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Global Latent TB Infection Testing Market $1.8 Billion by 2029

The global market for latent TB infection testing expected to reach $1.8 billion by 2029, growing at a CAGR of 5.6% over the forecast period, driven by recent advances in development of new diagnostic methods, increasing TB detection rate, rising elderly population, and government support.

  • Other factors driving the market growth include increasing cases of HIV/AIDS patients, organ transplantation recipients, silicosis, close contacts, chronic renal failure with or without dialysis, fibronodular disease, immigrants and refugees from TB infected countries, diabetes mellitus, and others.
Global Latent TB Infection Testing Market

The World Health Organization (WHO) defines latent tuberculosis infection (LTBI) as a state of persistent immune response to stimulation by M. tuberculosis antigens without evidence of clinically manifested active tuberculosis (TB) disease, including the absence of clinical signs or symptoms and a normal chest radiograph.

  • According to recent WHO estimates, approximately one-quarter of the global population is infected with LTBI.
    • Preventing the progression of LTBI to active TB disease is an important public health goal that can substantially reduce TB transmission.
      • The duration of latency is variable, and healthy individuals can harbor LTBI for a lifetime. In a small fraction (~5% to 15%), reactivation occurs, often within the first 2 to 5 years following infection.
        • Reactivation is the process by which a subclinical latent infection transitions into active TB disease. Thus, individuals with LTBI represent a major reservoir for new active TB cases.

In 2018, the WHO reported that approximately 1.7 billion people, 23% of the world’s population, were estimated to have LTBI, and in a lifetime, approximately 8-10% of LTBI reactivates into active TB, with clinical manifestations and spread-potential.

  • The WHO guidelines on LTBI consider the probability of progression to active TB disease in a specific risk group, the epidemiology and burden of TB, the availability of resources and the likelihood of a broad public health impact.
    • Not all individuals infected with M. tuberculosis develop active TB. It is estimated that the lifetime risk of an individual with LTBI for progression to active TB is 5–10%.
      • It is estimated that the lifetime risk of an individual with LTBI for progression to active TB is 5–10%. The WHO End TB Strategy has set the goal to reduce TB incidence globally by 90% and TB deaths by 95% by 2035.

Diagnosis and treatment of latent tuberculosis infection is one of the strategies recommended by the WHO to control and eliminate tuberculosis (TB) disease worldwide, and is one of the elements of the WHO End TB Strategy.

  • With regard to acceptable methods of LTBI diagnosis, the WHO guidelines recommend that either a tuberculin skin test (TST) or an interferon-γ release assay (IGRA) should be used to detect LTBI in high-income and upper middle-income countries with estimated TB incidences <100 per 100,000 population (currently, 113 countries globally).
    • The TST is preferred and IGRA should not replace TST in low- and other middle-income countries where TB incidence is ⩾100 per 100,000 population. However, in light of logistic challenges associated with IGRA, WHO updated the recommendation in 2018, recognizing global shortage of TST, and now recommends both IGRA and TST in all the settings.

The global market for latent TB infection testing research report provides market size ($million 2017 to 2027), market volume (number of tests performed), market share analysis, growth trends and forecast (CAGR%, 2021 to 2027).

The global latent TB infection testing market segmented by test type [Mantoux test / tuberculin skin test, interferon-gamma release assay (QuantiFERON-TB test, T-SPOT.TB test, other tests)]; by risk factor [HIV/AIDS patients, organ transplantation recipients, silicosis, TNF-alpha blockers, close contacts (contact investigation), chronic renal failure +/- dialysis, fibronodular disease on chest X-ray, immigrants from high-TB-prevalence countries, diabetes mellitus, smoking, use of corticosteroids]; by end user (hospitals, laboratories, others), and geography.

  • In tuberculin skin test (TST), the purified protein derivate (PPD) is used as the antigen, and the cellular immunity to PPD antigens can reflect exposure to bacillus Calmette-Guérin (BCG) vaccine strains or non-tuberculous mycobacteria.
  • IGRAs are an ex vivo blood test, measuring the T-cell response after overnight stimulation with antigens specific for M. tuberculosis complex.
    • These antigens are more specific for M. tuberculosis than PPD and are not produced by BCG strains, and thus, IGRA results are not impacted by prior BCG vaccination.
  • IGRAs have higher specificity than tuberculin skin testing, are less likely than TSTs to cross-react with the BCG vaccine, and correlate well with M. tuberculosis exposure, though stronger association with progression to active disease has not been conclusive.
    • Interferon-gamma release assays including QuantiFERON-TB Gold In Tube and T-SPOT.TB are immunological tests that are widely used to detect LTBI in high-income settings.
  • The TST and the IGRA are currently used to establish the diagnosis of LTB. However, neither TST nor IGRA is useful to discriminate between active and latent tuberculosis. Moreover, these tests cannot be used to predict whether an individual with LTBI will develop active tuberculosis (TB) or whether therapy for LTBI could be effective to decrease the risk of developing active TB.
    • Therefore, new approached involving immunological markers could be useful in distinguishing LTBI from TB and in evaluating the effectiveness of treatment of LTB on the risk of progression to active TB.
      • For example, in vitro models of latency combined with genome-wide transcriptome profiling have identified genes that remain upregulated during LTBI and code for proteins known as latency antigens.
  • The high-risk factors group (HIV/AIDS patients, organ transplantation recipients, silicosis, patients treated with immunosuppressive drugs such as anti TNF alpha drugs, close contacts or contact investigations, patients suffering from chronic renal failure with or without dialysis treatment) dominated the global latent tuberculosis diagnostics market, followed by moderate-risk factor and low-risk factor segments.
    • It has been estimated that, one in three people globally is latently infected with TB and that they have a 5-10% lifetime risk of progressing from LTBI to active TB disease.
      • WHO recommends to investigate and treat at risk groups for LTBI in high-income and upper middle-income countries with a TB incidence less than 100 per 100,000 population.
        • Growing urbanization, explosive economic growth, and aggressive medical treatment in developing countries have led to a surge in altered immunologic states and diseases that multiply TB reactivation risk.
  • In the general population, the lifetime risk of progression from LTBI to active disease is about 5% to 10%; with HIV co-infection, this rises to 30% (annual risk, 10%).
    • In addition, organ transplanted patients using immunosuppressive medication, and contacts of TB cases appear to have both a higher risk of TB infection and a higher risk of progression to active TB due to recent infection.

The global market for latent TB infection research report is further segmented by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World.

  • In countries with high TB prevalence, the majority of the population receive the BCG vaccine; therefore, IGRAs are a more useful LTBI diagnostic tool in these clinical settings. IGRAs are expensive to implement at scale in low-resource settings.
  • On the other hand, in countries with low-resource settings, the century-old TST, using purified protein derivative (PPD) as the antigen, continues to be the mainstay of LTBI screening and, thus, the main driver of LTBI therapy.
    • The TST has several advantages in low-resource settings, including low reagent cost, no equipment costs, limited skill requirement and no requirement for laboratories. However, TST does suffer from two major limitations.
      • First, the specificity of PPD-based TST is compromised by late (i.e. post-infancy) or repeated BCG vaccination (i.e. booster vaccinations), and, to a limited extent, by exposure to non-tuberculous mycobacteria.
      • The second limitation is the limited predictive value for TB disease. In other words, a majority of individuals with positive TST results do not progress to active TB disease.
  • While IGRAs are recommended for the diagnosis of LTBI in many high-income countries, they are not recommended by the WHO as a TST replacement for LTBI diagnosis in low- and middle- income countries. Previously, in light of logistic challenges associated with IGRA, WHO did not recommend its use in low- and middle-income countries. However, WHO updated the recommendation in 2018, recognizing global shortage of TST, and now recommends both IGRA and TST in all settings.
    • Furthermore, in no setting are IGRAs recommended for detection of active pulmonary TB, since IGRAs (like TST) cannot differentiate latent infection from active TB disease.
    • In case of high-burden settings, where 40% or more of the general population is latently infected with TB and therefore likely to test IGRA-positive (i.e., a test that is positive among all people with latent TB is likely to have a specificity of 60% or less when used for active TB), use of IGRAs to diagnose active pulmonary TB is particularly problematic.
      • This concern equally applies to the use of tuberculin skin test (TST) for active TB. Nevertheless, in many high-burden countries, there is growing concern that IGRAs (and, to a lesser extent, TST) are being used off-label, particularly in the private sector, for the diagnosis of active TB.
    • TB IGRA testing now accessible in high burden, low resource and decentralized settings.
      • For example, in 2021, QIAGEN launched and CE marking of QIAreach QuantiFERON-TB test for tuberculosis (TB) infection, in order to help achieve global TB elimination targets by increasing access to easy and reliable TB testing, especially in high burden countries, low-resource regions.
        • QIAreach QuantiFERON-TB is a portable device that enables the ultrasensitive digital detection of TB infection with an end-to-end workflow that is simple and cost efficient, and increases access to reliable Interferon Gamma Release Assay (IGRA) testing.
    • The US CDC now recommends TB blood tests for the majority of the US testing population. Doctors and hospitals trust to provide accurate, cost-effective testing in a single patient visit.
      • In addition, the healthcare providers are at increased risk for TB, and CDC has released updated tuberculosis testing guidelines for healthcare providers (HCPs) in the US. These updated tuberculosis testing guidelines have changed the way hospitals screen their patients and employees for TB. The occupational health setting carries unique risks for TB infection and latent TB reactivation.
        • National guidelines from the US Preventive Services Task Force (USPSTF) now recommend the screening of all persons entering congregate settings for latent TB infection (LTBI). Healthcare providers (HCPs) are also at an increased risk for TB and can benefit from systematic LTBI screening.
          • Moreover, the CDC and the American College Health Association (ACHA) now recommend targeted proactive testing and treatment for latent TB infection among college and university students.

The global market research report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.

Major players operating in the global latent TB infection testing market for Mantoux test (tuberculin skin test) and profiled in this report include Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., Endo International plc (Par Sterile Products, LLC/JHP Pharmaceuticals, LLC), Pharmstandard (Generium Pharmaceutical), Sanofi S.A./Sanofi Pasteur Ltd., Serum Institute of India Pvt. Ltd. (SIIPL), and Statens Serum Institut (SSI).

Major competitors operating in the global latent TB infection testing market for interferon-gamma release assays (IGRAs) and profiled in this report include Autoimmun Diagnostika (AID) GmbH, bioMérieux S.A., Boditech Med., Inc., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd., Erythra, Inc., Glory Biotechnologies Corp., Haikou VTI Biological Institute (Vaccine Technologies, Inc.), Immunoshop India Pvt. Ltd., LG Chem, Lionex Diagnostics & Therapeutics GmbH, Qiagen N.V., Quest Diagnostics, Inc. (U.S. Laboratory Services – Oxford Immunotec), PerkinElmer, Inc. (Oxford Immunotec Global plc), SD Biosensor, Inc. and R-Biopharm AG.

  • Test Type
    • Mantoux Test / Tuberculin Skin Test (TST)
    • Interferon-Gamma Release Assay (IGRA)
      • QuantiFERON-TB Test
      • T-SPOT.TB Test
      • Others
  • Risk Factor
    • HIV/AIDS Patients
    • Organ Transplantation Recipients
    • Silicosis
    • TNF-alpha Blockers
    • Close Contacts (Contact Investigation)
    • Chronic Renal Failure +/- Dialysis
    • Fibronodular Disease on Chest X-ray
    • Immigrants from High-TB-Prevalence Countries
    • Diabetes Mellitus
    • Smoking
    • Use of Corticosteroids
  • End User (Testing Location)
    • Hospitals
    • Laboratories
    • Others
  • Geography
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • Mantoux Test (Tuberculin Skin Test)
      • Anhui Zhifei Longcom Biopharmaceutical Co., Ltd.
      • Endo International plc (Par Sterile Products, LLC/JHP Pharmaceuticals, LLC)
      • Pharmstandard (Generium Pharmaceutical)
      • Sanofi S.A./Sanofi Pasteur Ltd.
      • Serum Institute of India Pvt. Ltd. (SIIPL)
      • Statens Serum Institut (SSI)
    • Interferon-gamma release assays (IGRAs)
      • Autoimmun Diagnostika (AID) GmbH
      • bioMérieux S.A.
      • Boditech Med., Inc.
      • Beijing Wantai Biological Pharmacy Enterprise Co. Ltd.
      • Erythra, Inc.
      • Glory Biotechnologies Corp.
      • Haikou VTI Biological Institute (Vaccine Technologies, Inc.)
      • Immunoshop India Pvt. Ltd.
      • LG Chem
      • Lionex Diagnostics & Therapeutics GmbH
      • Qiagen N.V.
      • Quest Diagnostics, Inc. (U.S. Laboratory Services – Oxford Immunotec)
      • PerkinElmer, Inc. (Oxford Immunotec Global plc)
      • SD Biosensor, Inc.
      • R-Biopharm AG

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