The Medical Device Contract Manufacturing Market is projected to grow at an annualized rate of 8%, till 2030
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
- PREFACE
- Scope of the Report
- Research Methodology
- Chapter Outlines
- EXECUTIVE SUMMARY
- INTRODUCTION
- Chapter Overview
- Medical Devices: An Overview
- History of Medical Devices
- Classification of Medical Devices
- Medical Device Manufacturing
- Challenges Associated with Medical Device Manufacturing
- Role of CMOs in Medical Device Manufacturing
- Role of Automation in Medical Device Manufacturing Process
- Historical Timeline for Medical Device CMOs
- Services Offered by Medical Device CMOs
- Advantages Offered by Medical Device CMOs
- Risks associated with Outsourcing to CMOs
- Key Considerations
- Concluding Remarks
- REGULATORY LANDSCAPE FOR MEDICAL DEVICES
- Chapter Overview
- General Regulatory Guidelines for Medical Devices
- Regulatory Landscape in North America
- The US Scenario
- Regulatory Authority
- Review / Approval Process
- The Canadian Scenario
- Regulatory Authority
- Review / Approval Process
- The US Scenario
- Regulatory Landscape in Europe
- Overall Scenario
- Regulatory Authority
- Review / Approval Process
- Case Study: Brexit -The UK Scenario
- Overall Scenario
- Regulatory Landscape in Asia-Pacific
- The Chinese Scenario
- Regulatory Authority
- Review / Approval Process
- The Japanese Scenario
- Regulatory Authority
- Review / Approval Process
- The Australian Scenario
- Regulatory Authority
- Review / Approval Process
- The Chinese Scenario
- Comparison of Regional Regulatory Environment
- MARKET OVERVIEW: THERAPEUTIC DEVICES
- Chapter Overview
- Medical Device CMOs Offering Services for Therapeutic Devices
- Analysis by Year of Establishment
- Analysis by Size of Employee Base
- Analysis by Location of Headquarters
- Analysis by Location of Manufacturing Facility
- Analysis by Regulatory Certifications / Accreditations
- Analysis by Production Services Offered
- Analysis by Post-production Services Offered
- Analysis by Other Services Offered
- Analysis by Device Class
- Analysis by Type of Material(s) Handled
- Analysis by Scale of Operation
- Leading Players
- MARKET OVERVIEW: DIAGNOSTIC DEVICES
- Chapter Overview
- Medical Device CMOs Offering Services for Diagnostic Devices
- Analysis by Year of Establishment
- Analysis by Size of Employee Base
- Analysis by Location of Headquarters
- Analysis by Location of Manufacturing Facility
- Analysis by Regulatory Certifications / Accreditations
- Analysis by Production Services Offered
- Analysis by Post-Production Services Offered
- Analysis by Other Services Offered
- Analysis by Device Class
- Analysis by Type of Material(s) Handled
- Analysis by Scale of Operation
- Leading Players
- MARKET OVERVIEW: DELIVERY SYSTEMS AND OTHERS
- Chapter Overview
- Catheters
- Medical Device CMOs Offering Services for Catheters
- Analysis by Year of Establishment
- Analysis by Size of Employee Base
- Analysis by Location of Headquarters
- Analysis by Location of Manufacturing Facility
- Analysis by Regulatory Certifications / Accreditations
- Analysis by Production Services Offered
- Analysis by Post-Production Services Offered
- Analysis by Other Services Offered
- Analysis by Device Class
- Analysis by Type of Material(s) Handled
- Analysis by Scale of Operation
- Leading Players
- Drug Delivery Devices
- Medical Device CMOs Offering Services for Drug Delivery Devices
- Analysis by Year of Establishment
- Analysis by Size of Employee Base
- Analysis by Location of Headquarters
- Analysis by Location of Manufacturing Facility
- Analysis by Regulatory Certifications / Accreditations
- Analysis by Production Services Offered
- Analysis by Post-Production Services Offered
- Analysis by Other Services Offered
- Analysis by Device Class
- Analysis by Type of Material(s) Handled
- Analysis by Scale of Operation
- Leading Players
- Other Devices
- Medical Device CMOs Offering Services for Other Medical Devices
- Analysis by Year of Establishment
- Analysis by Size of Employee Base
- Analysis by Location of Headquarters
- Analysis by Location of Manufacturing Facility
- Analysis by Regulatory Certifications / Accreditations
- Analysis by Production Services Offered
- Analysis by Post-Production Services Offered
- Analysis by Other Services Offered
- Analysis by Device Class
- Analysis by Type of Material(s) Handled
- Analysis by Scale of Operation
- BENCHMARK ANALYSIS
- Chapter Overview
- Benchmark Analysis: Methodology
- Region-wise Benchmark Analysis
- North America, Peer Group I
- North America, Peer Group II
- North America, Peer Group III
- North America, Peer Group IV
- North America, Peer Group V
- North America, Peer Group VI
- North America, Peer Group VII
- Europe, Peer Group VIII
- Europe, Peer Group IX
- Europe, Peer Group X
- Asia, Peer Group XI
- Asia, Peer Group XII
- Concluding Remarks
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