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Medical Device Contract Manufacturing Market, 2019-2030

  • ID: 4793276
  • Report
  • 323 Pages
  • Roots Analysis
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Medical Device Contract Manufacturing Market is Estimated to Reach a Net Worth of Approximately USD 430 Billion in 2020

FEATURED COMPANIES

  • 3i Group
  • AccuMED
  • Creganna Medical
  • Interplex
  • Oscor
  • Stellartech
  • MORE

Recent advances in data science technology solutions, such as Internet of Things, machine learning, artificial intelligence, and real-world evidence-based solutions, have enabled medical device developers to digitize and automate a number of product development and manufacturing processes. In 2020, the global medical devices market is estimated to reach a net worth of approximately USD 430 billion. However, most developers lack adequate resources and the necessary expertise to manufacture medical devices and related components. Moreover, given the rapid rate of evolution, the costs associated with acquiring the necessary infrastructure and capabilities in this field are high; therefore, it is difficult for companies with limited finances to acquire such resources and carry out such operations by themselves.

In addition, the evolving regulatory guidelines and complicated pathways to establishing reimbursement strategies render medical devices subject to rigorous quality assessments, especially for medium and high-risk devices. The aforementioned constraints have led many of the smaller players and certain established players to outsource a significant part of their manufacturing operations to capable contract manufacturing organizations (CMOs). CMOs are known to offer significant cost-benefits, access to sophisticated/up-to-date infrastructure, large production capacities and reduction in time-to-market.

Given the demand for medical devices, the opportunity for CMOs with expertise in medical devices is steadily rising. In fact, in 2018 alone, the USFDA approved over 100 medical devices. It is worth highlighting that, since 2000, more than 65 CMOs have been established. The demand for one-stop-shops and versatile supply chain management solutions have fuelled consolidation activity in this domain.

Contemporary contract service providers have been focusing on bolstering in-house capabilities to offer a wider range of services to their clients, covering product design to distribution and marketing, along with regulatory assistance. The medical device sector is among the most highly regulated industries, and we expect the demand for core competencies, such as design and engineering, prototype development and high volume manufacturing, to continue to drive sponsor companies to outsource various parts of their product development and manufacturing operations to capable contract service providers. Amidst tough competition, the availability of advanced tools and technologies is an important differentiating factor; CMOs that invest in such upgrades are likely to gain a competitive edge.

Scope of the Report

The “Medical Device CMOs Market, 2019-2030” report features a comprehensive study on the current landscape of contract manufacturing service providers focused on medical devices (specifically for drug-delivery devices, diagnostic devices, and therapeutic devices). The scope of the report primarily includes those manufacturers that offer finished product services for medical devices (excluding medical equipment, such as X-ray machines, ultrasound machines, operating tables, and other similar products).

The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

  • A detailed review of the overall landscape of the medical device contract manufacturing market, featuring a list of CMOs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, manufacturing facilities, geographical location, type of device manufactured (drug-delivery devices, diagnostic devices, therapeutic devices and others), scale of operation (pre-commercial and commercial) and types of services offered ([A] production services (such as design services, prototyping, component manufacturing, packaging, and sterilization), [B] post-production services (such as supply chain management services, labeling services, logistics, and shipping services) and [C] other services (such as regulatory services, project management services and documentation services).
  • An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional bubble analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe.
  • A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
  • An analysis of the medical device supply chain, highlighting the role of CMOs engaged in this domain and analysis based on services offered, such as supply chain management services, logistics services, shipping services, and warehousing services, to medical device companies.
  • Elaborate profiles of popular players that specialize in providing services for both pre-commercial and commercial-scale manufacturing of medical devices. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, as well as an informed future outlook.
  • A geographical clinical trial analysis of ongoing and planned studies related to medical devices, featuring details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, phase of development, type of sponsor, therapeutic area(s) and target disease indication(s), and number of patients enrolled.
  • A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019. The analysis provides information on the key value drivers for these mergers and acquisitions and the corresponding acquisition deal multiples. In addition, the analysis features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
  • An elaborate discussion on the future opportunities/trends related to the medical device contract manufacturing market that are likely to influence the growth within this domain over the coming years.
  • A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CMO industry.

