미국의 의료기기 위탁생산 시장 : 시장 규모, 점유율, 동향 분석 보고서 - 제품별, 서비스별, 치료 분야별, 최종 용도별, 부문별 예측(2025-2033년)

U.S. Medical Device Contract Manufacturing Market Summary

The U.S. medical device contract manufacturing market size was estimated at USD 16.72 billion in 2024 and is projected to reach USD 51.76 billion by 2033, growing at a CAGR of 13.77% from 2025 to 2033. The U.S. medical device contract manufacturing sector is witnessing significant growth, fueled by increasing incidence of chronic illnesses such as diabetes, cardiovascular issues, and cancer, rising outsourcing among small to medium sized original equipment manufacturers (OEMs), the growing complexity of medical technologies, rising demand for advanced, high-quality devices and growing need for cost-efficiency.

Moreover, integration of automation, 3D printing, and smart manufacturing technologies to enhance precision and scalability is anticipated to drive the market growth. In addition, rising investments and strategic mergers and acquisitions in U.S. medical device contract manufacturing is expected to expand the market's service portfolios, further contributing to market growth.

In addition, in the U.S. Original Equipment Manufacturers (OEMs) are increasingly outsourcing various production processes to improve operational efficiency, reduce capital expenses, and expedite product launches. These companies are increasingly shifting to CMOs to enhance their operations with standard quality, addressing the evolving demands of the medical device industry. Moreover, CMOs support facilitating faster market entry for medical devices, improving production and workflow efficiencies by managing multiple functional areas within production processes. Besides, medical devices companies are increasingly focusing on outsourcing a portion of their production further reducing the pressure on internal resources while maintaining lower costs. In addition, partnering with CMOs reduces the cost of device development by 10-30%, enabling further medical device companies to deliver innovative medical devices to stay ahead in a competitive market.

Moreover, in the U.S., strict regulatory standards imposed by the FDA necessitate contract manufacturers to establish comprehensive quality control systems, enhancing their competitiveness on a global scale. Moreover, with the increasing demand for smart and connected devices, medical device contract manufacturers are investing in Internet of Medical Things to focus on adhering the cybersecurity standards. In addition, trends such as reshoring and diversifying supply chains are expected to accelerate geopolitical developments and recent tariff adjustments, which further supports market growth.

Furthermore, the medical device manufacturers are increasingly witnessing increasing competition with rapid product development, increasing the need for contract manufacturers to address these challenges. Moreover, advancements in medical devices, such as minimally invasive techniques, wearable technologies, and diagnostic tools, combined with an increased focus on regulatory quality assurance are anticipated to drive the market growth over the estimated time period. These innovations are likely to enhance precision, scalability, and customization in the production of devices, particularly within minimally invasive and wearable technologies, as well as combination products. Thus, the U.S. medical device contract manufacturing market is expected to witness new opportunities within a technology-driven and innovation-centric landscape, addressing the evolving requirements of medical device companies by offering a wide array of services, including design, prototyping, assembly, testing, and regulatory compliance.

U.S. Medical Device Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. medical device contract manufacturing market report based on product, services, therapeutic area, and end use:

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Class I
• Class II
• Class III
• Services Outlook (Revenue, USD Million, 2021 - 2033)
• Accessories Manufacturing
• Assembly Manufacturing
• Component Manufacturing
• Device Manufacturing
• Packaging and Labeling
• Others
• Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
• Cardiovascular Devices
• Orthopedic Devices
• Ophthalmic Devices
• Diagnostic Devices
• Respiratory Devices
• Surgical Instruments
• Dental
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Original Equipment Manufacturers (OEMs)
• Pharmaceutical & Biopharmaceutical Companies
• Others

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
  • 1.2.1. Product
  • 1.2.2. Services
  • 1.2.3. Therapeutic Area
  • 1.2.4. End Use
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Value-Chain-Based Sizing & Forecasting
  • 1.7.3. Multivariate Model Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Medical Device Contract Manufacturing 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. Increase in offshoring medical device manufacturing to the developing economies
    • 3.2.1.2. Rising demand for advanced products
    • 3.2.1.3. Implementation of the international standards by contract manufacturers
    • 3.2.1.4. Rising Price competition and the requirement to reduce cost
    • 3.2.1.5. OEM Focus on Cost Reduction and Core Competency
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Compliance issues while outsourcing
    • 3.2.2.2. Rising labor and operational costs in key markets
    • 3.2.2.3. Contractual obligation
  • 3.2.3. Industry Challenges
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. U.S. Tariffs Impact Analysis on the Diagnostic Device Contract Manufacturing Market
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Force Analysis
  • 3.6.2. PESTEL by SWOT Analysis
  • 3.6.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Contract Manufacturing Market: Class Estimates & Trend Analysis

• 4.1. U.S. Medical Device Contract Manufacturing Market, By Class: Segment Dashboard
• 4.2. U.S. Medical Device Contract Manufacturing Market, By Class: Movement Analysis
• 4.3. U.S. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Class, 2021 - 2033 (USD Million)
• 4.4. Class I
  • 4.4.1. Class I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Class II
  • 4.5.1. Class II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Class III
  • 4.6.1. Class III Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Medical Device Contract Manufacturing Market: Service Estimates & Trend Analysis

• 5.1. U.S. Medical Device Contract Manufacturing Market, By Service: Segment Dashboard
• 5.2. U.S. Medical Device Contract Manufacturing Market, By Service: Movement Analysis
• 5.3. U.S. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
• 5.4. Accessories Manufacturing
  • 5.4.1. Accessories Manufacturing Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Assembly Manufacturing
  • 5.5.1. Assembly Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Component Manufacturing
  • 5.6.1. Component Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Device Manufacturing
  • 5.7.1. Device Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Packaging and Labeling
  • 5.8.1. Packaging and Labeling Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.9. Others
  • 5.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Medical Device Contract Manufacturing Market: Therapeutics Area Estimates & Trend Analysis

• 6.1. U.S. Medical Device Contract Manufacturing Market, By Therapeutics Area: Segment Dashboard
• 6.2. U.S. Medical Device Contract Manufacturing Market, By Therapeutics Area: Movement Analysis
• 6.3. U.S. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Therapeutics Area, 2021 - 2033 (USD Million)
• 6.4. Cardiovascular Devices
  • 6.4.1. Cardiovascular Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Orthopedic Devices
  • 6.5.1. Orthopedic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Ophthalmic Devices
  • 6.6.1. Ophthalmic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Diagnostic Devices
  • 6.7.1. Diagnostic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Respiratory Devices
  • 6.8.1. Respiratory Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.9. Surgical Instruments
  • 6.9.1. Surgical Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.10. Dental
  • 6.10.1. Dental Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.11. Others
  • 6.11.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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

• 7.1. U.S. Medical Device Contract Manufacturing Market, By End Use: Segment Dashboard
• 7.2. U.S. Medical Device Contract Manufacturing Market, By End Use: Movement Analysis
• 7.3. U.S. Medical Device Contract Manufacturing Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 7.4. Original Equipment Manufacturers (OEMs)
  • 7.4.1. Original Equipment Manufacturers (OEMs) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Pharmaceutical & Biopharmaceutical Companies
  • 7.5.1. Pharmaceutical & Biopharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Others
  • 7.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Market Participant Categorization
• 8.2. Company Market Share/Assessment Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. Jabil Inc.
    • 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. Terumo Corporation
    • 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. WuXi AppTec, Inc.
    • 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. Integer Holdings Corporation
    • 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. Flex Ltd.'s U.S
    • 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. Sanmina Corporation
    • 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. TE Connectivity
    • 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. Sonic Healthcare
    • 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. Forefront Medical Technology
    • 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. Nortech Systems
    • 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. Phillips-Medisize (a Molex company)
    • 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. Celestica HealthTech
    • 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. Viant Medical
    • 8.3.13.1. Company Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Service Benchmarking
    • 8.3.13.4. Strategic Initiatives

Chapter 9. Key Recommendations