Tuberculosis Diagnostics Market Size, Share & Trends Analysis Report By Test Type (Nucleic Acid Testing, Detection of Latent Infection), By End-use (Diagnostic Laboratories, Hospitals), By Region, And Segment Forecasts, 2024 - 2030

Tuberculosis Diagnostics Market Trends

The global tuberculosis diagnostics market size was valued at USD 2.19 billion in 2023 and is projected to grow at a CAGR of 5.97% from 2024 to 2030. The growth of the market is attributed to the increasing prevalence of tuberculosis, advancements in diagnostics technologies, and rising government funding programs for TB diagnosis, aided by growing awareness and screening programs. TB is one of the top ten causes of death worldwide; according to WHO, there were an estimated 10 million new cases globally, leading to the death of 1.5 million people every year.

The risk associated with the incidence is influenced by various factors, such as age, underlying health conditions, and exposure settings. Older individuals and those in certain environments face higher risks. This growing prevalence is anticipated to drive the demand for diagnostic procedures.

The COVID-19 pandemic significantly disrupted healthcare systems, affecting not only patients infected with COVID-19 but also others needing diagnosis and treatment services. Many hospitals had to cancel these services to manage and conserve resources, exacerbating shortages of healthcare professionals trained in diagnostic procedures. Government-imposed COVID-19 restrictions further hindered market growth. For instance, according to a March 2021 World Health Organization report titled 'Impact of the COVID-19 pandemic on TB detection and mortality in 2020,' approximately 1.4 million fewer individuals received treatment in 2020 compared to 2019, marking a 21% decline from the previous year.

Increased funding for TB diagnosis programs is essential in the global effort to combat this disease. Current funding for prevention, diagnosis, and treatment falls short of meeting demand, thereby impeding progress in reducing incidence and mortality rates. For instance, a targeted annual investment of USD 22 billion by 2027, alongside an additional USD 5 billion for research, underscores the shortfall, with only USD 5.8 billion allocated for TB services. This gap highlights the urgent need for sustained and increased funding to effectively tackle TB, as emphasized by the World Health Organization (WHO).

There is a growing awareness of the importance of screening, especially among high-risk populations such as healthcare workers, immigrants, and individuals living with HIV/AIDS. This increased awareness is driving demand for testing services and products. For instance, the U.S. Preventive Services Task Force has issued an updated final recommendation emphasizing the importance of screening asymptomatic adults at increased risk. This screening is crucial for reducing rates of active TB and safeguarding the health of people across the country.

Furthermore, the growing geriatric population is further driving the growth of the overall market. According to 2020 UN estimates, there were around 727 million people aged 65 and above globally. In addition, the number of individuals aged 80 and above is projected to double to approximately 1.5 billion by 2050. Aging has become a substantial risk factor for numerous diseases, including diabetes & obesity, which increases the risk of diseases and leads to metabolic imbalances. This is projected to fuel the demand for effective diagnostics. Moreover, the rising global population of elderly individuals presents a significant challenge to control within this demographic. TB case detection and incidence rates are notably elevated among older adults, underscoring the importance of integrating targeted measures into response strategies to address their increased risk.

Furthermore, the growing global population of elderly individuals presents a significant challenge in controlling TB within this demographic. Rates of TB case detection and incidence are notably elevated among older adults, underscoring the necessity of integrating targeted measures into TB response strategies to mitigate their heightened risk. In the Western Pacific region, where the demographic is rapidly aging, there has been a high prevalence of TB cases among older individuals, highlighting the urgency for tailored approaches to diagnosis, treatment, and care for this vulnerable group. This underscores the imperative for developing effective and efficient diagnostics to meet the increasing demand for managing tuberculosis among the elderly population.

However, the regulatory framework for approvals presents significant constraints on the growth of the pharmaceutical, biotechnology, and medical technology industries. Globally, the utilization and safety evaluations of diagnostic tests vary, and they are assessed differently by health regulatory agencies in each country. This variability contributes to slower approvals for novel products. Approval decisions for new products differ across countries, which can impede market expansion. Inconsistent regulatory frameworks and guidelines for diagnostics in developing economies could further restrict market growth.

Market Concentration & Characteristics

The market is highly innovative, particularly in advancements in molecular diagnostics, particularly with nucleic acid amplification tests (NAATs) such as the GeneXpert MTB/RIF assay. These tests detect TB bacteria and simultaneously assess rifampicin resistance, providing results in hours rather than weeks required by traditional methods.

The product expansion activities are moderate in the market. Companies and research institutions invest in developing novel diagnostic tests for TB. This includes nucleic acid amplification tests (NAATs), serological tests, rapid molecular tests, and next-generation sequencing approaches that enhance sensitivity and specificity compared to traditional methods. Moreover, ongoing investment in research and development (R&D) ensures that innovations in diagnosis keep pace with emerging challenges such as drug resistance, co-infections (e.g., TB-HIV), and variations in TB strains.

Regulations play a crucial role in shaping the tuberculosis diagnosis market, impacting various aspects from product development to market entry and commercialization. Regulatory agencies set stringent standards for the quality, safety, and performance of diagnostic tests.

The market shows a high-end user concentration, with a significant portion of the revenue generated from its utilization in various healthcare settings, including hospitals, clinics, laboratories, and community health centers. The concentration of end users varies based on the prevalence of TB, healthcare infrastructure, and access to diagnostic facilities in different regions.

Test Type Insights

The detection of Latent Infection (Skin Test & IGRA) segment dominated the market with a share of 41.27% in 2023, driven by the growing prevalence of tuberculosis among the population. Tuberculin Skin Test (TST) is a popular method to determine whether a person is infected with tuberculosis. The high market penetration rate of test type, increasing awareness about tuberculosis infection in the country, and cost-effectiveness of the test are likely to drive the segment over the forecast period. Moreover, IGRAs are widely adopted for blood tests owing to high test sensitivity and increasing adoption due to their advantages. Furthermore, QuantiFERON is a leading IGRA blood test known for its superiority over the tuberculin skin test, particularly in accurately identifying TB infections in individuals who have received BCG vaccinations.

The detection of the Drug Resistance (DST) segment is expected to register the fastest CAGR during the forecast period. DST determines which antibiotics are effective against the TB bacteria (Mycobacterium tuberculosis) infecting a patient. It identifies resistance to first-line drugs (isoniazid, rifampicin, ethambutol, pyrazinamide) and second-line drugs used for multidrug-resistant TB and extensively drug-resistant TB. DST guides treatment decisions, ensuring patients receive effective therapy tailored to their drug susceptibility profile. This is crucial for improving treatment outcomes, preventing further drug resistance, and reducing transmission of resistant TB strains.

End Use Insights

The diagnostic laboratories segment dominated the market with a share of 46.92% in 2023, owing to efforts to improve patient outcomes by providing diagnostic facilities at the retail level. Diagnostic laboratories are introducing advanced blood tests for screening and detection. For instance, independent laboratories like Dynacare and Life Labs offer tests such as QuantiFERON-TB and T-SPOT.TB at competitive prices to detect latent TB infection. Furthermore, these independent laboratories are facilitating online appointment booking for LTBI diagnosis, catering to customer convenience. The growing adoption of blood-based tests and customer preferences are projected to drive growth in this segment in the forecast period.

The hospitals and clinics segment is anticipated to grow at a significant growth over the forecast period. Individuals afflicted with medical conditions such as HIV/AIDS, chronic renal failure, and other immunocompromising diseases elevate their susceptibility to TB. The growing incidence of immune-related disorders is anticipated to amplify testing rates in healthcare facilities, including hospitals and clinics. In addition, in August 2023, Santa Clara Valley Healthcare (SCVH) inaugurated its Valley Health Center (VHC) Lundy primary care clinic, which houses the Tuberculosis Clinic & Refugee Health Assessment Program. This new facility is crucial for Santa Clara County, which has the third-highest tuberculosis case rate among California jurisdictions and welcomes the highest number of refugees in the state. 

Regional Insights

North America tuberculosis diagnostics market accounted for a significant share attributed to the increasing geriatric population, rising prevalence of TB, and high market penetration of technologically advanced diagnostic techniques, which are expected to drive market growth over the forecast period.

U.S. Tuberculosis Diagnostics Market Trends

The tuberculosis diagnostics market in the U.S. is expected to grow over the forecast period due to the increasing prevalence of TB. For instance, according to the CDC, 7,882 TB cases were reported in 2021 in the U.S., accounting for 2.4 cases per 100,000 persons.

