U.S. Tuberculosis (TB) Diagnostics Market Size, Share & Industry Analysis, By Type (Interferon Gamma Release Assay (IGRA), Tuberculin Skin Test (TST), Nucleic Acid Amplification Test (NAAT), Culture-based Diagnostics, Sputum Smear Microscopy, and Others), By End-user (Diagnostic Laboratories, Hospitals and Clinics, and Others), and Country Forecast, 2025-2032

The U.S. tuberculosis (TB) diagnostics market size was valued at USD 605.3 million in 2024. The market is projected to grow from USD 634.8 million in 2025 to USD 926.8 million by 2032, exhibiting a CAGR of 5.6% during the forecast period.

Tuberculosis (TB) diagnostics involve tests to detect both latent TB infection and active TB disease, as well as identify drug resistance. Common tests include the tuberculin skin test (TST), interferon-gamma release assays (IGRAs), nucleic acid amplification tests (NAATs), sputum smear microscopy tests, and others.

The market growth is mainly attributed to the advancements in tuberculosis testing technologies, such as molecular techniques, including nucleic acid amplification tests (NAATs) and polymerase chain reaction (PCR)-based methods, thus offering faster results over the traditional sputum microscopy or culture methods. Laboratories and hospitals are highly favoring these methods for tuberculosis detection in the U.S., thereby encouraging prominent players to introduce new products and surge the supply.

The prominent companies operating in the market include QIAGEN, Danaher (Cepheid), and F. Hoffman-La Roche Ltd. These players have a well-established footprint across the U.S. market. They are involved in implementing various growth strategies such as partnerships and acquisitions, which are expected to contribute to their dominant market share during the forecast period.

MARKET DYNAMICS

Market Drivers

Increasing Incidence of Tuberculosis to Propel the Market Growth

Over the past few years, the U.S. has been witnessing a considerable rise in new cases of tuberculosis due to several factors, such as the history of HIV epidemic, which has significantly increased the number of people with weakened immune systems, thereby growing susceptibility to tuberculosis infection. Moreover, the increasing international travel and migration patterns are also anticipated to facilitate the spread of tuberculosis in the U.S. These cases are mainly of latent tuberculosis, due to which healthcare organizations are focusing on detecting latent tuberculosis infection (LTBI) among the population.    

• For instance, in April 2025, the data published by the Centers for Disease Control and Prevention (CDC) reported an estimated 13.0 million cases of latent tuberculosis in the U.S. The progression from untreated latent TB infection to TB disease accounted for approximately 80.0% of U.S. TB cases.
• Similarly, according to the data published by the Centers for Disease Control and Prevention (CDC) in November 2024, there was an incidence rate of 2.9 TB cases per 100,000 persons in the U.S. in 2023.

Moreover, increase in travel and migration to the U.S. have also contributed to the growth in TB cases, which is stimulating prominent players to increase availability for tuberculosis diagnostic tests. Such a scenario is expected to drive the U.S. tuberculosis (TB) diagnostics market growth in the upcoming years.

Market Restraints

High Diagnostic Costs and Insurance Limitations to Impede the Market Growth

In the U.S., the advanced TB diagnostic tests, such as the nucleic acid amplification tests (NAATs) and interferon gamma release assays (IGRA), are often expensive compared to traditional sputum smear microscopy and culture-based TB diagnostics. Although these tests offer superior sensitivity and specificity, the high costs are deterring their adoption among resource-limited diagnostic settings, particularly for uninsured populations or low-income patients.

• For instance, according to the study published by ScienceDirect in May 2024, the total expected cost of administering QFT-Plus to 1000 subjects was USD 203,410, while TST was USD 113,040.

The programs, such as Medicaid, cover TB testing; several private insurers still require co-pays or pre-authorizations, adding an administrative burden in the U.S. Additionally, community health centers serving high-risk populations often lack funding to offer advanced diagnostics on a routine basis. Such barriers are restricting the accessibility and limiting market penetration for advanced diagnostic technologies, which is expected to hamper the market growth during the forthcoming years.

Market Opportunities

Development of Point-of-Care (POC) Diagnostics to Serve as a Lucrative Opportunity

Currently, there has been an increasing focus on development of affordable and portable point-of-care TB diagnostics for rapid Tuberculosis (TB) detection for addressing the growing TB incidence in the resource-limited settings across the U.S. These devices are improving access to timely and accurate TB diagnosis, leading to earlier treatment initiation and reduced transmission. As a result, the researchers and key players are exploring new tools by focusing on miniaturization, affordability, and ease of use.

• For instance, in April 2025, Tulane University researchers developed a smartphone-sized, battery-powered lab-in-tube assay (LIT) to deliver rapid and accurate tuberculosis diagnoses in less than an hour in resource-limited settings. This test is designed as an affordable solution, costing less than USD 800.0 per device and less than USD 3.0 per test.

Moreover, the increasing funding for research & development is further contributing to the developments, which are expected to introduce new and advanced products. Also, the key players are collaborating with research institutions and private/public TB testing facilities to accelerate such innovations and increase access to testing, thereby offering lucrative opportunities for the U.S. market expansion.

Market Challenges

Stringent Regulatory Pathways for New Diagnostics and Limited Skilled Personnel in Rural Areas to Challenge Market Expansion

In the U.S., the regulatory framework is governed by the FDA, which requires companies to undergo extensive clinical validation and costly regulatory submissions for tuberculosis diagnostics, involving multiple clinical trials to ensure safety and efficacy before widespread adoption. This is delaying the introduction of diagnostic products in the market, thereby posing significant challenges, particularly for molecular technologies.

Moreover, performing and interpreting complex TB diagnostic tests, such as using nucleic acid amplification tests (NAATs), requires trained laboratory professionals. As a result, a shortage of skilled personnel in the rural areas of the U.S. is limiting accessibility to these tests. For instance, according to the article published by the LigoLab Information Systems in April 2025, there is a projected shortage of between 20,000 and 25,000 laboratory technologists in the U.S. Such a shortage is anticipated to challenge the market expansion during the forecast period.

U.S. TUBERCULOSIS (TB) DIAGNOSTICS MARKET TRENDS

AI-based TB Diagnostics to Emerge as a Significant Market Trend

Currently, the artificial Intelligence (AI)-based diagnostics are emerging as a transformative trend in the U.S. tuberculosis (TB) diagnostics market, driven by the need for faster, more accurate, and scalable diagnostic solutions. Although the traditional tuberculosis detection methods, such as sputum microscopy, chest X-rays, and culture tests, are effective, they are time-consuming. Hence, AI technologies are being increasingly integrated to address these limitations. One notable area of advancement is AI-assisted interpretation of chest radiographs. These platforms automatically analyze X-ray images and detect potential cases with high TB diagnostic test sensitivity and specificity.

• For instance, according to BioMed Central Ltd, in December 2023, systems including Qure.ai’s qXR and Delft Imaging’s CAD4TB have demonstrated high accuracy in detecting TB-related abnormalities.

These tools are particularly being used in resource-limited or high-volume settings, helping radiologists and clinicians to reduce diagnostic delays. As a result, this technology is being explored in underserved or rural U.S. populations where access to pulmonologists and TB specialists is limited. Additionally, research institutions in the U.S. are collaborating with public health departments to develop machine learning models that can identify individuals at high risk of TB reactivation, especially in populations with latent TB infection. Such a scenario is reshaping the tuberculosis diagnostics landscape in the U.S.

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SEGMENTATION ANALYSIS

By Type

Interferon Gamma Release Assay (IGRA) Segment to Hold a Dominant Share Due to Associated Benefits

Based on the type, the market is segmented into interferon gamma release assay (IGRA), tuberculin skin test (TST), nucleic acid amplification test (NAAT), culture-based diagnostics, sputum smear microscopy, and others.

The interferon gamma release assay (IGRA) segment dominated the U.S. Tuberculosis (TB) Diagnostics Market in 2024. This growth is attributed to increasing preference for the interferon gamma release assay (IGRA) over the TST (Tuberculin Skin Test) for TB testing due to numerous benefits, such as requiring only one patient visit and less susceptibility to errors in reading. This is leading to an increase in regulatory approvals for such tests, thereby increasing availability across the U.S.

• For instance, in April 2025, Revvity received FDA approval for the Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test for latent tuberculosis.

The tuberculin skin test (TST) segment held the second-largest market share in 2024. The segment’s growth is mainly due to increasing recommendations of TST for U.S. individuals, such as healthcare workers, who require regular testing. Moreover, TSTs are generally preferred in the absence of IGRA and are also for children aged under 5 due to IGRA sensitivity in this age group. In consideration, prominent companies are consistently supplying these tests to diagnostic settings, which are expected to contribute to significant product penetration in the market.

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By End-User

Large Number of Diagnostic Laboratories to Cater to Growing Volume of Tuberculosis Detection Tests

Based on end-user, the market is segmented into diagnostic laboratories, hospitals and clinics, and others.

The diagnostic laboratories segment dominated the market in 2024. This segment's large share is attributed to the growing number of diagnostic laboratories in the U.S., thereby propelling the need for more specialized and advanced tuberculosis tests. TB diagnostic laboratories are equipped to handle the large test volumes, utilizing specialized media, microscopy, and molecular techniques. In such a scenario, prominent companies are expected to maintain a stable supply of tuberculosis diagnostic tests to these settings.

• For instance, as of July 2025, the Laboratory of Florida LLC stated that there are around 5,414 independent laboratories in the U.S., contributing to 32.0% of the lab test volume.

The hospitals and clinics segment accounted for the second-largest share of the market in 2024 and is expected to grow at the fastest CAGR in the forthcoming years. The segment’s growth is attributed to the increasing opening of clinical laboratories by hospitals to spur the accessibility for the diagnosis of tuberculosis, in the same setting. This is anticipated to boost the tuberculosis testing volume in the hospitals and clinics, thereby increasing the adoption of advanced tests.

COMPETITIVE LANDSCAPE

Key Market Players

QIAGEN, Danaher (Cepheid), and F. Hoffman-La Roche Ltd. To Hold the Dominant Market Share in 2024 Due to Involvement in Strategic Initiatives

The market is fragmented due to the established players holding a significant share of the market. QIAGEN, Danaher (Cepheid), and F. Hoffman-La Roche Ltd. held the largest U.S. tuberculosis (TB) diagnostics market share in 2024.  This dominance is attributed to growing emphasis on providing advanced tuberculosis diagnostics and high involvement in partnerships and collaborations for geographical expansion.

Additionally, Abbott, BD, and other prominent players held a significant market share owing to their increasing focus on new product launches and related platforms, contributing to enhancements in tuberculosis detection.  Moreover, the rising inorganic growth strategies by these companies, such as showcasing new technologies, are further expected to increase the market share of these companies.

LIST OF KEY U.S. TUBERCULOSIS (TB) DIAGNOSTICS COMPANIES PROFILED

• F. Hoffmann-La Roche Ltd. (Switzerland)
• Revvity (U.S.)
• QIAGEN (The Netherlands)
• BD (U.S.)
• Cepheid (Danaher) (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• Abbott (U.S.)
• Hologic Inc. (U.S.)
• Quest Diagnostics (U.S.)
• IntelliGenome (U.S.)

KEY INDUSTRY DEVELOPMENTS

• April 2025:  Revvity received FDA approval for the Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test for latent tuberculosis to deliver accurate diagnostic results to support timely treatment and containment in the U.S.
• April 2024: QIAGEN launched QIAseq xHYB Mycobacterium tuberculosis Panel for research use, representing a major advancement in solving the problem of bacterial WGS from complex host samples, utilizing next-generation sequencing (NGS). This diversified the company’s product offerings with advanced tuberculosis (TB) diagnostic solutions and strengthened its position in the U.S. market.
• March 2024: QIAGEN partnered with the International Panel Physicians Association (IPPA) to support and educate panel physicians around the globe on the latest tuberculosis (TB) screening requirements. This focused on interferon gamma release assay (IGRA) requirements and the associated benefits for patients and healthcare providers.
• February 2023: F. Hoffmann-La Roche Ltd. expanded its collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to strengthen laboratory systems in the fight against the HIV and tuberculosis epidemics.
• March 2021: Revvity PerkinElmer, Inc. acquired Oxford Immunotec to add the latent tuberculosis diagnostic product, T-SPOT. TB Test, expanding its portfolio in the market.

REPORT COVERAGE

The report provides a detailed analysis of the market. It focuses on key aspects, such as leading companies, type, and end-users. It also offers insights into the latest market trends and information on key industry developments. Besides this, the report includes the epidemiology of tuberculosis, technological advancements in tuberculosis diagnostics, new product launches & approvals. Also, it provides information on the competitive landscape and company profiles of leading players.

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Report Scope & Segmentation