Lack of effective therapy: A major Nontuberculous Mycobacteria Infection Market Driver

Nontuberculous Mycobacteria (NTM) is a ubiquitous, aerobic, non-motile, acid-fast bacteria, which, when inhaled, may cause severe lung disorders. Especially common in the elderly, individuals with lung diseases, slender caucasian women, and people with esophageal disorders, NTM affects both healthy persons and those with compromised immune systems. 

The bacteria most commonly can be found in the environment such as in soil and water, exposure to which paves a clear way to the bacteria to enter into the lungs. However, airborne NTM is the most common source of infection and plays an important role in causing respiratory disease. While in most people, NTM organisms do not cause infection as they are cleared from the lung naturally, however, some people are at higher risk of developing the infection, especially those with the history of lungs disease such as COPD, cystic fibrosis, infecting the airways and lung tissue leading to lung disease. Besides lungs, there are NTM species that often affect skin and bones.

NTM infection is diagnosed by analyzing patient’s medical history, physical examination, performing culture test of sputum samples, HPLC, line probe assays, and partial gene sequencing.

In 2017, the total NTM infection prevalent population in the seven major markets was recorded to be 365,273. The EU5 countries (Germany, France, Italy, Spain, and the UK) account for approximately 28% of total prevalent cases in seven major markets. As per the estimates, the highest Nontuberculous Mycobacteria infection prevalence was recorded in the US with 179,016 prevalent cases in 2017. 

Current Nontuberculous Mycobacteria infection treatment practice follows specific treatment guidelines provided by the American Thoracic Society (ATS) and the British Thoracic Society (BTS). The treatment regimen mainly includes oral antibiotics (azithromycin, ciprofloxacin, minocycline), oral+intravenous antibiotics (cefoxitin & imipenem), and inhaled antibiotics.

So far, only one drug, Arikayce, by Insmed Incorporated has been approved by the FDA in 2018, for refractory cases of mycobacterium avium complex (MAC) lung disease. Arikayce is an aminoglycoside antibacterial that has received breakthrough, orphan drug, qualified infectious disease product (QIDP) and fast track designations from the FDA. 

Despite such evident lack of targeted therapies, there are only a few products in the later stages of clinical development in the Nontuberculous Mycobacteria infection treatment market. Thiolanox, gaseous formulation of pharmaceutical nitric oxide (NO) by Novoteris; Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) by Savara Inc.; and NO by Beyond Air are in phase II stage of development for NTM infections.  

In the near future, these companies are expected to capture the major Nontuberculous Mycobacteria market share since only a few options are currently available for the treatment of NTM infection. This will increase the market size of NTM infection in the seven emerging markets, which was recorded at USD 1,815.12 Million in 2017. 

At present, the US holds the largest Nontuberculous Mycobacteria infection market size in comparison to EU5 countries, and Japan. Among the EU5 countries, Germany accounted for the largest market size in 2017; these numbers will see an advancement in the coming years.

Lack of effective and efficient therapies in the market builds a budding chance for the big players to enter into a highly untapped market and capture a larger market share.