The global in vitro diagnostics contract manufacturing market size was valued at USD 19.85 billion in 2023 and is anticipated to reach around USD 51.72 billion by 2033, growing at a CAGR of 10.05% from 2024 to 2033.
The global market is projected to expand quickly due to the rapid developments in the healthcare industry, and the increasing demand for fast and accurate diagnostics testing has led to a rise in demand for IVD to improve the speed and quality of diagnoses, detection, and prevention of patient care. In addition, the market growth is driven by the increasing burden of chronic diseases, rising demand for personalized medicine, and increasing regulatory scrutiny.
For instance, in July 2023, the U.S. FDA announced a renewed attempt to regulate laboratory-developed tests as medical devices. Later, in September 2023, the U.S. FDA proposed that LDT manufacturers comply with medical device statutes and regulations. FDA is planning to enforce this in phases starting in 2024 to 2028.
In addition, during the COVID-19 pandemic, the market for IVD contract manufacturing witnessed a sudden spike in demand for contract manufacturing services, as IVDs are widely used to diagnose, screen, and assess COVID-19 disease. IVDs have also supported reduced hospital stays, resulting in healthier populations, reduced costs, and economic growth in the long run, further contributing to market growth.
The market for IVD contract manufacturing consists of a large number of key players across the globe, including Sanmina Corporation, Jabil Inc., TE Connectivity, Savyon Diagnostics, Celestica Inc., West Pharmaceutical Services, Inc., and Thermo Fisher Scientific, among several others. The growing demand for IVD products among medical device companies is expected to increase the number of CDMOs/CMOs partnerships and acquisitions in the coming years, thus boosting the global market for in vitro diagnostics contract manufacturing. For instance, in January 2023, Meridian Bioscience, Inc., SD Biosensor, Inc., and SJL Partners LLC mentioned the Meridian Bioscience acquisition. In addition, Meridian Bioscience will continue to operate as an independent entity, under new ownership, headquartered in the U.S. Such initiatives are anticipated to drive the market growth over the estimated period.
Report Attribute | Details |
Market Size in 2024 | USD 21.84 Billion |
Market Size by 2033 | USD 51.72 Billion |
Growth Rate From 2024 to 2033 | CAGR of 10.05% |
Base Year | 2023 |
Forecast Period | 2024 to 2033 |
Segments Covered | Product, service, technology, end use, region |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Key Companies Profiled | Jabil Inc.; Sanmina Corporation; TE Connectivity; Celestica Inc.; Savyon Diagnostics; West Pharmaceutical Services, Inc.; Thermo Fisher Scientific; KMC Systems; Cenogenics Corporation; Novo Biomedical; Cone Bioproducts; Invetech; AVIOQ Inc.; Meridian Bioscience Inc.; Nemera |
Product Insights
Based on product, the market includes instruments, reagents & consumables, software & services. In 2023, the reagents & consumables segment accounted for the largest revenue share of 69.74%. The segment growth can be attributed to the rising demand for numerous reagents & consumables, growing demand for personalized medicine, rising prevalence of diseases, increasing R&D investments, and increasing regulatory compliance and quality control. In addition, the continuous demand for reagents & consumables to provide reliable and standardized techniques for identifying the presence or absence of live microorganisms in pharmaceutical products is expected to support the market growth globally.
The instruments segment is anticipated to witness significant growth during the forecast period. This segment is driven by growing outsourcing services, technological advancements, and a growing focus on quality instrument services for product safety. These instruments offer a full-service experience, enhance the precision level, and support manufacturers in meeting regulatory compliance.
Service Insights
In terms of service, the market is segmented into manufacturing services, assay development services, and other services. The manufacturing services segment accounted for the largest market share in 2023. The growing demand for pharmaceutical products, high prevalence of chronic diseases, increasing clinical trials, cost-effective manufacturing services, and the availability of industry experts are key factors anticipated to drive market growth in the coming years.
The assay development services segment is anticipated to show lucrative growth during the forecast period. Stringent quality control processes and growing requirements for accuracy and sensitive evaluation methods drive segmental revenue growth. Furthermore, ongoing technological advancements such as high-throughput screening and automation to enhance the efficiency and accuracy of assay development drive segment growth. Moreover, the integration of digital technologies and artificial intelligence (AI) is further transforming this segment by streamlining the development process, reducing time to market, and improving assay performance.
