Latent Tuberculosis Infection Detection Market Size Analysis:

The latent Tuberculosis Infection Detection Market size was valued at USD 1.65 billion in 2023 and is expected to reach USD 2.71 billion by 2032, growing at a CAGR of 5.72% from 2024-2032.

The Latent Tuberculosis Infection (LTBI) Detection Market report provides distinctive insights through the analysis of incidence and prevalence trends in major regions, pointing out differences in disease burden between various groups. It looks at diagnostic testing trends, contrasting the adoption rates of Interferon-Gamma Release Assays (IGRAs) and Tuberculin Skin Tests (TSTs) and evaluating regulatory policies and screening procedures. In addition, the report also includes test volume and adoption rates (2020-2032) that are based on the technological advancements in TB diagnostics. In addition, the report includes a comprehensive analysis of healthcare expenditure with a breakdown of government funding, reimbursement models, and out-of-pocket spending, giving an all-around view of financial investments in LTBI detection globally.

The U.S. Latent Tuberculosis Infection Detection Market size was USD 1.13 billion in 2023 and is expected to reach USD 1.86 billion by 2032, growing at a CAGR of 5.76% over the forecast period of 2024-2032.

The market is driven by rising awareness about tuberculosis screening, government initiatives for early detection, and increased testing among high-risk populations. Advances in diagnostic techniques, such as interferon-gamma release assays (IGRAs) and tuberculin skin tests (TSTs), are improving detection accuracy. Additionally, the growing focus on preventive healthcare and the need to control TB transmission are boosting the demand for latent TB infection detection services.

Latent Tuberculosis Infection Detection Market Dynamics

Drivers

• The increasing global prevalence of tuberculosis (TB) is a key driver of the latent tuberculosis infection (LTBI) detection market.

The growing worldwide burden of tuberculosis (TB) is one of the major drivers for the latent tuberculosis infection (LTBI) detection market. An estimated 1.7 billion people, or 23% of the world's population, have latent TB infection, according to the World Health Organization (WHO). Such individuals carry a 5–10% lifetime risk of progressing to active TB, highlighting the importance of early detection. Governments and healthcare agencies are giving high priority to screening programs, especially among high-risk groups, including immunocompromised patients and healthcare professionals. In 2023, the U.S. CDC extended its TB Elimination Program, allocating more funds for LTBI screening in high-risk groups. WHO's End TB Strategy also seeks to decrease TB deaths by 90% by 2030, further driving demand for sophisticated diagnostic equipment, including interferon-gamma release assays (IGRAs) and tuberculin skin tests (TSTs).

• Technological advancements in tuberculosis diagnostics are driving the adoption of highly specific and efficient tests for LTBI detection.

Advances in tuberculosis diagnostic technology are propelling the use of highly sensitive and effective tests for LTBI screening. Interferon-gamma release assays (IGRAs) like QuantiFERON-TB Gold Plus and T-SPOT.TB has gained considerable popularity as a result of its superior accuracy compared to the older tuberculin skin tests (TSTs). In 2023, Qiagen introduced the QIAreach QuantiFERON-TB test, providing a quick and digital method of LTBI screening. Likewise, Cepheid's Xpert MTB/RIF Ultra further enhances TB detection with increased sensitivity. With mounting usage in high-income countries and WHO recommendations for preferential use of IGRAs in high-income countries, the market is witnessing a transition to automated and laboratory-free detection. These developments, coupled with rising investments in TB diagnostics, are boosting early detection and treatment and decreasing the likelihood of active TB formation.  

Restraint

• High Cost and Limited Accessibility of Advanced Diagnostic Tests restraining the market from growing.

