Nontuberculous Mycobacterial Infection Treatment Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Statistics, Revenue, Therapies and Companies by DelveInsight

(Albany, USA) DelveInsight's "Nontuberculous Mycobacterial Infections Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of NTM Infections, historical and forecasted epidemiology, as well as the NTM Infections market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Nontuberculous Mycobacterial Infections market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Nontuberculous Mycobacterial Infections market size from 2020 to 2034 segmented by seven major markets. The Report also covers current Nontuberculous Mycobacterial Infections treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Nontuberculous Mycobacterial Infections market.

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Key Takeaways from the Nontuberculous Mycobacterial Market Report
• Nontuberculous Mycobacterial Infections Market Size in the US was approximately USD 360 million in 2023 and is projected to increase during the forecast period (2024-2034).
• In December 2024, Shanghai MicuRx Pharmaceutical (688373.SH) announced that its anti-infection drug, MRX-5, received Orphan Drug Designation (ODD) from the FDA for treating non-tuberculous mycobacteria (NTM) infections, marking a key milestone in NTM infection treatment.
• According to DelveInsight's epidemiology model, the total Nontuberculous Mycobacterial Infections diagnosed prevalent cases were approximately 108 thousand cases in the US in 2023 which are expected to increase during the forecast period (2024-2034) due to several factors. An aging population and rising rates of chronic lung diseases like COPD and bronchiectasis contribute significantly. Enhanced awareness and improved diagnostic tools have led to more frequent identification and reporting of these infections.
• In the US, NTM Infections exhibit a female preponderance compared to males in 2023. Of the total Nontuberculous Mycobacterial Infections diagnosed prevalent cases, femaes accounted for nearly 68%, while males accounted for approximately 32%. The prevalence of NTM infections is higher in females due to a combination of biological, behavioral, and environmental factors. Females are more likely to have certain chronic lung diseases, such as bronchiectasis, which predispose them to NTM infections. Hormonal differences and immune system variations may also play a role.
• In 2023, among the species-specific cases, M. avium accounted for the highest Nontuberculous Mycobacterial Infections diagnosed prevalent cases in the US accounting for nearly 76 thousand cases followed by M. abscessus with nearly 14 thousand cases, and others (M. kansasii, M. xenopi, etc.) with approximately 18 thousand cases. The diagnosed prevalent cases of NTM infections caused by M. avium species are higher in the United States due to the widespread presence of M. avium in the environment, including soil, water, and household plumbing systems, which increases the likelihood of exposure.
• In the US, there were approximately 86 thousand Nontuberculous Mycobacterial Infections diagnosed prevalent cases among pulmonary type and nearly 22 thousand cases among extrapulmonary type in 2023.
• In the US, the highest number of Nontuberculous Mycobacterial Infections diagnosed cases were moderate followed by mild and severe cases with approximately 58 thousand, 36 thousand, and 13 thousand cases respectively in 2023.
• The leading Nontuberculous Mycobacterial Companies such as AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others.
• Promising Nontuberculous Mycobacterial Therapies such as SPR720, Molgramostim, Thiolanox (Nitric Oxide), NUZYRA (omadacycline), CYT 107, and others.

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Nontuberculous Mycobacterial Epidemiology Segmentation in the 7MM
• Nontuberculous Mycobacterial Infections prevalent cases
• Total Nontuberculous Mycobacterial Infections diagnosed prevalent cases
• Nontuberculous Mycobacterial Infections gender-specific cases
• Nontuberculous Mycobacterial Species-specific cases
• Nontuberculous Mycobacterial Infections type-specific cases
• Nontuberculous Mycobacterial Infections severity-specific cases

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Nontuberculous Mycobacterial Infections Marketed Drugs

• ARIKAYCE (amikacin liposome inhalation suspension): Insmed
ARIKAYCE is the first FDA-approved therapy indicated for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE liposomal technology enables the delivery of amikacin directly to the lungs, where lung macrophages take it up, targeting the site of infection. This approach prolongs the release of amikacin in the lungs while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira Nebulizer System manufactured by PARI Pharma GmbH.

Nontuberculous Mycobacterial Infections Emerging Drugs

• Epetraborole: AN2 Therapeutics
Epetraborole (EBO), developed by AN2 Therapeutics, is a novel, once-daily, orally administered investigational treatment for patients with chronic NTM lung disease. Epetraborole is a boron-containing small molecule inhibitor of bacterial leucyl-tRNA synthetase, or LeuRS, an enzyme that catalyzes the attachment of leucine to transfer RNA, or tRNA, molecules, an essential step in protein synthesis. Epetraborole forms a complex with a tRNALEU molecule, trapping the terminal ribonucleotide of tRNALEU in the editing site of the enzyme, which prevents the synthetic site from attaching leucine to tRNALEU thus shutting down tRNA leucylation and leading to a block in protein synthesis.

• MNKD-101 (Clofazimine Inhalation Suspension): Mannkind Corporation
MNKD-101, a nebulized formulation of clofazimine, is being developed for the treatment of severe chronic and recurrent pulmonary infections, including NTM lung disease. An orally inhaled formulation of clofazimine is anticipated to offer several clinical advantages over the current solid oral dosage form of this drug. MNKD-101 has been designated as both an orphan drug and a qualified infectious disease product by the US FDA for the treatment of pulmonary NTM infections. Mannkind is also assessing the feasibility of developing a dry-powder formulation of clofazimine using Mannkind's technosphere formulation technology. MNKD-101 is designated with fast-track designation by the US FDA for the treatment of NTM lung infections.

• SPR720 (Fobrepodacin): Spero Therapeutics
SPR720, developed by Spero Therapeutics, is a broad-spectrum oral antibiotic designed to treat NTM pulmonary disease. SPR720 employs a novel mechanism and has no known cross-resistance with marketed antibiotics. SPR720 has demonstrated a broad spectrum of activity in preclinical studies against the most common organisms causing NTM infections, including M. avium complex, or MAC, M. kansasii, and M. abscessus. SPR720 is applicable to both nonrefractory and refractory patients.

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Nontuberculous Mycobacterial Infections Drugs Market
Current standard therapy for the most common NTM infection, MAC, involves a three-drug regimen taken for approximately 18 months. However, the rates of culture conversion with this approach are only 45-70%, and relapse or reinfection rates can be as high as 60%. EffectiveNontuberculous Mycobacterial Infections treatment requires a holistic, patient-centered approach, with close monitoring for drug side effects and adherence.

Nontuberculous Mycobacterial Infections Market Outlook
Nontuberculous Mycobacterial Infections treatment is challenging and requires prolonged, multidrug regimens that are often tailored to the specific NTM species and the site of infection. The management of these infections is complicated by the intrinsic resistance of many NTM species to standard antibiotics, necessitating the use of specialized and often costly medications. Consequently, NTM infections represent a significant and growing market within the pharmaceutical and healthcare industries, with ongoing research efforts focused on developing more effective diagnostic tools and novel therapeutics to improve patient outcomes.

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Scope of the Nontuberculous Mycobacterial Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Nontuberculous Mycobacterial Companies- AN2 Therapeutics, Mannkind Corporation, Spero Therapeutics, Paratek Pharmaceuticals, and others.
• Nontuberculous Mycobacterial Therapies- SPR720, Molgramostim, Thiolanox (Nitric Oxide), NUZYRA (omadacycline), CYT 107, and others.
• Nontuberculous Mycobacterial Therapeutic Assessment: Nontuberculous Mycobacterial current marketed and Nontuberculous Mycobacterial emerging therapies
• Nontuberculous Mycobacterial Market Dynamics: Nontuberculous Mycobacterial market drivers and Nontuberculous Mycobacterial market barriers
• Nontuberculous Mycobacterial Unmet Needs, KOL's views, Analyst's views, Nontuberculous Mycobacterial Market Access and Reimbursement

Table of Content
1. Key Insights
2. Report Introduction
3. NTM Infection Market Overview at a Glance
4. Epidemiology and Market Forecast Methodology
5. Executive Summary
6. Key Events
7. Disease Background and Overview
8. Patient Journey
9. Epidemiology and Patient Population
10. Marketed Drugs
11. Emerging Drugs
12. NTM Infections: Market Analysis
13. Key Opinion Leaders' Views
14. SWOT Analysis
15. Unmet Needs
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

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