Nontuberculous Mycobacterial (NTM) Infections - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The NTM Infections market is poised for steady growth, with a compound annual growth rate (CAGR) expected to remain strong during the forecast period (2024-2034). This growth will be driven primarily by advancements in diagnostic techniques, expected approval of new therapies, and increased awareness of the condition.
• The number of diagnosed prevalent cases are increasing due to several factors. The aging population, which is more susceptible to these infections, plays a significant role. These factors are set to enhance market revenue significantly.
• Current regimens are not optimal for efficient and sustained clearance of NTM infection. Therefore, the treatment of NTM infections relies on repurposed and combination antibiotic regimens, as there is a lack of novel drugs approved for these mycobacterial diseases, highlighting the urgent need for new therapeutic options.
• The treatment of NTM infections remains suboptimal, with high rates of treatment failure and relapse. Addressing the unique challenges posed by NTM, such as their genetic diversity and intrinsic resistance, is crucial to developing more effective and targeted therapeutic strategies for this growing public health concern.
• Currently, ARIKAYCE is the only US FDA-approved medication for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibiotic regimen in adult patients who have limited or no alternative treatment options and is currently being studied in patients with non-refractory MAC infections.
• The total market size of NTM infections was approximately USD 360 million in the US in 2023. the majority of the market share was of ARIKAYCE, with a revenue of approximately USD 223 million for refractory MAC. This figure is projected to grow further by 2034, driven by continued advancements in treatment and increasing awareness.
• Looking ahead, several new therapies are in various stages of development for NTM Infections. Emerging therapies in the pipeline include AN2 Therapeutics’ Epetraborole and Mannkind’s MNKD-101, among others. If these new therapies receive approval, they could significantly alter the current market landscape, providing much-needed improvements in the treatment of NTM Infections and potentially offering curative options.
• In conclusion, the future market for NTM infection treatments appears robust, with ongoing research and development likely to address existing gaps and unmet needs. The introduction of new therapies and diagnostic tools could revolutionize the management of NTM Infections, offering better outcomes for patients and driving market growth.

This 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.

The NTM Infections market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted United States NTM Infections market size from 2020 to 2034. The report also covers NTM infection treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

NTM Infections Understanding and Treatment Algorithm

NTM infections overview

Nontuberculous mycobacteria (NTM) infections refer to any diseases caused by bacteria belonging to the genus Mycobacterium, excluding those that cause tuberculosis (M. tuberculosis complex) or leprosy/Hansen's disease (M. leprae). According to the American Lung Association, Nontuberculous mycobacteria naturally inhabit soil, water, and dust worldwide. MAC is the predominant type of NTM bacteria in the US, causing the majority of NTM lung disease cases in the country.

There are two forms of NTM lung disease based on disease progression. Nodular bronchiectatic, which is a less progressive NTM disease, affects older women without a smoking history, causing airway inflammation and scarring, leading to recurrent respiratory infections like bronchitis and pneumonia. Cavitary NTM disease, which is more progressive and prevalent in smokers with existing lung conditions, results in lung tissue scarring, fibrosis, and cavity formation, potentially leading to respiratory failure.

Key Symptoms associated with NTM infection include chronic cough, fatigue, weight loss, night sweats, shortness of breath, coughing up blood or excessive mucus, fever, and recurrent respiratory infections. The main risk factors for NTM infection include pre-existing lung disease, quantitatively impaired ciliary function, heterozygosity for mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, breaches in skin or soft tissues, and immunodeficiency conditions.

NTM infections diagnosis

Diagnosing and treating NTM Infections is complex due to variability among NTM species and their clinical presentations, making reliance on symptoms or imaging alone insufficient for accurate diagnosis. Diagnosing NTM Infections involves a combination of medical history review, physical examination, imaging studies (such as chest X-rays or CT scans), and microbiological testing. Microbiological testing may include sputum cultures, bronchoscopy with bronchoalveolar lavage, or lung biopsy to identify the specific NTM species causing the infection.

NTM infections treatment

The treatment of NTM infections remains a significant challenge. Current standard therapy for the most common NTM infection, MAC, involves a three-drug regimen taken for approximately 18 months. Effective treatment of NTM infections requires a holistic, patient-centered approach, with close monitoring for drug side effects and adherence. For rapid-growing NTM species like M. abscessus, intravenous antibiotics may be necessary initially.

In some cases, surgery may be recommended to remove localized areas of disease, such as in individuals with bronchiectasis, cavitary disease, or refractory hemoptysis.

Currently, ARIKAYCE is the first and only US FDA-approved medication for the treatment of MAC lung disease as part of a combination antibiotic regimen in adult patients who have limited or no alternative treatment options and is currently being studied in patients with non-refractory MAC infections. Other commonly used antibiotics include macrolides, ethambutol, rifamycins, aminoglycosides, fluoroquinolones, imipenem, and linezolid. However, these regimens are not optimal for efficient and sustained clearance of NTM infection.

NTM Infections Epidemiology

As the market is derived using a patient-based forecast model, the NTM Infections epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of NTM infections, total diagnosed prevalent cases of NTM infection, gender-specific cases of NTM infections, species-specific cases of NTM infection, type-specific cases of NTM infections, and severity-specific cases of NTM infections in the United States from 2020 to 2034.

• According to This reporting of these infections.
• In the US, NTM Infections exhibit a female preponderance compared to males in 2023. Of the total diagnosed prevalent cases of NTM Infections, females 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 diagnosed prevalent cases of NTM infections 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 diagnosed prevalent cases of NTM infections among pulmonary type and nearly 22 thousand cases among extrapulmonary type in 2023.
• In the US, the highest number of diagnosed NTM infection cases were moderate followed by mild and severe cases with approximately 58 thousand, 36 thousand, and 13 thousand cases respectively in 2023.

NTM Infections Drug Chapters

The drug chapter segment of the NTM Infections report encloses a detailed analysis of NTM Infections-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the NTM Infections clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

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.

In January 2018, the US FDA approved ARIKAYCE, specifically indicated for the treatment of MAC lung disease in adult patients with limited treatment options.

The FDA has designated ARIKAYCE as an orphan drug and a QIDP for NTM lung disease. Insmed is also conducting a Phase III clinical trial of ARIKAYCE in adult patients with newly diagnosed NTM lung infections caused by MAC.

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.

Currently, the drug is in Phase II/III of clinical development for the treatment of patients with NTM lung disease.

AN2 Therapeutics intends to expand the indication targeted by epetraborole by pursuing development in other mycobacterial diseases, including treatment-naïve MAC lung disease. AN2 Therapeutics also intends to conduct trials in which they plan to incorporate epetraborole as part of first-line combination treatment for treatment-naive patients with NTM lung disease and M. abscessus lung infections.

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.

Mannkind intends to commence a Phase III registration study of MNKD-101 in the US in the second quarter of 2024.

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.

In September 2020, SPR720 received FTD for the treatment of adult patients with NTM pulmonary disease.

In March 2020, the US FDA granted ODD for SPR720 for the treatment of NTM infections.

In February 2019, Spero Therapeutics was granted QIDP designation for SPR720 capsule for oral use for the treatment of lung infections caused by NTM.

SPR720 is designated with QIDP, fast-track, and orphan drug designation by the US FDA. Currently, the drug is in Phase II of clinical development for the treatment of NTM pulmonary disease.

Drug Class Insights

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%. Effective treatment of NTM infections requires a holistic, patient-centered approach, with close monitoring for drug side effects and adherence.

Commonly used antibiotics for the treatment of NTM infections include macrolides, ethambutol, rifamycins, aminoglycosides, fluoroquinolones, imipenem, and linezolid. However, these regimens are not optimal for efficient and sustained clearance of NTM infection. Therefore, the treatment of NTM infections relies on repurposed and combination antibiotic regimens, as there is a lack of novel drugs approved for these mycobacterial diseases, highlighting the urgent need for new therapeutic options.

Continued in report…

Market Outlook

Treatment for NTM infections 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.

Antibiotics: Doctors often use a combination of antibiotics “off-label,” meaning they are approved for other conditions but demonstrate effectiveness against specific NTM strains. Common antibiotics used include macrolides (azithromycin, clarithromycin), rifamycins (rifampin, rifabutin), fluoroquinolones (ciprofloxacin), aminoglycosides (amikacin, streptomycin), and ethambutol.

The treatment of NTM infections is intricate and highly dependent on the specific NTM species, infection site, and patient health status. For pulmonary NTM disease, the regimen varies: MAC typically requires a combination of macrolides (such as clarithromycin or azithromycin), rifamycins (rifampin or rifabutin), and ethambutol, often for at least 12 months post-culture conversion. Mycobacterium kansasii infections are treated with rifampin, isoniazid (with pyridoxine), and ethambutol for a similar duration. More resistant species like M. abscessus necessitate an intensive initial phase using intravenous amikacin and imipenem or cefoxitin, followed by a continuation phase with oral macrolides and possibly inhaled amikacin, often extending treatment over several months to years. For skin and soft tissue infections, especially those caused by rapidly growing mycobacteria (RGM) like M. abscessus and M. fortuitum, treatment is guided by susceptibility testing and may include combinations of clarithromycin, amikacin, cefoxitin, and imipenem, alongside necessary surgical interventions.

ARIKAYCE (amikacin liposome inhalation suspension) stands as the only FDA-approved drug specifically targeting NTM infections. However, its approval is limited to the treatment of refractory MAC lung infections in adults. This means it is only used for patients whose NTM infection has not responded to conventional treatment.

Key players including AN2 Therapeutics, Mannkind Corporation, and Spero Therapeutics, among others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat NTM Infections.

• The total market size of NTM Infections in the US was approximately USD 360 million in 2023 and is projected to increase during the forecast period (2024-2034).
• According to the analyst's analysis, among the currently used therapies, the majority of market share was of ARIKAYCE, with a revenue of approximately USD 223 million for refractory MAC in the US in 2023 which is expected to increase during the forecast period (2024-2034).
• In 2023, the market share for macrolides was nearly USD 26 million in the US, and for ethambutol and rifamycin/rifampin, the market share was approximately USD 16 million each.
• The market share for off-label therapies was approximately USD 41 million in the US in 2023.

NTM Infections Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Epetraborole is expected to enter the US market by 2026 and is projected to have a medium uptake during the forecast period.

NTM Infections Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for NTM Infections.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on NTM infections evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the US. Centers like Regis University, Oregon Health & Science University, Massachusetts General Hospital, Medical University of South Carolina, and Washington University School of Medicine, among others were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or NTM Infections market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician’s View

According to our primary research analysis, NTM infections are becoming increasingly prevalent, particularly among individuals aged 65 and above in the United States, underscoring the urgent need for expanded research and improved clinical strategies to effectively address and mitigate the impact of these infections in this vulnerable demographic. Managing NTM lung disease generally necessitates a complex regimen of multiple antibiotics, customized according to the specific NTM species and drug susceptibility test results. Despite these measures, achieving successful treatment outcomes remains challenging, often requiring prolonged therapy that carries a significant risk of toxicity. This highlights the critical importance of developing novel therapeutic approaches and enhancing our understanding of NTM infections to improve patient outcomes and quality of life for older adults.

The current pipeline includes promising therapies such as AN2 therapeutics’ Epetraborole, Mannkind’s MNKD-101, and Spero Therapeutics’ SPR720, among others. The entry of these drugs will provide various options tailored to patient-specific needs based on the severity and type of the condition.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The current treatment regime for NTM Infections in the US has high costs of treatment that affect the affordability and access of drugs to patients. Several organizations in the US are working to provide support to NTM Infections patients and spread awareness, including the ARIKAYCE copay savings program.

Arikayce Copay savings program

Insurance covers ARIKAYCE for most people; savings and financial support resources are also available for eligible patients.

For people with commercial or private insurance

Patients may be eligible for a copay as low as USD 0 for ARIKAYCE. If patients have commercial or private insurance, they may be able to save on out-of-pocket costs with the ARIKAYCE copay savings program.

For people with government insurance

• If patients are enrolled in a Medicare Part D plan, recent changes in the Medicare Part D benefit may make their medications more affordable.
• If they have Medicare Part D, they may be able to get “Extra Help” with prescription medicine costs through the Extra Help program.

Extra Help is designed to help people who are on Medicare with a limited income. The program provides a range of financial assistance for prescription drug costs. Benefits may include:

• Help patients with their monthly premiums
• Reduced or no annual deductible
• USD 0 or reduced costs on brand-name drugs
• No gap in coverage (“donut hole”)

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of NTM Infections, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies that will impact the current treatment landscape.
• A detailed review of the NTM Infections market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the US drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the US NTM Infections market.

NTM Infections report insights

• Patient Population
• Therapeutic Approaches
• NTM Infections Pipeline Analysis
• NTM Infections Market Size and Trends
• Existing and Future Market Opportunity

NTM Infections report key strengths

• 11 years Forecast
• The US Coverage
• NTM Infections Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

NTM Infections report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the total market size of NTM Infections, the market size of NTM Infections by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will Epetraborole affect the treatment paradigm of NTM Infections?
• How will Epetraborole compete with other upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of NTM Infections? What will be the growth opportunities across the US with respect to the patient population pertaining to NTM Infections?
• What is the historical and forecasted NTM infection patient pool in the United States?
• What factors are contributing to the growth of NTM Infections cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of NTM Infections? What are the current clinical and treatment guidelines for treating NTM Infections?
• How many companies are developing therapies for the treatment of NTM Infections?
• How many emerging therapies are in the mid-stage and late stage of development for treating NTM Infections?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the US historical and forecasted market of NTM Infections?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the NTM Infections market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for NTM Infections, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.