One of the major constraints in the Latent Tuberculosis Infection (LTBI) Detection Market is the high cost and limited accessibility of modern diagnostic tests, particularly in low- and middle-income nations (LMICs) with the highest TB burden. Interferon-gamma release assays (IGRAs), including QuantiFERON-TB Gold Plus and T-SPOT.TB has higher accuracy compared to tuberculin skin tests (TSTs) but is much more expensive. WHO states that the price of IGRAs is as much as 10 times higher than that of TSTs, which poses a challenge to their large-scale implementation. Moreover, the tests need specialized laboratory facilities and trained staff, which restricts their use in resource-limited environments. In 2023, WHO highlighted the importance of cost-effective and decentralized TB diagnostic technologies to enhance global access. Lacking affordable options, gaps in the detection and treatment of LTBI persist to counteract efforts to eliminate TB worldwide.

Opportunities

• Expansion of Point-of-Care (POC) Testing for LTBI creates the opportunity for market growth.

One of the most important opportunities in the Latent Tuberculosis Infection (LTBI) Detection Market is the growth of point-of-care (POC) testing solutions that can enhance early diagnosis and access to treatment. Conventional LTBI tests, e.g., tuberculin skin tests (TSTs) and interferon-gamma release assays (IGRAs), are usually performed in a laboratory setting using skilled labor, which restricts their use in resource-constrained areas. A rapid, easy-to-use, and portable diagnostic device can fill this gap. In 2023, WHO and prominent diagnostic firms highlighted the necessity of decentralized TB screening products, especially in high-burden areas. Upcoming technologies such as AI-based lateral flow assays and microfluidic devices provide real-time TB detection, enhancing early intervention efforts. As more investment goes into POC testing, market participants have a considerable chance to drive global TB control efforts while resolving testing constraints in low-resource environments.

Challenges

• A significant challenge in the Latent Tuberculosis Infection (LTBI) Detection Market is the variability in diagnostic accuracy across different test types, leading to inconsistent detection rates.

One major issue with the Latent Tuberculosis Infection (LTBI) Detection Market is the test variability in accuracy among test types, which results in variable detection rates. Tuberculin skin tests (TSTs), though popular, suffer from false positives as a result of cross-reactivity with the BCG vaccine and environmental mycobacteria. On the other hand, interferon-gamma release assays (IGRAs) offer more specificity but can still give false negatives in immunocompromised individuals, including those with HIV. Evidence has demonstrated IGRA sensitivity from 75% to 95%, varying by patient population and infection stage. This variability impacts treatment and TB control. In 2023, scientists advocated for the creation of next-generation biomarkers and AI-based diagnostic devices to make LTBI testing more reliable. Solving this challenge is essential for achieving accurate and widespread TB detection.

Latent Tuberculosis Infection Detection Market Segmentation Analysis

By Brand

The Others segment dominated the latent tuberculosis infection (LTBI) detection market with a 75.26% market share in 2023 as various regional and up-and-coming brands have affordable and wide-ranging TB testing solutions. Though there are dominant brands such as QFT-Plus that are well known, various alternative tests like local IGRA-based tests, tuberculin skin tests (TSTs), and ELISA-based diagnostic kits support notable market share. Most of the developing world, especially in Asia Pacific and Africa, depends on cost-effective, locally produced LTBI screening kits, which are cost-saving for mass screening programs. Apart from that, the presence of government-sponsored TB screening programs using a range of diagnostic equipment other than QuantiFERON-TB Gold Plus also supported the Other segment's growth in 2023. The need for cost-effective measures and the increasing use of bespoke TB detection assays designed for various population requirements reinforced this segment's supremacy.

The QFT-Plus (QuantiFERON-TB Gold Plus) segment is anticipated to experience the fastest growth in the forecast period with its high accuracy, enhanced sensitivity, and rising adoption among healthcare professionals globally. In contrast to conventional tuberculin skin tests, QFT-Plus does not involve subjective interpretation and cross-reactivity, thus being the first choice in high-income nations and growing in emerging nations. The automated processing of the test aligns with the increasing trend toward laboratory-based high-throughput diagnostics, which is accelerating adoption further. Furthermore, in 2023, the U.S. CDC advised the use of IGRA-based tests such as QFT-Plus over TST for TB screening programs, which resulted in market expansion. Government-sponsored screening programs, especially in North America and Europe, and investments by the private sector in sophisticated LTBI diagnostics are anticipated to drive demand, making QFT-Plus the fastest-growing brand in the next few years.

By Test Type

The Tuberculin Skin Test (TST) segment dominated the latent tuberculosis infection detection market with a 71.06% market share in 2023 mostly on account of its extensive accessibility, affordability, and long history in TB screening interventions globally. Since it is an age-old technology for detecting LTBI, TST finds maximum application in low- and middle-income nations (LMICs) where convenience and cost considerations are top concerns. The World Health Organization (WHO) and some national TB programs still support the use of TST for mass screenings, particularly in resource-poor settings where more sophisticated tests such as Interferon Gamma Release Assays (IGRAs) are still expensive and less available. In addition, mass TB screening campaigns, especially in high-prevalence areas such as Asia Pacific and Africa, depend heavily on TST because of its ease of use, low requirement for laboratory facilities, and regulatory approvals in multiple healthcare environments.

In 2023, sustained uptake of TST in school-based and workplace health screening programs, especially among nations with high TB prevalence, solidified its market leadership. Further, public health policy support for the mass detection of TB and latent infection control helped maintain TST's strong market dominance. Even improved IGRA-based tests, affordability, universal clinician recognition, and sustained improvements in pediatric and high-risk population screenings have secured TST's position as the most prevalent type of test in LTBI detection.

By Application

The People Living with HIV (PLHIV) segment dominated the latent tuberculosis infection detection market with a 43.21% market share in 2023 because of the high risk of co-infection with TB in immunocompromised patients. The World Health Organization reports that individuals with HIV are 18 times more prone to developing active tuberculosis than those without HIV. Consequently, regular LTBI screening and preventive treatment have become a worldwide priority in HIV care programs, especially in countries with high TB burdens. Governments and health organizations, such as UNAIDS and the Global Fund, have prioritized early detection of TB among PLHIV as part of integrated care programs, resulting in greater use of tuberculin skin tests (TST) and interferon-gamma release assays (IGRAs) among this group.

In 2023, large-scale healthcare initiatives in countries like Sub-Saharan Africa, Asia Pacific, and Latin America, with the highest prevalence of HIV and TB co-infection, were a key driver behind the high demand for LTBI testing among PLHIV. Additionally, WHO's End TB Strategy and national protocols in several countries have made systematic LTBI screening a requirement for all newly identified HIV patients, further contributing to this segment's dominance. The presence of funding support, increased access to TB preventive therapy (TPT), and improvements in rapid LTBI testing specifically for HIV-infected patients have also contributed significantly to the PLHIV segment's market dominance.

By End-Use

The Diagnostic Laboratories segment dominated the market with a 55.42% market share in 2023 because of the large number of LTBI tests performed in laboratory settings. They have advanced testing capabilities, such as Interferon Gamma Release Assays (IGRAs) and molecular diagnostic methods, that are more precise and time-saving compared to older Tuberculin Skin Tests (TSTs). Besides, the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) encourage laboratory-based testing for LTBI, especially for high-risk individuals, including healthcare professionals, immunocompromised patients, and individuals in close contact with persons who have tested positive for TB. This has fueled the interest in centralized and high-throughput testing facilities provided by diagnostic labs.

Latent Tuberculosis Infection Detection Market Regional Insights

Asia Pacific dominated the latent tuberculosis infection (LTBI) detection market with a 43.12% market share in 2023 based on its TB burden, government-initiated screening programs, and rising healthcare expenditures. As per the WHO, close to 60% of all global TB cases are in Asia, and India, China, Indonesia, and the Philippines are some of the worst-affected nations. The region's high rate of TB has triggered intensive screening and detection efforts, such as large-scale latent TB infection testing drives. In 2023, India's National TB Elimination Program (NTEP) increased IGRA-based testing, increasing early detection rates.

