Multiple Sclerosis Market Insight, Epidemiology And Market Forecast - 2034
Description
Key Highlights
DelveInsight estimates that in 2024, there were around 1.6 million total diagnosed prevalent cases of MS across the 7MM.
The MS market is projected to see consistent growth, with a robust compound annual growth rate (CAGR) anticipated from 2025 to 2034. This expansion across the 7MM will be driven by the introduction of innovative therapies, remibrutinib, tolebrutinib, fenebrutinib, frexalimab, vidofludimus Calcium, CNM-Au8, and masitinib, among others. Furthermore, MS prevalence is rising due to modifiable environmental and lifestyle factors like Epstein-Barr virus, low vitamin D, smoking, obesity, and night shifts, with genetics and geography also contributing.
According to DelveInsight’s analysis, the MS market in the 7MM was valued at approximately USD 20 thousand million in 2024. Over the forecast period from 2025 to 2034, this market is projected to grow at a CAGR of 3.8%.
Currently, there are lot of drugs that have been approved for MS treatment, including OCREVUS (Ocrelizumab) by Roche, LEMTRADA (Alemtuzumab) by Sanofi, MAYZENT (Siponimod) by Novartis, and VUMERITY (Diroximel fumarate) by Biogen, among others.
MS treatment lacks neuroprotective and remyelinating therapies, with limited options for progressive MS. Current drugs focus on immune modulation but fail to reverse damage or halt progression. Diagnostic delays remain common due to nonspecific symptoms and limited biomarkers. There is a critical need for early detection tools, personalized therapies, and agents targeting neurodegeneration to improve outcomes in MS.
Roche, Sanofi, Novartis, and AB Science, among others are progressing their assets through various clinical trial phases, driving innovation in the MS market and creating significant growth opportunities.
In April 2025, NEJM also published findings from the Phase III GEMINI 1 and 2 studies, which evaluated tolebrutinib in patients with RMS; these data were likewise featured in the Clinical Trials Plenary Session at AAN 2025.
DelveInsight’s “Multiple Sclerosis (MS) – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of MS, historical and forecasted epidemiology, as well as the MS market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The MS market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MS market size from 2020 to 2034. The report also covers MS treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.
Multiple Sclerosis (MS) Understanding and Treatment Algorithm
Multiple Sclerosis (MS) overview
MS is a lifelong, unpredictable disease that affects each person differently. While a small group experiences a mild form with little disability, others face a steadily worsening condition that leads to significant limitations. Most people, however, go through cycles of symptom flare-ups such as vision problems, muscle weakness, or numbness followed by periods of recovery. Women are more often affected than men. Though MS is rarely fatal and many live long, full lives, the disease can take a heavy toll, especially without early treatment. Initial signs often include blurred or double vision, eye pain from optic neuritis, or weakness and stiffness in the arms or legs, sometimes accompanied by painful muscle spasms. People may also feel tingling or numbness, have trouble with balance, or struggle with bladder issues. Over time, fatigue can become overwhelming, and mental health may suffer, with mood swings, depression, or trouble thinking clearly. Emerging therapies now offer real hope to slow down disability, especially when started early making timely diagnosis and personalized care essential.
Further details related to country-based variations are provided in the report…
Multiple Sclerosis (MS) diagnosis
Diagnosing MS is complex, as there is no single test that can confirm it with certainty. Instead, clinicians use a combination of approaches to rule out other conditions and build a strong case for MS. The diagnostic journey typically starts with a detailed medical history, physical exam, and neurological evaluation to assess symptoms and nerve function. Magnetic resonance imaging (MRI) of the brain and spinal cord plays a central role by detecting lesions caused by demyelination - an MS hallmark. To better identify active inflammation, contrast dye is often used during the MRI scan. Additional tests may include a lumbar puncture to analyze cerebrospinal fluid for immune markers, evoked potentials to measure nerve signal responses, and optic nerve tests to detect damage related to vision. Together, these methods help form a comprehensive and accurate diagnosis.
Multiple Sclerosis (MS) treatment
While MS has no cure, several treatments are available to reduce the frequency and severity of relapses and to slow disease progression. During acute flare-ups, high-dose intravenous (IV) corticosteroids like methylprednisolone are often used for 3–5 days to rapidly reduce inflammation in the central nervous system (CNS). This is sometimes followed by a tapering course of oral steroids. These medications can accelerate recovery from relapses but do not alter the long-term trajectory of the disease. Their primary role is to manage acute symptoms and support faster short-term recovery. For long-term control, patients are typically placed on disease-modifying therapies (DMTs) that aim to reduce new lesion formation, prevent relapses, and delay disability progression.
Multiple Sclerosis (MS) Epidemiology
As the market is derived using a patient-based model, the MS epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of MS, gender-specific diagnosed prevalent cases of MS, phenotype-specific diagnosed prevalent cases of MS, and EDSS-specific diagnosed prevalent cases in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.
DelveInsight estimates that there were approximately 1,655 thousand prevalent cases of MS across the 7MM in 2024. These diagnosed prevalent cases are projected to rise by 2034 at a CAGR of 1.5% during the forecast period (2025–2034).
In 2024, approximately 920 thousand adults in the US were living with a diagnosed prevalent case of MS, a number projected to rise by 2034.
Among EU4 and the UK, Germany had the highest number of diagnosed prevalent cases of adults in 2024, with approximately 255 thousand cases, while Spain had the lowest, with around 65 thousand cases.
As of 2024, in EU4 and the UK, relapsing-remitting multiple sclerosis (RRMS) represents the most widespread form of MS, affecting approximately 490 thousand individuals. Secondary progressive MS (SPMS) is the next most common, with about 110 thousand cases. Primary progressive MS (PPMS), while less prevalent, still accounts for around 90 thousand cases. This distribution highlights the predominance of RRMS and emphasizes the importance of early intervention to potentially delay or mitigate progression to more severe MS forms.
As of 2024, MS in Japan continues to exhibit a marked gender disparity, with females accounting for approximately 69% of cases and males just 31%. This trend highlights the persistent female predominance in MS and reinforces the need for gender-informed research and therapeutic strategies in the Japanese population.
In Japan, 2024 data on MS cases by EDSS score reveals the highest concentration in the 0–2.5 range with approximately 17 thousand cases, indicating a majority of patients with minimal disability. This is followed by decreasing case counts across higher EDSS brackets—3.0–4.0 with around 8 thousand cases, 4.5–6.0 with approximately 5 thousand cases, 6.5–8.0 with nearly 4 thousand cases, and =8.5 with approximately 270 cases—reflecting fewer individuals with moderate to severe disability progression.
Multiple Sclerosis (MS) Drug Chapters
The drug chapter segment of the MS report encloses a detailed analysis of MS-marketed drugs and pipeline drugs. It also helps understand the MS clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Drugs
OCREVUS (ocrelizumab): Roche (Genentech)
OCREVUS is a humanized monoclonal antibody (mAb) designed to target CD20-positive B cells, which are implicated in driving inflammation and damage to myelin and nerve fibers in MS—a key contributor to long-term disability. It selectively binds to CD20-expressing B cells while sparing stem cells and plasma cells, helping maintain broader immune function. Administered IV, OCREVUS is available as a 300 mg/10 mL solution in a single-use vial, allowing for accurate and controlled dosing.
In March 2017, the US FDA approved OCREVUS (ocrelizumab) for treating adults with both relapsing forms of multiple sclerosis (RMS) and PPMS, making it the first therapy specifically approved for PPMS. This approval represented a major advancement in MS care, especially for patients with limited treatment options. OCREVUS is administered via IV infusion under medical supervision.
Acknowledging the significant unmet need in MS, the US FDA granted OCREVUS Fast Track Designation (FTD) and Priority Review in June 2016. These designations accelerated the drug’s development and evaluation, reflecting its potential to address serious forms of MS, including primary progressive MS, for which no approved treatments previously existed.
OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): F. Hoffmann-La Roche (Genentech)
OCREVUS ZUNOVO is a subcutaneous (SC) formulation of ocrelizumab for MS, enhanced by ENHANZE technology using hyaluronidase (rHuPH20) to increase tissue permeability and speed absorption. It targets CD20-positive B cells, which drive myelin and nerve damage, while sparing vital immune cells. Administered as a 920 mg injection every six months over 10 minutes, it offers a more convenient alternative to IV infusion. Patients require monitoring—one hour after the initial dose and 15 minutes for later doses to ensure safety.
In September 2024, the US FDA approved OCREVUS ZUNOVO as the first and only SC treatment for both relapsing and progressive MS. Given twice yearly, the injection takes just 10 minutes, offering a faster, more convenient alternative to IV infusion for long-term disease management in eligible patients.
In July 2024, the European Union (EU) approved the SC version of ocrelizumab for the treatment of MS.
LEMTRADA (alemtuzumab): Sanofi
LEMTRADA is a cytolytic mAb targeting CD52, approved for treating relapsing forms of MS, including active secondary progressive MS, in individuals aged 17 and older. Given its significant safety risks—such as autoimmune complications, serious infusion reactions, and potential malignancies—it is generally reserved for patients who have failed at least two prior MS treatments. LEMTRADA is not recommended for clinically isolated syndrome (CIS) and is accessible only through the LEMTRADA REMS Program to ensure safe use under strict monitoring.
In November 2014, the US FDA approved LEMTRADA, a CD52-directed cytolytic monoclonal antibody, for relapsing forms of MS. This approval introduced an immune-reconstitution approach that selectively depletes pathogenic lymphocytes implicated in MS activity, aiming to reset the immune system. LEMTRADA marked a shift toward targeting immune cells driving long-term inflammation and disease progression.
In June 2010, Genzyme reported that the US FDA had granted Fast Track designation (FTD) to its MS program for alemtuzumab. This designation, intended to accelerate the review of treatments for serious conditions, was specifically for patients with relapsing-remitting MS (RRMS), acknowledging alemtuzumab’s potential to meet a critical unmet therapeutic need.
Emerging Drugs
Tolebrutinib (SAR442168): Sanofi
Tolebrutinib is an investigational oral BTK inhibitor designed to cross the blood–brain barrier (BBB) and stay active within the central nervous system, specifically targeting smoldering neuroinflammation—a key driver of disability progression in MS. Unlike conventional therapies that act mainly on peripheral inflammation, tolebrutinib reaches therapeutic concentrations in the cerebrospinal fluid, enabling it to modulate both B cells and disease-relevant microglia. This dual mechanism aims to directly address the central inflammatory processes underlying neurodegeneration in MS.
In March 2025, the US FDA accepted tolebrutinib for priority review, signaling its potential to address a critical unmet need in non-relapsing secondary progressive multiple sclerosis (nrSPMS). The submission emphasizes tolebrutinib’s role in slowing disability progression independent of relapses. The US decision is expected by September 2025, while parallel regulatory evaluation is underway in the EU.
Fenebrutinib: Roche (Genentech)
Fenebrutinib is an investigational oral BTK inhibitor distinguished by its reversible and non-covalent binding, enabling it to influence both adaptive and innate immunity by targeting B cells and microglia. As the sole reversible BTK inhibitor in Phase III trials for multiple sclerosis, it may uniquely address disease activity and progression of long-term disability.
The Phase III program for fenebrutinib comprises two parallel trials in relapsing multiple sclerosis (FENhance 1 and 2), using teriflunomide as the comparator, and the FENtrepid study in primary progressive MS, uniquely comparing fenebrutinib head-to-head with the approved therapy ocrelizumab—the only such comparison for a BTK inhibitor in PPMS.
Remibrutinib : Novartis
Remibrutinib (LOU064) is an investigational, highly selective covalent BTK inhibitor designed to block BTK signaling and prevent histamine release. Intended for patients unresponsive to antihistamines, it is currently in Phase III REMODEL-1 and REMODEL-2 trials, with PCD expected in 2026 and regulatory filing in 2027. While not yet tested in MS trials, Phase IIb data in CSU showed promising safety and tolerability.
Drug Class Insights
The treatment landscape for MS has evolved significantly, encompassing acute management, long-term disease modification, and symptom control. Acute relapses are typically managed with high-dose corticosteroids to reduce CNS inflammation and accelerate recovery, although these do not alter long-term outcomes.
The MS treatment market comprises a diverse portfolio of approved drugs spanning multiple classes, each targeting distinct immune pathways. These include CD20-directed cytolytic mAb, CD52-directed mAb, S1P receptor modulators, NRF2 activators, and agents exerting cytotoxic effects on B and T lymphocytes. Notably, OCREVUS and its SC counterpart OCREVUS ZUNOVO represent CD20-directed therapies, both offering potent B-cell depletion. OCREVUS has been recognized with Fast Track Designation (FTD) and Priority Review by the US FDA, underscoring its clinical value. Similarly, LEMTRADA, a CD52-targeted therapy, has also earned FTD status, reflecting regulatory acknowledgment of its potential in high-need MS populations. These distinctions highlight the importance of targeted immune-modulating strategies in addressing disease heterogeneity and progression in MS.
Continued in report…
Market Outlook
MS is the most common primary demyelinating disorder of the central nervous system, characterized by progressive neurological decline. Although its exact cause remains unclear, it is believed to involve an autoimmune response against myelin, triggered by autoreactive T and B cells that breach the blood–brain barrier. This immune attack leads to demyelination, axonal damage, and neurodegeneration. While there is no cure, acute relapses are typically managed with intravenous corticosteroids like methylprednisolone, followed by oral tapering to accelerate recovery, though these do not impact long-term disease progression.
Long-term MS management centers on DMTs, which aim to reduce relapse rates and slow progression. These therapies are categorized into treatment lines based on efficacy and patient response, with interferons remaining a key option for early-stage MS. The treatment landscape is evolving toward personalized and targeted therapies, offering improved outcomes and tolerability. This shift underscores significant market growth potential, with emerging therapies expanding treatment choices across disease stages while improving patient quality of life and limiting disability.
OCREVUS (ocrelizumab) by Genentech/Roche is a cornerstone therapy in MS treatment, approved for relapsing forms—including CIS, RRMS, and active SPMS—as well as primary progressive MS (PPMS), for which it remains the only approved therapy. Initially available as an IV infusion, the recent approval of OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) introduces a SC formulation, enhancing administration flexibility. Sanofi’s LEMTRADA (alemtuzumab), a CD52-targeting mAb, is indicated for RRMS and aSPMS. The growing use of oral agents like MAYZENT (siponimod), VUMERITY (diroximel fumarate), and MAVENCLAD (cladribine) marks a shift toward more convenient, patient-centric treatment options. Specifically, MAYZENT, an S1P receptor modulator by Novartis, is approved for CIS, RRMS, and aSPMS in the US, and for aSPMS in EU4, the UK, and Japan.
Among IFN-based therapies, PLEGRIDY (peginterferon beta-1a) provides a more convenient dosing regimen—every two to four weeks—compared to the more frequent administration required by conventional interferons. Within the class of S1P receptor modulators, ZEPOSIA (ozanimod) and PONVORY (ponesimod) both offer once-daily oral dosing, enhancing patient adherence. ZEPOSIA has shown strong efficacy in relapsing MS with a favorable safety profile, particularly exhibiting fewer cardiac side effects. PONVORY approved in 2021, demonstrated superiority over teriflunomide in reducing annualized relapse rates and MRI lesions, establishing itself as a competitive option. CD20-directed therapies such as KESIMPTA (ofatumumab) and BRIUMVI (ublituximab-xiiy) reflect a shift toward high-efficacy B-cell depletion strategies. KESIMPTA, administered via SC injection at home, matches the efficacy of IV ocrelizumab while offering greater convenience, and is currently being evaluated in Phase III trials for pediatric relapsing MS. BRIUMVI, the most recent addition to this class, further expands treatment choices in this high-potency category.
Companies like Genetech (Fenebrutinib), Sanofi (Tolebrutinib), Novartis (Remibrutinib), and AB Science (Masitinib), among others are involved in the development of Phase III, Phase II and Phase I drugs.
The total market size of MS in the 7MM was approximately USD 20 thousand million in 2024 and is projected to increase during the forecast period (2025–2034).
The market size for MS in the US was approximately USD 16 thousand million in 2024 and is anticipated to increase due to the launch of emerging therapies.
The total market size of EU4 and the UK was calculated to be approximately USD 4 thousand million in 2024, which was nearly 20% of the total market revenue for the 7MM and is expected to increase by 2034.
In 2024, Germany dominated the market between EU4 and the UK, generating around USD 1,550 million. The UK followed closely with approximately USD 850 million, while Italy recorded around USD 700 million.
In 2024, the total market size of MS was approximately USD 230 million in Japan, which is anticipated to increase during the forecast period (2025–2034).
Multiple Sclerosis (MS) Drugs Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034.
Further detailed analysis of emerging therapies drug uptake in the report…
Multiple Sclerosis (MS) Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for MS.
KOL Views
To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on MS evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University Of Maryland, US, University of California San Francisco, US, Charité University, Germany, University of Lille, France, University of Florence, Italy, Loyola University, Spain, University College London, UK, Tohoku University, Japan, and Niigata University, Japan , among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician’s View
As per the KOLs from the US, the approval of OCREVUS ZUNOVO represents a significant advancement in the administration of ocrelizumab therapy. Backed by a decade of robust safety and efficacy data for OCREVUS, the new SC option enhances flexibility in personalizing treatment to align with each patient’s lifestyle. This expanded choice enables clinicians and individuals with MS to make more tailored, patient-centric treatment decisions.
As per the KOLs from France, MS is an escalating public health issue in France, with prevalence rates steadily increasing in recent years. It predominantly affects women and usually manifests in early adulthood. National data and research underscore its substantial burden, showing marked effects on quality of life, progressive disability, and a higher mortality risk than the general population.
As per the KOLs from Japan, MS presents a growing clinical and economic burden. As prevalence increases, so does the cost pressure from high-priced DMTs. Given that MS is a leading cause of disability in young adults, there is an urgent need for more effective and economically sustainable strategies for diagnosis and management within healthcare systems.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Attribute Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
To assess the effectiveness of these therapies, a comparative analysis was performed using the Expanded Disability Status Scale (EDSS), a validated tool for quantifying disability in individuals with MS. Each therapy was assigned a score based on its impact on EDSS outcomes, enabling a structured evaluation of how well each treatment slows disability progression and supports functional independence. This scoring approach provides valuable insight into the real-world performance of MS therapies beyond clinical relapse rates.
Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
? LEMTRADA: Sanofi
SUPPORT
To help make treatment more accessible and affordable for patients with relapsing MS, the LEMTRADA Co-Pay Program offers financial assistance in the form of a reimbursement benefit for eligible patients who have commercial insurance. Through this program, qualified patients may receive a LEMTRADA Co-Pay Card, which provides
Full reimbursement for out-of-pocket costs related to the LEMTRADA medication itself (resulting in a USD 0 cost to the patient for the drug), and.
Reimbursement of up to USD 100 per day for costs associated with the administration of the LEMTRADA infusion (such as fees from infusion centers or healthcare providers).
This support is designed to ease the financial burden of both the medication and its administration, making it easier for patients to access their prescribed treatment.
Further details will be provided in the report.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Scope of the Report
The report covers a segment of key events, an executive summary, and a descriptive overview of MS, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will affect the current treatment landscape.
A detailed review of the MS market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM MS market.
Multiple Sclerosis (MS) Report Insights
Patient Population
Therapeutic Approaches
MS Pipeline Analysis
MS Market Size and Trends
Existing and Future Market Opportunity
Multiple Sclerosis (MS) Report Key Strengths
10 years Forecast
The 7MM Coverage
MS Epidemiology Segmentation
Key Cross Competition
Attribute analysis
Drugs Uptake and Key Market Forecast Assumptions
Multiple Sclerosis (MS) Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Qualitative Analysis (SWOT and Attribute Analysis)
Key Questions
Market Insights
What was the total market size of MS, the market size of MS by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
How will fenebrutinib affect the treatment paradigm of MS?
How will OCREVUS compete with other upcoming products and marketed therapies?
Which drug is going to be the largest contributor by 2034?
What are the pricing variations among different geographies for approved and marketed therapies?
How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights
What are the disease risks, burdens, and unmet needs of MS? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to MS?
What is the historical and forecasted MS patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
Out of the countries mentioned above, which country would have the highest diagnosed prevalent MS population during the forecast period (2025–2034)?
What factors are contributing to the growth of MS cases?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
What are the current options for the treatment of MS? What are the current clinical and treatment guidelines for treating MS?
How many companies are developing therapies for the treatment of MS?
How many emerging therapies are in the mid-stage and late stage of development for treating MS?
What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
What is the cost burden of current treatment on the patient?
Patient acceptability in terms of preferred treatment options as per real-world scenarios?
What are the accessibility issues of approved therapy in the US?
What is the 7MM historical and forecasted market of MS?
Reasons to Buy
The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the MS market.
Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
The distribution of historical and current patient share is based on real-world prescription data in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
Detailed analysis, ranking of class-wise potential current, and emerging therapies under the attribute analysis section to provide visibility around leading classes.
Highlights of Access and Reimbursement policies for MS, barriers to accessibility of approved therapy, and patient assistance programs.
To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
DelveInsight estimates that in 2024, there were around 1.6 million total diagnosed prevalent cases of MS across the 7MM.
The MS market is projected to see consistent growth, with a robust compound annual growth rate (CAGR) anticipated from 2025 to 2034. This expansion across the 7MM will be driven by the introduction of innovative therapies, remibrutinib, tolebrutinib, fenebrutinib, frexalimab, vidofludimus Calcium, CNM-Au8, and masitinib, among others. Furthermore, MS prevalence is rising due to modifiable environmental and lifestyle factors like Epstein-Barr virus, low vitamin D, smoking, obesity, and night shifts, with genetics and geography also contributing.
According to DelveInsight’s analysis, the MS market in the 7MM was valued at approximately USD 20 thousand million in 2024. Over the forecast period from 2025 to 2034, this market is projected to grow at a CAGR of 3.8%.
Currently, there are lot of drugs that have been approved for MS treatment, including OCREVUS (Ocrelizumab) by Roche, LEMTRADA (Alemtuzumab) by Sanofi, MAYZENT (Siponimod) by Novartis, and VUMERITY (Diroximel fumarate) by Biogen, among others.
MS treatment lacks neuroprotective and remyelinating therapies, with limited options for progressive MS. Current drugs focus on immune modulation but fail to reverse damage or halt progression. Diagnostic delays remain common due to nonspecific symptoms and limited biomarkers. There is a critical need for early detection tools, personalized therapies, and agents targeting neurodegeneration to improve outcomes in MS.
Roche, Sanofi, Novartis, and AB Science, among others are progressing their assets through various clinical trial phases, driving innovation in the MS market and creating significant growth opportunities.
In April 2025, NEJM also published findings from the Phase III GEMINI 1 and 2 studies, which evaluated tolebrutinib in patients with RMS; these data were likewise featured in the Clinical Trials Plenary Session at AAN 2025.
DelveInsight’s “Multiple Sclerosis (MS) – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of MS, historical and forecasted epidemiology, as well as the MS market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The MS market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MS market size from 2020 to 2034. The report also covers MS treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.
Multiple Sclerosis (MS) Understanding and Treatment Algorithm
Multiple Sclerosis (MS) overview
MS is a lifelong, unpredictable disease that affects each person differently. While a small group experiences a mild form with little disability, others face a steadily worsening condition that leads to significant limitations. Most people, however, go through cycles of symptom flare-ups such as vision problems, muscle weakness, or numbness followed by periods of recovery. Women are more often affected than men. Though MS is rarely fatal and many live long, full lives, the disease can take a heavy toll, especially without early treatment. Initial signs often include blurred or double vision, eye pain from optic neuritis, or weakness and stiffness in the arms or legs, sometimes accompanied by painful muscle spasms. People may also feel tingling or numbness, have trouble with balance, or struggle with bladder issues. Over time, fatigue can become overwhelming, and mental health may suffer, with mood swings, depression, or trouble thinking clearly. Emerging therapies now offer real hope to slow down disability, especially when started early making timely diagnosis and personalized care essential.
Further details related to country-based variations are provided in the report…
Multiple Sclerosis (MS) diagnosis
Diagnosing MS is complex, as there is no single test that can confirm it with certainty. Instead, clinicians use a combination of approaches to rule out other conditions and build a strong case for MS. The diagnostic journey typically starts with a detailed medical history, physical exam, and neurological evaluation to assess symptoms and nerve function. Magnetic resonance imaging (MRI) of the brain and spinal cord plays a central role by detecting lesions caused by demyelination - an MS hallmark. To better identify active inflammation, contrast dye is often used during the MRI scan. Additional tests may include a lumbar puncture to analyze cerebrospinal fluid for immune markers, evoked potentials to measure nerve signal responses, and optic nerve tests to detect damage related to vision. Together, these methods help form a comprehensive and accurate diagnosis.
Multiple Sclerosis (MS) treatment
While MS has no cure, several treatments are available to reduce the frequency and severity of relapses and to slow disease progression. During acute flare-ups, high-dose intravenous (IV) corticosteroids like methylprednisolone are often used for 3–5 days to rapidly reduce inflammation in the central nervous system (CNS). This is sometimes followed by a tapering course of oral steroids. These medications can accelerate recovery from relapses but do not alter the long-term trajectory of the disease. Their primary role is to manage acute symptoms and support faster short-term recovery. For long-term control, patients are typically placed on disease-modifying therapies (DMTs) that aim to reduce new lesion formation, prevent relapses, and delay disability progression.
Multiple Sclerosis (MS) Epidemiology
As the market is derived using a patient-based model, the MS epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of MS, gender-specific diagnosed prevalent cases of MS, phenotype-specific diagnosed prevalent cases of MS, and EDSS-specific diagnosed prevalent cases in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.
DelveInsight estimates that there were approximately 1,655 thousand prevalent cases of MS across the 7MM in 2024. These diagnosed prevalent cases are projected to rise by 2034 at a CAGR of 1.5% during the forecast period (2025–2034).
In 2024, approximately 920 thousand adults in the US were living with a diagnosed prevalent case of MS, a number projected to rise by 2034.
Among EU4 and the UK, Germany had the highest number of diagnosed prevalent cases of adults in 2024, with approximately 255 thousand cases, while Spain had the lowest, with around 65 thousand cases.
As of 2024, in EU4 and the UK, relapsing-remitting multiple sclerosis (RRMS) represents the most widespread form of MS, affecting approximately 490 thousand individuals. Secondary progressive MS (SPMS) is the next most common, with about 110 thousand cases. Primary progressive MS (PPMS), while less prevalent, still accounts for around 90 thousand cases. This distribution highlights the predominance of RRMS and emphasizes the importance of early intervention to potentially delay or mitigate progression to more severe MS forms.
As of 2024, MS in Japan continues to exhibit a marked gender disparity, with females accounting for approximately 69% of cases and males just 31%. This trend highlights the persistent female predominance in MS and reinforces the need for gender-informed research and therapeutic strategies in the Japanese population.
In Japan, 2024 data on MS cases by EDSS score reveals the highest concentration in the 0–2.5 range with approximately 17 thousand cases, indicating a majority of patients with minimal disability. This is followed by decreasing case counts across higher EDSS brackets—3.0–4.0 with around 8 thousand cases, 4.5–6.0 with approximately 5 thousand cases, 6.5–8.0 with nearly 4 thousand cases, and =8.5 with approximately 270 cases—reflecting fewer individuals with moderate to severe disability progression.
Multiple Sclerosis (MS) Drug Chapters
The drug chapter segment of the MS report encloses a detailed analysis of MS-marketed drugs and pipeline drugs. It also helps understand the MS clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Drugs
OCREVUS (ocrelizumab): Roche (Genentech)
OCREVUS is a humanized monoclonal antibody (mAb) designed to target CD20-positive B cells, which are implicated in driving inflammation and damage to myelin and nerve fibers in MS—a key contributor to long-term disability. It selectively binds to CD20-expressing B cells while sparing stem cells and plasma cells, helping maintain broader immune function. Administered IV, OCREVUS is available as a 300 mg/10 mL solution in a single-use vial, allowing for accurate and controlled dosing.
In March 2017, the US FDA approved OCREVUS (ocrelizumab) for treating adults with both relapsing forms of multiple sclerosis (RMS) and PPMS, making it the first therapy specifically approved for PPMS. This approval represented a major advancement in MS care, especially for patients with limited treatment options. OCREVUS is administered via IV infusion under medical supervision.
Acknowledging the significant unmet need in MS, the US FDA granted OCREVUS Fast Track Designation (FTD) and Priority Review in June 2016. These designations accelerated the drug’s development and evaluation, reflecting its potential to address serious forms of MS, including primary progressive MS, for which no approved treatments previously existed.
OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): F. Hoffmann-La Roche (Genentech)
OCREVUS ZUNOVO is a subcutaneous (SC) formulation of ocrelizumab for MS, enhanced by ENHANZE technology using hyaluronidase (rHuPH20) to increase tissue permeability and speed absorption. It targets CD20-positive B cells, which drive myelin and nerve damage, while sparing vital immune cells. Administered as a 920 mg injection every six months over 10 minutes, it offers a more convenient alternative to IV infusion. Patients require monitoring—one hour after the initial dose and 15 minutes for later doses to ensure safety.
In September 2024, the US FDA approved OCREVUS ZUNOVO as the first and only SC treatment for both relapsing and progressive MS. Given twice yearly, the injection takes just 10 minutes, offering a faster, more convenient alternative to IV infusion for long-term disease management in eligible patients.
In July 2024, the European Union (EU) approved the SC version of ocrelizumab for the treatment of MS.
LEMTRADA (alemtuzumab): Sanofi
LEMTRADA is a cytolytic mAb targeting CD52, approved for treating relapsing forms of MS, including active secondary progressive MS, in individuals aged 17 and older. Given its significant safety risks—such as autoimmune complications, serious infusion reactions, and potential malignancies—it is generally reserved for patients who have failed at least two prior MS treatments. LEMTRADA is not recommended for clinically isolated syndrome (CIS) and is accessible only through the LEMTRADA REMS Program to ensure safe use under strict monitoring.
In November 2014, the US FDA approved LEMTRADA, a CD52-directed cytolytic monoclonal antibody, for relapsing forms of MS. This approval introduced an immune-reconstitution approach that selectively depletes pathogenic lymphocytes implicated in MS activity, aiming to reset the immune system. LEMTRADA marked a shift toward targeting immune cells driving long-term inflammation and disease progression.
In June 2010, Genzyme reported that the US FDA had granted Fast Track designation (FTD) to its MS program for alemtuzumab. This designation, intended to accelerate the review of treatments for serious conditions, was specifically for patients with relapsing-remitting MS (RRMS), acknowledging alemtuzumab’s potential to meet a critical unmet therapeutic need.
Emerging Drugs
Tolebrutinib (SAR442168): Sanofi
Tolebrutinib is an investigational oral BTK inhibitor designed to cross the blood–brain barrier (BBB) and stay active within the central nervous system, specifically targeting smoldering neuroinflammation—a key driver of disability progression in MS. Unlike conventional therapies that act mainly on peripheral inflammation, tolebrutinib reaches therapeutic concentrations in the cerebrospinal fluid, enabling it to modulate both B cells and disease-relevant microglia. This dual mechanism aims to directly address the central inflammatory processes underlying neurodegeneration in MS.
In March 2025, the US FDA accepted tolebrutinib for priority review, signaling its potential to address a critical unmet need in non-relapsing secondary progressive multiple sclerosis (nrSPMS). The submission emphasizes tolebrutinib’s role in slowing disability progression independent of relapses. The US decision is expected by September 2025, while parallel regulatory evaluation is underway in the EU.
Fenebrutinib: Roche (Genentech)
Fenebrutinib is an investigational oral BTK inhibitor distinguished by its reversible and non-covalent binding, enabling it to influence both adaptive and innate immunity by targeting B cells and microglia. As the sole reversible BTK inhibitor in Phase III trials for multiple sclerosis, it may uniquely address disease activity and progression of long-term disability.
The Phase III program for fenebrutinib comprises two parallel trials in relapsing multiple sclerosis (FENhance 1 and 2), using teriflunomide as the comparator, and the FENtrepid study in primary progressive MS, uniquely comparing fenebrutinib head-to-head with the approved therapy ocrelizumab—the only such comparison for a BTK inhibitor in PPMS.
Remibrutinib : Novartis
Remibrutinib (LOU064) is an investigational, highly selective covalent BTK inhibitor designed to block BTK signaling and prevent histamine release. Intended for patients unresponsive to antihistamines, it is currently in Phase III REMODEL-1 and REMODEL-2 trials, with PCD expected in 2026 and regulatory filing in 2027. While not yet tested in MS trials, Phase IIb data in CSU showed promising safety and tolerability.
Drug Class Insights
The treatment landscape for MS has evolved significantly, encompassing acute management, long-term disease modification, and symptom control. Acute relapses are typically managed with high-dose corticosteroids to reduce CNS inflammation and accelerate recovery, although these do not alter long-term outcomes.
The MS treatment market comprises a diverse portfolio of approved drugs spanning multiple classes, each targeting distinct immune pathways. These include CD20-directed cytolytic mAb, CD52-directed mAb, S1P receptor modulators, NRF2 activators, and agents exerting cytotoxic effects on B and T lymphocytes. Notably, OCREVUS and its SC counterpart OCREVUS ZUNOVO represent CD20-directed therapies, both offering potent B-cell depletion. OCREVUS has been recognized with Fast Track Designation (FTD) and Priority Review by the US FDA, underscoring its clinical value. Similarly, LEMTRADA, a CD52-targeted therapy, has also earned FTD status, reflecting regulatory acknowledgment of its potential in high-need MS populations. These distinctions highlight the importance of targeted immune-modulating strategies in addressing disease heterogeneity and progression in MS.
Continued in report…
Market Outlook
MS is the most common primary demyelinating disorder of the central nervous system, characterized by progressive neurological decline. Although its exact cause remains unclear, it is believed to involve an autoimmune response against myelin, triggered by autoreactive T and B cells that breach the blood–brain barrier. This immune attack leads to demyelination, axonal damage, and neurodegeneration. While there is no cure, acute relapses are typically managed with intravenous corticosteroids like methylprednisolone, followed by oral tapering to accelerate recovery, though these do not impact long-term disease progression.
Long-term MS management centers on DMTs, which aim to reduce relapse rates and slow progression. These therapies are categorized into treatment lines based on efficacy and patient response, with interferons remaining a key option for early-stage MS. The treatment landscape is evolving toward personalized and targeted therapies, offering improved outcomes and tolerability. This shift underscores significant market growth potential, with emerging therapies expanding treatment choices across disease stages while improving patient quality of life and limiting disability.
OCREVUS (ocrelizumab) by Genentech/Roche is a cornerstone therapy in MS treatment, approved for relapsing forms—including CIS, RRMS, and active SPMS—as well as primary progressive MS (PPMS), for which it remains the only approved therapy. Initially available as an IV infusion, the recent approval of OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) introduces a SC formulation, enhancing administration flexibility. Sanofi’s LEMTRADA (alemtuzumab), a CD52-targeting mAb, is indicated for RRMS and aSPMS. The growing use of oral agents like MAYZENT (siponimod), VUMERITY (diroximel fumarate), and MAVENCLAD (cladribine) marks a shift toward more convenient, patient-centric treatment options. Specifically, MAYZENT, an S1P receptor modulator by Novartis, is approved for CIS, RRMS, and aSPMS in the US, and for aSPMS in EU4, the UK, and Japan.
Among IFN-based therapies, PLEGRIDY (peginterferon beta-1a) provides a more convenient dosing regimen—every two to four weeks—compared to the more frequent administration required by conventional interferons. Within the class of S1P receptor modulators, ZEPOSIA (ozanimod) and PONVORY (ponesimod) both offer once-daily oral dosing, enhancing patient adherence. ZEPOSIA has shown strong efficacy in relapsing MS with a favorable safety profile, particularly exhibiting fewer cardiac side effects. PONVORY approved in 2021, demonstrated superiority over teriflunomide in reducing annualized relapse rates and MRI lesions, establishing itself as a competitive option. CD20-directed therapies such as KESIMPTA (ofatumumab) and BRIUMVI (ublituximab-xiiy) reflect a shift toward high-efficacy B-cell depletion strategies. KESIMPTA, administered via SC injection at home, matches the efficacy of IV ocrelizumab while offering greater convenience, and is currently being evaluated in Phase III trials for pediatric relapsing MS. BRIUMVI, the most recent addition to this class, further expands treatment choices in this high-potency category.
Companies like Genetech (Fenebrutinib), Sanofi (Tolebrutinib), Novartis (Remibrutinib), and AB Science (Masitinib), among others are involved in the development of Phase III, Phase II and Phase I drugs.
The total market size of MS in the 7MM was approximately USD 20 thousand million in 2024 and is projected to increase during the forecast period (2025–2034).
The market size for MS in the US was approximately USD 16 thousand million in 2024 and is anticipated to increase due to the launch of emerging therapies.
The total market size of EU4 and the UK was calculated to be approximately USD 4 thousand million in 2024, which was nearly 20% of the total market revenue for the 7MM and is expected to increase by 2034.
In 2024, Germany dominated the market between EU4 and the UK, generating around USD 1,550 million. The UK followed closely with approximately USD 850 million, while Italy recorded around USD 700 million.
In 2024, the total market size of MS was approximately USD 230 million in Japan, which is anticipated to increase during the forecast period (2025–2034).
Multiple Sclerosis (MS) Drugs Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034.
Further detailed analysis of emerging therapies drug uptake in the report…
Multiple Sclerosis (MS) Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for MS.
KOL Views
To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on MS evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University Of Maryland, US, University of California San Francisco, US, Charité University, Germany, University of Lille, France, University of Florence, Italy, Loyola University, Spain, University College London, UK, Tohoku University, Japan, and Niigata University, Japan , among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician’s View
As per the KOLs from the US, the approval of OCREVUS ZUNOVO represents a significant advancement in the administration of ocrelizumab therapy. Backed by a decade of robust safety and efficacy data for OCREVUS, the new SC option enhances flexibility in personalizing treatment to align with each patient’s lifestyle. This expanded choice enables clinicians and individuals with MS to make more tailored, patient-centric treatment decisions.
As per the KOLs from France, MS is an escalating public health issue in France, with prevalence rates steadily increasing in recent years. It predominantly affects women and usually manifests in early adulthood. National data and research underscore its substantial burden, showing marked effects on quality of life, progressive disability, and a higher mortality risk than the general population.
As per the KOLs from Japan, MS presents a growing clinical and economic burden. As prevalence increases, so does the cost pressure from high-priced DMTs. Given that MS is a leading cause of disability in young adults, there is an urgent need for more effective and economically sustainable strategies for diagnosis and management within healthcare systems.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Attribute Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
To assess the effectiveness of these therapies, a comparative analysis was performed using the Expanded Disability Status Scale (EDSS), a validated tool for quantifying disability in individuals with MS. Each therapy was assigned a score based on its impact on EDSS outcomes, enabling a structured evaluation of how well each treatment slows disability progression and supports functional independence. This scoring approach provides valuable insight into the real-world performance of MS therapies beyond clinical relapse rates.
Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
? LEMTRADA: Sanofi
SUPPORT
To help make treatment more accessible and affordable for patients with relapsing MS, the LEMTRADA Co-Pay Program offers financial assistance in the form of a reimbursement benefit for eligible patients who have commercial insurance. Through this program, qualified patients may receive a LEMTRADA Co-Pay Card, which provides
Full reimbursement for out-of-pocket costs related to the LEMTRADA medication itself (resulting in a USD 0 cost to the patient for the drug), and.
Reimbursement of up to USD 100 per day for costs associated with the administration of the LEMTRADA infusion (such as fees from infusion centers or healthcare providers).
This support is designed to ease the financial burden of both the medication and its administration, making it easier for patients to access their prescribed treatment.
Further details will be provided in the report.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Scope of the Report
The report covers a segment of key events, an executive summary, and a descriptive overview of MS, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will affect the current treatment landscape.
A detailed review of the MS market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM MS market.
Multiple Sclerosis (MS) Report Insights
Patient Population
Therapeutic Approaches
MS Pipeline Analysis
MS Market Size and Trends
Existing and Future Market Opportunity
Multiple Sclerosis (MS) Report Key Strengths
10 years Forecast
The 7MM Coverage
MS Epidemiology Segmentation
Key Cross Competition
Attribute analysis
Drugs Uptake and Key Market Forecast Assumptions
Multiple Sclerosis (MS) Report Assessment
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Market Attractiveness
Qualitative Analysis (SWOT and Attribute Analysis)
Key Questions
Market Insights
What was the total market size of MS, the market size of MS by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
How will fenebrutinib affect the treatment paradigm of MS?
How will OCREVUS compete with other upcoming products and marketed therapies?
Which drug is going to be the largest contributor by 2034?
What are the pricing variations among different geographies for approved and marketed therapies?
How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights
What are the disease risks, burdens, and unmet needs of MS? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to MS?
What is the historical and forecasted MS patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
Out of the countries mentioned above, which country would have the highest diagnosed prevalent MS population during the forecast period (2025–2034)?
What factors are contributing to the growth of MS cases?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
What are the current options for the treatment of MS? What are the current clinical and treatment guidelines for treating MS?
How many companies are developing therapies for the treatment of MS?
How many emerging therapies are in the mid-stage and late stage of development for treating MS?
What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
What is the cost burden of current treatment on the patient?
Patient acceptability in terms of preferred treatment options as per real-world scenarios?
What are the accessibility issues of approved therapy in the US?
What is the 7MM historical and forecasted market of MS?
Reasons to Buy
The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the MS market.
Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
The distribution of historical and current patient share is based on real-world prescription data in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
Detailed analysis, ranking of class-wise potential current, and emerging therapies under the attribute analysis section to provide visibility around leading classes.
Highlights of Access and Reimbursement policies for MS, barriers to accessibility of approved therapy, and patient assistance programs.
To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
Table of Contents
336 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. MS Market Overview at a Glance
- 3.1. Market Share (%) Distribution of MS by Therapies in the 7MM in 2020
- 3.2. Market Share (%) Distribution of MS by Therapies in the 7MM in 2034
- 4. Executive Summary
- 5. Key Events
- 6. Disease Background and Overview
- 6.1. Introduction
- 6.2. Signs and Symptoms
- 6.3. Classification Systems
- 6.4. Etiology
- 6.5. Risk Factors
- 6.6. Pathogenesis
- 6.7. Pathophysiology
- 6.8. Clinical Manifestations
- 6.9. Diagnosis
- 6.9.1. Diagnostic Algorithm
- 6.9.2. Diagnostic Criteria
- 6.9.3. Diagnostic Guidelines
- 6.10. Treatment
- 6.10.1. Treatment Algorithm
- 6.10.2. Treatment Guidelines
- 7. Epidemiology and Market Methodology
- 8. Epidemiology and Patient Population
- 8.1. Key Findings
- 8.2. Assumptions and Rationale: 7MM
- 8.2.1. Diagnosed Prevalence of MS
- 8.2.2. Gender-specific Diagnosed Prevalence of MS
- 8.2.3. Phenotype-specific Diagnosed Prevalence of MS
- 8.2.4. EDSS Distribution-specific Diagnosed Prevalence of MS
- 8.3. Total Diagnosed Prevalent Cases of MS in the 7MM
- 8.4. The United States
- 8.4.1. Total Diagnosed Prevalent Cases of MS in the US
- 8.4.2. Gender-specific Diagnosed Prevalent Cases of MS in the US
- 8.4.3. Phenotype-specific Diagnosed Prevalent Cases of MS in the US
- 8.4.4. EDSS-specific Diagnosed Prevalent Cases of MS in the US
- 8.5. EU4 and the UK
- 8.5.1. Total Diagnosed Prevalent Cases of MS in EU4 and the UK
- 8.5.2. Gender-specific Diagnosed Prevalent Cases of MS in EU4 and the UK
- 8.5.3. Phenotype-specific Diagnosed Prevalent Cases of MS in EU4 and the UK
- 8.5.4. EDSS-specific Diagnosed Prevalent Cases of MS in EU4 and the UK
- 8.6. Japan
- 8.6.1. Total Diagnosed Prevalent Cases of MS in Japan
- 8.6.2. Gender-specific Diagnosed Prevalent Cases of MS in Japan
- 8.6.3. Phenotype-specific Diagnosed Prevalent Cases of MS in Japan
- 8.6.4. EDSS-specific Diagnosed Prevalent Cases of MS in Japan
- 9. Patient Journey
- 10. Marketed Drugs
- 10.1. Key Cross Competition
- 10.2. OCREVUS (ocrelizumab): Roche (Genentech)
- 10.2.1. Product Description
- 10.2.2. Regulatory Milestones
- 10.2.3. Other Developmental Activities
- 10.2.4. Clinical Trials Information
- 10.2.5. Safety and Efficacy
- 10.3. OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): Roche (Genentech)
- 10.3.1. Product Description
- 10.3.2. Regulatory Milestones
- 10.3.3. Clinical Trials Information
- 10.3.4. Safety and Efficacy
- 10.4. LEMTRADA (Alemtuzumab): Sanofi
- 10.4.1. Product Description
- 10.4.2. Regulatory Milestones
- 10.4.3. Other Developmental Activities
- 10.4.4. Clinical Trials Information
- 10.4.5. Safety and Efficacy
- 10.5. MAYZENT (siponimod): Novartis
- 10.5.1. Product Description
- 10.5.2 Regulatory Milestone
- 10.5.3. Clinical Trials Information
- 10.5.4. Safety and Efficacy
- 10.6. VUMERITY (diroximel fumarate): Biogen
- 10.6.1. Product Description
- 10.6.2. Regulatory Milestones
- 10.6.3. Other Developmental Activities
- 10.6.4. Clinical Trials Information
- 10.6.5. Safety and Efficacy
- 10.7. MAVENCLAD (cladribine): Merck KGaA
- 10.7.1. Product Description
- 10.7.2. Regulatory Milestones
- 10.7.3. Other Developmental Activities
- 10.7.4. Clinical Trials Information
- 10.7.5. Safety and Efficacy
- 10.8. PLEGRIDY (peginterferon beta-1a): Biogen
- 10.8.1. Product Description
- 10.8.2. Regulatory Milestones
- 10.8.3. Other Developmental Activities
- 10.8.4. Clinical Trials Information
- 10.8.5. Safety and Efficacy
- 10.9. ZEPOSIA (ozanimod): Bristol Myers Squibb
- 10.9.1. Product Description
- 10.9.2. Regulatory Milestones
- 10.9.3. Other Developmental Activities
- 10.9.4. Clinical Trials Information
- 10.9.5. Safety and Efficacy
- 10.10. PONVORY (ponesimod): Vanda Pharmaceuticals/Juvisé Pharmaceuticals
- 10.10.1. Product Description
- 10.10.2. Regulatory Milestones
- 10.10.3. Other Developmental Activities
- 10.10.4. Clinical Trials Information
- 10.10.5. Safety and Efficacy
- 10.11. KESIMPTA (ofatumumab): Novartis
- 10.11.1. Product Description
- 10.11.2. Regulatory Milestones
- 10.11.3. Other Developmental Activities
- 10.11.4. Clinical Trials Information
- 10.11.5. Safety and Efficacy
- 10.12. BRIUMVI (ublituximab-xiiy): TG Therapeutics
- 10.12.1. Product Description
- 10.12.2. Regulatory Milestones
- 10.12.3. Other Developmental Activities
- 10.12.4. Clinical Trials Information
- 10.12.5. Safety and Efficacy
- 10.13. BAFIERTAM (monomethyl fumarate): Cycle Pharmaceuticals (Banner Life Sciences)
- 10.13.1. Product Description
- 10.13.2. Regulatory Milestones
- 10.13.3. Other Developmental Activities
- 10.13.4. Clinical Trials Information
- 10.13.5. Safety and Efficacy
- 11. Emerging Drug Profiles
- 11.1. Key Cross Competition of Emerging Drugs
- 11.2. Remibrutinib: Novartis
- 11.2.1. Drug Description
- 11.2.2. Clinical Trials Information
- 11.2.3. Safety and Efficacy
- 11.2.4. Analysts’ Views
- 11.3. Tolebrutinib (SAR442168): Sanofi
- 11.3.1. Drug Description
- 11.3.2. Other Developmental Activities
- 11.3.3. Clinical Trials Information
- 11.3.4. Safety and Efficacy
- 11.3.5. Analysts’ Views
- 11.4. Fenebrutinib: Roche (Genentech)
- 11.4.1. Drug Description
- 11.4.2. Other Developmental Activities
- 11.4.3. Clinical Trials Information
- 11.4.4. Safety and Efficacy
- 11.4.5 Analysts’ Views
- 11.5. Frexalimab (SAR441344): Sanofi
- 11.5.1. Drug Description
- 11.5.2. Other Developmental Activities
- 11.5.3. Clinical Trials Information
- 11.5.4. Safety and Efficacy
- 11.5.5. Analysts’ Views
- 11.6. Vidofludimus calcium (IMU-838): Immunic Therapeutics
- 11.6.1. Drug Description
- 11.6.2. Other Developmental Activities
- 11.6.3. Clinical Trials Information
- 11.6.4. Safety and Efficacy
- 11.6.5. Analysts’ Views
- 11.7. Masitinib: AB Science
- 11.7.1. Drug Description
- 11.7.2. Other Developmental Activities
- 11.7.3. Clinical Trials Information
- 11.7.4. Safety and Efficacy
- 11.7.5. Analysts’ Views
- 11.8. CNM-Au8: Clene Nanomedicine
- 11.8.1. Drug Description
- 11.8.2. Other Developmental Activities
- 11.8.3. Clinical Trials Information
- 11.8.4. Safety and Efficacy
- 11.8.5. Analysts’ Views
- 11.9. Orelabrutinib (ICP-022): InnoCare
- 11.9.1. Drug Description
- 11.9.2. Other Developmental Activities
- 11.9.3. Clinical Trials Information
- 11.9.4. Safety and Efficacy
- 11.9.5. Analysts’ Views
- 11.10. PIPE-307: Contineum Therapeutics
- 11.10.1. Drug Description
- 11.10.2. Other Developmental Activities
- 11.10.3. Clinical Trials Information
- 11.10.4. Analysts’ Views
- 12. Multiple Sclerosis (MS): Market Analysis
- 12.1. Key Findings
- 12.2. Market Outlook
- 12.3. Attribute Analysis
- 12.4. Key Market Forecast Assumptions
- 12.5. Total Market Size of MS in the 7MM
- 12.6. Market Size of MS by Therapies in the 7MM
- 12.7. Market Size of MS in the United States
- 12.7.1. Total Market of MS
- 12.7.2. Market Size of MS by Therapies in the United States
- 12.8. Market Size of MS in EU4 and the UK
- 12.8.1. Total Market Size of MS
- 12.8.2. Market Size of MS by Therapies in EU4 and the UK
- 12.9. Market Size of MS in Japan
- 12.9.1. Total Market Size of MS
- 12.9.2. Market Size of MS by Therapies in Japan
- 13. Key Opinion Leaders’ Views
- 14. Unmet Needs
- 15. SWOT Analysis
- 16. Market Access and Reimbursement
- 16.1. The United States
- 16.1.1. CMS
- 16.2. In EU4 and the UK
- 16.2.1. Germany
- 16.2.2. France
- 16.2.3. Italy
- 16.2.4. Spain
- 16.2.5. The United Kingdom
- 16.3. Japan
- 16.3.1. MHLW
- 17. Appendix
- 17.1. Acronyms and Abbreviations
- 17.2. Bibliography
- 17.3. Report Methodology
- 18. DelveInsight Capabilities
- 19. Disclaimer
- 20. About DelveInsight
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