The contract regulatory affairs-management services market for medical devices is estimated to be worth USD 820 million by 2030

Roots Analysis has done a detailed study on Medical Device CROs for Regulatory Affairs Management Market, 2019-2030., covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

 

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Key Market Insights

§  Over 400 companies claim to possess the required expertise to offer regulatory affairs management-related services to medical device-focused business entities

§  The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies

§  Service providers are catering to a diverse clientele, enabling sponsors to compliance to the standards of both regional and international regulators

§  Owing to the high competition, companies involved in this domain are steadily expanding their capabilities in order to augment their respective service portfolios and comply to evolving industry benchmarks

§  CROs are actively engaged in expanding their global footprint in order to enable their clients to navigate the technical and regulatory complexities across various geographies

§  The medical device regulatory affairs outsourcing market is anticipated to grow at an annualized rate of 6.8%; the opportunity is likely to be distributed across different therapeutic areas and geographies

§  Based on prevalent and anticipated trends, the revenue share will vary across important market segments, such as different types of services, size of service provider and device class

 

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Table of Contents

 

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview

3.2. Contract Research Organizations (CROs)

3.2.1. Evolution of CROs

3.3. Role of CROs in the Medical Device Industry

3.4. Types of Medical Device CROs

3.5. Types of Services Offered by CROs

3.5.1. Types of Regulatory Affairs-Related Services Offered by CROs

3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices

3.7. Key Considerations for Selecting a Suitable CRO Partner

3.8. Advantages of Working with CROs

3.9. Risks and Challenges Related to Working with CROs

3.10. Concluding Remarks

 

4. ROLE OF REGULATORY AFFAIRS IN MEDICAL DEVICE SUPPLY CHAIN

4.1. Chapter Overview

4.2. Overview of Medical Device Supply Chain

4.2.1. Importance of Regulatory Affairs in Medical Device Supply Chain

4.2.1.1. Concept and Feasibility Assessment Stage

4.2.1.2. Preclinical Stage

4.2.1.3. Manufacturing / Production Stage

4.2.1.4. Marketing Stage

4.2.1.5. Post-Marketing Stage

4.3. Factors Affecting the Medical Device Supply Chain

4.4. Key Performance Indicators for Medical Device Supply Chain Management

4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain

4.5.1. Digitalization of the Medical Device Supply Chain

 

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

5.3.1. The US Scenario

5.3.1.1. Regulatory Authority

5.3.1.2. Review / Approval Process

5.3.1.3. Reimbursement Landscape

5.3.1.3.1. Payer Mix

5.3.1.3.2. Reimbursement Process

5.3.2.    The Canadian Scenario

5.3.2.1. Regulatory Authority

5.3.2.2. Review / Approval Process

5.3.2.3. Reimbursement Landscape

5.3.2.3.1. Payer Mix

5.3.2.3.2. Reimbursement Process

5.3.3.    The Mexican Scenario

5.3.3.1. Regulatory Authority

5.3.3.2. Review / Approval Process

5.3.3.3. Reimbursement Landscape

5.3.3.3.1. Payer Mix

 

5.4.       Regulatory and Reimbursement Landscape in Europe

5.4.1.    Overall Scenario

5.4.1.1. Overall Regulatory Authority

5.4.1.2. Overall Review / Approval Process

5.4.2.    The UK Scenario

5.4.2.1. Regulatory Authority

5.4.2.2. Review / Approval Process

5.4.2.3. Reimbursement Landscape

5.4.2.3.1. Payer Mix

5.4.2.3.2. Reimbursement Process

5.4.3.    The French Scenario

5.4.3.1. Regulatory Authority

5.4.3.2. Review / Approval Process

5.4.3.3. Reimbursement Landscape

5.4.3.3.1. Payer Mix

5.4.3.3.2. Reimbursement Process

5.4.4.    The German Scenario

5.4.4.1. Regulatory Authority

5.4.4.2. Review / Approval Process

5.4.4.3. Reimbursement Landscape

5.4.4.3.1. Payer Mix

5.4.4.3.2. Reimbursement Process

5.4.5.    The Italian Scenario

5.4.5.1. Regulatory Authority

5.4.5.2. Review / Approval Process

5.4.5.3. Reimbursement Landscape

5.4.5.3.1. Payer Mix

5.4.5.3.2. Reimbursement Process

5.4.6.    The Spanish Scenario

5.4.6.1. Regulatory Authority

5.4.6.2. Review / Approval Process

5.4.6.3. Reimbursement Landscape

5.4.6.3.1. Payer Mix

5.4.6.3.2. Reimbursement Process

 

5.5.       Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World

5.5.1.    The Australian Scenario

5.5.1.1. Regulatory Authority

5.5.1.2. Review / Approval Process

5.5.1.3. Reimbursement Landscape

5.5.1.3.1. Payer Mix

5.5.1.3.2. Reimbursement Process

5.5.2.    The Brazilian Scenario

5.5.2.1. Regulatory Authority

5.5.2.2. Review / Approval Process

5.5.2.3. Reimbursement Landscape

5.5.2.3.1. Payer Mix

5.5.2.3.2. Reimbursement Process

5.5.3.    The Chinese Scenario

5.5.3.1. Regulatory Authority

5.5.3.2. Review / Approval Process

5.5.3.3. Reimbursement Landscape

5.5.3.3.1. Payer Mix

5.5.3.3.2. Reimbursement Process

5.5.4.    The Indian Scenario

5.5.4.1. Regulatory Authority

5.5.4.2. Review / Approval Process

5.5.4.3. Reimbursement Landscape

5.5.4.3.1. Payer Mix

5.5.5.    The Israeli Scenario

5.5.5.1. Regulatory Authority

5.5.5.2. Review / Approval Process

5.5.5.3. Reimbursement Landscape

5.5.5.3.1. Payer Mix

5.5.6.    The Japanese Scenario

5.5.6.1. Regulatory Authority

5.5.6.2. Review / Approval Process

5.5.6.3. Reimbursement Landscape

5.5.6.3.1. Payer Mix

5.5.6.3.2. Reimbursement Process

5.5.7.    The New Zealand Scenario

5.5.7.1. Regulatory Authority

5.5.7.2. Review / Approval Process

5.5.7.3. Reimbursement Landscape

5.5.7.3.1. Payer Mix

5.5.7.3.2. Reimbursement Process

5.5.8.    The Singaporean Scenario

5.5.8.1. Regulatory Authority

5.5.8.2. Review / Approval Process

5.5.8.3. Reimbursement Landscape

5.5.8.3.1. Payer Mix

5.5.8.3.2. Reimbursement Process

5.5.9.    The South Korea Scenario

5.5.9.1. Regulatory Authority

5.5.9.2. Review / Approval Process

5.5.9.3. Reimbursement Landscape

5.5.9.3.1. Payer Mix

5.5.9.3.2. Reimbursement Process

5.5.10. The South African Scenario

5.5.10.1. Regulatory Authority

5.5.10.2. Review / Approval Process

5.5.10.3. Reimbursement Landscape

5.5.11. The Taiwanese Scenario

5.5.11.1. Regulatory Authority

5.5.11.2. Review / Approval Process

5.5.11.3. Reimbursement Landscape

5.5.11.3.1. Payer Mix

5.5.11.3.2. Reimbursement Process

5.5.12. The Thailand Scenario

5.5.12.1. Regulatory Authority

5.5.12.2. Review / Approval Process

5.5.12.3. Reimbursement Landscape

5.6.       Comparison of Regional Regulatory Environment

5.7.       Concluding Remarks

 

6.         COMPETITIVE LANDSCAPE

6.1.       Chapter Overview

6.2.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies

6.2.1.    Analysis by Year of Establishment

6.2.2.    Analysis by Size of Employee Base

6.2.3.    Analysis by Location of Headquarters

6.2.4.    Analysis by Company Size and Geography

6.3.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Area of Specialization

6.3.1.    Analysis by Area of Specialization

6.4.       CROs Offering Medical Device Regulatory Services: Information on Type of Regulatory Affairs-Related Services Offered

6.4.1.    Analysis by Type of Regulatory Affairs-Related Service Offered

6.4.2.    Analysis by Year of Establishment, Geography and Type of Regulatory Affairs-Related Services           Offered

6.5.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type of  Additional Services Offered

6.5.1.    Analysis by Type of Additional Services Offered

6.6.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Device Class

6.6.1.    Analysis by Device Class

6.7.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Type and Size of Clientele

6.7.1.    Analysis by Type and Size of Clientele

6.8.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Medical Device Regulatory Compliance Authorities

6.8.1.    Analysis by Medical Device Regulatory Compliance Authorities

 

6.9.       CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Region-wise)

6.9.1.    Analysis by Geographical Reach (Region-Wise)

 

6.10.     CROs Offering Regulatory Affairs-Related Services for Medical Devices: Information on Geographical Reach (Country-wise)

6.10.1.  Analysis by Geographical Reach (Country-Wise)

 

Contact Details

Gaurav Chaudhary

+1 (415) 800 3415

gaurav.chaudhary@rootsanalysis.com