진단 기기 CDMO 시장 규모, 점유율, 동향 분석 보고서 : 서비스별, 클래스별, 용도별, 최종 용도별, 지역별, 부문별 예측(2025-2033년)

Diagnostics Device CDMO Market Summary

The global diagnostics device CDMO market size was estimated at USD 40.33 billion in 2024 and is projected to reach USD 113.12 billion by 2033, growing at a CAGR of 12.43% from 2025 to 2033. The market is driven by the rising burden of chronic & infectious diseases, shift toward point-of-care and rapid diagnostics, cost efficiency and faster time-to-market, and technological advancements in manufacturing.

In addition, the market is driven by the healthcare systems shifting toward faster, more accessible, and technology-driven diagnostic solutions. The rising prevalence of chronic and infectious diseases has compelled test developers to accelerate innovation, which has strengthened the need for specialized outsourcing partners. As diagnostic companies aim to shorten development timelines and navigate an increasingly complex regulatory landscape for device design, validation, and commercial-scale manufacturing, they are increasingly relying on CDMOs to manage production, quality assurance, and compliance activities that would otherwise slow in-house operations. This shift is further supported by the rapid move toward decentralized and point-of-care testing, where manufacturers depend on CDMOs capable of delivering compact, high-precision components and fully integrated platforms that meet stringent global quality standards.

Furthermore, evolving clinical needs have driven technological advancements within the manufacturing ecosystem, further strengthening the role of CDMOs in the diagnostics industry. Advancements in microfluidics, sensor integration, automation, and high-precision plastics have made outsourcing an efficient way for OEMs to access specialized infrastructure without significant capital investment. As companies focus more heavily on R&D, companion diagnostics, and molecular testing, they increasingly depend on CDMOs to manage complex assembly processes, reagent-device integration, and large-volume production. The growth of at-home test kits and rapid diagnostics has further reinforced this trend, with market participants turning to partners capable of scaling output while maintaining high levels of accuracy, reliability, and regulatory compliance.

Global Diagnostics Device CDMO Market Report Segmentation

This report forecasts revenue growth at global, 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 global diagnostics device CDMO market report based on service, class, application, end use, and region.

• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Contract Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing
• Contract Development
  • Product Design and Development Services
  • Testing & Validation
  • Quality Management
  • Others
• Packaging, Labelling & Sterilization
• Regulatory Affairs
• Others
• Class Outlook (Revenue, USD Million, 2021 - 2033)
• Class I
• Class II
• Class III
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Infectious Disease Diagnostics
• Oncology Diagnostics
• Cardiometabolic Diagnostics
• Genetic & Genomic Testing
• Respiratory & Critical Care Diagnostics
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Original Equipment Manufacturers (OEMs)
• Pharmaceutical & Biopharmaceutical Companies
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Norway
  • Sweden
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Oman
  • Qatar

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 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 (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

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

Chapter 3. Diagnostics Device CDMO Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Diagnostics Device CDMO Market Dynamics
  • 3.2.1. Market Driver Impact Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Market Opportunities
• 3.3. Technological Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Supply Chain Analysis
• 3.7. Market Analysis Tools
  • 3.7.1. Porter's Five Forces Analysis
  • 3.7.2. PESTEL by SWOT Analysis

Chapter 4. Diagnostics Device CDMO Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Diagnostics Device CDMO Market Service Movement Analysis
• 4.3. Global Diagnostics Device CDMO Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)
• 4.4. Contract Manufacturing
  • 4.4.1. Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.4.2. Accessories Manufacturing
    • 4.4.2.1. Accessories Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.4.3. Assembly Manufacturing
    • 4.4.3.1. Assembly Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.4.4. Component Manufacturing
    • 4.4.4.1. Component Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.4.5. Device Manufacturing
    • 4.4.5.1. Device Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.5. Contract Development
  • 4.5.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.2. Product Design and Development Services
    • 4.5.2.1. Product Design and Development Services Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.5.3. Testing & Validation
    • 4.5.3.1. Testing & Validation Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.5.4. Quality Management
    • 4.5.4.1. Quality Management Market Estimates and Forecasts, 2021 - 2033 (USD million)
  • 4.5.5. Others
    • 4.5.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.6. Packaging, Labelling & Sterilization
  • 4.6.1. Packaging, Labelling & Sterilization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Regulatory Affairs
  • 4.7.1. Regulatory Affairs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.8. Others
  • 4.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Diagnostics Device CDMO Market: Class Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Diagnostics Device CDMO Market Class Movement Analysis
• 5.3. Global Diagnostics Device CDMO Market Size & Trend Analysis, by Class, 2021 to 2033 (USD Million)
• 5.4. Class I
  • 5.4.1. Class I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Class II
  • 5.5.1. Class II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Class III
  • 5.6.1. Class III Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Diagnostics Device CDMO Market: Application Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Global Diagnostics Device CDMO Market Application Movement Analysis
• 6.3. Global Diagnostics Device CDMO Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 6.4. Infectious Disease Diagnostics
  • 6.4.1. Infectious Disease Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Oncology Diagnostics
  • 6.5.1. Oncology Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Cardiometabolic Diagnostics
  • 6.6.1. Cardiometabolic Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Genetic & Genomic Testing
  • 6.7.1. Genetic & Genomic Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Respiratory & Critical Care Diagnostics
  • 6.8.1. Respiratory & Critical Care Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.9. Others
  • 6.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Diagnostics Device CDMO Market: End Use Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. Global Diagnostics Device CDMO Market End Use Movement Analysis
• 7.3. Global Diagnostics Device CDMO Market Size & Trend Analysis, by End Use, 2021 to 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. Diagnostics Device CDMO Market: Regional Estimates & Trend Analysis by Product, Service, End Use

• 8.1. Regional Market Dashboard
• 8.2. Global Regional Market Snapshot
• 8.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 8.4. North America
  • 8.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (USD Million)
• 8.5. Europe
  • 8.5.1. Market Estimates and Forecasts, 2021 - 2033 (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. Europe Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (USD Million)
• 8.6. Asia Pacific
  • 8.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (USD Million)
  • 8.6.5. Australia
    • 8.6.5.1. Key Country Dynamics
    • 8.6.5.2. Competitive Scenario
    • 8.6.5.3. Regulatory Framework
    • 8.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (USD Million)
  • 8.6.7. Thailand
    • 8.6.7.1. Key Country Dynamics
    • 8.6.7.2. Competitive Scenario
    • 8.6.7.3. Regulatory Framework
    • 8.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.7. Latin America
  • 8.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (USD Million)
• 8.8. MEA
  • 8.8.1. MEA Market Estimates and Forecasts, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (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, 2021 - 2033 (USD Million)
  • 8.8.6. Oman
    • 8.8.6.1. Key Country Dynamics
    • 8.8.6.2. Competitive Scenario
    • 8.8.6.3. Regulatory Framework
    • 8.8.6.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.8.7. Qatar
    • 8.8.7.1. Key Country Dynamics
    • 8.8.7.2. Competitive Scenario
    • 8.8.7.3. Regulatory Framework
    • 8.8.7.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
  • 9.1.1. Market Leaders
  • 9.1.2. Emerging Players
• 9.2. Diagnostics Device CDMO Market Share 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. Product/Service Benchmarking
    • 9.3.1.4. Strategic Initiatives
  • 9.3.2. Thermo Fisher Scientific Inc.
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Financial Performance
    • 9.3.2.3. Product/Service Benchmarking
    • 9.3.2.4. Strategic Initiatives
  • 9.3.3. Integer Holdings Corporation
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Financial Performance
    • 9.3.3.3. Product/Service Benchmarking
    • 9.3.3.4. Strategic Initiatives
  • 9.3.4. FLEX Ltd.
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Financial Performance
    • 9.3.4.3. Product/Service Benchmarking
    • 9.3.4.4. Strategic Initiatives
  • 9.3.5. Sanmina Corporation
    • 9.3.5.1. Company Overview
    • 9.3.5.2. Financial Performance
    • 9.3.5.3. Product/Service Benchmarking
    • 9.3.5.4. Strategic Initiatives
  • 9.3.6. Celestica Inc.
    • 9.3.6.1. Company Overview
    • 9.3.6.2. Financial Performance
    • 9.3.6.3. Product/Service Benchmarking
    • 9.3.6.4. Strategic Initiatives
  • 9.3.7. Phillips-Medisize
    • 9.3.7.1. Company Overview
    • 9.3.7.2. Financial Performance
    • 9.3.7.3. Product/Service Benchmarking
    • 9.3.7.4. Strategic Initiatives
  • 9.3.8. Plexus Corp.
    • 9.3.8.1. Company Overview
    • 9.3.8.2. Financial Performance
    • 9.3.8.3. Product/Service Benchmarking
    • 9.3.8.4. Strategic Initiatives
  • 9.3.9. Nipro Corporation
    • 9.3.9.1. Company Overview
    • 9.3.9.2. Financial Performance
    • 9.3.9.3. Product/Service Benchmarking
    • 9.3.9.4. Strategic Initiatives
  • 9.3.10. Viant Technology LLC
    • 9.3.10.1. Company Overview
    • 9.3.10.2. Financial Performance
    • 9.3.10.3. Product/Service Benchmarking
    • 9.3.10.4. Strategic Initiatives