North America In-Vitro Diagnostics Market Forecast to 2030 - Regional Analysis by Product and Services, Technology, Application, and End User

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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.

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Product Code: TIPRE00022125

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