Diagnostics Device CDMO Market Size, Share & Trends Analysis Report By Service (Contract Development, Contract Manufacturing), By Class (Class I, Class II), By Application, By End Use, By Region, And Segment Forecasts, 2025 - 2033
Description
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.
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
150 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Workflow
- 1.2.2. Type
- 1.2.3. Scale
- 1.3. Estimates and Forecast Timeline
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR’s Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.6. Information Analysis
- 1.6.1. Data Analysis Models
- 1.7. Market Formulation & Data Visualization
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. List of Secondary Sources
- 1.10. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
- Chapter 3. Automated and Closed Cell Therapy Processing Systems Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.3. Business Environment Analysis
- 3.3.1. Industry Analysis - Porter’s Five Forces Analysis
- 3.3.2. PESTLE Analysis
- Chapter 4. Automated and Closed Cell Therapy Processing Systems Market: Workflow Business Analysis
- 4.1. Workflow Market Share, 2025 & 2033
- 4.2. Workflow Segment Dashboard
- 4.3. Market Size & Forecasts and Trend Analysis, by Workflow, 2021 to 2033 (USD Million)
- 4.4. Separation
- 4.4.1. Separation market, 2021 - 2033 (USD Million)
- 4.5. Expansion
- 4.5.1. Expansion market, 2021 - 2033 (USD Million)
- 4.6. Apheresis
- 4.6.1. Apheresis market, 2021 - 2033 (USD Million)
- 4.7. Fill- Finish
- 4.7.1. Fill- Finish market, 2021 - 2033 (USD Million)
- 4.8. Cryopreservation
- 4.8.1. Cryopreservation market, 2021 - 2033 (USD Million)
- 4.9. Others
- 4.9.1. Others market, 2021 - 2033 (USD Million)
- Chapter 5. Automated and Closed Cell Therapy Processing Systems Market: Type Business Analysis
- 5.1. Type Market Share, 2025 & 2033
- 5.2. Type Segment Dashboard
- 5.3. Market Size & Forecasts and Trend Analysis, by Type, 2021 to 2033 (USD Million)
- 5.4. Stem Cell Therapy
- 5.4.1. Stem cell therapy market, 2021 - 2033 (USD Million)
- 5.5. Non Stem Cell Therapy
- 5.5.1. Non stem cell therapy market, 2021 - 2033 (USD Million)
- Chapter 6. Automated and Closed Cell Therapy Processing Systems Market: Scale Business Analysis
- 6.1. Scale Market Share, 2025 & 2033
- 6.2. Scale Segment Dashboard
- 6.3. Market Size & Forecasts and Trend Analysis, by Scale, 2021 to 2033 (USD Million)
- 6.4. Pre-Commercial/ R&D Scale
- 6.4.1. Pre-commercial/ R&D scale market, 2021 - 2033 (USD Million)
- 6.5. Commercial Scale
- 6.5.1. Commercial scale market, 2021 - 2033 (USD Million)
- Chapter 7. Automated and Closed Cell Therapy Processing Systems Market: Regional Estimates & Trend Analysis by Workflow, Type, and Scale
- 7.1. Regional Market Share Analysis, 2025 & 2033
- 7.2. Regional Market Dashboard
- 7.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
- 7.4. North America
- 7.4.1. North America automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.4.2. U.S.
- 7.4.2.1. Key country dynamic
- 7.4.2.2. Regulatory framework
- 7.4.2.3. Competitive insights
- 7.4.2.4. U.S. automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.4.3. Canada
- 7.4.3.1. Key country dynamic
- 7.4.3.2. Regulatory framework
- 7.4.3.3. Competitive insights
- 7.4.3.4. Canada automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.4.4. Mexico
- 7.4.4.1. Key country dynamic
- 7.4.4.2. Regulatory framework
- 7.4.4.3. Competitive insights
- 7.4.4.4. Mexico automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5. Europe
- 7.5.1. Europe automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.2. UK
- 7.5.2.1. Key country dynamic
- 7.5.2.2. Regulatory framework
- 7.5.2.3. Competitive insights
- 7.5.2.4. UK automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.3. Germany
- 7.5.3.1. Key country dynamic
- 7.5.3.2. Regulatory framework
- 7.5.3.3. Competitive insights
- 7.5.3.4. Germany automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.4. France
- 7.5.4.1. Key country dynamic
- 7.5.4.2. Regulatory framework
- 7.5.4.3. Competitive insights
- 7.5.4.4. France automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.5. Italy
- 7.5.5.1. Key country dynamic
- 7.5.5.2. Regulatory framework
- 7.5.5.3. Competitive insights
- 7.5.5.4. Italy automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.6. Spain
- 7.5.6.1. Key country dynamic
- 7.5.6.2. Regulatory framework
- 7.5.6.3. Competitive insights
- 7.5.6.4. Spain automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.7. Denmark
- 7.5.7.1. Key country dynamic
- 7.5.7.2. Regulatory framework
- 7.5.7.3. Competitive insights
- 7.5.7.4. Denmark automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.8. Sweden
- 7.5.8.1. Key country dynamic
- 7.5.8.2. Regulatory framework
- 7.5.8.3. Competitive insights
- 7.5.8.4. Sweden automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.5.9. Norway
- 7.5.9.1. Key country dynamic
- 7.5.9.2. Regulatory framework
- 7.5.9.3. Competitive insights
- 7.5.9.4. Norway automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6. Asia Pacific
- 7.6.1. Asia Pacific automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.2. Japan
- 7.6.2.1. Key country dynamic
- 7.6.2.2. Regulatory framework
- 7.6.2.3. Competitive insights
- 7.6.2.4. Japan automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.3. China
- 7.6.3.1. Key country dynamic
- 7.6.3.2. Regulatory framework
- 7.6.3.3. Competitive insights
- 7.6.3.4. China automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.4. India
- 7.6.4.1. Key country dynamic
- 7.6.4.2. Regulatory framework
- 7.6.4.3. Competitive insights
- 7.6.4.4. India automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.5. Australia
- 7.6.5.1. Key country dynamic
- 7.6.5.2. Regulatory framework
- 7.6.5.3. Competitive insights
- 7.6.5.4. Australia automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.6. Thailand
- 7.6.6.1. Key country dynamic
- 7.6.6.2. Regulatory framework
- 7.6.6.3. Competitive insights
- 7.6.6.4. Thailand automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.6.7. South Korea
- 7.6.7.1. Key country dynamic
- 7.6.7.2. Regulatory framework
- 7.6.7.3. Competitive insights
- 7.6.7.4. South Korea automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.7. Latin America
- 7.7.1. Latin America automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.7.2. Brazil
- 7.7.2.1. Key country dynamic
- 7.7.2.2. Regulatory framework
- 7.7.2.3. Competitive insights
- 7.7.2.4. Brazil automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.7.3. Argentina
- 7.7.3.1. Key country dynamic
- 7.7.3.2. Regulatory framework
- 7.7.3.3. Competitive insights
- 7.7.3.4. Argentina automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8. Middle East and Africa
- 7.8.1. Middle East and Africa automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.2. South Africa
- 7.8.2.1. Key country dynamic
- 7.8.2.2. Regulatory framework
- 7.8.2.3. Competitive insights
- 7.8.2.4. South Africa automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.3. Saudi Arabia
- 7.8.3.1. Key country dynamic
- 7.8.3.2. Regulatory framework
- 7.8.3.3. Competitive insights
- 7.8.3.4. Saudi Arabia automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.4. UAE
- 7.8.4.1. Key country dynamic
- 7.8.4.2. Regulatory framework
- 7.8.4.3. Competitive insights
- 7.8.4.4. UAE automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- 7.8.5. Kuwait
- 7.8.5.1. Key country dynamic
- 7.8.5.2. Regulatory framework
- 7.8.5.3. Competitive insights
- 7.8.5.4. Kuwait automated and closed cell therapy processing systems market estimates and forecasts, 2021 - 2033 (USD Million)
- Chapter 8. Competitive Landscape
- 8.1. Participant Overview
- 8.2. Company Market Position Analysis
- 8.3. Company Categorization
- 8.4. Strategy Mapping
- 8.5. Company Profiles/Listing
- 8.5.1. Miltenyi Biotec
- 8.5.1.1. Overview
- 8.5.1.2. Financial performance
- 8.5.1.3. Product benchmarking
- 8.5.1.4. Strategic initiatives
- 8.5.2. Lonza
- 8.5.2.1. Overview
- 8.5.2.2. Financial performance
- 8.5.2.3. Product benchmarking
- 8.5.2.4. Strategic initiatives
- 8.5.3. Fresenius Kabi AG
- 8.5.3.1. Overview
- 8.5.3.2. Financial performance
- 8.5.3.3. Product benchmarking
- 8.5.3.4. Strategic initiatives
- 8.5.4. Danaher Corporation
- 8.5.4.1. Overview
- 8.5.4.2. Financial performance
- 8.5.4.3. Product benchmarking
- 8.5.4.4. Strategic initiatives
- 8.5.5. BioSpherix, LLC
- 8.5.5.1. Overview
- 8.5.5.2. Financial performance
- 8.5.5.3. Product benchmarking
- 8.5.5.4. Strategic initiatives
- 8.5.6. Terumo Corporation
- 8.5.6.1. Overview
- 8.5.6.2. Financial performance
- 8.5.6.3. Product benchmarking
- 8.5.6.4. Strategic initiatives
- 8.5.7. Sartorius AG
- 8.5.7.1. Overview
- 8.5.7.2. Financial performance
- 8.5.7.3. Product benchmarking
- 8.5.7.4. Strategic initiatives
- 8.5.8. ThermoGenesis Holdings, Inc.
- 8.5.8.1. Overview
- 8.5.8.2. Financial performance
- 8.5.8.3. Product benchmarking
- 8.5.8.4. Strategic initiatives
- 8.5.9. CELLARES
- 8.5.9.1. Overview
- 8.5.9.2. Financial performance
- 8.5.9.3. Product benchmarking
- 8.5.9.4. Strategic initiatives
- 8.5.10. Thermo Fisher Scientific Inc.
- 8.5.10.1. Overview
- 8.5.10.2. Financial performance
- 8.5.10.3. Product benchmarking
- 8.5.10.4. Strategic initiatives
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