Multiple Sclerosis – Landscape & Forecast – Disease Landscape & Forecast
The maturing yet highly lucrative market for multiple sclerosis (MS) disease-modifying therapies (DMTs) will continue to fragment as new entrants drive further shifts in a complicated treatment algorithm. Novartis's Kesimpta, Bristol Myers Squibb's Zeposia, and an array of other new and emerging next-generation compounds will intensify competition in the saturated relapsing MS market. Meanwhile, Ocrevus continues to transform treatment in the underserved PP-MS population while several emerging agents, including Sanofi Genzyme's tolebrutinib and Roche's fenebrutinib, are in Phase III development for progressive forms of MS. Separately, the looming entry of oral generics—and the recent U.S. entry of generics for dimethyl fumarate—will introduce a new variable in this high-cost market as reimbursement authorities race to rein in healthcare costs. Understanding these intersecting forces will be key to the success of current and future players in this evolving market.
Questions Answered:
- What is the commercial outlook for next-generation fumarates, S1P receptor modulators, and anti-CD20 monoclonal antibodies (MAbs) in the competitive relapsing MS space, and where will they fit into an evolving treatment algorithm?
- How will novel DMTs, including the emerging BTK inhibitors (e.g., evobrutinib), be incorporated in the treatment of relapsing MS?
- What impact will tolebrutinib, fenebrutinib, ibudilast, and masitinib have in the progressive MS markets?
- What clinical roles will entrenched platform injectables and mainstay orals play in the evolving MS treatment algorithm?
- How will generic competition shape the MS market?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 26 country-specific interviews with thought-leading neurologists, supported by survey data collected for this content and other DRG research.
Epidemiology: Diagnosed prevalence of MS by country, segmented by CIS, RR-MS, SP-MS, and PP-MS; drug-treated cases.
Emerging therapies: Phase II: 8 drugs; Phase III/preregistration: 7 drugs.
Key companies: AB Science, Banner Life Sciences, Biogen, Bristol Myers Squibb, Janssen, Merck KGaA / EMD Serono, MediciNova, Mylan, Mapi Pharma, Novartis, Roche / Genentech, Sanofi Genzyme, Teva, TG Therapeutics.
Market forecast features: Patient-based market forecast extending through 2029, segmented by brands and generics / biosimilars.
Product Description:
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution Enhancement
Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Table of contents
- Multiple Sclerosis - Landscape & Forecast - Disease Landscape & Forecast
- Key Updates
- Q4 2021
- October
- Q3 2021
- July
- Q2 2021
- June
- May
- April
- Q1 2021
- March 2021
- February 2021
- January 2021
- Q4 2020
- December 2020
- Q4 2021
- Key Findings
- Multiple Sclerosis - Key Findings - September 2021
- December 2020
- Multiple Sclerosis - Key Findings - September 2021
- Market Outlook
- Key Findings
- Market Share of Drug Classes for Multiple Sclerosis: 2020
- Market Share of Drug Classes for Multiple Sclerosis: 2030
- Multiple Sclerosis SWOT Analysis
- Major-Market Sales of Multiple Sclerosis Therapies by Drug Class: 2020-2030
- Major-Market Patient Share by Drug Class in CIS: 2020-2030
- Major-Market Patient Share by Drug Class in RR-MS: 2020-2030
- Major-Market Patient Share by Drug Class in SP-MS: 2020-2030
- Major-Market Patient Share by Drug Class in PP-MS: 2020-2030
- COVID-19: Market Forecast Impact
- Expert Insight: COVID-19
- Market Drivers and Constraints
- What Factors Are Driving the Market for Multiple Sclerosis?
- What Factors Are Constraining the Market for Multiple Sclerosis?
- Major-Market Sales of Multiple Sclerosis Therapies by Region: 2020-2030
- Major-Market Sales of Multiple Sclerosis Therapies by Subpopulation: 2020-2030
- Major-Market Sales of Branded and Generic/Biosimilar Therapies for Multiple Sclerosis: 2020-2030
- Major-Market Patient Share of Branded and Generic/Biosimilar Therapies for Multiple Sclerosis: 2020-2030
- Drug-Class-Specific Trends
- Major-Market Sales and Patient Share of Recombinant Inteferon-Betas for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of Polypeptides for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of Pyrimidine Synthesis Inhibitors for Multiple Sclerosis: 2019-2029
- Major-Market Sales and Patient Share of S1P Receptor Modulators for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of Nrf2 Pathway Activators for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of Oral Immunosuppressants for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of BTK Inhibitors for Multiple Sclerosis: 2020-2030
- Major-Market Sales of BTK Inhibitors for Multiple Sclerosis by Population: 2020-2030
- U.S. Sales and Patient Share of Phosphodiesterase Inhibitors for Multiple Sclerosis by Population: 2020-2030
- Major-Market Sales and Patient Share of Integrin Antagonists for Multiple Sclerosis: 2020-2030
- Major-Market Sales and Patient Share of Anti-CD20 MAbs for Multiple Sclerosis: 2020-2030
- Key Findings
- Forecast
- Market Forecast Assumptions
- Market Forecast Dashboard
- Etiology and Pathophysiology
- Disease Overview
- Natural History
- Clinical Forms of Multiple Sclerosis
- Select Symptomology of Multiple Sclerosis
- Natural History of Multiple Sclerosis
- Etiology
- Genetic and Environmental Risk Factors for Multiple Sclerosis
- Pathophysiology
- Demyelinating Plaques in Multiple Sclerosis
- Key Pathways and Drug Targets
- Inflammation / Autoimmune Attack
- Demyelination and Inhibition of Remyelination
- Neurodegeneration
- Key Pathways and Drug Targets in Multiple Sclerosis
- Multiple Sclerosis Immune Pathology
- Two Independent Signals in T-Cell Activation
- Migration of Activated T Cells Into the Central Nervous System
- Disease Overview
- Epidemiology
- Key Findings
- Key Updates
- Epidemiology Populations
- Disease Definition
- Methods
- Sources Used for Diagnosed Prevalence of Multiple Sclerosis
- Number of Diagnosed Prevalent Cases of Multiple Sclerosis in the Major Pharmaceutical Markets: 2020-2030
- Diagnosis of Multiple Sclerosis
- Disease Definition
- Methods
- Sources Used for Diagnosed Prevalent Cases by Disease Subtype
- Number of Diagnosed Prevalent Cases of Clinically Isolated Syndrome in the Major Pharmaceutical Markets: 2020-2030
- Number of Diagnosed Prevalent Cases of Relapsing-Remitting Multiple Sclerosis in the Major Pharmaceutical Markets: 2020-2030
- Number of Diagnosed Prevalent Cases of Secondary-Progressive Multiple Sclerosis in the Major Pharmaceutical Markets: 2020-2030
- Number of Diagnosed Prevalent Cases of Primary-Progressive Multiple Sclerosis in the Major Pharmaceutical Markets: 2020-2030
- Drug-Treated Prevalent Cases of Multiple Sclerosis in the Major Pharmaceutical Markets: 2020-2030
- Key Findings
- Current Treatment
- Key Findings
- Treatment Goals
- Key Endpoints Used in Clinical Trials for Multiple Sclerosis
- Key Current Therapies
- Overview
- Mechanism of Action of Key Current Drug Classes Used for Multiple Sclerosis
- Current Treatments Used for Multiple Sclerosis
- Regulatory Label Details of Current Treatments Used for Multiple Sclerosis
- Market Events Impacting the Use of Key Current Therapies in Multiple Sclerosis
- Ongoing Clinical Development of Interferon-Betas
- Advantages and Disadvantages of Interferon-Betas
- Advantages and Disadvantages of Glatiramer Acetate
- Ongoing Clinical Development of Natalizumab
- Advantages and Disadvantages of Tysabri
- Advantages and Disadvantages of Gilenya
- Advantages and Disadvantages of Mayzent
- Ongoing Clinical Development of Mayzent
- Expert Insight: Mayzent
- Advantages and Disadvantages of Zeposia
- Expert Insight: Zeposia
- Ponvory
- Ongoing Clinical Development of Ponvory
- Advantages and Disadvantages of Ponvory
- Expert Insight: Ponvory
- Advantages and Disadvantages of Aubagio
- Ongoing Clinical Development of Aubagio
- Ongoing Clinical Development of Tecfidera
- Advantages and Disadvantages of Nrf2 Pathway Activators
- Expert Insight: Nrf2 Pathway Activators
- Advantages and Disadvantages of Lemtrada
- Advantages and Disadvantages of Ocrevus
- Ongoing Clinical Development of Ocrevus
- Expert Insight: Ocrevus
- Kesimpta
- Advantages and Disadvantages of Kesimpta
- Ongoing Clinical Development of Kesimpta
- Expert Insight: Kesimpta
- Advantages and Disadvantages of Mavenclad
- Ongoing Clinical Development of Mavenclad
- Expert Insight: Mavenclad
- Medical Practice
- Overview
- Risk of PML With MS DMTs
- Factors Influencing Drug Selection in Multiple Sclerosis
- Treatment Decision Tree for CIS and RR-MS: United States
- Treatment Decision Tree for SP-MS and PP-MS: United States
- Treatment Decision Tree for CIS and RR-MS: Europe
- Treatment Decision Tree for SP-MS and PP-MS: Europe
- Treatment Decision Tree for CIS and RR-MS: Japan
- Treatment Decision Tree for SP-MS and PP-MS: Japan
- Key Findings
- Unmet Need Overview
- Current and Future Attainment of Unmet Needs in Multiple Sclerosis
- Top Unmet Needs in Multiple Sclerosis: Current and Future Attainment
- Emerging Therapies
- Key Findings
- Key Emerging Therapies
- Key Therapies in Development for Multiple Sclerosis
- Estimated Launch Dates of Key Emerging Therapies for the Treatment of Multiple Sclerosis
- Ublituximab Profile
- Analysis of the Clinical Development Program for Ublituximab
- Expert Insight: Ublituximab
- Expectations for Launch and Sales Opportunity of Ublituximab in Multiple Sclerosis
- GA Depot Profile
- Analysis of the Clinical Development Program for GA Depot
- Expert Insight: GA Depot
- Expectations for Launch and Sales Opportunity of GA Depot in Multiple Sclerosis
- Evobrutinib Profile
- Analysis of the Clinical Development Program for Evobrutinib
- Expert Insight: Evobrutinib
- Expectations for Launch and Sales Opportunity of Evobrutinib in Multiple Sclerosis
- Tolebrutinib Profile
- Analysis of the Clinical Development Program for Tolebrutinib
- Expert Insight: Tolebrutinib
- Expectations for Launch and Sales Opportunity of Tolebrutinib in Multiple Sclerosis
- Fenebrutinib Profile
- Analysis of the Clinical Development Program for Fenebrutinib
- Expert Insight: Fenebrutinib
- Expectations for Launch and Sales Opportunity of Fenebrutinib in Multiple Sclerosis
- Expert Insight: BTK Inhibitors
- Masitinib Profile
- Analysis of the Clinical Development Program for Masitinib
- Expert Insight: Masitinib
- Expectations for Launch and Sales Opportunity of Masitinib in Multiple Sclerosis
- Ibudilast Profile
- Analysis of the Clinical Development Program for Ibudilast
- Expert Insight: Ibudilast
- Expectations for Launch and Sales Opportunity of Ibudilast in Multiple Sclerosis
- Early-Phase Pipeline Analysis
- Select Compounds in Phase II Development
- Key Findings
- Access and Reimbursement Overview
- Region-Specific Reimbursement Practices
- Key Market Access Considerations in Multiple Sclerosis: United States
- General Reimbursement Environment: United States
- Key Market Access Considerations in Multiple Sclerosis: EU5
- General Reimbursement Environment: EU5
- Key Market Access Considerations in Multiple Sclerosis: Japan
- General Reimbursement Environment: Japan
- Region-Specific Reimbursement Practices
- Appendix
- Bibliography
- Key Updates
Jonathan W. Searles is a senior director on the CNS/Ophthalmology Disorders team at Clarivate. In this role, he oversees the team’s syndicated research stream in neurology, with a core focus on multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, epilepsy, migraine, and ischemic stroke. He earned his bachelor’s degree at Brandeis University, where he graduated summa cum laude.
Sunali Goonesekera, S.M., is a senior epidemiologist at Clarivate. Previously, Ms. Goonesekera conducted epidemiological research on racial/ethnic disparities in metabolic diseases at the New England Research Institute and lead-authored two manuscripts. She has contributed to multiple publications in peer-reviewed journals in epidemiology and the biological sciences. She holds a master’s degree in epidemiology from the Harvard School of Public Health and a B.A. in biology (Honors) from Dartmouth College.