MAC Lung Disease Market Poised for Growth Across the 7MM During the Forecast Period (2025-2034) Amid Rising Prevalence and New Therapeutic Solutions
LAS VEGAS, May 20, 2025 /PRNewswire/ — Mycobacterium avium Complex (MAC) refers to a group of bacteria, primarily Mycobacterium avium and Mycobacterium intracellulare, that are responsible for MAC lung disease. Accurate identification typically requires genetic testing. MAC is the leading cause of nontuberculous mycobacterial (NTM) lung infections in the United States and can affect people of all ages, although it is more common in older adults, postmenopausal women, smokers, and individuals with weakened immune systems or pre-existing lung conditions such as bronchiectasis, COPD, cystic fibrosis, emphysema, or a prior history of tuberculosis.
DelveInsight estimates that in 2023, there were around 119K diagnosed prevalent cases of MAC lung disease across the 7MM, with the United States accounting for approximately 64% of these cases. In 2023, there were an estimated 151K diagnosed prevalent cases of NTM lung disease across the 7MM, with the number expected to rise by 2034.
Treatment for MAC lung disease typically involves a combination of multiple antibiotics, most often including a macrolide (such as azithromycin or clarithromycin), a rifamycin (such as rifampin or rifabutin), and ethambutol. This regimen works by inhibiting protein synthesis, disrupting the bacterial cell wall, and preventing replication of the mycobacteria. Therapy generally continues for 12 to 18 months, depending on the severity of the disease and the pathogen's drug susceptibility.
Supportive therapies play an important role, especially for patients with preexisting lung conditions. Chest physiotherapy, mucolytic agents, and bronchodilators help clear mucus and alleviate airway obstruction. Additionally, devices like positive expiratory pressure (PEP) masks and high-frequency chest wall oscillation (HFCWO) devices can assist in reducing bacterial burden.
Learn more about the MAC lung disease treatment @ New Treatment for MAC Lung Disease
ARIKAYCE is the first FDA-approved therapy specifically for MAC lung disease. It is a once-daily inhaled formulation of amikacin, delivered using Insmed's proprietary PULMOVANCE technology to directly target the lungs while reducing systemic exposure. The treatment is administered through the Lamira Nebulizer System and was granted orphan drug status by the FDA in 2013.
In May 2024, new data from the ARISE study were presented at ATS 2024, highlighting outcomes in MAC lung disease patients who had not previously received antibiotic therapy. ARIKAYCE is approved in the US, European Union, and Japan, and is currently being studied in the Phase III ENCORE trial, which focuses on newly diagnosed or relapsed MAC patients who have not begun antibiotic treatment. Topline results from this study are anticipated in the first quarter of 2026.
Find out more on FDA-approved MAC lung disease drugs @ MAC Lung Disease Treatment Options
The scarcity of FDA-approved therapies for MAC lung disease, with only ARIKAYCE being the only approved option, limits treatment options, complicates management of resistant strains, and highlights the need for new therapies.
MannKind Corporation, Janssen Pharmaceutical, and Spero Therapeutics are progressing through various stages of clinical trials, driving innovation in the MAC lung disease market. This activity is creating a dynamic environment, offering significant opportunities for the MAC lung disease market expansion and growth. Among the emerging therapies, MNKD-101, a nebulized formulation of clofazimine, is currently in Phase III clinical development and is expected to launch in the market by 2027.
Discover which therapies are expected to grab major MAC lung disease market share @ MAC Lung Disease Market Report
MNKD-101 is a nebulized formulation of clofazimine being developed to treat severe, chronic, and recurrent lung infections, such as nontuberculous mycobacterial lung disease. This inhaled version is anticipated to provide therapeutic benefits over the existing oral form. MannKind is also working on a dry-powder variant using its proprietary Technosphere platform. In May 2024, the U.S. FDA granted Fast Track Designation to MNKD-101 for NTM lung disease, following its earlier designations as an orphan drug and a Qualified Infectious Disease Product (QIDP).
The FDA approved the Investigational New Drug (IND) application for MNKD-101 in April 2024, paving the way for a Phase III clinical trial. Similarly, Japan's PMDA authorized the Phase III ICoN-1 trial in September 2024, enabling the global trial to move forward.
Bedaquiline fumarate, marketed as SIRTURO, is a diarylquinoline antimycobacterial agent used in combination regimens to treat pulmonary tuberculosis caused by Mycobacterium tuberculosis strains resistant to both rifampin and isoniazid. It is approved for use in adults and children aged 5 years and older, weighing at least 15 kg.
Bedaquiline is currently being studied in a Phase II/III clinical trial as part of a treatment regimen with clarithromycin and ethambutol for adults with treatment-refractory Mycobacterium avium complex lung disease (MAC-LD).
Spero Therapeutics is developing SPR720, an oral therapy for NTM pulmonary disease. SPR720 is a stable prodrug that is rapidly converted into SPR719, which targets the ATPase subunits of gyrase and topoisomerase, mechanisms distinct from fluoroquinolones. Preclinical data have demonstrated SPR720's broad-spectrum activity against key NTM pathogens such as MAC, M. kansasii, and M. abscessus, in both treatment-refractory and treatment-naïve patients. The FDA has granted SPR720 Fast Track status, orphan drug designation, and QIDP designation.
Discover more about drugs for MAC lung disease in development @ MAC Lung Disease Clinical Trials
The anticipated launch of these emerging therapies for MAC lung disease are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the MAC lung disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for MAC lung disease is expected to grow from USD 474 million in the 7MM in 2023 at a significant CAGR by 2034. The market growth across the 7MM is expected to be fueled by the introduction of novel treatments such as MNKD-101, Bedaquiline fumarate (TMC207), and SPR720, among others. Additionally, the rising incidence of MAC lung disease driven by factors like aging populations, COPD, structural lung abnormalities, and exposure to MAC through soil, water, and aerosol-generating activities will likely contribute to an expanding MAC lung disease market opportunity.
DelveInsight's latest published market report, titled as MAC Lung Disease Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the MAC lung disease country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The MAC lung disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
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
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM MAC lung disease market. Highlights include:
10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement
Download this MAC lung disease market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the MAC lung disease market. Also, stay abreast of the mitigating factors to improve your market position in the MAC lung disease therapeutic space.
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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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
Contact UsShruti Thakur info@delveinsight.com +14699457679
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For more information on FAIR Health, visit Contact:Rachel KentExecutive Director of Communications and MarketingFAIR Health646-396-0795rkent@ 1 A claim line is an individual service or procedure listed on an insurance claim.2 Each telehealth service was attributed to a rural/urban designation in a region based on the patient's medical service area, which FAIR Health determines based on the unique geographical pattern of services utilized by the patient.
