Medical device CRO market is projected to an annualized rate of 6.4%, till 2030

Roots Analysis has done a detailed study on “Medical Device CRO Market (2nd Edition), 2020-2030”. covering various important aspects of the industry and identifying key future growth opportunities.

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Key Market Insights

• Since 2015, over 7,500 medical device focused clinical trials, involving the participation of close to 2.9 million patients across different hospitals / medical centers, have been registered worldwide
• Over 300 CROs presently claim to possess the necessary capabilities to offer a wide range of preclinical and clinical research-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
• Owing to the high competition in this field, stakeholders are steadily expanding their capabilities in order to augment their respective service portfolios and also comply to evolving industry benchmarks
• Over the years, the domain has witnessed an increase in merger and acquisition activity, with many CROs expanding their presence across multiple geographies and growing their respective service portfolios
• Several companies in this domain have established strong brand positions across different regions; in future, such companies are anticipated to contribute the most to the overall revenue generation potential
• Driven by the growing demand for effective treatment modalities across various therapeutic areas, the market is poised to witness sustained growth across various device classes and geographies
• In the long term, we expect the market to reach over USD 15 billion; the current and future opportunity is likely to be distributed across companies of different sizes offering various types of clinical and preclinical services

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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.                   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 for 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 Services Offered

4.2.8.                Analysis by Type of Regulatory Affairs-related Services Offered

4.2.9.                Analysis by Type of Additional Services Offered

4.2.10.              Analysis by Medical Device Regulatory Compliance Authorities

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 Services 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

5.3.1.                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 Sce