North America Infectious Disease In vitro Diagnostics Market Analysis and Forecast by Size, Share, Growth, Trends 2031

The North America Infectious Disease In vitro Diagnostics Market size is expected to reach US$ 31,137.0 Million by 2031 from US$ 19,096.4 Million in 2024. The market is estimated to record a CAGR of 7.3% from 2025 to 2031.

Executive Summary and North America Infectious Disease In vitro Diagnostics Market Analysis:

The infectious diseases in vitro diagnostics for market in North America is segmented into the US, Canada, and Mexico. The increasing acceptance of technologically advanced products, rising research and development activities, and growing use of in vitro diagnostics kits for infectious disease diagnosis, as well as the presence of large healthcare businesses, are among the key factors propelling the growth of the in vitro diagnostics for infectious diseases market in North America. The region is experiencing an increasing prevalence of infectious diseases and multiple product launches for its diagnosis by key players.

The growing focus of the Centers for Disease Control and Prevention (CDC) has established several international laboratory projects in North America. This includes two projects for the detection of drug-sensitive and drug-resistant TB cases in Sonora and Baja California, Mexico. The common goal of these two projects is to build capacity for the state and national disease control program to identify the group at risk and conduct rapid TB tests on that group. These initiatives for screening the masses for TB are creating awareness in the Mexican population. In addition, the rapidly growing pharmaceutical industry, developing healthcare infrastructure, and increasing demand for diagnostic testing products bolster the infectious diseases in vitro diagnostics market growth in North America.

North America Infectious Disease In vitro Diagnostics Market: Strategic Insights

North America Infectious Disease In vitro Diagnostics Market Segmentation Analysis:

• By Applications, the North America Infectious Disease In vitro Diagnostics Market is segmented into HIV or AIDS, Tuberculosis, Hepatitis B and C, Malaria, and Others. Hepatitis B and C held the largest share of the market in 2024.
• By End User, the North America Infectious Disease In vitro Diagnostics Market is segmented into Hospitals and Clinics, Diagnostic Laboratories, Blood Bank, and Others. Hospitals and Clinics held the largest share of the market in 2024.

North America Infectious Disease In vitro Diagnostics Market Players Density: Understanding Its Impact on Business Dynamics

The North America Infectious Disease In vitro Diagnostics Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

North America Infectious Disease In vitro Diagnostics Market Outlook

Technological advancements involving the development and integration of molecular diagnostics and automation systems enhance the accuracy, speed, and accessibility of infectious disease detection. Below are a few instances:

• In June 2024, MP Biomedicals introduced a new line of rapid immunochromatographic assays for Helicobacter pylori, Salmonella typhi, and Vibrio cholerae, intended for point-of-care in resource-constrained environments.
• In June 2024, Roche gained FDA Emergency Use Authorization (EUA) for its cobas liat multiplex PCR panel updated to detect SARS-CoV-2, influenza A/B, and RSV simultaneously, advancing syndromic respiratory infection management in less than 20 minutes.
• In July 2024, Sherlock Biosciences initiated clinical trials for its CRISPR-based over-the-counter (OTC) test for gonorrhea and chlamydia in May 2024, with an eye toward a 2025 launch. APEX-TB, integrating machine learning from AI and nanotechnology, was also launched to provide accurate, real-time molecular diagnostics using portable devices.
• In June 2024, QIAGEN introduced 35 new wet-lab tested digital PCR Microbial DNA Detection Assays to its digital PCR (dPCR) platform QIAcuity, noticeably strengthening its capabilities in microbial research.

These advancements are part of a larger movement toward decentralized, user-centric, and fast diagnostic technologies guiding the future of infectious disease care.

North America Infectious Disease In vitro Diagnostics Market Country Insights

By country, the North America Infectious Disease In vitro Diagnostics Market is segmented into the United States, Canada, and Mexico. The United States held the largest share in 2024.

The US is among the countries growing at a faster rate in the global infectious disease in vitro diagnostics market. Infectious diseases are growing significantly in the country. For instance, according to the Centers for Disease Control and Prevention, 9,633 US cases of TB disease were reported in 2023. This is an increase in the number of cases by 15.6% from 2022 (8,332 TB disease cases) and 8.3% from 2019 (8,895 TB disease cases), which was the previous year to the COVID-19 pandemic.

Market players are adopting organic and inorganic growth strategies for market expansion. For instance, in August 2024, MP Biomedicals completed its range of in vitro diagnostic infectious disease tests with fresh immunochromatographic-based qualitative rapid tests. MP Biomedicals' new diagnostic kits utilize advanced technology to provide accurate results, allowing health professionals a quick and accurate identification of Helicobacter pylori, Salmonella typhi, and Vibrio cholerae serogroups O1 and O139. Similarly, in March 2025, bioMérieux announced the US Food and Drug Administration (FDA) 510(k) clearance of VITEK COMPACT PRO. This advanced system for microorganism identification and antibiotic susceptibility testing is to be use in clinical laboratories to diagnose infectious diseases and fight antimicrobial resistance (AMR), as well as industrial laboratories to identify contaminants for maintaining consumer safety. Also, in August 2024, InBios International Inc., a prominent developer and producer of diagnostic tests for newly emerging infectious diseases and biothreats, is introducing an in vitro serological ELISA kit for presumptive clinical laboratory diagnosis of Strongyloides infection that provides results within 75 minutes.

North America Infectious Disease In vitro Diagnostics Market Company Profiles

Some of the key players operating in the market include 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 players are adopting various strategies such as expansion, product innovation, and mergers and acquisitions to provide innovative products to their consumers and increase their market share.

North America Infectious Disease In vitro Diagnostics Market Research Methodology

The following methodology has been followed for the collection and analysis of data presented in this report:

Secondary Research

The research process begins with comprehensive secondary research, utilizing internal and external sources to gather qualitative and quantitative data for each market. Commonly referenced secondary research sources include, but are not limited to:

• Company websites, annual reports, financial statements, broker analyses, and investor presentations
• Industry trade journals and other relevant publications
• Government documents, statistical databases, and market reports
• News articles, press releases, and webcasts specific to companies operating in the market

Note:

Primary Research

The Insight Partners conducts a significant number of primary interviews each year with industry stakeholders and experts to validate its data analysis and gain valuable insights. These research interviews are designed to:

• Validate and refine findings from secondary research
• Enhance the expertise and market understanding of the analysis team
• Gain insights into market size, trends, growth patterns, competitive dynamics, and future prospects

Primary research is conducted via email interactions and telephone interviews, encompassing various markets, categories, segments, and sub-segments across different regions. Participants typically include:

• Industry stakeholders: Vice Presidents, Business Development Managers, Market Intelligence Managers, and National Sales Managers
• External experts: Valuation specialists, research analysts, and key opinion leaders with industry-specific expertise