Neuromyelitis Optica Spectrum Disorder (NMOSD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Outlook and Forecast

Neuromyelitis Optica Spectrum Disorder (NMOSD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-04-11

Updated On : 2024-02-25

Pages : 154

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Outlook

Thelansis’s “Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" 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 Spectrum Disorder treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Neuromyelitis Optica Spectrum Disorder (NMOSD) Overview

Neuromyelitis optica spectrum disorder (NMOSD) presents as an autoimmune astrocytopathy targeting the central nervous system, characterized by inflammation primarily affecting the optic nerve and spinal cord, with potential involvement of the brainstem, notably the area postrema. While its etiology remains elusive, recent studies have distinguished NMOSD from multiple sclerosis (MS) in terms of disease mechanisms, clinical features, and therapeutic approaches. Whole-genome sequencing has identified certain genotypes predisposing individuals to NMOSD, notably major histocompatibility complexes such as HLA-DRB1*03:01, which exhibit similarities to systemic lupus erythematosus (SLE) rather than MS. The hallmark of NMOSD is the presence of IgG antibodies against aquaporin-4, detected in most patients, particularly in regions rich in aquaporin-4, such as the optic nerve, spinal cord, and area posttrauma. This autoimmune process mediated by aquaporin-4 antibodies leads to perivascular lymphocytic infiltration and subsequent axonal loss, predominantly affecting susceptible regions. Diagnostic evaluation of NMOSD involves clinical assessment, serologic testing for aquaporin-4 antibodies, and magnetic resonance imaging (MRI) with gadolinium enhancement. International consensus diagnostic criteria categorize NMOSD based on aquaporin-4 antibody status and define clinical and MRI features. Notable findings may include decreased color vision and central scotomas on visual field testing. In the differential diagnosis of optic neuritis, NMOSD should be distinguished from MS and MOG antibody-associated disease (MOGAD). MS is the most common, but NMOSD and MOGAD necessitate careful consideration due to their distinct prognostic implications and treatment requirements. Complications of NMOSD encompass visual field defects, motor impairment, and, in severe cases, myogenic respiratory failure, leading to increased mortality. Advances in understanding NMOSD pathogenesis have led to the development of monoclonal antibodies targeting various components of the immune response, including B-cells, the complement pathway, and interleukin 6 (IL-6), yielding therapeutic options such as ibalizumab, eculizumab, eculizumab, and natalizumab.

  • Despite progress in NMOSD treatment, a treatment gap persists, particularly in the pediatric population, with NMOSD affecting approximately 1-5 individuals per 100,000 worldwide.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

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.

KOL Insights:

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

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- 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

NPV/ IRR Calculator-

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.

Competitive Landscape:

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.

Clinical Trial Assessment-

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.

Unmet Medical Needs Overview-

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.

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Neuromyelitis Optica Spectrum Disorder (NMOSD) Competitive Landscape

S. no Asset Company Stage
1 Ultomiris (ravulizumab-cwvz) Alexion Pharmaceuticals, Inc. and AstraZeneca Phase 2/3
2 Divozilimab Biocad Phase 3
3 UPLIZNA® Horizon Therapeutics Ireland DAC Phase 3
4 MIL62 Beijing Mabworks Biotech Co., Ltd. Phase 3
5 BAT4406F Bio-Thera Solutions Phase 2
6 RC18 RemeGen Co., Ltd. Phase 3
7 Nabiximols Jazz Pharmaceuticals Phase 2
8 HBM9161 Injection Harbour BioMed (Guangzhou) Co. Ltd. Phase 1

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

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

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.

Neuromyelitis Optica Spectrum Disorder (NMOSD) Market Forecast

1.  Neuromyelitis Optica Spectrum Disorder (NMOSD) – 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 Spectrum Disorder (NMOSD) market scenario 2023
                     1.2.2. Neuromyelitis Optica Spectrum Disorder (NMOSD) market scenario 2028
                     1.2.3. Neuromyelitis Optica Spectrum Disorder (NMOSD) market scenario 2033

2. Neuromyelitis Optica Spectrum Disorder (NMOSD) 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 Spectrum Disorder (NMOSD)
         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 Spectrum Disorder (NMOSD) 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 Spectrum Disorder (NMOSD) management
         2.16.  Market Opportunity for Neuromyelitis Optica Spectrum Disorder (NMOSD)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Neuromyelitis Optica Spectrum Disorder (NMOSD)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Neuromyelitis Optica Spectrum Disorder (NMOSD)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Neuromyelitis Optica Spectrum Disorder (NMOSD)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Neuromyelitis Optica Spectrum Disorder (NMOSD)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Neuromyelitis Optica Spectrum Disorder (NMOSD) Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Neuromyelitis Optica Spectrum Disorder (NMOSD)
                             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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD) Market Forecast 2023-2033
                     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 Spectrum Disorder (NMOSD)
                                      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 Spectrum Disorder (NMOSD) 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 Spectrum Disorder (NMOSD)
         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 Spectrum Disorder (NMOSD) 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