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다발성 경화증 : 시장 인사이트, 역학 및 시장 예측(2036년)

Multiple Sclerosis - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 336 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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다발성 경화증(MS)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 주요 7개국의 MS 시장 규모는 2025년에 약 220억 달러로 평가되며, 첨단 치료법의 도입과 임상 관리의 개선이 예상됨에 따라 연평균 성장률(CAGR) 3.5%로 확대될 것으로 전망됩니다.
  • 2025년 기준으로, 미국 내 다발성 경화증(MS) 확진 환자 수는 약 95만 명에 달했으며, 주요 7개국 전체의 총 환자 수는 170만 명에 이르렀습니다. 이는 첨단 질환 수정 요법(DMT)에 대한 수요를 견인하는 상당한 규모의 환자 기반을 보여줍니다.
  • 현재 FDA(미국 식품의약국)가 승인한 DMT에는 로슈(Roche)사의 오크렐리주맙(OCREVUS), 사노피(Sanofi)사의 알렘츠주맙(LEMTRADA), 노바티스(Novartis)사의 시포니모드(MAYZENT), 바이오젠의 디록시메르 푸마르산염(VUMERITY), 머크 KGaA의 클라드리빈(MAVENCLAD) 등이 있으며, 현재 FDA 승인을 받은 DMT는 염증 기전을 조절하여 재발을 억제하고 신체 기능 저하를 늦추는 데 중점을 두고 있습니다. 이러한 치료법은 다발성 경화증(MS)의 다양한 병기에 맞춰 고안되었으며, 환자의 장기적인 예후를 개선하는 것을 목표로 합니다.
  • 로슈, 사노피, 노바티스, AB 사이언스 등은 자체 개발한 후보 약물을 다양한 임상시험 단계로 진행하며, 다발성 경화증(MS) 시장에서 혁신을 주도하고 큰 성장 기회를 창출하고 있습니다.
  • 다발성 경화증(MS)의 파이프라인은 견조한 모습을 보이고 있으며, 염증과 신경퇴행 모두를 다루는 혁신적인 작용 기전으로 전환되고 있습니다. 주요 개발 후보 약물로는 노바티스의 레미부르티닙(LOU064), 사노피의 플렉사리맙(SAR441344), 사노피의 트레브루티닙(SAR442168), 그리고 이뮤닉 테라퓨틱스의 비드플루딤 칼슘(IMU-838) 등이 있으며, 이들은 보다 효과적인 차세대 치료법으로의 전환을 시사하고 있습니다.
  • 다발성 경화증(MS)은 현재로서는 완치가 불가능하지만, 재발 빈도와 중증도를 줄이고 장기적인 질병 진행을 늦추기 위한 다양한 치료법이 이용 가능합니다. 급성 재발의 관리에 있어 코르티코스테로이드는 표준적인 치료법이며, 특히 메틸프레드니솔론의 정맥내 투여는 재발 기간과 그 영향을 줄이기 위해 널리 사용되고 있습니다.
  • 특히 진단상의 문제나 오진과 관련해서는 여전히 치료에 있어 큰 격차가 존재하고 있습니다. 비특이적인 증상이나 자기공명영상(MRI) 소견의 과도한 해석으로 인해 정확한 진단은 여전히 어렵습니다. 전문적인 신경학적 치료, 특히 첨단 영상 진단에 대한 인식과 접근성이 제한적인 점도 정확한 진단이 늦어지는 원인이 되고 있습니다. 적절하고 시기적절한 치료 시작을 보장하기 위해서는 진단 정확도의 향상이 매우 중요한 미충족 의료 수요가 되고 있습니다.

다발성 경화증(MS)의 시장 규모 및 전망

  • 2025년 주요 7개국 MS 시장 규모 : 220억 달러
  • 주요 7개국의 MS 성장률(2026-2036년) : 연평균 성장률(CAGR) 3.5%

본 MS 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. 또한, 다발성 경화증(MS) 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하여, 주요 7개 국가 및 지역 전체에 걸친 상세한 시장 규모 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시합니다. 본 보고서에서는 MS 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

대상 지역:

