The North America in-vitro diagnostics market is expected to grow from US$ 56,890.44 million in 2022 to US$ 78,479.05 million by 2028; it is estimated to register a CAGR of 4.1% from 2022 to 2030.

The increasing prevalence of chronic and infectious diseases and rising demand for in-vitro diagnostics during COVID-19 pandemic. However, the cumbersome reimbursement procedures and stringent regulations regarding product approvals hinder the growth of the North America in-vitro diagnostics market.

In-vitro diagnostics can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. Devices can range from simple tests to sophisticated DNA technology which include reagents, control materials, calibrators, kits, software, and related instruments. In-vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.

Integration of IVD Technologies with Digital Health Solutions to offer Lucrative Opportunities

The integration of IVD technologies with digital health solutions is gaining traction in North America. The use of data analytics, artificial intelligence, and remote monitoring enhance the value of diagnostic tests, leading to better patient management and outcomes. The digital health solutions allows IVD technologies to be integrated into clinical decision support system. As recognized by the WHO, digital health solutions could help in disease detection. Key technologies for disease detection are in-vitro diagnostic devices (IVDs). IVDs are used in clinical, laboratory or outpatient settings with the aim specifically to help in the detection of diseases and, as a consequence, in the selection of appropriate treatment protocols. Nowadays, the use of digital technology in healthcare is a way to increase access to diagnostic may improve the quality treatment. Emerging solutions including the use of artificial intelligence, health bots may present opportunities for patient care and address issues of high costs and time consumption. In genomic testing diagnostics, deep learning is be used to identify cancer cells, determine their type, and predict what mutations may occur in a tumor from images of a specific cancer. Artificial Intelligence and machine learning for in-vitro diagnostics (AI/ML) is revolutionizing medical device development and is being leveraged in applications ranging from digital image analysis to in-vitro diagnostics. Although it is expected that the number of AI/ML-enabled medical device products will increase exponentially in the future. AI-based IVDs have potential to exponentially improve healthcare decision making in the coming years. The integration and implementation of AI in IVDs has the potential to revolutionize the status quo of assessing disease and health. Smart Diagnostics are extremely scalable IVDs that use artificial intelligence to perform better than lab-based diagnostics at a fraction of the price. Additionally, Smart Diagnostics could derive emergent features through unique chemical and biological signature detection and analysis, which has the potential to significantly improve health care. These aspects are likely to offer lucrative opportunities to the market players, which is expected to fuel the growth of the North America in-vitro diagnostics market in the coming years.

Product and Services-Based Insights

Based on products and services, the North America in-vitro diagnostics market is segmented into kits, instruments, software and services. In 2022, the reagents and kits segment accounted for the largest in-vitro diagnostics market share and is anticipated to register a higher CAGR during the forecast period. The major driving factor for the growth of the automated segment is the rise in automated instruments that simplify the job and provide accurate results.

Technology-Based Insights

By technology, the North America in-vitro diagnostics market is categorized into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, microbiology, blood glucose self-monitoring, coagulation and hemostasis, hematology, urinalysis, and others. In 2022, the immunoassay/ immunochemistry segment held the largest share of the market. However, the molecular diagnostics segment is expected to grow at the fastest rate during the coming years owing to the launch of novel products and continuous evolution in technology. Moreover, COVID-19 has positively impacted immunoassay and molecular diagnostics.

Application-Based Insights

By application, the North America in-vitro diagnostics market is segmented into infectious disease, diabetes, oncology, cardiology, autoimmune disease, nephrology, and others. In 2022, the infectious disease segment held the largest share of the market. Moreover, the same segment is expected to register the highest CAGR of 4.6% in the market during the forecast period. The rising prevalence of infectious disease such as SARS-CoV-2, HIV, AIDS, TB, and pneumonia.

End User-Based Insights

Based on end user, the North America in-vitro diagnostics market is segmented into hospitals, laboratories, homecare, and others. In 2022, the hospitals segment held the largest share of the market due to an increase in hospitalizations, which need rapid diagnostics. Additionally, it is projected that the continued expansion of the healthcare infrastructure would improve the current hospital facilities. As a result, there is a rising demand for IVD testing performed in hospitals. However, the homecare segment is expected to grow at the fastest rate during the forecast period.

A few of the major primary and secondary sources referred to while preparing the report on the North America in-vitro diagnostics market are the company whitepaper (Roche) and World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), among others.

TABLE OF CONTENTS

1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 North America In-Vitro Diagnostics Market – by Product and Services
1.3.2 North America In-Vitro Diagnostics Market – by Technology
1.3.3 North America In-Vitro Diagnostics Market – by Application
1.3.4 North America In-Vitro Diagnostics Market – by End User
1.3.5 North America In-Vitro Diagnostics Market – by Country
2. North America In-Vitro Diagnostics Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. In-Vitro Diagnostics Market – Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 NORTH AMERICA – PEST Analysis
4.3 Expert Opinion
4.4 Regulatory Scenario
4.4.1 FDA IVD Regulation
4.4.2 LDT
4.4.3 RUO
5. In-Vitro Diagnostics Market – Key Market Dynamics
5.1 Market Drivers
5.1.1 Increasing Prevalence of Chronic and Infectious Diseases
5.1.2 Rise in the Demand for In-Vitro Diagnostics During COVID-19 Pandemic
5.2 Market Restraints
5.2.1 Cumbersome Reimbursement Procedures and Stringent Regulations Regarding Product Approvals
5.3 Market Opportunities
5.3.1 Integration of IVD Technologies with Digital Health Solutions
5.4 Impact analysis
6. North America In-Vitro Diagnostics Market Analysis
6.1 North America In-Vitro Diagnostics Market Revenue Forecast and Analysis
6.1.1 Market Positioning of Key Players in In-Vitro Diagnostics Market
7. North America In-Vitro Diagnostics Market Analysis – by Products and Services
7.1 Overview
7.2 Reagents and Kits
7.2.1 Overview
7.2.2 Reagents and Kits: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
7.3 Instruments
7.3.1 Overview
7.3.2 Instruments: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
7.4 Software and Services
7.4.1 Overview
7.4.2 Software and Services: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8. North America In-Vitro Diagnostics Market Analysis – by Technology
8.1 Overview
8.2 Immunoassay/Immunochemistry
8.2.1 Overview
8.2.2 Immunoassay/Immunochemistry: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.3 Clinical Chemistry
8.3.1 Overview
8.3.2 Clinical Chemistry: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.4 Molecular Diagnostics
8.4.1 Overview
8.4.2 Molecular Diagnostics: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.5 Microbiology
8.5.1 Overview
8.5.2 Microbiology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.6 Blood Glucose Self-Monitoring
8.6.1 Overview
8.6.2 Blood Glucose Self-Monitoring: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.7 Coagulation and Hemostasis
8.7.1 Overview
8.7.2 Coagulation and Hemostasis: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.8 Hematology
8.8.1 Overview
8.8.2 Hematology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.9 Urinalysis
8.9.1 Overview
8.9.2 Urinalysis: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
8.10 Others
8.10.1 Overview
8.10.2 Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9. North America In-Vitro Diagnostics Market Analysis – by Application
9.1 Overview
9.2 Infectious Disease
9.2.1 Overview
9.2.2 Infectious Disease: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.3 Diabetes
9.3.1 Overview
9.3.2 Diabetes: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.4 Oncology
9.4.1 Overview
9.4.2 Oncology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.5 Cardiology
9.5.1 Overview
9.5.2 Cardiology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.6 Autoimmune Disease
9.6.1 Overview
9.6.2 Autoimmune Disease: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.7 Nephrology
9.7.1 Overview
9.7.2 Nephrology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
9.8 Others
9.8.1 Overview
9.8.2 Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10. North America In-Vitro Diagnostics Market Analysis – by End User
10.1 Overview
10.2 Hospitals
10.2.1 Overview
10.2.2 Hospitals: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.3 Laboratories
10.3.1 Overview
10.3.2 Laboratories: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.4 Homecare
10.4.1 Overview
10.4.2 Homecare: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
10.5 Others
10.5.1 Overview
10.5.2 Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11. North America In-Vitro Diagnostics Market – Regional Analysis
