Tuberculosis (TB) Diagnostics Market Size, Share & Industry Analysis, By Type (Culture-based Diagnostics, Sputum Smear Microscopy, Rapid Molecular Diagnostics, and Others), By End-user (Diagnostics Laboratories and Hospitals), and Regional Forecast, 2024-2032

The global tuberculosis (TB) diagnostics market size was valued at USD 2.17 billion in 2023 and is projected to grow from USD 2.28 billion in 2024 to USD 3.58 billion by 2032, exhibiting a CAGR of 5.8% during the forecast period (2024-2032). Tuberculosis is a contagious disorder caused by a type of bacteria called Mycobacterium tuberculosis. The infection usually attacks the patient’s lungs. The infection can also attack other body parts such as the brain and spine. Tuberculosis diagnosis can be performed through skin tests and blood tests. The increasing prevalence of this disorder has increased the need for accurate and efficient diagnostic tests to control its spread. This factor is expected to significantly boost the demand for tuberculosis diagnostics in the coming years.

The tuberculosis diagnostics market growth is attributed to increasing TB incidences, growing awareness about the disease, and increased demand for tuberculosis diagnostics to control the disease burden. Furthermore, the rising focus of the market players on the approval and commercialization of their products for TB diagnoses has also been boosting market growth.

• In August 2021, bioMérieux SA announced the launch of an interferon gamma release assay in association with a desktop immunoassay analyzer, which could be used to detect Mycobacterium tuberculosis in blood samples.

The COVID-19 pandemic resulted in a decline in demand for tuberculosis diagnostic products during the pandemic due to the significant decline in patient volumes for TB diagnosis, and the resources devoted to tuberculosis diagnosis programs were diverted to fight against the coronavirus pandemic. However, there was a significant rebound for the market in 2021 and 2022, as TB testing increased significantly, especially in high-burden countries, as lockdown restrictions were lifted.

Tuberculosis (TB) Diagnostics Market Trends

Increased Public-Private Partnerships to Boost Market Growth

In the past few years, there has been an increase in public-private partnerships. The public-private partnerships have a strong positive impact on the market as they contribute to the expansion of tuberculosis diagnosis utilizing international healthcare standards. In the South Asia region, the private health sector provides a significant proportion of diagnostics for diseases, such as tuberculosis, as per government initiatives. Furthermore, government initiatives for increasing awareness regarding the disease and its early diagnosis are also expected to boost the market.

• For instance, as per the Ministry of Health & Family Welfare, in 2018, the Revised National Tuberculosis Control Programme (RNTCP) had a total of 685 collaborations with civil society/partners from all states of India.

Developments in terms of private-public partnerships are expected to positively impact the TB diagnostics market. In February 2023, Roche Diagnostics announced the enhancement of its partnership with the U.S. Centers for Disease Control and Prevention (CDC). This collaboration aims to bolster laboratory capacities in countries that have been heavily impacted by tuberculosis outbreaks. Such public-private partnerships are driving the growth of the global market.

Tuberculosis (TB) Diagnostics Market Growth Factors

Favorable Government Policies to Surge the Demand for Tuberculosis (TB) Diagnostics

Governments have increased the policies for the diagnosis of tuberculosis to reduce tuberculosis burden globally. The demand for diagnosis is expected to grow over the next few years, as there is a strong increase in the levels of awareness amongst countries regarding the severity of the disease. Many countries have emphasized the development of policies to increase the diagnosis rates for tuberculosis.

Factors, such as the high incidence of tuberculosis in high-burden countries and increasing demand for TB testing, further increase the need for government policies and regulations to improve tuberculosis diagnosis rates. Furthermore, the rising awareness in high TB burden countries where the key focus is to reduce tuberculosis cases is expected to strongly propel the sales of tuberculosis diagnostics in the coming years.

Tuberculosis incidence has been growing at a faster pace every year worldwide. For instance, as per the India TB Report 2022, the total number of TB patients, including new & relapse cases notified during 2021 was approximately 1.9 million, which was 19.0% higher than in 2020. Due to such high TB incidence rates, governments from different countries have increased their focus on improving their healthcare expenditure for tuberculosis diagnosis and care.

• According to the India TB Report 2022, India spent approximately USD 399.7 million in 2019-20, experiencing an increase of 39.9% in expenditure compared to 2018-19 for its national TB elimination program.

To reduce the incidence of TB, the government has been releasing policies, leading to strong growth prospects in the global market.

• For instance, in September 2022, the President of India, launched Pradhan Mantri TB Mukt Bharat Abhiyaan, with a vision to eliminate TB by 2025.

Such policies and government initiatives are expected to fuel the market growth during the forecast period.

Rising Incidence of Tuberculosis in High-Burden Countries to Boost Market Growth

One of the most critical drivers that are positively impacting the market growth is the significant increase in the incidence of this disease across emerging countries. For instance, over the past few decades, there has been a surge in patient population suffering from tuberculosis. This factor led to increased demand for research into effective diagnostic technologies for improved patient outcomes and greater accuracy in the diagnosis of these conditions.

• According to the Public Health Agency of Canada 2021, Canada reported a total of 1,904 active tuberculosis cases in 2021, with an incidence rate of 5.0 cases per 100,000 people. The incidence rate differed by gender, with 4.5 cases per 100,000 for females and 5.5 cases per 100,000 for males.


• As per the WHO Global Tuberculosis Report 2022, in 2021, approximately 10.6 million individuals fell ill with tuberculosis globally, representing 4.5% rise from 10.1 million cases reported in 2020. Likewise, between 2020 and 2021, there was an estimated 3.6% increase in tuberculosis incidence rate (new cases per 100,000 populations per year).

Moreover, the high prevalence of tuberculosis encourages the key players to increase their focus on developing new diagnostics, such as nucleic acid amplification tests (NAATs) and rapid molecular assays, which can offer faster and more accurate results, even in challenging cases. As these diagnostics have become vastly available and demonstrate their effectiveness, a significant number of healthcare systems in the high-burden countries are increasingly adopting them, considering the accuracy and quick results. As a result, healthcare agencies and government organizations are concentrating on updating their tuberculosis (TB) diagnosis guidelines and recommending the best available tests.

• For instance, in March 2023, according to the NCBI, the World Health Organization (WHO) updated the TB diagnosis guidelines in February 2021. It reported on commercially available nucleic acid amplification test (NAAT) platforms and developed an algorithm for disease identification.

Such strong incidence rates, increasing demand for TB diagnoses, and increased focus on research and development are expected to propel market growth in the coming years.

RESTRAINING FACTORS

Limitations of Existing Tuberculosis (TB) Diagnostics to Impede Market Growth

Despite a critical and increased need for advanced diagnostics technologies for these diseases, there are a few limitations that may hamper the market growth over the forecast period.

For instance, certain technical complexities associated with tuberculosis diagnostics can act as a major restraining factor for the market during the forecast period. The higher degree of technical challenges in developing these diagnostic technologies is one of the key reasons limiting the overall market growth.

• As per a research published in the IntechOpen in 2019, sputum smear microscopy was the most commonly used diagnostic test for TB but had limitations such as low sensitivity. False positive results may occur in children, older people, and HIV-infected patients. Furthermore, it also cannot be used to diagnose extrapulmonary TB.


• The same research stated that GeneXpert MTB/RIF assay may have some technical limitations such as the short shelf life of the cartridges (only 18 months) requirement and a very stable electricity supply requirement.

Such technical limitations associated with tuberculosis diagnostics are expected to hamper the market growth during the forecast timeframe.

Tuberculosis (TB) Diagnostics Market Segmentation Analysis

By Type Analysis

New Product Launches to Accelerate the Growth of Rapid Molecular Diagnostics Segment to Dominate

On the basis of type, the market is segmented into culture-based diagnostics, sputum smear microscopy, rapid molecular diagnostics, and others.

The rapid molecular diagnostics segment dominated the market in 2023 and is estimated to hold a significant market share throughout the forecast period. The segment's growth is attributed to the efficiency and accuracy associated with rapid molecular diagnostics for TB diagnosis. New product launches in the rapid molecular diagnostics segment are also anticipated to further drive the segment's growth during the forecast period.

• For instance, in March 2023, Illumina Inc. and GenoScreen collaboratively introduced a comprehensive solution that combines Illumina products with the GenoScreen Deeplex Myc-TB assay. This package utilizes targeted Next-Generation Sequencing (NGS) technology to enable rapid and thorough detection of drug resistance in tuberculosis cases. Such new product launches are expected to drive segmental growth over the forecast period.

Furthermore, the culture-based diagnostics segment is expected to grow substantially during the forecast period. The segment's growth is attributed to rising TB incidence, which is increasing the demand for efficient, technologically advanced diagnostics.

In addition, the sputum smear microscopy segment is expected to witness substantial growth during the forecast period as it is the primary tool for diagnosing pulmonary tuberculosis, especially in low- and middle-income countries. Moreover, this technique is simple and inexpensive, which increases their demand, propelling segmental growth.

By End-user Analysis

Strong Presence of Diagnostic Laboratories to Boost the Segment’s Growth

Based on end-user, the market is bifurcated into diagnostic laboratories and hospitals. The diagnostic laboratories segment accounted for a significant share of the market. The segment's growth is due to the strong presence of diagnostic laboratories worldwide. Moreover, an increasing trend of TB diagnosis being conducted in these diagnostic laboratories is responsible for the segment’s growth. 

• For instance, as of May 2021, there were approximately 29,227 diagnostic & medical laboratories in the U.S. The presence of numerous institutions may favor the expansion of the segment in the projected years.

The hospitals segment is estimated to grow at a significant CAGR during the forecast period owing to the substantial number of tuberculosis diagnosis procedures conducted in hospitals.

• For instance, according to Verdict Media Limited, in June 2022, one of the key countries in the global market, India, had an estimated 69,000 public and private hospitals. In emerging countries, including India, hospitals will play an important role as they are expected to conduct a significant number of these diagnostic procedures.

REGIONAL INSIGHTS

The market size in North America stood at USD 0.62 billion in 2023. The robust tuberculosis (TB) diagnostics market share of the region is due to the increasing prevalence of TB, which has been boosting the number of TB diagnosis being conducted in North America. Moreover, the strong presence of market players in this region is expected to contribute to the market growth during the forecast period.

Europe captured a substantial market share in 2023. The segment's growth is attributable to the increasing demand for TB diagnostics such as rapid molecular diagnostics in Europe and initiatives undertaken by the European government agencies to increase the number of diagnostic laboratories in key countries such as the U.K.

Asia Pacific is estimated to witness a significant CAGR in the market during the forecast period. The improvement in healthcare infrastructure in Asian countries, the high burden of TB disease in this region, and the increasing demand among individuals for better treatment outcomes are driving the market growth in Asia Pacific.

• For instance, according to the TUBERCULOSIS SURVEILLANCE CENTER report in 2022, during 2021, there were a total of 11,519 newly reported cases of tuberculosis in Japan, resulting in a notification rate of 9.2 per 100,000 populations.

Latin America and the Middle East & Africa regions are expected to expand at a comparatively low CAGR during the forecast period. These regions are expected to witness substantial growth during the forecast period, owing to an increasing number of companies penetrating these regions to expand their geographic presence.

List of Key Companies in Tuberculosis (TB) Diagnostics Market

Market Players with Strong Focus on Expansion of Tuberculosis (TB) Diagnostics Portfolio to Hold Major Market Share

bioMérieux SA, F. Hoffmann-La Roche Ltd., and Abbott are the prominent players in the market and accounted for significant market share in 2023.

bioMérieux SA dominated the market in 2023. The company’s market dominance is due to its strong product portfolio for test types such as IGRA tests and continuous novel product launches in the market. The company has a considerably strong product portfolio, including VIDAS TB-IGRA.

• In March 2021, bioMérieux 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.

Other significant players, including Cepheid (Danaher), Thermo Fisher, and Qiagen are increasing their emphasis on research & development activities for the development of innovative diagnostics and to strengthen their presence in the global market.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• bioMérieux SA (France)


• QIAGEN (Netherlands)


• BD (U.S.)


• Cepheid (Danaher) (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• Abbott Laboratories (U.S.)


• Hologic, Inc. (U.S.)


• Hain Lifescience GmbH (Germany)


• Oxford Immunotec USA, Inc. (U.K.)

KEY INDUSTRY DEVELOPMENTS:

• September 2023 - QIAGEN donated 3,000 QuantiFERON-TB Gold Plus tests to the Ministry of Health (MOH) Malaysia. It served as a diagnostic tool for latent tuberculosis infection (LTBI) screening, focused on assisting the check-ups of immunocompromised individuals.


• February 2023 - QIAGEN announced that it received the certification of QuantiFERON-TB Gold Plus (QFT-Plus) under the European Union’s 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR). Moreover, QFT-Plus is validated by the WHO, which helps indirectly detect the bacteria that cause tuberculosis (TB).


• September 2022 - BD India announced the launch of the BD MAX molecular diagnostic system and the BD MAX MDR-TB panel at a scientific session to enable clinicians to rapidly test for tuberculosis and multidrug resistance as a first-line test.


• May 2022 – F. Hoffmann-La Roche Ltd entered into a partnership with the Global Fund to support low and middle-income countries in strengthening critical diagnosis infrastructure against infectious diseases.


• March 2022 – Thermo Fisher Scientific Inc. launched the SeqStudio Flex Series Genetic Analyzer for research & development of infectious disease detection, which is expected to expand the company's product portfolio in the market.


• February 2022 – QIAGEN announced that its QuantiFERON tuberculosis testing solution received the approval of the fourth generation of a modern gold standard test in China.


• July 2021 – F. Hoffmann-La Roche Ltd. announced that WHO included the company’s products cobas MTB and cobas MTB-RIF/INH tests as Nucleic Acid Amplification Tests (NAATs). These products are nucleic acid testing products used to detect tuberculosis and drug resistant TB.


• March 2021 – Hologic, Inc. announced the CE marking of its tuberculosis IGRA test on VIDAS. VIDAS TB-IGRA is an automated assay that helps in the diagnosis of infection with Mycobacterium tuberculosis.

REPORT COVERAGE

The research report provides a detailed competitive landscape. It focuses on key points such as new product launches in the market. Additionally, it includes the incidence of tuberculosis and key industry developments such as partnerships, mergers, and acquisitions. Furthermore, the report covers regional analysis of different segments, company profiles of key market players, and the impact of COVID-19 on the market. The report consists of qualitative and quantitative insights contributing to the market growth.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Growth Rate	CAGR of 5.8% from 2024-2032
Unit	Value (USD Billion)
Segmentation	By Type Culture-based Diagnostics Sputum Smear Microscopy Rapid Molecular Diagnostics Others
By End-user Diagnostic Laboratories Hospitals
By Region North America (By Type, By End-user) U.S. Canada Europe (By Type, By End-user) U.K. Germany France Italy Russia Nordic Rest of Europe Asia Pacific (By Type, By End-user) China Japan South Korea Southeast Asia India Australia Rest of Asia Pacific Latin America (By Type, By End-user) Brazil Mexico Rest of Latin America Middle East & Africa (By Type, By End-user) GCC South Africa Rest of the Middle East & Africa