The clinically isolated syndrome (CIS) market is estimated to be valued at USD 16.03 Bn in 2024 and is expected to reach USD 25.19 Bn by 2031, growing at a compound annual growth rate (CAGR) of 6.7% from 2024 to 2031. The market is driven by rising prevalence of multiple sclerosis and growing awareness about early diagnosis and treatment of the CIS condition to delay progression to multiple sclerosis.

Market Driver - Growing Awareness about Early Neurological Disorders

Clinically Isolated Syndrome is often considered as the initial clinical presentation of Multiple Sclerosis. However, it can progress to MS in some cases while remain isolated in others. This brings a sense of uncertainty for patients experiencing CIS symptoms. In recent years, advocacy initiatives by non-profit organizations as well as social media influence have ensured dissemination of information about subtle yet significant symptoms of early signs of MS and other neurological conditions.

Patients today are much more informed than ever before as they actively look for reasons behind new health issues themselves instead of ignoring them. Also, more doctors are able to recognize and explain CIS in detail to patients experiencing odd neurological episodes now. Family and friends also play an important supporting role by encouraging timely medical consultations.

All this has prompted many to seek specialist opinions for even the slightest of sensory issues or visual disturbances in the past. Overall, growing health awareness is effectively reducing diagnostic delays and supports early identification of CIS cases. This plays a big role in clinical management and holds significance for long-term prognosis.

Market Driver - Increasing Diagnostic Capabilities and Advancements in Neuroimaging Techniques

Advancements in medical technologies have significantly changed the prognostic landscape for various neurological conditions. Neuroimaging has become a valuable diagnostic tool aiding clinicians to distinguish between different conditions presenting similar symptoms and reach an accurate CIS or MS diagnosis. Periodic scans are also able to detect new lesions not visible on previous images, thereby helping evaluate disease progression accurately over the long-run.

MRIs are able to identify minute tissue abnormalities invisible on older, low-resolution machines. Availability of improved MRI equipment along with optimized scanning protocols at major hospitals have enabled radiologists and neurologists to detect even asymptomatic white matter lesions seen in early MS with a high degree of certainty.

Furthermore, accessibility of techniques like Magnetic Resonance Spectroscopy (MRS) allows analysis of biochemical variations in lesions. All these cutting-edge advancements have revolutionized the way CIS determination is approached at present.

Additionally, Positron Emission Tomography (PET) scans examining biochemical and pathological brain changes at cellular level provide important disease insights beyond traditional MRI findings. Overall, ongoing innovations in neuroimaging sphere have elevated CIS and MS diagnostic abilities to an unprecedented level. This empowers clinicians worldwide to detect CIS at its onset and make well-informed management decisions promptly.

Market Challenge - High Cost of Diagnosis and Treatment

One of the key challenges faced by the clinically isolated syndrome (CIS) market is the high cost associated with diagnosing and treating CIS patients. Diagnosing CIS requires advanced medical imaging techniques like MRI scans of the brain and spine to detect lesions. Performing detailed MRI scans regularly to monitor the progression of lesions in CIS patients contribute significantly to the overall cost of diagnosis.

The development of new lesions can help identify patients who are likely to convert into multiple sclerosis (MS) within a short time period. However, the high acquisition and operation cost of advanced MRI scanners pose financial barriers in many healthcare settings. Moreover, the frequent hospital visits and medical examinations needed to carefully track the condition of CIS patients over time further increase the cost of management.

While several highly effective disease-modifying therapies are available for CIS patients who progress to MS, their high drug prices restrict access for many patients. The out-of-pocket costs incurred for treatments especially for patients from lower socioeconomic backgrounds can be enormous and often prove to be unsustainable. Addressing these financial challenges surrounding diagnosis and treatment will be important for the long-term growth of the clinically isolated syndrome (CIS) market.

Market Opportunity - Development of Novel Biomarkers for Early Diagnosis

One of the key opportunities in the Clinically Isolated Syndrome (CIS) market is the development of novel biomarkers that allow early and accurate diagnosis. Currently, CIS can only be diagnosed by detecting lesions in the central nervous system using MRI technology.

However, MRI may not always be able to identify early lesions. The development of liquid biomarkers that can be detected through simple blood or CSF tests can help diagnose CIS at a much earlier stage before lesions appear on MRI. Biomarker research focused on identifying proteins, genes or metabolites specifically associated with the onset and progression of CIS can potentially enable detecting the disease even before the appearance of initial clinical symptoms.

Early diagnosis through reliable biomarkers is crucial as it provides opportunities for timely intervention with disease modifying therapies. This can help prevent or delay the progression of CIS to multiple sclerosis.

Wider adoption of accurate and easy-to-use biomarkers for CIS diagnosis globally would significantly expand the addressable market size over the long term. Several companies are actively investing in biomarker research to tap into this high growth opportunity area within the clinically isolated syndrome (CIS) market.

CIS refers to the initial clinical presentation of multiple sclerosis (MS), characterized by an acute, clinically documented attack of neurologic symptoms. For patients diagnosed with CIS, prescribers generally consider disease-modifying therapies (DMTs) soon after the event to help prevent or delay progression to clinically definite MS.

The first-line therapy is often a high-efficacy DMT such as subcutaneous interferon beta-1a (Rebif), intramuscular interferon beta-1a (Avonex), or subcutaneous glatiramer acetate (Copaxone). These therapies have demonstrated ability to reduce new lesion development and annualized relapse rates. However, their administration method via injection may impact patient preference and adherence.

For patients who continue experiencing relapses or show signs of disease progression on first-line therapies, prescribers may switch to second-line high-potency DMTs. Popular options include oral teriflunomide (Aubagio), which offers convenience, or injectable dimethyl fumarate (Tecfidera), which has a milder side effect profile than some alternatives. Daclizumab (Zinbryta) was previously used but has been withdrawn from markets due to safety concerns.

Prescriber preference may also be influenced by insurance coverage, tolerability, administration route, side effect management, and patient goals for lifestyle impact or pregnancy potential. The choice of DMT and line of therapy ultimately depends on each patient's individual disease characteristics and needs.

CIS represents the earliest stage of multiple sclerosis (MS), where patients present with a single clinical episode suggestive of demyelination in the central nervous system. There are typically three stages seen in CIS progression - CIS itself, relapsing-remitting MS (RRMS), and secondary progressive MS (SPMS).

For CIS, the main treatment goal is to prevent or delay progression to RRMS. First-line therapies typically include interferon beta-1b (Betaseron) or interferon beta-1a (Avonex, Rebif). These medicines work to reduce inflammation and help control immune system attacks on the myelin sheath. Their administration is via injection but have relatively mild side effect profiles.

If patients progress to RRMS, treatments aim to reduce relapse rate and new lesion formation. Highly effective therapies include glatiramer acetate (Copaxone), teriflunomide (Aubagio), dimethyl fumarate (Tecfidera), and the monoclonal antibodies like alemtuzumab (Lemtrada) and ocrelizumab (Ocrevus). Selection depends on factors like efficacy evidence from trials, route of administration, side effect risks, insurance coverage and patient preference.

Later in RRMS when disability starts accumulating, treatment moves to slowing progression which is seen more in SPMS. Medications like mitoxantrone (Novantrone) and ozanimod (Zeposia) may be used. For very active or aggressive cases, an autologous hematopoietic stem cell transplant may be considered to induce remission.

Product Innovation: Successful companies in this market have continuously innovated and launched new products to address unmet needs. In 2017, Roche launched Ocrevus, the first and only disease modifying treatment approved for both relapsing-remitting MS (RRMS) and CIS. This was a breakthrough as it was the first drug approved for CIS treatment. Ocrevus saw strong uptake and achieved $1 billion in sales by 2019.

Targeted Acquisitions: Players have strategically acquired companies with promising pipelines in CIS/MS. In 2015, Biogen acquired antibodies giant BioLegend for $890 million, gaining access to its extensive CIS/MS antibody and reagent portfolio. This strengthened Biogen's position in CIS research and diagnostics.

Expanded Indications: Obtaining approval for additional CIS/MS indications expands addressable markets. In 2019, Novartis gained FDA approval of Gilenya for treating CIS based on data from the FREEDOMS II trial. This grew Gilenya's revenue by 10% as it captured more CIS patients before progression to MS.

Partnerships: Collaborations help advance research and development. In 2021, Roche partnered with Kyowa Kirin on a Phase 3 trial evaluating anti-LINGO-1 antibody opicinumab as monotherapy in CIS patients. The results are expected in 2024 and could lead to opicinumab becoming the first CIS monotherapy if positive.

Insights, By Diagnosis: Neuroimaging Drives Diagnosis Segment Due to Precision and Early Detection Capabilities

The neuroimaging segment is estimated to hold 55.3% market share in 2024, for CIS diagnosis due to its unique ability to detect lesions in the central nervous system with great precision. Magnetic resonance imaging (MRI) can reveal even very small lesions that may not be detected through other diagnostic methods like neurological exams. This high resolution and sensitivity make neuroimaging the gold standard for CIS diagnosis.

Doctors often prefer neuroimaging as the initial diagnostic step because it can clearly show whether the patient has experienced a clinically isolated event caused by inflammation or demyelination in the brain or spinal cord. Since CIS may be an early warning sign of multiple sclerosis, timely and accurate diagnosis is important for guiding treatment decisions. Neuroimaging directly provides visual evidence of lesions that neurological exams and other tests can only infer. It removes doubt and ambiguity around the etiology of a patient's symptoms.

New contrast agents further increase the visibility of lesions. These continual improvements boost the diagnostic value of neuroimaging, driving its uptake among clinicians. Overall, neuroimaging emerges as the preferred initial tool for CIS diagnosis due to its proven accuracy, sensitivity and reassurance it provides patients and physicians alike regarding the need for swift treatment intervention.

Insights, By Treatment: Disease-Modifying Therapies Dominate Treatment due to Potential to Slow Disease Progression

Disease-modifying therapies (DMTs) is projected to constitute 47.7% of the market share in 2024, primarily due to their ability to potentially slow the progression to clinically definite multiple sclerosis (MS). DMTs target the underlying disease process in MS rather than just symptom relief. They work to reduce inflammation, prevent new lesions from forming, and limit existing lesion activity/growth. Evidence shows early treatment with effective DMTs after a CIS event can cut the risk of converting to MS by 30-50% within two years.

The first-line DMTs approved for CIS treatment are interferon beta preparations and glatiramer acetate, which have well-established long-term efficacy and safety profiles. While more expensive than generic drugs, they provide easier administration routes that improve adherence. Advancing research continually provides insights into the mechanisms of MS pathology, driving the development of new and improved DMTs with stronger efficacy against inflammation and neurodegeneration, which is why this treatment segment garners the largest market share.

By modifying the underlying disease, clinicians aim to prevent or delay subsequent disabling relapses and onset of progressive disability that significantly impacts quality of life. This makes early DMT initiation post-CIS diagnosis crucial from both medical and economic perspectives. It underscores the dominance of the disease-modifying therapies segment in CIS treatment protocols due to its potential for slowing disease progression long-term.

• In 2023, Spain had 826 CIS cases, expected to increase during the forecast period.
• Phenotype-specific prevalence data provided for multiple sclerosis subtypes in various countries.
• Early treatment after the first clinical event reduces the risk of progression to multiple sclerosis.
• Elevated NfL levels increase the likelihood of progression to MS, suggesting it could serve as a prognostic marker.

The major players operating in the Clinically Isolated Syndrome (CIS) Market include NIHON KOHDEN CORPORATION, Koninklijke Philips N.V., GENERAL ELECTRIC COMPANY, Siemens Healthcare Private Limited, Natus Medical Incorporated, and Compumedics Limited.

• In April 2024, high blood levels of neurofilament light chain (NfL) were identified as a prognostic marker for the progression to multiple sclerosis (MS) in patients with Clinically Isolated Syndrome (CIS). Studies showed that CIS patients with elevated NfL levels had a higher risk of converting to MS and transitioned earlier than those with lower NfL levels. Early treatment following the first clinical event significantly reduced the risk of this transition​.
• In August 2023, the FDA approved Tyruko® (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab), for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS). The approval was based on robust Phase I and III clinical trials, demonstrating that Tyruko provides similar efficacy, safety, and immunogenicity as the reference medicine Tysabri. This makes Tyruko the first and only FDA-approved biosimilar for these indications​.

• By Diagnosis
  • Neuroimaging
  • Laboratory Tests
  • Lumbar Puncture
  • Neurological Examination
• By Treatment
  • Disease-Modifying Therapies
  • Symptomatic Treatment
  • Corticosteroids