Asia Pacific Tuberculosis Diagnostics Market Trends

Asia Pacific tuberculosis diagnostics market dominated globally, with the largest revenue share of 35.74% in 2023. The increasing opportunities for scientific research, the presence of high untapped opportunities in the form of unmet medical needs, and positive economic growth are some primary growth drivers of this market. Moreover, the evolving healthcare regulatory landscape in rapidly developing nations is anticipated to attract international players to benefit from and invest in available opportunities. Favorable developments, including increasing awareness, government-provided healthcare benefits, and the demand for advanced medical diagnostics, are anticipated to drive market growth. In addition, the significant burden of tuberculosis (TB) and large affected population are factors expected to fuel market growth.

The tuberculosis diagnostics market in China is expected to grow over the forecast period, owing to the high burden of TB and ongoing efforts to improve healthcare infrastructure and diagnostic capabilities.

The Japan tuberculosis diagnostics market is expected to grow over the forecast period owing to the rising demand for tuberculosis diagnostics solutions aided with the high prevalence of TB and the unprecedented outbreak of the COVID-19 pandemic that have led to an increase in R&D activities for developing novel diagnostics.

Europe Tuberculosis Diagnostics Market Trends

The Europe tuberculosis diagnostics market was identified as a lucrative region in this industry due to increasing number of research institutes and market players present in the area. Furthermore, favorable government and nonprofit initiatives aimed at funding research and development activities and increasing awareness about the advantages of early disease diagnosis are anticipated to drive market growth.

The tuberculosis diagnostics market in the UK is growing primarily due to increasing awareness about diagnosis, increasing prevalence of TB, and developments in healthcare infrastructure.

The France tuberculosis diagnostics market is expected to witness lucrative growth over the forecast period due to rapid technological advancements, the increase in the prevalence of tuberculosis, and the rise in awareness about TB.

Latin America Tuberculosis Diagnostics Market Trends

The tuberculosis diagnostics market in Latin America was identified as a lucrative region in this industry. This is attributed to the advancement of healthcare infrastructure in emerging economies, accompanied by rising healthcare expenditures. The growth of numerous diagnostic and pharmaceutical manufacturers in countries like Brazil, Mexico, and Argentina reflects their heightened government focus on establishing robust healthcare facilities.

The Brazil tuberculosis diagnostics market is expected to grow over the forecast period owing to the developing economy, increasing prevalence of TB, and reforms in the country’s healthcare system, which are also key factors driving the market's growth.

MEA Tuberculosis Diagnostics Market Trends

MEA tuberculosis diagnostics market was identified as lucrative, which can be attributed to increasing healthcare expenditure and the steady development of healthcare facilities in emerging economies.

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

Key Tuberculosis Diagnostics Company Insights

Some of the leading players operating in the market include BD, Thermo Fisher Scientific, Inc., QIAGEN, and Oxford Immunotec. These companies focus on capturing the market by increasing their presence using various business initiatives, such as collaborations and partnerships with the government. Their well-established product portfolios help them capture major market share.

SD Biosensor, Inc., Wantai BioPharm., and Lionex GmbH are among the emerging market participants. These companies' prevalent operating strategies include developing and launching improved and new diagnostic tools that offer higher accuracy, faster results, and easier usability.

Recent Developments

• In March 2024, Noze received funding of 1.8 million for the launch of a clinical study aimed at the diagnosis of tuberculosis.

• 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 (IVDR), replacing the 98/79/EC In Vitro Diagnostic Directive (IVDD). QFT-Plus is a leading TB blood test endorsed 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.

Tuberculosis Diagnostics Market Report Scope

Global Tuberculosis Diagnostics Market Report Segmentation

This report forecasts revenue 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 tuberculosis diagnostics market report based on test type, end use, and region:

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

  • Nucleic Acid Testing

  • Detection of Latent Infection (Skin Test & IGRA)

  • Detection of Drug Resistance (DST)

  • Other Methods

  • Phage Assay

  • Cytokine Detection Assay

  • Diagnostic Laboratory Methods

  • Radiographic Method

  • Other Methods

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

  • Diagnostic Laboratories

  • Hospitals & Clinics

  • Others

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

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

    • Singapore

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait