Multiple sclerosis (MS) is widely recognized as the most common neurological and inflammatory disorder of the central nervous system (CNS) in the adult population. It is a chronic, recurrent, progressive autoimmune disorder characterized by repeated episodes of inflammation of the white matter nervous tissue of the CNS. The location of the inflammation varies from person to person and from episode to episode, and as such, results in a variety of clinical symptoms. The periventricular regions, optic nerves, brainstem, cerebellum, and spinal cord are common locations for inflammation in MS. The average age for disease onset is 30 years, with women being twice as likely to develop MS compared to men.
CONTENTS
6 OVERVIEW
6 Latest key takeaways
7 DISEASE BACKGROUND
7 Definition
7 Patient segmentation
8 Symptoms
9 Risk factors
9 Diagnosis
10 TREATMENT
15 Summary of key treatment guideline recommendations
18 EPIDEMIOLOGY
18 Prevalence methodology
21 MARKETED DRUGS
26 PIPELINE DRUGS
34 KEY REGULATORY EVENTS
34 Victory Swings Back To Gilenya Generics With Latest US Supreme Court Order
34 EU Commission Targets Teva Over Alleged Copaxone Antitrust Breach
34 Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri
35 Viatris Grabs Tentative Fingolimod Nod
35 FDA Reviews Natalizumab For Sandoz And Polpharma
35 HEC Pharm Awaits Fate As Novartis Petitions On US Gilenya Victory
36 Polpharma Celebrates Being First With Natalizumab In Europe
36 Apotex Launches Generic Version Of Aubagio In Canada
37 HEC Pharm Wins Key Reversal In US Gilenya Dosing Patent Fight
37 Japan Lifts Decades-Old Bans On Somatropin In Diabetes, IFNβ In Pregnancy
38 Three EU Tecfidera Generics Recommended As Biogen Battles For Exclusivity
38 English Reimbursement Win For Janssen’s Oral Multiple Sclerosis Drug
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 Viatris Swats Away Concerns Over Divestment Valuations
40 Pasithea Therapeutics Acquires Alpha-5 Integrin
41 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
43 Sponsors by phase
44 Recent events
48 DRUG ASSESSMENT MODEL
48 Genericized DMTs
48 Anti-CD20 drugs
49 S1P receptor modulator drugs
49 Pipeline drugs
51 MARKET DYNAMICS
52 FUTURE TRENDS
52 Widespread genericization will deplete key brands’ market share
52 Drugs utilizing novel mechanisms for MS are in development
52 Key brands will face competition from pipeline “me-too” drugs, though uptake may be slow if distinguishing factors cannot be established
53 More DMTs will become available for underserved MS patient populations
54 CONSENSUS FORECASTS
59 KEY UPCOMING EVENTS
60 KEY OPINION LEADER INSIGHTS
60 Quotes regarding specific drug use
60 Quote regarding unmet needs
60 Quote regarding pricing
62 UNMET NEEDS
62 More effective therapies for PPMS/SPMS
62 Development of neuroprotective/remyelinating therapies
63 BIBLIOGRAPHY
65 APPENDIX
LIST OF FIGURES
20 Figure 1: Trends in prevalent cases of multiple sclerosis, 2018–27
26 Figure 2: Overview of pipeline drugs for multiple sclerosis in the US
26 Figure 3: Pipeline drugs for multiple sclerosis, by company
27 Figure 4: Pipeline drugs for multiple sclerosis, by drug type
27 Figure 5: Pipeline drugs for multiple sclerosis, by classification
39 Figure 6: Probability of success in the multiple sclerosis pipeline
41 Figure 7: Clinical trials in multiple sclerosis
41 Figure 8: Top 10 drugs for clinical trials in multiple sclerosis
42 Figure 9: Top 10 companies for clinical trials in multiple sclerosis
42 Figure 10: Trial locations in multiple sclerosis
43 Figure 11: Multiple sclerosis trials status
44 Figure 12: Multiple sclerosis trials sponsors, by phase
48 Figure 13: Datamonitor Healthcare’s drug assessment summary for multiple sclerosis
51 Figure 14: Market dynamics in multiple sclerosis
52 Figure 15: Future trends in multiple sclerosis
59 Figure 16: Key upcoming events in multiple sclerosis
LIST OF TABLES
8 Table 1: Clinical subtypes of multiple sclerosis
11 Table 2: Leading disease-modifying therapies for multiple sclerosis
16 Table 3: Available DMTs and the strength of the evidence base supporting their efficacy in preventing MS relapses
19 Table 4: Prevalent cases of multiple sclerosis, 2018–27
22 Table 5: Marketed drugs for multiple sclerosis
28 Table 6: Pipeline drugs for multiple sclerosis in the US
55 Table 7: Historical global sales, by drug ($m), 2017–21
57 Table 8: Forecasted global sales, by drug ($m), 2022–26
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