Relapsing-Remitting Multiple Sclerosis - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• Relapsing-Remitting Multiple Sclerosis (RRMS) is the most common form of multiple sclerosis, characterized by clearly defined episodes of neurological symptoms (relapses) followed by periods of partial or complete recovery (remissions).
• Relapsing-Remitting Multiple Sclerosis (RRMS) is the most prevalent form of multiple sclerosis, representing approximately 80% of multiple sclerosis diagnosed cases in 2024.
• In 2024, there were an estimated ~1 million cases of Relapsing-Remitting Multiple Sclerosis (RRMS) in the United States, with this number projected to increase steadily over the 2025-2034 forecast period.
• Many drugs are approved for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS); some of these include OCREVUS (ocrelizumab) and OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) by Hoffmann-La Roche (Genentech), PONVORY (ponesimod) by Vanda Pharmaceuticals, VUMERITY (diroximel fumarate) by Biogen, LEMTRADA (alemtuzumab) by Sanofi, and MAYZENT (siponimod) by Novartis.
• RRMS has several emerging therapies in development, including vidofludimus calcium (IMU-838) by Immunic, CLS12311 by Cellerys AG, and other novel agents targeting immune modulation and neuroprotection, among others.
• In June 2025, Immunic, reported new long-term data from its Phase II EMPhASIS trial of vidofludimus calcium (IMU-838) in RRMS patients, showing that at Week 144, 92.3% remained free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW. The oral Nurr1 activator continues to demonstrate a favorable safety and tolerability profile.

DelveInsight's comprehensive report titled "Relapsing-Remitting Multiple Sclerosis (RRMS) - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of relapsing-remitting multiple sclerosis. The report presents historical and projected epidemiological data covering Total Prevalent Cases of Multiple Sclerosis, Total Diagnosed Prevalent Cases of Multiple Sclerosis, Total Diagnosed Prevalent Cases of Relapsing-Remitting Multiple Sclerosis (RRMS), Age-specific Cases of Relapsing-Remitting Multiple Sclerosis (RRMS), Gender-specific Cases of Relapsing-Remitting Multiple Sclerosis (RRMS), and Treated Cases of Relapsing-Remitting Multiple Sclerosis (RRMS). In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in Relapsing-Remitting Multiple Sclerosis (RRMS). It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Relapsing-Remitting Multiple Sclerosis (RRMS) Overview

Relapsing-remitting multiple sclerosis (RRMS) is the most common form of multiple sclerosis. It is characterized by clearly defined relapses, periods of new or worsening neurological symptoms followed by periods of partial or complete recovery (remissions). The cause of relapsing-remitting multiple sclerosis is not fully understood but is believed to involve an autoimmune attack on the central nervous system, leading to inflammation and damage to the myelin sheath that protects nerve fibers. Relapsing-remitting multiple sclerosis often begins in early adulthood and affects more women than men.

Relapsing-Remitting Multiple Sclerosis (RRMS) Diagnosis and Treatment Algorithm

The diagnosis of relapsing-remitting multiple sclerosis is primarily clinical, supported by magnetic resonance imaging (MRI) and other tests. Key diagnostic criteria include evidence of lesions in the brain or spinal cord that are separated in both time and space, meaning they occurred at different points and in different locations. MRI scans are critical in detecting these lesions. Additional diagnostic tools include lumbar puncture (to detect oligoclonal bands in cerebrospinal fluid), evoked potentials (to assess nerve conduction), and blood tests to rule out other conditions. The 2017 revisions to the McDonald criteria have improved the sensitivity of relapsing-remitting multiple sclerosis diagnosis, enabling earlier and more accurate etc.

Treatment for relapsing-remitting multiple sclerosis focuses on managing relapses, slowing disease progression, and alleviating symptoms. Disease-modifying therapies (DMTs) are central to long-term management and include a wide range of options such as injectables, oral agents, and infusions. Approved DMTs for relapsing-remitting multiple sclerosis include OCREVUS and ZUNOVO (ocrelizumab and hyaluronidase-ocsq, Genentech), PONVORY (ponesimod, Vanda Pharmaceuticals), VUMERITY (diroximel fumarate, Biogen), MAYZENT (siponimod, Novartis), and others. These therapies help reduce relapse frequency, delay disability progression, and minimize new lesion formation. Acute relapses are often managed with corticosteroids, while symptomatic treatments address issues such as fatigue, spasticity, and mobility challenges. Multidisciplinary care, including physical therapy and lifestyle modifications, also plays a key role in comprehensive relapsing-remitting multiple sclerosis management.

Relapsing-Remitting Multiple Sclerosis (RRMS) Epidemiology

The epidemiology section of the relapsing-remitting multiple sclerosis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of relapsing-remitting multiple sclerosis. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

• In 2024, the United States accounted for the highest number of diagnosed prevalent cases of relapsing-remitting multiple sclerosis, representing approximately 60% of the total cases across the 7MM.
• In 2024, approximately 500,000 individuals were living with relapsing-remitting multiple sclerosis across the EU4 and the UK, with Germany contributing the highest burden at ~200,000 cases.
• The epidemiology of relapsing-remitting multiple sclerosis is expected to change during the forecast period (2025-2034).

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Outlook

The Relapsing-Remitting Multiple Sclerosis (RRMS) therapeutics market is projected to experience steady growth over the forecast period (2025-2034), fueled by rising global prevalence, increased awareness, advancements in diagnostic technologies, and the development of more targeted and personalized therapies.

• While current treatments primarily aim to reduce relapses and slow disease progression, the emergence of next-generation oral agents, immune tolerance approaches, and biomarker-driven therapies reflects a growing shift toward precision medicine and early intervention.
• RRMS continues to present a significant unmet need, particularly in addressing subclinical progression, cognitive decline, and long-term neuroprotection, which are not fully addressed by existing therapies.
• A robust pipeline featuring novel candidates such as vidofludimus calcium, CLS12311, and other emerging biologics and small molecules holds strong potential to reshape the RRMS treatment landscape over the next decade, offering hope for more durable responses and improved quality of life for patients.

Relapsing-Remitting Multiple Sclerosis (RRMS) Drug Chapters

Marketed Relapsing-Remitting Multiple Sclerosis (RRMS) Drugs

OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): Hoffmann-La Roche (Genentech)

OCREVUS ZUNOVO is a subcutaneous (SC) formulation of ocrelizumab for multiple sclerosis, 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 subcutaneous (SC) treatment for both relapsing and progressive forms of Multiple Sclerosis, including Relapsing-Remitting Multiple Sclerosis (RRMS).

PONVORY (ponesimod): Vanda Pharmaceuticals/Janssen Pharmaceutical

PONVORY (ponesimod), developed by Vanda Pharmaceuticals, is an oral, once-daily sphingosine-1-phosphate (S1P) receptor modulator. It works by preventing immune cells from reaching the central nervous system, thereby reducing inflammation and disease activity. PONVORY offers a convenient oral treatment option with demonstrated efficacy in lowering relapse rates and slowing the progression of multiple sclerosis.

In December 2023, Vanda Pharmaceuticals acquired the US and Canadian rights to PONVORY from Actelion Pharmaceuticals, a Johnson & Johnson company. Approved in 2021 by the FDA for relapsing forms of multiple sclerosis including relapsing-remitting multiple sclerosis.

Emerging Relapsing-Remitting Multiple Sclerosis (RRMS) Drugs

Vidofludimus calcium (IMU-838): Immunic AG

Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis. Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of multiple sclerosis. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH).

In June 2025, Immunic, announced the completion of enrollment for both Phase III ENSURE trials evaluating vidofludimus calcium in patients with relapsing multiple sclerosis, including RRMS. Top-line results from these pivotal studies are expected by the end of 2026.

CLS12311: Cellerys AG

CLS12311 is an investigational cell therapy developed by Cellerys AG, designed to induce antigen-specific immune tolerance in relapsing-remitting multiple sclerosis. It uses a patient's own red blood cells chemically coupled with 5 multiple sclerosis-related peptides to retrain the immune system and reduce autoreactivity.

In June 2024, Cellerys AG announced the initiation of its RED4MS Phase Ib/IIa clinical trial in patients with relapsing-remitting multiple sclerosis, with patient screening now underway. The trial, conducted across four European countries, aims to evaluate the potential of immune tolerance-based therapy as a novel approach for treating relapsing-remitting multiple sclerosis.

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Segmentation

DelveInsight's 'Relapsing-Remitting Multiple Sclerosis (RRMS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future relapsing-remitting multiple sclerosis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Size by Countries

The Relapsing-Remitting Multiple Sclerosis (RRMS) market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) relapsing-remitting multiple sclerosis market. This dominance is projected to persist, especially with the potential introduction of new products.

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Size by Therapies

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Relapsing-Remitting Multiple Sclerosis (RRMS) Drugs Uptake

This section focuses on the sales uptake of potential relapsing-remitting multiple sclerosis drugs that have recently been launched or are anticipated to be launched in the relapsing-remitting multiple sclerosis market between 2020 and 2034. It estimates the market penetration of relapsing-remitting multiple sclerosis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the relapsing-remitting multiple sclerosis market.

The emerging relapsing-remitting multiple sclerosis therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the relapsing-remitting multiple sclerosis market.

Relapsing-Remitting Multiple Sclerosis (RRMS) Market Access and Reimbursement

DelveInsight's 'Relapsing-Remitting Multiple Sclerosis (RRMS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of Relapsing-Remitting Multiple Sclerosis (RRMS).

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current Relapsing-Remitting Multiple Sclerosis (RRMS) market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the relapsing-remitting multiple sclerosis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or relapsing-remitting multiple sclerosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the relapsing-remitting multiple sclerosis unmet needs.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 25+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of California, Yale School of Medicine, Stanford University, University of Girona, ellvitge-Idibell University Hospital, Walton Centre, and University of Tokyo, among others.

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the Relapsing-Remitting Multiple Sclerosis (RRMS) Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Relapsing-Remitting Multiple Sclerosis (RRMS) Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for Relapsing-Remitting Multiple Sclerosis (RRMS). It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging Relapsing-Remitting Multiple Sclerosis (RRMS) therapies.

Relapsing-Remitting Multiple Sclerosis (RRMS) Report Insights

• Patient Population
• Therapeutic Approaches
• Pipeline Analysis
• Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

Relapsing-Remitting Multiple Sclerosis (RRMS) Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Relapsing-Remitting Multiple Sclerosis (RRMS) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions:

• How common is relapsing-remitting multiple sclerosis?
• What are the key findings of relapsing-remitting multiple sclerosis epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for relapsing-remitting multiple sclerosis?
• What are the disease risk, burden, and unmet needs of relapsing-remitting multiple sclerosis?
• At what CAGR is the relapsing-remitting multiple sclerosis market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the relapsing-remitting multiple sclerosis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of relapsing-remitting multiple sclerosis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of relapsing-remitting multiple sclerosis?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the relapsing-remitting multiple sclerosis 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.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions

1. What are the treatment goals for Relapsing-Remitting Multiple Sclerosis (RRMS)?

The primary treatment goals for Relapsing-Remitting Multiple Sclerosis (RRMS) are to reduce the frequency and severity of relapses, delay disability progression, and minimize new disease activity as seen on MRI. Additional goals include preserving neurological function, improving quality of life, and managing symptoms such as fatigue, mobility issues, and cognitive impairment. Achieving long-term disease stability through individualized therapy and proactive monitoring is also a key objective.

2. What are the challenges in managing Relapsing-Remitting Multiple Sclerosis (RRMS)?

Managing Relapsing-Remitting Multiple Sclerosis (RRMS) presents several challenges, including the heterogeneous nature of the disease, which makes predicting relapses and treatment response difficult. Treatment-related side effects, long-term adherence, and balancing efficacy with safety remain ongoing concerns. Additionally, limited access to advanced therapies in some regions, high treatment costs, and the lack of curative options contribute to the complexity of care. Monitoring disease progression and managing comorbidities also require a multidisciplinary, long-term approach.

3. What are the key factors driving the growth of the Relapsing-Remitting Multiple Sclerosis (RRMS) market?

The growth of the Relapsing-Remitting Multiple Sclerosis (RRMS) market is driven by rising disease prevalence, advances in novel therapies such as oral agents and immune tolerance approaches, and increasing awareness leading to early diagnosis. Supportive regulatory frameworks, expanding access in emerging markets, and the shift toward personalized medicine further fuel market expansion by improving treatment outcomes and broadening the eligible patient base.

4. How will the Relapsing-Remitting Multiple Sclerosis (RRMS) Market and Epidemiology Forecast Report benefit the clients?

The report will provide comprehensive insights into the current Relapsing-Remitting Multiple Sclerosis (RRMS) market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.