Latent Tuberculosis Infection Detection Market Size & Share Analysis - Growth Trends And Forecast (2025 - 2030)

Global Latent Tuberculosis Infection Detection Market Trends and Insights

Government-funded LTBI screening mandates

National and state agencies now require routine latent tuberculosis testing for healthcare workers, immunocompromised patients, and immigrants from high-burden regions. The 2024 CDC preventive-service update removed out-of-pocket costs for these tests under the Affordable Care Act, catalyzing stable demand. U.S. states such as Colorado and Rhode Island enforce annual screening rules, and California has rolled out statewide TB risk-assessment tools for hospitals.^{[1]Centers for Disease Control and Prevention, “Tuberculosis Preventive Service Coverage Tables,” cdc.gov} Comparable policies across the European Union provide a compliance-driven backbone, anchoring consistent test volumes that buffer the latent tuberculosis infection detection market from economic cycles. IGRAs benefit most, given their single-visit workflow and accuracy in BCG-vaccinated cohorts.

Expansion of migrant & refugee health programs

Continued geopolitical instability has heightened TB vigilance among asylum seekers. WHO guidance published in November 2024 recommends structured screening on arrival, prompting adoption of dual active-TB and latent-TB algorithms in Europe, Canada, and Australia.^{[2]World Health Organization, “WHO Releases New Report Addressing TB Among Refugees and Migrants,” who.int} ECDC data show Ukrainian refugees screened in 2023 presented TB notification rates of 16.9 per 100,000, more than double host-country averages.^{[3]European Centre for Disease Prevention and Control, “TB among Refugees from Ukraine in European Countries,” ecdc.europa.eu} South Korea’s pilot IGRA program in immigrants revealed latent infection incidence of 312.5 per 100,000 person-years among untreated IGRA-positive participants, reinforcing the importance of early detection. These findings are accelerating funding for portable IGRA analyzers at border clinics, contributing to latent tuberculosis infection detection market expansion.

Rising uptake of IGRAs in low-incidence countries

Low-incidence regions struggle with tuberculin skin-test false positives due to historic BCG vaccination. WHO’s 2024 diagnostic module recommends IGRAs in these contexts, leading to swift guideline updates across Western Europe and Japan. QIAGEN’s 24% revenue jump in its QuantiFERON franchise during 2023 illustrates practitioner preference for IGRA accuracy. EMA’s 2024 positive opinion on a recombinant ESAT-6/CFP-10 IGRA expands the product landscape, signaling further growth.

Bundled reimbursement for LTBI diagnostics

Payers increasingly bundle TB tests with related outpatient visits, protecting providers from piecemeal reimbursement risk. Updated Medicare guidance distinguishes between ELISA IGRA (CPT 86480) and T-cell enumeration assays (CPT 86481), clarifying payment for both formats. Medicaid covers TB-infected individuals for diagnostics under 42 CFR 435.215, ensuring continuity of testing once infection is confirmed. Such clarity encourages providers to incorporate the latest IGRA technology without financial uncertainty, fortifying the latent tuberculosis infection detection market.

Supply shortages of purified protein derivative antigens

Manufacturing bottlenecks periodically constrain tuberculin skin-test availability. Because many LMIC screening programs rely on skin tests for cost reasons, stockouts disrupt surveillance schedules, widen testing backlogs, and erode confidence in routine programs. While shortages often push stakeholders to evaluate IGRA alternatives, transition requires capital investment, creating interim gaps that temper latent tuberculosis infection detection market momentum.

High per-test IGRA cost in LMICs

IGRA reagents can cost up to 10 times more than tuberculin vials. When budgets are tight, public TB programs ration advanced assays to narrow cohorts, slowing widespread replacement of skin tests. External donor grants reduce the gap, yet many ministries of health still struggle to scale procurement, limiting the latent tuberculosis infection detection market in high-burden regions

Segment Analysis

By Test Method: IGRA Adoption Accelerates

In 2024 the tuberculin skin test retained 54.38% share of the latent tuberculosis infection detection market size, while IGRAs recorded a 9.46% CAGR that will steadily erode the dominance of skin testing. Cost-sensitive public programs continue purchasing skin-test kits, yet operational drawbacks—two-visit workflow and subjective reading—dampen their long-term utility. Developed nations, employer health plans, and immunology clinics increasingly select IGRAs for single-visit accuracy. The WHO 2024 diagnostic pathway places molecular rapid diagnostics at the head of the algorithm, a policy that indirectly favors IGRA confirmation after abnormal radiography.