One of the key objectives of this report was to evaluate the current opportunity and the future market potential of the medical device CMOs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] type of devices (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and Rest of the world) and [E] leading players. To account for the uncertainties associated with the growth of the medical device CMO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

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.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • 3i Group
  • AccuMED
  • Creganna Medical
  • Interplex
  • Oscor
  • Stellartech
  • MORE

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. History of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Medical Device Manufacturing
3.3.1. Associated Challenges
3.3.2. Role of Contract Manufacturing Organizations (CMOs)
3.3.3. Role of Automation
3.4. Overview of Medical Device CMOs
3.5. Services Offered by Medical Device CMOs
3.6. Advantages of Medical Device CMOs
3.7. Risks Associated with Outsourcing Manufacturing Operations
3.8. Key Considerations for Selecting a CMO Partner
3.9. Concluding Remarks

4. MEDICAL DEVICE REGULATORY LANDSCAPE
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 Manufacturing 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

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 Certification / Accreditations
6.2.6. Analysis by Manufacturing 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

7. MARKET OVERVIEW: DRUG-DELIVERY DEVICES AND OTHERS
7.1. Chapter Overview
7.2. Medical Device CMOs Offering Services for Drug Delivery Devices
7.2.1. Analysis by Year of Establishment
7.2.2. Analysis by Size of Employee Base
7.2.3. Analysis by Location of Headquarters
7.2.4. Analysis by Location of Manufacturing Facility
7.2.5. Analysis by Regulatory Certifications / Accreditations
7.2.6. Analysis by Manufacturing Services Offered
7.2.7. Analysis by Post-Production Services Offered
7.2.8. Analysis by Other Services Offered
7.2.9. Analysis by Device Class
7.2.10. Analysis by Type of Material(s) Handled
7.2.11. Analysis by Scale of Operation
7.3. Medical Device CMOs Offering Services for Other Devices
7.3.1. Analysis by Year of Establishment
7.3.2. Analysis by Size of Employee Base
7.3.3. Analysis by Location of Headquarters
7.3.4. Analysis by Location of Manufacturing Facility
7.3.5. Analysis by Regulatory Standards of Manufacturing Facility
7.3.6. Analysis by Manufacturing Services Offered
7.3.7. Analysis by Post-Production Services Offered
7.3.8. Analysis by Other Services Offered
7.3.9. Analysis by Device Class
7.3.10. Analysis by Type of Material(s) Handled
7.3.11. 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
8.3.13. Asia, Peer Group XIII
8.4. Concluding Remarks

9. SUPPLY CHAIN ANALYSIS
9.1. Chapter Overview
9.2. Overview of Medical Device Value Chain
9.2.1. Value Chain versus Supply Chain
9.3 Factors Affecting the Medical Device Supply Chain
9.4. Supply Chain Improvement Strategies
9.5. Key Performance Indicators
9.6. Visible Supply Chain and Related Advantages
9.6.1. Augmenting Supply Chain Visibility Through Digitalization
9.6.1.1. Benefits of Digital Supply Chain Management
9.7. Supply Chain Optimization

10. COMPANY PROFILES
10.1. Chapter Overview
10.2. CMOs Headquartered in North America
10.2.1. Cirtec Medical
10.2.1.1. Company Overview
10.2.1.2. Service Portfolio
10.2.1.3. Manufacturing Capabilities and Facilities
10.2.1.4. Future Outlook
10.2.2. DynaFlex Technologies
10.2.2.1. Company Overview
10.2.2.2. Service Portfolio
10.2.2.3. Manufacturing Capabilities and Facilities
10.2.2.4. Future Outlook
10.2.3. I-Tek Medical Technologies
10.2.3.1. Company Overview
10.2.3.2. Service Portfolio
10.2.3.3. Manufacturing Capabilities and Facilities
10.2.3.4. Future Outlook
10.2.4. Keystone Solutions Group
10.2.4.1. Company Overview
10.2.4.2. Service Portfolio
10.2.4.3. Manufacturing Capabilities and Facilities
10.2.4.4. Future Outlook
10.2.5. Oscor
10.2.5.1. Company Overview
10.2.5.2. Service Portfolio
10.2.5.3. Manufacturing Capabilities and Facilities
10.2.5.4. Future Outlook
10.2.6. SMC
10.2.6.1. Company Overview
10.2.6.2. Service Portfolio
10.2.6.3. Manufacturing Capabilities and Facilities
10.2.6.4. Future Outlook
10.2.7. Stellartech
10.2.7.1. Company Overview
10.2.7.2. Service Portfolio
10.2.7.3. Manufacturing Capabilities and Facilities
10.2.7.4. Future Outlook
10.3. CMOs Headquartered in Europe
10.3.1. Creganna Medical
10.3.1.1. Company Overview
10.3.1.2. Service Portfolio
10.3.1.3. Manufacturing Capabilities and Facilities
10.3.1.4. Future Outlook
10.3.2. Europlaz Technologies
10.3.2.1. Company Overview
10.3.2.2. Service Portfolio
10.3.2.3. Manufacturing Capabilities and Facilities
10.3.2.4. Future Outlook
10.3.3. Riverside Medical Packaging
10.3.3.1. Company Overview
10.3.3.2. Service Portfolio
10.3.3.3. Manufacturing Capabilities and Facilities
10.3.3.4. Future Outlook
10.3.4. Synecco
10.3.4.1. Company Overview
10.3.4.2. Service Portfolio
10.3.4.3. Manufacturing Capabilities and Facilities
10.3.4.4. Future Outlook
10.3.5. Trelleborg Sealing Solutions
10.3.5.1. Company Overview
10.3.5.2. Service Portfolio
10.3.5.3. Manufacturing Capabilities and Facilities
10.3.5.4. Future Outlook
10.4. CMOs Headquartered in Asia
10.4.1. Interplex
10.4.1.1. Company Overview
10.4.1.2. Service Portfolio
10.4.1.3. Manufacturing Capabilities and Facilities
10.4.1.4. Future Outlook
10.4.2. Modern Medical
10.4.2.1. Service Portfolio
10.4.2.2. Manufacturing Capabilities and Facilities
10.4.2.3. Future Outlook
10.4.3. Providence Enterprise
10.4.3.1. Company Overview
10.4.3.2. Service Portfolio
10.4.3.3. Manufacturing Capabilities and Facilities
10.4.3.4. Future Outlook
10.4.4. Suzhou Jenitek
10.4.4.1. Company overview
10.4.4.2. Service Portfolio
10.4.4.3. Manufacturing Capabilities and Facilities
10.4.4.4. Future Outlook

11. CLINICAL TRIAL ANALYSIS
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. Clinical Trial Analysis: Word Cloud of Trial Titles
11.4. Analysis of Clinical Trials
11.4.1. Analysis by Trial Start Year
11.4.2. Analysis by Trial Status
11.4.3. Analysis by Phase of Development
11.4.4. Analysis by Target Indication
11.4.5. Analysis by Type of Sponsor
11.4.6. Analysis by Geography
11.4.7. Analysis by Trial Start Year and Geography
11.5. Analysis of Enrolled Patient Population
11.5.1. Analysis by Trial Status
11.5.2. Analysis by Phase of Development
11.5.3. Analysis by Geography
11.6. Analysis of Focus Therapeutic Areas
11.6.1. Analysis by Type of Sponsor
11.6.2. Analysis by Geography
11.6.2.1. North American Scenario
11.6.2.2. European Scenario
11.6.2.3. Asia Pacific Scenario
11.6.2.4. Rest of the World Scenario
11.6.3. Cardiovascular Disorders
11.6.3.1. Analysis by Trial Start Year
11.6.3.2. Analysis by Type of Sponsor
11.6.3.3. Analysis by Geography
11.6.4. Oncological Disorders
11.6.4.1. Analysis by Trial Start Year
11.6.4.2. Analysis by Type of Sponsor
11.6.4.3. Analysis by Geography
11.6.5. Central Nervous System (CNS) Disorders
11.6.5.1. Analysis by Trial Start Year
11.6.5.2. Analysis by Type of Sponsor
11.6.5.3. Analysis by Geography
11.6.6. Orthopedic Disorders
11.6.6.1. Analysis by Trial Start Year
11.6.6.2. Analysis by Type of Sponsor
11.6.6.3. Analysis by Geography
11.6.7. Respiratory Disorders
11.6.7.1. Analysis by Trial Start Year
11.6.7.2. Analysis by Type of Sponsor
11.6.7.3. Analysis by Geography

