MAC Lung Disease Market Size (7MM) was ~USD 474 million in 2023 and is projected to increase by 2034, estimates DelveInsight | Insmed, Mannkind Corporation, Johnson and Johnson (Janssen Pharmaceutical K.K.), Spero Therapeutics, AN2 Therapeutics

DelveInsight's "MAC Lung Disease Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of MAC lung disease, historical and forecasted epidemiology, as well as the MAC lung disease market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the MAC Lung Disease Market Report
• In October 2025, Janssen Pharmaceutical K.K. conducted a study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).
• In October 2025, Spero Therapeutics conducted a Phase 2 study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease.
• In 2023, there were an estimated 151 thousand diagnosed prevalent cases of NTM lung disease across the 7MM, with the number expected to rise by 2034.
• In 2023, the US reported approximately 40 thousand diagnosed prevalent cases of NTM lung disease in males and 55 thousand in females.
• Among the 7MM in 2023, the species-specific prevalent cases of NTM lung disease included approximately 119 thousand cases for MAC, 6 thousand cases for Mycobacterium abscessus, and 27 thousand cases for other species.
• In 2023, the US reported the highest number of diagnosed prevalent cases of MAC lung disease among the 7MM, with approximately 76 thousand cases. This figure is projected to increase by 2034.
• In 2023, Germany recorded the highest number of diagnosed prevalent cases of MAC lung disease among the EU4 and the UK, with approximately 26 hundred cases, followed by Italy with nearly 22 hundred cases. In contrast, Spain had the fewest cases, with approximately 7 hundred cases.
• In 2023, Japan had approximately 33 thousand diagnosed prevalent cases of MAC lung disease, with expectations for this number to change by 2034.
• The leading MAC Lung Disease Companies such as Insmed, Mannkind Corporation, Johnson and Johnson (Janssen Pharmaceutical K.K.), Spero Therapeutics, AN2 Therapeutics, Inc, and others
• Promising MAC Lung Disease Therapies such as ARIKAYCE (Amikacin Liposome Inhalation Suspension), MNKD-101 (clofazimine inhalation suspension), Bedaquiline fumarate (TMC207), SPR720 (fobrepodacin), Epetraborole, RHB-204, and others

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MAC Lung Disease Epidemiology Segmentation in the 7MM
• Total Diagnosed Prevalent Cases of NTM Lung Disease
• Gender-specific Diagnosed Prevalent Cases of NTM Lung Disease
• Species-specific Diagnosed Prevalent Cases of NTM Infection
• Total Diagnosed Prevalent Cases of MAC Lung Disease

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MAC Lung Disease Marketed Drugs
• ARIKAYCE (Amikacin Liposome Inhalation Suspension): Insmed
ARIKAYCE is the first FDA-approved treatment for MAC lung disease, offered as a once-daily inhaled amikacin formulation using Insmed's PULMOVANCE technology. This delivery method targets the infection directly while minimizing systemic exposure, administered through the Lamira Nebulizer System. The treatment received orphan drug designation from the US FDA in 2013. In May 2024, late-breaking data from the ARISE study was presented at ATS 2024, focusing on MAC lung infections in patients who had not previously received antibiotic treatment. Approved in the US, EU, and Japan, ARIKAYCE is also part of the ongoing Phase III ENCORE study, evaluating patients with newly diagnosed or recurrent MAC lung infection who have not yet started antibiotics, with topline data expected in Q1 2026.

MAC Lung Disease Emerging Drugs
• MNKD-101 (clofazimine inhalation suspension): Mannkind Corporation
MNKD-101, a nebulized clofazimine formulation, is being developed for severe chronic and recurrent pulmonary infections, including NTM lung disease. This inhaled version is expected to offer clinical advantages over the current oral form. MannKind is also exploring a dry-powder formulation using its technosphere technology. In May 2024, the US FDA granted Fast Track Designation (FTD) to MNKD-101 for NTM lung disease, after previously designating it as an orphan drug and QIDP. The US FDA cleared the IND application for MNKD-101 in April 2024, enabling a Phase III trial. Additionally, Japan's PMDA approved the Phase III ICoN-1 trial in September 2024, allowing the global study to proceed.

