Diagnostic Contract Manufacturing Market

Diagnostic Contract Manufacturing Market by Device (In Vitro Diagnostic Devices and Diagnostic Imaging Devices), Service (Device Development & Manufacturing, Quality Management, and Packaging & Assembly), Application, Region - Global Forecast to 2028

Report Code: MD 8985 Apr, 2024, by marketsandmarkets.com

The global diagnostic contract manufacturing market in terms of revenue was estimated to be worth $26.0 billion in 2023 and is poised to reach $44.9 billion by 2028, growing at a CAGR of 11.5% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

The growth in this market is attributed to the rising number of diagnostic public-private partnerships, and government grants will increase the use of medical devices in emerging countries, leading to a boom in contract manufacturing. On the other hand, a lack of constant innovation to balance technological capabilities against cost may challenge the growth of the diagnostic contract manufacturing market.

Attractive Opportunities in the Diagnostic contract manufacturing Industry

Diagnostic Contract Manufacturing Market

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Diagnostic Contract Manufacturing Market

Global Diagnostic contract manufacturing Dynamics

DRIVER: High cost of in-house IVD manufacturing

Contract manufacturing services in the IVD field have gained significant adoption as companies seek to expand their customer base by providing competitively priced products. Many CMOs are emerging in the Asia Pacific region, providing enormous opportunities for OEMs in IVD. According to a report by the Medical Device Outsourcing Association (MDOA), over 70% of medical device companies considered outsourcing in 2021. Thus, the high cost associated with the in-house manufacturing of IVD products has opened the doors to outsourcing manufacturing.

RESTRAINT: IP protection concerns and the possibility of IP theft

Diagnostic contract manufacturing includes outsourcing the production of the devices like IVD equipment, diagnostic imaging devices, and other devices to third-party manufacturers. OEM shares sensitive and proprietary information with contract manufacturers about diagnostic devices' design, technology, and manufacturing process. And with this exchange of sensitive information, data security becomes crucial.

OPPORTUNITY: Growth opportunities in emerging countries

Developing economies such as India, China, Brazil, South Korea, Turkey, Russia, and South Africa offer high growth opportunities for major players in the diagnostic contract manufacturing market. Furthermore, emerging economies offer lower manufacturing costs. For instance, outsourcing to China would reduce the overall manufacturing cost by ~30% compared to manufacturing in the US.

CHALLENGE: Adoption of refurbished diagnostic imaging systems

due to the strong demand for diagnostic imaging procedures globally, hospitals that cannot afford to invest in new imaging systems opt for refurbished ones. This is because refurbished systems are priced lower than new systems (40% to 60% of the price of new equipment). Many independent suppliers provide high-end refurbished and re-used systems at a significantly lower price.

Diagnostic Contract Manufacturing Industry Ecosystem

Prominent companies in this market include well-established, financially stable players in diagnostic contract manufacturing. These companies have been operating in the market for several years and possess a diversified product portfolio, state-of-the-art technologies, and strong global sales and marketing networks. Prominent companies in this market include Jabil Inc. (US), Flex Ltd. (Singapore), Plexus Corp (US), Sanmina Corporation (US), TE Connectivity Ltd. (Switzerland), and Celestica Inc. (Canada).

Diagnostic Contract Manufacturing Market Ecosystem

In 2022, In Vitro Diagnostic devices to observe the highest share of the diagnostic contract manufacturing industry, by product.

Based on the devices, the global diagnostic contract manufacturing market is broadly segmented into In vitro diagnostic devices, diagnostic imaging devices, and other devices. IVD equipment and devices are used to conduct laboratory tests to diagnose diseases and medical conditions and monitor patient status. IVD devices observe the highest market share during the forecast period. The high growth rate can be attributed to the increased adoption of automated diagnostic tools. 

In 2022, device development and manufacturing services segment to dominate the diagnostic devices industry, by service.

Based on service, the diagnostic contract manufacturing market is segmented into device development and manufacturing services, quality management services, packaging and assembly services, and other services. Diagnostic device makers are currently under intense pressure to bring new devices to market faster and lower production costs. As a result, medical device manufacturing service providers continually evolve their services and find new ways to make production more efficient.

In 2022, North America to hold second largest in diagnostic contract manufacturing industry after Asia Pacific.

The global diagnostic contract manufacturing market is segmented into North America, Europe, Asia Pacific, and Rest of the World. North America is expected to observe significant growth during the forecast period, primarily due to the presence of a large number of diagnostic contract manufacturing companies in the region and improved industrial and healthcare infrastructure. The region also offers technological advancements in diagnostic devices, offering innovative solutions to their OEM partners.

Diagnostic Contract Manufacturing Market by Region

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The diagnostic contract manufacturing market is dominated by players such as Jabil Inc. (US), Flex Ltd. (Singapore), Plexus Corp (US), Sanmina Corporation (US), TE Connectivity Ltd. (Switzerland), and Celestica Inc. (Canada).

Scope of the Diagnostics Contract Manufacturing Industry

Report Metric


Market Revenue in 2023

$26.0 billion

Projected Revenue by 2028

$44.9 billion

Revenue Rate

Poised to Grow at a CAGR of 11.5%

Market Driver

High cost of in-house IVD manufacturing

Market Opportunity

Growth opportunities in emerging countries

This research report categorizes the Diagnostic contract manufacturing market to forecast revenue and analyze trends in each of the following submarkets:

By Region

  • North America
  • Europe
  • Asia Pacific
  • Rest of the World

By Product

  • In Vitro Diagnostic Devices
    • IVD Consumables
    • IVD Equipment
  • Diagnostic Imaging Devices
    • CT
    • X-ray
    • Ultrasound
    • MRI
    • Others
  • Other Devices

By Service

  • Device Development and Manufacturing Services
  • Quality Management Services
  • Packaging and Assembly Services
  • Other Services

By Application

  • In Vitro Diagnostic Devices
    • Infectious Diseases
    • Diabetes
    • Oncology
    • Cardiology
    • Other Applications
  • Diagnostic Imaging Devices
    • Cardiology
    • Oncology
    • Orthopedics
    • Neurology
    • Other Applications
  • Other Devices
    • Gastroenterology
    • Gynecology
    • Other Applications

Recent Developments of Diagnostic Contract Manufacturing Industry:

  • In 2022, IdentifySensors Biologics partnered with Jabil Inc. to develop processes for the reliable and robust manufacturing of portable devices that rapidly detect a wide range of infections at the molecular level with an accuracy that is superior to PCR testing.
  • In 2022, Plexus Corp. expanded its manufacturing facility in Bangkok, Thailand.
  • In 2021, TE Connectivity (US) acquired three companies focused on microfluidic cartridge and blister reagent package development, usability testing, and clinical research and manufacturing.
  • In 2020, Sanmina Corporation achieved the Medical Device Single Audit Program (MDSAP) Certification at facilities in Malaysia, Singapore, and Sweden. The certification ensures its compliance with quality practices and audits.

Frequently Asked Questions (FAQ):

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1 Introduction 
    1.1 Objectives of the Study 
    1.2 Market Definition 
           1.2.1 Inclusions and Exclusions of the Study
           1.2.2 Markets Covered
           1.2.3 Years Considered for the Study
    1.3 Currency 
    1.4 Limitations 
    1.5 Stakeholders 
2 Research Methodology 
    2.1 Research Data 
           2.1.1 Secondary Data
           Key Data From Secondary Sources
           2.1.2 Primary Data
           Key Data From Primary Sources
           Breakdown of Primaries
           Key Industry Insights
    2.2 Market Size Estimation 
    2.3 Market Breakdown & Data Triangulation 
    2.4 Market Share Estimation 
    2.5 Assumptions for the Study 
3 Executive Summary 
4 Premium Insights 
    4.1 Diagnostic Contract Manufacturing Market Overview 
    4.2 Diagnostic Contract Manufacturing Market: Geographic Mix 
    4.3 Diagnostic Contract Manufacturing Market , By Region (2023-2028) 
    4.4 Diagnostic Contract Manufacturing Market: Developed Vs. Developing Markets 
5 Market Overview 
    5.1 Introduction 
    5.2 Market Dynamics 
           5.2.1 Drivers
           5.2.2 Restraints
           5.2.3 Opportunities
           5.2.4 Challenges
    5.3 Regulatory Analysis 
           5.3.1 Regulatory Landscape
           5.3.2 Regulatory Bodies, government agencies and other organization
    5.5 Porter's Five Force Analysis 
    5.6 Supply Chain Analysis 
    5.7 Ecosystem Mapping 
    5.8 Technology Analysis 
    5.9 Key Conferences and events in 2022-2023 
6 Diagnostic Contract Manufacturing , By Device Type 
    6.1 Introduction 
    6.2 In Vitro Diagnostic Devices 
           6.2.1 IVD Consumables
           6.2.2 IVD Equipment
    6.3 Diagnostic Imaging Devices 
           6.3.1 X-ray
           6.3.2 CT scan
           6.3.3 Ultrasound
           6.3.4 MRI
           6.3.5 Others
    6.4 Other Devices 
7 Diagnostic Contract Manufacturing , By Service 
    7.1 Introduction 
    7.2 Device Development and Manufacturing Services 
    7.3 Quality Management Services 
    7.4 Packaging and Assembly Services 
    7.5 Other Services 
8 Diagnostic Contract Manufacturing , By Application 
    8.1 In Vitro Diagnostic Devices 
           8.1.1 Infectious Diseases
           8.1.2 Diabetes
           8.1.3 Oncology
           8.1.4 Cardiology
           8.1.5 Others
    8.2 Diagnostic Imaging Devices 
           8.2.1 Cardiology
           8.2.2 Neurology
           8.2.3 Orthopedics
           8.2.4 Oncology
           8.2.5 Others
    8.3 Other Devices 
           8.3.1 Gastroenterology
           8.3.2 Gynecology
           8.3.3 Others
9 Diagnostic Contract Manufacturing , By Region 
    9.1 Introduction 
    9.2 North America 
           9.2.1 Recession Impact
           9.2.2 US 
           9.2.3 Canada
    9.3 Europe 
           9.3.1 Recession Impact
           9.3.2 Germany
           9.3.3 France
           9.3.4 UK
           9.3.5 Italy
           9.3.6 Spain
           9.3.7 Rest of Europe
    9.4 Asia Pacific 
           9.4.1 Recession Impact
           9.4.2 Japan
           9.4.3 China
           9.4.4 India
           9.4.5 Rest of Asia Pacific
    9.5 Rest of the World 
           9.5.1 Recession Impact
10 Competitive Landscape 
     10.1 Overview 
     10.2 Key Player Strategies  
     10.3 Revenue Share Analysis of Top Market Players  
     10.4 Market Share Analysis 2022 
     10.5 Company Evaluation Quadrant   
             10.5.1 Stars
             10.5.2 Emerging leaders
             10.5.3 Pervasive players
             10.5.4 Participants
     10.6 Product and Geographical Footprint Analysis of Top Players  
     10.7 Company Geographic footprint  
     10.8 Competitive Situation and Trends 
             10.8.1 Product launches and regulatory approvals 
             10.8.2 Key deals 
             10.8.3 Other developments 
11 Company Profiles 
     11.1 Key Players  
             11.1.1 Jabil Inc.
             11.1.2 Plexus Corp.
             11.1.3 Sanmina Corporation 
             11.1.4 TE Connectivity
             11.1.5 Celestica Inc.
             11.1.6 Integer Holdings Corporation
             11.1.7 Nipro Medical Corporation 
             11.1.8 Thermo Fisher Scientific 
             11.1.9 West Pharmaceutical Services, Inc.
             11.1.10 Benchmark Electronics Inc.
             11.1.11 Kimball Electronics Inc.
             11.1.12 KMC Systems
             11.1.13 Savyon Diagnostics 
             11.1.14 Nova Biomedical 
     11.2 Other Players  
             11.2.1 Cenogenic Corporation
             11.2.2 Cone Bioproducts 
             11.2.3 Avioq Inc.
             11.2.4 Philips-Medisize Corporation
             11.2.5 Invetech
             11.2.6 Meridian Bioscience, Inc.
             11.2.7 Nolato AB
             11.2.8 Fujirebio 
             11.2.9 Sekisui
             11.2.10 Prestige Diagnostics 
             11.2.11 Biokit
12 Appendix 
     12.1 Discussion Guide 
     12.2 Knowledge Store: MarketsandMarkets- Subscription Portal 
     12.3 Available Customizations 
     12.4 Related Reports 
     12.5 Author Details 

The objective of the study is to analyze the key market dynamics, such as drivers, opportunities, challenges, restraints, and key player strategies. To track company developments such as acquisitions, product/service launches, expansions, collaborations, agreements, and partnerships of the leading players, the competitive landscape of the diagnostic contract manufacturing market to analyze market players on various parameters within the broad categories of business and product strategy. Top-down and bottom-up approaches were used to estimate the market size. To estimate the market size of segments and subsegments, the market breakdown and data triangulation were used.