12. MERGERS & ACQUISITIONS
12.1. Chapter Overview
12.2. Acquisition Models
12.3. Medical Device Contract Manufacturing Market: Mergers and Acquisitions
12.3.1. Analysis by Year of Mergers and Acquisitions
12.3.2. Analysis by Type of Acquisition
12.3.3. Most Active Acquirers: Analysis by Number of Acquisitions
12.3.4. Analysis by Key Value Drivers
12.3.4.1. Analysis by Key Value Drivers and Year of Acquisition
12.3.5. Analysis by Type of Device
12.3.5.1. Analysis by Type of Device and Key Value Drivers
12.3.6. Analysis by Therapeutic Area
12.3.7. Analysis by Type of Services Offered
12.3.8. Regional Analysis
12.3.8.1. Continent-wise Distribution
12.3.8.2. Country-wise Distribution
12.3.8.3. Intercontinental and Intracontinental Deals
12.4. Key Acquisitions: Deal Multiples
12.4.1. Relationship between Deal Multiples

13. CASE STUDY: OFFSHORING MEDICAL DEVICE CONTRACT MANUFACTURING
13.1. Chapter Overview
13.2. Emerging Markets: Definitions and Key Regions
13.3. Global Manufacturing Market: Role of Emerging Markets
13.3.1. Contributions to the Automobile Industry
13.3.2. Contributions to the Aerospace and Defence Industries
13.4. Overview of Medical Device Manufacturing in Emerging Markets
13.4.1. The US-Chinese Scenario
13.4.2. Comparative Analysis between Developed Regions and Emerging Markets
13.4.3. Partnerships with Companies in Emerging Markets
13.5. Medical Device-focused Multinational Companies in Emerging Markets
13.6. Medical Device Manufacturing Business Models Used in Emerging Markets
13.6.1. Case Studies
13.6.1.1. Study 1: Overview
13.6.1.1.1. Value Proposition
13.6.1.1.2. Value creation
13.6.1.2. Study 2: Overview
13.6.1.2.1. Value Proposition
13.6.1.2.2. Value creation
13.7. Innovation in Medical Device Industry: Key Challenges
13.7.1. Limitations of In-House Innovation
13.8. Advantages of Establishing Innovation Hubs in Emerging Markets
13.8.1. Challenges and Market Restraints
13.8.2. Strategies to Address Existing Challenges
13.9. Future Perspectives

14. MARKET FORECAST
14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Overall Medical Device Contract Manufacturing Market, 2019-2030
14.3.1. Medical Device Contract Manufacturing Market: Distribution by Application Areas, 2019 and 2030
14.3.1.1. Medical Device Contract Manufacturing Market for Therapeutic Devices, 2019-2030
14.3.1.2. Medical Device Contract Manufacturing Market for Diagnostic Devices, 2019-2030
14.3.1.3. Medical Device Contract Manufacturing Market for Drug Delivery Devices, 2019-2030
14.3.1.4. Medical Device Contract Manufacturing Market for Other Devices, 2019-2030
14.3.2. Medical Device Contract Manufacturing Market: Distribution by Device Class, 2019 and 2030
14.3.2.1. Medical Device Contract Manufacturing Market: Class I Devices, 2019 and 2030
14.3.2.2. Medical Device Contract Manufacturing Market: Class II Devices, 2019 and 2030
14.3.2.3. Medical Device Contract Manufacturing Market: Class III Devices, 2019 and 2030
14.3.3. Medical Device Contract Manufacturing Market: Leading Players, 2019-2030
14.3.4. Medical Device Contract Manufacturing Market: Distribution by Therapeutic Area, 2019 and 2030
14.3.4.1. Medical Device Contract Manufacturing Market for Cardiovascular Disorders, 2019-2030
14.3.4.2. Medical Device Contract Manufacturing Market for Disorders, 2019-2030
14.3.4.3. Medical Device Contract Manufacturing Market for Metabolic Disorders, 2019-2030
14.3.4.4. Medical Device Contract Manufacturing Market for Oncological Disorders, 2019-2030
14.3.4.5. Medical Device Contract Manufacturing Market for Orthopedic Disorders, 2019-2030
14.3.4.6. Medical Device Contract Manufacturing Market for Ophthalmic Disorders, 2019-2030
14.3.4.7. Medical Device Contract Manufacturing Market for Pain Disorders, 2019-2030
14.3.4.8. Medical Device Contract Manufacturing Market for Respiratory Disorders, 2019-2030
14.3.4.9. Medical Device Contract Manufacturing Market for Other Therapeutic Areas, 2019-2030
14.4. Medical Device Contract Manufacturing Market: Distribution by Geography, 2019 and 2030
14.4.1. Medical Device Contract Manufacturing Market in North America, 2019-2030
14.4.1.1. Medical Device Contract Manufacturing Market in the US, 2019-2030
14.4.1.2. Medical Device Contract Manufacturing Market in Rest of North America, 2019-2030
14.4.1.3. Medical Device Contract Manufacturing Market in North America, 2019-2030: Class I Devices
14.4.1.4. Medical Device Contract Manufacturing Market in North America, 2019-2030: Class II Devices
14.4.1.5. Medical Device Contract Manufacturing Market in North America, 2019-2030: Class III Devices
14.4.1.6. Medical Device Contract Manufacturing Market in North America for Cardiovascular Disorders, 2019-2030
14.4.1.7. Medical Device Contract Manufacturing Market in North America for CNS Disorders, 2019-2030
14.4.1.8. Medical Device Contract Manufacturing Market in North America for Metabolic Disorders, 2019-2030
14.4.1.9. Medical Device Contract Manufacturing Market in North America for Oncological Disorders, 2019-2030
14.4.1.10. Medical Device Contract Manufacturing Market in North America for Orthopedic Disorders, 2019-2030
14.4.1.11. Medical Device Contract Manufacturing Market in North America for Ophthalmic Disorders, 2019-2030
14.4.1.12. Medical Device Contract Manufacturing Market in North America for Pain Disorders, 2019-2030
14.4.1.13. Medical Device Contract Manufacturing Market in North America for Respiratory Disorders, 2019-2030
14.4.1.14. Medical Device Contract Manufacturing Market in North America for Other Therapeutic Areas, 2019-2030
14.4.2. Medical Device Contract Manufacturing Market in Europe, 2019-2030
14.4.2.1. Medical Device Contract Manufacturing Market in Italy, 2019-2030
14.4.2.2. Medical Device Contract Manufacturing Market in Germany, 2019-2030
14.4.2.3. Medical Device Contract Manufacturing Market in France, 2019-2030
14.4.2.4. Medical Device Contract Manufacturing Market in Spain, 2019-2030
14.4.2.5. Medical Device Contract Manufacturing Market in the UK, 2019-2030
14.4.2.6. Medical Device Contract Manufacturing Market in Rest of Europe, 2019-2030
14.4.2.7. Medical Device Contract Manufacturing Market in Europe: Class I Devices, 2019-2030
14.4.2.8. Medical Device Contract Manufacturing Market in Europe: Class II Devices, 2019-2030
14.4.2.9. Medical Device Contract Manufacturing Market in Europe: Class III Devices, 2019-2030
14.4.2.10. Medical Device Contract Manufacturing Market in Europe for Cardiovascular Disorders, 2019-2030
14.4.2.11. Medical Device Contract Manufacturing Market in Europe for CNS Disorders, 2019-2030
14.4.2.12. Medical Device Contract Manufacturing Market in Europe for Metabolic Disorders, 2019-2030
14.4.2.13. Medical Device Contract Manufacturing Market in Europe for Oncological Disorders, 2019-2030
14.4.2.14. Medical Device Contract Manufacturing Market in Europe for Orthopedic Disorders, 2019-2030
14.4.2.15. Medical Device Contract Manufacturing Market in Europe for Ophthalmic Disorders, 2019-2030
14.4.2.16. Medical Device Contract Manufacturing Market in Europe for Pain Disorders, 2019-2030
14.4.2.17. Medical Device Contract Manufacturing Market in Europe for Respiratory Disorders, 2019-2030
14.4.2.18. Medical Device Contract Manufacturing Market in Europe for Other Therapeutic Areas, 2019-2030
14.4.3. Medical Device Contract Manufacturing Market in Asia and Rest of the World, 2019-2030
14.4.3.1. Medical Device Contract Manufacturing Market in China, 2019-2030
14.4.3.2. Medical Device Contract Manufacturing Market in Japan, 2019-2030
14.4.3.3. Medical Device Contract Manufacturing Market in India, 2019-2030
14.4.3.4. Medical Device Contract Manufacturing Market in Rest of Asia and Rest of the World, 2019-2030
14.4.3.5. Medical Device Contract Manufacturing Market in Asia and Rest of the World: Class I Devices, 2019-2030
14.4.3.6. Medical Device Contract Manufacturing Market in Asia and Rest of the World: Class II Devices, 2019-2030
14.4.3.7. Medical Device Contract Manufacturing Market in Asia and Rest of the World: Class III Devices, 2019-2030
14.4.3.8. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Cardiovascular Disorders, 2019-2030
14.4.3.9. Medical Device Contract Manufacturing Market in Asia and Rest of the World for CNS Disorders, 2019-2030
14.4.3.10. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Metabolic Disorders, 2019-2030
14.4.3.11. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Oncological Disorders, 2019-2030
14.4.3.12. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Orthopedic Disorders, 2019-2030
14.4.3.13. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Ophthalmic Disorders, 2019-2030
14.4.3.14. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Pain Disorders, 2019-2030
14.4.3.15. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Respiratory Disorders, 2019-2030
14.4.3.16. Medical Device Contract Manufacturing Market in Asia and Rest of the World for Other Therapeutic Areas, 2019-2030

