In Vitro Diagnostics Market By Products & Services (Reagents & Kits, Instruments, Data Management Software, and Services), By Technology (Immuno Diagnostics, Molecular Diagnostics, Microbiology, Hematology, Clinical Chemistry, and Others), By Application (Infectious Diseases, Oncology, Diabetes, Cardiology, Autoimmune Diseases, Nephrology, and Others), By End User (Laboratories, Hospitals, Academic & Medical Schools, Point-Of-Care Testing, and Others), Industry Trends, Estimation & Forecast, 2023-2030

Market Definition

In vitro diagnostics are medical devices used to perform tests on samples such as tissue or blood that have been taken from the human body. In vitro diagnostics can detect diseases and can be used to monitor a person’s overall health to help prevent, treat, and cure diseases. In vitro diagnostics is also used in precision medicine to identify patients who can be benefited from specific treatments or therapies. The in vitro diagnostics can include next-generation sequencing tests, which scan a person’s DNA to detect genomic variations.

In Vitro Diagnostics market was valued at 126.7 billion US$ in 2022 and is projected to reach 176.1 billion US$ by 2030, at a CAGR of 4.2% during the forecast period.

Market Dynamics

Increasing prevalence of chronic and infectious diseases are boosting the global In Vitro Diagnostics market. For instance, according to the World Health Organization, chronic disease is expected to rise by 57%. According to the National Health Council, chronic diseases affect approximately 133 million Americans, representing more than 40% of the total population in 2018, and it is to grow to by 157 million, with 81 Billion having multiple conditions. The rising incidence of Coronavirus has increased the demand for In Vitro Diagnostics in the current situation. For instance, Coronavirus COVID-19 has affected 195 countries and territories around the world. According to the World Health Organization (WHO), there are more than 380,000 confirmed cases of coronavirus disease around the world, with more than 16,000 deaths. Abbott has introduced molecular point-of-care test to detect novel coronavirus. Abbott ID NOW COVID-19 test is the fastest available molecular point-of-care test for detecting coronavirus (COVID-19), delivering positive results in little than five minutes and negative results in 13 minutes. Thus, rising cases of Coronavirus has increased the production of In Vitro Diagnostics test. Further, technological advancements in IVD are key driving factors of the market. However, unfavorable reimbursement policies might hamper market growth. For instance, in genetic testing getting reimbursement from third-party payers is challenging. Reimbursement is available too late in the process. It can take years for payers to cover the costs of their tests, and in many cases, reimbursement never comes. Moreover, regulatory approval for IVD would provide lucrative opportunities for the market in coming years.

Market Segmentation

The global In Vitro Diagnostics market is mainly classified based on Product & Service, Technology, Application, End User. Product & Service is further segmented into Reagents & Kits, Instruments, Data Management Software, and Services. By Technology the market is divided into Immuno Diagnostics, Molecular Diagnostics, Microbiology, Hematology, Clinical Chemistry, and Others. By Application, the market is further divided into Infectious Diseases, Oncology, Diabetes, Cardiology, Autoimmune Diseases, Nephrology, and Others. By End User, the global In Vitro Diagnostics market is divided as Laboratories, Hospitals, Academic & Medical Schools, and Point-Of-Care Testing.

Reagents & Kits was dominating the global In Vitro Diagnostics market, by Product & Service in 2019. The increasing commercialization of In Vitro Diagnostic reagents & kits, regulatory approval for the products, and partnership between companies to develop reagents & kits and expand their global presence are some of the factors boosting the global In Vitro Diagnostics market. For instance, Illumina, Inc. and QIAGEN N.V. has introduced to broaden the use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management. According to the agreement, QIAGEN has non-exclusive rights to develop and globally commercialize IVD kits to be used together with Illumina’s MiSeq Dx and NextSeq 550Dx Systems.

Regional Analysis

Based on geography, the global In Vitro Diagnostics market is divided into North America, Europe, Asia-Pacific, South America, and Middle East & Africa. North America is further divided in the U.S., Canada, and Mexico, whereas Europe consists of the UK, Germany, France, Italy, and Rest of Europe. Asia-Pacific is segmented into India, China, Japan, South Korea, and Rest of Asia-Pacific. The South America region includes Brazil, Argentina, and the Rest of South America, while the Middle East & Africa is categorized into GCC Countries, Egypt, South Africa, and Rest of Middle East & Africa.

North America was dominating the global In Vitro Diagnostics market in 2019. Rising cases of chronic and infectious diseases in the U.S and other North American countries, increasing commercialization of In Vitro Diagnostic products, the partnership between companies to develop In Vitro Diagnostic products and expand their global presence, government initiatives towards the support of In Vitro Diagnostic and regulatory approval for the products are some of the factors boosting the global In Vitro Diagnostics market. For instance, Hologic, Inc. has received the U.S. Food and Drug Administration (FDA) approval for its Aptima Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized sexually transmitted infection (STI). This Aptima assay help combat the rise of STIs in the U.S.

Competitive landscape

Key players operating in the In Vitro Diagnostics industry include Abbott Laboratories, Danaher Corporation, Roche Diagnostics, Thermo Fisher Scientific, Siemens AG, Becton, Dickinson and Company, Sysmex Corporation, Bio-Rad Laboratories, Inc., Ortho Clinical Diagnostics, Hologic, Inc., Biomérieux SA, Illumina, Inc., Qiagen, DiaSorin, Luminex Corporation.

The partnership between companies to develop In Vitro Diagnostic products and expand their global presence, regulatory approval for the products, and Increasing commercialization of In Vitro Diagnostic products are some of the strategies adopted by the companies. For instance, QIAGEN has introduced its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test obtained CE marking to be sold as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2.

In Vitro Diagnostics Market Key Segments

By Product & Service
• Reagents & Kits
• Instruments
• Data Management Software
• Services

By Technology
• Immuno Diagnostics
• Molecular Diagnostics
• Microbiology
• Hematology
• Clinical Chemistry
• Others

By Application
• Infectious Diseases
• Oncology
• Diabetes
• Cardiology
• Autoimmune Diseases
• Nephrology
• Others

By End-User
• Laboratories
• Hospitals
• Academic & Medical Schools
• Point-Of-Care Testing
• Others

Key Global In Vitro Diagnostics Industry Players
• Abbott Laboratories
• Danaher Corporation
• Roche Diagnostics
• Thermo Fisher Scientific
• Siemens AG
• Becton, Dickinson and Company
• Sysmex Corporation
• Bio-Rad Laboratories, Inc.
• Ortho Clinical Diagnostics
• Hologic, Inc.
• Biomérieux SA
• Illumina, Inc.
• Qiagen
• DiaSorin
• Luminex Corporation

Table of Content

1. Market Introduction
1.1. Executive Summary
1.2. Market Definition
1.3. Market Scope

2. Research Methodology
2.1. Primary Research
2.2. Research Methodology
2.3. Assumptions & Exclusions
2.4. Secondary data sources

3. In Vitro Diagnostics Market Overview
3.1. Report Segmentation & Scope
3.2. Key Market Trend
3.3. Drivers
3.3.1. Increasing prevalence of chronic and infectious diseases
3.3.2. Technological advancements in IVD
3.4. Restraints
3.4.1. Unfavorable reimbursement policies
3.5. Opportunity
3.5.1. Regulatory approval for IVD
3.6. Porter’s Five Forces Analysis
3.6.1. Porter’s Five Forces Analysis
3.7. Market Share Analysis

4. Product & Service Overview
4.1. Introduction
4.1.1. Market Size & Forecast
4.2. Reagents & Kits
4.2.1. Market Size & Forecast
4.3. Instruments
4.3.1. Market Size & Forecast
4.4. Data Management Software
4.4.1. Market Size & Forecast
4.5. Services
4.5.1. Market Size & Forecast

5. Technology Overview
5.1. Introduction
5.1.1. Market Size & Forecast
5.2. Immuno Diagnostics
5.2.1. Market Size & Forecast
5.3. Molecular Diagnostics
5.3.1. Market Size & Forecast
5.4. Microbiology
5.4.1. Market Size & Forecast
5.5. Hematology
5.5.1. Market Size & Forecast
5.6. Clinical Chemistry
5.6.1. Market Size & Forecast
5.7. Others
5.7.1. Market Size & Forecast

6. Application Overview
6.1. Introduction
6.1.1. Market Size & Forecast
6.2. Infectious Diseases
6.2.1. Market Size & Forecast
6.3. Oncology
6.3.1. Market Size & Forecast
6.4. Diabetes
6.4.1. Market Size & Forecast
6.5. Cardiology
6.5.1. Market Size & Forecast
6.6. Autoimmune Diseases
6.6.1. Market Size & Forecast
6.7. Nephrology
6.7.1. Market Size & Forecast
6.8. Others
6.8.1. Market Size & Forecast

7. End-User Overview
7.1. Introduction
7.1.1. Market Size & Forecast
7.2. Laboratories
7.2.1. Market Size & Forecast
7.3. Hospitals
7.3.1. Market Size & Forecast
7.4. Academic & Medical Schools
7.4.1. Market Size & Forecast
7.5. Point-Of-Care Testing
7.5.1. Market Size & Forecast
7.6. Others
7.6.1. Market Size & Forecast

