#Saudi IVD Market by Applications
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Saudi Authorized Representative for Medical Devices | OMC Medical Limited
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Medical device manufacturers aiming to enter the Saudi market must comply with the Saudi Food and Drug Authority (SFDA) regulations. For companies without a legal entity in the Kingdom of Saudi Arabia (KSA), appointing a Saudi Authorized Representative (Saudi AR) is a mandatory requirement. This post explores the responsibilities of a Saudi AR and the advantages of working with medical device regulatory consultants in Saudi Arabia.
Key Responsibilities of a Saudi AR
Device Registration and Approvals: Managing and submitting medical device and IVD registration applications to the SFDA, a vital step in the Saudi medical device registration process.
Fee Administration: Overseeing all SFDA-related fees on behalf of the manufacturer.
Post-Market Compliance: Reporting adverse events, coordinating recalls or Field Safety Corrective Actions (FSCA), and notifying the SFDA of device modifications.
Regulatory Communication: Serving as the primary point of contact with the SFDA, addressing inquiries, and ensuring compliance with Saudi Arabia medical device regulations.
Distributor Independence: Protecting intellectual property and allowing manufacturers to maintain control over distribution strategies in Saudi Arabia.
Why Choose Us?
Streamlined Registration Process. Regulatory Expertise in UAE Compliance. Cost-Effective & Timely Support.
Contact us today to streamline your registration process.
Read full detailed article here: https://omcmedical.com/saudi-authorized-representative-for-medical-devices/
#saudimedicaldeviceregistration #sfda #saudimedicaldevicemarket
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Meticulous Research® Forecasts Middle East IVD Market to Reach $2.15 Billion by 2031
The report highlights market dynamics, growth drivers, key challenges, and opportunities across the region.
Meticulous Research®, a globally recognized leader in market intelligence, has released a new report titled, "Middle East IVD Market by Offering (Kits, Software), Technology (Immunoassay, Molecular Diagnostics [PCR, NGS, Microarray], Rapid Tests, Biochemistry), Application (Infectious Diseases, Oncology), Diagnostic Approach (Lab) - Forecast to 2031." According to the findings, the Middle East in vitro diagnostics (IVD) market is projected to reach $2.15 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.1% from 2024 to 2031.
Key Market Drivers
The growth of the Middle East IVD market is driven by several factors, including the rising prevalence of chronic and infectious diseases, increased demand for point-of-care (PoC) and rapid diagnostic solutions, expanding healthcare expenditures, and an aging population. Moreover, growing healthcare awareness, especially in countries such as the UAE and Saudi Arabia, is also contributing to market expansion. However, the high costs associated with IVD tests and inconsistencies in results from rapid diagnostic tests present challenges to sustained growth.
Download Sample Report Here: https://www.meticulousresearch.com/download-sample-report/cp_id=5764
Emerging Opportunities
Increasing awareness around early disease detection and personalized medicine, particularly in the UAE and Saudi Arabia, is creating opportunities for market players. These regions are witnessing an uptick in the adoption of advanced diagnostic technologies, which is expected to fuel demand in the coming years. Nonetheless, issues such as false positives in immunoassays and PoC tests remain significant hurdles that stakeholders need to address.
Competitive Landscape
The Middle East IVD market is dominated by global healthcare giants such as Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), BioMérieux S.A. (France), Danaher Corporation (U.S.), F. Hoffmann-La Roche (Switzerland), and Siemens Healthineers AG (Germany). Other key players include QIAGEN N.V. (Netherlands), Thermo Fisher Scientific Inc. (U.S.), and Bio-Rad Laboratories, Inc. (U.S.), among others.
Request Sample Report Here: https://www.meticulousresearch.com/request-sample-report/cp_id=5764
Market Segmentation Insights
The report provides a detailed breakdown of the Middle East IVD market based on various parameters:
Offerings: The kits and reagents segment is expected to register the highest growth rate due to their extensive use in diagnosing chronic and infectious diseases. This is attributed to the increasing volume of tests for diseases such as HIV and influenza, alongside growing consumer awareness of self-testing options.
Technologies: Molecular diagnostics, including PCR and next-generation sequencing (NGS), is expected to capture the largest market share in 2024, driven by the rising prevalence of communicable and non-communicable diseases and the need for high-volume, accurate testing.
Applications: Infectious disease testing is set to dominate the market, with respiratory infections, hepatitis, HIV, and sexually transmitted diseases (STDs) being the primary drivers. The region's aging population and increasing healthcare demand are also contributing to the rise in testing.
Diagnostic Approach: Point-of-care testing is expected to exhibit the highest growth, propelled by the increasing burden of chronic diseases and the launch of innovative PoC diagnostics by market leaders.
End Users: Hospitals and clinics will continue to be the largest segment, performing a wide range of diagnostic tests for various medical conditions, particularly in urban areas where access to healthcare services is more robust.
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Country Insights
Among the Middle Eastern countries, Saudi Arabia is projected to dominate the IVD market in 2024, largely due to its rapidly aging population, the high incidence of chronic and infectious diseases, and the growing adoption of self-testing. The Kingdom’s healthcare sector is also experiencing a boost thanks to its Vision 2030 strategy, which aims to elevate healthcare standards and increase investments in medical technologies. Healthcare expenditure in Saudi Arabia is expected to grow annually by 3.0% from 2022 to 2025, further supporting market growth.
Conclusion
The Middle East IVD market presents lucrative opportunities for growth, driven by evolving healthcare needs, technological advancements, and rising awareness around early disease detection. However, market players must navigate challenges related to pricing and diagnostic accuracy to fully capitalize on the region’s potential.
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About Meticulous Research®
Meticulous Research® is a globally recognized market research and consulting firm known for delivering in-depth insights across a variety of industries. We provide high-quality market intelligence and strategic guidance to clients across the globe.
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In Vitro Diagnostics Market To Reach $101.58 Billion By 2030
The global in vitro diagnostics market size is expected to reach USD 101.58 billion by 2030, according to a new report by Grand View Research, Inc. It is estimated to register a CAGR of 4.4% over the forecast period driven by the increasing geriatric population, COVID-19 pandemic, and technological advancements in diagnostics that are supporting its adoption. Technological advancements in terms of portability, accuracy, and cost-effectiveness are projected to be one of the high-impact rendering drivers. Technological advancements were further accelerated by the launch of COVID-19 IVD diagnostics and enhanced the adoption of instruments and consumables for technologies, such as PCR. Competitors in the market are increasingly adopting agreement and partnership strategies to maintain a constant flow of business for manufacturers & diagnostics for users.
