The global tuberculosis diagnostics market size was valued at USD 2.28 billion in 2022 and is anticipated to grow at a compound anuual growth rate (CAGR) of 5.2% from 2023 to 2030. The rising burden of tuberculosis is one of the biggest concerns among the government and healthcare agencies. This is a common occurrence in developing countries. In addition, significant investments are being made to develop effective diagnostic technologies to improve patient outcomes and accuracy. According to the World Health Organization (WHO), in 2021, 10.6 million people around the world were infected with tuberculosis.
The WHO also reported that in 2021, 30 high-tuberculosis-bearing countries accounted for around 87.0% of new TB cases. The low and middle-income countries account for over 80% of cases and deaths. These high incidence rates are expected to drive market revenue growth in the coming years. The development of tuberculosis diagnostics plays an important role in the growth of the market. There is a growing need for appropriate diagnostic tests at all healthcare system levels. Because tuberculosis is one of the most difficult diseases to diagnose, market companies invest a lot in product research and development. The infection is diagnosed by Mantoux Tuberculin Skin Test (TST) or TB blood test. Depending on the infected organs, additional tests are needed to confirm the presence of TB disease. Chest radiography is used in pulmonary TB to detect chest abnormalities, as well as acidic-fast staining, and microscopic examination of sputum. Extrapulmonary TB is diagnosed using CT, MRI, or ultrasound scans, laparoscopy, endoscopy, biopsies, urine, blood tests, and lumbar punctures.
Diagnostic tools must also be able to diagnose pulmonary or extrapulmonary diseases when testing a broad range of clinical samples with different bacillary loads. It is essential to differentiate between active and latent infections. Furthermore, accurate diagnosis in the initial stages of the disease, when bacillary loads in samples are still high, is necessary to reduce mortality, morbidity, and transmission risks. Product innovation and substantial investments in the integration of automation technologies enhance diagnostic performance and clarify latent and active TB. For instance, in sub-Saharan Africa where malaria and TB are prevalent, research progress leads to the development of novel or updated prevention strategies as well as new treatment tools, thereby saving lives and strengthening health systems. The development of better analytical tools, improved data usage, and sharing, more accurate and cost-effective diagnostic tests, and advances in delivering and monitoring safer and more cost-effective treatment enable more people to be treated more quickly and with better results.
In addition, the tuberculosis diagnostics market is further driven by the growing prevalence of multidrug-resistant tuberculosis (MDR-TB) around the world. MDR tuberculosis is a disease caused by bacteria that resist rifampicin and isoniazid, which are some of the most effective antimicrobial drugs used to treat TB. The availability of technologically advanced Point-of-Care (POC) diagnostic methods is boosting market growth. Advances in diagnostic methods such as Nucleic acid amplification tests (NAAT) and Interferon-Gamma Release Assay (IGRA) are more precise, convenient, and deliver faster results compared to traditional methods. Other factors that are driving the market growth include the growing geriatric population, rising healthcare expenditure, and government initiatives and R&D investments. Healthcare infrastructure improvements and awareness among the general public about various diagnostic procedures are also responsible for market growth.
The COVID-19 pandemic had a significant effect on healthcare systems, affecting not only virus-infected patients but also non-infected patients which resulted in the cancellation of diagnosis and treatment services to manage and reserve resources, and many hospitals experienced a shortage of professionals to help with these diagnostic procedures. Government-imposed pandemic restrictions affected market expansion. For instance, the WHO reported in March 2021 that the "Impact of the COVID-19 pandemic on TB detection and mortality in 2020" study found that 1.4 million fewer people than in 2019 received TB treatment in 2020, a 21% drop from 2019.
According to an article published by the International Journal of Tuberculosis and Lung Disease in June 2021, titled "The impact of COVID-19 on TB: a review of the data", it was observed that the provision of TB services was hampered by a high TB burden due to restrictions on migration (affecting healthcare staff, supplies, and stock), inadequate capacity and equipment, and resource reallocation. In addition, tuberculosis patients had difficulty accessing care because of stigmatization fears, SARS-CoV-2 infections, mobility issues, decreased hospital working hours, or a lack of funding for treatment or transportation. Globally, this affected TB diagnosis, treatment, and prevention.
The TB diagnostics market based on test type is segmented into radiographic methods, diagnostic laboratory methods, nucleic acid testing, phage assay, detection of latent infection, cytokine detection assay, detection of drug resistance, and others. The diagnostic laboratory methods segment consisting of smear microscopy and culture-based tests held the largest revenue share of 41.5% in 2022. Penetration of these methods in the developing regions, where high incidences pose a huge burden, governed the growth of this segment. Smear microscopy and culture-based tests are available in most hospitals and clinics around the world. This makes them a good option for diagnosing tuberculosis in patients who may not have access to more advanced diagnostic tests. While newer tests, such as nucleic acid amplification tests (NAATs), are becoming more widely available, smear microscopy and culture-based tests are still considered to be the most accurate tests for diagnosing tuberculosis. This is because they can detect even small amounts of the bacteria that cause tuberculosis.
Tests such as nucleic acid tests and latent infection detection tests, which include skin tests and IGRA, are anticipated to witness lucrative growth over the forecast period. NAATs are highly sensitive and specific as well as provide faster results than other tests. According to information released by the WHO in February 2021, the organization modified its guidelines on molecular assays used to diagnose TB and treatment resistance during its meeting in December 2020 that covered the high diagnostic accurateness of three new technology classes. The drug resistance detection segment is expected to grow at a sturdy rate. Misuse of antibiotics contributes to the high incidences of drug resistance.
The diagnostic laboratories segment held the largest revenue share of 47.2% in 2022 owing to the rising demand for versatile & affordable diagnostic devices in diagnostic laboratories. Market players are considering investing in product development and removing the high-end microscopy complexities without sacrificing performance, which is an important factor driving segment growth. Diagnostic laboratories have access to skilled professionals who are trained to perform TB diagnostics. This is important for ensuring the accuracy and reliability of the test results. In January 2023, there were approximately 25,500 diagnostic and medical laboratories in the U.S. The presence of various institutions is likely to favor the expansion of the segment over the forecast period.
The hospitals & clinics segment is expected to grow at a significant CAGR over the forecast period. There is a growing awareness among the public and healthcare professionals about the importance of early diagnosis and treatment of TB. This is leading to increased demand for TB diagnostics in hospitals and clinics. For instance, according to the Institut Montaigne, in 2020, India, had a total of 43,486 private hospitals.
Asia Pacific dominated the market and accounted for the largest revenue share of 38.3% in 2022 and is expected to witness the fastest CAGR of 5.7% due to its high burden as well as the rapid proliferation of this disease. One of the main factors fueling the increase in market revenue is the rising tuberculosis rates in various countries in this region. In addition, other significant aspects that contribute to the market revenue growth in this region include the high mortality rate and poor human development index. In 2021, the WHO’s South-East Asian Region reported the largest number of new TB cases, around 46.0%. The affected countries in this region are Bangladesh, China, India, Indonesia, Pakistan, and the Philippines. The Asia Pacific area benefited from assistance from the United States Agency for International Development (USAID) in combating and preventing tuberculosis.
In addition, North America also held a significant revenue share in the market due to the increasing prevalence of TB which is boosting the number of TB diagnostic procedures conducted in this region. The presence of well-established healthcare infrastructure and increased healthcare spending. For instance, in May 2023, the International AIDS Vaccine Initiative (IAVI), a global not-for-profit research organization dedicated to creating antibodies and vaccines against infectious & neglected diseases, and the Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, announced that they signed an agreement to develop a TB vaccine candidate MTBVAC. It has the potential to be used as a substitute for bacille Calmette-Guérin (BCG), the only available TB vaccine. In addition, Latin America and the Middle East & Africa are anticipated to exhibit remunerative CAGR over the forecast period due to the increasing number of companies penetrating these regions to expand their global presence.
New product launches, mergers & acquisitions, collaborations, and expansions are the important business strategies undertaken by key market players to grow their global reach. For instance, in June 2023, QIAGEN highlighted the unique value of its proprietary TB blood testing technology - QuantiFERON-TB Gold Plus test, an interferon-gamma release assay (IGRA) that enabled the detection of CD4 T-cell responses & CD8 T-cell responses in TB1 & TB2 blood collection tubes respectively. QuantiFERON-TB Gold Plus gained CE-marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) in February 2023.
In addition, in February 2023, Thermo Fisher Scientific announced that it obtained licensing rights for the Applied Biosystems TaqPath PCR kits from the Central Drugs Standard Control Organization (CDSCO) for various infectious diseases including M. tuberculosis complex (MTB), multi-drug-resistant tuberculosis (MTB MDR) among others. These kits will be produced in partnership with Mylab Discovery Solutions in India. The following are some of the major participants in the global tuberculosis diagnostics market:
Abbott Laboratories
Becton, Dickinson and Company
F. Hoffmann-La Roche AG
Thermo Fisher Scientific Inc.
BioMérieux SA
Hain Lifescience GmbH
QIAGEN GmbH
Cepheid
Hologic, Inc.
BD
Report Attribute |
Details |
Market size value in 2023 |
USD 2.33 billion |
Revenue forecast in 2030 |
USD 3.34 billion |
Growth Rate |
CAGR of 5.2% from 2023 to 2030 |
Base year for estimation |
2022 |
Historical data |
2018 - 2021 |
Forecast period |
2023 - 2030 |
Report updated |
September 2023 |
Quantitative units |
Revenue in USD million and CAGR from 2023 to 2030 |
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Segments covered |
Test Type, end-use, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
Country scope |
U.S.; Canada; UK; Germany; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; Australia; South Korea; Thailand; Brazil; Mexico; Argentina; Saudi Arabia; South Africa; UAE; Kuwait |
Key companies profiled |
Abbott Laboratories; Becton, Dickinson and Company; F. Hoffmann-La Roche AG; Thermo Fisher Scientific Inc.; BioMérieux SA; Hain Lifescience GmbH; QIAGEN GmbH; Cepheid; Hologic, Inc.; BD |
Customization scope |
Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global tuberculosis diagnostics market based on test type, end-use, and region:
Test Type Outlook (Revenue, USD Million, 2018 - 2030)
Radiographic Method
Diagnostic Laboratory Methods
Nucleic Acid Testing
Phage Assay
Detection of Latent Infection (Skin Test & IGRA)
Cytokine Detection Assay
Detection of Drug Resistance (DST)
Other Methods
End-use Outlook (Revenue, USD Million, 2018 - 2030)
Diagnostic Laboratories
Hospitals & Clinics
Others
Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
UK
Germany
France
Italy
Spain
Sweden
Norway
Denmark
Asia Pacific
China
Japan
India
Australia
Thailand
South Korea
Latin America
Brazil
Mexico
Argentina
Middle East and Africa
Saudi Arabia
South Africa
UAE
Kuwait
b. The global tuberculosis diagnostics market size was estimated at USD 2.28 billion in 2022 and is expected to reach USD 2.33 billion in 2023.
b. The global tuberculosis diagnostics market is expected to grow at a compound annual growth rate of 5.2% from 2023 to 2030 to reach USD 3.34 billion by 2030.
b. Diagnostic laboratory methods dominated the tuberculosis diagnostics market with a share of 41.4% in 2022. This is attributable to these tests consist of smear microscopy and culture-based tests that are in high demand in developing regions, where high incidences pose a huge burden.
b. Some key players operating in the tuberculosis diagnostics market include Thermo Fisher Scientific, Inc., Hologic Corporation, Abbott Laboratories, Alere, Inc., Becton, Dickinson and Company, F. Hoffmann-La Roche AG, bioMerieux SA, Sanofi, Cepheid, Hain Lifescience GmbH, and QIAGEN.
b. Key factors that are driving the tuberculosis diagnostics market growth include the rising burden of tuberculosis, awareness through government initiatives and programs, and the advent of advanced diagnostic methods, such as cytokine detection assay, Interferon-gamma Release Assay (IGRA), and serological tests.
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