15. SWOT ANALYSIS
15.1. Chapter Overview
15.2. Strengths
15.3. Weaknesses
15.4. Opportunities
15.5. Threats
15.6. Concluding Remarks

16. CONCLUSION

17. SURVEY / INTERVIEW TRANSCRIPTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • 3i Group
  • AccuMED
  • Creganna Medical
  • Interplex
  • Oscor
  • Stellartech
  • MORE

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view of the current state of the medical device contract manufacturing market and its likely evolution in the short-mid and long terms.

Chapter 3 provides a brief introduction to medical devices, highlighting key historical milestones, their classification, and associated manufacturing requirements. It emphasizes on the contract services market for such medical products, featuring an overview of the various challenges faced by medical device manufacturers, and highlighting the role of CMOs and diverse range of benefits offered by such service provider entities. It also includes a discussion on the services offered by CMOs, along with a list of advantages and risks associated with outsourcing. Further, it describes the various factors that need to be taken into consideration by sponsor companies, while selecting a suitable CMO partner.

Chapter 4 features a detailed discussion on the various guidelines established by regulatory bodies for medical device approval, across different geographical regions, namely North America (the US and Canada), Europe (specifically the UK scenario), and Asia-Pacific (Japan, China, and Australia). In addition, the chapter features an insightful, multi-dimensional bubble analysis that compares the current regulatory scenario within the overall medical device industry.

