Latent TB Testing Market - Global Forecast 2025-2030

The Latent TB Testing Market size was estimated at USD 1.29 billion in 2024 and expected to reach USD 1.36 billion in 2025, at a CAGR 5.70% to reach USD 1.80 billion by 2030.

The burden of latent tuberculosis infection (LTBI) remains a critical public health challenge both globally and within the United States. According to the World Health Organization’s 2024 report, approximately 10.8 million people were newly diagnosed with active TB, with latent infections serving as the reservoir of future disease cases worldwide. In the United States, the Centers for Disease Control and Prevention estimates that up to 13 million individuals harbor latent TB infection, underscoring the persistent gap in identifying and treating this hidden cohort. Without timely detection and intervention, these untreated infections pose a risk of progressing to active TB disease, contributing to both community transmission and individual morbidity.

Over the past decade, the landscape of latent TB diagnostics has undergone seismic shifts driven by both technological advances and evolving clinical guidelines. Traditional tuberculin skin testing, while historically indispensable, has increasingly given way to more specific blood-based interferon-gamma release assays (IGRAs), a transition catalyzed by new evidence and regulatory endorsements. In late 2024, the U.S. Food and Drug Administration granted approval for the fourth-generation QuantiFERON-TB Gold Plus test, cementing its status as a benchmark for accuracy in latent infection detection. Parallel to this, the T-SPOT.TB assay developed by Oxford Immunotec has gained traction in the United States and Europe, appreciated for its rapid turnaround and robust specificity unaffected by prior BCG vaccination.

In 2025, the U.S. Trade Representative’s reinstatement and expansion of Section 301 tariffs has placed a renewed focus on the vulnerability of medical supply chains. Consumable components critical to latent TB testing-such as syringes, needles, blood collection tubes, and immunoassay reagents-now face duties ranging from 25% to 100% when imported from China, Canada, or Mexico, as detailed by the USTR tariff schedules released in late 2024. These measures have accelerated cost pressures for diagnostic laboratories, compelling many to reassess procurement strategies and consider alternative sourcing routes.

A nuanced understanding of market segmentation reveals the intricate interplay between product portfolios, test modalities, and end-user requirements. Instruments, kits, and reagents form the foundational product typology, each tailored to facilitate specific assay workflows and throughput demands. At the core of diagnostic diversity lie two principal test types: interferon-gamma release assays and tuberculin skin tests. The former encompasses chemiluminescence-based platforms and ELISA methodologies to quantify antigen-stimulated immune responses, while the latter features both intradermal administration and multipuncture techniques to elicit delayed-type hypersensitivity reactions. Within this framework, sample matrices such as blood, plasma, and serum cater to varied laboratory settings and processing capacities.

Application insights indicate that diagnostic testing remains the foremost use case, supported by burgeoning research initiatives in both new assay development and vaccine innovation. Screening practices, driven by health check-up protocols and immigration health requirements, further underscore the societal imperative for broad-scale detection programs. Diverse end users-including diagnostic centers, hospital laboratories, public health departments, and research institutes-navigate this segmented ecosystem through channels that range from direct sales partnerships to third-party distribution networks, reflecting the multifaceted pathways through which latent TB diagnostic solutions reach the field.

Regional dynamics cast a defining light on the contours of latent TB testing adoption and resource allocation. In the Americas, the United States leads public health efforts with voluntary reporting frameworks and targeted NHANES-derived prevalence estimates, yet continues to wrestle with an estimated 13 million latent TB cases and a resurgence of active TB rates post-pandemic. Conversely, in Europe, the Middle East & Africa, latent TB testing expansion has been uneven: wealthier Western European nations leverage established IGRA platforms, while high-burden countries in Eastern Europe and parts of North Africa face infrastructure constraints and funding gaps. Meanwhile, across the Asia-Pacific region, where countries like India, Indonesia, China, the Philippines, and Pakistan collectively account for the majority of global TB incidence, robust screening campaigns and donor-backed programs have galvanized widespread IGRA deployment despite ongoing challenges in rural access and laboratory capacity.

The competitive terrain of latent TB diagnostics is anchored by a handful of specialized developers and global diagnostics firms. QIAGEN’s QuantiFERON-TB Gold Plus stands out for its dual-antigen stimulation design and capacity to discern CD4 and CD8 T-cell responses, features that were underscored in its U.S. FDA approval announcement and supported by a robust clinical evidence base exceeding 800 peer-reviewed studies. Oxford Immunotec’s T-SPOT.TB assay, relying on ELISpot technology to quantify antigen-specific effector T cells, has similarly cemented its role in settings where rapid turnaround and high specificity are paramount. Beyond these, select instrument manufacturers and reagent suppliers continue to introduce automation-friendly formats and integrated software solutions to streamline laboratory workflows, collectively advancing the precision and scalability of latent TB testing worldwide.

Industry leaders should prioritize a multidimensional strategy that balances technological innovation with supply chain resilience. Embracing automated IGRA platforms not only enhances throughput and reduces variability but also mitigates labor shortages by simplifying hands-on steps. At the same time, diversifying supplier portfolios-especially for critical consumables subject to Section 301 tariffs-can cushion laboratories against abrupt cost increases and geopolitical disruptions. Strategic partnerships with regional distributors and public health agencies will further accelerate access to underserved markets, while investment in mobile testing units and point-of-care adaptations can extend diagnostic reach into marginalized communities. Moreover, proactive engagement with regulatory bodies to seek tariff exemptions for life-saving diagnostic tools and participation in collaborative procurement consortia can help align industry interests with broader public health imperatives.

This market research leverages a rigorous dual-pillar approach combining extensive secondary data review and targeted primary research. Secondary intelligence was drawn from public health agency reports, regulatory filings, peer-reviewed journals, and tariff documentation to establish a foundational understanding of the diagnostic landscape. Complementing this, a series of in-depth interviews with thought leaders, laboratory directors, and procurement specialists provided qualitative insights into emerging adoption barriers and innovation drivers. Data triangulation techniques were applied to reconcile divergent sources, while thematic analysis identified recurring trends across geographies and end-user segments. The resulting framework was validated through expert workshops to ensure both the relevance and accuracy of the findings. This methodology underpins an authoritative and transparent view of the latent TB testing domain, equipping stakeholders with confidence in the report’s conclusions.

In facing the persistent challenge of latent tuberculosis infection, the convergence of advanced diagnostic assays, strategic supply chain adaptations, and region-specific outreach initiatives offers a path forward. The transition from traditional skin testing to sophisticated IGRA platforms has heightened both clinical accuracy and operational efficiency, yet cost pressures and logistical constraints underscore the need for agile procurement models. Regional insights reveal that while high-income settings continue to lead in technology adoption, high-burden regions are driving scale through donor partnerships and innovative field deployments. Ultimately, closing the gap in latent TB detection requires coordinated efforts across industry, public health institutions, and policy makers-aligned around concepts of affordability, accessibility, and quality. By integrating cutting-edge science with pragmatic market strategies, stakeholders can collectively advance toward the global goal of TB elimination.

To take the next step toward strengthening your strategic planning and operational execution in the latent TB testing space, reach out directly to Ketan Rohom, Associate Director of Sales & Marketing. Ketan can provide you with tailored guidance on how the comprehensive market research report can address your specific needs, whether you are evaluating new product launches, seeking to optimize supply chain resilience, or exploring collaborative partnerships. Engaging with Ketan will grant you access to deeper data layers, bespoke regional insights, and expert-driven analysis designed to inform high-stakes decision-making. Don’t miss this opportunity to leverage the report’s actionable intelligence and position your organization at the forefront of latent tuberculosis diagnostic innovation. Connect with Ketan today to secure your copy of the market research report and chart a course toward sustained market leadership.