의료기기 위탁생산 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 서비스별, 치료 분야별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Medical Device Contract Manufacturing Market Growth & Trends:

The global medical device contract manufacturing market size is anticipated to reach USD 151.98 billion by 2030 and is projected to grow at a CAGR of 12.36% from 2025 to 2030, according to a new report by Grand View Research, Inc. Market growth can be attributed to benefits offered to medical device companies, such as cost savings, scalability, growing adoption of technology, rising focus on quality assurance, and the ability to focus on core competencies.

Outsourcing manufacturing processes to contract manufacturers supports medical device companies to focus on their core competencies, such as R&D, product design, and marketing. Besides, the growing adoption of robotics and AI-driven automation, which support enhanced precision, scalability, and efficiency, is expected to drive market growth. In addition, medical devices focus on innovation from design to deployment; prototype technologies such as computer-aided design (CAD) software, 3D printing, and software allow for rapid testing and iteration. Likewise, the automation testing process ensures quality checks that are frequent and consistent.

Contract manufacturing continues to refine its operations to serve the evolving needs of device OEMs better. A contract manufacturer often supports highly skilled and knowledgeable experience about the latest medical device technologies, processes, and innovations. These OEMs benefit from the contract manufacturer's existing expertise. This supports companies stay competitive and updated on state-of-the-art production techniques without significant investment.

The rising demand for portable, complex medical devices to address unmet medical needs has boosted the market. Besides, the requirement for single-use and disposable devices is increasing, leading to increased attraction in diagnostics and infection control. Technologies like wearable and IoT-enabled devices can drastically drive the market growth in electronics and micro-manufacturing.

The regulation is one of the significant factors for medical device companies that have fueled the demand for medical device contract manufacturing. The FDA plays a pivotal role in ensuring the safety and efficiency of medical devices in the market. Besides, Medical device contract manufacturers must comply with the QSR, 21 CFR Part 820, which outlines the current Good Manufacturing Practices (cGMP) for medical devices.

Strategic partnerships and co-development models between OEMs and contract manufacturers are streamlining supply chains and accelerating product launches. In addition, the growing focus on patient-specific and personalized devices is boosting demand for customized medical devices. For instance, in June 2024, Donatelle Plastics Incorporated, a medical device contract manufacturer in designing, developing, and manufacturing medical components and devices, was acquired by DuPont. The acquisition will bring advanced technologies & capabilities, including medical device injection molding, liquid silicone rubber processing, precision machining, device assembly, & tool building.

Medical Device Contract Manufacturing Market Report Highlights:

• The Class II segment led the market with the largest revenue share of 81.25% in 2024. Growth in the segment can be attributed to the increasing prevalence of chronic diseases, growing FDA approval for the market through the PMA or 510(k), and the launch of various medical devices that integrate digital health platforms to treat various diseases.
• Based on services, the accessories manufacturing segment held the largest market share in 2024, attributed to the increasing requirements for various complementary components that enhance functionality, usability, and patient outcomes. In addition, these access manufacturing support optimize the performance of medical devices.
• Based on the therapeutic area, the cardiovascular devices segment dominated the market with the largest revenue share of 27.17% in 2024, attributing to the growing incidence of cardiovascular diseases and the growing early diagnosis & treatment of these disorders. Moreover, to meet the increasing demand for devices, market players have leverage on contract manufacturers' production, warehousing, and distribution capabilities, which ultimately help market players save costs and sustain rising competition.
• Based on end use, the original equipment manufacturers segment led the market with the largest revenue share of % in 2024. This segment is driven by increasing support for OEMs to manage device production from prototyping & regulatory compliance to final assembly and delivery, ensuring high-quality, safe, and reliable products.
• Asia Pacific market is expected to register at the fastest CAGR of 12.75% over the forecast period. Due to the rising number of medical device companies & contract manufacturing organizations in countries like Japan, China, and India, Asia Pacific will likely witness rapid growth over the estimated time. Furthermore, the availability of a skilled workforce within the region at a lower cost compared to the U.S. is another factor that is anticipated to propel the market growth.

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment 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. Parent Market 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 Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. 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
  • 3.2.2. Market Restraint Analysis
• 3.3. Technological Advancements
• 3.4. Clinical trials volume analysis (2024)
• 3.5. Medical Device Contract Manufacturing Market Analysis Tools
  • 3.5.1. Industry Analysis - Porter's Five Analysis
  • 3.5.2. PESTEL Analysis
  • 3.5.3. COVID-19 Impact Analysis

Chapter 4. Medical Device Contract Manufacturing Market: Product Estimates & Trend Analysis

• 4.1. Medical Device Contract Manufacturing Market, By Product: Segment Dashboard
• 4.2. Medical Device Contract Manufacturing Market, By Product: Movement Analysis
• 4.3. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Product, 2018 - 2030
• 4.4. Class I
  • 4.4.1. Class I Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Class II
  • 4.5.1. Class II Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Class III
  • 4.6.1. Class III Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Medical Device Contract Manufacturing Market: Services Estimates & Trend Analysis

• 5.1. Medical Device Contract Manufacturing Market, By Services: Segment Dashboard
• 5.2. Medical Device Contract Manufacturing Market, By Services: Movement Analysis
• 5.3. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Services, 2018 - 2030
• 5.4. Accessories Manufacturing
  • 5.4.1. Accessories Manufacturing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Assembly Manufacturing
  • 5.5.1. Assembly Manufacturing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Component Manufacturing
  • 5.6.1. Component Manufacturing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Device Manufacturing
  • 5.7.1. Device Manufacturing Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.8. Packaging and Labeling
  • 5.8.1. Packaging and Labeling Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.9. Others
  • 5.9.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Medical Device Contract Manufacturing Market: Therapeutic Area Estimates & Trend Analysis

• 6.1. Medical Device Contract Manufacturing Market, By Therapeutic Area: Segment Dashboard
• 6.2. Medical Device Contract Manufacturing Market, By Therapeutic Area: Movement Analysis
• 6.3. Medical Device Contract Manufacturing Market Estimates & Forecasts, By Synthesis, 2018 - 2030
• 6.4. Cardiovascular Devices
  • 6.4.1. Cardiovascular Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Orthopedic Devices
  • 6.5.1. Orthopedic Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Ophthalmic Devices
  • 6.6.1. Ophthalmic Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Diagnostic Devices
  • 6.7.1. Diagnostic Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. Respiratory Devices
  • 6.8.1. Respiratory Devices Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.9. Surgical Instruments
  • 6.9.1. Surgical Instruments Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.10. Dental
  • 6.10.1. Dental Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.11. Others
  • 6.11.1. Others Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

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

• 7.1. Medical Device Contract Manufacturing Market, By End Use: Segment Dashboard
• 7.2. Medical Device Contract Manufacturing Market, By End Use: Movement Analysis
• 7.3. Medical Device Contract Manufacturing Market Estimates & Forecasts, By End Use, 2018 - 2030
• 7.4. Original Equipment Manufacturers (OEMs)
  • 7.4.1. Original Equipment Manufacturers (OEMs) Market, 2018 to 2030, (USD Million)
• 7.5. Pharmaceutical & Biopharmaceutical Companies
  • 7.5.1. Pharmaceutical & Biopharmaceutical Companies Market, 2018 to 2030, (USD Million)
• 7.6. Others
  • 7.6.1. Others Market, 2018 to 2030, (USD Million)

Chapter 8. Medical Device Contract Manufacturing Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Global Regional Market Snapshot
• 8.4. North America
  • 8.4.1. North America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.2. U.S
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Competitive Scenario
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Canada
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. Mexico
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Competitive Scenario
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. Mexico Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Europe
  • 8.5.1. Europe Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. UK
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. UK Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. Germany
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. Germany Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. France
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. France Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Italy
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Competitive Scenario
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Italy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. Spain
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Competitive Scenario
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. Spain Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Denmark
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Competitive Scenario
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.8. Sweden
    • 8.5.8.1. Key Country Dynamics
    • 8.5.8.2. Competitive Scenario
    • 8.5.8.3. Regulatory Framework
    • 8.5.8.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.9. Norway
    • 8.5.9.1. Key Country Dynamics
    • 8.5.9.2. Competitive Scenario
    • 8.5.9.3. Regulatory Framework
    • 8.5.9.4. Norway Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. Japan
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Japan Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. China
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. China Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.4. India
    • 8.6.4.1. Key Country Dynamics
    • 8.6.4.2. Competitive Scenario
    • 8.6.4.3. Regulatory Framework
    • 8.6.4.4. India Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.5. Thailand
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Competitive Scenario
    • 8.6.5.3. Regulatory Framework
    • 8.6.5.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.6. South Korea
    • 8.6.6.1. Key Country Dynamics
    • 8.6.6.2. Competitive Scenario
    • 8.6.6.3. Regulatory Framework
    • 8.6.6.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.7. Australia
    • 8.6.7.1. Key Country Dynamics
    • 8.6.7.2. Competitive Scenario
    • 8.6.7.3. Regulatory Framework
    • 8.6.7.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.2. Brazil
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Competitive Scenario
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. Brazil Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Argentina
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Competitive Scenario
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.8. MEA
  • 8.8.1. MEA Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.2. South Africa
    • 8.8.2.1. Key Country Dynamics
    • 8.8.2.2. Competitive Scenario
    • 8.8.2.3. Regulatory Framework
    • 8.8.2.4. South Africa Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.3. Saudi Arabia
    • 8.8.3.1. Key Country Dynamics
    • 8.8.3.2. Competitive Scenario
    • 8.8.3.3. Regulatory Framework
    • 8.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.4. UAE
    • 8.8.4.1. Key Country Dynamics
    • 8.8.4.2. Competitive Scenario
    • 8.8.4.3. Regulatory Framework
    • 8.8.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.8.5. Kuwait
    • 8.8.5.1. Key Country Dynamics
    • 8.8.5.2. Competitive Scenario
    • 8.8.5.3. Regulatory Framework
    • 8.8.5.4. Kuwait Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Market Participant Categorization
• 9.2. Company Market Share Analysis, 2024
• 9.3. Company Profiles
  • 9.3.1. Albany Molecular Research Inc.
    • 9.3.1.1. Company Overview
    • 9.3.1.2. Financial Performance
    • 9.3.1.3. Service Benchmarking
    • 9.3.1.4. Strategic Initiatives
  • 9.3.2. Jabil Inc.
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Financial Performance
    • 9.3.2.3. Service Benchmarking
    • 9.3.2.4. Strategic Initiatives
  • 9.3.3. Thermo Fisher Scientific Inc.
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Financial Performance
    • 9.3.3.3. Service Benchmarking
    • 9.3.3.4. Strategic Initiatives
  • 9.3.4. Integer Holdings Corporation
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Financial Performance
    • 9.3.4.3. Service Benchmarking
    • 9.3.4.4. Strategic Initiatives
  • 9.3.5. FLEX LTD.
    • 9.3.5.1. Company Overview
    • 9.3.5.2. Financial Performance
    • 9.3.5.3. Service Benchmarking
    • 9.3.5.4. Strategic Initiatives
  • 9.3.6. Sanmina Corporation
    • 9.3.6.1. Company Overview
    • 9.3.6.2. Financial Performance
    • 9.3.6.3. Service Benchmarking
    • 9.3.6.4. Strategic Initiatives
  • 9.3.7. Celestica Inc.
    • 9.3.7.1. Company Overview
    • 9.3.7.2. Financial Performance
    • 9.3.7.3. Service Benchmarking
    • 9.3.7.4. Strategic Initiatives
  • 9.3.8. Phillips-Medisize
    • 9.3.8.1. Company Overview
    • 9.3.8.2. Financial Performance
    • 9.3.8.3. Service Benchmarking
    • 9.3.8.4. Strategic Initiatives
  • 9.3.9. Plexus Corp.
    • 9.3.9.1. Company Overview
    • 9.3.9.2. Financial Performance
    • 9.3.9.3. Service Benchmarking
    • 9.3.9.4. Strategic Initiatives
  • 9.3.10. Nipro Corporation
    • 9.3.10.1. Company Overview
    • 9.3.10.2. Financial Performance
    • 9.3.10.3. Service Benchmarking
    • 9.3.10.4. Strategic Initiatives
  • 9.3.11. Viant Technology LLC
    • 9.3.11.1. Company Overview
    • 9.3.11.2. Financial Performance
    • 9.3.11.3. Service Benchmarking
    • 9.3.11.4. Strategic Initiatives
  • 9.3.12. West Pharmaceutical Services, Inc.
    • 9.3.12.1. Company Overview
    • 9.3.12.2. Financial Performance
    • 9.3.12.3. Service Benchmarking
    • 9.3.12.4. Strategic Initiatives
  • 9.3.13. Mack Molding
    • 9.3.13.1. Company Overview
    • 9.3.13.2. Financial Performance
    • 9.3.13.3. Service Benchmarking
    • 9.3.13.4. Strategic Initiatives
  • 9.3.14. Cirtec Medical
    • 9.3.14.1. Company Overview
    • 9.3.14.2. Financial Performance
    • 9.3.14.3. Service Benchmarking
    • 9.3.14.4. Strategic Initiatives
  • 9.3.15. Cogmedix
    • 9.3.15.1. Company Overview
    • 9.3.15.2. Financial Performance
    • 9.3.15.3. Service Benchmarking
    • 9.3.15.4. Strategic Initiatives
  • 9.3.16. Synecco Ltd
    • 9.3.16.1. Company Overview
    • 9.3.16.2. Financial Performance
    • 9.3.16.3. Service Benchmarking
    • 9.3.16.4. Strategic Initiatives
  • 9.3.17. TE Connectivity
    • 9.3.17.1. Company Overview
    • 9.3.17.2. Financial Performance
    • 9.3.17.3. Service Benchmarking
    • 9.3.17.4. Strategic Initiatives
  • 9.3.18. Keller Technology Corp.
    • 9.3.18.1. Company Overview
    • 9.3.18.2. Financial Performance
    • 9.3.18.3. Service Benchmarking
    • 9.3.18.4. Strategic Initiatives
  • 9.3.19. HDA Technology, Inc.
    • 9.3.19.1. Company Overview
    • 9.3.19.2. Financial Performance
    • 9.3.19.3. Service Benchmarking
    • 9.3.19.4. Strategic Initiatives

Chapter 10. Key Recommendations