11.1 North America In-Vitro Diagnostics Market
11.1.1 Overview
11.1.2 North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.3 North America: In-Vitro Diagnostics Market, by Product and Services, 2020–2030 (US$ Million)
11.1.4 North America: In-Vitro Diagnostics Market, by Technology, 2020–2030 (US$ Million)
11.1.5 North America: In-Vitro Diagnostics Market, by Application, 2020–2030 (US$ Million)
11.1.6 North America: In-Vitro Diagnostics Market, by End User, 2020–2030 (US$ Million)
11.1.6.1 US: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.1.1 Overview
11.1.6.1.2 US: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.1.3 US: In-Vitro Diagnostics Market, by Product and Services, 2020–2030 (US$ Million)
11.1.6.1.4 US: In-Vitro Diagnostics Market, by Technology, 2020–2030 (US$ Million)
11.1.6.1.5 US: In-Vitro Diagnostics Market, by Application, 2020–2030 (US$ Million)
11.1.6.1.6 US: In-Vitro Diagnostics Market, by End User, 2020–2030 (US$ Million)
11.1.6.2 Canada: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.2.1 Overview
11.1.6.2.2 Canada: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.2.3 Canada: In-Vitro Diagnostics Market, by Product and Services, 2020–2030 (US$ Million)
11.1.6.2.4 Canada: In-Vitro Diagnostics Market, by Technology, 2020–2030 (US$ Million)
11.1.6.2.5 Canada: In-Vitro Diagnostics Market, by Application, 2020–2030 (US$ Million)
11.1.6.2.6 Canada: In-Vitro Diagnostics Market, by End User, 2020–2030 (US$ Million)
11.1.6.3 Mexico: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.3.1 Overview
11.1.6.3.2 Mexico: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
11.1.6.3.3 Mexico: In-Vitro Diagnostics Market, by Product and Services, 2020–2030 (US$ Million)
11.1.6.3.4 Mexico: In-Vitro Diagnostics Market, by Technology, 2020–2030 (US$ Million)
11.1.6.3.5 Mexico: In-Vitro Diagnostics Market, by Application, 2020–2030 (US$ Million)
11.1.6.3.6 Mexico: In-Vitro Diagnostics Market, by End User, 2020–2030 (US$ Million)
12. Pre and Post Covid-19 Impact on North America In-Vitro Diagnostics Market
12.1 Pre and Post Covid-19 Impact
13. North America In-Vitro Diagnostics Market – Industry Landscape
13.1 Overview
13.2 Growth Strategies in North America In-Vitro Diagnostics Market
13.3 Organic Growth Strategies
13.3.1 Overview
13.4 Inorganic Growth Strategies
13.4.1 Overview
14. Company Profiles
14.1 Abbott Laboratories
14.1.1 Key Facts
14.1.2 Business Description
14.1.3 Products and Services
14.1.4 Financial Overview
14.1.5 SWOT Analysis
14.1.6 Key Developments
14.2 F. Hoffmann-La Roche Ltd
14.2.1 Key Facts
14.2.2 Business Description
14.2.3 Products and Services
14.2.4 Financial Overview
14.2.5 SWOT Analysis
14.2.6 Key Developments
14.3 Danaher Corp
14.3.1 Key Facts
14.3.2 Business Description
14.3.3 Products and Services
14.3.4 Financial Overview
14.3.5 SWOT Analysis
14.3.6 Key Developments
14.4 Siemens AG
14.4.1 Key Facts
14.4.2 Business Description
14.4.3 Products and Services
14.4.4 Financial Overview
14.4.5 SWOT Analysis
14.4.6 Key Developments
14.5 Sysmex Corp
14.5.1 Key Facts
14.5.2 Business Description
14.5.3 Products and Services
14.5.4 Financial Overview
14.5.5 SWOT Analysis
14.5.6 Key Developments
14.6 Thermo Fisher Scientific Inc
14.6.1 Key Facts
14.6.2 Business Description
14.6.3 Products and Services
14.6.4 Financial Overview
14.6.5 SWOT Analysis
14.6.6 Key Developments
14.7 Becton Dickinson and Co
14.7.1 Key Facts
14.7.2 Business Description
14.7.3 Products and Services
14.7.4 Financial Overview
14.7.5 SWOT Analysis
14.7.6 Key Developments
14.8 bioMerieux SA
14.8.1 Key Facts
14.8.2 Business Description
14.8.3 Products and Services
14.8.4 Financial Overview
14.8.5 SWOT Analysis
14.8.6 Key Developments
14.9 Bio-Rad Laboratories Inc
14.9.1 Key Facts
14.9.2 Business Description
14.9.3 Products and Services
14.9.4 Financial Overview
14.9.5 SWOT Analysis
14.9.6 Key Developments
14.10 Qiagen NV
14.10.1 Key Facts
14.10.2 Business Description
14.10.3 Products and Services
14.10.4 Financial Overview
14.10.5 SWOT Analysis
14.10.6 Key Developments
15. Appendix
15.1 About The Insight Partners
15.2 Glossary of Terms