Technology Insights
Based on technology, the market is segmented into immunoassays, clinical chemistry, molecular diagnostics, hematology, microbiology, coagulation, and others. The immunoassays segment dominated the market with the largest revenue share in 2023. This can be attributed to the growing demand for point-of-care immunoassays, the development of novel immunoassay technologies, and enhanced sensitivity for rapid & accurate detection of pathogens. In addition, the growing trend for outsourcing manufacturing of immunoassay technologies among manufacturers to focus on R&D and other core competencies is accelerating segmental growth potential.
The clinical chemistry segment is anticipated to witness considerable revenue growth over the forecast period. The segment growth is driven by increasing requirements for product safety and growing demand for testing services to assess the concentration of certain substances within samples for routine quality tests and control.
End-use Insights
In terms of end use, the market is segmented into medical device companies, academic & research institutions, and others. The medical device companies segment dominated the market with the largest revenue share in 2023. This can be attributed to the increasing introduction of new medical devices in the past two decades.
In addition, the medical device market has been experiencing growth due to technological advancements and increased healthcare expenditure across the globe. The growing complexities of IVD equipment require specialized expertise and facilities. Outsourcing to specialized medical device manufacturing for accurate and reliable results drives the overall market growth
Regional Insights
The in vitro diagnostics contract manufacturing market in North America dominated the global market in 2023 with the largest revenue share of 42.11%. The presence of established CDMOs specializing in In Vitro Diagnostics contract manufacturing, such as Jabil Inc., Sanmina Corporation, and TE Connectivity, among others in the market, accelerates market progression. In addition, key CDMOs and CMOs offering IVD production services and multinational pharmaceutical & biopharmaceutical companies making significant investments in research have contributed to market growth in North America. Likewise, increasing demand for efficient healthcare in the region is expected to be a key factor propelling North America's market growth.
U.S. In Vitro Diagnostics Contract Manufacturing Market Trends
The in vitro diagnostics contract manufacturing market in the U.S. accounts for the largest share of the North American region owing to established market players, increasing demand for molecular diagnostics, growing focus on the accuracy and efficiency of IVD, rising geriatric population, and increasing prevalence of chronic diseases. The U.S. has increased the number of market players offering IVD contract manufacturing to various end users to improve efficiency, accuracy, and throughput, further driving the market growth.
The in vitro diagnostics contract manufacturing market in Canada is driven by an increased burden of diseases, and the well-established medical device sector is likely to leverage the pipeline of promising treatments in this country. According to the International Trade Agency (ITA), the medical device market in Canada accounted for USD 6.5 billion in 2022, which is expected to grow at a rate of 2.1 % by 2026. The ITA also states that the demand for medical devices is increasing in the country owing to the growing burden of chronic diseases. This is expected to improve research on new devices in the country, thus supporting market growth. Such initiatives are expected to drive market growth over the estimated period.
Europe In Vitro Diagnostics Contract Manufacturing Market Trends
Europe's in vitro diagnostics (IVD) contract manufacturing market is driven by advanced technologies and well-established healthcare infrastructure; demand for outsourcing services and emerging research and development activities are further resulting in improved healthcare facilities and patient care, stimulating market growth. In addition, there are a large number of CDMOs and CDMOs specializing in IVD innovation in various European countries such as the UK, Germany, and France, which is expected to contribute to market growth in this region.
Germany accounts for the largest share of the European market owing to the country's increasing demand for diagnostic tests and the continuous growth in the medical/pharmaceutical industry. In addition, the demand for IVD development in CMOs has significantly changed the pharmaceutical and medical device industry over the past few years. As a result, many companies have shifted their focus towards developing and producing IVD with the support of CMOs.
UK in vitro diagnostics contract manufacturing market is driven by the presence of various multinational CDMOs. Significant R&D spending, healthcare research, and the rapidly evolving pharmaceutical/medical device industry have fueled the demand for UK in vitro diagnostics (IVD) contract manufacturing, which is anticipated to fuel the market. Such factors are expected to drive market growth.
Asia Pacific In Vitro Diagnostics Contract Manufacturing Market Trends:
The in vitro diagnostics contract manufacturing market in Asia Pacific is expected to witness the fastest CAGR over the forecast period. The increasing burden of infectious diseases, the growing number of medical device research organizations, and the evolving clinical trial scenario drive the market in Asia Pacific. Moreover, improvements in the regulatory framework and higher cost savings are a few factors supporting the growth of the market.
The in vitro diagnostics contract manufacturing market in Japan is anticipated to be driven by diverse benefits associated with medical device outsourcing, such as optimizing R&D activities for higher productivity, regulatory compliance, cost savings, and easy market entry.
The in vitro diagnostics (IVD) contract manufacturing market in China is driven by strong presence of local players, low operational cost, technological advancement, and growing product development in the field of IVD, such as immune diagnosis, biochemical diagnosis, molecular diagnosis, and the availability of quality services for diagnosis are further boosting the growth of the China market. Also, growing R&D expenditures by key players for the new products’ development have led to a rise in outsourcing trends, further fueling market growth.
India's in vitro diagnostics contract manufacturing market is driven by key players offering a comprehensive range of medical equipment, continuous technological developments, and an increasing burden of chronic diseases. These factors have led to the rising outsourcing of IVD products. Moreover, the growing medical research and developing pharmaceuticals are further expected to drive market growth in India.
The following are the leading companies in the in-vitro-diagnostics-contract-manufacturing market. These companies collectively hold the largest market share and dictate industry trends.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the In Vitro Diagnostics Contract Manufacturing market.
By Product
By Service
By Technology
By End Use
By Region
Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Regional Scope
1.1.2. Estimates And Forecast Timeline
1.2. Market Definitions
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. nova one advisor 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. In Vitro Diagnostics 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. Technology Landscape
3.4. Industry Ecosystem Analysis
3.5. Industry Analysis Tools
3.5.1. Porter’s Five Forces Analysis
3.5.2. PESTEL Analysis
3.5.3. COVID-19 Impact Analysis
Chapter 4. In Vitro Diagnostics (Contract Manufacturing Market: Phases Estimates & Trend Analysis
4.1. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Product: Segment Dashboard
4.2. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Product: Movement Analysis
4.3. In Vitro Diagnostics (IVD) Contract Manufacturing Market Estimates & Forecasts, By Product, 2018 - 2030 (USD Million)
4.4. Instruments
4.4.1. Instruments Market, 2021 to 2033 (USD Million)
4.5. Reagents & Consumables
4.5.1. Reagents & Consumables Market, 2021 to 2033 (USD Million)
4.6. Software & Services
4.6.1. Software & Services Market, 2021 to 2033 (USD Million)
Chapter 5. In Vitro Diagnostics Contract Manufacturing Market: Service Estimates & Trend Analysis
5.1. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Service: Segment Dashboard
5.2. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Service: Movement Analysis
5.3. In Vitro Diagnostics (IVD) Contract Manufacturing Market Estimates & Forecasts, By Service, 2018 - 2030 (USD Million)
5.4. Manufacturing Services
5.4.1. Manufacturing Services Market, 2021 to 2033 (USD Million)
5.5. Assay Development Services
5.5.1. Assay Development Services Market, 2021 to 2033 (USD Million)
5.6. Other Services
5.6.1. Other Services Market, 2021 to 2033 (USD Million)
Chapter 6. In Vitro Diagnostics Contract Manufacturing Market: Technology Estimates & Trend Analysis
6.1. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Technology: Segment Dashboard
6.2. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By Technology: Movement Analysis
6.3. In Vitro Diagnostics (IVD) Contract Manufacturing Market Estimates & Forecasts, By Technology, 2018-2030
6.4. Immunoassays
6.4.1. Immunoassays Market, 2021 to 2033 (USD Million)
6.5. Clinical Chemistry
6.5.1. Clinical Chemistry Market, 2021 to 2033 (USD Million)
6.6. Molecular Diagnostics
6.6.1. Molecular Diagnostics Market, 2021 to 2033 (USD Million)
6.7. Hematology
6.7.1. Hematology Market, 2021 to 2033 (USD Million)
6.8. Microbiology
6.8.1. Microbiology Market, 2021 to 2033 (USD Million)
6.9. Coagulation