Further, China's TB prevention policy incorporates AI-enabled diagnostic tools and molecular testing for better detection precision. Global alliances, like that of Japan and the Stop TB Partnership, add to diagnostic efficiency. Additionally, the growing affordability of TB tests and increased awareness regarding latent TB treatment among high-risk groups, such as diabetics and immunocompromised patients, also propel the market. With expanding healthcare infrastructure and ongoing investments in sophisticated TB detection technologies, Asia Pacific continues to be the largest contributor to the LTBI detection market.

Latent Tuberculosis Infection Detection Market Key Players

• Qiagen N.V. (QuantiFERON-TB Gold Plus, QuantiFERON-TB Gold In-Tube)

• F. Hoffmann-La Roche Ltd. (COBAS TaqMan MTB Test, COBAS Amplicor MTB Test)

• Abbott Laboratories (Abbott RealTime MTB Assay, m2000 RealTime System)

• Thermo Fisher Scientific Inc. (TaqMan TB Detection Kit, ProFlex PCR System)

• BD (Becton, Dickinson and Company) (BD BACTEC MGIT 960 System, BD MAX MDR-TB Assay)

• bioMérieux SA (VIDAS TB-IGRA, BACT/ALERT 3D System)

• Danaher Corporation (Cepheid Xpert MTB/RIF Assay, GeneXpert System)

• Hologic, Inc. (APTIMA MTB Assay, Panther System)

• Siemens Healthineers (VERSANT TB Molecular Assay, ADVIA Centaur TB Test)

• PerkinElmer Inc. (ELISA-based TB Detection Kit, Chemagic 360 Instrument)

• Luminex Corporation (ARIES MTB Assay, xMAP Technology)

• Bio-Rad Laboratories, Inc. (TB Ag ELISA Test, CFX96 Touch Real-Time PCR)

• Oxford Immunotec Ltd. (T-SPOT.TB Test, T-Cell Xtend Reagent)

• DiaSorin S.p.A. (LIAISON TB Assay, LIAISON XL Analyzer)

• Eiken Chemical Co., Ltd. (Loopamp MTBC Detection Kit, Loopamp PURE DNA Extraction Kit)

• Fujifilm Holdings Corporation (DRI-CHEM Immunoassay System, TB LAM Ag Detection Kit)

• Hain Lifescience GmbH (GenoType MTBDRplus Assay, FluoroType MTB Assay)

• Lionex GmbH (LIOFeron TB/LTBI Assay, LIOFeron TB/LTBI ELISA)

• Creative Diagnostics (TB IgG/IgM Rapid Test, TB ELISA Kit)

• ZeptoMetrix Corporation (Mycobacterium tuberculosis Controls, NATtrol TB Verification Panel)

Suppliers (These suppliers provide critical materials such as enzymes, reagents, primers, probes, and other molecular biology components essential for the development and production of latent tuberculosis infection detection assays.) in the Latent Tuberculosis Infection Detection Market.

• Thermo Fisher Scientific Inc.

• Sigma-Aldrich (Merck KGaA)

• Roche Diagnostics

• Qiagen N.V.

• Bio-Rad Laboratories, Inc.

• PerkinElmer Inc.

• Integrated DNA Technologies, Inc.

• New England Biolabs, Inc.

• Promega Corporation

• Takara Bio Inc.

Recent Development in the Latent Tuberculosis Infection Detection Market

• April 2024 – QIAGEN N.V. Frankfurt Prime Standard: QIA) today announced the introduction of the QIAseq xHYB Mycobacterium tuberculosis Panel, a research-use-only system to help facilitate tuberculosis (TB) detection and research. The new panel will contribute to initiatives in the global fight against TB, which remains the globe's top infectious disease killer.

• September 2023 – Danaher Corporation has committed to increase global accessibility of TB testing by providing Cepheid's Xpert MTB/RIF Ultra diagnostic test cartridges for USD 7.97 per cartridge. These will be available to the Global Fund to Fight AIDS, TB, and Malaria and low-income countries eligible through Cepheid's Global Access Program, expanding access to high-quality TB diagnostics.