Medical Device Vigilance Market Synopsis:
Medical Device Vigilance Market Size Was Valued at USD 80.42 Billion in 2023, and is Projected to Reach USD 163.05 Billion by 2032, Growing at a CAGR of 8.17 % From 2024-2032.
The Medical Device Vigilance Market has been classified as the sum total activities involved in reporting, analysing and assessing the post-market safety and efficiency of the medical devices. This is what makes activities such as monitoring of adverse event, device failure and most importantly the safety issues associated with medical devices permissible. This market also incorporates the PMS related regulations as are the part of health authorities’ jurisdictions and other global regulatory bodies such as FDA of USA, EMA of EU and much more. These activities is centered on protecting the membership of the public from risks associated with medical devices by establishing that manufacturers act appropriately where necessary.
The Medical Device Vigilance Market is expected to maintain its stability because of the current changes that require sophisticated safety standards and policies in medical devices industry. Higher concern over all the threats that are bounded to medical devices in combination with higher report on adverse incidences have fostered betterment of standards on the global regulations associated to medical devices. It is also being driven by the increased inflow of new medical devices into the market as stakeholders keep on inventing more enhanced products such as the wearable health technologies, diagnostics products and minimally invasive surgical equipment.
Data technologic advancement of data, real-time monitoring and artificial intelligence are therefore coming up with great input on monitoring and reporting of medical device safety. These technologies assist in post-market surveillance, these also assist in the quality of reporting adverse events and also aid in compliance. Therefore, medical device companies are looking for more precise systems, which help to recognise potential failures or risks for the device beforehand. This trend toward safety and compliance is a large opportunity for current and new medical device vigilance market competitors.
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Medical Device Vigilance Market Trend Analysis:
Shift Towards Advanced Surveillance Systems for Enhanced Compliance
- They also found another big trend of implementing more effective monitoring in terms of a higher level of technology using state-of-art approaches and tools by introducing digital technologies such as AI and ML in the medical device vigilance market. Such technologies are altering the way that manufacturers apply in monitoring and managing the post-market surveillance of ME’s. Real-time adverse event monitoring allows many manufactures to detect patterns, process big data and act on potential safety risks with AI figures. Permissiveness of automated and AI based systems in vigilance processes also enhances speed and competency of the process and compliance to regulation as well as an increase in patient safety index. However, many structured Cloud bases data storage and availability platforms have enabled tracking of the device performance and managing of AERs for many of the manufacturers in the various countries and territories of the world.
Expansion in Emerging Markets for Medical Device Vigilance
- Currently, the Asian-Pacific region, along with Latin America and the Middle Eastern countries, is a vast potential market for the services of medical device vigilance as the delivery of medical devices is rapidly growing in these countries. There is more concern towards the safety and enforcement of regulations when the growing number of countries adopt technologies in the healthcare sectors in these regions for medical devices. The legal authorities in EMs are also increasing the conditions for post market monitoring in order to achieve international standards, to determine the safety of the device there are signs needed. Besides, growth of healthcare awareness in these areas and evolving infrastructures required better surveillance or faster growth that forms a favourable environment for such key players in this market within these emerging economies.
Medical Device Vigilance Market Segment Analysis:
Medical Device Vigilance Market is Segmented on the basis of Delivery Mode, Application, End User, and Region
By Delivery mode, Cloud-based segment is expected to dominate the market during the forecast period
- Considering the deployment models, the cloud based medical device vigilance market is expected to claim the largest market share in the forecast period as a result of the growing trend of integrating cloud technology within the healthcare systems. Cloud based solutions can be implemented at large for storage of data, data management and real time as well for post monitoring of medical devices with market launch that forms a crucial part. Such a way these platforms give allow manufacturers, regulators and healthcare providers to have an easy access to such information which could improve their decisions making or enable them to identify quickly any adverse effects. The other benefit inherent in the application of vigilance systems is the opportunities concerning the receipt and analysis of large amounts of device-related data received from diverse sources with the use of big data tools. Moreover the real-time Mar IQ reporting system that is used to report on manufacturers’ performance gives improved relationship between manufacturers, the regulators and the healthcare sector because this reporting system being based on cloud, quick and global updates give timely, efficient and updated to global standards. The global and local trend to observe today is that more organisations evolve to digital health solutions, thus, the cloud-based segment will too.
By Application, Diagnostic segment expected to held the largest share
- The diagnostic segment of the medical device vigilance is expected to dominate the market because diagnostics medical devices are widely used across various healthcare centers. These are diagnostic imaging systems, IVD products and laboratory instruments, that are incredibly interesting regarding disease detection. As these diagnostic gadgets are the heart of patient care, the post-launch safety and efficacy of the equipment are thus very important. A good example where vigilance systems would be needed is where such devices need to be assured of their reliability all the time and pose no harm at all to the patients. Along the development of technology towards better and sophisticated diagnostics such as the machine learning form of diagnostics to the current diagnostic, there is also going to be an importance of strong vigilance practice to support and develop these results. This segment’s progress is boosted by growth of incidence rates of chronic diseases, which call for repeats of diagnosing procedures, as well as popularity of point of care testing.
Medical Device Vigilance Market Regional Insights:
North America is Expected to Dominate the Market Over the Forecast period
- North America will retain its position as the highest consumer of the medical device vigilance services positioned throughout the forecast timeframe owing to improvements in technology, effectiveness of the regulatory framework and a strengthened and consolidated spending on health care and a well-developed medical device industry. The United States has one of the largest medical device regulatory systems worldwide owing to the FDA’s enhanced scrutiny over post-deployment watching and reporting of negative effects of medical gadgets. Thirty five percent of the respondents mentioned that they were aware of a particular development in the FDA active approach to the monitoring of safety and reliability of medical devices hence the actual realization of the need to look for effective monitoring systems by the manufactures. The number of medical devices out there continues to go up and is huge and the continuous introduction of new high technology products especially in North America is a driver to growth as companies need highly scalable systems that check and ensure medical device safety and compliance in the market at all times.
- Moreover, the digital health in North America is growing at an exponential rate with solutions like cloud, AI & real-time monitoring happening for medical devices and their vigilance processes. They support stakeholders – healthcare providers, manufacturers and regulatory bodies – to cooperate in improving overall general post-market surveillance. Public awareness of diseases such as diabetes, cardiovascular diseases and cancer as well as their increasing need for diagnostic and therapeutic devices placed a greater demand of a careful monitoring process. North America is estimated to be the biggest and wealthiest market for MDMVS because of care facilities and device makers’ drive to increase patient security and meet crucial national and intergovernmental requests.
Active Key Players in the Medical Device Vigilance Market
- Abbott Laboratories (U.S.)
- Baxter International Inc. (U.S.)
- Boston Scientific Corporation (U.S.)
- Cardinal Health (U.S.)
- CareFusion (U.S.)
- Cypress Semiconductor (U.S.)
- Danaher Corporation (U.S.)
- GE Healthcare (U.S.)
- Johnson & Johnson (U.S.)
- Medtronic PLC (Ireland)
- Philips Healthcare (Netherlands)
- Stryker Corporation (U.S.)
- Siemens Healthineers (Germany)
- Smith & Nephew (U.K.)
- Thermo Fisher Scientific Inc. (U.S.)
- Other Active Players
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Global Medical Device Vigilance Market |
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Base Year: |
2023 |
Forecast Period: |
2024-2032 |
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Historical Data: |
2017 to 2023 |
Market Size in 2023: |
USD 80.42 Billion |
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Forecast Period 2024-32 CAGR: |
8.17 % |
Market Size in 2032: |
USD 163.05 Billion |
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Segments Covered: |
By Delivery Mode |
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By Application |
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By End User |
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By Region |
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Key Market Drivers: |
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Key Market Restraints: |
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Key Opportunities: |
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Companies Covered in the report: |
and Other Active Players. |
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Chapter 1: Introduction
1.1 Scope and Coverage
Chapter 2:Executive Summary
Chapter 3: Market Landscape
3.1 Market Dynamics
3.1.1 Drivers
3.1.2 Restraints
3.1.3 Opportunities
3.1.4 Challenges
3.2 Market Trend Analysis
3.3 PESTLE Analysis
3.4 Porter's Five Forces Analysis
3.5 Industry Value Chain Analysis
3.6 Ecosystem
3.7 Regulatory Landscape
3.8 Price Trend Analysis
3.9 Patent Analysis
3.10 Technology Evolution
3.11 Investment Pockets
3.12 Import-Export Analysis
Chapter 4: Medical Device Vigilance Market by Delivery Mode
4.1 Medical Device Vigilance Market Snapshot and Growth Engine
4.2 Medical Device Vigilance Market Overview
4.3 Cloud-based
4.3.1 Introduction and Market Overview
4.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
4.3.3 Key Market Trends, Growth Factors and Opportunities
4.3.4 Cloud-based: Geographic Segmentation Analysis
4.4 On-Premise
4.4.1 Introduction and Market Overview
4.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
4.4.3 Key Market Trends, Growth Factors and Opportunities
4.4.4 On-Premise: Geographic Segmentation Analysis
Chapter 5: Medical Device Vigilance Market by Application
5.1 Medical Device Vigilance Market Snapshot and Growth Engine
5.2 Medical Device Vigilance Market Overview
5.3 Therapeutic
5.3.1 Introduction and Market Overview
5.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.3.3 Key Market Trends, Growth Factors and Opportunities
5.3.4 Therapeutic: Geographic Segmentation Analysis
5.4 Diagnostics
5.4.1 Introduction and Market Overview
5.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.4.3 Key Market Trends, Growth Factors and Opportunities
5.4.4 Diagnostics: Geographic Segmentation Analysis
5.5 Surgical
5.5.1 Introduction and Market Overview
5.5.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.5.3 Key Market Trends, Growth Factors and Opportunities
5.5.4 Surgical: Geographic Segmentation Analysis
5.6 Research
5.6.1 Introduction and Market Overview
5.6.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
5.6.3 Key Market Trends, Growth Factors and Opportunities
5.6.4 Research: Geographic Segmentation Analysis
Chapter 6: Medical Device Vigilance Market by End-user
6.1 Medical Device Vigilance Market Snapshot and Growth Engine
6.2 Medical Device Vigilance Market Overview
6.3 Hospitals
6.3.1 Introduction and Market Overview
6.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.3.3 Key Market Trends, Growth Factors and Opportunities
6.3.4 Hospitals: Geographic Segmentation Analysis
6.4 Diagnostic Imaging Centre
6.4.1 Introduction and Market Overview
6.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.4.3 Key Market Trends, Growth Factors and Opportunities
6.4.4 Diagnostic Imaging Centre: Geographic Segmentation Analysis
6.5 Contract Research Organisation
6.5.1 Introduction and Market Overview
6.5.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.5.3 Key Market Trends, Growth Factors and Opportunities
6.5.4 Contract Research Organisation: Geographic Segmentation Analysis
6.6 Business Process Outsourcing
6.6.1 Introduction and Market Overview
6.6.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.6.3 Key Market Trends, Growth Factors and Opportunities
6.6.4 Business Process Outsourcing: Geographic Segmentation Analysis
6.7 Original Equipment manufacturers
6.7.1 Introduction and Market Overview
6.7.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.7.3 Key Market Trends, Growth Factors and Opportunities
6.7.4 Original Equipment manufacturers: Geographic Segmentation Analysis
6.8 Other
6.8.1 Introduction and Market Overview
6.8.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
6.8.3 Key Market Trends, Growth Factors and Opportunities
6.8.4 Other: Geographic Segmentation Analysis
Chapter 7: Company Profiles and Competitive Analysis
7.1 Competitive Landscape
7.1.1 Competitive Benchmarking
7.1.2 Medical Device Vigilance Market Share by Manufacturer (2023)
7.1.3 Industry BCG Matrix
7.1.4 Heat Map Analysis
7.1.5 Mergers and Acquisitions
7.2 ABBOTT LABORATORIES (U.S.)
7.2.1 Company Overview
7.2.2 Key Executives
7.2.3 Company Snapshot
7.2.4 Role of the Company in the Market
7.2.5 Sustainability and Social Responsibility
7.2.6 Operating Business Segments
7.2.7 Product Portfolio
7.2.8 Business Performance
7.2.9 Key Strategic Moves and Recent Developments
7.2.10 SWOT Analysis
7.3 BOSTON SCIENTIFIC CORPORATION (U.S.)
7.4 MEDTRONIC PLC (IRELAND)
7.5 SIEMENS HEALTHINESS (GERMANY)
7.6 OTHER ACTIVE PLAYERS
Chapter 8: Global Medical Device Vigilance Market By Region
8.1 Overview
8.2. North America Medical Device Vigilance Market
8.2.1 Key Market Trends, Growth Factors and Opportunities
8.2.2 Top Key Companies
8.2.3 Historic and Forecasted Market Size by Segments
8.2.4 Historic and Forecasted Market Size By Delivery Mode
8.2.4.1 Cloud-based
8.2.4.2 On-Premise
8.2.5 Historic and Forecasted Market Size By Application
8.2.5.1 Therapeutic
8.2.5.2 Diagnostics
8.2.5.3 Surgical
8.2.5.4 Research
8.2.6 Historic and Forecasted Market Size By End-user
8.2.6.1 Hospitals
8.2.6.2 Diagnostic Imaging Centre
8.2.6.3 Contract Research Organisation
8.2.6.4 Business Process Outsourcing
8.2.6.5 Original Equipment manufacturers
8.2.6.6 Other
8.2.7 Historic and Forecast Market Size by Country
8.2.7.1 US
8.2.7.2 Canada
8.2.7.3 Mexico
8.3. Eastern Europe Medical Device Vigilance Market
8.3.1 Key Market Trends, Growth Factors and Opportunities
8.3.2 Top Key Companies
8.3.3 Historic and Forecasted Market Size by Segments
8.3.4 Historic and Forecasted Market Size By Delivery Mode
8.3.4.1 Cloud-based
8.3.4.2 On-Premise
8.3.5 Historic and Forecasted Market Size By Application
8.3.5.1 Therapeutic
8.3.5.2 Diagnostics
8.3.5.3 Surgical
8.3.5.4 Research
8.3.6 Historic and Forecasted Market Size By End-user
8.3.6.1 Hospitals
8.3.6.2 Diagnostic Imaging Centre
8.3.6.3 Contract Research Organisation
8.3.6.4 Business Process Outsourcing
8.3.6.5 Original Equipment manufacturers
8.3.6.6 Other
8.3.7 Historic and Forecast Market Size by Country
8.3.7.1 Russia
8.3.7.2 Bulgaria
8.3.7.3 The Czech Republic
8.3.7.4 Hungary
8.3.7.5 Poland
8.3.7.6 Romania
8.3.7.7 Rest of Eastern Europe
8.4. Western Europe Medical Device Vigilance Market
8.4.1 Key Market Trends, Growth Factors and Opportunities
8.4.2 Top Key Companies
8.4.3 Historic and Forecasted Market Size by Segments
8.4.4 Historic and Forecasted Market Size By Delivery Mode
8.4.4.1 Cloud-based
8.4.4.2 On-Premise
8.4.5 Historic and Forecasted Market Size By Application
8.4.5.1 Therapeutic
8.4.5.2 Diagnostics
8.4.5.3 Surgical
8.4.5.4 Research
8.4.6 Historic and Forecasted Market Size By End-user
8.4.6.1 Hospitals
8.4.6.2 Diagnostic Imaging Centre
8.4.6.3 Contract Research Organisation
8.4.6.4 Business Process Outsourcing
8.4.6.5 Original Equipment manufacturers
8.4.6.6 Other
8.4.7 Historic and Forecast Market Size by Country
8.4.7.1 Germany
8.4.7.2 UK
8.4.7.3 France
8.4.7.4 The Netherlands
8.4.7.5 Italy
8.4.7.6 Spain
8.4.7.7 Rest of Western Europe
8.5. Asia Pacific Medical Device Vigilance Market
8.5.1 Key Market Trends, Growth Factors and Opportunities
8.5.2 Top Key Companies
8.5.3 Historic and Forecasted Market Size by Segments
8.5.4 Historic and Forecasted Market Size By Delivery Mode
8.5.4.1 Cloud-based
8.5.4.2 On-Premise
8.5.5 Historic and Forecasted Market Size By Application
8.5.5.1 Therapeutic
8.5.5.2 Diagnostics
8.5.5.3 Surgical
8.5.5.4 Research
8.5.6 Historic and Forecasted Market Size By End-user
8.5.6.1 Hospitals
8.5.6.2 Diagnostic Imaging Centre
8.5.6.3 Contract Research Organisation
8.5.6.4 Business Process Outsourcing
8.5.6.5 Original Equipment manufacturers
8.5.6.6 Other
8.5.7 Historic and Forecast Market Size by Country
8.5.7.1 China
8.5.7.2 India
8.5.7.3 Japan
8.5.7.4 South Korea
8.5.7.5 Malaysia
8.5.7.6 Thailand
8.5.7.7 Vietnam
8.5.7.8 The Philippines
8.5.7.9 Australia
8.5.7.10 New Zealand
8.5.7.11 Rest of APAC
8.6. Middle East & Africa Medical Device Vigilance Market
8.6.1 Key Market Trends, Growth Factors and Opportunities
8.6.2 Top Key Companies
8.6.3 Historic and Forecasted Market Size by Segments
8.6.4 Historic and Forecasted Market Size By Delivery Mode
8.6.4.1 Cloud-based
8.6.4.2 On-Premise
8.6.5 Historic and Forecasted Market Size By Application
8.6.5.1 Therapeutic
8.6.5.2 Diagnostics
8.6.5.3 Surgical
8.6.5.4 Research
8.6.6 Historic and Forecasted Market Size By End-user
8.6.6.1 Hospitals
8.6.6.2 Diagnostic Imaging Centre
8.6.6.3 Contract Research Organisation
8.6.6.4 Business Process Outsourcing
8.6.6.5 Original Equipment manufacturers
8.6.6.6 Other
8.6.7 Historic and Forecast Market Size by Country
8.6.7.1 Turkiye
8.6.7.2 Bahrain
8.6.7.3 Kuwait
8.6.7.4 Saudi Arabia
8.6.7.5 Qatar
8.6.7.6 UAE
8.6.7.7 Israel
8.6.7.8 South Africa
8.7. South America Medical Device Vigilance Market
8.7.1 Key Market Trends, Growth Factors and Opportunities
8.7.2 Top Key Companies
8.7.3 Historic and Forecasted Market Size by Segments
8.7.4 Historic and Forecasted Market Size By Delivery Mode
8.7.4.1 Cloud-based
8.7.4.2 On-Premise
8.7.5 Historic and Forecasted Market Size By Application
8.7.5.1 Therapeutic
8.7.5.2 Diagnostics
8.7.5.3 Surgical
8.7.5.4 Research
8.7.6 Historic and Forecasted Market Size By End-user
8.7.6.1 Hospitals
8.7.6.2 Diagnostic Imaging Centre
8.7.6.3 Contract Research Organisation
8.7.6.4 Business Process Outsourcing
8.7.6.5 Original Equipment manufacturers
8.7.6.6 Other
8.7.7 Historic and Forecast Market Size by Country
8.7.7.1 Brazil
8.7.7.2 Argentina
8.7.7.3 Rest of SA
Chapter 9 Analyst Viewpoint and Conclusion
9.1 Recommendations and Concluding Analysis
9.2 Potential Market Strategies
Chapter 10 Research Methodology
10.1 Research Process
10.2 Primary Research
10.3 Secondary Research
|
Global Medical Device Vigilance Market |
|||
|
Base Year: |
2023 |
Forecast Period: |
2024-2032 |
|
Historical Data: |
2017 to 2023 |
Market Size in 2023: |
USD 80.42 Billion |
|
Forecast Period 2024-32 CAGR: |
8.17 % |
Market Size in 2032: |
USD 163.05 Billion |
|
Segments Covered: |
By Delivery Mode |
|
|
|
By Application |
|
||
|
By End User |
|
||
|
By Region |
|
||
|
Key Market Drivers: |
|
||
|
Key Market Restraints: |
|
||
|
Key Opportunities: |
|
||
|
Companies Covered in the report: |
and Other Active Players. |
||
