Nontuberculous Mycobacterial Infections Market: Epidemiology, Therapies, Companies, DelveInsight | AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals

Nontuberculous Mycobacterial Infections therapies, such as ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), and others, are expected to boost the Nontuberculous Mycobacterial Infections Market in the upcoming years.

DelveInsight has launched a new report on "Nontuberculous Mycobacterial Infections - Market Insights, Epidemiology, and Market Forecast-2034" that delivers an in-depth understanding of the Nontuberculous Mycobacterial Infections, historical and forecasted epidemiology as well as the Nontuberculous Mycobacterial Infections market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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Some of the key facts of the Nontuberculous Mycobacterial Infections Market Report:

The Nontuberculous Mycobacterial (NTM) Infections market is expected to witness steady expansion from 2024 to 2034, supported by improved diagnostics, rising disease awareness, and anticipated approvals of novel therapies.
A growing number of diagnosed NTM cases-largely driven by an aging, more vulnerable population-is set to contribute significantly to market revenue.
Currently, treatment options are limited to repurposed or combination antibiotics, which often lead to suboptimal outcomes, including high relapse and failure rates. This reflects the urgent need for more effective, targeted therapies to address challenges like NTM's genetic variability and natural resistance.
ARIKAYCE remains the only FDA-approved therapy in the U.S. for Mycobacterium avium complex (MAC) lung disease in patients with few or no alternative treatment options. In 2023, ARIKAYCE generated approximately USD 223 million, dominating the U.S. NTM treatment market, which totaled around USD 360 million. Continued growth is projected through 2034.
Promising pipeline therapies such as Epetraborole (AN2 Therapeutics) and MNKD-101 (MannKind) could reshape the treatment landscape if approved, addressing current gaps and improving patient outcomes.
In summary, the NTM treatment market has strong growth potential, with ongoing R&D efforts poised to deliver innovative therapies and diagnostics that could transform disease management and expand access to more effective care.
According to DelveInsight's epidemiological analysis, approximately 108,000 diagnosed cases of Nontuberculous Mycobacterial (NTM) infections were reported in the U.S. in 2023, with this number projected to rise through 2034. Contributing factors include an aging population and increasing prevalence of chronic lung conditions such as COPD and bronchiectasis. Additionally, improved diagnostic capabilities and greater awareness have led to more frequent detection and reporting of NTM infections.
In December 2024, Shanghai MicuRx Pharmaceutical (688373.SH) announced that its anti-infective candidate, MRX-5, was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of nontuberculous mycobacterial (NTM) infections, representing a significant advancement in the development of therapies for this challenging condition.
In 2023, NTM infections in the U.S. showed a higher prevalence among females, who accounted for about 68% of diagnosed cases, compared to 32% in males. This female predominance is likely influenced by a combination of biological, behavioral, and environmental factors. Women are more frequently affected by underlying conditions like bronchiectasis, which increase susceptibility to NTM. Differences in immune response and hormonal influences may also contribute to this disparity.
Key Nontuberculous Mycobacterial Infections companies such as AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others are evaluating new drugs for Nontuberculous Mycobacterial Infections to improve the treatment landscape.
Promising Nontuberculous Mycobacterial Infections therapies include ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), and others.

Nontuberculous Mycobacterial Infections Overview

Nontuberculous mycobacterial (NTM) infections are diseases caused by Mycobacterium species other than those responsible for tuberculosis (M. tuberculosis complex) or leprosy (M. leprae). As noted by the American Lung Association, these bacteria are commonly found in natural environments such as soil, water, and dust. In the United States, the Mycobacterium avium complex (MAC) is the most prevalent NTM species, responsible for the majority of NTM-related lung infections.

NTM lung disease can present in two distinct forms based on disease severity. The nodular bronchiectatic form, typically seen in older women with no history of smoking, progresses slowly and causes airway inflammation and damage, leading to frequent respiratory infections like bronchitis and pneumonia. The cavitary form is more aggressive, primarily affecting smokers or individuals with underlying lung conditions, and results in lung scarring, cavity formation, and fibrosis-potentially progressing to respiratory failure.

Common symptoms of NTM infection include a persistent cough, fatigue, weight loss, night sweats, shortness of breath, hemoptysis (coughing up blood), excessive mucus production, fever, and recurrent respiratory infections. Risk factors include chronic lung disease, impaired ciliary function, CFTR gene mutations, skin or soft tissue injuries, and compromised immune function.
Nontuberculous Mycobacterial Infections Market Outlook

Treating nontuberculous mycobacterial (NTM) infections presents significant clinical challenges due to the need for long-term, multidrug therapies that must be tailored to the specific NTM species involved and the site of infection. Many NTM species are naturally resistant to conventional antibiotics, requiring the use of specialized and often expensive treatments. As a result, NTM infections represent a growing area of focus within the pharmaceutical and healthcare industries. Continued research is aimed at advancing diagnostic capabilities and developing new therapies to enhance treatment outcomes. Physicians frequently prescribe combinations of antibiotics off-label-approved for other indications but effective against particular NTM strains. Commonly used antibiotics include macrolides such as azithromycin and clarithromycin; rifamycins like rifampin and rifabutin; fluoroquinolones such as ciprofloxacin; aminoglycosides like amikacin and streptomycin; and ethambutol. The treatment approach depends on multiple factors, including the species of NTM, disease site, and overall patient health. For pulmonary infections caused by Mycobacterium avium complex (MAC), the standard regimen includes a macrolide, rifamycin, and ethambutol, typically continued for at least 12 months after culture conversion. Mycobacterium kansasii is usually treated with rifampin, isoniazid (with pyridoxine), and ethambutol. Infections caused by more resistant organisms like M. abscessus require an initial phase of intravenous treatment with agents such as amikacin and imipenem or cefoxitin, followed by a prolonged oral phase with macrolides and potentially inhaled amikacin. For skin and soft tissue infections, especially those involving rapidly growing mycobacteria like M. abscessus and M. fortuitum, therapy is guided by drug susceptibility testing and may involve antibiotic combinations alongside surgical procedures. Currently, ARIKAYCE (amikacin liposome inhalation suspension) is the only FDA-approved therapy specifically indicated for NTM infections, but its use is limited to adults with treatment-refractory MAC lung disease. Meanwhile, companies such as AN2 Therapeutics, MannKind Corporation, and Spero Therapeutics are actively developing new treatments for NTM, with several drug candidates undergoing various stages of clinical evaluation. These efforts reflect the pressing need for more effective and accessible therapies to manage this complex and increasingly prevalent condition.

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Marketed Nontuberculous Mycobacterial Infections Drugs
ARIKAYCE (amikacin liposome inhalation suspension): Insmed
Nontuberculous Mycobacterial Infections Emerging Drugs
Epetraborole: AN2 Therapeutics
MNKD-101 (Clofazimine Inhalation Suspension): Mannkind Corporation
SPR720 (Fobrepodacin): Spero Therapeutics

Scope of the Nontuberculous Mycobacterial Infections Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Nontuberculous Mycobacterial Infections Companies: AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others
Nontuberculous Mycobacterial Infections Therapies: ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), and others.
Nontuberculous Mycobacterial Infections Therapeutic Assessment: Nontuberculous Mycobacterial Infections current marketed and Nontuberculous Mycobacterial Infections emerging therapies
Nontuberculous Mycobacterial Infections Market Dynamics: Nontuberculous Mycobacterial Infections market drivers and Nontuberculous Mycobacterial Infections market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Nontuberculous Mycobacterial Infections Unmet Needs, KOL's views, Analyst's views, Nontuberculous Mycobacterial Infections Market Access and Reimbursement

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Key benefits of the Nontuberculous Mycobacterial Infections Market Report:
The Nontuberculous Mycobacterial Infections market report covers a descriptive overview and comprehensive insight of the Nontuberculous Mycobacterial Infections Epidemiology and Nontuberculous Mycobacterial Infections market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
The Nontuberculous Mycobacterial Infections market report provides insights into the current and emerging therapies.
The Nontuberculous Mycobacterial Infections market report provides a global historical and forecasted market covering drug outreach in 7MM.
The Nontuberculous Mycobacterial Infections market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Nontuberculous Mycobacterial Infections market.

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Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Nontuberculous Mycobacterial Infections Patient Share (%) Overview at a Glance
5. Nontuberculous Mycobacterial Infections Market Overview at a Glance
6. Nontuberculous Mycobacterial Infections Disease Background and Overview
7. Nontuberculous Mycobacterial Infections Epidemiology and Patient Population
8. Country-Specific Patient Population of Nontuberculous Mycobacterial Infections
9. Nontuberculous Mycobacterial Infections Current Treatment and Medical Practices
10. Unmet Needs
11. Nontuberculous Mycobacterial Infections Emerging Therapies
12. Nontuberculous Mycobacterial Infections Market Outlook
13. Country-Wise Nontuberculous Mycobacterial Infections Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Nontuberculous Mycobacterial Infections Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

Nontuberculous Mycobacterial Infections Pipeline Insights, DelveInsight

"Nontuberculous Mycobacterial Infections Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Nontuberculous Mycobacterial Infections market. A detailed picture of the Nontuberculous Mycobacterial Infections pipeline landscape is provided, which includes the disease overview and Nontuberculous Mycobacterial Infections treatment guidelines.

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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