United States Tuberculosis Testing Market is estimated to reach US$ 2058.0 million by 2030 | Top 3 key players - Thermo Fisher Scientific, Inc., Hologic Corporation, Cepheid (A Danaher Company).

Market Size and Growth:

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 (2024-2031). The Market is growing due to the rising prevalence of TB, increased government initiatives for early diagnosis, and advancements in rapid and accurate testing technologies.

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The Tuberculosis (TB) Testing Market encompasses diagnostic solutions used to detect active and latent TB infections. It includes molecular tests, skin tests, interferon-gamma release assays (IGRAs), and culture-based methods. Rising TB prevalence, advancements in rapid diagnostic technologies, and increasing healthcare awareness drive market growth. These tests aid early detection, effective treatment, and disease control globally.

Industry Recent Developments:

United States:

✅ Increasing incidence of tuberculosis driven by factors such as the HIV epidemic, international travel, and migration has led to a rise in latent tuberculosis cases, prompting heightened focus on early detection through advanced testing methods like nucleic acid amplification tests (NAATs) and polymerase chain reaction (PCR). Also, diagnostic laboratories and hospitals are increasingly adopting these molecular techniques for faster and more accurate TB detection. (August-October 2025)

✅ Prominent U.S. market players, including QIAGEN, Danaher, and F. Hoffman-La Roche Ltd., are implementing growth strategies such as partnerships and acquisitions to maintain a dominant market share and increase product availability. (September 2025)

✅ Hospitals are expanding clinical laboratory facilities to improve accessibility to TB diagnostics, which is expected to boost test volume and accelerate the adoption of advanced tuberculosis detection technologies. (October 2025)

Japan:

✅ Japan's Global Health Innovative Technology Fund invested $4.5 million to develop a compact, ultrasensitive, and non-invasive TB diagnostic platform using advanced biomarker technology. This multinational collaboration aims to create a highly sensitive, urine-based point-of-care test integrated into a portable system. (August 2025)

✅ The country is tackling diagnosis and treatment delays linked to limited awareness among patients and physicians, which hinders timely TB testing. Efforts focus on improving accessibility, sensitivity, and turnaround time for diagnostic tools, especially for populations with challenges providing sputum samples such as children. (September 2025)

✅ Japan provided a mobile X-ray machine to the Philippines as part of its Official Development Assistance program, demonstrating mobile diagnostic technology deployment to support international public health and TB screening efforts abroad. (August 2025)

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Major 5 Key Players:

1. Thermo Fisher Scientific, Inc.
Overview: Thermo Fisher Scientific is a leading provider of laboratory instruments and reagents, with a significant presence in the TB diagnostics sector.

Key Offerings: The company offers advanced diagnostic tools such as the VersaTREK® system for mycobacterial growth detection and the TaqPathTM MTB MDR Kit for rapid molecular testing of multidrug-resistant TB.

Recent Developments: Thermo Fisher reported a strong third-quarter performance in 2025, driven by increased demand for its laboratory tools and biopharma technologies. The company continues to expand through acquisitions, including the purchase of Solventum's filtration business for $4.1 billion.

2. Hologic Corporation
Overview: Hologic is a prominent player in medical diagnostics, specializing in women's health and infectious disease testing.

Key Offerings: The company provides molecular diagnostic solutions for TB detection, contributing to global efforts in TB control.

Strategic Moves: In October 2025, Hologic announced plans to be acquired by Blackstone and TPG in a deal valued at up to $18.3 billion, indicating strong investor confidence in its diagnostic capabilities.

3. Cepheid (A Danaher Company)
Overview: Cepheid is renowned for its rapid molecular diagnostic platforms, particularly in infectious diseases.

Key Offerings: The GeneXpert® system is widely used for TB testing, offering quick and accurate results, which is crucial in resource-limited settings.

Market Impact: Cepheid's GeneXpert platform has significantly increased market share, with reports indicating growing adoption in various regions.

4. F. Hoffmann-La Roche AG
Overview: Roche is a global leader in pharmaceuticals and diagnostics, with a strong portfolio in infectious disease testing.

Key Offerings: Roche provides molecular diagnostic solutions for TB, including tests for drug-resistant strains.

Market Position: The company continues to innovate in the TB diagnostics space, contributing to global TB control efforts.

5. bioMérieux SA
Overview: bioMérieux is a French multinational specializing in in vitro diagnostics, with a focus on infectious diseases.

Key Offerings: The company offers diagnostic solutions for TB, including tests for detecting Mycobacterium tuberculosis and assessing drug resistance.

Global Reach: bioMérieux's products are widely used in hospitals and laboratories around the world, supporting TB diagnosis and treatment monitoring.

FDA Approvals and Innovations:

1. FDA Approves Auto-Pure 2400 System
In April 2025, the FDA approved the Auto-Pure 2400 liquid handling platform integrated with the T-SPOT.TB test. This system enhances the speed and accuracy of latent TB diagnostics by combining liquid handling and magnetic cell isolation techniques.

2. Revvity's Automated Latent TB Test
Revvity received FDA approval for an improved automated latent TB test in April 2025. This advancement aims to streamline TB testing processes, contributing to more efficient diagnostics.

3. CRISPR-TB Blood Test Receives Breakthrough Device Designation
IntelliGenome's CRISPR-TB blood test was granted FDA Breakthrough Device Designation in January 2025. Utilizing CRISPR technology, this test detects Mycobacterium tuberculosis DNA in blood samples, offering a non-invasive and rapid diagnostic method.

Mergers and Acquisitions:

The TB testing market has seen moderate M&A activity in 2025, primarily driven by:

Strategic Acquisitions: Larger companies acquiring smaller firms to expand product portfolios and market reach.

Focus Areas: Emphasis on integrating advanced diagnostic technologies and enhancing distribution networks.

Regulatory Developments:

1. FDA Withdraws and Revises Guidance on TB Transmission Risk
In May 2025, the FDA withdrew its final guidance on reducing the risk of Mycobacterium tuberculosis transmission through human cells, tissues, and cellular and tissue-based products. The guidance was reissued as a draft with revisions based on public feedback.

2. WHO Releases Updated Target Product Profiles
The World Health Organization (WHO) released new Target Product Profiles in August 2025, providing technology-agnostic guidance for TB screening tests. These profiles aim to standardize and improve the effectiveness of TB diagnostics globally

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Segments Covered in the Tuberculosis Testing Market:

1. By Test Type
This segment classifies the market based on the kind of TB tests available:

Tuberculin Skin Test (TST) - Detects latent TB infection by injecting purified protein derivative under the skin.

Interferon-Gamma Release Assays (IGRAs) - Blood tests (e.g., QuantiFERON-TB Gold) that measure immune response to TB bacteria.

Molecular Tests - Advanced tests like GeneXpert MTB/RIF, which detect TB DNA and drug resistance rapidly.

Microscopy & Culture Tests - Traditional methods where sputum is examined under a microscope or cultured to identify TB bacteria.

2. By Sample Type
This segment categorizes tests by the sample collected:

Sputum - Most common for pulmonary TB diagnosis.

Blood - Mainly for IGRAs.

Urine / Other Body Fluids - Less common, used in specific TB types (e.g., extrapulmonary TB).

3. By End User
This segment looks at where TB testing is conducted:

Hospitals & Clinics - Routine testing for suspected TB cases.

Diagnostic Laboratories - Specialized labs using molecular and culture techniques.

Government & Public Health Programs - Mass TB screening initiatives.

Home Care / Point-of-Care Testing - Emerging trend for rapid and easy testing outside clinical settings.

4. By Geography
Markets are also segmented by regions:

North America - Focus on advanced molecular diagnostics.

Europe - High adoption of IGRAs and government screening programs.

Asia-Pacific - Largest patient pool; growing adoption of rapid molecular tests.

Latin America & Middle East & Africa - TB prevalence drives government-led initiatives.

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People Also Ask:

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