North America Infectious Disease Rapid Diagnostics Market - A Regional Analysis: Focus on Product, Technology, Application, and Country-Level Analysis - Analysis and Forecast, 2025-2035

Infectious Disease Rapid Diagnostics are tests designed to quickly detect and identify infectious agents such as bacteria, viruses, or fungi, enabling fast treatment decisions. These tests provide results in minutes to a few hours, crucial for early detection and effective management of infections. They include molecular diagnostics, antigen tests, and serological assays for diseases such as influenza, COVID-19, and STIs.

The increasing incidence of infectious diseases such as influenza, sexually transmitted infections (STIs), respiratory infections, and hospital-acquired infections (HAIs) is a major driver of the North American rapid diagnostics market. For instance, the CDC reported in 2023 that the U.S. experienced an uptick in flu cases, with over 15 million cases reported that year, emphasizing the need for fast and efficient diagnostic tests. The growing threat of antimicrobial resistance (AMR) and the emergence of novel pathogens, such as the resurgence of multidrug-resistant tuberculosis and the rise of drug-resistant gonorrhea, have made early and accurate disease detection more critical than ever to control outbreaks and prevent further resistance.

Moreover, governments and healthcare organizations are heavily investing in rapid testing solutions to enhance early disease detection and control outbreaks. During the 2023 influenza season, the U.S. government expanded the use of Quidel’s Sofia 2 SARS Antigen FIA test for quick identification of flu and COVID-19 co-infections in emergency departments. The demand for point-of-care (POC) diagnostics in emergency settings, outpatient clinics, and remote locations has risen as healthcare systems strive to reduce diagnostic turnaround times and improve patient outcomes. For instance, the Abbott ID NOW molecular diagnostic system has been deployed widely in rural and remote areas to quickly detect respiratory infections such as flu and COVID-19, providing results in just 15 minutes.

A significant opportunity in the North American rapid diagnostics market lies in the expansion of point-of-care testing (POCT) across decentralized healthcare settings, such as pharmacies, urgent care centers, and home-based testing. The rising demand for fast, reliable, and affordable diagnostics outside of traditional hospital environments is opening new growth avenues for diagnostic companies. With growing government support and increasing regulatory approvals for POCT, the adoption of portable diagnostic devices is expected to surge, particularly for diseases like STIs, respiratory infections, and gastrointestinal infections.

However, the major challenges faced by the North America infectious disease rapid diagnostics market are the stringent regulatory framework and pricing constraints. The FDA approval process for new diagnostic tests can be time-consuming and complex, delaying product launches and market entry. For instance, Cepheid's Xpert Xpress COVID-19 test, while highly effective, faced regulatory hurdles and delays before it received Emergency Use Authorization (EUA) in 2020. The approval process for new technologies can extend product launch timelines, delaying access to critical diagnostics.

Additionally, the high cost of advanced molecular diagnostic technologies such as q-PCR and INAAT makes them less accessible, particularly in resource-limited settings. Although reimbursement policies are improving, inconsistent insurance coverage for rapid diagnostic tests remains a barrier to widespread adoption. A study published by the National Institutes of Health (NIH) found that the cost of a single qPCR test for COVID-19 could range from $100 to $200, limiting accessibility in smaller clinics or remote healthcare settings.

Pricing pressures also arise due to competition from generic or low-cost diagnostic alternatives, especially in non-hospital settings. Moreover, healthcare providers are often hesitant to adopt new diagnostic technologies without clear cost-effectiveness data or strong clinical validation. These regulatory and pricing challenges could slow market growth and limit accessibility to cutting-edge diagnostic solutions.

Key market players in the North American infectious disease rapid diagnostics market are focusing on innovation, strategic partnerships, and expanding product offerings to meet the growing demand for faster, more accurate testing solutions. For instance, in April 2022, Thermo Fisher Scientific, Inc. launched the TaqPath COVID-19 RNase P 2.0 Assay Kit, designed to detect SARS-CoV-2, including emerging variants.

Key players in the market are Abbott Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corporation, DiaSorin S.p.A, Hologic, Inc., BGI Group,Quidel Corporation, Cellex,bioMérieux S.A., and Thermo Fisher Scientific Inc., etc.

Market Segmentation:

Segmentation 1: by Product

• Assays
• Platforms

Assay to Lead the Infectious Disease Rapid Diagnostics Market (by Product)

Assays dominate the North America infectious disease rapid diagnostics market due to their widespread applicability, affordability, and efficiency in detecting a range of infectious diseases. Assays, including immunoassays and molecular assays, are used extensively in hospitals, clinics, and point-of-care (POC) settings for rapid disease detection, enabling timely treatment decisions. Their cost-effectiveness compared to fully automated diagnostic systems makes them accessible to a broader range of healthcare providers.

With the rising prevalence of infectious diseases such as respiratory infections, sexually transmitted infections (STIs), and gastrointestinal infections, demand for rapid and accurate diagnostic assays is increasing. Advances in multiplex assays, capable of detecting multiple pathogens from a single sample, further enhance their clinical value. Additionally, regulatory approvals for at-home diagnostic assays, particularly for diseases like COVID-19 and influenza, are expected to drive market expansion. As a result, assays remain a cornerstone of infectious disease diagnostics.

Segmentation 2: by Technology

• Real-Time PCR (q-PCR)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Others

Real-Time Polymerase Chain Reaction (q-PCR) to Lead the Infectious Disease Rapid Diagnostics Market (by Technology)

Real-Time Polymerase Chain Reaction (q-PCR) is projected to be the dominant technology in the North America infectious disease rapid diagnostics market due to its high sensitivity, specificity, and rapid turnaround time. q-PCR is widely used for detecting viral and bacterial infections, particularly in hospital laboratories and reference labs where accuracy is crucial for clinical decision-making.

One key advantage of q-PCR is its ability to quantify pathogen load, enabling physicians to monitor disease progression and treatment effectiveness. The increasing incidence of respiratory infections (e.g., COVID-19, influenza, RSV) has led to widespread adoption of q-PCR tests. Moreover, innovations in portable and automated q-PCR devices are expanding the technology's usability in point-of-care (POC) and decentralized settings.

With ongoing advancements in multiplex PCR assays, which allow simultaneous detection of multiple pathogens, q-PCR will continue to be the gold standard for rapid, high-accuracy infectious disease diagnostics.

Segmentation 3: by Application

• Respiratory Infection
• Gastro-Intestinal Infection
• Hospital Acquired Infection
• Sexually Transmitted Infections
• Others

Segmentation 4: by Country

• U.S.
• Canada

U.S. Region to Lead the North America Infectious Disease Rapid Diagnostics Market (by Country)

The U.S. is expected to lead the North America infectious disease rapid diagnostics market throughout the forecast period due to several key factors. The country has a high prevalence of infectious diseases, such as respiratory, gastrointestinal, and sexually transmitted infections, which drives the demand for rapid diagnostic solutions. The U.S. also boasts a robust healthcare infrastructure with well-established hospitals, diagnostic centers, and research institutions that promote the adoption of innovative diagnostic technologies. Regulatory support from the FDA, including expedited approval pathways, allows faster market entry for new diagnostic products, further fueling growth. Additionally, increased investments from government initiatives, private sector funding, and collaborations between biotech companies and academic institutions are boosting R&D in rapid diagnostics. The U.S. remains at the forefront of adopting advanced diagnostic technologies, including molecular diagnostic platforms, AI-driven tools, and portable rapid test kits. While Canada experiences steady growth, the U.S. will continue to be the primary driver of market expansion in the region.

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