as the first to observe microorganisms at around the same time). In 1878 Robert Koch discovered how to grow bacteria in a Petri dish (named after his assistant Julius Petri). Circa 1900 Martinus Beijernick extended the work of both Koch and Pasteur to develop what is now the enrichment culture techniques used today. However, in the present day, it is generally believed that the vast majority of microorganisms present in common environments cannot be successfully cultured and characterised using current standard testing methods [1-5]. Ever since the discoveries of Semmelweis in 1847, and in spite of our industrial, academic and clinical efforts to reduce HAI’s (Hospital Acquired Infections), we have had varying degrees of success. There have been longstanding theories and hypotheses surrounding the contributing factors to HAIs; for example, effectiveness of hand hygiene and the impact of airborne contaminates amongst many others. Although there has been a significant amount of research done in the food preparation sector, until recently there has been limited evidence focused on surface bio burden, and its relevance in specialised critical areas of healthcare [6-8].[6,8].
The root cause of this is multifactorial, although one main reason can be associated with the technological advances, or lack thereof in the standard testing methodology used to confirm successful cleaning of clinical areas. In 2004, when Dancer proposed a standard for microbiological assessment of surfaces, many routine molecular techniques were not available outside either academic research or the military [5]. It took over a decade more, before the creation of the UK Environmental Special Interest Group (ESIG) with a remit to explore further advances and changes around updated standards (Data unpublished). It is therefore unsurprising that many healthcare facilities and researchers still consider culture as the “gold standard” for confirmation of the absence of potential pathogens that could cause HAIs [9]. These test methodologies are used predominantly to initially detect the presence or absence of microorganisms and to subsequently identify ideally to a species level. However, techniques such as culture have not changed significantly in many years and continue to have significant limitations in both sensitivity and specificity. Although a pure bacterial culture remains important for the study of virulence, antibiotic susceptibility, and genome profiling in order to facilitate the understanding and treatment of caused diseases, there continues to be little correlation between in-vitro evidence and its relevance in-situ.
The recent availability of molecular diagnostic technology has provided greater sensitivity and specificity in the detection of microorganisms. Evidence would suggest improvement in detection methods provides greater insight into the efficiency of current cleaning and decontamination of clinical environments [10]. Improved detection methods may also help us to understand the true extent of bacterial resistance to disinfectants. It is now considered “routine” for molecular diagnostics to deliver results in hours and minutes compared to traditional culture results taking days and in some cases weeks.
Current Available Tests
Visual inspection
Unfortunately, due to many factors including the lack of a fast, accurate test, visual inspection is still used by the vast majority of healthcare institutions, even though the evidence is clear that it is not an accurate test of cleanliness, let alone bioburden [11,12].
Total ATP
Adenosine Tri Phosphate is present in all living cells except viruses. It is measured by the inexpensive test kits, in relative light units (RLU), and is a fast, simple way to measure extra cellular and some intra cellular ATP. Total ATP testing has been undertaken for more than a decade in the food industry, yet no statistically relevant direct relationship has been found between RLU and Colony Forming Units (CFU) [13,14]. As there is no certainty that the test equipment is able to measure intra cellular ATP, even a zero count cannot be considered relevant.
Culture
The first culture conditions used various parameters such as incubation time, nutrients, atmosphere, and temperature. Refinement around such parameters has continued since its conception over 100 years ago. The use of culture in clinical microbiology was prompted by microbiologists initially specializing in intracellular bacteria [15,16]. The shell vial procedure allowed the culture of new species of Rickettsia. The design of axenic media for growing fastidious bacteria such as Tropheryma whipplei and Coxiella burnetii, and the ability of amoebal coculture to discover new bacteria constituted major advances. Strong efforts associating optimized culture media, detection methods, and a microaerophilic atmosphere allowed a dramatic decrease of the time of Mycobacterium tuberculosis culture. The use of a new versatile medium allowed an extension of the repertoire of archaea. Finally, to optimize the culture of anaerobes in routine bacteriology laboratories, the addition of antioxidants in culture media under an aerobic atmosphere, allowed the growth of strictly anaerobic species [17-19,]. There is increasing need to improve the relevance of in-vitro testing and provide much greater correlation between the evidence gained within the laboratory environment, and that of the clinical setting.
This should ultimately lead to a better understanding of the colonisation of clinical surfaces, and how those organisms change in characteristics and concentration over time. Although there are a large number of reasons that surface bacterium may not be easily cultured in the lab, most of these can be reduced to the difficulty of replicating the very precise environment conditions certain microbes require for growth. Early culturing efforts focused on microbes that were easily grown under standard conditions, largely due to adaptation to the incubator-like conditions of an animal body. By contrast, free-living environmental microbes can have a broad array of environmental requirements. One example of interest is the discovery that many organisms cannot survive in the high-nutrient conditions favoured by standard cultural practices [1,2,20,21]. The development of low-nutrient media has greatly increased the number of organisms that have been successfully cultured. Many soil organisms are incapable of surviving under high-oxygen conditions. These obligate anaerobes would naturally not survive standard culturing approaches, but there have been some successes with growing them in anaerobic chambers [22]. However, in respect to cultures usefulness in accurately testing the efficacy of disinfectants, the US CDC states, “Attempts to substantiate the bactericidal label claims of phenolics using the AOAC Use-Dilution Method occasionally have failed” [23]. However, results from these same studies have varied dramatically among laboratories testing identical products (Figure 1 ) [24].
Figure 1: A typical culture plate depicting organism growth from a nonsterile site.
Polymerase Chain Reaction (PCR)
PCR is a technique used to amplify a segment of DNA across several orders of magnitude [25]. This then generates thousands to millions of copies of a particular DNA sequence. Developed in 1983 by the Cetus Corporation [26], it is a reliable way to repeatedly replicate a focused segment of DNA. This technique is used in biomedical research, criminal forensics, and molecular archaeology [27]. PCR is now a common and often indispensable technique used in clinical and research laboratories for a broad variety of applications. For example, these applications can include DNA cloning for sequencing, gene cloning and manipulation, functional analysis of genes and detection and characterisation of microorganisms causing disease. The vast majority of PCR methods rely on thermal cycling, which involves exposing the reactants to cycles of repeated heating and cooling, permitting different temperature- dependent reactions, specifically, DNA melting and enzyme-driven DNA replication [28]. Short DNA fragments containing sequences comple mentary to the target region, along with a DNA polymerase, enable selective and repeated amplification. As the PCR progresses, the DNA generated is itself used as a template for replication, setting in motion a chain reaction in which the original DNA template is exponentially amplified.
Figure 2: Conventional PCR Cycle, involving DNA, primers and nucleotides, with typical temperatures associated with each reaction step.
The simplicity of the basic principle underlying PCR means it can be extensively modified to perform a wide array of genetic manipulations previously described. In terms of detection and characterisation of organisms causing disease, PCR has been used in environmental sampling for some time and in certain situations has been an advantage when compared with more traditional culture techniques. Such examples would be detection of legionella from water sources, where often culture techniques would take several days, whereas a PCR can take several hours (Figure 2) [29,30]. The challenge we have with all these techniques is understanding the unknown bio burden of an environmental sample. Techniques are rapidly developing, looking at the Microbiome of a sample type. These are techniques which identify and semi-quantify the organisms which exists within a sample type. However, understanding their relationship to one another and how they communicate, as well as how they interact with other hosts, such as humans, still remains an area of active research (Figure 3).
Figure 3: Real-Time PCR (RT-PCR) graph depicting the amplification curves for a number of different pathogens (A-E), which are translated into Cycle Threshold (CT) values. A positive reaction is detected by accumulation of a fluorescent signal. The CT is defined as the number of cycles required for the fluorescent signal to cross the threshold (e.g. exceeds background level).
Bacteria Specific Rapid Metabolic Assay (BSRMA)
This test allows surface, water and air testing for estimation of bacterial bio burden/ load with increased sensitivity and specificity compared to culture techniques [31-33]. Within a few minutes of sampling, the assay measures only the live bacteria present and requires no culture procedures. This type of test should not be confused with the standard total ATP (Adenosine Tri Phosphate) tests used in some food manufacturing facilities, which due to the lack of any relationship between total ATP and bacterial ATP, have no diagnostic value. There are multiple recent studies regarding the efficacy of bacteriophage-related lytic enzymes (BPLE) or viruses that infect bacteria. By degrading the cell wall of the targeted bacteria, these lytic enzymes have been shown to efficiently lyse Gram-positive and Gram-negative bacteria [34]. Bacteriophages are viruses that kill bacteria. They do not contribute to antimicrobial resistance, are safe for humans, animals, and the environment. The current focus on BPLE’s has been on their use as anti-infectives in humans and more recently in agricultural research models. The initial translational application of lytic enzymes, however, was not associated with treating or preventing a specific disease but rather as an extraction method to be incorporated in a rapid bacterial detection assay [35].
We can trace the translational history of BPLE’s from their initial discovery in 1986 for the rapid detection of group A streptococcus in clinical specimens to evolving applications in the detection and prevention of disease in humans and in agriculture [30-31]. The three -stage test uses BPLE technology to removal of all Somatic cells (all cells except bacteria) from the sample (stage 1), leaving only living bacteria in the sample to be lysed for measuring (stage2). Luminescence is then added to the sample using the positive charge on the ATP within the cell to produce light. A direct correlation between cell numbers and amount of light produced shows a statistically proven 1 – 1 Relative Light Unit (RLU) to Colony Forming Unit count [31-32]. The BSRMA was compared with the gold standard culture techniques as part of a standard of care orthopaedic pathway within an NHS hospital. The difference in sensitivity of the two tests using the same samples was stark. It is clear from this, and other studies [36-37], that the BSRMA test method is far more sensitive than standard culture techniques and, increases the users’ ability to see the numbers of live bacteria, in areas previously determined to be bacteria free. Evidence of this is seen in a recent study [10], using the BSRMA test, at multiple time points over a 4-day period.
One of the most interesting findings in the study was the levels of contamination seen immediately after the finish of the operating list, after standard night-time cleaning with Sodium Hypochlorite, and then again immediately before the first patient entered the operating theatre the next morning. Importantly, this study showed that bacterial bioburden on surfaces had returned to approximately the same levels as at the end of the previous days operating lists. Had just culture been used, levels of bacteria on surfaces at all three time points would have remained unseen.
Summary
In environmental cleaning and contamination there are two main factors associated with HAI’s, namely, the types of microorganism’s present (identification and characterisation) and the amount present (Bio burden), primarily on clinically relevant surfaces. We still do not fully understand the true interactions between, air, surfaces and hands in our healthcare facilities, but we do know they are interrelated in respect to hosting CFUs and sponsoring HAIs. Prioritising these will depend greatly on the risks attached to the hospital department, and what procedures/ work is done in those areas. Operating rooms are one of the main high-risk areas within a hospital environment for maintaining perceived aseptic conditions. There has been for many years a focus on the quality of air filtering with recommendations on issues such as air pressure, air exchanges, temperature, humidity, and filtration levels. These have been reviewed every 10-15 years since the first attempt in HTM 2025, followed by HTM 03-01 [38-39]. In the same time period, environmental cleaning and testing has for the most part been left to individual departments to decide upon, with little standardised guidance [40-43].
With the ever-increasing numbers of antibiotic resistant and disinfectant resistant bacterial species, this situation will need to change if we are to provide a safe environment for surgery to take place. Professor Dame Sally Davies (current UK Chief Medical Officer) was correct in her assessment, “if we do not do something to change the current situation of an ever-increasing risk of resistant infection post-surgery, at some point in our future we will have to stop doing what we now consider routine surgical operations as the risk from infection will be greater than the risk of not having surgery” [44]. Until we can convince organisations such as the CDC and the WHO that there is sufficient evidence to support changes, we are left with many outdated guidance documents that still impact our behaviours [45,46]. Sometimes miss quoted as being spoken first by Albert Einstein, in 1981 US Narcotics anonymously published a brochure with the phrase “Insanity is repeating the same mistakes and expecting different results”. It is clear from these small samples of data, that a lot more work is needed to accurately determine the infection risks associated with surface bacterial bioburden. Choice of the most appropriate test methodology to determine levels of bio burden is key to successful intervention.
It is certain that we must learn more from our environment, and effect change in order to improve. We should perhaps consider thinking in the same terms as Peter Drucker a management consultant who is quoted as saying, “If you can’t measure it, you can’t improve it”. Regular, fast, accurate, reliable measurement of surfaces, air and hands, has to be the goal of all healthcare facilities if we are to improve the quality of the environment in which we treat our most vulnerable patients. If we cannot achieve this goal in a timely fashion, Dame Sally Davies’s prediction of “at some point in the future”, may end up be a lot closer than anyone would like to admit. The NHS environmental SIG has drafted an Environmental Cleaning Guidance and Standards Document (ECGSD) [7] which is hoped will be the basis of a new Healthcare Technical Memoranda (HTM) looking specifically at the issues of environmental cleaning and disinfection as suggested by Dancer in 2004. The risk averse healthcare systems are now paralysed by dogma and lack of true accountability [47]. The ECGSD guide will help users to decide, where to test, which test to use, in which areas, frequency of testing with a pass/ fail test standard relevant to risk. The final guidance from this is expected to be available to trusts in the near future with standards available soon after, this is of course dependant on approval by government.
Next Steps
A microbiological environmental cleaning hospital map that colour codes risk giving guidance on all these questions to hospital infection control, microbiologists and hospital cleaners may be appropriate to help simplify the bewilderingly complex risk/ materials/ test matrix.
Final Comments
The current methods of environmental hygiene audit in hospitals and other healthcare facilities need to be supported by microbiological sampling, and further developed in line with the sample pathway previously described. The focus on process has been well described, as is the focus on the people who support it. The potential for improved changes in the behaviour of staff who know they are being observed is well understood. Goodheart’s law, sometimes confused with Heisenberg’s uncertainty principle, but which is in fact a social analogue of Heisenberg’s uncertainty principle, states “Measuring the system usually disturbs it”. In reality, the Hawthorne effect, describes a type of reactivity in which individuals modify or improve an aspect of their behaviour in response to awareness of being observed. Each variation of the theme has a common core of understanding, “If people know they are being observed, they change their behaviour”. This idea has been described many times as the “observer expectancy effect” and has been used in industry and academic institutions over many years. It may significantly underutilise as a method of achieving improvements in healthcare staff behaviour [48-51]. It could therefore have a significantly positive impact in helping to reduce the now visualisable surface bioburden that is almost certainly endemic in our healthcare facilities.
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