Chapter 5 provides a comprehensive overview of the overall landscape of the drug-delivery device CMOs. It includes information related to over 70 companies that actively offer manufacturing services for drug-delivery devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of the employee base, location of the manufacturing facility, scale of operation (pre-commercial and commercial) and types of services offered.

Chapter 6 provides a comprehensive overview of the overall landscape of diagnostic device CMOs. It includes information related to over 80 companies that actively offer manufacturing services for diagnostic devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of the employee base, location of the manufacturing facility, scale of operation (pre-commercial and commercial) and types of services offered.

Chapter 7 provides a comprehensive overview of the global landscape of therapeutic device CMOs. It includes information related to over 170 companies that actively offer manufacturing services for therapeutic devices. In addition, it features an in-depth analysis of the market, based on parameters such as year of establishment, size of the employee base, location of the manufacturing facility, scale of operation (pre-commercial and commercial) and types of services offered.

Chapter 8 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of small-sized, mid-sized and large companies in terms of their expertise in medical device-related services. Further, the analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 9 features an analysis of the medical device value-chain, highlighting the role of CMOs engaged in this domain and analysis based on services such as, such as supply chain management services, logistics services, warehouse services, and shipping services.

Chapter 10 features detailed profiles of popular players that specialize in providing services for both pre-commercial and commercial-stage medical device manufacturing. Each profile features an overview of the company, its service portfolio, details on manufacturing facilities, and an informed future outlook.

Chapter 11 presents a geographical clinical trial analysis of ongoing and planned studies related to medical devices. For the purpose of this analysis, we considered those clinical studies that have been initiated since 2013 and analysed them on the basis of various parameters, such as year of registration, regional distribution, current status of trials, phase of development, funder type, therapeutic area(s) and target disease indication(s), and number of patients enrolled across different geographies.

Chapter 12 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2014-2019, based on parameters such as key-value drivers, year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, and financial details of the deal (if available). The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. In addition, the chapter evaluates the deal multiples of acquisitions specifically focused on medical devices, analyzing them based on a number of parameters, namely annual revenues, number of employees and the experience of the acquired company. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals.

Chapter 13 features a case study highlighting the manufacturing overview of key market sectors, such as automobiles, telecommunication, banking, defense and aerospace that have experienced tremendous growth within emerging markets. It highlights the ongoing evolution in the medical device manufacturing industry within developed and emerging countries, featuring a qualitative comparative analysis. Further, the chapter includes discussions regarding the business models, associated challenges and strategies to mitigate these constraints for multinational, medical device-focused companies within emerging countries.

Chapter 14 presents a likely evolution of the market in the short to mid-term and long term (2018-2030). In addition, we have provided the likely distribution of the opportunity across different A] type of device (drug-delivery, therapeutic and diagnostic devices), [B] device class (class I, class II and class III), therapeutic areas (cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and Rest of the world) and [E] leading players.

Chapter 15 provides a discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical devices CMO industry.

Chapter 16 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the medical device CMOs market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of medical device CMOs.

Chapter 17 is a collection of survey transcripts of the discussions held with key stakeholders in this market.

Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix that contains the list of companies and organizations mentioned in this report.

Note: Product cover images may vary from those shown
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  • 3D Medical Manufacturing (acquired by Tecomet)
  • 3i Group
  • Accellent
  • Access Point Technologies
  • AccuMED
  • Adroit Medical Systems
  • Cirtec Medical
  • Creganna Medical
  • DynaFlex Technologies
  • Europlaz Technologies
  • I-Tek Medical Technologies
  • Interplex
  • Keystone Solutions Group
  • Modern Medical
  • Oscor
  • Providence Enterprise
  • Riverside Medical Packaging
  • SMC
  • Stellartech
  • Suzhou Jenitek
  • Synecco
  • Trelleborg Sealing Solutions
Note: Product cover images may vary from those shown
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