The four steps involved in estimating the market size are

Collecting Secondary Data

The secondary research data collection process involves the usage of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B), annual reports, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the diagnostic contract manufacturing market. A database of the key industry leaders was also prepared using secondary research.

Collecting Primary Data

The primary research data was conducted after acquiring knowledge about the diagnostic contract manufacturing market scenario through secondary research. A significant number of primary interviews were conducted with stakeholders from both the demand side (such as clinical laboratories, hospitals, and academic & research institutes) and supply side (such as included various industry experts, such as Directors, Chief X Officers (CXOs), Vice Presidents (VPs) from business development, marketing, and product development teams, product manufacturers, wholesalers, channel partners, and distributors) across major countries of North America, Europe, Asia Pacific, and Rest of the World. Approximately 40% of the primary interviews were conducted with stakeholders from the demand side, while those from the supply side accounted for the remaining 60%. Primary data for this report was collected through questionnaires, emails, and telephonic interviews.

A breakdown of the primary respondents is provided below:

Breakdown of Primary Participants:

Diagnostic Contract Manufacturing Market Size, and Share

Note 1: *Others include sales managers, marketing managers, and product managers.

Note 2: Tiers are defined based on a company’s total revenue as of 2022: Tier 1=> USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3=< USD 500 million.

To know about the assumptions considered for the study, download the pdf brochure

Market Size Estimation

All major product manufacturers offering various sleep apnea were identified at the global/regional level. Revenue mapping was done for the major players and was extrapolated to arrive at the global market value of each type of segment. The market value diagnostic contract manufacturing market was also split into various segments and subsegments at the regional and country level based on the following:

  • Product mapping of various manufacturers for each type of diagnostic contract manufacturing market at the regional and country-level 
  • Relative adoption pattern of each diagnostic contract manufacturing market among key application segments at the regional and/or country-level 
  • Detailed primary research to gather qualitative and quantitative information related to segments and subsegments at the regional and/or country level. 
  • Detailed secondary research to gauge the prevailing market trends at the regional and/or country-level 

Global Diagnostic contract manufacturing Market Size: Botton Up Approach

Diagnostic Contract Manufacturing Market Size, and Share

To know about the assumptions considered for the study, Request for Free Sample Report

Global Diagnostic contract manufacturing market Size: Top-Down Approach

Diagnostic Contract Manufacturing Market Size, and Share

Data Triangulation

After arriving at the overall market size—using the market size estimation processes—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides in the Diagnostic contract manufacturing industry.

Market Definition

Diagnostic contract manufacturing is a process wherein a manufacturing company makes diagnostic devices or the components of devices that can be sold later by other companies. Diagnostic device contract manufacturers specialize in a certain process or task and offer expertise due to their frequent practice of manufacturing.

Key Stakeholders

  • Senior Management
  • End User
  • Finance/Procurement Department
  • R&D Department

Report Objectives

  • To define, describe, segment, and forecast the global diagnostic contract manufacturing market by device type, service, application, and region
  • To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, challenges, and trends)
  • To analyze the micro markets with respect to individual growth trends, prospects, and contributions to the overall diagnostic contract manufacturing market
  • To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
  • To forecast the size of the market segments with respect to four regions, namely, North America, Europe, the Asia Pacific, and the Rest of the World
  • To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
  • To benchmark players within the market using the proprietary Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business and product excellence

Available Customizations

MarketsandMarkets offers the following customizations for this market report:

Additional country-level analysis of the Diagnostic contract manufacturing market

  • Profiling of additional market players (up to 5)

Product Analysis

  • Product matrix, which provides a detailed comparison of the product portfolio of each company in the Diagnostic contract manufacturing Market
Custom Market Research Services

We will customize the research for you, in case the report listed above does not meet with your exact requirements. Our custom research will comprehensively cover the business information you require to help you arrive at strategic and profitable business decisions.

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Report Code
MD 8985
Published ON
Apr, 2024
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