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

Key Market Insights
• Over 270 companies worldwide have the necessary expertise and authorization to offer contract manufacturing services for various types of medical devices, including therapeutic and diagnostic products
• The market landscape is fragmented, featuring the presence of both established players and new entrants; presently, most medical device manufacturing facilities are located in the developed geographies
• Medical device CMOs are actively engaged in aligning their operations to comply to the standards established by various global and regional regulatory bodies
• Companies involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and comply to evolving industry benchmarks
• In the last six years, over 9,600 trials evaluating various medical devices have been registered by different types of sponsors covering a wide range of therapeutic areas
• Implants have emerged as one of the most prominent segments for which the acquisition activity is relatively higher; key value drivers behind such acquisitions include capability addition and geographical consolidation
• Driven by a rapidly growing demand, medical device contract services market is anticipated to grow at annualized rate of 8% for a variety of therapeutic areas and geographies for finished products
• Established CMOs currently occupy a major share; in the long term, the opportunity is anticipated to be better distributed across different types of companies, device classes and application areas

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. Medical Devices: An Overview
3.2.1. History of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Medical Device Manufacturing
3.3.1. Challenges Associated with Medical Device Manufacturing
3.3.2. Role of CMOs in Medical Device Manufacturing
3.3.3. Role of Automation in Medical Device Manufacturing Process
3.4. Historical Timeline for Medical Device CMOs
3.5. Services Offered by Medical Device CMOs
3.6. Advantages Offered by Medical Device CMOs
3.7. Risks associated with Outsourcing to CMOs
3.8. Key Considerations
3.9. Concluding Remarks

4. REGULATORY LANDSCAPE FOR MEDICAL DEVICES
4.1. Chapter Overview
4.2. General Regulatory Guidelines for Medical Devices
4.3. Regulatory Landscape in North America
4.3.1. The US Scenario
4.3.1.1. Regulatory Authority
4.3.1.2. Review / Approval Process
4.3.2. The Canadian Scenario
4.3.2.1. Regulatory Authority
4.3.2.2. Review / Approval Process
4.4. Regulatory Landscape in Europe
4.4.1. Overall Scenario
4.4.1.1. Regulatory Authority
4.4.1.2. Review / Approval Process
4.4.2. Case Study: Brexit -The UK Scenario
4.5. Regulatory Landscape in Asia-Pacific
4.5.1. The Chinese Scenario
4.5.1.1. Regulatory Authority
4.5.1.2. Review / Approval Process
4.5.2. The Japanese Scenario
4.5.2.1. Regulatory Authority
4.5.2.2. Review / Approval Process
4.5.3. The Australian Scenario
4.5.3.1. Regulatory Authority
4.5.3.2. Review / Approval Process
4.6. Comparison of Regional Regulatory Environment

5. MARKET OVERVIEW: THERAPEUTIC DEVICES
5.1. Chapter Overview
5.2. Medical Device CMOs Offering Services for Therapeutic Devices
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Size of Employee Base
5.2.3. Analysis by Location of Headquarters
5.2.4. Analysis by Location of Manufacturing Facility
5.2.5. Analysis by Regulatory Certifications / Accreditations
5.2.6. Analysis by Production Services Offered
5.2.7. Analysis by Post-production Services Offered
5.2.8. Analysis by Other Services Offered
5.2.9. Analysis by Device Class
5.2.10. Analysis by Type of Material(s) Handled
5.2.11. Analysis by Scale of Operation
5.2.12. Leading Players

6. MARKET OVERVIEW: DIAGNOSTIC DEVICES
6.1. Chapter Overview
6.2. Medical Device CMOs Offering Services for Diagnostic Devices
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 Location of Manufacturing Facility
6.2.5. Analysis by Regulatory Certifications / Accreditations
6.2.6. Analysis by Production Services Offered
6.2.7. Analysis by Post-Production Services Offered
6.2.8. Analysis by Other Services Offered
6.2.9. Analysis by Device Class
6.2.10. Analysis by Type of Material(s) Handled
6.2.11. Analysis by Scale of Operation
6.2.12. Leading Players

7. MARKET OVERVIEW: DELIVERY SYSTEMS AND OTHERS
7.1. Chapter Overview
7.2. Catheters
7.2.1. Medical Device CMOs Offering Services for Catheters
7.2.2. Analysis by Year of Establishment
7.2.3. Analysis by Size of Employee Base
7.2.4. Analysis by Location of Headquarters
7.2.5. Analysis by Location of Manufacturing Facility
7.2.6. Analysis by Regulatory Certifications / Accreditations
7.2.7. Analysis by Production Services Offered
7.2.8. Analysis by Post-Production Services Offered
7.2.9. Analysis by Other Services Offered
7.2.10. Analysis by Device Class
7.2.11. Analysis by Type of Material(s) Handled
7.2.12. Analysis by Scale of Operation
7.2.13. Leading Players
7.3. Drug Delivery Devices
7.3.1. Medical Device CMOs Offering Services for Drug Delivery Devices
7.3.2. Analysis by Year of Establishment
7.3.3. Analysis by Size of Employee Base
7.3.4. Analysis by Location of Headquarters
7.3.5. Analysis by Location of Manufacturing Facility
7.3.6. Analysis by Regulatory Certifications / Accreditations
7.3.7. Analysis by Production Services Offered
7.3.8. Analysis by Post-Production Services Offered
7.3.9. Analysis by Other Services Offered
7.3.10. Analysis by Device Class
7.3.11. Analysis by Type of Material(s) Handled
7.3.12. Analysis by Scale of Operation
7.3.13. Leading Players
7.4. Other Devices
7.4.1. Medical Device CMOs Offering Services for Other Medical Devices
7.4.2. Analysis by Year of Establishment
7.4.3. Analysis by Size of Employee Base
7.4.4. Analysis by Location of Headquarters
7.4.5. Analysis by Location of Manufacturing Facility
7.4.6. Analysis by Regulatory Certifications / Accreditations
7.4.7. Analysis by Production Services Offered
7.4.8. Analysis by Post-Production Services Offered
7.4.9. Analysis by Other Services Offered
7.4.10. Analysis by Device Class
7.4.11. Analysis by Type of Material(s) Handled
7.4.12. Analysis by Scale of Operation

8. BENCHMARK ANALYSIS
8.1. Chapter Overview
8.2. Benchmark Analysis: Methodology
8.3. Region-wise Benchmark Analysis
8.3.1. North America, Peer Group I
8.3.2. North America, Peer Group II
8.3.3. North America, Peer Group III
8.3.4. North America, Peer Group IV
8.3.5. North America, Peer Group V
8.3.6. North America, Peer Group VI
8.3.7. North America, Peer Group VII
8.3.8. Europe, Peer Group VIII
8.3.9. Europe, Peer Group IX
8.3.10. Europe, Peer Group X
8.3.11. Asia, Peer Group XI
8.3.12. Asia, Peer Group XII
8.4. Concluding Remarks

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