결핵 진단 검사 시장 크기 및 공유 2025 - 2034

Tuberculosis Diagnostics Test Market Size

The global tuberculosis diagnostics test market size was estimated at USD 2.4 billion in 2024. The market is expected to grow from USD 2.5 billion in 2025 to USD 4.1 billion in 2034, at a CAGR of 5.6% during the forecast period. The growth of the global market is largely influenced by the growing prevalence of tuberculosis, advances in the development of tuberculosis diagnostic techniques, rising awareness and screening programs, and surge in point of care testing (POCT).
 

The growth of the market is highly attributed to the rising prevalence of tuberculosis across the globe. For instance, according to the World Health Organization, an estimated 10.8 million people suffered from TB in 2023, a marginal increase from 10.7 million in 2022. Additionally, TB mortality remains high, with 1.25 million deaths reported in 2023, despite modest progress in reducing the fatality rate. Thus, this statistic highlights the need for enhanced tuberculosis diagnostic tests that enable early, accurate and rapid detection, specifically in high-burden and resource limited areas.
 

Moreover, rising awareness and emphasis on screening programs has emerged as a keystone to fight against tuberculosis. This is further supported by government and health organization initiatives that aim at enhancing early detection through widespread screening and diagnostic campaigns. For instance, India bears the highest TB burden globally, which has significantly intensified its national initiatives. The National TB Elimination Programme (NTEP) has introduced targeted strategies such as the 100-Day TB Elimination Campaign, launched in December 2024, to enhance active case finding and diagnosis among high-risk and underserved populations.
 

Tuberculosis diagnostic tests are a type of medical test which are used to detect the presence of mycobacterium tuberculosis, the bacterium that causes tuberculosis in an individual. Further, these tests help to determine whether the person has a latent TB infection (LTBI) or active TB disease, which is important for initiating appropriate treatment.
 

Tuberculosis Diagnostics Test Market Trends

• The growing technological advancement in diagnostic techniques has transformed the landscape of tuberculosis (TB) testing, driving the growth of the market by enabling efficient and early detection. These innovations have enhanced diagnostic accuracy, reduced turnaround times, and improved accessibility, thereby contributing to better patient outcomes.
   
• A key development in the TB diagnostics market is the introduction of advanced molecular diagnostics, which is estimated to reach USD 36 billion by 2032. Platforms, such as Cepheid’s GeneXpert system, have made significant progress. In 2021, the launch of the GeneXpert MTB/XDR cartridge offered rapid detection of resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin in less than 90 minutes.
   
• In addition to this, portable molecular platforms such as Molbio’s TrueNat have gained traction. TrueNat was approved by WHO in 2020 and offers real-time PCR-based TB and rifampicin resistance detection.
   
• Further, another innovation is AI-powered digital chest X-ray (CXR) which has algorithms such as CAD4TB, qXR, and Lunit INSIGHT CXR that use deep learning for screening of pulmonary TB, even in asymptomatic individuals. This AI powered digital X ray was recommended by WHO in 2021 for screening and triage purpose.
   
• Thus, these advances in TB diagnostics are helping to improve the global fight against tuberculosis by making testing faster, more accurate, and accessible, especially in area with high infection rates and limited resources. Thus, these innovations are further accelerating growth of the market.
   

Tuberculosis Diagnostics Test Market Analysis

In 2021, the global market was valued at USD 2.1 billion. The following year, it saw a slight increase to USD 2.2 billion, and by 2023, the market further climbed to USD 2.3 billion. Based on test type, the market is segmented into radiographic method, diagnostic laboratory methods, molecular diagnostics, detection of latent infection, cytokine detection assay, detection of drug resistance (DST), phage assay, and other test types. The molecular diagnostics segment dominated the market with the largest revenue share of 36.6% in 2024 and is expected to grow at a CAGR of 5.9% over the forecast period.
 

• Molecular diagnostics have transformed tuberculosis (TB) detection by providing accurate, fast, and highly sensitive methods that help to identify mycobacterium tuberculosis (Mtb) and its drug resistance patterns.
   
• Polymerase chain reaction (PCR) is a keystone of molecular diagnostic techniques that is used to amplify and detect specific DNA sequences of mycobacterium tuberculosis (Mtb) in clinical specimens. PCR-based methods offer high sensitivity and specificity, enabling early detection of TB.
   
• Further, nucleic acid amplification tests (NAATs) have significantly advanced the diagnosis of tuberculosis (TB) by enabling rapid and specific detection of Mycobacterium tuberculosis (Mtb) DNA or RNA directly from clinical specimens. It delivers results within 2 to 48 hours, considerably faster than traditional culture methods.
   
• Moreover, the GeneXpert MTB/RIF assay is an innovative molecular diagnostic tool that simultaneously detects mycobacterium tuberculosis (Mtb) and rifampicin (RIF) resistance directly from clinical specimens. Thus, these molecular diagnostic advantages in tuberculosis testing are further accelerating the growth of the market.
   

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Based on modality, the tuberculosis diagnostics test market is bifurcated into point of care testing (POCT) and laboratory-based testing (Non-POCT). The laboratory-based testing (Non-POCT) segment dominated the market with 65% market share in 2024.
 

• This significant market share is mainly attributed to the continuous use of centralized, high-volume and accurate testing methods which are important for detecting TB. Lab-based testing is an important method for the diagnosis of TB, specifically for complicated or drug-resistant TB cases, that need careful and precise testing.
   
• These tests are mostly done in public health labs, hospitals, and certified private labs. These places use advanced techniques such as culture-based methods (MGIT, solid culture), smear microscopy, and interferon-gamma release assays (IGRAs), which help doctors understand how serious the disease is and whether it is resistant to treatment.
   
• Further, this type of testing is specifically important because it handles many samples at once and offers accurate and effective results. Thus, these advantages are further propelling the growth of the market.
   

Based on end use, the tuberculosis diagnostics test market is segmented into pathological laboratories and other end users. The pathological laboratories segment held market revenue of USD 1.8 billion in 2024 and is expected to grow at a CAGR of 5.9% over the forecast period.
 

• The pathological laboratories conduct a wide range of TB tests, which includes smear microscopy, culture methods, nucleic acid amplification tests, IGRAs (interferon-gamma release assays), and drug resistance testing. These laboratories manage complex procedures and also maintain high testing standards.
   
• This type of lab testing services is available in cities and towns, specifically in countries with high TB rates such as India, South Africa, and Brazil. In these areas, large labs often act as central testing hubs, helping national TB control programs by processing samples and performing advanced tests.
   
• For instance, in India, there were over 20,000 certified microscopy centers by 2020, along with more than 1,100 CBNAAT labs at the district level for early TB detection. The country also has six national-level reference labs for complex testing, showing its strong, multi-level system for diagnosing TB.
   
• The segment's growth is further fueled by the adoption of automated systems, digitization of laboratory operations, and integration with hospital information systems, which collectively improve diagnostic accuracy and turnaround time.
   

The Asia Pacific tuberculosis diagnostics test market is anticipated to grow at a CAGR of 5.6% during the analysis timeframe. The growing burden of TB cases, rising health awareness, continuous advancements in tuberculosis diagnostic tests, rapid growth in the number of pathological laboratories along with government policies aimed at improving diagnostic capabilities are contributing to the growth of the market in the region.
 

India market was valued at USD 432.8 million and USD 447.8 million in 2021 and 2022, respectively. The market size reached USD 467.2 million in 2024, growing from USD 489.9 million in 2023.
 

• The rising prevalence of tuberculosis in the country is significantly driving the growth of the market.
   
• For instance, according to the report from the government of India, the country accounts for nearly 27% of the global TB burden, with an estimated 2.8 million cases out of 10.6 million TB cases globally in 2022. Further, to tackle this, the government of India has launched Pradhan Mantri TB Mukt Bharat Abhiyaan, which aims at improving treatment outcomes through community engagement and additional patient support.
   

The North America tuberculosis diagnostics test market accounted for a market share of 2.8% in 2024. The increasing prevalence of tuberculosis, rising awareness about tuberculosis, and rapid adoption of tuberculosis diagnostic tests are significantly driving the growth of the market in the region. The U.S. market is anticipated to witness lucrative growth between 2025 - 2034.
 

• The growth of the market in the country is highly attributed to the rising prevalence of tuberculosis post COVID-19 in the country.
   
• For instance, the U.S. reported 9,615 TB cases in 2023, a 16% increase from 2022 and the highest annual count since 2013. The incidence rate rose from 2.5 to 2.9 per 100,000 persons, with increases observed across all age groups and in 40 states. This high volume of TB patients is stimulating significant demand for tuberculosis diagnostic tests in the country.
   
• Additionally, tuberculosis rapid diagnostic test kits, molecular diagnostic tests, diagnostic laboratory methods and other tests, facilitate continuous monitoring of tuberculosis treatment adherence and patient health, thereby accelerating the growth of the market in the country.
   

Europe tuberculosis diagnostics test market accounted for USD 153.8 million in 2024 and is anticipated to show lucrative growth over the forecast period.
 

• One of the key catalysts for the growth of the market in the region is the rising aging population, as the risk of tuberculosis is significantly higher among older adults.
   
• For instance, according to the European Commission, 21.1% of the EU population was aged 65 or older in 2022, a figure projected to reach 32.5% by 2100. Therefore, as the population ages, the demand for advanced and effective tuberculosis diagnostic tests in the region is anticipated to rise in the foreseeable future.
   

The tuberculosis diagnostics test market in UK is expected to experience significant and promising growth from 2025 to 2034.
 

• The rising number of cases in the country is a significant catalyst for the growth of the market in the country. For instance, according to the report from UK Health Agency in 2023, 4,855 people were notified with TB in England, an increase of 11% in numbers and notification rate compared to 2022. This statistic highlights the growing demand to find better solutions for improving the TB conditions in the country.
   
• Further, the growth of tuberculosis diagnostic test market in this country is anticipated to be strengthened by the UK government's commitment towards tackling chronic conditions via initiatives such as public health campaigns and guidelines that promote healthier lifestyles, contributing to market growth.
   

Brazil is experiencing significant growth in the Latin America tuberculosis diagnostics test market.
 

• The growth of the market in the country is highly attributed to the rising awareness of tuberculosis and the available treatment options in the country.
   
• For instance, awareness campaigns led by organizations in Brazil such as the STOP-TB Brazil campaign, have increased public knowledge about TB, leading to higher diagnosis rates and reduced stigma. Therefore, as awareness increases, so does the rate of diagnosis, in turn stimulating the need for effective TB diagnosis, fostering market growth.
   

The tuberculosis diagnostics test market in South Africa is expected to experience significant and promising growth from 2025 to 2034.
 

• The increasing prevalence of tuberculosis in South Africa is significantly accelerating the growth of the market in the country. For instance, according to the data from World Health Organization in 2022, an estimated 280,000 individuals were diagnosed with tuberculosis in South Africa.
   
• The South African government is making substantial investments in healthcare to integrate tuberculosis diagnostic tests within the labs and diagnostic centers to provide utmost care to the individuals suffering from TB in the country. Such investment is anticipated to enhance the accessibility and quality of medical services among the individuals of the country, accelerating market growth in the country.
   

Tuberculosis Diagnostics Test Market Share

The top 6 companies in the market such as Abbott Laboratories, Becton, Dickinson and Company, Danaher Corporation, F. Hoffmann-La Roche, bioMérieux and Qiagen N.V. account for 56% market share. These companies maintain their dominance in the market through innovative product launches, extensive distribution networks and strong regulatory approvals.
 

Moreover, strategic partnerships with research institutes and government agencies play a primary role in advancing the development of advanced diagnostic tests and getting the necessary permits. The development of public awareness about TB and its health impact through social media platforms will encourage more individuals to seek treatment, enabling market players to strengthen their position in this growing sector.
 

Tuberculosis Diagnostics Test Market Companies

Some of the eminent market participants operating in the tuberculosis diagnostics test industry include:

• Abbott Laboratories
• Anhui Zhifei Longcom Biopharmaceutical Co.
• Becton, Dickinson and Company
• bioMérieux
• Danaher Corporation (Cepheid)
• F. Hoffmann-La Roche
• Generium Pharmaceuticals
• Hain Lifescience
• Hologic
• Japan BCG Laboratory
• NIPRO
• Oxford Immunotec
• Qiagen N.V.
• Sanofi
• Siemens Healthineers
• Thermo Fisher Scientific

• Abbott Laboratories has a strong product portfolio leading to larger adoption and significant market expansion. Abbott provides a diverse range of products pertaining to tuberculosis diagnostic tests such as Determine TB LAM Ag Test, ABON TB Rapid Test Device, among others.
   
• Thermo Fisher Scientific Inc. has a strong global workforce of approximately 122,000 employees, which enables the company to drive innovation and deliver high-quality solutions.
   
• Danaher Corporation has strong geographical presence which enables it to enhance its market reach. Danaher operates in more than 60 countries, comprising a robust distribution network.
   

Tuberculosis Diagnostics Test Industry News:

• In April 2023, bioMérieux and Oxford Nanopore Technologies partnered to co-develop nanopore-based solutions for rapid TB drug resistance detection and pathogen identification, integrating with the EPISEQ CS platform to enhance real-time diagnostics and outbreak monitoring.
   
• In September 2022, BD launched the BD MAX MDR-TB panel in India, enabling rapid detection of Mycobacterium tuberculosis and resistance to rifampicin and isoniazid in a single WHO-endorsed molecular assay. This innovation supports faster, more accurate treatment decisions and strengthens BD's position in the TB diagnostics market.
   

The tuberculosis diagnostics test market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 - 2034 for the following segments: