非結核性抗酸菌 (NTM) 感染症：市場洞察・疫学・市場予測 (～2034年)

主なハイライト

• 非結核性抗酸菌 (NTM) 感染症の市場は着実な成長を遂げ、予測期間中のCAGRは堅調に推移すると見込まれています。この成長を牽引するのは、主に診断技術の進歩、新規治療薬の承認見込み、NTM感染症に対する認知度の向上です。
• 診断有病症例数はいくつかの要因により増加しています。これらの感染症にかかりやすい高齢者人口の増加も重要な要因です。これらの要因により、市場収益は大幅に増加するものと思われます。
• 現在のレジメンは、NTM感染を効率的かつ持続的に除去するのに最適なものではありません。したがって、NTM感染症の治療は、転用薬や抗生物質の併用レジメンに依存しています。これらのマイコバクテリア疾患に対して承認された新規薬剤が不足しているため、新たな治療オプションの緊急の必要性が浮き彫りになっています。
• NTM感染症の治療は依然として最適とは言えず、治療の失敗や再発の割合が高いです。遺伝的多様性や内在性耐性など、NTMがもたらす特有の課題に対処することは、この増大する公衆衛生上の懸念に対して、より効果的で的を絞った治療戦略を開発する上で極めて重要です。
• 2023年の米国におけるNTM感染症の市場規模は約3億6,000万米ドルでした。市場シェアの大半を占めるのはARIKAYCEで、難治性MACに対する収益は約2億2,300万米ドルでした。この数字は、継続的な治療の進歩と認知度の向上により、2034年までにさらに拡大すると予測されています。

非結核性抗酸菌 (NTM) 感染症の疫学

• 2023年の米国におけるNTM感染症の診断有病症例数は約10万8,000例であり、いくつかの要因により予測期間中も増加すると予測されています。人口の高齢化とCOPDや気管支拡張症などの慢性肺疾患の増加率が大きく寄与しています。認知度の向上と診断ツールの改善により、これらの感染症がより頻繁に特定され報告されるようになっています。
• 2023年の米国における症例数は男性よりも女性の方が多い結果となりました。NTM感染症と診断された有病者のうち、女性は約68％を占め、男性は約32％でした。NTM感染症の有病率は、生物学的、行動学的、環境的要因の組み合わせにより、女性の方が高いものとなっています。女性は気管支拡張症などの特定の慢性肺疾患に罹患している可能性が高く、NTM感染症に罹患しやすいです。ホルモンの違いや免疫系の変化も関連している可能性があります。
• 2023年に米国でNTM感染症と診断された有病症例数は、菌種別ではM.aviumが約7万6,000人ともっとも多く、次いでM.abscessusが約1万4,000人、その他 (M.kansasii、M.xenopiなど) が約1万8,000人でした。米国では、土壌、水、家庭の配管システムなどの環境中にM.aviumが広く存在し、曝露の可能性が高いため、M.avium種によるNTM感染症の有病率が高いと診断されています。
• 米国の2023年の診断有病症例数は、肺型が約8万6,000人、肺外型が約2万2,000人でした。
• 米国の2023年の診断有病症例数は中等症が約5万8,000例でもっとも多く、次いで軽症が約3万6,000例、重症が約1万3,000例となっています 。

当レポートでは、世界の主要7カ国における非結核性抗酸菌 (NTM) 感染症の市場を調査し、疾患の背景・概要、疫学、治療と管理の概要、市場促進要因と障壁、アンメットニーズ、上市薬およびパイプライン薬のプロファイル、主要国の市場規模の推移・予測、競合情勢などをまとめ、最良の機会を発掘し、市場の潜在力を評価します。

目次

第1章 重要な洞察

第2章 レポート概要

第3章 非結核性抗酸菌 (NTM) 感染症：市場概要

• 2020年の市場シェア分布
• 2034年の市場シェア分布

第4章 疫学と市場予測手法

第5章 エグゼクティブサマリー

第6章 重要な出来事

第7章 疾患の背景と概要

• 分類
• 兆候と症状
• リスク要因
• 病態生理
• 診断
• 診断ガイドライン
• 治療と管理
• 治療ガイドライン

第8章 ペイシェントジャーニー

第9章 疫学と患者人口

• 主な調査結果
• 疫学と患者人口
• 前提と根拠
• 米国
  • 総有病症例数
  • 診断有病症例数
  • 症例数：性別
  • 症例数：種別
  • 症例数：タイプ別
  • 症例数：重症度別

第10章 上市製品

• ARIKAYCE (amikacin liposome inhalation suspension): Insmed

第11章 新興治療薬

• 主なクロスコンペティション
• Epetraborole: AN2 Therapeutics
• MNKD-101 (clofazimine inhalation suspension): Mannkind Corporation
• SPR720 (fobrepodacin): Spero Therapeutics
• NUZYRA (omadacycline): Paratek Pharmaceuticals

第12章 非結核性抗酸菌 (NTM) 感染症：市場分析

• 主な調査結果
• 主な前提条件
• 市場見通し
• コンジョイント分析
• 総市場規模

第13章 KOLの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Epidemiology and Market (2020-2034)
• Table 2: Key Events for NTM Infections
• Table 3: Total Prevalent Cases of NTM Infections in the US (2020-2034)
• Table 4: Total Diagnosed Prevalent Cases of NTM Infections in the US (2020-2034)
• Table 5: Gender-specific Cases of NTM Infections in the US (2020-2034)
• Table 6: Species-specific Cases of NTM Infections in the US (2020-2034)
• Table 7: Type-specific Cases of NTM Infections in the US (2020-2034)
• Table 8: Severity-specific Cases of NTM Infections in the US (2020-2034)
• Table 9: ARIKAYCE, Clinical Trial Description, 2024
• Table 10: Comparison of Emerging Drugs for Treatment
• Table 11: Epetraborole, Clinical Trial Description, 2024
• Table 12: MNKD-101 (Clofazimine Inhalation Suspension), 2024
• Table 13: SPR720, Clinical Trial Description, 2024
• Table 14: NUZYRA, Clinical Trial Description, 2024
• Table 15: Key Market Forecast Assumptions for Epetraborole
• Table 16: Key Market Forecast Assumptions for Clofazimine Inhalation Suspension (MNKD-101)
• Table 17: Market Size of NTM Infections in the US, in USD million (2020-2034)
• Table 18: The Market Size of NTM Infections by Therapies in the US, in USD million (2020-2034)

List of Figures

• Figure 1: Classification of NTM
• Figure 2: Signs and Symptoms of NTM Infection
• Figure 3: Causes and risk factors of NTM infection
• Figure 4: ATS Diagnostic Guidelines
• Figure 5: Patient Journey
• Figure 6: Total Prevalent Cases of NTM Infections in the US (2020-2034)
• Figure 7: Total Diagnosed Prevalent Cases of NTM Infections in the US (2020-2034)
• Figure 8: Gender-specific Cases of NTM Infections in the US (2020-2034)
• Figure 9: Species-specific Cases of NTM Infections in the US (2020-2034)
• Figure 10: Type-specific Cases of NTM Infections in the US (2020-2034)
• Figure 11: Severity-specific Cases of NTM Infections in the US (2020-2034)
• Figure 12: Market Size of NTM Infections in the US, in USD million (2020-2034)
• Figure 13: Market Size of NTM Infections by Therapies in the US, in USD million (2020-2034)
• Figure 14: SWOT Analysis of NTM Infections
• Figure 15: Unmet Needs of NTM
• Figure 16: Health Technology Assessment

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.

DelveInsight's "NTM 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.

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.

Further details are provided in the report...

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 DelveInsight's epidemiology model, the total diagnosed prevalent cases of NTM Infections 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 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-naive 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 DelveInsight'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.

Further detailed analysis of emerging therapies drug uptake in the report...

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.

DelveInsight's 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")

Further details will be provided in the report.

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.

Table of Contents

1. Key Insights

2. Report Introduction

3. NTM Infection Market Overview at a Glance

• 3.1. Market Share (%) Distribution of NTM Infection in 2020
• 3.2. Market Share (%) Distribution of NTM Infection in 2034

4. Epidemiology and Market Forecast Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Classification
• 7.3. Sign and Symptoms
• 7.4. Risk Factors
• 7.5. Pathophysiology
• 7.6. Diagnosis
• 7.7. Diagnostic Guidelines
  • 7.7.1. American Thoracic Society (ATS) Diagnostic Guidelines
• 7.8. Treatment and Management
• 7.9. Treatment Guidelines
  • 7.9.1. ATS/Infectious Diseases Society of American (IDSA) Treatment Guidelines (2020)

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Epidemiology and Patient Population
• 9.3. Assumption and Rationale
  • 9.3.1. Prevalent Cases of NTM Infections
  • 9.3.2. Diagnosed Prevalent Cases of NTM Infections
  • 9.3.3. Gender-specific Cases of NTM Infections
  • 9.3.4. Species-specific Cases of NTM Infections
  • 9.3.5. Type-specific Cases of NTM Infections
  • 9.3.6. Severity-specific Cases of NTM Infections
• 9.4. The US
  • 9.4.1. Total Prevalent Cases of NTM Infections in the US
  • 9.4.2. Total Diagnosed Prevalent Cases of NTM Infections in the US
  • 9.4.3. Gender-specific Cases of NTM Infections in the US
  • 9.4.4. Species-specific Cases of NTM Infection in the US
  • 9.4.5. Type-specific Cases of NTM Infections in the US
  • 9.4.6. Severity-specific Cases of NTM Infections in the US

10. Marketed Drugs

• 10.1. ARIKAYCE (amikacin liposome inhalation suspension): Insmed
  • 10.1.1. Product Description
  • 10.1.2. Regulatory Milestone
  • 10.1.3. Other Developmental Activities
  • 10.1.4. Clinical Trials Information
  • 10.1.5. Safety and Efficacy

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Epetraborole: AN2 Therapeutics
  • 11.2.1. Product Description
  • 11.2.2. Other Developmental Activities
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analysts' Views
• 11.3. MNKD-101 (clofazimine inhalation suspension): Mannkind Corporation
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activities
  • 11.3.3. Clinical Trials Information
  • 11.3.4. Safety and Efficacy
  • 11.3.5. Analysts' Views
• 11.4. SPR720 (fobrepodacin): Spero Therapeutics
  • 11.4.1. Product Description
  • 11.4.2. Other Developmental Activities
  • 11.4.3. Clinical Trials Information
  • 11.4.4. Safety and Tolerability
  • 11.4.5. Analysts' Views
• 11.5. NUZYRA (omadacycline): Paratek Pharmaceuticals
  • 11.5.1. Product Description
  • 11.5.2. Other Developmental Activities
  • 11.5.3. Clinical Trials Information
  • 11.5.4. Analysts' Views

12. NTM Infections: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Conjoint Analysis
• 12.5. Total Market Size of NTM Infections in the US
  • 12.5.1. Total Market Size of NTM Infections
  • 12.5.2. The Market Size of NTM Infections by Therapies

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight