TB Diagnostics Market

Market Overview

The global TB diagnostics market size was valued at USD 1,337.30 million in 2021 and is expected to reach a valuation of USD 2,148 million by 2030 growing at a CAGR of 5.56% during the forecast period (2022–2030).

Tuberculosis (TB) is a contagious disease caused by the bacteria Mycobacterium tuberculosis (MTB). Tuberculosis affects the lungs in most cases, but it can also affect other body parts. The majority of infections are asymptomatic, which is known as latent tuberculosis. Around 10% of latent infections advance to active illness, killing around half of the infected individuals if left untreated.

Chronic cough with bloody mucus, fever, night sweats, and weight loss are all common symptoms of active tuberculosis. A skin test is the most prevalent tuberculosis diagnostic method, while blood tests are becoming more common.

Market Dynamics

TB Diagnostics Market Drivers

• Increase in the Prevalence of Tuberculosis

Tuberculosis is a disease caused by the bacteria Mycobacterium tuberculosis. Even though it is treatable, it is still one of the leading causes of death in adults, especially in developing nations. The World Health Organization (WHO) estimates that around a quarter of the world's population is infected with tuberculosis. It signifies that people have been infected with tuberculosis bacteria but are not (yet) sick and hence cannot spread the disease.

Also, tuberculosis-infected individuals have a 5% to 10% chance of becoming severely ill. Those with weakened immune systems, such as those suffering from HIV, malnutrition, diabetes, or those who smoke, are more likely to become sick. Tuberculosis is the world's thirteenth leading cause of death and, after COVID-19, the second-leading infectious killer, surpassing HIV/AIDS. 1.5million people died from tuberculosis in 2020, including 214000 people with HIV.

Two-thirds of the world's tuberculosis patients live in only eight countries. China, the Philippines, Indonesia, Pakistan, Bangladesh, Nigeria, and South Africa are the top seven countries on the list. Tuberculosis affects people of all ages and from all over the world. This increased prevalence is likely to impact market growth during the forecast period.

• Preponderance of Multidrug-Resistant Tuberculosis Infection

Multidrug-resistant tuberculosis (MDR-TB) is a type of tuberculosis that does not react to the most effective first-line antituberculosis medications, isoniazid and rifampicin. MDR-TB remains a public health crisis and a threat to public health security. According to WHO Tuberculosis Fact Sheets, only 1 in 3 persons with drug-resistant tuberculosis received treatment in 2020.

People who have come into contact with a drug-resistant tuberculosis patient, who do not take their medicines as prescribed by their doctor, who redevelop tuberculosis after being treated once, and who come from locations where drug-resistant tuberculosis is common are more likely to develop drug-resistant tuberculosis.

Multidrug-resistant TB diagnosis can be time-consuming and costly. MDR-TB can be treated with second-line medicines. On the other hand, second-line treatment options are limited and need prolonged chemotherapy (up to two years of treatment) with costly and harmful drugs. In 2018, the global treatment success rate for MDR/RR TB patients was 59%. As a result, as previously stated, these factors are expected to grow significantly during the forecast period.

TB Diagnostics Market Restraints

• High Cost for Tuberculosis Diagnostics

Due to lack of adequate medical treatment and diagnosis, developing countries are home to many infectious diseases. Millions of individuals, mostly tuberculosis patients, live in impoverished nations without access to competent diagnostics. According to a study published in the European Respiratory Journal in 2018, the mean total expenses for tuberculosis in low and middle-income nations ranged from USD 55 to USD 8198.

The entire cost was 58% (5-306%) of reported yearly individual income and 39% (4-148%) of reported household income on average. Taking out loans and selling home belongings were two of the most regularly mentioned coping techniques in this survey. In addition, in these nations, the lack of health coverage and cheap patient care services is driving up the cost of tuberculosis diagnoses, hampering the global market growth..

Emerging Key Trends in TB Diagnostics Market

• Increasing Number of Market Approval of Pipeline Diagnostic Products

Several novel tuberculosis diagnosis options have recently been available on the market. However, the reality remains unchanged, with new tuberculosis cases being reported. Despite the availability of the GeneXpert MTB/RIF, the sputum smear microscopy test (which does not reveal medication susceptibility) is still considered the diagnostic gold standard in most countries.

In late January 2015, the World Health Organization (WHO) authorized Alere's TB lipoarabinomannan (LAM) test, a significant step forward in tuberculosis diagnostics. It's a simple, quick, non-invasive, and low-cost point-of-care (POC) test for persons with HIV who have a low CD4 level. WHO has recommended new versions of line probe assays such as MTBDRsl, Hain's MTBDRplus, and Nipro's product for quick drug susceptibility testing (DST).

Advances in nucleic acid amplification tests (NAATs), such as GeneXpert Omni and Ultra, and Molbio's TrueNAT, have been verified in recent years. Encouragement of gene set research to forecast active tuberculosis disease and distinguish it from latent tuberculosis and other infections could eventually lead to the creation of new blood tests. There is currently no viable serological test for active tuberculosis. In addition, progress is being made in the identification of pediatric tuberculosis.

Thus, rising investments in research and development to seek precise and effective TB diagnosis methods will likely create growth opportunities for the market over the forecast period.

Segmental Analysis

The global TB diagnostics market has been classified based on the test type, end-user, and region.

The TB diagnostics market has been segmented into nucleic acid testing (NAT), skin test / Mantoux test (TST), blood test/serology tests, SMEAR microscopy, cultured-based tests, and radiography tests, and others based on test type. The nucleic acid testing (NAT) segment is expected to dominate the global market, and it is projected to reach USD 561.32 million by 2030, at a CAGR of 5.91% during the forecast period.

Nucleic acid amplification has become a popular method for detecting and diagnosing Mycobacterium TB. Bacterial DNA (or ribosomal RNA transcribed into DNA) is enzymatically amplified and detected using a signal-generating probe with an appropriate reading device. Several enzymatic amplification techniques are also commercially accessible in markets around the world. PCR (polymerase chain reaction), TMA (transcription-mediated amplification), and SDA (strand displacement amplification) are some of the most commonly utilized methods. As this NAT method provides precise detection of tuberculosis, its adoption is likely to grow over the forecast period.

The TB diagnostics market has been segmented into hospitals and diagnostic laboratories, physician’s office laboratories, reference laboratories, and academics and research facilities based on the end-user. The hospitals and diagnostic laboratories segment are expected to dominate the global market, and it is projected to reach USD 934.93 million by 2030, at a CAGR of 5.87% during the forecast period.

According to the CDC, over 13 million people in the United States have latent tuberculosis infection. MDR (multi-drug resistant) TB's increasing prevalence and need for diagnostic techniques in hospital settings are expected to drive segmental growth. Furthermore, the government and private healthcare organizations have launched many programs to combat the spread of infectious diseases, which is likely to boost the segment's growth.

Impact of covid-19

The COVID-19 pandemic caused a severe setback in progress toward tuberculosis targets, necessitating the use of new tuberculosis control and care strategies. According to recent studies, around 1 million persons had trouble diagnosed with tuberculosis during the pandemic. As a result, demand for tuberculosis diagnostic tests and measures is forecast to rise in multiple regions across the globe.

The pandemic has changed the socio-economic landscape and access to healthcare services. The outbreak's immediate impact, on the other hand, was uneven. In collaboration with its regional and country offices, the WHO Global TB Program has published an information note on the use of essential services for tuberculosis patients during the COVID-19 outbreak. Thus, the pandemic has positively influenced the demand for TB diagnostics.

Market Recovery Timeline and its Challenges

The post-pandemic phase will be significant for the global TB diagnostics market growth. The market will face a slight slowdown in growth as the COVID-19 pandemic passes. Other reasons, such as the growing prevalence of tuberculosis among individuals across the globe, will continue to propel the market growth during the forecast period. Overall, the global TB diagnostics market will recover quickly, showing positive signs of growth post-pandemic.

Regional Analysis

Supremacy of North America Over Others

The global TB diagnostics market has been segregated into the Americas, Europe, Asia-Pacific, and the Middle East and Africa.

With an expected market value of USD 905.08 million by 2030, at a CAGR of 5.66%, North America is expected to be the largest market for TB diagnostics. The growing demand for sophisticated healthcare and the usage of technology and innovative tests for diagnosis, treatment, care, rehabilitation, and overall healthcare improvement can be ascribed to the strong regional market. The tuberculosis diagnostics market is likely to benefit from increased research & development spending for better tuberculosis diagnostics.

The increase can be due to the rising number of tuberculosis diagnostic advances. For tuberculosis diagnosis, various products are available, ranging from laboratory-based molecular diagnostics to Al for CXR interpretation. In 2020, the Centers for Disease Control and Prevention recorded 7,174 TB cases in the United States. The rise in tuberculosis cases in the country is likely to raise the market for tuberculosis diagnostics.

With an expected market value of USD 644.14 million by 2030, registering a CAGR of 5.77%, Asia-Pacific is the second-largest market for TB diagnostics. The rising frequency of tuberculosis in Japan's senior population is likely to drive the demand for tuberculosis diagnostics. The countries with the highest number of new tuberculosis cases and mortality rates had the highest government health expenditure per capita, corruption perception score, and countries with minimum food supplements.

Tuberculosis is directly linked to a lack of access to adequate water, sanitation, and hospital beds. As Asia-Pacific is a developing region, all increased facilities are not available. As the incidence of tuberculosis rises, so does the market for tuberculosis diagnostics.

Recent Developments

• July 2021- Rache announced that the proprietary Cobas MTB and Cobas MTB-RIF/INH tests are included in the latest World Health Organization (WHO) policy guidelines on nucleic acid amplification tests (NAATs) for tuberculosis and drug-resistant TB detection.
• October 2021- Qiagen announced that it has been approved with the CE mark and is launching the QIAreach QuantiFeron-TB Test to diagnose tuberculosis infection.
• March 2021- BioMerieux announced that it received the CE marking of its innovative and fully-automated test VIDAS TB IGRA (Interferon-Gamma Release Assay) to diagnose latent TB infection.
• July 2020- The Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. launched the new Xpert MTB/XDR test, enabling expanded drug-resistance tuberculosis (TB) profiling in less than 90 minutes.
• September 2020- Oxford Immunotec announced that it had received FDA approval for its TB Spot test for pediatric usage.
• May 2020- Thermo Fisher Scientific announced that the company acquired Qiagen, a molecular diagnostic focused organization, for USD 11.5 billion. The acquisition aims to advance the portfolio in precision medicine by increasing focus on infectious diseases, cancer, and genetic disorders by utilizing Qiagen’s QuantiFeron-TB Gold Plus latent tuberculosis detection test, the QiaSymphony platform for molecular diagnostics infectious disease testing, and the QiaStart-Dx syndromic testing system.

TB Diagnostics Market Segmentation

By Test Type

• Nucleic Acid Testing (NAT)
• Skin Test / Mantoux Test (TST)
• Blood Test / Serology Test
• SMEAR Microscopy
• Cultured-Based Tests
• Radiography Tests
• Others

By End-User

• Hospitals and Diagnostic Laboratories
• Physician’s Office Laboratories
• Reference Laboratories
• Academics and Research Facilities

By Region

• Americas
• Europe
• Asia-Pacific
• The Middle East and Africa