미국의 의료기기 아웃소싱 시장 규모, 점유율, 동향 분석 보고서 : 서비스별, 용도별, 클래스별, 국가별, 부문별 예측(2025-2030년)

U.S. Medical Device Outsourcing Market Growth & Trends:

The U.S. medical device outsourcing market size is expected to reach USD 63.40 billion in 2030 and is expected to grow at a CAGR of 13.0% over the forecast period, according to a new report by Grand View Research, Inc. This market is growing as a result of increased offshore trends, a rise in demand for high-tech medical devices, and stringent regulation for medical devices in the U.S.

The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.

The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials .gov. In case of the medical device also significant studies are conducted in the U.S.

For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials .gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.

U.S. Medical Device Outsourcing Market Report Highlights:

• The U.S. medical device outsourcing industry is developing due to stricter FDA regulations, which require manufacturers to seek specialized compliance support
• The market is rapidly transforming due to evolving regulatory requirements, cost pressures, and the need for faster time to market
• The U.S. medical device outsourcing industry is driven by cost containment pressures, stringent regulatory compliance, and increasing complexity in device development.
• The contract manufacturing segment accounted for the largest share of 46.74% in 2024. The segment growth is owing to increasing cost pressures, stringent FDA regulatory requirements, and the growing complexity of medical devices
• Based on application, the cardiology segment dominated the market in 2024. The growing demand for cardiovascular devices due to the high prevalence rate of cardiovascular diseases (CVDs) is attributed to the growth of outsourcing these devices

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Estimates and Forecast Timeline
• 1.2. Market Definitions
• 1.3. Research Methodology
  • 1.3.1. Information Procurement
  • 1.3.2. Purchased Database
  • 1.3.3. GVR's Internal Database
  • 1.3.4. Secondary Sources
  • 1.3.5. Primary Research
• 1.4. Information or Data Analysis
  • 1.4.1. Information Analysis
  • 1.4.2. Market Formulation & Data Visualization
  • 1.4.3. Data Validation & Publishing
• 1.5. Model Details
  • 1.5.1. Commodity Flow Analysis (Model 1)
  • 1.5.2. Top Down Market Estimation (Model 2)
  • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
  • 1.5.4. Multivariate Analysis (Model 4)
  • 1.5.5. Bottom-Up Approach (Model 5)
• 1.6. List of Secondary Sources
• 1.7. List of Abbreviations
• 1.8. Objectives

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Changing Regulatory Landscape
    • 3.2.1.2. Increase in the Offshoring of Medical Device Manufacturing
    • 3.2.1.3. Rising Demand for Advanced Products
    • 3.2.1.4. Implementation of International Standards by Contract Manufacturers
    • 3.2.1.5. Rising Price Competition and the Need to Reduce Costs
    • 3.2.1.6. Increasing Complexity in Product Design and Engineering
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance Issues While Outsourcing
    • 3.2.2.2. Regulatory and Legal Compliance
    • 3.2.2.3. Contractual Obligations
  • 3.2.3. Industry Challenges
    • 3.2.3.1. Managing Relationships
• 3.3. Technological Advancements
• 3.4. Regulatory Framework
• 3.5. Pricing Model Analysis
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Forces Analysis
  • 3.6.2. PESTEL by SWOT Analysis
  • 3.6.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. U.S. Medical Device Outsourcing Market, By Service: Segment Dashboard
• 4.2. U.S. Medical Device Outsourcing Market, By Service: Movement Analysis
• 4.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Service, 2018 - 2030
• 4.4. Quality Assurance Services
  • 4.4.1. Quality Assurance Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.5. Regulatory Affairs Services
  • 4.5.1. Regulatory Affairs Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.5.2. Clinical Trial Applications & Product Registration
    • 4.5.2.1. Clinical Trial Applications & Product Registration Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.5.3. Regulatory Writing & Publishing
    • 4.5.3.1. Regulatory Writing & Publishing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.5.4. Legal Representation
    • 4.5.4.1. Legal Representation Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.5.5. Others
    • 4.5.5.1. Others Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.6. Product Design and Development Services
  • 4.6.1. Product Design and Development Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.6.2. Designing & Engineering
    • 4.6.2.1. Designing & Engineering Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.6.3. Machining
    • 4.6.3.1. Machining Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.6.4. Molding
    • 4.6.4.1. Molding Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.6.5. Packaging
    • 4.6.5.1. Packaging Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.7. Data Management and Biostatistics
  • 4.7.1. Data Management and Biostatistics Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.8. Product Testing & Sterilization Services
  • 4.8.1. Product Testing & Sterilization Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.9. Product Implementation Services
  • 4.9.1. Product Implementation Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.10. Product Upgrade Services
  • 4.10.1. Product Upgrade Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.11. Product Maintenance Services
  • 4.11.1. Product Maintenance Services Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.12. Contract Manufacturing
  • 4.12.1. Contract Manufacturing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.12.2. Accessories Manufacturing
    • 4.12.2.1. Accessories Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.12.3. Assembly Manufacturing
    • 4.12.3.1. Assembly Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.12.4. Component Manufacturing
    • 4.12.4.1. Component Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 4.12.5. Device Manufacturing
    • 4.12.5.1. Device Manufacturing Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 4.13. Others
  • 4.13.1. Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 5. U.S. Medical Device Outsourcing Market: Application Estimates & Trend Analysis

• 5.1. U.S. Medical Device Outsourcing Market, By Application: Segment Dashboard
• 5.2. U.S. Medical Device Outsourcing Market, By Application: Movement Analysis
• 5.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Application, 2018 - 2030
• 5.4. Cardiology
  • 5.4.1. Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.5. Diagnostic Imaging
  • 5.5.1. Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.6. Orthopedic
  • 5.6.1. Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.7. IVD
  • 5.7.1. IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.8. Ophthalmic
  • 5.8.1. Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.9. General & Plastic Surgery
  • 5.9.1. General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.10. Drug Delivery
  • 5.10.1. Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.10.2. Prefilled Syringe
    • 5.10.2.1. Prefilled Syringe Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.10.3. Autoinjectors
    • 5.10.3.1. Autoinjectors Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.10.4. Infusion Pump
    • 5.10.4.1. Infusion Pump Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 5.10.5. Others
    • 5.10.5.1. Others Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.11. Dental
  • 5.11.1. Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.12. Endoscopy
  • 5.12.1. Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.13. Diabetes Care
  • 5.13.1. Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 5.14. Others
  • 5.14.1. Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 6. U.S. Medical Device Outsourcing Market: Class Estimates & Trend Analysis

• 6.1. U.S. Medical Device Outsourcing Market, By Class: Segment Dashboard
• 6.2. U.S. Medical Device Outsourcing Market, By Class: Movement Analysis
• 6.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By Class, 2018 - 2030
• 6.4. Class I
  • 6.4.1. Class I Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 6.5. Class II
  • 6.5.1. Class II Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 6.6. Class III
  • 6.6.1. Class III Medical Device Outsourcing Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 7. U.S. Medical Device Outsourcing Market: End Use Estimates & Trend Analysis

