Summary

Report Overview
Global In Vitro Diagnostics Market reached US$ 98.3 billion in 2023 and is expected to reach US$ 145.7  billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031
In Vitro Diagnostics (IVD) is a field of tests used to detect diseases, conditions, or infections using human samples. These tests are conducted outside the body, typically in laboratory settings, using advanced instruments and reagents. IVD is crucial in modern medicine, providing critical information for disease diagnosis, treatment decisions, and monitoring patient health. The market for IVD is rapidly growing due to technological advancements, an aging global population, chronic diseases, and personalized medicine demand.
Market Dynamics: Drivers & Restraints
Rise in technological advancements
The rise in technological advancements help the market to grow during the forecast period. Molecular diagnostics, including PCR and NGS, enable early genetic disease detection, improving diagnosis accuracy and treatment outcomes. Point-of-care testing devices enable faster diagnosis and treatment in remote settings. Automation and digitalization in IVD systems improve efficiency, reduce human error, and provide more accurate results, especially in remote settings.
The introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. For instance, in June 2023, Toray Industries, Inc. received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. 
Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.
Lack of skilled professionals
The global in vitro diagnostics market faces several challenges, including stringent regulatory requirements, high costs of advanced diagnostic technologies, and a lack of skilled professionals. These factors can delay the entry of new diagnostic products and limit their adoption in developing countries with limited healthcare budgets. Overall, these factors pose significant challenges for companies operating in the IVD market.
Market Segment Analysis
The global in vitro diagnostics market is segmented based on product type, technique, application, end-user, and region.
The reagents from the product type segment accounted for approximately 41.3% of the in vitro diagnostics  market share
The reagents from the product type segment accounted for approximately 41.3%. Reagents are essential components in in vitro diagnostics for detecting and quantifying biological markers in patient samples. They are designed to react with target analytes, enabling the identification and measurement of diseases, conditions, or infections. Reagents are crucial for the accuracy and reliability of diagnostic tests, directly affecting the sensitivity and specificity of results. They are used in various diagnostic applications, including immunoassays, molecular diagnostics, clinical chemistry, and hematology. The demand for high-quality reagents has increased due to personalized medicine growth and rapid diagnostics.
For instance, in October 2023, US-based chemical supplier Alfa Chemistry introduced three IVD products for laboratory use, enhancing its range of biological reagents, to aid in research on diseases detected through tests on samples like blood or tissue.
Market Geographical Share
North America is estimated to hold about 38.4% of the total market share throughout the forecast period
North America is estimated to hold about 38.4% of the total market share throughout the forecast period due rising incidence of chronic diseases, the presence of strong players, the increasing number of novel test launches, and supportive government funding.
For instance, in January 2023, BD and CerTest Biotec received EUA from the U.S. FDA for a PCR test for Mpox virus detection in the U.S. Moreover, the increasing requirement for genetic testing for personalized health care, such as that for diabetes and cancer, is expected to drive market growth in North America.
Market Segmentation
By-Product Type
Instruments
Reagents
Software and Services
By Technique
Immunoassays
POC diagnostics
Molecular diagnostics
Hematology
Tissue diagnostics
Microbiology
Self-Blood-Glucose Monitoring
Others
By Application
Infectious Diseases
Diabetes
Cancer/Oncology
Cardiology
Autoimmune Diseases
Nephrology
Drug Testing
Others
By End User
Diagnostic Laboratories
Hospitals
Academics and Research Institutes
Others
By Region
North America
The U.S.
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
Rest of Europe
South America
Brazil
Argentina
Rest of South America
Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
Middle East and Africa
Market Competitive Landscape
The major global players in the market include BioMérieux, Danaher Corporation, Roche Diagnostics, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Abbott Laboratories, Bayer AG, Arkray, Inc., Sysmex Corporation, Siemens AG among others.
Key Developments
In January 2024, ELITech Group proudly announces the introduction of the GI Bacterial PLUS ELITe MGB Kit, a robust addition to its diagnostic portfolio. Tailored specifically for diagnosing gastrointestinal bacterial infections, the in vitro assay exclusively targets major bacterial pathogens including Campylobacter spp.
In September 2023, NeoDx Biotech Labs, a Bengaluru-based startup launched a Real-time PCR-Technology-based in vitro diagnostic (IVD) kit for Ankylosing Spondylitis & empowered healthcare services to improve their testing capabilities.
Why Purchase the Report?
To visualize the global in vitro diagnostics market segmentation based on product type, technique, application, end-user, and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development. 
Excel data sheet with numerous data points of the in vitro diagnostics market level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as excel consisting of key products of all the major players.
The global in vitro diagnostics market report would provide approximately 64 tables, 61 figures, and 186 pages.
Target Audience 2024
Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Product Type
3.2. Snippet by Technique
3.3. Snippet by Application
3.4. Snippet by End User
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Rise in technological advancements
4.1.1.2. Rise in the prevalence of chronic diseases
4.1.2. Restraints
4.1.2.1. Lack of skilled professionals
4.1.2.2. XX
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Patent Analysis
5.6. PESTLE Analysis
5.7. SWOT Analysis
5.8. DMI Opinion
6. By Product Type
6.1. Introduction
6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
6.1.2. Market Attractiveness Index, By Product Type
6.2. Instruments*
6.2.1. Introduction
6.3. Reagents
6.4. Software and Services
7. By Technique
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
7.2. Market Attractiveness Index, By Technique
7.3. Immunoassays*
7.3.1. Introduction
7.3.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.4. POC diagnostics
7.5. Molecular diagnostics
7.6. Hematology
7.7. Tissue diagnostics
7.8. Microbiology
7.9. Self-Blood-Glucose Monitoring
7.10. Others
8. By Application
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
8.1.2. Market Attractiveness Index, By Application
8.2. Infectious Diseases*
8.2.1. Introduction
8.3. Diabetes
8.4. Cancer/Oncology
8.5. Cardiology
8.6. Autoimmune Diseases
8.7. Nephrology
8.8. Drug Testing
8.9. Others
9. By End User
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
9.1.2. Market Attractiveness Index, By End User
9.2. Diagnostic Laboratories*
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Hospitals
9.4. Academics and Research Institutes
9.5. Others
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.7.1. The U.S.
10.2.7.2. Canada
10.2.7.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.7.1. Germany
10.3.7.2. UK
10.3.7.3. France
10.3.7.4. Italy
10.3.7.5. Spain
10.3.7.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.7.1. Brazil
10.4.7.2. Argentina
10.4.7.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.7.1. China
10.5.7.2. India
10.5.7.3. Japan
10.5.7.4. South Korea
10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. BioMérieux*
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Danaher Corporation
12.3. Roche Diagnostics
12.4. Becton, Dickinson and Company
12.5. Bio-Rad Laboratories, Inc.
12.6. Abbott Laboratories
12.7. Bayer AG
12.8. Arkray, Inc
12.9. Sysmex Corporation
12.10. Siemens AG (*LIST NOT EXHAUSTIVE)
13. Appendix
13.1. About Us and Services
13.2. Contact Us