Tuberculosis (TB) Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Type (Culture-based Diagnostics, Sputum Smear Microscopy, Rapid Molecular Diagnostics, and Others), By End-user (Diagnostics Laboratories and Hospitals), and Regional Forecast, 2022-2029

The global tuberculosis (TB) diagnostics market size was valued at USD 1.71 billion in 2021 and is projected to grow from USD 2.07 billion in 2022 to USD 3.13 billion by 2029, exhibiting a CAGR of 6.1% during the forecast period. Based on our analysis, the global market exhibited a decline of -21.5% in 2020 as compared to 2019. The global COVID-19 pandemic has been unprecedented and staggering, with tuberculosis diagnostics experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels.

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 been increasing 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 the 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.

COVID-19 IMPACT

Declining Diagnosis of Tuberculosis Negatively Impacted Market Growth  

The COVID-19 pandemic resulted in a decline in the demand for tuberculosis diagnostic products during the pandemic. This factor was due to the significant decline in patient volumes for TB diagnosis. The global market witnessed a decline in its growth by -21.5% in 2020 compared to the prior year.

The COVID-19 pandemic caused a decline in the rate of TB testing across the high-burden regions of the global market. Despite the strong infectious nature of the disease, during the initial days of the pandemic, the resources devoted to tuberculosis diagnosis programs were diverted to fight against the coronavirus pandemic.

As the cases attributable to COVID-19 increased worldwide, in 2020, various health workers, testing machines, laboratories, and health centers were diverted from tuberculosis care to COVID-19 care.

• For instance, according to the Global Fund surveys in March 2021, in the top 13 high TB burden countries, the number of patients undergoing TB testing experienced an estimated decline of 29.0% as compared to the prior year. Moreover, testing for the more severe form of the disease, including antimicrobial resistance, multidrug-resistant TB experienced a decline of 45.0% compared to the prior year.

The market players also experienced a decline in revenues due to decreased sales of their TB diagnosis instruments and consumables during the pandemic. For instance, bioMérieux SA’s immunoassay business segment, which includes tuberculosis diagnostics, witnessed a decline of -9.7% in 2020 compared to the prior year.

However, there was a significant rebound for the market in 2021, as TB testing increased significantly, especially in the high-burden countries. As lockdown restrictions were lifted, the testing levels for tuberculosis increased and are likely to gain similar levels of procedural volume during the forecast period as it was before the pandemic.

LATEST TRENDS

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Increased Public-Private Partnerships to Boost the 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 the 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 over all states of India.

Developments in terms of private-public partnerships are expected to positively impact the TB diagnostics market. In 2018, GAIL India launched an innovative TB-Free Pata Project, which encompasses aspects such as awareness, screening, diagnosis, and nutritional support in India. The objective of the project is to promote early diagnosis and treatment adherence. Such public-private partnerships are driving the growth of the global market.

DRIVING FACTORS

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

Governments have increased the policies for the diagnosis of tuberculosis to reduce the 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 TB 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 incident TB patients, including both new & relapse cases notified during 2021 was approximately 1.9 million, which was 19.0% higher than 2020. Due to such high TB incidence rates, governments from different countries have increased their focus on improving their healthcare expenditure for TB 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 the 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 2018, the Government of India launched the TB-free India campaign, where it set a target to eliminate tuberculosis from the country by 2025. Also, the National Strategic Plan by the Government of India for TB elimination is backed by funding of over USD 1,627.8 million for diagnosis, treatment, and support.

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's 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.

• For instance, as per the WHO statistics, in 2020, 1.1 million children fell ill with TB globally. Child and adolescent TB is often overlooked by health providers, which causes an increase in the prevalence of TB among them globally.


• As per the same WHO statistics, in 2020, the 30 high TB burden countries reported 86.0% of new TB cases. Eight countries accounted for two-thirds of the total cases, including India, Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa.

Such strong incidence rates and increasing demand for TB diagnosis are expected to propel the global 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 in 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 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 extra pulmonary 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.

SEGMENTATION

By Type Analysis

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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 2021 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 July 2020, the Foundation for Innovative New Diagnostics (FIND) and Cepheid, Inc. announced the launch of the new Xpert MTB/XDR test, which allows profiling for expanded drug-resistance tuberculosis in less than 90 minutes. Such new product launches are expected to drive segmental growth in 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.

By End-user Analysis

Strong Presence of Diagnostic Laboratories to Boost 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 United States 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 the Institut Montaigne, in 2020, one of the key countries in the global market, India, had an estimated 43,486 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

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The market size in North America stood at USD 0.49 billion in 2021. The robust share of the region is due to the increasing prevalence of TB, which has been boosting the number of TB diagnosis being conducted in the region. 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 2021. 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 rate in the Asia Pacific.

• For instance, according to a research published in BMJ Global Health, in November 2020, tuberculosis affected an estimated 2.64 million Indians in 2019 and killed approximately 450,000 individuals in India. Such a high burden of tuberculosis in India is expected to increase the demand for diagnostics in the coming years.

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

KEY INDUSTRY PLAYERS

Market Players with Strong Focus on Expansion of Tuberculosis 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 a significant tuberculosis diagnostics market share in 2021.

bioMérieux SA dominated the market in 2021. 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 and 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:

• 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 and 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 resistance TB.


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

REPORT COVERAGE

An Infographic Representation of Tuberculosis (TB) Diagnostics Market

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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 a 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's growth.

Report Scope & Segmentation