Nontuberculous Mycobacterial Infection Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

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).
Nontuberculous Mycobacterial Market Summary

The Nontuberculous Mycobacterial (NTM) infections market is expected to grow steadily from 2024 to 2034, driven by improved diagnostics, new therapies, and greater disease awareness. Aging populations, who are more susceptible to NTM infections, contribute to rising diagnosed cases. Current treatments rely on repurposed and combination antibiotics, as there are few novel therapies, resulting in high relapse and treatment failure rates. ARIKAYCE is currently the only FDA-approved therapy for refractory Mycobacterium avium complex (MAC) lung disease in adults. The US NTM treatment market was valued at approximately USD 360 million in 2023, with ARIKAYCE accounting for USD 223 million. Emerging therapies, including Epetraborole and MNKD-101, could transform the treatment landscape, addressing unmet needs and improving patient outcomes. Overall, ongoing R&D and new treatment options are expected to drive market growth and enhance NTM infection management.

DelveInsight's report, "Nontuberculous Mycobacterial Infections Market Insights, Epidemiology, and Market Forecast - 2034," provides a comprehensive analysis of NTM infections, including historical and projected epidemiology and market trends across the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. The report details current treatment approaches, emerging therapies, market share of individual drugs, and the NTM infections market size from 2020 to 2034 across seven key markets. Additionally, it examines treatment algorithms, market drivers, barriers, and unmet medical needs, highlighting opportunities and evaluating the overall growth potential of the NTM infections market.

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Key Takeaways from the Nontuberculous Mycobacterial (NTM) Market Report

* The US NTM infections market was valued at approximately USD 360 million in 2023 and is expected to grow steadily from 2024 to 2034.
* In July 2025, Insmed Incorporated has announced results of ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
* In December 2024, Shanghai MicuRx Pharmaceutical (688373.SH) announced that its anti-infective drug MRX-5 received FDA Orphan Drug Designation for NTM infections, representing a significant milestone.
* DelveInsight estimates around 108,000 diagnosed NTM cases in the US in 2023, projected to rise due to factors like an aging population, increasing chronic lung diseases (COPD, bronchiectasis), better awareness, and improved diagnostics.
* NTM infections are more common in females, accounting for ~68% of diagnosed cases in 2023, influenced by biological, behavioral, and environmental factors.
* Among species-specific cases, M. avium led with ~76,000 cases, followed by M. abscessus (~14,000) and other species (~18,000), largely due to environmental exposure.
* Pulmonary NTM cases (~86,000) outnumbered extrapulmonary (~22,000). Moderate cases (~58,000) were most frequent, followed by mild (~36,000) and severe (~13,000).
* Leading companies in the space include AN2 Therapeutics, Mannkind, Spero Therapeutics, and Paratek Pharmaceuticals.
* Promising therapies under development include SPR720, Molgramostim, Thiolanox, NUZYRA (omadacycline), CYT 107, and others.

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Nontuberculous Mycobacterial Epidemiology

DelveInsight's epidemiology model estimates that approximately 108,000 individuals in the US were diagnosed with Nontuberculous Mycobacterial (NTM) infections in 2023, with numbers expected to rise from 2024 to 2034. Key factors driving this increase include an aging population and the growing prevalence of chronic lung conditions such as COPD and bronchiectasis. Greater awareness and advancements in diagnostic methods have also contributed to more frequent detection and reporting of these infections.

In 2023, NTM infections were more prevalent among females, who accounted for about 68% of diagnosed cases, compared to 32% in males. This higher prevalence is influenced by biological, behavioral, and environmental factors, including a greater likelihood of chronic lung diseases, as well as hormonal and immune system differences.

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 Drugs Uptake and Pipeline Analysis

- 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.

- 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 Market Outlook

The US Nontuberculous Mycobacterial market was valued at approximately USD 360 million in 2023, dominated by ARIKAYCE (~USD 223 million), and is projected to grow steadily through 2034. Treatment of Nontuberculous Mycobacterial (NTM) infections is complex, requiring prolonged, multidrug regimens tailored to the specific NTM species, infection site, and patient health. Management is complicated by intrinsic resistance, often necessitating costly and specialized antibiotics. Pulmonary MAC infections are typically treated with macrolides, rifamycins, and ethambutol for at least 12 months post-culture conversion, while M. kansasii requires rifampin, isoniazid, and ethambutol. Resistant species like M. abscessus demand intensive IV therapy followed by long-term oral regimens. Skin and soft tissue infections caused by rapidly growing mycobacteria involve combination therapy guided by susceptibility testing and sometimes surgery. ARIKAYCE (amikacin liposome inhalation suspension) is currently the only FDA-approved drug specifically for refractory MAC lung infections. Key Nontuberculous Mycobacterial Infections companies such as AN2 Therapeutics, Mannkind, and Spero Therapeutics are advancing novel therapies.

Nontuberculous Mycobacterial Infections Market Drivers:

* Rising Prevalence of NTM Infections: Increasing diagnosed cases globally, particularly in the US, EU5, and Japan, are driving demand for effective treatments.
* Aging Population: Older adults are more susceptible to NTM infections, contributing to higher diagnosis rates and expanding the treatment market.
* Growth of Chronic Lung Diseases: Conditions like COPD, bronchiectasis, and cystic fibrosis increase vulnerability to NTM infections, boosting the need for therapeutic interventions.
* Advancements in Diagnostics: Improved diagnostic tools, including molecular testing and imaging techniques, enable earlier detection and better disease management.
* Emerging Therapies and Pipeline Development: Investigational therapies such as SPR720, Epetraborole, and MNKD-101 offer potential improvements over current treatments, expanding the market.
* Increasing Awareness: Enhanced clinician and patient awareness about NTM infections supports early diagnosis and treatment uptake.

Nontuberculous Mycobacterial Infections Market Barriers:

* Limited Approved Therapies: Currently, ARIKAYCE is the only FDA-approved therapy for refractory MAC lung disease, leaving significant unmet treatment needs.
* High Treatment Costs: Biologics and combination regimens are expensive, restricting accessibility for certain patient populations.
* Treatment Complexity: Heterogeneity of NTM species and intrinsic antibiotic resistance make treatment regimens lengthy, complex, and prone to failure.
* Regulatory Challenges: Lengthy clinical trial requirements and approval timelines can delay the introduction of new therapies.
* Relapse and Treatment Failure: High rates of relapse and suboptimal outcomes with existing regimens limit long-term efficacy.

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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. Nontuberculous Mycobacterial Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Nontuberculous Mycobacterial Background and Overview

8. Nontuberculous Mycobacterial Patient Journey

9. Nontuberculous Mycobacterial Epidemiology and Patient Population

10. Marketed Nontuberculous Mycobacterial Drugs

11. Emerging Nontuberculous Mycobacterial Drugs

12. NTM Infections Market Analysis

13. Key Opinion Leaders' Views

14. Nontuberculous Mycobacterial SWOT Analysis

15. Nontuberculous Mycobacterial Unmet Needs

16. Nontuberculous Mycobacterial Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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