• Bedaquiline fumarate (TMC207): Johnson and Johnson (Janssen Pharmaceutical K.K.)
Bedaquiline fumarate, sold under the brand name SIRTURO, is a diarylquinoline antimycobacterial medication used in combination therapy for adults and pediatric patients (aged 5 years and older, weighing at least 15 kg) with pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. Currently, bedaquiline is being investigated in a Phase II/III clinical trial as part of a treatment regimen with clarithromycin and ethambutol for adult patients with treatment-refractory MAC lung disease (MAC-LD).

• SPR720 (fobrepodacin): Spero Therapeutics
Spero is advancing SPR720, an oral treatment for NTM pulmonary disease (NTM-PD). This stable prodrug rapidly converts to its active form, SPR719, which targets the ATPase subunits of gyrase and topoisomerase, distinct from fluoroquinolones. Preclinical studies have shown SPR720's broad activity against major NTM pathogens, including MAC, M. kansasii, and M. abscessus, in both refractory and nonrefractory patients. The US FDA has granted SPR720 Fast Track Designation, orphan drug status, and Qualified Infectious Disease Product (QIDP) designation. A Phase IIa trial (SPR720-202) is ongoing for the treatment of MAC PD, with results expected in Q4 2024.

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MAC Lung Disease Treatment Landscape
MAC lung disease treatment primarily involves a multidrug regimen, typically combining macrolides (azithromycin or clarithromycin), rifamycin (rifampin or rifabutin), and ethambutol. This approach targets mycobacterial infections through protein synthesis inhibition, cell wall disruption, and bacterial replication prevention, with therapy lasting 12-18 months based on disease severity and drug susceptibility. Adjunctive therapies, including chest physiotherapy, mucolytics, and bronchodilators, are crucial for patients with underlying lung conditions, helping with sputum clearance and mucus obstruction. Devices like PEP masks and HFCWO devices also aid in reducing bacterial load. Emerging therapies, such as clofazimine inhalation suspension, bedaquiline, and SPR720, offer potential improvements in efficacy and safety. MNKD-101, a nebulized formulation of clofazimine developed by Mannkind, is being investigated for severe chronic and recurrent pulmonary infections, including NTM lung disease. This inhaled formulation is expected to offer clinical advantages over the current oral dosage by delivering the drug directly to the lungs, enhancing efficacy while minimizing systemic side effects.

MAC Lung Disease Market Outlook
The MAC lung disease relies on a multidrug regimen, typically including macrolides (azithromycin or clarithromycin), rifamycins (rifampin or rifabutin), and ethambutol. This combination targets the infection by inhibiting protein synthesis, cell wall formation, and bacterial replication. Treatment duration is usually 12-18 months, depending on disease severity and drug susceptibility. Macrolides are essential, but resistance is a concern, requiring close monitoring and potential adjustments. In refractory cases, aminoglycosides like amikacin may be used. Adjunctive therapies are crucial, particularly for those with structural lung disease. Techniques like chest physiotherapy, mucolytics, and bronchodilators help clear sputum and reduce obstruction. Mechanical devices, such as PEP masks and HFCWO devices, support airway clearance and bacterial load reduction, improving quality of life and preventing further damage.

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MAC Lung Disease Companies
Insmed, Mannkind Corporation, Johnson and Johnson (Janssen Pharmaceutical K.K.), Spero Therapeutics, AN2 Therapeutics, Inc, and others

Scope of the MAC Lung Disease Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• MAC Lung Disease Companies- Insmed, Mannkind Corporation, Johnson and Johnson (Janssen Pharmaceutical K.K.), Spero Therapeutics, AN2 Therapeutics, Inc, and others.
• MAC Lung Disease Therapies- ARIKAYCE (Amikacin Liposome Inhalation Suspension), MNKD-101 (clofazimine inhalation suspension), Bedaquiline fumarate (TMC207), SPR720 (fobrepodacin), Epetraborole, RHB-204, and others
• MAC Lung Disease Therapeutic Assessment: MAC Lung Disease current marketed and MAC Lung Disease emerging therapies
• MAC Lung Disease Market Dynamics: MAC Lung Disease market drivers and MAC Lung Disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• MAC Lung Disease Unmet Needs, KOL's views, Analyst's views, MAC Lung Disease Market Access and Reimbursement

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Table of Contents
1. Key Insights
2. Report Introduction
3. 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. MAC Lung Disease: 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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