Tuberculosis Diagnostics Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Radiographic Method, Diagnostic Laboratory Methods, Nucleic Acid Testing, Phage Assay, Detection of Latent Infection, Cytokine Detection Assay, Detection of Drug Resistance (DST), others), By End-use (Diagnostic Laboratories, Hospitals & Clinics, others), by Region, and Competition, 2020-2030F

Market Overview

The Global Tuberculosis Diagnostics Market, valued at USD 2.52 Billion in 2024, is projected to experience a CAGR of 6.37% to reach USD 3.65 Billion by 2030. The global tuberculosis diagnostics market develops and deploys tests and tools for identifying *Mycobacterium tuberculosis*, the causative agent of tuberculosis. Market expansion is driven by the significant global disease burden and the imperative for swift, precise detection. Technological advancements, particularly in molecular assays, alongside increasing governmental and organizational support for TB control, further stimulate growth. According to the World Health Organization Global Tuberculosis Report 2024, an estimated 10.8 million people globally fell ill with tuberculosis in 2023.

The escalating prevalence of drug-resistant tuberculosis strains additionally fuels demand for advanced diagnostic solutions. According to the same report, 8.2 million new cases were diagnosed in 2023, the highest recorded since 1995. A notable challenge impeding market progress is ensuring affordable and accessible advanced diagnostic technologies, especially within resource-limited regions confronting high disease incidence.

Key Market Drivers

The advancements in diagnostic technologies significantly propel the global tuberculosis diagnostics market by enhancing the speed, accuracy, and accessibility of testing solutions. Innovations such as molecular diagnostics, artificial intelligence powered imaging, and next-generation sequencing are transforming the diagnostic landscape, enabling earlier detection and more effective disease management. These technological improvements are particularly crucial for identifying latent tuberculosis infection and for deployment in diverse healthcare settings, from central laboratories to point-of-care environments. For instance, according to a Pharmacy Times news report, in April 2025, the FDA approved the Auto-Pure 2400 liquid handling platform with the T-SPOT. TB test, which allows laboratories to process up to 24 samples in under 3.5 hours for faster and more accurate latent TB diagnosis. This progress directly translates into improved patient outcomes and reduced disease transmission by facilitating timely initiation of treatment.

The growing incidence of drug-resistant tuberculosis strains is another critical factor driving expansion in the diagnostics market, necessitating sophisticated and rapid tests to accurately identify resistance patterns. Traditional diagnostic methods often require prolonged culture periods, delaying the initiation of appropriate treatment regimens and contributing to further spread of resistant strains. The emergence of multidrug-resistant and extensively drug-resistant TB highlights an urgent demand for advanced molecular assays that can detect specific drug resistance mutations swiftly. According to the World Health Organization, in 2023, the estimated annual number of people who developed multidrug-resistant or rifampicin-resistant tuberculosis was 400,000, underscoring the substantial burden of drug-resistant forms of the disease. Addressing this challenge requires continuous development and deployment of diagnostic tools capable of providing comprehensive drug susceptibility testing. Furthermore, the Global Fund to Fight AIDS, Tuberculosis and Malaria reported that as of June 2025, it had invested US$10.5 billion in programs aimed at preventing and treating tuberculosis, demonstrating substantial financial commitment to the overall market.

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Key Market Challenges

Ensuring affordable and accessible advanced diagnostic technologies in resource-limited regions presents a significant impediment to the expansion of the Global Tuberculosis Diagnostics Market. The high capital expenditure required for advanced molecular diagnostic platforms, coupled with the recurring costs of reagents and consumables, creates substantial financial barriers for public health systems in high-burden, low-income countries. This economic constraint often leads to the underutilization or non-adoption of advanced diagnostic tools despite their accuracy and speed. Consequently, a considerable portion of individuals with tuberculosis in these critical regions continues to be diagnosed using less effective, conventional methods, or remain undiagnosed entirely. According to the World Health Organization Global Tuberculosis Report 2024, in 2023, only 48% of the 8.2 million people newly diagnosed with TB were initially tested using a WHO-recommended rapid molecular test. This persistent disparity between the demand for precise diagnostics and the actual market penetration due to affordability and accessibility issues directly curtails revenue generation and overall growth within the global tuberculosis diagnostics sector.

Key Market Trends

The rise in automated diagnostic platforms significantly drives the global tuberculosis diagnostics market by enhancing testing throughput and operational efficiency. These systems streamline laboratory workflows, minimizing manual intervention and accelerating sample processing, thereby reducing turnaround times for results. By the end of 2023, the Stop TB Partnership reported that cumulative global procurement of GeneXpert machines, representing key automated molecular platforms, exceeded 16,000 units across 167 countries, demonstrating substantial integration into diagnostic infrastructure. This increased capacity is crucial for managing high sample volumes in high-burden settings. Revvity, in April 2025, announced FDA approval for its Auto-Pure 2400 liquid handling platform with the T-SPOT. TB test, enabling laboratories to process latent TB tests at higher volumes.

The development of compact and portable diagnostic devices critically shapes the global tuberculosis diagnostics market by expanding testing accessibility to remote and underserved populations. These smaller, often battery-powered units facilitate decentralized testing beyond traditional laboratories, lessening reliance on extensive infrastructure and specialized personnel. The Foundation for Innovative New Diagnostics (FIND), in its 2024 report, noted that the deployment of portable molecular platforms allowed testing closer to patients in remote and rural areas, with over 30 countries having piloted or adopted these devices by the end of 2023. This decentralization enables earlier diagnosis and treatment. Tulane University, in April 2025, announced researchers developed a handheld lab-in-tube assay device capable of diagnosing tuberculosis in under an hour using a saliva sample.

Segmental Insights

In the Global Tuberculosis Diagnostics Market, the Diagnostic Laboratory Methods segment is experiencing the most rapid growth, driven by significant advancements in detection technology. This acceleration is primarily due to the development and widespread adoption of highly sensitive and specific molecular diagnostic techniques, such as nucleic acid amplification tests. These modern laboratory approaches offer substantial improvements over traditional methods by providing faster turnaround times for results and enabling the prompt identification of drug-resistant *Mycobacterium tuberculosis* strains. The World Health Organization's endorsements of these rapid diagnostic tools further underscore their critical role in enhancing early detection, facilitating timely patient treatment, and effectively curbing disease transmission globally.

Regional Insights

North America holds a leading position in the global tuberculosis diagnostics market, primarily driven by its advanced healthcare infrastructure and substantial investments in research and development for innovative diagnostic solutions. The region benefits from well-established diagnostic facilities and a proactive approach to disease surveillance and control. Additionally, favorable reimbursement policies and robust government initiatives support TB diagnostic programs and the adoption of state-of-the-art diagnostic techniques, ensuring broader access and utilization of tests such as nucleic acid amplification tests (NAATs). The presence of key market players and a high awareness of infectious disease management further solidify North America's dominance in this sector.

Recent Developments

• In February 2025, AlterDiag announced a strategic partnership with the Institut Pasteur for the research and development of next-generation rapid diagnostic technologies. This collaboration aims to create affordable and user-friendly rapid diagnostic tests for infectious diseases by utilizing single-domain antibodies and lateral flow immunochromatography. AlterDiag will be responsible for the industrialization, regulatory registrations, and commercialization of these new diagnostic tools, which are intended to provide high-performance point-of-care solutions within the global tuberculosis diagnostics market.

• In February 2025, QIAGEN received a favorable ruling from the German Federal Patent Court, which reaffirmed the validity of an important patent protecting key innovations in its QuantiFERON technology. This decision strengthens QIAGEN's intellectual property portfolio related to its QuantiFERON-TB Gold Plus, a leading diagnostic test for latent tuberculosis infection. The reaffirmation of this patent is crucial for maintaining the company's position and protecting its scientific advancements in the global tuberculosis diagnostics market, ensuring continued innovation in detection methods.

• In July 2024, Roche completed its acquisition of LumiraDx's point-of-care technology assets, a strategic move aimed at expanding its diagnostic capabilities. Following this acquisition, Roche confirmed its ongoing partnership with the Bill & Melinda Gates Foundation. This collaboration focuses on advancing the platform's molecular diagnostic capabilities by developing an innovative and rapid point-of-care molecular test specifically for tuberculosis, addressing critical diagnostic gaps in primary care settings globally. This initiative underscores Roche's commitment to improving access to timely and actionable diagnostic results for infectious diseases.

• In April 2024, QIAGEN introduced the QIAseq xHYB Mycobacterium tuberculosis Panel for research use, significantly expanding its tuberculosis diagnostics portfolio. This new tool allows for culture-free whole-genome sequencing directly from complex samples, such as sputum or cerebrospinal fluid, eliminating the need for lengthy bacterial cultures. The panel is designed to cover major TB lineages and all antimicrobial resistance-related genes, facilitating rapid identification of resistant tuberculosis strains and enhancing real-time epidemiological surveillance to combat antimicrobial resistance globally.

Key Market Players

• Abbott Laboratories Inc.
• Becton, Dickinson, and Company
• F. Hoffmann-La Roche Ltd.
• Thermo Fisher Scientific Inc.
• BioMérieux SA
• Hain Lifescience GmbH
• QIAGEN NV
• Cepheid
• Hologic, Inc.

Report Scope:

In this report, the Global Tuberculosis Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Tuberculosis Diagnostics Market, By Test Type:

• Tuberculosis Diagnostics Market, By End-Use:

• Tuberculosis Diagnostics Market, By Region:

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Tuberculosis Diagnostics Market.

Available Customizations:

Global Tuberculosis Diagnostics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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