Tuberculosis Diagnostics Market Size, Share, Forecast, & Trends Analysis by Test Type (Mantoux, IGRA, Radiography [X-ray, CT] Molecular [NAAT, WGS, Rapid] Culture, Sputum Smear), End User (Hospital, Diagnostic Lab), Infection Stage – Global Forecast to 2031

The Tuberculosis Diagnostics Market was valued at $2.41  billion in 2023. This market is expected to reach $3.56  billion by 2031, from an estimated $2.54  billion in 2024, at a CAGR of 5% during the forecast period 2024-2031.

Tuberculosis Diagnostics Market Size & Forecast

The growth of this market can be attributed to the rising prevalence of tuberculosis (TB) in low—and middle-income countries, the emergence of drug-resistant strains, and favorable initiatives for TB diagnosis and treatment. Moreover, initiatives by governments and organizations to raise awareness regarding tuberculosis are expected to generate growth opportunities for the players operating in the tuberculosis diagnostics market.

Tuberculosis Diagnostics Market Growth Drivers

Rising Prevalence of Tuberculosis in Low- and Middle-Income Countries

Around a quarter of the global population is estimated to have been infected with TB bacteria. According to the World Health Organization (WHO), in 2022, around 1.3 million people succumbed to tuberculosis (TB) globally. Moreover, 10.6 million people fell ill from TB in 2022 globally. However, the middle- and low-income countries have the highest TB burden, accounting for 80% of total deaths caused by TB. In 2022, the largest number of new TB cases occurred in WHO’s Southeast Asian Region, accounting for 46%, the African Region, accounting for 23%, and the Western Pacific region, accounting for 18%. Around 87% of new TB cases occurred in the 30 high TB-burden countries, with more than two-thirds of the global total in Bangladesh, China, the Democratic Republic of the Congo, India, Indonesia, Nigeria, Pakistan, and the Philippines.

Reducing the TB burden in low- and middle-income countries is expected to lead to the adoption of diagnostic tests for early diagnosis and treatment, driving market growth.

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Tuberculosis Diagnostics Market Trends

Growing Biomarker Research for Tuberculosis

Biomarker research for tuberculosis (TB) is growing, and there is a wide range of biomarkers that can be used to detect the presence of the disease. These biomarkers can be related to either the pathogen or the host and include:

Pathogen Biomarkers: Mycobacterium tuberculosis (Mtb) products can be detected in blood, urine, or sputum. Mtb DNA can be detected in the blood and urine of pulmonary TB patients with greater sensitivity than Mtb culture.

Host Biomarkers: These include antibody response, cytokine response, and blood-based gene expression signatures. Antibodies are often used because they are inexpensive and easy to test. Cytokine response involves measuring the release of Interferon‐Gamma (IFN‐γ) after blood stimulation with Mtb‐specific antigens.

The growing research on TB biomarkers is expected to lead to the discovery of novel biomarkers, which will aid in the development of better and more precise tests for TB diagnosis.

Emergence of Point-of-Care (PoC) Testing

Point-of-care (POC) diagnostic tests for tuberculosis (TB) are portable, user-friendly tests that can be performed near the patient without the need for specialized training or extensive laboratory infrastructure. POC tests can help to: Detect TB early, Initiate treatment immediately, Reduce TB transmission, and Improve patient outcomes. These tests are beneficial, especially in the camps and temporary medical centers established by global organizations such as the United Nations and WHO. These medical centers are established at places of TB outbreaks or underdeveloped regions where governments are unable to carry out effective TB management. Thus, the emergence of PoC tests is expected to positively impact the growth of the tuberculosis diagnostics market.

Tuberculosis Diagnostics Market Opportunity

Initiatives by Governments and Organizations to Raise Awareness regarding Tuberculosis

Due to the huge burden of TB globally, several initiatives are being undertaken to raise awareness about tuberculosis. For instance:

• In September 2023, the United Nations (UN) held a second high-level meeting concerning TB. Highlights of the meeting include improving access to TB services, accelerating research, aiming to reduce vulnerability, and mobilizing resources for effective TB control. This is aimed at a global effort to combat tuberculosis.

• In 2022, the President of India launched Pradhan Mantri TB Mukt Bharat Abhiyaan, a campaign to eliminate TB from the country by 2025.
• In 2022, the United States Agency for International Development (USAID) released its eight-year Global Tuberculosis (TB) Strategy 2023-2030, which aims to achieve a 35% decline in TB incidence and a 52% reduction in TB mortality compared to 2019 levels. Additionally, the goals entail diagnosing and initiating treatment for 90% of new TB and drug-resistant TB cases, maintaining a 90% treatment success rate for both drug-sensitive and drug-resistant TB, and administering TB preventive treatment to 30 million individuals.

Tuberculosis Diagnostics Market Analysis: Key Findings

By Test Type: In 2024, the Skin Test/Mantoux Segment to Dominate the Tuberculosis Diagnostics Market

Based on test type, the market is segmented into skin test/Mantoux, radiographic tests, molecular tests, sputum smear microscopy, culture & drug resistance tests, and other test types. In 2024, the skin test segment is expected to account for the largest share of 38.2% of the tuberculosis diagnostics market. The large market share of this segment is attributed to the ease and simplicity of the test, cost-effectiveness, and the ability to test for latent infections.

However, the molecular tests segment is projected to register the highest growth rate of 5.8% during the forecast period of 2024–2031. The segment’s growth is driven by the high efficiency and accuracy of molecular tests, technological advancements in molecular diagnostic technology, increasing availability of molecular tests for TB, and initiatives by the companies to introduce rapid molecular diagnostic tests for TB & drug resistance. Moreover, the new guidelines by public organizations such as the WHO regarding molecular TB tests further drive the segment’s growth. For instance, in March 2024, the WHO published recommendations on the use of a new class of diagnostic technologies: targeted next-generation sequencing (NGS) tests for the diagnosis of drug-resistant tuberculosis (TB).

By Infection Stage: In 2024, the Active Segment to Dominate the Tuberculosis Diagnostics Market

Based on infection stage, the tuberculosis diagnostics market is segmented into active and latent. In 2024, the active segment is expected to account for the larger share of 52.0% of the tuberculosis diagnostics market. The large share of the segment is attributed to the large burden of active cases globally, rising awareness regarding tuberculosis, and favorable initiatives for TB diagnosis and treatment. For instance, on 24^th March 2023, the Stop TB Partnership hosted by the United Nations Office for Project Services (UNOPS) released a toolkit called “Yes! We Can End TB.” This toolkit was launched to bring attention to TB and the efforts to end TB by the year 2030.

Similarly, the active segment is expected to register the highest CAGR during the forecast period of 2024-2031. This segment’s growth is attributed to the increasing prevalence of tuberculosis in low- and middle-income countries, aims and goals set by the governments and public organizations to manage the TB burden, and growing instances of TB outbreaks. For instance, in May 2024, the City Council in Long Beach, California (U.S.) declared a health emergency due to the outbreak of TB in the city. Moreover, as of April 29, 2024, 14 cases were found infected, and around 170 people were exposed.

By End User: In 2024, the Diagnostic Laboratories Segment to Dominate the Tuberculosis Diagnostics Market

Based on end user, the tuberculosis diagnostics market is segmented into diagnostic laboratories, hospitals & clinics, academic & research institutes, and other end users. In 2024, the diagnostic laboratories segment is expected to account for the largest share of the market. The availability of a wide menu of tests, rising awareness regarding TB, and increased identification of TB cases due to prompt testing contribute to the segment’s large share.

The diagnostic laboratories segment is also expected to register the highest CAGR during the forecast period. This segment’s growth is attributed to favorable initiatives to raise awareness regarding TB and the launch of new diagnostic tests for TB and drug resistance. For instance, in January 2023, Molbio Diagnostics Pvt. Ltd. (India) launched the Treunat MTB-INH to test the presence of isoniazid resistance in Mycobacterium tuberculosis bacteria.

Geographical Analysis

In 2024, North America is expected to account for the largest share of 34.1% of the tuberculosis diagnostics market. Among the U.S. and Canada, in 2024, the U.S. is expected to account for the largest share of the tuberculosis diagnostics market in North America. The region’s large share is attributed to the high awareness regarding TB, routine TB testing for latent infections by the people traveling to the TB burdened countries, and adoption of advanced diagnostic methods.

However, Asia-Pacific is slated to register the highest CAGR of 6.6% during the forecast period. Among the countries in the Asia-Pacific region, India and China are expected to register the highest CAGR during the forecast period. This growth is attributed to favorable government initiatives to strengthen the TB diagnostic infrastructure in the countries, aiming towards the eradication of TB and increasing awareness regarding TB.

Tuberculosis Diagnostics Market: Key Companies

The report offers a competitive analysis based on an extensive assessment of the leading players’ product portfolios, geographic presence, and key growth strategies adopted in the last 3–4 years. The key players operating in the tuberculosis diagnostics market are F. Hoffmann-La Roche Ltd. (Switzerland), Becton, Dickinson and Company (U.S.), Abbott Laboratories, Inc. (U.S.), Thermo Fisher Scientific, Inc. (U.S.), QIAGEN GmbH (Germany), Hologic, Inc. (U.S.), bioMérieux SA (France), Danaher Corporation (U.S.), Oxford Immunotec Ltd. (U.K.), Hain Lifescience GmbH (Germany), and Creative Diagnostics (U.S.).

Mental Health Apps Industry Overview: Latest Developments from Key Industry Players

• In November 2023, Revvity, Inc. (U.S.) launched its T-SPOT.TB test for latent TB screening in India.

• In October 2023, the Serum Institute of India launched a point-of-care skin test for detecting latent tuberculosis infections.

• In April 2023, Boditech Med Inc. (South Korea) entered into an agreement with the Menarini Group (Italy). Under this agreement, Menarini will be the exclusive distributor of Boditech’s AFIAS-10 Single Test Immuno-Assay System, including IGRA-Tuberculosis, in 34 European countries.

Tuberculosis Diagnostics Market Research Summary:

Key questions answered in the tuberculosis diagnostics market report: