The Nontuberculous Mycobacterial (NTM) Infections market is expected to grow in the coming years, driven by the development and adoption of therapies such as ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), among others.
DelveInsight has released a comprehensive report titled “Nontuberculous Mycobacterial Infections – Market Insights, Epidemiology, and Market Forecast 2034”, providing an in-depth analysis of NTM infections. The report covers historical and projected epidemiology, as well as market trends, across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
Key companies driving the NTM infections market include AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, and Paratek Pharmaceuticals.
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Some of the key facts of the Nontuberculous Mycobacterial Infections Market Report:
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The Nontuberculous Mycobacterial (NTM) infections market is projected to experience consistent growth from 2024 to 2034, driven by advances in diagnostics, increased disease awareness, and the expected approval of novel therapies. Rising diagnosis rates—largely due to an aging and more vulnerable population—are anticipated to significantly boost market revenue.
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Current treatment options are mostly repurposed or combination antibiotics, which often result in suboptimal outcomes, including high relapse and treatment failure rates. This highlights the critical need for more effective, targeted therapies capable of overcoming challenges such as NTM’s genetic variability and natural drug resistance.
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In the U.S., ARIKAYCE remains the only FDA-approved therapy for Mycobacterium avium complex (MAC) lung disease in patients with limited treatment alternatives. In 2023, ARIKAYCE generated around USD 223 million, capturing the majority of the U.S. NTM treatment market, which totaled approximately USD 360 million, with continued growth expected through 2034.
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Pipeline therapies, including Epetraborole (AN2 Therapeutics) and MNKD-101 (MannKind), have the potential to transform the treatment landscape by addressing current gaps and improving patient outcomes. Overall, the NTM treatment market shows strong growth potential, supported by ongoing R&D efforts aimed at delivering innovative therapies and diagnostics to enhance disease management and access to care.
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According to DelveInsight’s epidemiological analysis, there were approximately 108,000 diagnosed NTM cases in the U.S. in 2023, a number expected to rise through 2034. This increase is fueled by an aging population and the growing prevalence of chronic lung conditions, such as COPD and bronchiectasis, along with improved diagnostics and heightened awareness leading to more frequent detection.
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In December 2024, Shanghai MicuRx Pharmaceutical (688373.SH) announced that its anti-infective candidate, MRX-5, received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of NTM infections, marking a significant step forward in the development of therapies for this challenging disease.
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Epidemiological data from 2023 show that NTM infections were more common in females, who accounted for roughly 68% of diagnosed cases, compared to 32% in males. This disparity is influenced by biological, behavioral, and environmental factors, including a higher prevalence of underlying conditions like bronchiectasis in women, as well as potential differences in immune response and hormonal influences.
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Leading companies involved in the NTM market, such as AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others, are actively developing new therapies to improve patient outcomes. Promising treatments under investigation include ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), and additional candidates.
Nontuberculous Mycobacterial Infections Overview
Nontuberculous mycobacterial (NTM) infections are caused by Mycobacterium species other than those responsible for tuberculosis (M. tuberculosis complex) or leprosy (M. leprae). According to 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 frequently encountered NTM species and accounts for the majority of NTM-related lung infections.
NTM lung disease typically manifests in two main forms, distinguished by severity. The nodular bronchiectatic form is usually observed in older women without a history of smoking. It progresses slowly, causing airway inflammation and damage, which increases susceptibility to recurrent respiratory infections like bronchitis and pneumonia. The cavitary form is more aggressive, mainly affecting smokers or individuals with pre-existing lung conditions, and can lead to lung scarring, cavity formation, fibrosis, and in severe cases, respiratory failure.
Common symptoms of NTM infection include persistent cough, fatigue, weight loss, night sweats, shortness of breath, hemoptysis (coughing up blood), excessive mucus production, fever, and repeated respiratory infections. Risk factors include chronic lung disease, impaired ciliary function, CFTR gene mutations, skin or soft tissue injuries, and weakened immune function.
Nontuberculous Mycobacterial Infections Market Outlook
Treating nontuberculous mycobacterial (NTM) infections is clinically challenging due to the need for long-term, multidrug regimens tailored to the specific NTM species and infection site. Many NTM strains are naturally resistant to standard antibiotics, necessitating specialized and often costly treatments. This has made NTM a growing focus in pharmaceutical research and healthcare innovation, with efforts aimed at improving diagnostics and developing more effective therapies.
Physicians frequently use off-label antibiotic combinations, selected based on species and patient factors. Commonly employed drugs include macrolides (azithromycin, clarithromycin), rifamycins (rifampin, rifabutin), fluoroquinolones (ciprofloxacin), aminoglycosides (amikacin, streptomycin), and ethambutol. For pulmonary Mycobacterium avium complex (MAC) infections, the standard regimen combines a macrolide, rifamycin, and ethambutol for at least 12 months after culture conversion. Mycobacterium kansasii is treated with rifampin, isoniazid (with pyridoxine), and ethambutol, while resistant species like M. abscessus require an initial intravenous phase with agents such as amikacin and imipenem, followed by a prolonged oral phase, sometimes including inhaled amikacin. Skin and soft tissue infections, particularly from rapidly growing mycobacteria (e.g., M. abscessus, M. fortuitum), are managed based on drug susceptibility testing, often combining antibiotics with surgical intervention.
Currently, ARIKAYCE (amikacin liposome inhalation suspension) is the only FDA-approved therapy specifically for NTM infections, indicated for adults with treatment-refractory MAC lung disease. Meanwhile, companies like AN2 Therapeutics, MannKind Corporation, and Spero Therapeutics are actively developing new treatments, with several candidates in clinical trials. These developments underscore the urgent need for more effective, accessible therapies to address the complexities of this increasingly prevalent condition.
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Marketed Nontuberculous Mycobacterial Infections Drugs
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ARIKAYCE (amikacin liposome inhalation suspension): Insmed
Nontuberculous Mycobacterial Infections Emerging Drugs
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Epetraborole: AN2 Therapeutics
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MNKD-101 (Clofazimine Inhalation Suspension): Mannkind Corporation
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SPR720 (Fobrepodacin): Spero Therapeutics
Scope of the Nontuberculous Mycobacterial Infections Market Report
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Study Period: 2020-2034
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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
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Key Nontuberculous Mycobacterial Infections Companies: AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others
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Nontuberculous Mycobacterial Infections Therapies: ARIKAYCE (amikacin liposome inhalation suspension), Epetraborole, MNKD-101 (Clofazimine Inhalation Suspension), SPR720 (Fobrepodacin), and others.
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Nontuberculous Mycobacterial Infections Therapeutic Assessment: Nontuberculous Mycobacterial Infections current marketed and Nontuberculous Mycobacterial Infections emerging therapies
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Nontuberculous Mycobacterial Infections Market Dynamics: Nontuberculous Mycobacterial Infections market drivers and Nontuberculous Mycobacterial Infections market barriers
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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
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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:
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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).
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The Nontuberculous Mycobacterial Infections market report provides insights into the current and emerging therapies.
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The Nontuberculous Mycobacterial Infections market report provides a global historical and forecasted market covering drug outreach in 7MM.
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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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“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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