북미 : 미국

유럽 : 독일, 프랑스, 이탈리아, 스페인, 영국

아시아태평양 : 일본

다발성 경화증(MS)의 이해와 치료 알고리즘

다발성 경화증(MS)의 개요와 진단

다발성 경화증(MS)은 평생에 걸쳐 예측할 수 없는 질환으로, 환자마다 증상이 다르게 나타납니다. 경미한 증상에 그치는 사람도 있는 반면, 진행성 장애를 일으키는 사람도 있지만, 대다수의 환자는 재발과 회복을 반복합니다. 일반적인 초기 증상으로는 시력 장애, 근력 저하, 저림, 균형 감각 장애 등이 있으며, 시간이 지남에 따라 피로감이나 인지 기능의 변화, 기분 변동이 나타날 수도 있습니다. 여성의 발병 빈도는 남성보다 높습니다. MS로 인해 사망에 이르는 경우는 드물지만, 삶의 질에 중대한 영향을 미칠 가능성이 있으므로 조기 진단과 적시의 치료가 매우 중요합니다. 특히, 질병의 진행을 늦추는 데 도움이 되는 새로운 치료법이 이용 가능한 현재 상황에서는 더욱 그렇습니다.

MS의 진단은 결정적인 검사 방법이 하나도 없기 때문에 어려움이 따릅니다. 대신, 임상의는 임상 평가와 진단 도구를 종합하여 다른 질환을 배제한 뒤, 이 질환을 확정합니다. 이 과정은 일반적으로 증상 및 신경 기능을 평가하기 위한 상세한 병력 청취, 신체 검사, 신경학적 평가로 시작됩니다. 뇌와 척수의 MRI는 탈수초 병변을 확인하는 데 중요한 역할을 하며, 대부분의 경우 조영제를 사용하여 활동성 염증을 감지합니다. 또한, 뇌척수액을 평가하기 위한 요추 천자, 신경 신호의 반응을 측정하는 유발 전위 검사, 시신경 평가 등의 추가 검사를 실시함으로써 진단의 정확도를 높이고 종합적인 평가를 수행할 수 있습니다.

다발성 경화증(MS) 치료의 현황

MS 치료는 질환의 병기와 중증도에 따라 이루어집니다. 현재 FDA(미국 식품의약국)가 승인한 DMT(질병 수정 치료제)로는 로슈(Roche)사의 오렐리주맙(OCREVUS)과 노바티스(Novartis)사의 시포니모드(MAYZENT) 등이 있으며, 이들은 주로 염증 과정을 표적으로 하여 재발을 억제하고 장애의 진행을 늦추는 것을 목적으로 합니다. 이러한 치료법은 환자의 예후를 크게 개선했으나, 신경 퇴행이나 장기적인 장애를 완전히 해결하는 데에는 한계가 있습니다. 이러한 점이 차세대 치료법 개발을 뒷받침하고 있습니다. 노바티스의 레미부르티닙(LOU064), 사노피의 플렉사리맙(SAR441344), 이뮤닉 테라퓨틱스의 비드플루디무스 칼슘(IMU-838)과 같은 새로운 후보 약물은 염증과 신경퇴행성 기전 모두를 표적으로 삼아 보다 종합적인 질환 관리를 목표로 하고 있습니다.

다발성 경화증(MS)의 역학

다발성 경화증(MS)의 역학적 분석 및 예측에 관한 주요 조사 결과

  • 2025년 기준으로, 주요 7개국에서 다발성 경화증(MS) 진단을 받은 환자 수는 약 150만 명으로 추정되며, 이는 주요 시장 전체에서 이 질환이 주는 막대한 부담을 반영하고 있습니다.
  • 2025년에는 미국이 약 95만 건으로 가장 큰 비중을 차지할 것으로 예상되며, 이는 첨단 진단 기술과 질병에 대한 인식 제고 덕분입니다.
  • EU4 국가와 영국을 합치면 약 70만 건에 달하며, 그중 영국이 약 14만 건을 차지하고, 2025년에는 유럽 내에서 가장 큰 단일 시장이 될 전망입니다.
  • 2025년까지 미국에서는 여성들이 다발성 경화증(MS)의 영향을 불균형적으로 받고 있으며, 여성 환자 수는 약 70만 명으로 추정되는 반면, 남성 환자 수는 약 25만 명으로 남성 환자 수가 훨씬 적을 것으로 예상됩니다.

다발성 경화증(MS) 시장의 전망

MS는 중추신경계(CNS)에서 가장 흔한 원발성 탈수초성 질환으로, 심각한 신경학적 장애로 진행될 가능성이 있습니다. 그 병인은 여전히 불분명하지만, 현재의 연구 결과에 따르면 미엘린 항원을 표적으로 하는 자가면역 반응이 관여하고 있는 것으로 추정됩니다. 자가반응성 T세포 및 B세포가 혈액-뇌 장벽(BBB)을 통과하여 미엘린에 대한 면역 반응을 유발함으로써, 탈수초성 플라크가 형성됩니다. 이러한 면역 매개성 공격은 중추신경계(CNS) 내의 염증성 및 신경독성 경로를 통해 축삭 손상과 신경퇴행을 유발합니다.

현재의 치료법을 형성하는 주요 시판 치료제

  • 오크레리주맙(OCREVUS) - Roche사 : OCREVUS는 CD20 양성 B세포를 특이적으로 표적으로 삼도록 설계된 인간화 단일클론 항체입니다. CD20 양성 B세포는 다발성 경화증(MS)에서 장애의 주요 원인인 미엘린 및 축삭 손상을 유발하는 데 핵심적인 역할을 하는 것으로 여겨집니다. 전임상 연구에 따르면, OCREVUS는 특정 B세포 표면의 CD20 단백질에 결합하는 반면, 조혈모세포나 형질세포에는 영향을 미치지 않으므로, 면역계의 중요한 기능을 유지할 수 있을 가능성이 있습니다.
  • 알렘츠주맙(LEMTRADA) - 사노피(Sanofi) : CD52를 표적으로 하는 세포 용해성 단일클론 항체로, 17세 이상의 환자를 대상으로 재발-완화형 다발성 경화증(RRMS)(활동성 이차 진행형 다발성 경화증 포함)의 치료제로 승인되었습니다. 이러한 위험 프로파일 때문에 일반적으로 지금까지 적어도 두 가지 종류의 다발성 경화증 치료에 충분한 반응을 보이지 않은 환자에게만 사용됩니다. LEMTRADA는 그 안전성 프로파일로 인해 일과성 뇌증(CIS) 환자에게는 사용이 권장되지 않습니다.
  • 시포니모드(MAYZENT) - 노바티스 : MAYZENT는 스핑고신-1-인산(S1P) 수용체의 선택적 조절제로, S1P1 및 S1P5 아형을 표적으로 합니다. S1P1 수용체에 결합함으로써 림프절에서 림프구의 유출을 억제하고, 이를 통해 중추신경계(CNS)로의 림프구 침윤을 제한하여 다발성 경화증(MS)의 염증을 완화합니다. 또한, MAYZENT는 혈액-뇌 장벽(BBB)을 통과하여 아스트로사이트와 올리고덴드로사이트에 존재하는 S1P5 수용체와 상호작용합니다. 전임상 MS 모델에서, 이러한 상호작용은 중추신경계(CNS) 내에서 신경 보호 효과 및 재수초화 효과를 나타낼 가능성이 있음을 시사합니다.

게다가

전반적으로, 다발성 경화증(MS) 분야에서는 바이오의약품의 출시, 자가항체 검사를 통한 진단 정확도 향상, 그리고 질환에 대한 인지도 제고가 2022년부터 2036년까지 주요 7개국의 MS 시장에서 꾸준한 성장을 견인할 것으로 예상되며, 이는 이미 시판 중인 제품과 개발 중인 파이프라인 모두에게 큰 상업적 의미를 가질 것으로 전망됩니다.

  • 주요 7개국 중 미국은 MS 시장 규모가 가장 크며, 2025년에는 약 180억 달러로 평가되었습니다.
  • 치료 동향에서 최근 가장 중요한 변화는 기존의 항염증제에 그치지 않고, 다발성 경화증(MS)의 장기적인 진행을 억제하는 데 초점을 맞추고 있다는 점입니다. 오크레리주맙(OCREVUS)이나 오파툼맙(KESIMPTA)과 같은 고효능 DMT가 주요 시장 전반에서 여전히 표준 치료법으로 자리 잡고 있지만, 특히 BTK 억제제와 같은 차세대 후보 약물의 등장은 큰 도약을 의미합니다. 이러한 첨단 경구용 약물은 혈액-뇌 장벽(BBB)을 통과하여 중추신경계(CNS) 내의 면역 세포를 조절함으로써, 신경 퇴행을 지연시키고 환자의 장기적인 기능적 예후를 개선하는 것을 목표로 하고 있습니다.
  • 단일클론 항체(mAb) : mAb는 재발-완화형 다발성 경화증(RRMS) 및 이차 진행형 다발성 경화증(aSPMS)에 적응증이 있지만, 중대한 안전성 문제가 있으므로 일과성 뇌병증(CIS)에 대한 사용은 권장되지 않습니다. 미국에서는 자가면역, 수액 반응, 악성 종양 등의 심각한 위험이 있으므로, LEMTRADA 위험 평가 및 완화 전략(REMS) 프로그램에 따라 그 사용이 제한되고 있습니다. 확고한 3상 임상시험 데이터가 있음에도 불구하고, 그 위험 프로필과 엄격한 모니터링 요건으로 인해 사용은 여전히 제한적입니다. 사노피가 전 세계 개발권을 보유하고 있으며, 바이엘은 매출액에 기반한 로열티를 받고 있습니다.
  • CD20 표적 치료 : 오파투무맙(KESIMPTA) 등의 CD20 표적 치료는 다발성 경화증(MS) 관리에 있어 고효능 B세포 제거 전략으로의 중요한 전환을 상징합니다. KESIMPTA는 환자 스스로 투여할 수 있는 피하 주사제로서, 정맥내 투여 옵션에 필적하는 임상적 유효성을 제공할 뿐만 아니라 환자의 편의성이라는 추가적인 장점도 갖추고 있습니다. 현재 소아 다발성 골수종(RMS)을 대상으로 한 3상 임상시험이 진행 중이며, 이는 강력한 질병 관리와 유연한 투여의 균형을 맞추는 것을 통해 맞춤형 의료에 대한 중요성이 높아지고 있음을 반영하고 있습니다.

자주 묻는 질문

  • 2025년 주요 7개국의 다발성 경화증(MS) 시장 규모는 어떻게 되나요?
  • 2026년부터 2036년까지 주요 7개국의 MS 시장 성장률은 어떻게 예상되나요?
  • 2025년 미국 내 다발성 경화증(MS) 확진 환자 수는 얼마인가요?
  • 현재 FDA에서 승인된 다발성 경화증(MS) 치료제는 어떤 것들이 있나요?
  • 다발성 경화증(MS)의 진단 과정은 어떻게 이루어지나요?
  • 다발성 경화증(MS) 치료의 현황은 어떤가요?
  • 다발성 경화증(MS) 환자의 성별 분포는 어떻게 되나요?

목차

제1장 주요 인사이트

제2장 소개

제3장 다발성 경화증 : 시장 개요

제4장 주요 요약

제5장 주요 사건

제6장 질환 배경과 개요 : 다발성 경화증(MS)

제7장 역학 및 시장 조사 방법

제8장 역학 및 환자 인구

제9장 환자 경과

제10장 시판 치료제

제11장 개발중인 치료법 : 다발성 경화증(MS)

제12장 MS : 주요 7개국 시장 분석

제13장 KOL의 견해

제14장 미충족 수요

제15장 SWOT 분석

제16장 시장 진입 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

Multiple Sclerosis (MS) Insights and Trends

  • According to DelveInsight's analysis, the MS market across the 7MM was valued at approximately USD 22 billion in 2025 and is projected to expand at a Compound Annual Growth Rate of 3.5%, reflecting steady growth driven by the anticipated entry of advanced therapies and improved clinical management.
  • In 2025, the United States accounted for approximately 950,000 diagnosed prevalent cases of MS, while the total cases across the 7MM reached 1,700,000 cases, representing a substantial patient base driving the demand for advanced disease-modifying therapies (DMTs).
  • Current FDA-approved DMTs, such as ocrelizumab (OCREVUS) by Roche, alemtuzumab (LEMTRADA) by Sanofi, siponimod (MAYZENT) by Novartis, diroximel fumarate (VUMERITY) by Biogen, and cladribine (MAVENCLAD) by Merck KGaA, focus on controlling inflammatory mechanisms to reduce relapses and delay disability. These therapies are tailored to various stages of MS to improve long-term patient outcomes.
  • 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.
  • The MS pipeline is robust, transitioning toward innovative mechanisms that address both inflammation and neurodegeneration. Key investigational candidates include remibrutinib (LOU064) by Novartis, frexalimab (SAR441344) by Sanofi, tolebrutinib (SAR442168) by Sanofi, and vidofludimus calcium (IMU-838) by Immunic Therapeutics, signaling a shift toward more effective, next-generation interventions.
  • While MS cannot yet be cured, various treatments are available to reduce the frequency and intensity of relapses and to slow long-term disease progression. For managing acute relapses, corticosteroids are the standard approach-most notably IV methylprednisolone, which is widely used to shorten the duration and impact of flare-ups.
  • Significant treatment gaps persist, notably around diagnostic challenges and misdiagnosis. Accurate diagnosis remains complex due to nonspecific symptoms and over interpretation of Magnetic Resonance Imaging data. Limited awareness and access to specialized neurological care, especially advanced imaging, delay accurate diagnosis. Improving diagnostic precision is a critical unmet need to ensure appropriate and timely treatment initiation.

Multiple Sclerosis (MS) Market size and forecast

  • 2025 MS Market Size in the 7MM: USD 22 billion
  • MS Growth Rate (2026-2036) in the 7MM: 3.5% CAGR

DelveInsight's 'Multiple Sclerosis (MS) - Market Insights, Epidemiology and Market Forecast - 2036' 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, Spain, Italy, and France), the United Kingdom, and Japan.

The MS market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, MS patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across the 7MM regions. The report highlights key unmet medical needs in MS and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Geography Covered:

North America: The United States

Europe: Germany, France, Italy, Spain and the United Kingdom

Asia-Pacific: Japan

Multiple Sclerosis (MS) Understanding and Treatment Algorithm

Multiple Sclerosis (MS) Overview and Diagnosis

MS is a lifelong and unpredictable disease that affects individuals differently. While some experience mild symptoms, others develop progressive disability, though most go through cycles of relapses and recovery. Common early signs include vision problems, muscle weakness, numbness, and balance issues, with fatigue and cognitive or mood changes emerging over time. Women are more frequently affected than men. Although MS is rarely fatal, it can significantly impact quality of life, making early diagnosis and timely treatment crucial, especially with newer therapies that can help slow disease progression.

Diagnosing MS is challenging, as there is no single definitive test. Instead, clinicians use a combination of clinical evaluation and diagnostic tools to rule out other conditions and confirm the disease. The process typically begins with a detailed medical history, physical examination, and neurological assessment to evaluate symptoms and nerve function. MRI of the brain and spinal cord plays a key role in identifying demyelinating lesions, often with the use of contrast dye to detect active inflammation. Additional tests, such as a lumbar puncture to assess cerebrospinal fluid, evoked potentials to measure nerve signal responses, and optic nerve evaluations, help strengthen the diagnosis and ensure a comprehensive assessment.

Multiple Sclerosis (MS) Treatment Landscape

Treatment of MS is guided by disease stage and severity, with current FDA-approved DMTs such as orelizumab (OCREVUS) by Roche and siponimod (MAYZENT) by Novartis primarily targeting inflammatory processes to reduce relapses and delay disability progression. While these therapies have significantly improved patient outcomes, they have limitations in fully addressing neurodegeneration and long-term disability. This has driven the development of next-generation treatments. Emerging candidates like remibrutinib (LOU064) by Novartis, frexalimab (SAR441344) by Sanofi, and vidofludimus Calcium (IMU-838) by Immunic therapeutics aim to offer more comprehensive disease control by targeting both inflammation and neurodegenerative mechanisms.

Multiple Sclerosis (MS) Unmet Needs

The section "unmet needs of MS" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Lack of curative therapies and challenges in addressing progressive neurodegeneration

2. Absence of FDA-approved treatments with exclusivity for pediatric MS

3. Long-term disability progression

4. Diagnostic challenges and risk of misdiagnosis

5. Limited progress in biomarker development

6. Lack of approved therapies for Non-active Secondary Progressive Multiple Sclerosis (SPMS)

Multiple Sclerosis (MS) Epidemiology

Key Findings from Multiple Sclerosis (MS) Epidemiological Analysis and Forecast

  • As of 2025, the diagnosed prevalent population of MS across the 7MM is estimated at approximately 1.5 million cases, reflecting the significant burden of the disease across major markets.
  • The United States represents the largest share in 2025, with nearly 950,000 cases, driven by advanced diagnostics and higher disease awareness.
  • The combined EU4 and the UK contribute around 700,000 cases, with the UK accounting for approximately 140,000 cases, making it the largest individual European segment in 2025.
  • By 2025, females in the United States are disproportionately affected by MS, with an estimated approx. 700,000 diagnosed cases, while the number of diagnosed males is significantly lower, at around 250,000.

Multiple Sclerosis (MS) Drug Analysis & Competitive Landscape

The MS drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I to Phase III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the MS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the MS therapeutics market.

Approved Therapies for Multiple Sclerosis (MS)

Ocrelizumab and Hyaluronidase-ocsq (OCREVUS ZUNOVO): Roche

Ocrelizumab and Hyaluronidase-ocsq (OCREVUS ZUNOVO) is a humanized monoclonal antibody (mAb) that selectively targets CD20-positive B cells-an immune cell type believed to play a significant role in the damage of myelin and axons, which can lead to disability in individuals with MS. Preclinical studies indicate that OCREVUS binds to CD20 proteins found on specific B cells, but not on stem or plasma cells, potentially preserving essential immune functions.

  • In September 2024, the US Food and Drug Administration (FDA) approved OCREVUS ZUNOVO as the first and only SC injection administered twice a year in just 10 min for adults with relapsing and progressive forms of MS.
  • In April 2024, OCREVUS ZUNOVO subcutaneous formulation was introduced in the EU as the first and only twice-yearly, 10-minute injection for treating Relapsing Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS).

Multiple Sclerosis (MS) Pipeline Analysis

Tolebrutinib (SAR442168): Sanofi

It is an investigational oral Bruton's tyrosine kinase (BTK) inhibitor engineered to penetrate the brain and remain bioactive within the central nervous system, aiming to target smoldering neuroinflammation major contributor to disability progression in MS. Unlike traditional MS therapies that focus on peripheral inflammation, tolebrutinib crosses the blood-brain barrier to reach therapeutic levels in the cerebrospinal fluid, enabling it to modulate both B cells and disease-associated microglia.

  • Tolebrutinib (SAR442168) is also being evaluated in the Phase III PERSEUS trial for PPMS, with results anticipated in late 2025 and a potential regulatory submission planned for 2026.
  • In March 2025, the US FDA accepted tolebrutinib for priority review to treat MS, particularly non-relapsing secondary progressive MS (nrSPMS), with a decision expected by September 2025 and a parallel review underway in the EU by Sanofi.

Multiple Sclerosis (MS) Key Players, Market Leaders and Emerging Companies

  • Roche
  • Sanofi
  • Novartis
  • Biogen
  • Merck KGaA
  • AB Science
  • Clene Nanomedicine
  • InnoCare and more

Multiple Sclerosis (MS) Drug Updates

  • On January 2025, National Institute for Health and Care Excellence (NICE) approved natalizumab, administered via injection or infusion, for adults with RRMS.
  • In January 2026, the US FDA approved a generic glatiramer acetate injection for the treatment of MS, expanding access to more affordable therapy options for patients.
  • In February 2026, Roche announced that its fenebrutinib met its primary endpoint in a late-stage clinical trial for the treatment of MS.

Multiple Sclerosis (MS) Market Outlook

MS is the most common primary demyelinating disease of the CNS, with the potential to progress to significant neurological disability. Though its pathogenesis remains unclear, current evidence suggests an autoimmune response targeting myelin antigens. Autoreactive T and B cells cross the BBB and initiate immune responses against myelin, leading to the formation of demyelinating plaques. These immune-mediated attacks result in axonal damage and neurodegeneration through both inflammatory and neurotoxic pathways within the CNS.

