Latent Tuberculosis Infection Detection Market Size, Share & Trends Analysis Report By Brand (QFT-Plus), By Test Type, By Application, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global latent tuberculosis infection detection market size was estimated at USD 1.75 billion in 2023 and is projected to grow at a CAGR of 5.44% from 2024 to 2030. The growth of the market is attributed to the increasing risk of developing active tuberculosis and the growing awareness among people to diagnose tuberculosis infection at an early stage. Moreover, ongoing government initiatives to combat the threat of tuberculosis and the increasing introduction of novel diagnostic solutions are anticipated to fuel the Latent Tuberculosis Infection (LTBI) detection market growth.

Individuals with LTBI face a lifetime risk of reactivation, which is expected to be around 5% to 15%, with the majority of the population developing TB within the first five years. For those with LTBI, the absence of treatment for both LTBI and HIV infection can lead to a high reactivation risk of about 7%-10% annually, emphasizing the importance of timely intervention. In addition, most TB cases in the U.S. result from the progression of LTBI acquired over two years prior, highlighting the significance of addressing LTBI to prevent future cases.

Increasing funding for TB diagnosis programs is crucial in the fight against this global disease. The current funding for prevention, diagnosis, and treatment is insufficient to meet the demand, hindering progress in reducing incidence and mortality rates. For instance, an annual investment of USD 22 billion by 2027 was set, with an additional USD 5 billion for research, and only USD 5.8 billion was allocated for TB services, falling short of the required amounts to achieve global targets. Moreover, WHO emphasizes the need for sustained & increased funding to combat TB effectively.

Hence, the U.S. government has significantly increased its funding for TB initiatives, from USD 233 million in 2013 to USD 406 million in 2023. Investments in screening and preventive treatment have shown significant health & economic benefits, with a return on investment of up to USD 39 for every dollar spent. Hence, expanding investments in TB diagnosis programs is essential to improve access to diagnosis, treatment, and prevention to eliminate the TB epidemic by 2030. Moreover, the Global Fund contributes 76% of total international funding for TB, having allocated USD 9.2 billion toward prevention & treatment programs and an extra USD 1.5 billion for TB/HIV initiatives by June 2023. In countries receiving support from the Global Fund, TB-related fatalities have decreased by 36% from 2002 to 2022.

Moreover, the increasing number of elderly individuals worldwide poses a major hurdle in the control of TB within this age group. The rates of TB case detection & incidence are particularly high among older adults, emphasizing the importance of incorporating specific measures in TB response strategies to address their increased risk. In the Western Pacific, where the population is aging rapidly, there has been a notable increase in TB cases among older individuals, propelling the need for customized approaches to diagnosis, treatment, and care for this vulnerable demographic. This is expected to improve the need for the development of effective & efficient diagnostics to meet the rising demand for management among the older population.

However, the regulatory framework for approvals poses major restraints on the growth rate of the pharmaceutical, biotechnology, and medical technology industries. Globally, usage & safety profiles of diagnostic tests vary and are evaluated by health regulatory agencies of each country differently. This makes the approval of novel products slower.

Market Concentration & Characteristics

The degree of innovation is high in the market characterized by a growing level of research and development. Advances in diagnostic technologies, such as IGRAs, are improving the accuracy and efficiency of LTBI diagnosis. These advancements create opportunities for companies to develop and market innovative diagnostic solutions.

The level of merger and acquisition activities in the market is very low. The majority of players are focusing on partnerships and collaboration to enhance their global presence and gain product advantage.

The regulatory framework for product approvals has always been one of the major restraining factors in the pharmaceutical, biotechnology, and medical technology industries. Approval decisions for novel products vary on a case-to-case basis in every country, which may hinder market growth. Unclear regulatory frameworks/guidelines for diagnostics in developing economies might restrain market growth.

The level of substitution is generally low for the market. LTBI diagnostics have no significant external substitutes. However, any technological advancements in diagnostic tests that offer more efficient screening methods and deliver more accurate & faster test results prove to be an internal substitute.

The end-use concentration of LTBI detection tests is majorly in diagnostics laboratories. Diagnostic laboratories are focusing on providing newer blood tests for the screening or detection of LTBIs. For instance, independent laboratories such as Dynacare and Life Labs provide tests, such as QuantiFERON-TB blood tests and T-SPOT.TB tests, for the detection of LTBI at comparatively lower prices.

Brand Insights

Others brand segment led the market in 2023 and accounted for 76.15% of the global revenue in 2023. A total of 13 TB detection in vitro tests are currently in the pipeline or commercialized but are not endorsed by the WHO. Twelve of these tests are whole-blood interferon-gamma release assays (IGRAs), while the GBTsol Latent TB Test Kit utilizes a novel patented technology, which will be described later. In addition, five new skin tests are also in the pipeline. Among the ELISA-based whole-blood IGRAs are STANDARD E TB-Feron (SD Biosensor), LIOFeron TB/LTBI (LIONEX Diagnostics & Therapeutics), and AdvanSure TB-IGRA ELISA (LG Chem), all of which are commercially available. These tests operate on a technological principle and have operational characteristics similar to QFT-GIT technology.

QFT-Plus (QuantiFERON-TB Gold Plus) segment is anticipated to grow at the fastest CAGR over the forecast period. QFT-Plus is the latest generation of IGRA approved by the U.S. FDA, replacing its predecessor, QuantiFERON-TB Gold In-Tube (QFT-GIT). QFT-Plus offers several advantages over the Tuberculin Skin Test (TB skin test), including higher sensitivity (>95%) and the highest specificity among all TB infection tests. One of its key innovations is its ability to elicit a response from both CD4 and CD8 T cells, providing a more comprehensive assessment of the cell-mediated immune response to TB infection.

Test Type Insights

Tuberculin Skin Test (TST) led the market in 2023, with a market share of 70.33% in 2023. The dominance of the segment is attributed to the popularity associated with this test. It is a reliable test to screen LTBI and is performed by injecting tuberculin-purified protein derivative into the inner surface of the skin. An induration of 15 mm and more is considered positive in individuals with no risk factor for tuberculosis. Administration and reading of tests require standardization of procedures, training, and practice. The TST should be read between 48 to 72 hours after administration of tuberculin. High market penetration rate of test type, rising awareness about tuberculosis infection in the country, and cost-effectiveness of the test are likely to drive the segment over the forecast period.

Interferon Gamma Released Assay (IGRA) segment is anticipated to grow at the fastest CAGR over the forecast period owing to increasing adoption of IGRAs due to their advantages over TSTs and high sensitivity associated with the test assay. IGRAs measure immune reactivity to Mycobacterium tuberculosis bacteria in the blood sample. The white blood cells of an infected person release Interferon-gamma (IFN-g) when they react with antigens derived from tuberculosis bacteria. To conduct an IGRA test, only one visit is required to collect the blood sample, and healthcare providers are encouraged to use blood tests to screen. IGRAs are the preferred blood tests for people who have recently received the BCG vaccine, as results are not affected by BCG vaccination status, preventing the likelihood of false positives. However, IGRAs require laboratories with adequate equipment and professional technicians to conduct tests.

Application Insights

PLHIV led the market with a revenue share of 42.53% in 2023. In 2020, an estimated 9.9 million people worldwide were afflicted with tuberculosis (TB), and a quarter of the global population has been exposed to latent TB. People living with HIV (PLHIV) accounted for 8% of TB cases and contributed to around 14% of TB-related deaths that year. HIV is the most significant known risk factor for developing active TB, with PLHIV being 20-30 times more likely to advance TB than those without HIV. Among the approximate 37 million PLHIV globally, at least one-third are infected with M. tuberculosis. Screening all PLHIV for TB at least once is recommended. Treating LTBI in PLHIV is of utmost importance.

Household contacts with the Pulmonary TB segment are anticipated to grow at the fastest CAGR over the forecast period. Household contacts of individuals with infectious pulmonary tuberculosis face a heightened risk of contracting TB and progressing to active disease. This group is a priority for contact investigation and tuberculosis preventive treatment (TPT). Treating TB infection in these individuals is crucial to prevent disease progression. It is a key focus of the National Tuberculosis Elimination Program in India, which aims to eliminate TB by 2025. A study involving 118 pulmonary TB cases and 330 household contacts revealed that 26.36% of contacts had latent TB, while 3.03% had active TB. These findings emphasize the importance of targeted interventions.

End-use Insights

Diagnostic laboratories led the market with a revenue share of 54.78% in 2023 and is anticipated to grow at the fastest CAGR over the forecast period owing to efforts to improve patient outcomes by providing diagnostic facilities at the retail level. Moreover, the ability of laboratories to handle a large volume of tests at an expedited rate is expected to fuel the segment over the forecast period further. Furthermore, diagnostic laboratories also deal with samples received from clinics and hospitals. Diagnostic laboratories are providing newer blood tests for the screening or detection of LTBIs. For instance, independent laboratories such as Dynacare and Life Labs provide tests, such as QuantiFERON-TB blood tests and T-SPOT.TB tests, for the detection of LTBI at comparatively lower prices. Moreover, independent laboratories are booking online appointments for latent TB infection diagnosis, as per customer convenience.

The hospital & clinics segment is projected to witness a lucrative CAGR over the forecast period. Individuals with medical conditions, such as HIV/AIDS, chronic renal failure, and other diseases that weaken the immune system, increase the risk of LTBI and its development into an active TB case. The increasing prevalence of diseases that affect the immune system is likely to boost the testing rate for LTBIs in hospitals and clinics. The penetration of TST is higher in hospitals and clinics, as it requires standardization of procedures and trained professionals to conduct tests & read the skin test reaction. Moreover, TST does not require specific equipment and reagent kits to detect latent tuberculosis infection.

Regional Insights

The latent tuberculosis infection detection market in North America is anticipated to grow lucratively over the forecast period. North America is the most developed latent tuberculosis infection detection market. The increasing geriatric population, rising prevalence of TB, and high market penetration of technologically advanced diagnostic techniques are expected to drive market growth over the forecast period. Rising patient awareness, increasing preference for novel approaches, and the availability of favorable reimbursement policies are also expected to drive the regional market.

U.S. Latent Tuberculosis Infection Detection Market Trends

The latent tuberculosis infection detection market in the U.S. is expected to grow over the forecast period due to the increasing prevalence of TB in the country. For instance, according to the CDC, it is estimated that 7,882 TB cases were reported in 2021 in the U.S., accounting for 2.4 cases per 100,000 persons. TB is a serious airborne respiratory disease.

Asia Pacific Latent Tuberculosis Infection Detection Market Trends

The latent tuberculosis infection detection market in Asia Pacific accounted for 42.79% of the global revenue share in 2023 and is anticipated to grow at the fastest growth over the forecast period. The presence of high untapped opportunities in the form of unmet medical needs, increasing opportunities for scientific research, and positive economic growth are some primary growth drivers of this market. Moreover, expanding the healthcare regulatory scenario in high-growth countries is expected to attract international players to capitalize and invest in existing opportunities. Positive changes, such as increased awareness, healthcare benefits provided by the government, and the urge to avail of high-end medical diagnostics, are also expected to drive the market growth. In addition, the high prevalence of Tuberculosis (TB) in the region and presence of a large, affected population are some of the factors expected to fuel the market growth.

The India latent tuberculosis infection detection market is expected to grow over the forecast period. Due to many existing R&D institutions and rich resources in the country, India has become one of the major areas for setting up research laboratories and production units by multinational companies. In addition, public sector enterprises, such as Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology (DBT), have promoted R&D in the field of biotechnology across the country. Hence, rapidly growing biotechnology & pharmaceutical industries and frequent government initiatives to support R&D activities in the country are expected to create lucrative opportunities for growth.

The latent tuberculosis infection detection market in Japan is expected to grow steadily in the coming years due to varying test requirements depending on physicians’ demand.

Europe Latent Tuberculosis Infection Detection Market Trends

The latent tuberculosis infection detection market in Europe was identified as a lucrative region in the global market due to the presence of major research institutes and market players operating in the region. Moreover, favorable initiatives undertaken by the government & other nonprofit organizations to fund R&D activities and create awareness about the benefits of early disease diagnosis are expected to boost market growth.

The UK latent tuberculosis infection detection market is expected to grow over the forecast period due to increasing prevalence of TB, growing awareness about diagnosis, and improvements in healthcare infrastructure.

The latent tuberculosis infection detection market in France is expected to grow over the forecast period attributed to the increase in prevalence of infectious diseases, rapid technological advancements, and rise in awareness about infectious diseases.

The Germany latent tuberculosis infection detection market is expected to grow over the forecast period owing to its established biopharmaceutical industry, increasing R&D activities by biopharmaceutical companies, and high prevalence of TB.

Latin America Latent Tuberculosis Infection Detection Market Trends

The growth in latent tuberculosis infection detection market in Latin America can be attributed to the steady development of healthcare facilities in emerging economies coupled with increasing healthcare expenditure. The emergence of many diagnostic & pharmaceutical manufacturers in countries such as Brazil, Mexico, and Argentina, with their increased government priority toward building stable healthcare facilities, is expected to further drive market growth in this region.

The Brazil latent tuberculosis infection detection market is one of the lucrative markets in the region. The increasing prevalence of TB, developing economy, and reforms in the country’s healthcare system are key factors driving the growth of the latent tuberculosis infection detection market.

MEA Latent Tuberculosis Infection Detection Market Trends

The latent tuberculosis infection detection market in MEA was identified as a lucrative region in this industry. The growth in this region can be attributed to the steady development of healthcare facilities in emerging economies and increasing healthcare expenditure.

The latent tuberculosis infection detection market in Saudi Arabia is expected to grow over the forecast period owing to increased consumer demand due to the growing prevalence of chronic illnesses, a higher need for localized testing, and decreasing sequencing prices.

Key Latent Tuberculosis Infection Detection Company Insights

Some of the leading players operating in the market include QIAGEN, BIOMÉRIEUX, Oxford Immunotec, and Par Pharmaceutical, Inc. These companies focus on capturing the market by increasing their presence using various business initiatives, such as partnerships and collaborations with the government. Moreover, these companies have a well-established product portfolio, which helps them capture major market share.

SD Biosensor, Inc., Wantai BioPharm, Lionex GmbH, Serum Institute of India Pvt. Ltd, ARKRAY, Inc. are some of the emerging market participants. Developing & launching new and improved diagnostic tools that offer faster results, higher accuracy, and easier usability are observed as prevalent operating strategies by these companies. The players may face challenges in penetrating the market due to competition and regulatory hurdles.

Recent Developments

• In March 2024, QIAGEN entered into a partnership with the International Panel Physicians Association (IPPA) to educate and support panel physicians worldwide on the latest TB screening requirements. The focus will be on the new IGRA requirements and their benefits for patients & healthcare providers.

• In November 2023, Revvity launched its T-SPOT TB test for latent TB screening in India during the 46th Edition of MICROCON in Lucknow. The company emphasizes that it is the sole commercially available IGRA based on ELISPOT technology to have received FDA approval.

• In February 2023, QIAGEN announced the certification of its QFT-Plus test under the European Union’s 2017/746 IVD Medical Devices Regulation, replacing the 98/79/EC In Vitro Diagnostic Directive. QFT-Plus is a leading TB blood test authorized by the WHO, aiding in the indirect detection of TB-causing bacteria. This certification follows the IVDR CE-marking of QIAGEN’s ipsogen JAK2 RGQ PCR Kit, NeuMoDx Systems, and reagents in late 2022.

Latent Tuberculosis Infection Detection Market Report Scope

Global Latent Tuberculosis Infection Detection Market Report Segmentation

This report forecasts revenue & volume growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global latent tuberculosis infection detection market report based on brand, test type, application, end-use, and region.

• Brand Outlook (Volume, Number of Tests in Thousands; Revenue, USD Million, 2018 - 2030)

  • QFT-Plus (QuantiFERON-TB Gold Plus)

  • Others

• Test Type Outlook (Volume, Number of Tests in Thousands; Revenue, USD Million, 2018 - 2030)

  • Tuberculin Skin Test (TST)

  • Interferon Gamma Released Assay (IGRA)

• Application Outlook (Volume, Number of Tests in Thousands; Revenue, USD Million, 2018 - 2030)

  • Household Contacts with Pulmonary TB

  • PLHIV

  • Others

• End-use Outlook (Volume, Number of Tests in Thousands; Revenue, USD Million, 2018 - 2030)

  • Diagnostic Laboratories

  • Hospitals/clinics

  • Academic & Research Institutions

• Regional Outlook (Volume, Number of Tests in Thousands; Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

    • Netherlands

    • Belgium

    • Finland

    • Luxembourg

    • Iceland

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

    • Singapore

    • Bangladesh

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • Kuwait

    • UAE