North America Infectious Disease In vitro Diagnostics Market Size and Forecast (2021 - 2031), Regional Share, Trend, and Growth Opportunity Analysis

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, bioMérieux 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.