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市场调查报告书
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美国医疗设备契约製造市场规模、份额、趋势分析报告：按产品、服务、治疗领域、最终用途和细分市场预测，2025 年至 2033 年

U.S. Medical Device Contract Manufacturing Market Size, Share & Trends Analysis Report By Product, By Services, By Therapeutic Area, By End Use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10个工作天内

价格

美国医疗设备契约製造市场摘要

美国医疗设备契约製造市场规模预计在 2024 年为 167.2 亿美元，预计到 2033 年将达到 517.6 亿美元，2025 年至 2033 年的复合年增长率为 13.77%。由于糖尿病、心血管疾病和癌症等慢性病患病率上升，中小型目的地医疗设备契约製造美国性增加，对先进和高品质设备的需求不断增长，以及对成本效益的需求不断增加，美国医疗器械OEM製造业正在经历显着增长。

此外，自动化、3D列印和智慧製造技术的集成，以提高精度和扩充性，预计将推动市场成长。此外，美国医疗设备契约製造的投资和策略併购不断增加，预计将扩大市场的服务组合，进一步促进市场成长。

此外，在美国，目的地设备製造商 (OEM) 越来越多地将各种製造流程外包，以提高业务效率、降低资本支出并加快产品上市速度。这些公司越来越多地转向 CMO，以满足医疗设备业不断变化的需求，并以标准品质增强业务。此外，CMO 透过管理生产过程中的多个功能区域，帮助医疗设备更快进入市场，提高生产和工作流程效率。此外，医疗设备製造商越来越注重将部分生产外包，进一步减轻内部资源压力，同时降低成本。此外，与 CMO 合作可以将设备开发成本降低 10-30%，使更多医疗设备公司能够提供创新医疗设备，在竞争激烈的市场中占据优势。

此外，美国药物管理局（FDA）实施的严格监管标准要求契约製造製造商建立全面的品管体系，从而提高其在全球范围内的竞争力。此外，随着对智慧连网型设备的需求不断增长，医疗设备契约製造製造商正在投资医疗物联网，并专注于遵守网路安全标准。此外，回流和供应链多元化等趋势，加上地缘政治发展和近期的关税调整，预计将进一步推动市场发展。

此外，由于产品开发速度加快，医疗设备製造商面临的机会日益激烈，因此对契约製造的需求也随之增加，以应对这些挑战。此外，微创技术、穿戴式技术和诊断工具等医疗设备的进步，加上对监管品质保证的日益关注，预计将在预期期内推动市场成长。这些技术创新可能会提高设备製造的精度、扩充性和客製化，尤其是微创和穿戴式技术以及组合产品。因此，美国医疗设备契约製造市场预计将带来新的机会，因为它可以透过在技术主导和机会为中心的环境中提供包括设计、原型设计、组装、测试和法规遵循的广泛服务来满足医疗设备公司不断变化的需求。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国医疗设备契约製造市场变数、趋势与范围

  • 市场展望
    • 母市场展望
    • 相关/支持市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
    • 产业挑战
  • 技术格局
  • 定价模式分析
  • 美国关税对诊断设备契约製造市场的影响分析
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析
    • COVID-19影响分析

第四章美国医疗设备契约製造市场：类别评估与趋势分析

  • 美国医疗设备契约製造市场（按类别）：细分仪表板
  • 美国医疗设备契约製造市场（按类别）：变化分析
  • 按类别，2021-2033
  • I类
  • II 类
  • III 类

第五章美国医疗设备契约製造市场：服务估算与趋势分析

  • 美国医疗设备契约製造市场（按服务）：细分仪表板
  • 美国医疗设备契约製造市场（按服务）：变化分析
  • 按服务划分，2021-2033 年
  • 配件製造
  • 组装製造
  • 零件製造
  • 设备製造
  • 包装和标籤
  • 其他的

第六章美国医疗设备契约製造市场：治疗药物细分市场的估计与趋势分析

  • 美国医疗设备契约製造市场（按治疗领域）：细分仪表板
  • 美国医疗设备契约製造市场（按治疗领域）：变化分析
  • 依治疗领域，2021-2033
  • 心血管设备
  • 整形外科器械
  • 眼科设备
  • 诊断设备
  • 呼吸装置
  • 手术器械
  • 牙科
  • 其他的

第七章美国医疗设备契约製造市场：最终用途估计与趋势分析

  • 美国医疗设备契约製造市场（按最终用途）：细分仪表板
  • 美国医疗设备契约製造市场（按最终用途）：变化分析
  • 依最终用途，2021-2033 年
  • 原始设备製造商（OEM）
  • 製药和生物製药公司
  • 其他的

第八章 竞争态势

  • 市场参与企业分类
  • 2024 年公司市场占有率/估值分析
  • 公司简介
    • Jabil Inc.
    • Terumo Corporation
    • WuXi AppTec, Inc.
    • Integer Holdings Corporation
    • Flex Ltd.'s US
    • Sanmina Corporation
    • TE Connectivity
    • Sonic Healthcare
    • Forefront Medical Technology
    • Nortech Systems
    • Phillips-Medisize（a Molex company）
    • Celestica HealthTech
    • Viant Medical

第九章 主要建议

Product Code: GVR-4-68040-633-0

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

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. Medical Device Contract Manufacturing Market Estimates and Forecasts, by Country, 2021 - 2033 (USD Million)
  • Table 4 U.S. Medical Device Contract Manufacturing Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
  • Table 5 U.S. Medical Device Contract Manufacturing Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
  • Table 6 U.S. Medical Device Contract Manufacturing Market Estimates and Forecasts, by Therapeutics Area, 2021 - 2033 (USD Million)
  • Table 7 U.S. Medical Device Contract Manufacturing Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Medical Device Contract Manufacturing Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Medical Device Contract Manufacturing Market: Product outlook and key takeaways
  • Fig. 20 U.S. Medical Device Contract Manufacturing Market: Product movement analysis
  • Fig. 21 Class I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Class II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Class III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. Medical Device Contract Manufacturing Market: Service outlook and key takeaways
  • Fig. 25 U.S. Medical Device Contract Manufacturing Market: Service movement analysis
  • Fig. 26 Accessories Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Assembly Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Component Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Device Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Packaging and Labeling Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 U.S. Medical Device Contract Manufacturing Market: Therapeutic Area outlook and key takeaways
  • Fig. 33 U.S. Medical Device Contract Manufacturing Market: Therapeutic Area movement analysis
  • Fig. 34 Cardiovascular Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Orthopedic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Ophthalmic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 Diagnostic Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 38 Respiratory Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Surgical Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Dental Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 U.S. Medical Device Contract Manufacturing Market: End Use outlook and key takeaways
  • Fig. 43 U.S. Medical Device Contract Manufacturing Market: End Use movement analysis
  • Fig. 44 Original Equipment Manufacturers (OEMs) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Pharmaceutical & Biopharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Service heat map analysis
  • Fig. 48 Strategic framework