8. In Vitro Diagnostics Market Regional Overview
8.1. Introduction
8.1.1. Market Size & Forecast
8.2. North America In Vitro Diagnostics Market
8.2.1. North America Market Size & Forecast, By Country
8.2.2. North America Market Size & Forecast, By Product & Service
8.2.3. North America Market Size & Forecast, By Technology
8.2.4. North America Market Size & Forecast, By Application
8.2.5. North America Market Size & Forecast, By End User
8.2.6. The U.S.
8.2.6.1. Market Size and Forecast
8.2.7. Canada
8.2.7.1. Market Size and Forecast
8.2.8. Mexico
8.2.8.1. Market Size and Forecast
8.3. Europe In Vitro Diagnostics Market
8.3.1. Europe Market Size & Forecast, By Country
8.3.2. Europe Market Size & Forecast, By Product & Service
8.3.3. Europe Market Size & Forecast, By Technology
8.3.4. Europe Market Size & Forecast, By Application
8.3.5. Europe Market Size & Forecast, By End User
8.3.6. Germany
8.3.6.1. Market Size and Forecast
8.3.7. France
8.3.7.1. Market Size and Forecast
8.3.8. UK
8.3.8.1. Market Size and Forecast
8.3.9. Italy
8.3.9.1. Market Size and Forecast
8.3.10. Spain
8.3.10.1. Market Size and Forecast
8.3.11. Rest of Europe
8.3.11.1. Market Size and Forecast
8.4. Asia-Pacific In Vitro Diagnostics Market
8.4.1. Asia-Pacific Market Size & Forecast, By Country
8.4.2. Asia-Pacific Market Size & Forecast, By Product & Service
8.4.3. Asia-Pacific Market Size & Forecast, By Technology
8.4.4. Asia-Pacific Market Size & Forecast, By Application
8.4.5. Asia-Pacific Market Size & Forecast, By End User
8.4.6. Japan
8.4.6.1. Market Size and Forecast
8.4.7. China
8.4.7.1. Market Size and Forecast
8.4.8. Australia
8.4.8.1. Market Size and Forecast
8.4.9. India
8.4.9.1. Market Size and Forecast
8.4.10. South Korea
8.4.10.1. Market Size and Forecast
8.4.11. Rest of Asia-Pacific
8.4.11.1. Market Size and Forecast
8.5. South America In Vitro Diagnostics Market
8.5.1. South America Market Size & Forecast, By Country
8.5.2. South America Market Size & Forecast, By Product & Service
8.5.3. South America Market Size & Forecast, By Technology
8.5.4. South America Market Size & Forecast, By Application
8.5.5. South America Market Size & Forecast, By End User
8.5.6. Brazil
8.5.6.1. Market Size and Forecast
8.5.7. Argentina
8.5.7.1. Market Size and Forecast
8.5.8. Rest of South America
8.5.8.1. Market Size and Forecast
8.6. Middle East & Africa In Vitro Diagnostics Market
8.6.1. Middle East & Africa Market Size & Forecast, By Country
8.6.2. Middle East & Africa Market Size & Forecast, By Product & Service
8.6.3. Middle East & Africa Market Size & Forecast, By Technology
8.6.4. Middle East & Africa Market Size & Forecast, By Application
8.6.5. Middle East & Africa Market Size & Forecast, By End User
8.6.6. GCC Countries
8.6.6.1. Market Size and Forecast
8.6.7. Egypt
8.6.7.1. Market Size and Forecast
8.6.8. South Africa
8.6.8.1. Market Size and Forecast
8.6.9. Rest of Middle East & Africa
8.6.9.1. Market Size and Forecast

9. Company Profile
9.1. Abbott Laboratories
9.1.1. Company Basic Information, Manufacturing Base, Sales Area and Its Competitors
9.1.2. Abbott Laboratories Product Category, Application, and Specification
9.1.3. Abbott Laboratories Financial Performance (2016-2018)
9.1.4. Main Business/Business Overview
9.2. Danaher Corporation
9.3. Roche Diagnostics
9.4. Thermo Fisher Scientific
9.5. Siemens AG
9.6. Becton, Dickinson and Company
9.7. Sysmex Corporation
9.8. Bio-Rad Laboratories, Inc.
9.9. Ortho Clinical Diagnostics
9.10. Hologic, Inc.
9.11. Biomérieux SA
9.12. Illumina, Inc.
9.13. Qiagen
9.14. DiaSorin
9.15. Luminex Corporation