LIST OF TABLES

Table 1. North America: In-Vitro Diagnostics Market, by Product and Services – Revenue and Forecast to 2030 (US$ Million)
Table 2. North America: In-Vitro Diagnostics Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 3. North America: In-Vitro Diagnostics Market, by Application – Revenue and Forecast to 2030 (US$ Million)
Table 4. North America: In-Vitro Diagnostics Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 5. US: In-Vitro Diagnostics Market, by Product and Services – Revenue and Forecast to 2030 (US$ Million)
Table 6. US: In-Vitro Diagnostics Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 7. US: In-Vitro Diagnostics Market, by Application – Revenue and Forecast to 2030 (US$ Million)
Table 8. US: In-Vitro Diagnostics Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 9. Canada: In-Vitro Diagnostics Market, by Product and Services – Revenue and Forecast to 2030 (US$ Million)
Table 10. Canada: In-Vitro Diagnostics Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 11. Canada: In-Vitro Diagnostics Market, by Application – Revenue and Forecast to 2030 (US$ Million)
Table 12. Canada: In-Vitro Diagnostics Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 13. Mexico: In-Vitro Diagnostics Market, by Product and Services – Revenue and Forecast to 2030 (US$ Million)
Table 14. Mexico: In-Vitro Diagnostics Market, by Technology – Revenue and Forecast to 2030 (US$ Million)
Table 15. Mexico: In-Vitro Diagnostics Market, by Application – Revenue and Forecast to 2030 (US$ Million)
Table 16. Mexico: In-Vitro Diagnostics Market, by End User – Revenue and Forecast to 2030 (US$ Million)
Table 17. Recent Organic Growth Strategies in North America In-Vitro Diagnostics Market
Table 18. Recent Inorganic Growth Strategies in the North America In-Vitro Diagnostics Market
Table 19. Glossary of Terms, North America In-Vitro Diagnostics Market

LIST OF FIGURES

Figure 1. In-Vitro Diagnostics Tube Market Segmentation
Figure 2. In-Vitro Diagnostics Market Segmentation, by Country
Figure 3. North America In-Vitro Diagnostics Market Overview
Figure 4. Reagents and Kits Held Largest Share of Product and Services Segment in In-Vitro Diagnostics Market
Figure 5. North America In-Vitro Diagnostics Market – Leading Country Markets (US$ Million)
Figure 6. North America In-Vitro Diagnostics Market, Industry Landscape
Figure 7. North America PEST Analysis
Figure 8. North America In-Vitro Diagnostics Market Impact Analysis of Driver and Restraints
Figure 9. North America In-Vitro Diagnostics Market – Revenue Forecast and Analysis – 2020–2030
Figure 10. North America In-Vitro Diagnostics Market, by Products and Services, 2022 & 2030 (%)
Figure 11. Reagents and Kits: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 12. Instruments: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 13. Software and Services: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 14. North America In-Vitro Diagnostics Market, by Technology, 2022 & 2030 (%)
Figure 15. Immunoassay/Immunochemistry: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 16. Clinical Chemistry: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 17. Molecular Diagnostics: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 18. Microbiology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 19. Blood Glucose Self-Monitoring: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 20. Coagulation and Hemostasis: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 21. Hematology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 22. Urinalysis: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 23. Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 24. North America In-Vitro Diagnostics Market, by Application, 2022 & 2030 (%)
Figure 25. Infectious Disease: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 26. Diabetes: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 27. Oncology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 28. Cardiology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 29. Autoimmune Disease: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 30. Nephrology: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 31. Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 32. North America In-Vitro Diagnostics Market, by Application, 2022 & 2030 (%)
Figure 33. Hospitals: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 34. Laboratories: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 35. Homecare: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 36. Others: North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 37. North America In-Vitro Diagnostics Market, by Key Country – Revenue (2022) (US$ Million)
Figure 38. North America In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 39. North America In-Vitro Diagnostics Market, by Country, 2022 & 2030 (%)
Figure 40. US: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 41. Canada: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 42. Mexico: In-Vitro Diagnostics Market – Revenue and Forecast to 2030 (US$ Million)
Figure 43. Pre and Post Covid-19 Impact on In-Vitro Diagnostics Market in North America
Figure 44. Growth Strategies in North America In-Vitro Diagnostics Market

● Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the North America in-vitro diagnostics market.
● Highlights key business priorities in order to assist companies to realign their business strategies.
● The key findings and recommendations highlight crucial progressive industry trends in the North America in-vitro diagnostics market, thereby allowing players across the value chain to develop effective long-term strategies.
● Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.
● Scrutinize in-depth country market trends and outlook coupled with the factors driving the market, as well as those hindering it.
● Enhance the decision-making process by understanding the strategies that underpin security interest with respect to client products, segmentation, pricing and distribution

The List of Companies – North America In-Vitro Diagnostics Market
● Abbott Laboratories
● F. Hoffmann-La Roche Ltd
● Danaher Corp
● Siemens AG
● Sysmex Corp
● Thermo Fisher Scientific Inc
● Becton Dickinson and Co
● bioMerieux SA
● Bio-Rad Laboratories Inc
● Qiagen NV