Tag: Worldwide

DUBLIN, Dec. 28, 2022 /PRNewswire/ — The “Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035” report has been added to  ResearchAndMarkets.com’s offering.

This report features an extensive study of the current market landscape and future opportunities associated with the medical device contract research organizations market. The study also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices.

Moreover, the medical devices are expected to capture more than 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years.

However, only a few players engaged in this domain claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in this domain.

In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments.

Story continues

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in this domain.

Further, in order to support the growing demand, medical device CROs have been re-evaluating and bolstering their existing capabilities to offer a wide range of services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors.

To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent grow, till 2035.

The report features detailed transcripts of interviews held with the following stakeholders:

• Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)

• Lee King (Senior Vice President, Business Development and Marketing)

• Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)

• Claus Hemiker (Head, Business Development)

• Christian Wolflehner (General Manager, CW Research & Management)

• Troy W. Mccall (Chief Commercial Officer, CROMSOURCE)

• Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research)

• C. Omprakash (Technical Director and Partner, Vyomus Consulting)

• Tania Persson (Director of Business Development, A+ Science)

• Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Who are the key players engaged in offering contract research services for medical devices?

• Which regions represent the key contract research hubs for medical devices?

• What are the key regulatory guidelines, related to medical devices that have been established across various geographies?

• What are the key value drivers of the merger and acquisition activity observed within this domain?

• What percentage of the medical devices research operations are presently outsourced?

• What are the likely future trends in contract research services market for medical devices?

• How is the current and future opportunity likely to be distributed across key market segments?

• What is the total cost of ownership required to set up a medical device contract research organization?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Medical Devices
3.2.1. Historical Evolution of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations While Selecting a Suitable CRO Partner

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Area of Specialization
4.2.6. Analysis by Device Class
4.2.7. Analysis by Type of Clinical Operation Service Offered
4.2.8. Analysis by Type of Regulatory Affairs-related Service Offered
4.2.9. Analysis by Type of Additional Service Offered
4.2.10. Analysis by Medical Device Regulatory Compliance Authority
4.3. Medical Device CROs: Preclinical Service Providers
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Analysis by Type of Preclinical Service Offered
4.4. Medical Device CROs: Standalone Service Providers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Analysis by Company Size and Location of Headquarters

5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.4. Regulatory and Reimbursement Landscape in Europe
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks

6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Recent Developments and Future Outlook
6.3. Charles River Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. CROMSOURCE
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Recent Developments and Future Outlook
6.5. CSSi LifeSciences
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Recent Developments and Future Outlook
6.6. Eurofins Medical Device Testing
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Recent Developments and Future Outlook
6.7. IQVIA
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Recent Developments and Future Outlook
6.8. Medpace
6.8.1. Company Overview
6.8.2. Service Portfolio
6.8.3. Recent Developments and Future Outlook
6.9. NAMSA
6.9.1. Company Overview
6.9.2. Service Portfolio
6.9.3. Recent Developments and Future Outlook
6.10. Qserve Group
6.10.1. Company Overview
6.10.2. Service Portfolio
6.10.3. Recent Developments and Future Outlook
6.11. WuXi AppTec
6.11.1. Company Overview
6.11.2. Service Portfolio
6.11.3. Recent Developments and Future Outlook

7. MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS
7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks

8. COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Assumptions and Methodology
8.3. Competitive Benchmarking by Region
8.4. Concluding Remarks

9. BRAND POSITIONING OF KEY INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: Labcorp
9.4. Brand Positioning Matrix: IQVIA
9.5. Brand Positioning Matrix: Syneos Health
9.6. Brand Positioning Matrix: PPD
9.7. Brand Positioning Matrix: ICON
9.8. Brand Positioning Matrix: Charles River Laboratories
9.9. Brand Positioning Matrix: WuXi AppTec
9.10. Brand Positioning Matrix: Medpace

10. CLINICAL TRIAL ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
10.4. Medical Devices: Analysis by Enrolled Patient Population

11. MERGERS AND ACQUISITIONS
11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Medical Device CROs: Mergers and Acquisitions

12. TOTAL COST OF OWNERSHIP IN MEDICAL DEVICES CONTRACT RESEARCH ORGANIZATION
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Expenditures Incurred by a Medical Device Contract Research Organization
12.4. Total Cost of Ownership of Medical Devices Contract Research Organizations, 2022-2042
12.5. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by CAPEX and OPEX Costs, 2022 and 2042
12.6. Concluding Remarks

13. SURVEY INSIGHTS
13.1. Chapter Overview
13.2. Designation of Respondents
13.3. Types of Services Offered
13.4. Target Therapeutic Area
13.5. Average Number of Annual Projects
13.6. Market Opportunity

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

15. SWOT ANALYSIS

16. FUTURE TRENDS AND OPPORTUNITIES

17. INTERVIEW TRANSCRIPTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/6jr6c5

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