North America Infectious Disease In vitro Diagnostics Market Revenue to cross US$ 31,137.0 Million by 2031


PRESS RELEASE BY The Insight Partners 25 Nov 2025

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According to The Insight Partners' research, the North America Infectious Disease In vitro Diagnostics Market was valued at US$ 19,096.4 Million in 2024 and is expected to reach US$ 31,137.0 Million by 2031, registering a CAGR of 7.3% from 2025 to 2031.

Increasing prevalence of infectious diseases and technological advancements portal are among the critical factors attributed to the North America infectious disease in-vitro diagnostics market expansion.

As per the World Health Organization (WHO), tuberculosis (TB) affects 10 million people globally each year. Even though TB can be both prevented and cured, it still claims 1.5 million lives annually, making it among the leading infectious causes of death worldwide. The majority of TB cases occur in low- and middle-income countries, though the disease is found across the globe. In alignment with global health trends, the prevalence of HIV continues to escalate worldwide. According to data from the World Health Organization, an estimated 39.9 million individuals were living with HIV as of the end of 2023, with projections ranging from 36.1 to 44.6 million. Approximately 0.6% of the global adult population aged 15-49 years is affected, although the magnitude and implications of the epidemic vary substantially across different countries and regions.

Furthermore, increasing fungal infections are one of the major concerns among a large population base globally, affecting millions. According to the Global Action Fund for Fungal Infections (GAFFI) 2024, more than 80 million people are at high risk of developing fungal disease every year, and approximately 6.55 million patients develop life-threatening fungal infections, of which 3.75 million people die annually. Thus, the growing cases of infectious diseases create a significant need for in vitro diagnosis to detect diseases and infections before proceeding with the desired treatment. Further, the escalating prevalence of HIV, hepatitis, tuberculosis, influenza, and new viral infections has intensified the demand for rapid and precise diagnostic solutions. Innovations in molecular diagnostics, better point-of-care testing, and greater emphasis on early detection and disease surveillance are collectively driving the adoption of in vitro diagnostics methodologies across both developed and emerging healthcare markets.

On the contrary, inadequate reimbursement scenario hampers the growth of North America infectious disease in-vitro diagnostics market.

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. The Hepatitis B and C segment is projected to expand at 6.8% CAGR during 2025 - 2031.
  • By End User, the North America Infectious Disease In vitro Diagnostics Market is segmented into Hospitals and Clinics, Diagnostic Laboratories, Blood Bank, and Others. The Hospitals and Clinics segment is projected to expand at 7.3% CAGR during 2025 - 2031.

By country, the North America Infectious Disease In vitro Diagnostics Market is categorized into the United States, Canada, and Mexico. The United States is projected to expand at 7.4% CAGR during 2025 - 2031.

Key players operating in the Infectious Disease In vitro Diagnostics Market are 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, among others.

  • In May 2022, Abbott announced the launch of the HBsAg Next Qualitative solution in India to enhance the detection of the Hepatitis B virus (HBV). This assay will help improve patient outcomes while maintaining safe blood supplies. This highly sensitive chemiluminescent microparticle immunoassay (CMIA) assists in the early and enhanced detection of HBV in human serum and plasma (blood) samples and in population screening.
  • In October 2022, Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and cobas 8800 Systems. This standalone test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by their healthcare provider.

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