진단 기기 수탁제조 시장 규모, 점유율, 동향 분석 리포트 : 제품별, 서비스별, 용도별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

Market Size & Trends:

The global diagnostic device contract manufacturing market size was estimated at USD 31.49 billion in 2024 and is projected to grow at a CAGR of 9.84% from 2025 to 2030. The diagnostic device contract manufacturing industry's growth is driven by rapid technological advancements, evolving healthcare needs, and strategic shifts in manufacturing models.

As diagnostic testing shifts towards decentralization, especially with the growing popularity of point-of-care and at-home diagnostics, Original Equipment Manufacturers (OEMs) are increasingly turning to contract manufacturers. Outsourcing supports improving the scalability, shortening time-to-market, and managing operational costs effectively. In addition, the presence of well-established manufacturing hubs of highly reliable, complex, and high-quality medical devices in the region has led to increased demand for diagnostic devices, which is crucial for enhancing healthcare efficiency. Moreover, the rising prevalence of diseases and the need for a range of medical devices are expected to be one of the major factors propelling the development of the diagnostic device contract manufacturing industry.

Emerging technologies like microfluidics, AI-driven quality assurance, advanced biosensors, and IoT integration are transforming the capabilities and design demands of medical devices. These advancements require precision engineering, adherence to strict regulatory standards, and high-quality manufacturing processes, where specialized Contract Manufacturing Organizations (CMOs) are expected to hold the competitive edge. Moreover, the rising use of 3D printing for rapid prototyping and low-volume production allows for customization and development cycles, driving the market growth.

The growth is further fueled by an increasing focus on early disease detection, an aging population, a growing burden of chronic diseases, and improved access to diagnostics in emerging economies. Furthermore, regional influences, including shifts in trade policy and U.S.-China tariffs, have prompted manufacturers to reevaluate global supply chains, leading to diversification in sourcing and production. These factors are expected to drive market growth.

Global Diagnostic Device Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global diagnostic device contract manufacturing market report based on product, service, application, end use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)
• In Vitro Diagnostic Devices
  • IVD Consumables
  • IVD Equipment
• Diagnostic Imaging Devices
• Others
• Service Outlook (Revenue, USD Million, 2018 - 2030)
• Device Development and Manufacturing Services
• Quality Management Services
• Packaging and Assembly Services
• Others
• Application Outlook (Revenue, USD Million, 2018 - 2030)
• Infectious Diseases
• Diabetes
• Oncology
• Cardiology
• Orthopedics
• Neurology
• Gastroenterology
• Gynecology
• Others
• End Use Outlook (Revenue, USD Million, 2018 - 2030)
• Original Equipment Manufacturers (OEMs)
• Medical Device Companies
• Others
• Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Thailand
  • South Korea
  • Australia
• Latin America
  • Brazil
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

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. Service
  • 1.2.3. Application
  • 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 Outlook
• 2.3. Competitive Insights

Chapter 3. Diagnostic 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. Rising Emphasis on Early Disease Detection and Expanding Range of Clinical Diagnostic Applications
    • 3.2.1.2. Growing Integration of Robotics and Automation to Enhance Precision and Scalability in Manufacturing
    • 3.2.1.3. Reduction in Operational Costs for Diagnostic Companies
    • 3.2.1.4. Increased Adoption of Point-of-care Testing.
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Regulatory Complexity
    • 3.2.2.2. Diverse and Evolving Global Regulations may Hinder Market Entry and Expansion.
• 3.3. Pricing Model Analysis
• 3.4. Technology Landscape
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Force Analysis
  • 3.5.2. PESTEL by SWOT Analysis
  • 3.5.3. COVID-19 Impact Analysis

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

• 4.1. Diagnostic Device Contract Manufacturing Market, By Product: Segment Dashboard
• 4.2. Diagnostic Device Contract Manufacturing Market, By Product: Movement Analysis
• 4.3. Diagnostic Device Contract Manufacturing Market Estimates & Forecasts, By Product, 2018 - 2030 (USD Million)
• 4.4. In Vitro Diagnostic Devices
  • 4.4.1. In Vitro Diagnostic Devices Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.2. IVD Consumables
    • 4.4.2.1. IVD Consumables Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.4.3. IVD Equipment
    • 4.4.3.1. IVD Equipment Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Diagnostic Imaging Devices
  • 4.5.1. Diagnostic Imaging Devices Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Others
  • 4.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Diagnostic Device Contract Manufacturing Market: Service Estimates & Trend Analysis

• 5.1. Diagnostic Device Contract Manufacturing Market, By Service: Segment Dashboard
• 5.2. Diagnostic Device Contract Manufacturing Market, By Service: Movement Analysis
• 5.3. Diagnostic Device Contract Manufacturing Market Estimates & Forecasts, By Service, 2018 - 2030 (USD Million)
• 5.4. Device Development and Manufacturing Services
  • 5.4.1. Device Development and Manufacturing Services Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Quality Management Services
  • 5.5.1. Quality Management Services Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Packaging and Assembly Services
  • 5.6.1. Packaging and Assembly Services Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.7. Others
  • 5.7.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Diagnostic Device Contract Manufacturing Market: Application Estimates & Trend Analysis

