North America Infectious Disease In vitro Diagnostics Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Application (HIV or AIDS, Tuberculosis, Hepatitis B and C, Malaria, and Others) and End User (Hospitals and Clinics, Diagnostic Laboratories, Blood Bank, and Others)

March 2026 | 159 pages | ID: NDBCFEB0AE54EN
The Insight Partners

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The North America Infectious Disease In Vitro Diagnostics Market is projected to grow significantly, reaching an estimated size of approximately US$ 31,137.0 million by 2031, up from US$ 19,096.4 million in 2024. This growth reflects a compound annual growth rate (CAGR) of 7.3% from 2025 to 2031.
Executive Summary and Market Analysis
The market for infectious disease in vitro diagnostics in North America is divided into three primary regions: the United States, Canada, and Mexico. Several factors are driving the growth of this market, including the increasing acceptance of advanced technological products, heightened research and development activities, and a growing reliance on in vitro diagnostic kits for the diagnosis of infectious diseases. Additionally, the presence of major healthcare companies in the region contributes to market expansion.
The prevalence of infectious diseases is on the rise, prompting numerous product launches aimed at improving diagnostic capabilities. The Centers for Disease Control and Prevention (CDC) has initiated various international laboratory projects in North America, including efforts to detect both drug-sensitive and drug-resistant tuberculosis (TB) in regions such as Sonora and Baja California, Mexico. These initiatives aim to enhance the capacity of state and national disease control programs to identify at-risk populations and conduct rapid TB testing, thereby raising awareness among the Mexican populace. Furthermore, the burgeoning pharmaceutical industry, improvements in healthcare infrastructure, and an increasing demand for diagnostic testing products are all contributing to the growth of the infectious disease in vitro diagnostics market in North America.
Market Segmentation
The North America Infectious Disease In Vitro Diagnostics Market can be segmented by application and end user.
  • By Applications: The market includes segments for HIV/AIDS, Tuberculosis, Hepatitis B and C, Malaria, and others. Notably, Hepatitis B and C are expected to hold the largest market share in 2024.
  • By End User: The market is also segmented into Hospitals and Clinics, Diagnostic Laboratories, Blood Banks, and others, with Hospitals and Clinics anticipated to dominate the market share in 2024.
Market Outlook
Technological advancements are playing a crucial role in enhancing the accuracy, speed, and accessibility of infectious disease diagnostics. Recent innovations include:
  • In June 2024, MP Biomedicals launched a new series of rapid immunochromatographic assays for detecting Helicobacter pylori, Salmonella typhi, and Vibrio cholerae, designed for point-of-care use in resource-limited settings.
  • Roche received FDA Emergency Use Authorization (EUA) in June 2024 for its updated cobas liat multiplex PCR panel, which can simultaneously detect SARS-CoV-2, influenza A/B, and RSV in under 20 minutes, thereby improving management of syndromic respiratory infections.
  • Sherlock Biosciences began clinical trials for a CRISPR-based over-the-counter test for gonorrhea and chlamydia, with plans for a 2025 launch. Additionally, APEX-TB, which integrates AI and nanotechnology, was introduced to provide real-time molecular diagnostics using portable devices.
  • QIAGEN expanded its digital PCR platform, QIAcuity, by introducing 35 new wet-lab tested microbial DNA detection assays, enhancing its capabilities in microbial research.
These advancements reflect a broader trend towards decentralized, user-friendly, and rapid diagnostic technologies that are shaping the future of infectious disease management.
Country Insights
The North America Infectious Disease In Vitro Diagnostics Market is further segmented by country, with the United States holding the largest market share in 2024. The US is experiencing a notable increase in infectious diseases, as evidenced by the CDC reporting 9,633 cases of TB in 2023, marking a 15.6% rise from 2022 and an 8.3% increase from 2019.
Market players are employing both organic and inorganic growth strategies to expand their market presence. For instance, in August 2024, MP Biomedicals expanded its range of in vitro diagnostic tests with new rapid tests for infectious diseases. Similarly, bioM?rieux announced FDA 510(k) clearance for its VITEK COMPACT PRO system, aimed at microorganism identification and antibiotic susceptibility testing, which is crucial for combating antimicrobial resistance. InBios International Inc. also introduced a new serological ELISA kit for diagnosing Strongyloides infection, providing results in just 75 minutes.
Key Players
The market features several prominent players, including Abbott Laboratories, F. Hoffmann-La Roche Ltd, Sysmex Corp, bioMerieux SA, Bio-Rad Laboratories Inc, QIAGEN NV, Bruker Corp, QuidelOrtho Corp, Becton, Dickinson and Co, and Danaher Corp. These companies are actively pursuing strategies such as product innovation, expansion, and mergers and acquisitions to enhance their offerings and increase market share.
1. INTRODUCTION

1.1 Report Guidance
1.2 Market Segmentation

2. EXECUTIVE SUMMARY

2.1 Key Insights
2.2 Market Attractiveness

3. RESEARCH METHODOLOGY

3.1 Secondary Research
3.2 Primary Research
  3.2.1 Hypothesis formulation:
  3.2.2 Macroeconomic factor analysis:
  3.2.3 Developing base number:
  3.2.4 Data Triangulation:
  3.2.5 Country-level data:

5. NORTH AMERICA INFECTIOUS DISEASE IN VITRO DIAGNOSTICS MARKET - KEY MARKET DYNAMICS

5.1 Market Drivers
5.2 Market Restraints
5.3 Market Opportunities
5.4 Future Trends
5.5 Impact of Drivers and Restraints:

6. INFECTIOUS DISEASE IN VITRO DIAGNOSTICS MARKET - NORTH AMERICA MARKET ANALYSIS

6.1 North America Infectious Disease In vitro Diagnostics Market Revenue (US$ Million), 2024 - 2031
6.2 North America Infectious Disease In vitro Diagnostics Market Forecast and Analysis

7. NORTH AMERICA INFECTIOUS DISEASE IN VITRO DIAGNOSTICS MARKET REVENUE ANALYSIS - BY APPLICATIONS

7.1 HIV or AIDS
  7.1.1 Overview
  7.1.2 HIV or AIDS: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.2 Tuberculosis
  7.2.1 Overview
  7.2.2 Tuberculosis: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.3 Hepatitis B and C
  7.3.1 Overview
  7.3.2 Hepatitis B and C: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.4 Malaria
  7.4.1 Overview
  7.4.2 Malaria: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
7.5 Others
  7.5.1 Overview
  7.5.2 Others: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)

8. NORTH AMERICA INFECTIOUS DISEASE IN VITRO DIAGNOSTICS MARKET REVENUE ANALYSIS - BY END USER

8.1 Hospitals and Clinics
  8.1.1 Overview
  8.1.2 Hospitals and Clinics: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
8.2 Diagnostic Laboratories
  8.2.1 Overview
  8.2.2 Diagnostic Laboratories: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
8.3 Blood Bank
  8.3.1 Overview
  8.3.2 Blood Bank: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
8.4 Others
  8.4.1 Overview
  8.4.2 Others: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)

9. NORTH AMERICA INFECTIOUS DISEASE IN VITRO DIAGNOSTICS MARKET - COUNTRY ANALYSIS

9.1 North America
  9.1.1 North America Infectious Disease In vitro Diagnostics Market Revenue and Forecast and Analysis - by Country
    9.1.1.1 North America Infectious Disease In vitro Diagnostics Market Revenue and Forecast and Analysis - by Country
    9.1.2.2 United States: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
      9.1.2.2.1 United States: North America Infectious Disease In vitro Diagnostics Market Share - by Applications
      9.1.2.2.2 United States: North America Infectious Disease In vitro Diagnostics Market Share - by End User
    9.2.3.3 Canada: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
      9.2.3.3.1 Canada: North America Infectious Disease In vitro Diagnostics Market Share - by Applications
      9.2.3.3.2 Canada: North America Infectious Disease In vitro Diagnostics Market Share - by End User
    9.3.4.4 Mexico: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
      9.3.4.4.1 Mexico: North America Infectious Disease In vitro Diagnostics Market Share - by Applications
      9.3.4.4.2 Mexico: North America Infectious Disease In vitro Diagnostics Market Share - by End User

10 COMPETITIVE LANDSCAPE

10.1 Heat Map Analysis by Key Players
10.2 Company Positioning & Concentration

11 INDUSTRY LANDSCAPE

11.1 Overview
11.2 New Product Development
11.3 Merger and Acquisition
11.4 Other Strategic Developments

12 COMPANY PROFILES

12.1 Abbott Laboratories
  12.1.1 Key Facts
  12.1.2 Business Description
  12.1.3 Products and Services
  12.1.4 Financial Overview
  12.1.5 SWOT Analysis
  12.1.6 Key Developments
12.2 F. Hoffmann-La Roche Ltd
  12.2.1 Key Facts
  12.2.2 Business Description
  12.2.3 Products and Services
  12.2.4 Financial Overview
  12.2.5 SWOT Analysis
  12.2.6 Key Developments
12.3 Sysmex Corp
  12.3.1 Key Facts
  12.3.2 Business Description
  12.3.3 Products and Services
  12.3.4 Financial Overview
  12.3.5 SWOT Analysis
  12.3.6 Key Developments
12.4 bioMerieux SA
  12.4.1 Key Facts
  12.4.2 Business Description
  12.4.3 Products and Services
  12.4.4 Financial Overview
  12.4.5 SWOT Analysis
  12.4.6 Key Developments
12.5 Bio-Rad Laboratories Inc
  12.5.1 Key Facts
  12.5.2 Business Description
  12.5.3 Products and Services
  12.5.4 Financial Overview
  12.5.5 SWOT Analysis
  12.5.6 Key Developments
12.6 QIAGEN NV
  12.6.1 Key Facts
  12.6.2 Business Description
  12.6.3 Products and Services
  12.6.4 Financial Overview
  12.6.5 SWOT Analysis
  12.6.6 Key Developments
12.7 Bruker Corp
  12.7.1 Key Facts
  12.7.2 Business Description
  12.7.3 Products and Services
  12.7.4 Financial Overview
  12.7.5 SWOT Analysis
  12.7.6 Key Developments
12.8 QuidelOrtho Corp
  12.8.1 Key Facts
  12.8.2 Business Description
  12.8.3 Products and Services
  12.8.4 Financial Overview
  12.8.5 SWOT Analysis
  12.8.6 Key Developments
12.9 Becton, Dickinson and Co
  12.9.1 Key Facts
  12.9.2 Business Description
  12.9.3 Products and Services
  12.9.4 Financial Overview
  12.9.5 SWOT Analysis
  12.9.6 Key Developments
12.10 Danaher Corp
  12.10.1 Key Facts
  12.10.2 Business Description
  12.10.3 Products and Services
  12.10.4 Financial Overview
  12.10.5 SWOT Analysis
  12.10.6 Key Developments

13. APPENDIX

13.1 About The Insight Partners
LIST OF TABLES

Table 1. North America Infectious Disease In vitro Diagnostics Market Segmentation
Table 3. North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Table 4. North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Applications
Table 5. North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by End User
Table 6. North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Country
Table 7. United States: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Applications
Table 8. United States: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by End User
Table 9. Canada: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Applications
Table 10. Canada: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by End User
Table 11. Mexico: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by Applications
Table 12. Mexico: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million) - by End User
Table 13. Heat Map Analysis by Key Players
LIST OF FIGURES

Figure 1. North America Infectious Disease In vitro Diagnostics Market Segmentation - Country
Figure 4. North America Infectious Disease In vitro Diagnostics Market - Key Market Dynamics
Figure 5. Impact Analysis of Drivers and Restraints
Figure 6. North America Infectious Disease In vitro Diagnostics Market Revenue (US$ Million), 2024 - 2031
Figure 7. North America Infectious Disease In vitro Diagnostics Market Share (%) - by Applications, 2024 and 2031
Figure 8. HIV or AIDS: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 9. Tuberculosis: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 10. Hepatitis B and C: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 11. Malaria: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 12. Others: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 13. North America Infectious Disease In vitro Diagnostics Market Share (%) - by End User, 2024 and 2031
Figure 14. Hospitals and Clinics: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 15. Diagnostic Laboratories: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 16. Blood Bank: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 17. Others: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 18. North America Infectious Disease In vitro Diagnostics Market Breakdown by Key Countries, 2024 and 2031 (%)
Figure 19. United States: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 20. Canada: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 21. Mexico: North America Infectious Disease In vitro Diagnostics Market - Revenue and Forecast, 2021 - 2031 (US$ Million)
Figure 22. Company Positioning & Concentration


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