Published Date : 2021-11-19
Published Date : 2021-11-19
Updated On : 2023-09-15
Pages : 167
Thelansis’s “Neuromyelitis Optica (NMO) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 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 Neuromyelitis Optica (NMO) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Neuromyelitis optica (NMO), also known as Devic syndrome, manifests as a clinical syndrome characterized by recurrent acute optic neuritis and transverse myelitis. In the majority of patients, NMO is driven by pathogenic serum IgG autoantibodies targeting aquaporin 4 (AQP4), which happens to be the most prevalent water-channel protein within the central nervous system (CNS). In more than 80% of cases, NMO is a result of the presence of pathogenic IgG autoantibodies directed against aquaporin 4 (AQP4-IgG), the predominant water channel protein in the CNS. Roughly 10–40% of individuals diagnosed with NMO who do not possess AQP4-IgG instead have IgG autoantibodies targeting myelin oligodendrocyte glycoprotein (MOG-IgG). Notably, MOG-IgG is also detected in a subgroup of patients, primarily children, with acute disseminated encephalomyelitis (ADEM). The most prominent risk factor for NMO is gender, with a strong association observed in females, particularly in those with AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD). NMO can manifest at any age, with a median age at onset of 40 years for AQP4-IgG-positive patients and 31 years for MOG-IgG-positive patients. It is more prevalent in women than men, especially among those with AQP4-IgG (male-to-female ratio ranging from 1:9 to 1:10). This gender discrepancy is less pronounced in patients with seronegative NMO and those with MOG-IgG. The management and treatment of NMO/NMOSD involve various strategies, including addressing symptoms, managing acute relapses, and implementing long-term maintenance through immunosuppressive therapies. Symptomatic therapy encompasses the treatment of pain, fatigue, bowel/bladder issues, cognitive deficits, sexual dysfunction, and muscle spasms. Acute relapse management includes corticosteroid therapy and plasma exchange (PLEX). However, approximately 90% of patients may eventually experience relapses and/or develop permanent disabilities. Consequently, long-term symptom management with immunotherapy is crucial in NMO/NMOSD due to its association with relapse-related disability, unfavorable prognosis, and high mortality risk in untreated individuals. The FDA has granted approval to three drugs for NMO relapse treatment in adults: Eculizumab (Soliris, Elizaria), Satralizumab (Enspryng), and Inebilizumab (Uplizna).
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 | Satralizumab | Hoffmann-La Roche | Phase 3 |
2 | Ravulizumab | Alexion | Phase 3 |
3 | Inebilizumab | MedImmune LLC | Phase 3 |
4 | Divozilimab | Biocad | Phase 3 |
5 | ABX-1431 | Abide Therapeutics | Phase 1 |
6 | MIL62 | Beijing Mabworks Biotech Co., Ltd. | Phase 3 |
7 | BAT4406F | Bio-Thera Solutions | Phase 2 |
8 | RC18 | RemeGen Co., Ltd. | Phase 3 |
9 | HBM9161 | Harbour BioMed (Guangzhou) Co. Ltd. | Phase 1 |
10 | SHR1459 | Reistone Biopharma Company Limited | Phase 2 |
Continued...
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. Neuromyelitis Optica (NMO) – 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. Neuromyelitis Optica (NMO) market scenario 2021 |
1.2.2. Neuromyelitis Optica (NMO) market scenario 2025 |
1.2.3. Neuromyelitis Optica (NMO) market scenario 2032 |
2. Neuromyelitis Optica (NMO) 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 Neuromyelitis Optica (NMO) |
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. Neuromyelitis Optica (NMO) 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 Neuromyelitis Optica (NMO) management |
2.16. Market Opportunity for Neuromyelitis Optica (NMO) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Neuromyelitis Optica (NMO) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Neuromyelitis Optica (NMO) Epidemiology in US (2021-2032) |
3.2.1.1. Incidence of Neuromyelitis Optica (NMO) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Neuromyelitis Optica (NMO) Epidemiology in EU-5 (2021-2032) |
3.2.2.1. Incidence of Neuromyelitis Optica (NMO) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Neuromyelitis Optica (NMO) Epidemiology in Japan (2021-2032) |
3.2.3.1. Incidence of Neuromyelitis Optica (NMO) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Neuromyelitis Optica (NMO) Epidemiology in China (2021-2032) |
3.2.4.1. Incidence of Neuromyelitis Optica (NMO) |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) Market Forecast 2021-2032 |
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 Neuromyelitis Optica (NMO) |
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 Neuromyelitis Optica (NMO) 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 Neuromyelitis Optica (NMO) |
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 Neuromyelitis Optica (NMO) 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 |