Tuberculosis Diagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2028

Tuberculosis Diagnostics Market By Product Type (Instruments And Assay, Kits, & Reagents), Test Type (Radiographic Test, Laboratory Test, Nucleic Acid Testing, Cytokine Detection Test, Drug Resistance Test, And Others), End-User (Hospitals And Clinics, Diagnostic Centers, And Others), and geography is expected to grow at a steady CAGR forecast till 2028 owing to the increasing prevalence of tuberculosis and increasing demand of point-of-care (POC) diagnostic.

The global tuberculosis diagnostics market is estimated to grow at a CAGR of 5.11% during the forecast period from 2023 to 2028. The demand for tuberculosis diagnostics is primarily being boosted by the increasing prevalence of tuberculosis and multidrug-resistant tuberculosis (MDR-TB). Moreover, the availability of technologically advanced Point-of-Care (POC) diagnostic methods, increasing awareness about early diagnosis, increasing product launches and approvals, and innovation in product development among others, thereby contribute to the overall growth of the tuberculosis diagnostics market during the forecast period from 2023-2028.

Tuberculosis Diagnostics Market Dynamics:

The increasing prevalence of tuberculosis across the globe will increase the overall market of tuberculosis diagnostics. For instance, as per the World Health Organization (WHO) 2023, in 2021, an estimated 10.6 million people fell ill with tuberculosis (TB) worldwide which accounted for six million men, 3.4 million women, and 1.2 million children.

As per the same source, Multidrug-resistant TB (MDR-TB) remains a public health crisis and a health security threat. Only about 1 in 3 people with drug-resistant TB accessed treatment in 2021. Also, the same source concluded that an estimated 74 million lives were saved through TB diagnosis and treatment between 2000 and 2021.

Similarly, the TB incidence rate increased by 3.6% between 2020 and 2021. Geographically, most TB cases in 2021 were in the WHO regions of South-East Asia (45%), Africa (23%), and the Western Pacific (18%), with smaller shares in the Eastern Mediterranean (8.1%), the Americas (2.9%), and Europe (2.2%).

Further, the WHO Global TB Report 2022 stated that India's TB incidence for the year 2021 was 210 per 100,000 population. The afore-mentioned source also stated that in 2020, 163,602 incident TB cases were notified in the European Region.

As per the latest report of the Government of India published in March 2021, there were an estimated 124,000 cases of MDR/RR-TB in India, in 2021.

Thus, from the above sources, it can be concluded that the prevalence of tuberculosis is high across various regions worldwide. This in turn will increase the need for better diagnostic tests and treatment ultimately anticipated to propel the market growth during the forecast period.

Furthermore, the growing company's focus on research and development activities and intensive product pipelines are also contributing to the growth of the market. For instance, in October 2021, Qiagen launched the QIAreach QuantiFERON-TB test, built on the proven QuantiFERON-TB Gold Plus technology for tuberculosis (TB) infection.

Also, in February 2023, the Indian Institute of Technology Madras (IIT Madras) partnered with the General Insurance Corporation of India, a Public Sector Undertaking, to develop a urine-based tuberculosis diagnosis or screening. The envisaged product for urine-based TB screening/diagnosis is anticipated to be faster and far more affordable than the existing point-of-care diagnostic kits available for various diseases such as blood glucose monitors.

Therefore, the above-mentioned factors will propel the tuberculosis diagnostics market during the forecast period from 2023-2028.

However, false positive results, low coverage, or absence of insurance in the emerging market, and others may restrict the growth of the overall tuberculosis diagnostics market.

Tuberculosis Diagnostics Market Segment Analysis:

Tuberculosis Diagnostics Market by Product Type (Instruments and Assay, Kits, & Reagents), Test Type (Radiographic Test, Laboratory Test, Nucleic Acid Testing, Cytokine Detection Test, Drug Resistance Test, and Others), End-User (Hospitals and clinics, Diagnostic Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the test type segment of the tuberculosis diagnostics market, the nucleic acid testing category is expected to amass a significant revenue share in the year 2022. This can be ascribed to the advantages and applications associated with the segment.

A nucleic acid amplification test (NAAT), for tuberculosis (TB) is a molecular test used to detect the DNA (deoxyribonucleic acid) of Mycobacterium tuberculosis complex (MTBC) in a sputum or other respiratory sample. A NAAT can detect MTBC genetic material even when very small amounts are present in the sample tested.

The NAAT results are typically available in 24 to 48 hours. Rapid results from NAAT enable earlier diagnosis of TB, earlier initiation of treatment, a reduced period of infectiousness, and improved patient outcomes.

The GeneXpert MTB/RIF NAAT also provides rapid identification of RIF resistance, a predictor of multi-drug resistant TB. In most cases, patients resistant to RIF are also resistant to isoniazid (INH).

The Cepheid offers the Xpert MTB/RIF assay for Nucleic Acid Amplification Tests (NAATs). It is an automated molecular diagnostic test that is used to detect the presence of Mycobacterium tuberculosis complex (MTB-complex) DNA in respiratory specimens from both adults and children.

Therefore, owing to the above-mentioned factors, the nucleic acid testing category is expected to register significant growth, thereby driving the growth of the overall tuberculosis diagnostics market during the forecast period.

North America is expected to dominate the overall Tuberculosis Diagnostics Market:

Among all the regions, North America is estimated to account for the largest share of the tuberculosis diagnostics market in the year 2022. Owing to the significance of key growth factors such as the rising prevalence of tuberculosis and multidrug-resistant tuberculosis (MDR-TB), availability of technologically advanced point-of-care (POC) diagnostic methods, increasing awareness about early diagnosis, increasing product launches and approvals, high disposable income, sophisticated healthcare infrastructure, presence of key players, increasing product development activities, and others, the market for tuberculosis diagnostics is expected to witness prosperity in the region during the forecast period 2022-2028.

The growing prevalence of tuberculosis (TB) is anticipated to increase market growth. For instance, according to the Centers for Disease Control and Prevention (CDC) 2023, in 2022, 8,300 TB cases were reported in the United States, compared with 7,874 cases reported in 2021. TB incidence also increased slightly in 2022, with 2.5 cases per 100,000 persons.

As per the same source, about 7,882 new cases of TB were reported in 2021 and about 7,171 in 2020 in the United States.

The source Public Health Agency of Canada in Tuberculosis in Canada: Infographic (2021) stated that in 2021, about 1,829 active TB cases were reported in Canada. The corresponding incidence was 4.8 active TB cases per 100,000 population. The incidence for females was 4.3 cases per 100,000, and 5.3 cases per 100,000 for males.

Thus, from the above sources, it can be concluded that the prevalence of TB is high in the North American region, which in turn will increase the demand for tuberculosis diagnostics kits, tools, assays, and others.

Further, the increasing approvals by the US FDA will also impact the market of tuberculosis diagnostics in the upcoming years. For instance, in March 2023, the US Food and Drug Administration approved the use of two additional cell isolation instruments from PerkinElmer's Oxford Immunotec with the company's previously approved T-Cell Select™ reagent kit that helps diagnose tuberculosis (TB) in vitro. The approved instrumentation offers plate- or strip-based sample preparation to meet variable throughput requirements.

Thus, the above-mentioned factors are likely to propel the growth of the tuberculosis diagnostics market in the region during the forecast period from 2023-2028.

Tuberculosis Diagnostics Market Key Players:

Some of the key market players operating in the tuberculosis diagnostics market include: Abbott, BD, BioMerieux SA, F. Hoffmann-La Roche Ltd, Serum Institute of India, Thermo Fisher Scientific Inc, SRL Diagnostic, Cepheid, Bruker Daltonics GmbH & Co. KG, Hologic Corporation, QIAGEN, AdvaCare Pharma, Revvity, Creative Diagnostics, Lionex GmbH, Par Pharmaceutical, Akonni Biosystems, Inc., Epistem limited, PerkinElmer, Sanofi, and others.

Recent Developmental Activities in the Tuberculosis Diagnostics Market:

• In March 2022, SRL Diagnostics was the first company to offer a test for TB that looked at the whole genome. This test not only cuts down on the time it takes to find tuberculosis that doesn't respond to many treatments but also gives a full profile of resistance to 18 different TB drugs.
• In March 2021, bioMerieux SA announced that it received CE mark approval from the European Union for its TB IGRA test on VIDAS. The test is used for the diagnosis of latent TB infection.
• In July 2020, The Foundation for Innovative New Diagnostics and Cepheid, Inc, announced today the launch of the new Xpert® MTB/XDR test, which enables expanded drug-resistance tuberculosis (TB) profiling in less than 90 minutes. Xpert MTB/XDR can be used to empower clinicians to quickly prescribe treatment regimens for extensively drug-resistant TB (XDR-TB).
• In December 2019, the FDA approved Qiagen and DiaSorin's test for latent tuberculosis, the companies said Wednesday. The approval brings Qiagen's QuantiFERON-TB Gold plus TB blood test to DiaSorin's Liaison immunoassay analyzers.

Key Takeaways from the Tuberculosis Diagnostics Market Report Study:

• Market size analysis for current tuberculosis diagnostics market size (2022), and market forecast for 5 years (2023-2028)
• Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the global tuberculosis diagnostics market.
• Various opportunities available for the other competitors in the tuberculosis diagnostics market space.
• What are the top-performing segments in 2022? How these segments will perform in 2028?
• Which are the top-performing regions and countries in the current tuberculosis diagnostics market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for tuberculosis diagnostics market growth in the coming future?

Target Audience who can be benefited from this Tuberculosis Diagnostics Market Report Study:

• Tuberculosis diagnostics product providers
• Research organizations and consulting companies
• Tuberculosis diagnostics-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in tuberculosis diagnostics
• Various End-users who want to know more about the tuberculosis diagnostics market and the latest technological developments in the tuberculosis diagnostics market.

Frequently Asked Questions for the Tuberculosis Diagnostics Market:

1. What are tuberculosis diagnostic devices?

• The devices, kits, agents, assays, and others used for the diagnosis of tuberculosis are termed tuberculosis diagnostic devices. Tuberculosis (TB) refers to an infectious bacterial disease that primarily affects the lungs (pulmonary), along with other parts of the body (extrapulmonary). The infection is diagnosed via a Mantoux tuberculin skin test (TST) or the TB blood test. Additional tests are required to confirm TB disease, depending on the infected organs.

2. What is the market for global tuberculosis diagnostics?

• The global tuberculosis diagnostics market is estimated to grow at a CAGR of 5.11% during the forecast period from 2023 to 2028.

3. What are the drivers for the global tuberculosis diagnostics market?

• The demand for tuberculosis diagnostics is primarily being boosted by the increasing prevalence of tuberculosis and multidrug-resistant tuberculosis (MDR-TB), surging awareness about early diagnosis, availability of technologically advanced Point-of-Care (POC) diagnostic, favorable government policies to surge the demand for tuberculosis (TB) diagnostics, increasing product launches and approvals, and others thereby contributing to the overall growth of the tuberculosis diagnostics market during the forecast period from 2023-2028.

4. Who are the key players operating in the global tuberculosis diagnostics market?

• Some of the key market players operating in the tuberculosis diagnostics market include Abbott, BD, BioMerieux SA, F. Hoffmann-La Roche Ltd, Serum Institute of India, Thermo Fisher Scientific Inc, SRL Diagnostic, Cepheid, Bruker Daltonics GmbH & Co. KG, Hologic Corporation, QIAGEN, AdvaCare Pharma, Revvity, Creative Diagnostics, Lionex GmbH, Par Pharmaceutical, Akonni Biosystems, Inc., Epistem limited, PerkinElmer, Sanofi, and others.

5. Which region has the highest share in the tuberculosis diagnostics market?

• North America is expected to dominate the overall tuberculosis diagnostics market during the forecast period from 2023-2028. Owing to factors such as rising prevalence of tuberculosis and multidrug-resistant tuberculosis (MDR-TB), high disposable income, sophisticated healthcare infrastructure, regulatory approval for new devices, and high awareness about the biomaterial base tuberculosis diagnostics among others, the North America tuberculosis diagnostics market is expected to growth in coming years.