• 6.1. Diagnostic Device Contract Manufacturing Market, By Application: Segment Dashboard
• 6.2. Diagnostic Device Contract Manufacturing Market, By Application: Movement Analysis
• 6.3. Diagnostic Device Contract Manufacturing Market Estimates & Forecasts, By Application, 2018 - 2030 (USD Million)
• 6.4. Infectious Diseases
  • 6.4.1. Infectious Diseases Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Diabetes
  • 6.5.1. Diabetes Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Oncology
  • 6.6.1. Oncology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.7. Cardiology
  • 6.7.1. Cardiology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.8. Orthopedics
  • 6.8.1. Orthopedics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.9. Neurology
  • 6.9.1. Neurology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.10. Gastroenterology
  • 6.10.1. Gastroenterology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.11. Gynecology
  • 6.11.1. Gynecology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.12. Others
  • 6.12.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

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

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

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

• 8.1. Regional Market Dashboard
• 8.2. Regional Market Share Analysis, 2024 & 2030
• 8.3. North America
  • 8.3.1. North America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.2. U.S
    • 8.3.2.1. Key Country Dynamics
    • 8.3.2.2. Competitive Scenario
    • 8.3.2.3. Regulatory Framework
    • 8.3.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.3. Canada
    • 8.3.3.1. Key Country Dynamics
    • 8.3.3.2. Competitive Scenario
    • 8.3.3.3. Regulatory Framework
    • 8.3.3.4. Canada Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.4. Mexico
    • 8.3.4.1. Key Country Dynamics
    • 8.3.4.2. Competitive Scenario
    • 8.3.4.3. Regulatory Framework
    • 8.3.4.4. Mexico Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.4. Europe
  • 8.4.1. Europe Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.2. UK
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Competitive Scenario
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. UK Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Germany
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Germany Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. France
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Competitive Scenario
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. France Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.5. Italy
    • 8.4.5.1. Key Country Dynamics
    • 8.4.5.2. Competitive Scenario
    • 8.4.5.3. Regulatory Framework
    • 8.4.5.4. Italy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.6. Spain
    • 8.4.6.1. Key Country Dynamics
    • 8.4.6.2. Competitive Scenario
    • 8.4.6.3. Regulatory Framework
    • 8.4.6.4. Spain Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.7. Denmark
    • 8.4.7.1. Key Country Dynamics
    • 8.4.7.2. Competitive Scenario
    • 8.4.7.3. Regulatory Framework
    • 8.4.7.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.8. Sweden
    • 8.4.8.1. Key Country Dynamics
    • 8.4.8.2. Competitive Scenario
    • 8.4.8.3. Regulatory Framework
    • 8.4.8.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.9. Norway
    • 8.4.9.1. Key Country Dynamics
    • 8.4.9.2. Competitive Scenario
    • 8.4.9.3. Regulatory Framework
    • 8.4.9.4. Norway Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Asia Pacific
  • 8.5.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. Japan
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Japan Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. China
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. China Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. India
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. India Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Thailand
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Competitive Scenario
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. South Korea
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Competitive Scenario
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Australia
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Competitive Scenario
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Latin America
  • 8.6.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. Brazil
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Brazil Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. Argentina
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.7. MEA
  • 8.7.1. MEA Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.2. South Africa
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Competitive Scenario
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. South Africa Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Saudi Arabia
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Competitive Scenario
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.4. UAE
    • 8.7.4.1. Key Country Dynamics
    • 8.7.4.2. Competitive Scenario
    • 8.7.4.3. Regulatory Framework
    • 8.7.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.5. Kuwait
    • 8.7.5.1. Key Country Dynamics
    • 8.7.5.2. Competitive Scenario
    • 8.7.5.3. Regulatory Framework
    • 8.7.5.4. Kuwait Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Market Participant Categorization
• 9.2. Company Market Share/Assessment Analysis, 2024
• 9.3. Company Profiles
  • 9.3.1. Jabil 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. Flex Ltd.
    • 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. Becton Dickinson and Company (BD)
    • 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. TE Connectivity Ltd.
    • 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. Plexus Corp
    • 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. Sekisui Diagnostics LLC
    • 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. Sanmina Corporation
    • 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. Celestica Inc.
    • 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. Nipro Medical Corporation
    • 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. Integer Holdings 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. West Pharmaceutical Services Inc.
    • 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. Benchmark Electronics 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. Kimball Electronics Inc.
    • 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. KMC Systems
    • 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. Savyon Diagnostics Ltd.
    • 9.3.15.1. Company Overview
    • 9.3.15.2. Financial Performance
    • 9.3.15.3. Service Benchmarking
    • 9.3.15.4. Strategic Initiatives

Chapter 10. Key Recommendations