• 7.1. U.S. Medical Device Outsourcing Market, By End Use: Segment Dashboard
• 7.2. U.S. Medical Device Outsourcing Market, By End Use: Movement Analysis
• 7.3. U.S. Medical Device Outsourcing Market Estimates & Forecasts, By End Use, 2018 - 2030
• 7.4. Cardiology
  • 7.4.1. Class I
    • 7.4.1.1. Class I Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.4.2. Class II
    • 7.4.2.1. Class II Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.4.3. Class III
    • 7.4.3.1. Class III Cardiology Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.5. Diagnostic Imaging
  • 7.5.1. Class I
    • 7.5.1.1. Class I Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.5.2. Class II
    • 7.5.2.1. Class II Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.5.3. Class III
    • 7.5.3.1. Class III Diagnostic Imaging Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.6. Orthopedic
  • 7.6.1. Class I
    • 7.6.1.1. Class I Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.6.2. Class II
    • 7.6.2.1. Class II Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.6.3. Class III
    • 7.6.3.1. Class III Orthopedic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.7. IVD
  • 7.7.1. Class I
    • 7.7.1.1. Class I IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.7.2. Class II
    • 7.7.2.1. Class II IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.7.3. Class III
    • 7.7.3.1. Class III IVD Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.8. Ophthalmic
  • 7.8.1. Class I
    • 7.8.1.1. Class I Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.8.2. Class II
    • 7.8.2.1. Class II Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.8.3. Class III
    • 7.8.3.1. Class III Ophthalmic Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.9. General & Plastic Surgery
  • 7.9.1. Class I
    • 7.9.1.1. Class I General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.9.2. Class II
    • 7.9.2.1. Class II General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.9.3. Class III
    • 7.9.3.1. Class III General & Plastic Surgery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.10. Drug Delivery
  • 7.10.1. Class I
    • 7.10.1.1. Class I Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.10.2. Class II
    • 7.10.2.1. Class II Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.10.3. Class III
    • 7.10.3.1. Class III Drug Delivery Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.11. Dental
  • 7.11.1. Class I
    • 7.11.1.1. Class I Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.11.2. Class II
    • 7.11.2.1. Class II Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.11.3. Class III
    • 7.11.3.1. Class III Dental Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.12. Endoscopy
  • 7.12.1. Class I
    • 7.12.1.1. Class I Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.12.2. Class II
    • 7.12.2.1. Class II Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.12.3. Class III
    • 7.12.3.1. Class III Endoscopy Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.13. Diabetes Care
  • 7.13.1. Class I
    • 7.13.1.1. Class I Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.13.2. Class II
    • 7.13.2.1. Class II Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.13.3. Class III
    • 7.13.3.1. Class III Diabetes Care Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
• 7.14. Others
  • 7.14.1. Class I
    • 7.14.1.1. Class I Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.14.2. Class II
    • 7.14.2.1. Class II Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)
  • 7.14.3. Class III
    • 7.14.3.1. Class III Others Market Estimates and Segment Forecasts, 2018 to 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Market Position Analysis, 2024 (Heat Map Analysis)
• 8.3. Company Profiles
  • 8.3.1. SGS SA
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Laboratory Corporation Of America Holdings
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Eurofins Scientific
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Pace Analytical Services, Inc.
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. TUV SUD
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. Charles River Laboratories
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Freyr
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Global Regulatory Partners
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Parexel International Corporation
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Genpact
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. Criterium, Inc.
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service Benchmarking
    • 8.3.11.4. Strategic Initiatives
  • 8.3.12. Promedica International
    • 8.3.12.1. Company Overview
    • 8.3.12.2. Financial Performance
    • 8.3.12.3. Service Benchmarking
    • 8.3.12.4. Strategic Initiatives
  • 8.3.13. Medpace
    • 8.3.13.1. Company Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Service Benchmarking
    • 8.3.13.4. Strategic Initiatives
  • 8.3.14. ICON Plc.
    • 8.3.14.1. Company Overview
    • 8.3.14.2. Financial Performance
    • 8.3.14.3. Service Benchmarking
    • 8.3.14.4. Strategic Initiatives
  • 8.3.15. IQVIA Inc.
    • 8.3.15.1. Company Overview
    • 8.3.15.2. Financial Performance
    • 8.3.15.3. Service Benchmarking
    • 8.3.15.4. Strategic Initiatives
  • 8.3.16. Integer Holdings Corporation
    • 8.3.16.1. Company Overview
    • 8.3.16.2. Financial Performance
    • 8.3.16.3. Service Benchmarking
    • 8.3.16.4. Strategic Initiatives
  • 8.3.17. Jabil Inc.
    • 8.3.17.1. Company Overview
    • 8.3.17.2. Financial Performance
    • 8.3.17.3. Service Benchmarking
    • 8.3.17.4. Strategic Initiatives
  • 8.3.18. Flex Ltd.
    • 8.3.18.1. Company Overview
    • 8.3.18.2. Financial Performance
    • 8.3.18.3. Service Benchmarking
    • 8.3.18.4. Strategic Initiatives
  • 8.3.19. Plexus Corp.
    • 8.3.19.1. Company Overview
    • 8.3.19.2. Financial Performance
    • 8.3.19.3. Service Benchmarking
    • 8.3.19.4. Strategic Initiatives
  • 8.3.20. West Pharmaceutical Services, Inc.
    • 8.3.20.1. Company Overview
    • 8.3.20.2. Financial Performance
    • 8.3.20.3. Service Benchmarking
    • 8.3.20.4. Strategic Initiatives