DUBLIN--(BUSINESS WIRE)--The "Medical Device Contract Manufacturing Market, 2019-2030" report has been added to ResearchAndMarkets.com's offering.
Medical Device Contract Manufacturing Market is Estimated to Reach a Net Worth of Approximately USD 430 Billion in 2020
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).
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.
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.
Key Topics Covered:
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
5. MARKET OVERVIEW: THERAPEUTIC DEVICES
5.1. Chapter Overview
5.2. Medical Device CMOs Offering Services for Therapeutic Devices
6. MARKET OVERVIEW: DIAGNOSTIC DEVICES
6.1. Chapter Overview
6.2. Medical Device CMOs Offering Services for Diagnostic Devices
7. MARKET OVERVIEW: DRUG-DELIVERY DEVICES AND OTHERS
7.1. Chapter Overview
7.2. Medical Device CMOs Offering Services for Drug Delivery Devices
7.3. Medical Device CMOs Offering Services for Other Devices
8. BENCHMARK ANALYSIS
8.1. Chapter Overview
8.2. Benchmark Analysis: Methodology
8.3. Region-wise Benchmark Analysis
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
10.2.2. DynaFlex Technologies
10.2.3. I-Tek Medical Technologies
10.2.4. Keystone Solutions Group
10.2.5. Oscor
10.2.6. SMC
10.2.7. Stellartech
10.3. CMOs Headquartered in Europe
10.3.1. Creganna Medical
10.3.2. Europlaz Technologies
10.3.3. Riverside Medical Packaging
10.3.4. Synecco
10.3.5. Trelleborg Sealing Solutions
10.4. CMOs Headquartered in Asia
10.4.1. Interplex
10.4.2. Modern Medical
10.4.3. Providence Enterprise
10.4.4. Suzhou Jenitek
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
11.6. Analysis of Focus Therapeutic Areas
11.6.1. Analysis by Type of Sponsor
11.6.2. Analysis by Geography
11.6.3. Cardiovascular Disorders
11.6.4. Oncological Disorders
11.6.5. Central Nervous System (CNS) Disorders
11.6.6. Orthopedic Disorders
11.6.7. Respiratory Disorders
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
13.7. 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
14.4. Medical Device Contract Manufacturing Market: Distribution by Geography, 2019 and 2030
15. SWOT ANALYSIS
16. CONCLUSION
17. SURVEY / INTERVIEW TRANSCRIPTS
18. APPENDIX 1: TABULATED DATA
19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
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