Clinically Isolated Syndrome (CIS) - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights:

• CIS is a first neurological episode caused by central nervous system inflammation and demyelination, often serving as an early indicator of multiple sclerosis. It highlights the risk of progression to clinically definite multiple sclerosis.
• Secondary analysis estimates the incidence of CIS in the US at 3.4 per 100,000, emphasizing its rarity and significance as a potential first sign of demyelinating disease, where early recognition can impact long-term neurological outcomes.
• The rising cases of CIS may be attributed to multiple factors, including improved awareness, earlier detection through advanced imaging, and possible shifts in epidemiology. Contributing factors under investigation include genetic susceptibility, environmental triggers, increasing surveillance of neurological symptoms, and a growing recognition of CIS as a precursor to multiple sclerosis.
• Novartis's KESIMPTA (ofatumumab) is a key FDA-approved therapy for CIS, addressing a vital need for early immunomodulation to delay disease progression. Its targeted B-cell mechanism supports ongoing research into next-generation disease-modifying therapies (DMTs) and personalized approaches, reflecting a dynamic CIS market with strong potential for innovation and improved long-term outcomes.
• Despite advances in DMTs, there remains a clear unmet need in CIS treatment for options that can more effectively prevent conversion to multiple sclerosis, offer neuroprotection, and target early pathological mechanisms. Innovative therapies that go beyond traditional immunomodulation are essential to address these gaps, enhance patient outcomes, and reshape the CIS treatment landscape in the years ahead.
• Another key unmet need in CIS management lies in the lack of highly sensitive and specific diagnostic tools that can accurately differentiate CIS from other neurological conditions at the earliest stage. Addressing this gap could enable timely intervention, reduce misdiagnosis, and improve long-term outcomes by preventing progression in high-risk patients.

DelveInsight's comprehensive report titled "Clinically Isolated Syndrome (CIS) - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of CIS. The report presents historical and projected epidemiological data covering total incident cases of CIS, gender-specific incident cases of CIS, and treated cases of CIS. 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 CIS. 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.

Clinically Isolated Syndrome (CIS) Overview

CIS represents the first episode of neurological symptoms resulting from inflammation or demyelination within the central nervous system, frequently marking the earliest clinical indication of multiple sclerosis. It most commonly affects young adults between the ages of 20 and 40, with a higher incident in women, and is believed to arise from a complex interplay of genetic susceptibility, autoimmune dysfunction, and environmental triggers such as low vitamin D levels or viral exposures. The clinical presentation of CIS varies widely based on the location of demyelination, with common symptoms including sudden vision loss or blurring (optic neuritis), numbness or tingling in the limbs, muscle weakness, coordination or balance difficulties, and occasionally bladder dysfunction or cognitive disturbances. While these symptoms may partially or completely resolve, CIS carries a significant risk of conversion to multiple sclerosis, especially when MRI reveals brain lesions characteristic of the disease. Given this risk, early diagnosis and prompt initiation of disease-modifying therapies are essential to delay progression and optimize long-term neurological outcomes.

Clinically Isolated Syndrome (CIS) Diagnosis and Treatment Algorithm

Diagnosing CIS can be challenging due to its symptom overlap with other neurological disorders, including stroke, migraines, or peripheral neuropathies. Clinicians rely on a detailed neurological history and examination, with a focus on the sudden onset of symptoms such as optic neuritis, limb numbness or weakness, balance disturbances, or sensory changes, often lasting more than 24 hours and not explained by fever or infection. A critical component of diagnosis is MRI imaging of the brain and spinal cord, which can reveal demyelinating lesions characteristic of CIS and help assess the risk of conversion to multiple sclerosis. Additional tests, such as evoked potentials and cerebrospinal fluid (CSF) analysis for oligoclonal bands, may support the diagnosis but are not definitive on their own.

Early diagnosis is essential, as patients with MRI evidence of multiple lesions are at significantly higher risk of developing MS. Clinical tools such as the McDonald criteria, when combined with imaging and cerebrospinal fluid analysis, play a critical role in confirming CIS and guiding treatment strategies. Management typically involves reducing acute inflammation with high-dose corticosteroids and considering early initiation of disease-modifying therapies (DMTs) in high-risk patients to delay or prevent progression. Long-term care focuses on regular neurological assessments, MRI monitoring, patient education, and addressing modifiable risk factors to support better clinical outcomes.

Clinically Isolated Syndrome (CIS) Epidemiology

The epidemiology section of the CIS 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 incident of CIS. 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.

Key Findings

• Clinically Isolated Syndrome occurs more frequently in females than males, reflecting the broader pattern of female predominance in autoimmune demyelinating disorders and suggesting potential hormonal or immunological factors influencing disease susceptibility.
• An estimated 30% to 82% of CIS cases progress to MS over time, underscoring the condition's role as a critical early warning sign and highlighting the importance of timely intervention to alter disease trajectory.
• A key unmet need in the CIS landscape is the lack of robust, population-level epidemiological data. Current estimates vary widely due to inconsistent diagnostic criteria, underreporting, and regional differences in surveillance. This gap hinders accurate assessment of disease burden, limits strategic planning for healthcare resources, and challenges the design of large-scale clinical trials. Establishing standardized, high-quality epidemiological datasets is critical to better understand CIS incidence, progression rates, and regional variations, ultimately guiding earlier diagnosis and more effective intervention strategies.

The epidemiology of CIS is expected to change during the forecast period (2025-2034).

Clinically Isolated Syndrome (CIS) Market Outlook

The CIS therapeutics market is further expected to increase by the major drivers, such as the rising incident population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

In August 2020, the US FDA approved KESIMPTA (ofatumumab) for the treatment of relapsing multiple sclerosis, including CIS, offering a convenient, once-monthly subcutaneous option in the early-stage MS setting. With its targeted CD20 mechanism, favorable safety profile, and self-administration design, KESIMPTA is well-positioned to capture a significant share of the evolving immunotherapy market for CIS and related relapsing forms.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the CIS market in the 7MM is expected to change significantly during the study period 2020-2034.

Clinically Isolated Syndrome (CIS) Drug Chapters

CIS Marketed Drugs

KESIMPTA (ofatumumab): Novartis Pharmaceuticals

KESIMPTA, developed by Novartis, is a self-administered, once-monthly subcutaneous CD20-directed cytolytic antibody approved in the US for the treatment of relapsing multiple sclerosis (RMS), including CIS, Relapsing-Remitting Multiple Sclerosis (RRMS), and active Secondary Progressive Multiple Sclerosis (aSPMS). It offers a targeted B-cell therapy with a favorable safety and tolerability profile, providing an effective and convenient alternative to intravenous infusions for patients seeking long-term disease control in early and active forms of MS.

• In August 2020, the US FDA approved KESIMPTA for the treatment of CIS in adults.

OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq): Genentech

OCREVUS ZUNOVO, developed by Genentech, is a subcutaneous CD20-directed monoclonal antibody formulation approved for the treatment of relapsing forms of multiple sclerosis, including CIS, RRMS, and aSPMS. It offers a shorter administration time compared to the intravenous form of ocrelizumab, maintaining efficacy while improving patient convenience and infusion center efficiency, making it a strong option for long-term B-cell targeted therapy in MS management.

• In September 2024, the US FDA approved OCREVUS ZUNOVO as the first and only twice-yearly subcutaneous injection for relapsing MS, including CIS, offering a rapid 10-minute administration and enhanced treatment convenience.

BRIUMVI (ublituximab-xiiy): TG Therapeutics

BRIUMVI is an anti-CD20 monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis, including CIS. Administered via IV infusion, BRIUMVI offers a shorter infusion time compared to other B-cell therapies, providing an effective and efficient option for patients seeking rapid administration and sustained disease control.

• In December 2022, the US FDA approved BRIUMVI for the treatment of RMS in adults, including CIS, RRMS, and aSPMS.

Clinically Isolated Syndrome (CIS) Market Segmentation

DelveInsight's 'Clinically Isolated Syndrome (CIS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future CIS 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.

Clinically Isolated Syndrome (CIS) Market Size by Countries

The CIS market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) CIS market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Clinically Isolated Syndrome (CIS) Drugs Uptake

This section focuses on the sales uptake of potential CIS drugs that have recently been launched or are anticipated to be launched in the CIS market between 2020 and 2034. It estimates the market penetration of CIS 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 CIS market.

The emerging CIS 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 CIS market.

Clinically Isolated Syndrome (CIS) Market Access and Reimbursement

DelveInsight's 'Clinically Isolated Syndrome (CIS) - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of CIS.

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 CIS market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the CIS domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or CIS market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the CIS unmet needs.

Clinically Isolated Syndrome (CIS): KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as University of California, US; University of Munich, Germany; Badajoz University Hospital, Spain; Bellvitge-Idibell Vita-Salute San Raffaele University, Italy; University of Nottingham, UK; and NHO Utano National Hospital, Japan, among others.

"Diagnosing CIS remains a nuanced clinical challenge, as it requires careful correlation of clinical presentation with MRI findings and, in some cases, cerebrospinal fluid analysis. Tools like the McDonald criteria aid in diagnosis, but no single test can definitively confirm CIS in all patients. The variability in symptoms and overlap with other neurological conditions highlight the need for timely clinical evaluation, imaging, and structured diagnostic pathways to accurately identify CIS and assess the risk of progression to multiple sclerosis."

"Initial management of CIS focuses on reducing acute inflammation, typically through high-dose corticosteroids to accelerate symptom resolution. In patients with a high risk of progression to multiple sclerosis-often indicated by MRI lesions-early initiation of disease-modifying therapies is recommended to delay or prevent disease conversion. Given the variability in individual risk and treatment response, careful patient selection, imaging follow-up, and long-term monitoring are essential."

"A key unmet need in the management of CIS is the development of more precise therapies that can effectively prevent progression to multiple sclerosis while minimizing long-term immunosuppression risks. Despite advances in disease-modifying treatments, gaps remain in identifying which patients are most likely to benefit from early intervention, highlighting the need for novel targeted agents and more personalized, risk-adapted treatment strategies"

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the CIS 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.

Clinically Isolated Syndrome (CIS) 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 CIS. 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 CIS therapies.

Clinically Isolated Syndrome (CIS) Report Insights

• CIS Patient Population
• Therapeutic Approaches
• CIS Market Size and Trends
• CIS Market Opportunities

Clinically Isolated Syndrome (CIS) Report Key Strengths

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

Clinically Isolated Syndrome (CIS) Report Assessment

• CIS Current Treatment Practices
• Unmet Needs
• CIS Marketed Product Profiles
• CIS Market Attractiveness

Key Questions:

• What are the key findings of CIS 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 CIS?
• What are the disease risk, burden, and unmet needs of CIS?
• At what CAGR is the CIS market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the CIS market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of CIS in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the CIS Market.
• Insights on patient burden/disease incidence, 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 UK, 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 therapies 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 CIS?

The main treatment goals for CIS are to reduce acute inflammation, prevent future neurological damage, and delay or stop progression to multiple sclerosis. Management focuses on resolving initial symptoms, often with corticosteroids, while identifying high-risk patients who may benefit from early initiation of disease-modifying therapies. Long-term goals include minimizing relapse risk, preserving neurological function, and tailoring follow-up through regular imaging and clinical monitoring to ensure sustained control and timely intervention.

2. What are the challenges in managing CIS?

The main challenges in managing CIS stem from its variable and sometimes subtle neurological symptoms, which can complicate early diagnosis and risk assessment. Differentiating CIS from other neurological disorders requires careful interpretation of clinical findings, MRI results, and, in some cases, CSF analysis. Initiating disease-modifying therapy involves balancing potential benefits in delaying multiple sclerosis progression against treatment-related risks, especially in patients with uncertain prognosis. Long-term management requires personalized monitoring strategies, regular imaging, and sustained patient engagement to ensure early detection of conversion and optimize therapeutic outcomes.

3. What are the key factors driving the growth of the CIS market?

The CIS market is driven by rising incidence rates, advances in diagnostics and interventions, and growing awareness. Together, these factors boost demand for safer, more effective treatment options and support sustained market growth.

4. How will the CIS Market and Epidemiology Forecast Report benefit the clients?

The CIS Market and Epidemiology Forecast Report provides clients with in-depth insights into disease trends, patient populations, treatment patterns, and competitive landscapes. This helps stakeholders identify growth opportunities, make informed strategic decisions, and optimize market positioning for future advancements and investments.