The latent tuberculosis infection detection market now sees novel biomarker assays entering early commercial pilots. Recombinant antigen cocktails and host-RNA signatures seek to distinguish latent from active infection, a feature that could shorten clinical work-ups. Academic consortia testing T-cell metabolism panels report promising sensitivity, but regulatory approval timelines place widespread rollout beyond 2030.

Note: Segment shares of all individual segments available upon report purchase

By Sample Type: Blood-Based Testing Prevails

Blood draws accounted for 62.57% of the latent tuberculosis infection detection market share in 2024, and this format leads growth at 8.52% CAGR to 2030. Venous sampling supports automated IGRA workflows, allows simultaneous chemistry panels, and minimizes inter-reader variability. Rapid plasma separation and microfluidic cartridges now let health posts process samples on site, widening rural reach.

Skin-based tests linger in pediatric and field campaigns where phlebotomy is impractical. Researchers explore saliva and stool matrices to improve diagnosis in HIV-positive and very young cohorts. While early results are encouraging, validation cohorts remain small, keeping these alternatives a niche within the latent tuberculosis infection detection market.

By Technology Platform: Rapid Testing Gains Ground

ELISA IGRA analyzers held 47.59% of 2024 revenue, capitalizing on lab familiarity, high throughput, and mature quality-control frameworks. Point-of-care lateral-flow systems, however, are posting a 9.06% CAGR through 2030 as policymakers prioritize same-day diagnosis for mobile populations. Roche’s 2024 LumiraDx acquisition inserts a multinational into the handheld immunoassay race and validates investor confidence.

Chemiluminescence and fluorescence immunoassay platforms address hospitals that demand tighter analytical precision. AI integration now differentiates platform value; algorithm-guided result interpretation reduces human error and supports automatic electronic-health-record feeds, further streamlining latent tuberculosis infection detection market workflows.

Note: Segment shares of all individual segments available upon report purchase

By End-User: Laboratory Centralization Expands

Hospitals delivered 37.59% of latent tuberculosis infection detection market revenue in 2024 thanks to embedded occupational screening routines for staff and routine pre-surgical workups. Infection-control committees fund IGRA analyzers to comply with OSHA mandates, ensuring high baseline testing volumes.

Reference laboratories post an 8.42% CAGR as health systems outsource complex diagnostics. Central labs negotiate reagent discounts, run night-shift ELISA batches, and dispatch results by dawn, delivering economic scale unattainable for smaller hospitals. Public-health agencies, meanwhile, continue to procure skin-test kits for community drives, preserving a mixed-method environment within the latent tuberculosis infection detection market.

Geography Analysis

North America controlled 32.49% of latent tuberculosis infection detection market size in 2024, anchored by federal coverage mandates and OSHA compliance testing for healthcare workers. Private insurers uniformly reimburse IGRAs, driving a steady migration from tuberculin skin tests. Canada’s immigration physicals incorporate IGRA screening, further solidifying demand.

Asia-Pacific is forecast to expand at 7.52% CAGR through 2030 as India, China, and Indonesia invest in national TB elimination programs that integrate latent infection screening. South Korea’s immigrant IGRA pilot confirmed high reactivation risk, nudging regional policymakers toward widespread use of blood-based assays. Deployment of AI-enabled X-ray triage in rural clinics creates fresh referral flows, boosting latent tuberculosis infection detection market test volumes.

Europe maintains substantial share through structured migrant and refugee health checks. Systematic screening of Ukrainian arrivals recorded 1,247 TB cases in 2023, with latent infection detection rates of 16.9 per 100,000 among screened cohorts. Multi-country reimbursement alignment underlines stable procurement of IGRAs, sustaining marketplace resilience. The Middle East, Africa, and South America present long-term upside as economic growth funds laboratory upgrades, although budget constraints and intermittent reagent supply temper near-term latent tuberculosis infection detection market acceleration.