Myasthenia Gravis (U.S.), November 2022
The MarketVue®: Myasthenia Gravis market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: Myasthenia Gravis report is supported by 5 qualitative interviews with key opinion leaders, a quantitative survey with 26 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- UCB
- Immunovant
- Janssen
- Alexion/Astrazeneca
- Regeneron
- Sanofi
- Hoffmann-La Roche
- RemeGen
- NMD Pharma
- Cartesian Therapeutics
- Cabaletta Bio
- IASO Bio
Key drugs mentioned:
- Rituximab
- Eculizumab (Soliris)
- Efgartigimod (Vyvgart)
- Ravulizumab (Ultomiris)
- Pyridostigmine (Mestinon)
- Mycophenolate
- Azathioprine
- Rozanolixizumab (Rystiggo)
- Batoclimab
- Nipocalimab / M281
- Zilucoplan (Zilbrysq) / RA101495
- Gefurulimab / ALXN1720
- Pozelimab (Veopoz) + Cemdisiran
- Satralizumab (Enspryng)
- Inebilizumab (Uplizna)
- Tolebrutinib
- Telitacicept
- NMD670
- Vemircopan / ALXN2050
- Descartes-08
- MuSK-CAART
- CT103A + Cyclophosphamide + Fludarabine
1. DISEASE OVERVIEW
A rare, chronic, autoimmune disease marked by muscle weakness and fatigue
Figure 1.1. Select clinical manifestations of MG
FcRn inhibition, B-cell directed therapies, and the complement pathway are common drug targets
Figure 1.2 MG drugs targets in AChR+ patients
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. Diagnosed prevalent cases of MG by region
Table 2.1 Diagnosed prevalent and drug-treated patients in the US and EU5
3. DIAGNOSIS & CURRENT TREATMENT
Overview
Figure 3.1. Diagnostic pathway for MG patients
Diagnostic testing for auto-antibodies is standard and disease severity criteria for MG are clearly defined
Table 3.1. MGFA Clinical Classification
Figure 3.2. Neurologist-reported percentage of MG patients misdiagnosed/not diagnosed in a timely manner
Figure 3.3. Neurologist-reported percentage of their patients in each clinical category
Improvement of symptoms and restoring patient’s baseline function and quality of life are the ultimate goals
Table 3.2. Treatment goals for MG
Figure 3.4. Neurologist-reported proportion of MG patients currently treated with drug therapy
Treatment flow for MG
There is no standard approach to treatment; biologics are emerging as key players in recent years
Figure 3.5. Neurologist-reported current treatment share for MG patients: 1st-line setting
Figure 3.6. Neurologist-reported % of patients not well-managed by first-line therapy
Figure 3.7. Neurologist-reported current treatment share for MG patients: 2nd-line and later settings
Upsides and downsides of current non-biologic MG treatments
Head-to-head comparison of FDA-approved biologics
Table 3.3. Comparison of approved biologics
Physician perspectives on current biologics
Table 3.4 . KOL insights on approved biologics
Cost, dosing convenience, and safety profile are the key factors that drive biologic choice
Table 3.5. KOL feedback on biologics based on key differentiators that drive treatment choice
With Argenx taking the lead, the race is on to develop more conveniently dosed biologics
Table 3.6. Summary of the ADAPT-SC trial results
Key treatment dynamics that will shape disease management and drug use in MG
Figure 3.7. Important dynamics of MG market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in MG
Figure 4.2. Neurologist-reported unmet needs in MG
High unmet needs persist despite three approved biologics for MG
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Percentage of neurologists (n=26) rating target as “promising” for MG (score of 6 or 7)
The late-stage pipeline for MG is very active
Table 5.1. Key MG therapies in Phase 3
The late-stage pipeline for MG is very active
Table 5.1. Emerging MG therapies in Phase 3 (cont.)
Rozanolixizumab and zilucoplan are poised to be the latest entrants to the MG market
Figure 5.2. Phase 3 results for UCB’s Rozanolixizumab in MycarinG trial
Figure 5.3. Phase 3 results for UCB’s Zilucoplan in RAISE trial
The early-stage pipeline is also active and focused on largely similar mechanisms
Table 5.2. Notable MG therapies in Phase 1 / 2 Development
Neurologists’ opinions on the MG pipeline
6. VALUE & ACCESS
Overview
Table 6.1. Current MG therapy pricing, U.S.
Table 6.2. Typical U.S. commercial payer coverage ofrituximab for MG patients (Aetna, BCBS, Cigna, United)
Prior authorization criteria for biologics
Table 6.3. Typical U.S. commercial payer coverage of biologics for MG patients
Alexion and Argenx utilize patient support programs to expand access
Figure 6.1. Growth in lives covered through VBAs since launch of Vyvgart
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
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