• March 2022, SRL Diagnostics launched a whole genome sequencing test for tuberculosis. The test reduces the time taken to diagnose multi-drug resistant tuberculosis and offers a complete resistance profiling to 18 different TB drugs.

• May 2022, The Drug Controller General of India (DCGI) granted market authorization to the Serum Institute, India, Cy-Tb kit for 18 years and above that can be used for a skin test for diagnosis of latent tuberculosis.

In this report, the Tuberculosis Diagnostics Market has been segmented by Technology, Disease Stage, End User and Geography.

Tuberculosis Diagnostics Market, Segmentation by Technology

The Tuberculosis Diagnostics Market has been segmented by Technology into Radiographic Test and Laboratory Test - Smear Microscopy and Culture-based Test, Nucleic Acid Testing, Cytokine Detection Test, Drug Resistance Test, and Others.

Radiographic Test

Radiographic tests account for approximately 15% of the tuberculosis diagnostics market. These are primarily used for initial screening and pulmonary TB detection through chest X-rays. While non-specific, radiographic imaging plays a key role in identifying cases that require further microbiological confirmation.

Laboratory Test - Smear Microscopy and Culture-based Test

Smear microscopy and culture-based tests together represent about 30% of the market. Smear microscopy is widely used in low-resource settings due to its cost-effectiveness, while culture-based methods remain the gold standard for definitive TB diagnosis and drug susceptibility testing.

Nucleic Acid Testing

Nucleic acid testing contributes around 25% of the market and is valued for its high sensitivity and rapid results. Techniques like PCR and GeneXpert enable early detection of Mycobacterium tuberculosis and are especially effective in multidrug-resistant TB diagnosis.

Cytokine Detection Test

Cytokine detection tests, including interferon-gamma release assays (IGRAs), hold approximately 12% of the market. These are primarily used to detect latent TB infections and offer higher specificity compared to the tuberculin skin test. Their utility is expanding in developed countries.

Drug Resistance Test

Drug resistance testing represents about 10% of the market. These tests are essential for identifying multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB cases, guiding appropriate treatment regimens. Rapid molecular diagnostics are enhancing the efficiency of this segment.

Others

The "Others" category includes serological tests, biomarker-based assays, and next-generation sequencing methods, contributing nearly 8% to the market. These emerging technologies are under evaluation for their role in improving diagnostic accuracy and reducing time-to-diagnosis.

Tuberculosis Diagnostics Market, Segmentation by Disease Stage

The Tuberculosis Diagnostics Market has been segmented by Disease Stage into Latent TB, and Active TB.

Latent TB

Latent TB accounts for approximately 35% of the global tuberculosis diagnostics market. Diagnosis primarily relies on interferon-gamma release assays (IGRAs) and the tuberculin skin test. While asymptomatic, identifying latent TB is critical for preventing disease progression and reducing community transmission.

Active TB

Active TB dominates the market with nearly 65% share due to its high clinical urgency and greater need for confirmatory diagnostics. Tools such as smear microscopy, culture-based testing, and nucleic acid amplification are commonly used for pulmonary and extrapulmonary TB detection.

Tuberculosis Diagnostics Market, Segmentation by End User

The Tuberculosis Diagnostics Market has been segmented by End User into Hospital/Clinic, Diagnostics/Research Laboratory and Others.

Hospital/Clinic

Hospitals and clinics represent the largest end-user segment, accounting for approximately 55% of the tuberculosis diagnostics market. These facilities provide first-line diagnosis and immediate access to radiographic and microbiological tests. Their integration with national TB programs enhances early detection and treatment initiation.

Diagnostics/Research Laboratory

Diagnostics and research laboratories contribute around 35% to the market. Equipped with advanced testing infrastructure, they offer a wide range of TB diagnostics, including culture-based methods, nucleic acid testing, and drug susceptibility assays. These labs are essential for accurate confirmation and surveillance studies.

Others

The "Others" category, comprising mobile diagnostic units, NGO-run clinics, and community health centers, holds about 10% of the market. These providers play a critical role in last-mile TB detection, particularly in rural and underserved regions, where access to conventional diagnostics is limited.

Tuberculosis Diagnostics Market, Segmentation by Geography

In this report, the Tuberculosis Diagnostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Tuberculosis Diagnostics Market Share (%), by Geographical Region

North America

North America accounts for approximately 22% of the global tuberculosis diagnostics market. The region benefits from advanced diagnostic technologies, government-led screening programs, and a strong focus on latent TB testing, especially in the U.S. where TB remains a concern in at-risk populations.

Europe

Europe holds around 25% of the market, supported by robust public health infrastructure and growing demand for drug-resistant TB diagnostics. Countries like Germany, the UK, and France are leading in active case detection and cross-border TB control initiatives.

Asia Pacific

Asia Pacific dominates the tuberculosis diagnostics market with a share of nearly 38%. High TB burden countries such as India, China, and Indonesia are driving demand for affordable and rapid testing. Increased government investment and global health partnerships are accelerating diagnostic deployment in the region.

Middle East and Africa

Middle East and Africa contribute about 9% of the global market. The region faces a high incidence of undiagnosed TB cases, particularly in sub-Saharan Africa. International funding and improved access to portable diagnostic technologies are gradually improving testing capacity.

Latin America

Latin America accounts for approximately 6% of the tuberculosis diagnostics market. Countries like Brazil, Peru, and Mexico are advancing efforts in national TB control programs, with rising adoption of nucleic acid amplification tests and community-based diagnostics.

This report provides an in depth analysis of various factors that impact the dynamics of Tuberculosis Diagnostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing healthcare awareness
• Rising prevalence of tuberculosis

• Government initiatives and funding - Strong involvement from governments worldwide is playing a pivotal role in advancing the tuberculosis diagnostics market. Through national programs and global collaborations, public health agencies are offering targeted funding and structured support to strengthen TB detection and control. These efforts are improving early diagnosis, boosting access to modern technologies, and expanding the availability of testing services in underserved regions.

  Government funding has significantly improved infrastructure for TB diagnostics, particularly in high-burden countries. Subsidized diagnostic kits, public-private collaborations, and WHO-endorsed platforms are increasingly being integrated into national TB control strategies. This shift is accelerating the adoption of reliable molecular diagnostics and digital tools within public healthcare systems.

  Major initiatives like India’s RNTCP and global programs funded by the Global Fund and Stop TB Partnership have helped bridge technological and financial gaps. These programs focus not just on procurement but also on staff training, awareness campaigns, and long-term disease management—contributing significantly to market expansion.

  By enhancing access to diagnostics and driving innovation through structured investment, government backing is setting a foundation for widespread TB screening. This continued emphasis on public health commitment is expected to fuel sustained growth for the tuberculosis diagnostics market in the years ahead.

Restraints

• High cost of diagnostic tests
• Limited access to healthcare facilities
• Stigma associated with tuberculosis

• Lack of skilled healthcare professionals - The shortage of trained healthcare professionals is a critical hurdle limiting the growth of the tuberculosis diagnostics market. Despite technological advancements, many regions still lack qualified personnel capable of properly using diagnostic tools and interpreting results with accuracy. This results in delays, diagnostic errors, and underutilization of available equipment.

  Technologies like nucleic acid amplification tests and digital radiography require hands-on expertise and training. In areas where such training is unavailable or inconsistent, diagnostic capacity remains constrained. This issue is especially pronounced in rural and low-resource settings where staff shortages and high turnover are common.

  Even when governments and international donors supply modern diagnostic tools, implementation suffers without trained personnel. The inability to support technical deployment with human resources slows down the intended benefits of large-scale screening and weakens overall program efficiency. Consequently, TB case detection targets often remain unmet despite investments.

  Though digital training platforms and telemedicine are emerging solutions, their success depends on stable internet access and infrastructure—both of which are limited in many critical regions. Without comprehensive strategies to close this talent gap, the growth of the tuberculosis diagnostics market will continue to face serious limitations.

Opportunities

• Growing demand for point-of-care testing
• Expansion in emerging markets
• Development of innovative diagnostic tools

• Integration of artificial intelligence technologies - The adoption of artificial intelligence (AI) in tuberculosis diagnostics represents a powerful growth opportunity for the market. AI-driven tools offer rapid, accurate analysis of radiographic images and diagnostic data, improving both efficiency and decision-making in clinical settings. These systems help streamline workflows and support healthcare professionals in interpreting complex test results.

  AI algorithms have demonstrated strong capabilities in detecting early TB indicators on digital X-rays, particularly in areas where specialist radiologists are unavailable. This reduces human error, improves diagnostic consistency, and speeds up patient triage. Pilot projects integrating AI with chest radiography in remote clinics have already shown positive results in screening outcomes.

  Moreover, AI can leverage patient histories and diagnostic patterns to deliver predictive insights, which is essential for managing resistant TB strains and personalizing treatment. As data quality improves and machine learning models evolve, these tools are expected to become even more accurate and responsive to real-world clinical demands.

  With AI-enabled systems now being combined with cloud-based diagnostics and mobile platforms, real-time surveillance and centralized reporting are also becoming feasible. These capabilities not only enhance public health response but also unlock new business opportunities for companies developing AI-based healthcare innovations within the TB diagnostics space.

Key players in Tuberculosis Diagnostics Market include:

• Abbott Laboratories
• BD (Becton, Dickinson and Company)
• bioMérieux SA
• Cepheid
• F. Hoffmann-La Roche Ltd
• Hologic, Inc
• Qiagen N.V
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc
• Quidel Corporation

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis