Tuberculosis Testing Market Set for Steady Growth to US$ 2,058.0 Million by 2030, Led by North America's 38.9% Market Share | Key Players - Abbott Laboratories, Becton Dickinson and Company, F. Hoffmann-La Roche AG

The Tuberculosis Testing Market size was valued at US$ 1,337.10 million in 2023 and is estimated to reach US$ 2058.0 million by 2030, growing at a CAGR of 6.0% during the forecast period (2023-2030).

Market growth is driven by the rising global incidence of tuberculosis, expanding access to rapid diagnostic tools in high-burden regions, and heightened public health initiatives post-COVID. Advancements in molecular diagnostics like GeneXpert, increasing adoption of interferon-gamma release assays (IGRAs), growing investments in TB elimination programs by WHO and governments, and regulatory endorsements for point-of-care testing are further accelerating market expansion.

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Key Industry Developments

United States:
✅ February 2026: QIAGEN launched an enhanced version of its QuantiFERON-TB Gold Plus assay with improved sensitivity for detecting latent TB infections, incorporating advanced interferon-gamma release advancements to support early intervention in high-risk populations.​

✅ January 2026: Hologic announced R&D progress on a next-generation Aptima Mycobacterium tuberculosis assay, featuring automated nucleic acid amplification for superior detection of drug-resistant strains.​

✅ November 2025: Roche expanded its cobas MTB assay portfolio with a point-of-care module certified for U.S. use, leveraging real-time PCR technology for on-site TB confirmation.​

Asia Pacific / Japan:
✅ January 2026: Fujirebio (H.U. Group) introduced the ImmuQuikTB rapid lateral flow test in Japan, a novel immunoassay for TB antigen detection optimized for high-burden settings.​

✅ December 2025: Thermo Fisher Scientific unveiled a localized version of its Accula TB test for Asia Pacific markets, incorporating AI-driven result interpretation for enhanced accuracy.​

✅ October 2025: Danaher's Beckman Coulter debuted the DxI TB assay in Japan, a high-throughput immunoassay with multiplexing for simultaneous latent and active TB detection.​

Strategic Mergers and Acquisitions:
✅ Danaher Corporation acquired Abcam plc in August 2023 for over $5.7 billion, enhancing its life sciences capabilities with Abcam's reagents and antibodies, including those supporting tuberculosis diagnostics to meet demand for advanced TB research tools.

Key Players:
Abbott Laboratories | Becton, Dickinson and Company | F. Hoffmann-La Roche AG | bioMérieux SA | Sanofi | Cepheid | Hain Lifescience GmbH

Strategic Leadership Report: Top 5 Players in Tuberculosis Testing Market 2026
-Abbott Laboratories: Launched the Determine TB LAM Ag rapid test for point-of-care detection of active TB in HIV-positive patients via urine samples, enabling faster screening and earlier treatment in resource-limited settings.

-Becton Dickinson and Company: Introduced the BD Max MDR-TB panel, a molecular assay that simultaneously detects TB bacteria and resistance to isoniazid and rifampicin, supporting rapid first-line diagnosis and optimal patient treatment.

-F. Hoffmann-La Roche AG: Released the cobas MTB-RIF/INH test on cobas 6800/8800 systems, providing flexible detection of TB and drug-resistant strains from a single sample to accelerate diagnosis and reduce infection spread.

-bioMérieux SA: Partnered with Oxford Nanopore to launch AmPORE-TB, a research-use sequencing solution for rapid characterization of drug-resistant TB mutations, targeting high-burden regions for improved resistance management.

-Cepheid: Advanced the Xpert MTB/RIF assay portfolio with next-generation cartridges for enhanced sensitivity in detecting TB and rifampicin resistance at the point-of-care, streamlining workflow in decentralized labs.

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Market Drivers and Key Trends:
-Rising TB Incidence: Persistent high burden of tuberculosis, especially multidrug-resistant (MDR-TB) strains in developing regions like Asia-Pacific and Africa, drives demand for advanced diagnostics.

-Diagnostic Innovations: Rapid molecular tests like nucleic acid amplification (NAATs) and point-of-care tools such as Xpert MTB/RIF enable faster, more accurate detection over traditional microscopy.

-Government Initiatives: Global TB elimination programs by WHO, coupled with increased funding and subsidies in high-burden countries, boost testing adoption and infrastructure.

-Drug Resistance Focus: Growing prevalence of resistant TB strains necessitates drug susceptibility testing integration, accelerating market for sophisticated diagnostics.

-Market Hurdles: High costs of advanced technologies, limited access in resource-poor settings, and regulatory complexities constrain broader scalability.

Regional Insights:
-North America: 38.9% (Largest share, driven by comprehensive insurance coverage and CDC laboratory upgrades).​

-Asia Pacific: 38.5% (Fastest growing at 6.74% CAGR, fueled by high TB burden in India, China, and Indonesia).

-Europe: 20% (Supported by ECDC funding, refugee screening, and regulatory pathways for advanced diagnostics).​​

Market Opportunities & Challenges: Tuberculosis Testing Market 2026
-Opportunities:
A "Molecular Diagnostics Surge" accelerates point-of-care adoption; next-gen NAAT platforms enable rapid MDR-TB detection in high-burden regions. WHO's End TB Strategy funding and GxP-compliant AI triage tools offer low-risk entry for precision medtech innovators targeting latent TB screening.

-Challenges:
Post-2025 supply chain disruptions inflate reagent costs, while regulatory harmonization gaps hinder multi-country rollouts. MDR strain variability demands continuous assay validation amid fragmented national screening protocols.

-Strategic Verdict:
Portable GeneXpert evolutions and AI-enhanced interferon-gamma release assays anchor 2026 expansion.

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Market Segmentation Analysis:
-By Test Type: Nucleic Acid Testing Leads with Rapid Diagnostics
Nucleic acid testing dominates at 40% market share in 2024, prized for quick, high-sensitivity detection of Mycobacterium tuberculosis DNA in active cases via PCR methods.
Culture-based tests follow at 25%, serving as gold standard for confirming viability but slowed by 2-6 week incubation.
Drug susceptibility testing claims 15%, vital for MDR-TB management; cytokine detection assay and latent infection detection (e.g., IGRA) each hold 10%, targeting immune response screening; others make 10%.

-By End-User: Hospital Laboratories Command Volume
Hospital laboratories lead with 45% share, handling high-volume diagnostics in TB-endemic regions with integrated infrastructure.
Diagnostic centers capture 30%, offering specialized outpatient testing for faster results.
Research laboratories take 15%, focused on trials-By Test Type: Nucleic Acid Testing Leads with Rapid Diagnostics
Nucleic acid testing dominates at 40% market share in 2024, prized for its high sensitivity, quick results in hours, and pivotal role in detecting active TB via PCR methods like GeneXpert.
Culture-based tests follow at 25%, the gold standard for confirming TB but limited by 2-6 week turnaround.
Drug susceptibility testing claims 15%, crucial for MDR-TB management; cytokine detection assay and latent infection detection (e.g., IGRA) each hold 10%, targeting immune response screening; others fill 10%.

-By End-User: Hospital Laboratories Command Volume
Hospital laboratories lead with 45% share, central to high-volume TB screening, diagnosis, and public health programs in endemic regions.
Diagnostic centers capture 30%, offering specialized rapid testing for outpatients.
Research laboratories take 15%, focused on R&D and novel diagnostics; clinic laboratories account for 10%, serving point-of-care needs in primary care.

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