The U.S. infectious disease diagnostics market is projected to grow at a CAGR of 5.65% from 2025 to 2032, increasing from USD 10.14 billion in 2024 to USD 15.48 billion by 2032. This growth is primarily driven by the rising prevalence of infectious diseases, the availability of a wide range of diagnostic tests, and the growing adoption of point-of-care testing methods. Additionally, ongoing advancements in diagnostic technologies, increasing investments in disease analysis, and strategic initiatives by key market players are further fueling market expansion.
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Infectious Disease Diagnostics: Purpose and Methods
Infectious disease diagnostics involve identifying pathogens such as bacteria, viruses, fungi, or parasites in individuals presenting symptoms. This process is essential for determining appropriate treatment plans. Diagnostic methods range from laboratory tests (blood, urine, and tissue samples) to imaging scans that detect disease-related changes. Pathogen detection can be achieved through cell culture isolation, biochemical and antigenic identification, or molecular techniques such as DNA analysis. These methods, along with immune response-based diagnostics, play a crucial role in accurately identifying infections, particularly in resource-limited settings.
Market Challenges
Despite its growth, the market faces obstacles, including limited awareness of innovative diagnostic tools, a lack of standardized regulatory guidelines, and challenges related to inadequate laboratory infrastructure, which can lead to lower diagnostic accuracy. However, market players are actively launching new products and implementing strategic business moves to drive expansion.
In January 2025, Inflammatix, Inc. received FDA approval for its TriVerity Test System, a molecular diagnostic tool that differentiates between bacterial and viral infections and assesses disease severity. This innovation is expected to strengthen market growth by improving diagnostic accuracy and enhancing clinicians’ ability to evaluate patient conditions effectively.
Key Market Drivers
Increasing Prevalence of Infectious Diseases
The 21st century has witnessed a surge in infectious diseases such as COVID-19, SARS, and swine flu, significantly impacting public health. Factors contributing to this rise include environmental changes, increased human interaction with previously unknown microbes, and demographic shifts. As infectious diseases continue to spread, the demand for reliable diagnostic solutions grows. For instance, according to the World Health Organization (WHO), tuberculosis (TB) remained the leading infectious disease in 2023. The Centers for Disease Control and Prevention (CDC) reported an increase in TB cases in the U.S. from 8,332 in 2022 to 9,633 in 2023—a 15.6% rise—highlighting the need for improved diagnostic capabilities.
Growing Demand for Point-of-Care Diagnostics
Factors such as international travel, urbanization, antibiotic resistance, and climate change have contributed to the rising prevalence of infectious diseases. Additionally, aging populations and increased susceptibility to infections have intensified the need for efficient diagnostic solutions. The U.S. aims to reduce new HIV infections from 32,800 in 2022 to 9,300 by 2025 and further to 3,000 by 2030. As infections rise, so does the demand for rapid and accessible diagnostic tools, particularly point-of-care diagnostics (POCD). These solutions facilitate early disease detection, enabling timely treatment and improved epidemic control.
In response to this growing demand, industry stakeholders are expanding their efforts. In April 2025, Cepheid Inc., a subsidiary of Danaher Corporation, received WHO prequalification for its Xpert HIV-1 Qual XC, an in-vitro diagnostic test designed to detect HIV-1 in blood samples.
Wide Availability of Diagnostic Tests
A variety of diagnostic tests, including laboratory-based methods, rapid tests, serological assays, and polymerase chain reaction (PCR) tests, contribute to market expansion. These tests detect antibodies, antigens, and specific pathogens, enabling accurate disease diagnosis. Laboratory tests analyze blood, urine, and sputum samples using staining, culturing, and molecular techniques, while rapid diagnostic tests deliver quick results for clinical decision-making. Serological tests identify prior infections through antibody detection, and PCR tests pinpoint pathogens through genetic material analysis.
The availability of these diverse diagnostic tools strengthens market growth. For example, in December 2024, Delve Bio, Inc. introduced Delve Detect, a metagenomic testing solution capable of analyzing cerebrospinal fluid (CSF) for over 68,000 pathogens within 48 hours. By offering rapid and reliable pathogen detection, this innovation enhances diagnostic capabilities in the U.S. market.
Leading Market Segments
Dominance of Reagents, Kits, and Consumables
The reagents, kits, and consumables segment holds a significant share of the U.S. infectious disease diagnostics market, driven by repeat purchases and a growing emphasis on patient-friendly testing options. The segment benefits from advances in molecular diagnostics, rising infection rates, and competition among suppliers.
In December 2024, Panadea Diagnostics GmbH launched innovative ELISA kits for detecting IgG antibodies against Zika, Dengue, and West Nile viruses, as well as an IgM detection kit for Dengue. Such developments reinforce the dominance of diagnostic kits and consumables in the market by providing efficient and accurate testing solutions.
Future Market Outlook (2025-2032)
The regulatory landscape for infectious disease diagnostics is evolving, with increasing approvals expected to support market growth. The Biomedical Advanced Research and Development Authority (BARDA) has backed numerous medical solutions, leading to 86 FDA approvals, clearances, or licensures. Similarly, the Infectious Diseases Society of America (IDSA) has advocated for new incentives and regulatory reforms to encourage R&D in diagnostics and therapeutics.
With rising regulatory approvals, competitive innovation, and expanding diagnostic capabilities, the U.S. infectious disease diagnostics market is poised for steady growth.
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