Published Date : 2022-08-12
Published Date : 2022-08-12
Updated On : 2023-05-22
Pages : 158
Thelansis’s “Nontuberculous Mycobacterial (NTM) Lung Disease Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Nontuberculous Mycobacterial (NTM) Lung Disease treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Non-tuberculosis mycobacterial (NTM) lung infections are less prevalent than infections caused by Mycobacterium tuberculosis. The transmission of NTM occurs through the inhalation of aerosolized droplets containing the infectious agents. Risk factors for NTM transmission include proximity living, coughing, and failure to use facial masks. Factors such as advanced age, immunosuppression, and corticosteroid usage increase the likelihood of acquiring NTM microorganisms. Following the entry into the body, NTM microorganisms predominantly settle in the lower airways and may induce an inflammatory response characterized by an influx of lymphocytes. This immune response releases cytokines and other mediators, resulting in a pneumonia-like infectious process. Common symptoms of NTM lung infections, such as fever, weight loss, night sweats, decreased appetite, and energy loss, are often nonspecific and vague. The prognosis of NTM lung infections is generally uncertain. Patients with compromised immune systems experience worse outcomes than those with normal immune function. Moreover, the prognosis may vary depending on the specific type of NTM infection. Recent research suggests that patients with NTM infections caused by Mycobacterium avium complex (MAC) generally have a more favorable prognosis than those with other NTM infections. Conversely, patients with Mycobacterial abscessus lung infections have higher mortality rates than patients with different NTM lung infections. Chronic underlying lung diseases, particularly Mycobacterial abscessus infection, in combination with the specific type of NTM infection, appear to be significant predictors of mortality in NTM lung infections. NTM lung disease typically presents in three major clinical forms: fibro-cavitary, nodular bronchiectasis, and hypersensitivity pneumonitis. The clinical manifestations of NTM lung infections can resemble those of other lung infections, such as Mycobacterium tuberculosis, as well as atypical bacterial infections and chronic lung diseases. Infections, neoplasms, and connective tissue diseases are common differential diagnoses similar to NTM lung infections.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | NUZYRA® (omadacycline) | Paratek Pharmaceuticals Inc | Phase 2 |
2 | Interleukin-7 (CYT107) t | Revimmune | Phase 3 |
3 | Liposomal amikacin for inhalation (LAI) | Insmed Incorporated | Phase 2 |
4 | SPR720 | Spero Therapeutics | Phase 2 |
5 | Epetraborole | AN2 Therapeutics, Inc | Phase 3 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Nontuberculous Mycobacterial (NTM) Lung Disease – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Nontuberculous Mycobacterial (NTM) Lung Disease market scenario 2022 |
1.2.2. Nontuberculous Mycobacterial (NTM) Lung Disease market scenario 2025 |
1.2.3. Nontuberculous Mycobacterial (NTM) Lung Disease market scenario 2032 |
2. Nontuberculous Mycobacterial (NTM) Lung Disease Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Nontuberculous Mycobacterial (NTM) Lung Disease |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Nontuberculous Mycobacterial (NTM) Lung Disease Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Nontuberculous Mycobacterial (NTM) Lung Disease management |
2.16. Market Opportunity for Nontuberculous Mycobacterial (NTM) Lung Disease |
2.17. KOL Comments on current and upcoming/expected treatment practices in Nontuberculous Mycobacterial (NTM) Lung Disease |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Nontuberculous Mycobacterial (NTM) Lung Disease Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Nontuberculous Mycobacterial (NTM) Lung Disease |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Nontuberculous Mycobacterial (NTM) Lung Disease Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Nontuberculous Mycobacterial (NTM) Lung Disease |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Nontuberculous Mycobacterial (NTM) Lung Disease Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Nontuberculous Mycobacterial (NTM) Lung Disease |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Nontuberculous Mycobacterial (NTM) Lung Disease Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Nontuberculous Mycobacterial (NTM) Lung Disease |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Nontuberculous Mycobacterial (NTM) Lung Disease Market Forecast 2022-2032 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Nontuberculous Mycobacterial (NTM) Lung Disease |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Nontuberculous Mycobacterial (NTM) Lung Disease Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Nontuberculous Mycobacterial (NTM) Lung Disease |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Nontuberculous Mycobacterial (NTM) Lung Disease Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |