Multiple Sclerosis – Landscape & Forecast – Disease Landscape & Forecast
The maturing yet highly lucrative market for multiple sclerosis (MS) disease-modifying therapies (DMTs) continues to fragment as newer entrants (e.g., Novartis’s Kesimpta, Bristol Myers Squibb’s Zeposia, Biogen’s Vumerity) propel ongoing shifts and intensify competition in the saturated relapsing MS market. Meanwhile, many developers have renewed focus on developing treatments for the underserved progressive MS population, including Sanofi and Roche’s BTK inhibitors and several other novel products. Meanwhile, the U.S. launch of generics competition for Tecfidera in 2020 and the entry of more generic orals in the United States and Europe in the coming years will constrain uptake of follow-on compounds and exert new pressures on the market overall as reimbursement authorities struggle to rein in healthcare costs. Understanding these market forces will be key to the success of current and future players in this evolving market.
Questions answered:
- What is the commercial outlook for new S1P receptor modulators and novel fumarates compared with their first-to-market counterparts? What is the market potential for new MOAs like BTK inhibitors in relapsing MS?
- What impact has Ocrevus had in the relapsing and progressive MS markets, and how will Kesimpta and ublituximab further shape the anti-CD20s class?
- How will the recent and anticipated launch of oral generics competition impact the MS market?
- What do key opinion leaders think about emerging agents for progressive MS patients, and what is the commercial outlook for these therapies?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 23 country-specific interviews with thought-leading neurologists, supported by survey data collected for this content and other Clarivate 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: 10 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, Teva, TG Therapeutics.
Market forecast features: Patient-based market forecast extending through 2031, 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 continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Multiple Sclerosis - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Multiple Sclerosis - Key findings - November 2022
- Key updates
- Q4 2022
- November 2022
- Q2 2022
- May 2022
- April 2022
- Q1 2022
- March 2022
- February 2022
- January 2022
- Q4 2021
- December 2021
- Q4 2022
- Market outlook
- Key findings
- Market share of drug classes for multiple sclerosis: 2021
- Market share of drug classes for multiple sclerosis: 2031
- Multiple sclerosis SWOT analysis
- Major-market sales of multiple sclerosis therapies by drug class: 2021-2031
- Major-market patient share by drug class in CIS: 2021-2031
- Major-market patient share by drug class in RR-MS: 2021-2031
- Major-market patient share by drug class in SP-MS: 2021-2031
- Major-market patient share by drug class in PP-MS: 2021-2031
- 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: 2021-2031
- Major-market sales of multiple sclerosis therapies by subpopulation: 2021-2031
- Major-market sales of branded and generic/biosimilar therapies for multiple sclerosis: 2021-2031
- Major-market patient share of branded and generic/biosimilar therapies for multiple sclerosis: 2021-2031
- Drug-class-specific trends
- Major-market sales and patient share of recombinant interferon-betas for multiple sclerosis: 2021-2031
- Major-market sales and patient share of polypeptides for multiple sclerosis: 2021-2031
- Major-market sales and patient share of pyrimidine synthesis inhibitors for multiple sclerosis: 2021-2031
- Major-market sales and patient share of S1P receptor modulators for multiple sclerosis: 2021-2031
- Major-market sales and patient share of Nrf2 pathway activators for multiple sclerosis: 2021-2031
- Major-market sales and patient share of oral immunosuppressants for multiple sclerosis: 2021-2031
- Major-market sales and patient share of BTK inhibitors for multiple sclerosis: 2021-2031
- Major-market sales of BTK inhibitors for multiple sclerosis by population: 2021-2031
- Major-market sales and patient share of other tyrosine kinase inhibitors for multiple sclerosis: 2021-2031
- U.S. sales and patient share of phosphodiesterase inhibitors for multiple sclerosis by population: 2021-2031
- Major-market sales and patient share of integrin antagonists for multiple sclerosis: 2021-2031
- Major-market sales and patient share of anti-CD20 MAbs for multiple sclerosis: 2021-2031
- 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, and sources used
- Diagnosed prevalent cases of multiple sclerosis: 2021-2031
- Diagnosis of multiple sclerosis
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of clinically isolated syndrome: 2021-2031
- Diagnosed prevalent cases of relapsing-remitting multiple sclerosis: 2021-2031
- Diagnosed prevalent cases of secondary-progressive multiple sclerosis: 2021-2031
- Diagnosed prevalent cases of primary-progressive multiple sclerosis: 2021-2031
- 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
- Expert insight: interferon-betas
- Advantages and disadvantages of Glatiramer acetate
- Expert insight: Glatiramer acetate
- Ongoing clinical development of Tysabri
- Advantages and disadvantages of Tysabri
- Expert insight
- Advantages and disadvantages of Gilenya
- Expert insight
- 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
- Ongoing clinical development of Aubagio
- Advantages and disadvantages of Aubagio
- Expert insight
- Ongoing clinical development of Tecfidera
- Advantages and disadvantages of Nrf2 pathway activators
- Expert insight: Nrf2 pathway activators
- Advantages and disadvantages of Lemtrada
- Ongoing clinical development of Ocrevus
- Advantages and disadvantages of Ocrevus
- Expert insight: Ocrevus
- Kesimpta
- Advantages and disadvantages of Kesimpta
- Ongoing clinical development of Kesimpta
- Expert insight: Kesimpta
- Ongoing clinical development of Mavenclad
- Advantages and disadvantages 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
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- 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
- Analysis of the clinical development program for Remibrutinib
- Expectations for launch and sales opportunity of Remibrutinib 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
- Abbreviations
- Bibliography
- Key findings
Grant Nix, M.B.A., is an analyst on the CNS/Ophthalmology Disorders team at Clarivate. In this role, he conducts primary and secondary research to analyze pharmaceutical markets, with a focus on neurology indications, including multiple sclerosis. Prior to joining Clarivate, he worked as an operations analyst at UNC Health, positioned on a behavioral health unit. He earned his M.B.A. at North Carolina Central University, where he specialized in finance. He also holds a B.S. in chemistry from Campbell University.
Navya Vardhan, M.Sc., Epidemiologist, Epidemiology. She obtained her M.Sc. in biostatistics and demography from the International Institute for Population Sciences in Mumbai. She also holds a B.Sc. in mathematics.