These agreements are also a result of the harsh price containment strategies for government laboratories, which lowers the price in government settings. For instance, in April 2021, the Italian subsidiary of Seegene, Inc. received a USD 108.25 million tenders for public procurement for the supply of extraction reagents, as well as 7.15 million SARS-CoV-2 diagnostic tests. However, it increases the multiparty nature and complexity of the supply chain. The high prevalence of cancer and Cardiovascular Diseases (CVDs) globally is anticipated to drive diagnostic innovation to facilitate early diagnosis and meet the constantly evolving needs of consumers. Novel technologies, such as plasmonic PCR, are anticipated to commercially enter the market during the forecast period, influencing the business of existing products adversely.
Request a free sample copy or view the report summary: In Vitro Diagnostics Market Report
In Vitro Diagnostics Market Report Highlights
Molecular diagnostics is anticipated to grow at the fastest CAGR from 2024 to 2030 owing to the rising adoption and usage rate
Reagents held the largest market share owing to the surge in demand for genetic testing and enhanced availability of technologically advanced diagnostic tests in lower and middle-income countries with unmet clinical needs
The infectious diseases application segment held the largest market share owing to the large volume of testing for infectious diseases globally
North America dominated the global market in 2023 owing to the high demand for novel technologies, a large pool of key players, high prevalence of diseases, and advanced healthcare infrastructure
In Vitro Diagnostics Market Segmentation
Grand View Research has segmented the global in vitro diagnostics (IVD) market report based on product, technology, application, end-use, test location, and region:
IVD Product Outlook (Revenue, USD Million, 2018 - 2030)
Instruments
Reagents
Services
IVD Technology Outlook (Revenue, USD Million, 2018 - 2030)
Immunoassay
Instruments
Reagents
Services
Hematology
Instruments
Reagents
Services
Clinical Chemistry
Instruments
Reagents
Services
Molecular Diagnostics
Instruments
Reagents
Services
Coagulation
Instruments
Reagents
Services
Microbiology
Instruments
Reagents
Services
Others
Instruments
Reagents
Services
IVD Application Outlook (Revenue, USD Million, 2018 - 2030)
Infectious Diseases
Diabetes
Oncology
Cardiology
Nephrology
Autoimmune Diseases
Drug Testing
Others
IVD Test Location Outlook (Revenue, USD Million, 2018 - 2030)
Point of Care
Home-care
Others
IVD End-use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals
Laboratory
Home-care
Others
IVD Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Russia
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
South Korea
Australia
Thailand
Singapore
Latin America
Brazil
Mexico
Argentina
Middle East and Africa (MEA)
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players of In Vitro Diagnostics (IVD) Market
Abbott
bioMérieux SA
QuidelOrtho Corporation
Siemens Healthineers AG
Bio-Rad Laboratories, Inc.
Qiagen
Sysmex Corporation
Charles River Laboratories
Quest Diagnostics Incorporated
Agilent Technologies, Inc.
Danaher Corporation
BD
F. Hoffmann-La Roche Ltd.
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Companion Animal Vaccines Market Size, Share, Trends, Growth Opportunities, Key Drivers and Competitive Outlook
"Global Companion Animal Vaccines Market report puts light on analysis of prime manufacturers, trends, opportunities, marketing strategies analysis, market effect factor analysis and consumer needs by major regions, types, and applications globally. This market research report performs an estimation of the growth rate and the market value based on market dynamics and growth inducing factors. Local, regional as well as global market has been considered here to conduct the research study of Companion Animal Vaccines Market report. The report can be accessible to the users in the form of PDF or spreadsheet. Moreover, PPT format can also be offered depending upon client’s requirement.
While preparing an outstanding Companion Animal Vaccines Market report, combination of best industry insight, practical solutions, talent solutions and latest technology have been utilized. The report aids in taking important decisions for the growth of business. What is more, with the utilization of best-practice models, comprehensive market analysis and research methodologies in this business report, it becomes simple to obtain perfect market segmentation and insights. The report also takes into consideration the detailed profiles of market’s major manufacturers and importers who are dominating the market. The world class Companion Animal Vaccines Market report enlists key competitors with the required specifications and also endows with the strategic insights and analysis of the main factors influencing the industry.
Access Full 350 Pages PDF Report @
Core Objective of Companion Animal Vaccines Market:
Every firm in the Companion Animal Vaccines Market has objectives but this market research report focus on the crucial objectives, so you can analysis about competition, future market, new products, and informative data that can raise your sales volume exponentially.
Size of the Companion Animal Vaccines Market and growth rate factors. Important changes in the future Companion Animal Vaccines Market. Top worldwide competitors of the Market. Scope and product outlook of Companion Animal Vaccines Market. Developing regions with potential growth in the future. Tough Challenges and risk faced in Market. Global Companion Animal Vaccinestop manufacturers profile and sales statistics.
Highlights of TOC:
Chapter 1: Market overview
Chapter 2: Global Companion Animal Vaccines Market
Chapter 3: Regional analysis of the Global Companion Animal Vaccines Market industry
Chapter 4: Companion Animal Vaccines Market segmentation based on types and applications
Chapter 5: Revenue analysis based on types and applications
Chapter 6: Market share
Chapter 7: Competitive Landscape
Chapter 8: Drivers, Restraints, Challenges, and Opportunities
Chapter 9: Gross Margin and Price Analysis
Regional Analysis for Companion Animal Vaccines Market:
APAC (Japan, China, South Korea, Australia, India, and Rest of APAC; Rest of APAC is further segmented into Malaysia, Singapore, Indonesia, Thailand, New Zealand, Vietnam, and Sri Lanka) Europe (Germany, UK, France, Spain, Italy, Russia, Rest of Europe; Rest of Europe is further segmented into Belgium, Denmark, Austria, Norway, Sweden, The Netherlands, Poland, Czech Republic, Slovakia, Hungary, and Romania) North America (U.S., Canada, and Mexico) South America (Brazil, Chile, Argentina, Rest of South America) MEA (Saudi Arabia, UAE, South Africa)
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What are the importance and procedure of ISO 13485 Certification in Saudi Arabia?
INTRODUCTION
ISO 13485 certification in Saudi Arabia validates the efficiency and effectiveness of pleasant control structures for medical devices primarily based on the ISO 13485 popular. It appears after the tactics related to secure manufacture to secure disbursal of scientific gadgets. ISO 13485 Certification aims to make your agency’s management gadget compliant with the relevant regulatory requirements. Those international locations that export scientific devices can benefit if corporations generate and dispense such gadgets with ISO 13485 certificates. Therefore, Applying ISO 13485 certification in Saudi Arabia will become crucial for companies developing or exporting medical devices.ISO certification in Saudi Arabia
ISO 13485 CERTIFICATION IN SAUDI ARABIA: WHAT IS THE BENEFIT?
Consumer satisfaction
Reduced operational fees
Better dating with your stakeholders
Legal compliance with your techniques
Boosts your picture inside the market
This places you in a favorable position as a dealer
Improved chance management
ISO 9001 certification in Saudi Arabia, The first edition of ISO 13485 was published in 1996 using the International Organization for Standardization (ISO). Every 6 to 8 years, those requirements go through a thorough assessment to keep them updated. The first updated model of ISO 13485 was published in 2003, while today’s fashionable replacement was made in 2016. So, it is spelled as ISO 13485:2016.
As per ISO, updating this standard was required “to reply to the latest great management machine practices, such as adjustments in generation and regulatory requirements.” The manufacturers can ensure consistency inside the great of medical devices with the help of making use of ISO 13485 for scientific instruments, which is granted with the aid of the certification body after a radical audit of the management machine.
What are the necessities of ISO 13485?
ISO 14001certification in Saudi Arabia , The choicest high-quality scientific gadgets- IVD and implantable- may be accomplished by following the necessities of ISO 13485 Certification in Saudi Arabia. It additionally assures that the expectations of clients are met continuously, and. In evaluation, the producers are worried it ensures they can meet the u. S .’s regulatory necessities.
For companies manufacturing scientific devices, ISO 13485:2016 provides a framework for constructing and executing high-quality management systems for clinical gadgets. The applicability of this trend is going beyond the scale of industries. Because of this, it will be applied to every small and massive organization that offers the production, distribution, or retail of medical gadgets.
It is one of the desired alternatives for suppliers or carriers of clinical devices. The structure of ISO 13485 Standard incorporates eight sections, with the first three on the whole introductory and the closing 5 containing the requirements for first-rate control systems for medical gadgets. Let us, in short, apprehend the ultimate five sections of this general:
Section 4: Quality Management System – It offers information control, a satisfactory guide, and manipulation of documents, which fulfill the documentation requirements of an excellent control gadget that uses medical equipment.
Section 5: Management Responsibility – discusses the obligation of pinnacle management for efficaciously imposing QMS for clinical devices. It provides for the ordinary evaluation of ongoing strategies through the pinnacle control to check for the performance of the control machine.
Section 6: Resource Management – It specifies how to mobilize resources to enforce an exemplary clinical device control system. It includes human sources, infrastructural assets, etc.
Section 7: Product Realization – This section offers all the techniques that cause the improvement of merchandise. They include design, purchase, and device manipulation to reveal and measure the goods and procedures. This segment may be unnoticed even as implementing the control device for agencies not producing medical gadgets.
Section 8: Measurement, analysis, and improvement – This section describes your requirements for monitoring and dimensioning your QMS for efficiency and effectiveness. It is completed by assessing patron delight, internal audits, regularly monitoring products and tactics, studying non-conformities, and undergoing corrective and preventive movements.
What is the Eligibility for ISO 13485 Certification in Saudi Arabia?
ISO 45001 certification in Saudi Arabia, In the case of groups in Saudi Arabia worried about the production, distribution, or retail of medical gadgets, ISO 13485 certification is applicable. It is the preferred preference while deciding on providers for the supply of scientific gadgets. Therefore, large and small groups can apply online for ISO 13485 certification in Saudi Arabia and demonstrate their commitment to scientific device first-rate. It contains the necessities for businesses that can be a part of all or any of the producing ranges of medical devices and those worried about the pharmaceutical supply chain.
ISO 13485 certification makes the organizations compliant with stringent regulatory norms of the nation’s authorities. Hence, it becomes very vital for the producers.
DO YOU WANT ISO 13485 CERTIFICATION IN SAUDI ARABIA?
ISO 27001 certification in Saudi Arabia, The certification process starts offevolved most effectively after you have carried out the exceptional control device for your agency and operated it for a while to verify its effectiveness. This needs to be well documented at some stage in the certification audit. Once your control system’s operations, Apply for ISO 13485 Certification in Riyadh, Saudi Arabia. First off, you’re required to fill out the utility form and overview the requirements of the certification. It would help if you adopted an internal audit in case your processes’ documentation fits the ISO 13485 standard’s necessities.
The following are the specific steps for obtaining ISO 13485 certification:
Internal audit: This is performed using an inner celebration to test for the consistency of documents regarding the standard’s requirements.
Management audit: At this degree, the control opinions the gaps from internal audits and decides how each section of the ISO applies to your enterprise.
Corrective activities – At this stage, you should enforce disciplinary actions to shut the gaps recognized from the above ranges. This calls for you to report your corrective movements.
The certification technique of ISO 13485 contains the following ranges:
Stage one (documentation survey) – auditors from the certification body of your preference overview your documentation to test your preparedness for the certification audit.
Stage Two (number one audit) – At this degree, the auditors review your techniques and documentation by ISO 13485. This is completed by reviewing reviews, information, and your organization’s practices.
Why Factocert?
If you seek ISO 13485 certification in Saudi Arabia, contact the Factocert group. With its sizeable enjoyment in certification audits and its fulfillment stories with 16000+ satisfied clients from greater than 55 nations, Factocert, an ISO Certification Body in Saudi Arabia, gives you a trouble-free certification experience
.We provide the best ISO consultants in South Africa, Who are very knowledgeable and provide you with the best solution. And to know how to get ISO certification in South Africa? Kindly reach us at [email protected] ISO Certification consultants follow the guidelines set by the international organization for standardization and help the organization to implement ISO certification in South Africa in an easy way with proper documentation and audit.
For Furthermore information visit ISO Certification In South AfricaRelated Articles: ISO 13485 Certification in Saudi Arabia
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Saudi Arabia IVD Market is poised to reach US$ 700 Million by the year 2024
According to Renub Research market research report "Saudi Arabia In Vitro Diagnostics (IVD) Market, by Techniques (Immunochemistry, Clinical Chemistry, Hematology, Hemostasis, Microbiology, SMBG, POCT), Applications (Infectious, Cardiovascular Diseases), End User, Companies" Saudi Arabia In Vitro Diagnostics Market is forecasted to reach US$ 700 Million by the year 2024.
For More Information:
https://www.renub.com/saudi-arabia-in-vitro-diagnostics-market-nd.php
#Saudi Arabia In Vitro Diagnostics Market#Saudi Arabia IVD Market#IVD Market#Saudi IVD Market by Techniques#Saudi IVD Market by Applications#Saudi IVD Market by End User#Saudi IVD Companies
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In vitro diagnostics (IVD) market is expected to gain market growth in the forecast period of 2021 to 2028
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In Vitro Diagnostics Market Trend, Forecast, Drivers, Restraints, Company Profiles and Key Players Analysis by 2028
Rising prevalence of chronic diseases, such as cancer and diabetes, and growing adoption of advanced diagnostic techniques are predicted to fuel market growth
The global in vitro diagnostics quality control market size is expected to reach USD 1,306.5 million by 2028 at a CAGR of 4.1%, according to the latest report by Reports and Data. Rising prevalence of chronic and cardiovascular diseases (CVDs), growing burden of infectious diseases, and rising demand for advanced and rapid diagnostic systems are key factors expected to increase global market growth in the upcoming years. Rising demand for third-party IVD quality controls, increasing number of accredited clinical laboratories, technological advances in IVD techniques, and favorable regulatory policies for in vitro diagnostics quality control are expected to further drive market growth over the forecast years. In addition, rapidly increasing demand for at-home IVD products such as blood glucose monitoring kits and growing focus of manufacturers on providing efficient quality control support are other vital factors supporting the growth of this market.
Get a sample of the report @ https://www.reportsanddata.com/sample-enquiry-form/1508
The report provides extensive coverage of the supply chain, key players of the industry, consumer base, company profiles, production and consumption rate, primary applications, and other relevant data. It provides an in-depth assessment of the key companies operating in the market along with their company profiles, business overview, production and manufacturing capacity, product portfolio, financial standing, global position, and business expansion plans. It also studies recent mergers and acquisitions, joint ventures, product launches, partnerships, collaborations, and agreements among other. The report also provides insights into new entrants and their strategic alliances to gain a robust footing in the market.
Key Manufacturers in the Global CIn Vitro Diagnostics Market:
Thermo Fisher Scientific Inc., Abbott Laboratories Inc., Bio-Rad Laboratories Inc., Danaher Corporation, Roche Diagnostics, Siemens Healthineers, Technopath Clinical Diagnostics, Fortress Diagnostics, Randox Laboratories Ltd., Bio-Techne Corporation, Ortho-Clinical Diagnostics, Inc., SeraCare Life Sciences Inc., Sysmex Corporation, and Helena Laboratories
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The report also provides an extensive regional segmentation to offer the readers key insights into the spread of the market over key geographical regions. It covers production and consumption patterns, import/export, supply and demand, consumer demand and behavior, key trends, and presence of key players in each region. The report also offer a country-wise analysis to impart a better understanding of the revenue growth of the market in each region.
North America (U.S., Canada, Mexico)
Europe (U.K., Italy, Germany, France, Rest of Europe)
Asia Pacific (India, Japan, China, South Korea, Australia, Rest of APAC)
Latin America (Chile, Brazil, Argentina, Rest of Latin America)
Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)
By Product & Service Type (Revenue, USD Million; 2018-2028)
Quality Control Products
Whole Blood-based Controls
Serum/Plasma-based Controls
Urine-based Controls
Data Management Solutions
Quality Assurance Services
Source-based IVD Quality Controls
By Manufacturer (Revenue, USD Million; 2018-2028)
Third-Party Control Manufacturers
Original Equipment Manufacturers (OEMs)
Instrument-Specific Controls
Independent Controls
By Application (Revenue, USD Million; 2018-2028)
Immunochemistry/Immunoassay
Coagulation & Hemostasis
Molecular Diagnostics
Clinical Chemistry
Microbiology
Hematology
Others
By End-user (Revenue, USD Million; 2018-2028)
Hospitals
Home Care
Clinical Laboratories
Academic & Research Institutes
Contract Research Organizations (CROs)
IVD Manufacturers
Others
To know more about the report @ https://www.reportsanddata.com/report-detail/in-vitro-diagnostics-ivd-quality-control-market
Key Questions Addressed in the Report:
What is the market size the global CIn Vitro Diagnostics market is expected to reach over the forecast period? What is the expected CAGR?
What are the key segments of the market?
What are the key products and applications of the CIn Vitro Diagnostics market?
What factors are expected to drive and restrain market growth over the forecast period?
What are the key outcomes of SWOT analysis and Porter’s Five Forces analysis?
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Thank you for reading our report. The report can be customized based on regional segmentation and competitive landscape. Kindly get in touch with us to know more and our team will ensure the report is well suited to meet your requirements.
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In-Vitro Diagnostics (IVD) Quality Control Market Revenue Trends, Company Profiles, Revenue Share Analysis, 2020–2028
A new research report titled global In-Vitro Diagnostics (IVD) Quality Control Market report published by Reports and Data provides a brief overview of the industry and gives an estimation of growth and revenue for the forecast period of 2021-2028. The report covers profiling and study of major manufacturers of the In-Vitro Diagnostics (IVD) Quality Control market along with their sales, revenue, and market share. The report further analyzes market segments, size, trends, growth drivers, restraining factors, opportunities and challenges, cost overview, SWOT analysis, and Porter’s Five Forces Analysis. The report all includes industrial chain analysis, revenue growth, sales estimation, value chain analysis, capacity, regional market examination, and market forecast up to 2028. The report offers insightful information that will assist in gaining a market position and maximize on lucrative growth opportunities.
Get a sample of the report @ https://www.reportsanddata.com/sample-enquiry-form/1508
The report provides an in-depth analysis of the key developments and innovations of the market such as research and development advancements, product launches, mergers & acquisitions, joint ventures, partnerships, government deals, and collaborations. The report offers a comprehensive assessment of key players in the market along with their global position, financial standing, business expansion plans, production and manufacturing capacity, and strategic alliances.
Key players in the market include
Abbott Laboratories Inc., Bio-Rad Laboratories Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Randox Laboratories Ltd., Technopath Clinical Diagnostics, Fortress Diagnostics, Roche Diagnostics, Bio-Techne Corporation, Danaher Corporation, SeraCare Life Sciences Inc., Ortho-Clinical Diagnostics, Inc., Sysmex Corporation, and Helena Laboratories.
Furthermore, the report segments In-Vitro Diagnostics (IVD) Quality Control market on the basis of key product types and applications and provides details about the revenue growth, revenue CAGR, and revenue share each segment is expected to register over the forecast period.
Product & Service Type Outlook (Revenue, USD Million; 2020-2028)
· Quality Control Products
· Whole Blood-based Controls
· Serum/Plasma-based Controls
· Urine-based Controls
· Data Management Solutions
· Quality Assurance Services
· Source-based IVD Quality Controls
Manufacturer Outlook (Revenue, USD Million; 2020-2028)
· Third-Party Control Manufacturers
· Original Equipment Manufacturers (OEMs)
· Instrument-Specific Controls
· Independent Controls
Application Outlook (Revenue, USD Million; 2020-2028)
· Immunochemistry/Immunoassay
· Coagulation & Hemostasis
· Molecular Diagnostics
· Clinical Chemistry
· Microbiology
· Hematology
· Others
End-use Outlook (Revenue, USD Million; 2020-2028)
· Hospitals
· Home Care
· Clinical Laboratories
· Academic & Research Institutes
· Contract Research Organizations (CROs)
· IVD Manufacturers
· Others
For a better understanding of the global In-Vitro Diagnostics (IVD) Quality Control market dynamics, a regional analysis of the market across key geographical areas is offered in the report. The market is spread across key geographical regions such as North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. Each region is analysed on the basis of the market scenario in the major countries of the regions to provide a deeper understanding of the market. It provides insights into production and consumption patterns, supply and demand ratio, export/import, current and emerging trends and demands, market share, market size, revenue contribution, and presence of key players in each region.
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In-depth regional analysis includes:
· North America (U.S., Canada, Mexico)
· Europe (Italy, U.K., Germany, France, Rest of EU)
· Asia Pacific (India, China, Japan, South Korea, Australia, Rest of APAC)
· Latin America (Chile, Brazil, Argentina, Peru, Rest of Latin America)
· Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)
To know more about the report @ https://www.reportsanddata.com/report-detail/in-vitro-diagnostics-ivd-quality-control-market
Benefits of the Global In-Vitro Diagnostics (IVD) Quality Control Report:
· Comprehensive analysis of the opportunities and risks of the In-Vitro Diagnostics (IVD) Quality Control market
· Detailed study of the latest product and technological developments and innovations of the In-Vitro Diagnostics (IVD) Quality Control market
· Business strategies and plans are analysed for understanding the In-Vitro Diagnostics (IVD) Quality Control market scenario
· Revenue forecast of In-Vitro Diagnostics (IVD) Quality Control market for the forecast period 2020-2028
· Comprehensive analysis of the drivers, constraints, limitations, challenges, and opportunities
· Latest and emerging market trends analysis and their impact on product and application demand
· Study of recent M&A, joint ventures, collaborations, partnerships, product launches and brand promotions among others
· Extensive SWOT analysis and Porter’s Five Forces analysis along with investment return analysis and feasibility
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Meticulous Research® Forecasts Middle East IVD Market to Reach $2.15 Billion by 2031
The report highlights market dynamics, growth drivers, key challenges, and opportunities across the region.
Meticulous Research®, a globally recognized leader in market intelligence, has released a new report titled, "Middle East IVD Market by Offering (Kits, Software), Technology (Immunoassay, Molecular Diagnostics [PCR, NGS, Microarray], Rapid Tests, Biochemistry), Application (Infectious Diseases, Oncology), Diagnostic Approach (Lab) - Forecast to 2031." According to the findings, the Middle East in vitro diagnostics (IVD) market is projected to reach $2.15 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.1% from 2024 to 2031.
Key Market Drivers
The growth of the Middle East IVD market is driven by several factors, including the rising prevalence of chronic and infectious diseases, increased demand for point-of-care (PoC) and rapid diagnostic solutions, expanding healthcare expenditures, and an aging population. Moreover, growing healthcare awareness, especially in countries such as the UAE and Saudi Arabia, is also contributing to market expansion. However, the high costs associated with IVD tests and inconsistencies in results from rapid diagnostic tests present challenges to sustained growth.
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Emerging Opportunities
Increasing awareness around early disease detection and personalized medicine, particularly in the UAE and Saudi Arabia, is creating opportunities for market players. These regions are witnessing an uptick in the adoption of advanced diagnostic technologies, which is expected to fuel demand in the coming years. Nonetheless, issues such as false positives in immunoassays and PoC tests remain significant hurdles that stakeholders need to address.
Competitive Landscape
The Middle East IVD market is dominated by global healthcare giants such as Abbott Laboratories (U.S.), Becton, Dickinson and Company (U.S.), BioMérieux S.A. (France), Danaher Corporation (U.S.), F. Hoffmann-La Roche (Switzerland), and Siemens Healthineers AG (Germany). Other key players include QIAGEN N.V. (Netherlands), Thermo Fisher Scientific Inc. (U.S.), and Bio-Rad Laboratories, Inc. (U.S.), among others.
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Market Segmentation Insights
The report provides a detailed breakdown of the Middle East IVD market based on various parameters:
Offerings: The kits and reagents segment is expected to register the highest growth rate due to their extensive use in diagnosing chronic and infectious diseases. This is attributed to the increasing volume of tests for diseases such as HIV and influenza, alongside growing consumer awareness of self-testing options.
Technologies: Molecular diagnostics, including PCR and next-generation sequencing (NGS), is expected to capture the largest market share in 2024, driven by the rising prevalence of communicable and non-communicable diseases and the need for high-volume, accurate testing.
Applications: Infectious disease testing is set to dominate the market, with respiratory infections, hepatitis, HIV, and sexually transmitted diseases (STDs) being the primary drivers. The region's aging population and increasing healthcare demand are also contributing to the rise in testing.
Diagnostic Approach: Point-of-care testing is expected to exhibit the highest growth, propelled by the increasing burden of chronic diseases and the launch of innovative PoC diagnostics by market leaders.
End Users: Hospitals and clinics will continue to be the largest segment, performing a wide range of diagnostic tests for various medical conditions, particularly in urban areas where access to healthcare services is more robust.
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Country Insights
Among the Middle Eastern countries, Saudi Arabia is projected to dominate the IVD market in 2024, largely due to its rapidly aging population, the high incidence of chronic and infectious diseases, and the growing adoption of self-testing. The Kingdom’s healthcare sector is also experiencing a boost thanks to its Vision 2030 strategy, which aims to elevate healthcare standards and increase investments in medical technologies. Healthcare expenditure in Saudi Arabia is expected to grow annually by 3.0% from 2022 to 2025, further supporting market growth.
Conclusion
The Middle East IVD market presents lucrative opportunities for growth, driven by evolving healthcare needs, technological advancements, and rising awareness around early disease detection. However, market players must navigate challenges related to pricing and diagnostic accuracy to fully capitalize on the region’s potential.
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In Vitro Diagnostic (IVD) Reagents Market Size Report Top Countries Research Trends, Share, Manufactures, Detailed Analysis, Applications and Forecasts Up To 2028
Global In Vitro Diagnostic (IVD) Reagents Market, Geography (North America (United States, Canada and Mexico), South America (China, Japan, Korea, India and Southeast Asia), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), Middle East and Africa (Saudi Arabia, Egypt, Nigeria and South Africa)) Industry Trends 2021-2028
<strong>Market Overview</strong> Illustrative analysis of critical sides such as resulting factors and competitive landscape are conveyed with the help of significant resources, such as charts, tables, graphs. The report executes a deep investigation of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also estimates the effect of different industrial sides on the In Vitro Diagnostic (IVD) Reagents market divisions and regions. The research also divides the In Vitro Diagnostic (IVD) Reagents Market on the basis of end-user, product type, application, and demography for the forecast period 2021–2028.
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<strong>Methodology</strong> The conditions influencing the market dynamics are considered and studied and examined to prepare an accurate report. In the report preparation process mainly two types of approaches are made- primary research approach and secondary research approach. In the primary research approach, both the supply and demand chain are interviewed where the supply chain consists of product, opinion leaders, etc. while the demand chain consists of industry experts. The secondary research approach involves various secondary sources like press releases, government agencies, and other commercial aspects of the market.
<strong>Report Summary</strong> Preparing a business report on In Vitro Diagnostic (IVD) Reagents is the most important of all information-based writing because most of the business decisions are related to the organization after the evaluation of the situation as per the report. They are responsible for the documentation of the progress of the business and also serve several important purposes. The ability to write reports, quickly, and accurately is one of the key requirements of managers at every level. The reports allow them to convey vital information to subordinates and superiors. . The report on In Vitro Diagnostic (IVD) Reagents prepared by us serves as a medium for understanding important business elements at the industrial and managerial level. Our report-making services entail flexible payment modes and budget-friendly rates.
<strong>Market segmentation</strong> The study splits the industry into a variety of sub-segments and thus represents the whole market. In addition, an estimate of the sales figures for the entire industry and its sub-segments are given in this report. It determines the variables that rapidly influence the market, including manufacturing methods and methodologies, channels for growth, and the product model. The report also outlines some of the biggest development opportunities, the introduction of the new products, market prediction, and forecasting, numerous economic factors that are key in deciding the In Vitro Diagnostic (IVD) Reagents market pattern, buying decisions, and market attractiveness. The report would help stakeholders such as producers and distributors in finding and capturing high-potential markets. The research also addresses various environmental and regulatory critical factors.
<strong>Growth Mapping</strong> contains reason behind this report is to give a growth map with respect to the activities taken by key participants of the In Vitro Diagnostic (IVD) Reagents market like item delivery, joint ventures, influencing the In Vitro Diagnostic (IVD) Reagents market and undertaking in general and furthermore influencing the business, import, fare, income and CAGR values. The report conveys the overall current realities about market definition, orders, applications, and commitment for the In Vitro Diagnostic (IVD) Reagents market that are basic lead the market. The report moreover combines the overall organization profiles of the top players referred and also reflecting the drivers and limitations of the market with the support of SWOT analysis.
<strong>Top Listed Companies in the In Vitro Diagnostic (IVD) Reagents Market Include</strong>
Roche,Ortho Clinical Diagnostics,Thermal Fisher,Danaher,Siemens,Abbott Laboratories,Bio-Rad,Biomerieux,Sysmex Corporation,BD,Wondfo,Leadman,Myriad Genetics,KHB,Mindray Medical,Hologic,Biosino,Da An Gene,QIAGEN
<strong>Reasons to buy this report:</strong> Learn about the Covid-19 Impact on In Vitro Diagnostic (IVD) Reagents market strategies that are being adopted by leading respective organizations. To understand the future outlook and prospects for the market. Besides the standard structure reports, we also provide custom research according to specific requirements. To gain insightful analyses of the research Industry and have a comprehensive understanding of the global In Vitro Diagnostic (IVD) Reagents market and its commercial landscape. To understand the future outlook and prospects for the In Vitro Diagnostic (IVD) Reagents market with Marketing & Price (Price and Margin, Factors of Price Change, Manufacturers Gross Margin Analysis).
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<strong>Regional Analysis</strong> Different regions of the world such as North America, Latin America, the Asia-Pacific region, Europe, and India, China, and Australia have been analyzed on the basis of various parameters that would benefit the development of the market in the area. It contains the territorial as well as the wide level investigation of the market. It was observed that North America and Asia-pacific countries have shown impressive development opportunities in their region. Asia-Pacific nations due to such a large population in the area could be the prime region for developing a fully flourishing market full of consumer and low-cost labor. However, Europe, being a region of most developed countries seems to be lagging in the survey due to its climatic-driven guidelines which will affect the new settlement of the market.
<strong>Customization of the report: </strong> The customized report is provided by our consultancy at a reasonable price. We provide updated information according to the requirements of the customers in the market world.
<strong>Benefits:</strong> 1. Well updated information. 2. Statistical report provided. 3. Discount offer in customization. 4. Service at the global level. 5. Company research report provided.
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<strong>Frequently Asked Questions?</strong> Q1. What is the total market value of the In Vitro Diagnostic (IVD) Reagents market report? Q2. What would be the forecast period in the In Vitro Diagnostic (IVD) Reagents market report? Q3. What is the base year considered in the In Vitro Diagnostic (IVD) Reagents market report? Q4. Which are the top companies hold the market share in the In Vitro Diagnostic (IVD) Reagents market ? Q5. Which is expected to be the fastest growing segment in the In Vitro Diagnostic (IVD) Reagents market? Q6. Which market holds the maximum market share of the In Vitro Diagnostic (IVD) Reagents market ? Q7. How the company profile has been selected? Q8. What will be the market value of the In Vitro Diagnostic (IVD) Reagents market in 2028?
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What are the Certification Methods and Benefits of ISO 13485 Certification?
ISO 13485 Certification in Bahrain apply to all medical device organizations notwithstanding size, kind, and structure. ISO 13485 is helpful for several organizations because it is used by suppliers, still, as external parties that are attached providing medical device products and services. Third-party review of associate organization’s quality management system provides internal and external verification to customers of the monitoring, measurement, and management of your processes, still as builds confidence to fulfill applicable restrictive needs. the quality is ready to attempt for continual method improvement and quality performance, still as time and cost savings after implementation of this standard.
Organizations that are involved in one or a lot of stages of the life-cycle, from style and development to production, storage/distribution, installation, or union of medical devices, take pleasure in our medical team’s experience in quality management. As a valued partner, we guarantee transparency and clarity throughout the audit method. While ISO 13485. strives to form a safer world, ISO 13485 supports the reduction of sudden risks and enhances the management of these risks to fulfill the company’s desired goals. This improvement not solely will increase the organization’s reputation within the eyes of their customers, however, conjointly includes a sensible and effective answer to demonstrate a commitment to the restrictive needs.
Certifications method
Initial information: The process starts with the client’s wants and expectations. needs to be told regarding the client’s organization, its management system, size, and kinds of operation. along each party can outline objectives for the assessment and/or certification, as well as applicable standards and specifications.
Offer and Contract: ISO 13485 Registration in Dubai can give an in-depth supply for assessment and certification services, tailored to individual shopper wants, supported the knowledge provided at the start. A written contract can specify all relevant deliverables still as applicable assessment and certification criteria.
Pre-Audit: A pre-audit will function initial performance or gap analysis, distinctive strengths, and areas for improvement. For larger assessment and certification comes a project coming up with a meeting provides a valuable chance for the shopper to fulfill the lead tax assessor and develop a custom assessment set up for all functions and locations concerned. each services ar facultative.
Stage 1 audit: The assessment procedure itself begins with review and analysis of system documentation, goals, results of management review, and internal audits. throughout this method, it'll be determined whether or not the client’s management system is sufficiently developed and prepared for certification. The tax assessor can justify findings and coordinate any needed activities to arrange for the on-the-spot system assessment.
![Tumblr media](https://64.media.tumblr.com/8264d4937af5c5ddfa7031dff4e41268/b76bf760fc5e60f9-32/s250x250_c1/9c678a97e8b7d3d44184578e29e8ed42b88a14f1.jpg)
Stage 2 audit: The assigned auditor team can audit the client’s management system at the place of production or service delivery. Applying outlined management system standards and specifications, the ISO 13485 Services in Saudi Arabia team can evaluate the effectiveness of all useful areas still as all management system processes, primarily based upon observations, inspections, interviews, review of pertinent records, and alternative assessment techniques. The audit result, as well as all findings, are going to be given to the shopper throughout the closing meeting. needed action plans are going to be given as necessary.
System analysis: The freelance certification performs of can evaluate the audit method and its results, and judge severally regarding issuing of the certificate. The shopper receives an associate audit report, documenting the audit results. once all applicable needs are consummated the shopper conjointly receives the certificate.
Surveillance audits: Either semi-annually or a minimum of once p.a., there'll be an associate on-the-spot audit of the important parts of the management system. Improvement potential is going to be known, with a spotlight on continual improvement and sustained effectiveness.
Re-Audit: A management system certificate is valid for a restricted amount of your time, often for most of 3 years. At the tip of this cycle, a re-audit is going to be administered to make sure the continuing fulfillment of all application needs. Subject to the current fulfillment, a brand new certificate is going to be issued.
Benefits of ISO 13485
ISO 13485 consultant in Bangalore focuses powerfully on the compliance of store-bought merchandise and production processes with EU directives for MD or IVD such as:
• Provision of technical documentation (medical device file / technical product file)
• Specific vogue & development wants
• Labelling, packaging, and installation
• Sterile MD / IVD
• Implementation of a risk management technique
• Health, safety, and employee’s hygiene wants
• Change management, market observations, and procedures for product recall
Compliance with ISO 13485 is achieved through certification by an approved certification body and freelance internal audits.
How to get ISO 13485 Consulting services in Dubai?
If you are wondering how to get ISO 13485 Consultants in Dubai never give it a second thought approaching Certvalue with a 100% track record of success without any fail in the certification process. ISO 13485 in Dubai are easy and simple with Certvalue. You can easily reach Certvalue by simply visiting www.certvalue.com where you can chat with an expert or you can also write an enquiry to [email protected] so that one of our experts shall contact you at the earliest to provide the best possible solution available in the market.
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Saudi Arabia IVD Market Outlook
In-Vitro Diagnostic tests provide adequate information about the diseases without interacting directly to the human body. Saudi Arabia IVD Market is poised to reach US$ 700 Million by the year 2024. Renub Research report titled “Saudi Arabia In Vitro Diagnostics (IVD) Market, by Techniques, by Applications, by End User and by Companies (Roche, Abbott, Siemens Healthineers, Sysmex Corporation and Danaher Corporation)” provides a complete analysis of Saudi Arabia In-Vitro Diagnostics (IVD) Market.
Access full Research:
https://www.renub.com/saudi-arabia-in-vitro-diagnostics-market-p.php
#Saudi Arabia In Vitro Diagnostics Market#Saudi Arabia IVD Market#IVD Market#Saudi IVD Market by Techniques#Saudi IVD Market by Applications#Saudi IVD Market by End User#Saudi IVD Companies
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D-Amino Acids Overview, Size, Share and Trends 2021-2028
This report elaborates the market size, market characteristics, and market growth of the Telemedicine Robots industry, and breaks down according to the type, application, and consumption area of Telemedicine Robots. The report also conducted a PESTEL analysis of the industry to study the main influencing factors and entry barriers of the industry.
ALSO READ : http://www.marketwatch.com/story/telemedicine-robots-market-research-report-with-size-share-value-cagr-outlook-analysis-latest-updates-data-and-news-2021-2028-2021-06-22
In Chapter 3.4 of the report, the impact of the COVID-19 outbreak on the industry was fully assessed. Fully risk assessment and industry recommendations were made for Telemedicine Robots in a special period. This chapter also compares the markets of Pre COVID-19 and Post COVID-19. In addition, chapters 8-12 consider the impact of COVID-19 on the regional economy.
ALSO READ : http://www.marketwatch.com/story/global-medical-sterile-gloves-market-by-type-by-application-by-segmentation-by-region-and-by-country-2021-2021-05-11
Key players in the global Telemedicine Robots market covered in Chapter 13: Omnicell, Inc. Accuray Hocoma AG (DIH International Limited) Stryker Corporation Hansen Medical Inc. (Auris Health, Inc.) ARxIUM Kirby Lester (Capsa Healthcare) Ekso Bionics Holdings, Inc. Mazor Robotics Intuitive Surgical, Inc.
ALSO READ : http://www.marketwatch.com/story/global-lithium-silicon-battery-market-outlook-industry-analysis-and-prospect-2021-2027-2021-05-25
In Chapter 6, on the basis of types, the Telemedicine Robots market from 2015 to 2025 is primarily split into: Surgical Robots Rehabilitation Robots Noninvasive Radiosurgery Robots Hospital & Pharmacy Robots Others
ALSO READ : http://www.marketwatch.com/story/global-ivd-antibodies-market-by-type-by-application-by-segmentation-by-region-and-by-country-2020-2021-05-11
In Chapter 7, on the basis of applications, the Telemedicine Robots market from 2015 to 2025 covers: Laparoscopy Orthopedics Neurology Others
Geographically, the detailed analysis of production, trade of the following countries is covered in Chapter 4.2, 5: United States Europe China Japan India
Geographically, the detailed analysis of consumption, revenue, market share and growth rate of the following regions are covered in Chapter 8, 9, 10, 11, 12: North America (Covered in Chapter 8) United States Canada Mexico Europe (Covered in Chapter 9) Germany UK France Italy Spain Others Asia-Pacific (Covered in Chapter 10) China Japan India South Korea Southeast Asia Others Middle East and Africa (Covered in Chapter 11) Saudi Arabia UAE South Africa Others South America (Covered in Chapter 12) Brazil Others
Years considered for this report: Historical Years: 2015-2019 Base Year: 2019 Estimated Year: 2020 Forecast Period: 2020-2025
Table of Contents
1 Telemedicine Robots Market - Research Scope 1.1 Study Goals 1.2 Market Definition and Scope 1.3 Key Market Segments 1.4 Study and Forecasting Years
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2 Telemedicine Robots Market - Research Methodology 2.1 Methodology 2.2 Research Data Source 2.2.1 Secondary Data 2.2.2 Primary Data 2.2.3 Market Size Estimation 2.2.4 Legal Disclaimer
3 Telemedicine Robots Market Forces 3.1 Global Telemedicine Robots Market Size 3.2 Top Impacting Factors (PESTEL Analysis) 3.2.1 Political Factors 3.2.2 Economic Factors 3.2.3 Social Factors 3.2.4 Technological Factors 3.2.5 Environmental Factors 3.2.6 Legal Factors 3.3 Industry Trend Analysis 3.4 Industry Trends Under COVID-19 3.4.1 Risk Assessment on COVID-19 3.4.2 Assessment of the Overall Impact of COVID-19 on the Industry 3.4.3 Pre COVID-19 and Post COVID-19 Market Scenario 3.5 Industry Risk Assessment
4 Telemedicine Robots Market - By Geography 4.1 Global Telemedicine Robots Market Value and Market Share by Regions 4.1.1 Global Telemedicine Robots Value ($) by Region (2015-2020) 4.1.2 Global Telemedicine Robots Value Market Share by Regions (2015-2020) 4.2 Global Telemedicine Robots Market Production and Market Share by Major Countries 4.2.1 Global Telemedicine Robots Production by Major Countries (2015-2020) 4.2.2 Global Telemedicine Robots Production Market Share by Major Countries (2015-2020) 4.3 Global Telemedicine Robots Market Consumption and Market Share by Regions 4.3.1 Global Telemedicine Robots Consumption by Regions (2015-2020) 4.3.2 Global Telemedicine Robots Consumption Market Share by Regions (2015-2020)
5 Telemedicine Robots Market - By Trade Statistics 5.1 Global Telemedicine Robots Export and Import 5.2 United States Telemedicine Robots Export and Import (2015-2020) 5.3 Europe Telemedicine Robots Export and Import (2015-2020) 5.4 China Telemedicine Robots Export and Import (2015-2020) 5.5 Japan Telemedicine Robots Export and Import (2015-2020) 5.6 India Telemedicine Robots Export and Import (2015-2020)
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In Vitro Diagnostics Quality Control Market Expected To Trigger A Revenue To $113.9 Billion By 2026
The global in vitro diagnostics market size is expected to reach USD 113.9 billion by 2027, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 4.5% from 2021 to 2027. The growth is driven by the growing geriatric population and technological advancements in diagnostics that are supporting its adoption.
Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high impact rendering drivers of this market. For instance, in June 2017, Agena Bioscience launched the MassARRAY system integrated with CHIP Prep Module in Europe. The system was marketed as a CE-IVD product under Directive 98/79/EC. Moreover, Real-Time Polymerase Chain Reaction (qPCR) is one of the fastest-growing application segments of the in vitro diagnostics (IVD) market.
The IVD market is highly competitive in nature. Consequently, manufacturers are required to improvise products in terms of specificity, accuracy, precision, speed, and other parameters, in order to gain an advantage over previously marketed products.
A steady rise in consumer awareness about diagnosing infectious diseases and increasing disease prevalence, especially in developing and under-developed countries, are driving the market penetration of the products. For instance, in February 2019, Abbott received CE Mark for DETERMINE HBSAG 2 test for detection and diagnosis of hepatitis B surface antigen.
Organizations promote funding to support R&D and product development exercises pertaining to clinical diagnostics. For instance, Vela Diagnostics received USD 225,000 as Biomedical Advanced Research and Development Authority (BARDA) fund to develop COVID-19 tests. Moreover, the introduction of the American Health Care Act of 2017 is expected to improve the healthcare of the U.S. Rising government initiatives pertaining to the importance of IVD will fuel market growth.
The presence of effective technologies such as molecular diagnostics is expected to reduce the threat of substitutes. Moreover, their contribution in the field of genetic testing is of paramount importance and, therefore, experience a low threat of substitutes. However, high prices of these tests are expected to encourage patients to shift to external substitutes.
Major players in the market are Roche Diagnostics; Becton Dickinson; Abbott Laboratories; Siemens; and bioMerieux, which are well-established. Therefore, local companies and new organizations have little scope to enter the market and ensure sustainability. However, companies such as Danaher Corporation and Hologic have successfully excelled in the market through mergers and acquisitions. The seed capital required is high.
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In Vitro Diagnostics Market Report Highlights
Molecular diagnostics is expected to witness the fastest growth over the forecast period
High use of reagents in IVD testing, high demand for over-the-counter diagnostic tests, and increase in adoption of these tests in nonmedical facilities, such as home, are some of the factors that are driving the growth, providing it a clinical advantage over other IVD tests
Reagents held the largest market share in 2020 owing to the increasing demand for genetic testing and availability of technologically advanced cancer diagnostic tests in countries with unmet clinical needs, such as India and Middle East & Africa
The growing availability of CE-IVD certified kits globally to diagnose and screen patients during epidemic situations is expected to boost the growth of reagents and instruments segments
Key players are updating their range of testing options for qPCR instruments by undertaking R&D initiatives for the development of kits that target emerging diseases, or by entering into agreements with other kit manufacturing companies
In Vitro Diagnostics Market Segmentation
Grand View Research has segmented the global in-vitro diagnostics market based on the product, technology, application, end-use, and region:
In Vitro Diagnostics Product Outlook (Revenue, USD Million, 2016 - 2027)
Instruments
Reagents
Services
In Vitro Diagnostics Technology Outlook (Revenue, USD Million, 2016 - 2027)
Immunoassay
Hematology
Clinical Chemistry
Molecular Diagnostics
Coagulation
Microbiology
Others
Instruments
Reagents
Services
Instruments
Reagents
Services
Instruments
Reagents
Services
Instruments
Reagents
Services
Instruments
Reagents
Services
Instruments
Reagents
Services
Instruments
Reagents
Services
In Vitro Diagnostics Application Outlook (Revenue, USD Million, 2016 - 2027)
Infectious Disease
Diabetes
Oncology
Cardiology
Nephrology
Autoimmune Disease
Drug testing
Others
In Vitro Diagnostics End-use Outlook (Revenue, USD Million, 2016 - 2027)
Hospitals
Laboratories
Home Care
Others
In Vitro Diagnostics Regional Outlook (Revenue, USD Million, 2016 - 2027)
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
U.S.
Canada
U.K.
Germany
France
Italy
Spain
Russia
Japan
China
India
South Korea
Singapore
Australia
Brazil
Argentina
Mexico
South Africa
Saudi Arabia
UAE
List of Key Players of In Vitro Diagnostics Market
Abbott
Danaher
bioMérieux SA
Bio-Rad Laboratories, Inc.
Becton, Dickinson and Company
Siemens Healthineers AG
QIAGEN
Quidel Corporation
F. Hoffmann-La Roche AG
Sysmex Corporation
Charles River Laboratories International, Inc.
Quest Diagnostics
Agilent Technologies
About Grand View Research
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.
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