6.9.1. Coagulation Market, 2021 to 2033 (USD Million)
6.10. Others
6.10.1. Others Market, 2021 to 2033 (USD Million)
Chapter 7. In Vitro Diagnostics Contract Manufacturing Market: End Use Estimates & Trend Analysis
7.1. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By End Use: Segment Dashboard
7.2. In Vitro Diagnostics (IVD) Contract Manufacturing Market, By End Use: Movement Analysis
7.3. In Vitro Diagnostics (IVD) Contract Manufacturing Market Estimates & Forecasts, By End Use, 2018 - 2030 (USD Million)
7.4. Medical Device Companies
7.4.1. Medical Device Companies Market, 2021 to 2033 (USD Million)
7.5. Academic & Research Institutions
7.5.1. Academic & Research Institutions Market, 2021 to 2033 (USD Million)
7.6. Others
7.6.1. Others Market, 2021 to 2033 (USD Million)
Chapter 8. In Vitro Diagnostics Contract Manufacturing Market: Regional Estimates & Trend Analysis
8.1. Regional Market Share Analysis, 2023 & 2030
8.2. Regional Market Dashboard
8.3. Global Regional Market Snapshot
8.4. North America
8.4.1. Market Estimates and Forecast, 2018-2030 (Revenue, 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. Market Estimates and Forecast, 2018-2030 (Revenue, 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. Sweden
8.5.7.1. Key Country Dynamics
8.5.7.2. Competitive Scenario
8.5.7.3. Regulatory Framework
8.5.7.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
8.5.8. Denmark
8.5.8.1. Key Country Dynamics
8.5.8.2. Competitive Scenario
8.5.8.3. Regulatory Framework
8.5.8.4. Denmark 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. Market Estimates and Forecast, 2018-2030 (Revenue, 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. Market Estimates and Forecast, 2018-2030 (Revenue, 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. Market Estimates and Forecast, 2018-2030 (Revenue, 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
9.1.1. Market Leaders
9.1.2. Emerging Players
9.2. Company Market Share/Assessment Analysis, 2023
9.3. Service Heat Map Analysis, 2023
9.4. Company Profiles
9.4.1. Jabil Inc.
9.4.1.1. Company Overview
9.4.1.2. Financial Performance
9.4.1.3. Service Benchmarking
9.4.1.4. Strategic Initiatives
9.4.2. Sanmina Corporation
9.4.2.1. Company Overview
9.4.2.2. Financial Performance
9.4.2.3. Service Benchmarking
9.4.2.4. Strategic Initiatives
9.4.3. TE Connectivity
9.4.3.1. Company Overview
9.4.3.2. Financial Performance
9.4.3.3. Service Benchmarking
9.4.3.4. Strategic Initiatives
9.4.4. Celestica Inc.
9.4.4.1. Company Overview
9.4.4.2. Financial Performance
9.4.4.3. Service Benchmarking
9.4.4.4. Strategic Initiatives
9.4.5. Savyon Diagnostics
9.4.5.1. Company Overview
9.4.5.2. Financial Performance
9.4.5.3. Service Benchmarking
9.4.5.4. Strategic Initiatives
9.4.6. West Pharmaceutical Services, Inc.
9.4.6.1. Company Overview
9.4.6.2. Financial Performance
9.4.6.3. Service Benchmarking
9.4.6.4. Strategic Initiatives
9.4.7. Thermo Fisher Scientific
9.4.7.1. Company Overview
9.4.7.2. Financial Performance
9.4.7.3. Service Benchmarking
9.4.7.4. Strategic Initiatives
9.4.8. KMC Systems
9.4.8.1. Company Overview
9.4.8.2. Financial Performance
9.4.8.3. Service Benchmarking
9.4.8.4. Strategic Initiatives
9.4.9. Cenogenics Corporation
9.4.9.1. Company Overview
9.4.9.2. Financial Performance
9.4.9.3. Service Benchmarking
9.4.9.4. Strategic Initiatives
9.4.10. Novo Biomedical
9.4.10.1. Company Overview
9.4.10.2. Financial Performance
9.4.10.3. Service Benchmarking
9.4.10.4. Strategic Initiatives
9.4.11. Cone Bioproducts
9.4.11.1. Company Overview
9.4.11.2. Financial Performance
9.4.11.3. Service Benchmarking
9.4.11.4. Strategic Initiatives
9.4.12. Invetech
9.4.12.1. Company Overview
9.4.12.2. Financial Performance
9.4.12.3. Service Benchmarking
9.4.12.4. Strategic Initiatives
9.4.13. AVIOQ Inc.
9.4.13.1. Company Overview
9.4.13.2. Financial Performance
9.4.13.3. Service Benchmarking
9.4.13.4. Strategic Initiatives
9.4.14. Meridian Bioscience Inc.
9.4.14.1. Company Overview
9.4.14.2. Financial Performance
9.4.14.3. Service Benchmarking
9.4.14.4. Strategic Initiatives
9.4.15. Nemera
9.4.15.1. Company Overview
9.4.15.2. Financial Performance
9.4.15.3. Service Benchmarking
9.4.15.4. Strategic Initiatives