Key marketed therapies shaping current management

  • Ocrelizumab (OCREVUS) - Roche: OCREVUS is a humanized mAb engineered to specifically target CD20-positive B cells, which are believed to play a central role in causing myelin and axonal damage-key factors contributing to disability in MS. Preclinical research suggests that OCREVUS binds to CD20 proteins on select B cells while sparing stem cells and plasma cells, potentially preserving essential immune system functions.
  • Alemtuzumab (LEMTRADA) - Sanofi: A CD52-targeting cytolytic mAb, is approved for treating RRMS -including active secondary progressive MS -in patients aged 17 and older. Due to its risk profile, it is typically reserved for those who have not responded adequately to at least two prior MS therapies. LEMTRADA is not recommended for use in patients with CIS because of its safety profile.
  • Siponimod (MAYZENT) - Novartis: MAYZENT is a selective modulator of sphingosine 1-phosphate (S1P) receptors, targeting S1P1 and S1P5 subtypes. By binding to the S1P1 receptor, it restricts lymphocyte exit from lymph nodes, thereby limiting their infiltration into the CNS and reducing inflammation in MS. Additionally, MAYZENT crosses the Blood Brain Barrier (BBB) and interacts with S1P5 receptors located on astrocytes and oligodendrocytes. In preclinical MS models, this engagement has demonstrated potential neuroprotective and remyelinating properties within the CNS.

And more

Overall, in MS, the launch targeted biologics, improved diagnosis through autoantibody testing, and increasing disease awareness are expected to drive steady growth in the 7MM MS market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.

  • Among the 7MM, the United States accounted for the largest MS market size, which was valued at nearly USD 18 billion in 2025.
  • The most meaningful recent shift in the treatment landscape has been the focus on addressing the long-term progression of MS by shifting beyond traditional anti-inflammatory agents. While high-efficacy DMTs like ocrelizumab (OCREVUS) and ofatumumab (KESIMPTA) remain the standards of care across key markets, the emergence of next-generation candidates specifically BTK inhibitors represents a significant leap. These advanced oral agents aim to cross the BBB and modulate immune cells within the CNS to potentially slow neurodegeneration and improve long-term functional outcomes for patients.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Multiple Sclerosis (MS) (2022-2036 Forecast)

The MS treatment landscape is strategically structured between managing acute relapses with anti-inflammatory corticosteroids and long-term disease modification using various DMTs. While acute therapies focus on quick functional recovery, long-term management is essential for reducing relapse frequency and slowing disability progression. The market is increasingly shifting toward high-efficacy and innovative emerging therapies that aim to preserve neurological function and improve the overall Quality of Life (QoL) for patients through 2036.

  • Monoclonal Antibodies (mAb): mAb indicated for RRMS and aSPMS, but is not recommended for CIS due to significant safety concerns. Its use is restricted under the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program in the US due to serious risks including autoimmunity, infusion reactions, and malignancies. Despite robust Phase III data, its utilization remains limited by its risk profile and stringent monitoring requirements. Sanofi holds global development rights, while Bayer receives sales-based royalties.
  • CD20-Directed Therapies: CD20-directed therapies, such as ofatumumab (KESIMPTA), represent a significant shift toward high-efficacy B-cell depletion strategies in MS management. As a self-administered subcutaneous injection, KESIMPTA offers clinical efficacy comparable to intravenous options with the added benefit of patient convenience. Currently under Phase III investigation for pediatric RMS, it reflects the growing emphasis on individualized care by balancing potent disease control with flexible administration.

Multiple Sclerosis (MS) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the MS drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The emergence of next-generation therapies is significantly expanding the treatment paradigm in MS. A transformative asset in this space is ocrelizumab and hyaluronidase-ocsq (OCREVUS ZUNOVO), developed by Roche. This humanized mAb selectively targets CD20-positive B cells to mitigate myelin and axonal damage while preserving essential immune stem cells. By leveraging the ENHANZE drug delivery platform, it utilizes recombinant human hyaluronidase PH20 (rHuPH20) to temporarily enhance tissue permeability, allowing for efficient subcutaneous absorption. Positioned to offer patients greater administration flexibility without compromising efficacy, OCREVUS ZUNOVO is anticipated to have a Medium-Fast uptake trajectory, signaling a significant shift toward more convenient and individualized disease management.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Multiple Sclerosis (MS)

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Multiple Sclerosis (MS) therapies Price Scenario & Trends

Pricing and analogue assessment of MS therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of Multiple Sclerosis (MS) Approved Drugs

Ocrelizumab (OCREVUS) - The US list price of ocrelizumab (OCREVUS), a therapy approved for the treatment of MS, is nearly USD 78,000, reflecting its status as a high-cost specialty medication used to manage both relapsing and primary progressive forms of the disease.

Industry Experts and Physician Views for Multiple Sclerosis (MS)

To keep up with MS market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the MS emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts engaged with 10+ key opinion leaders (KOLs) across major markets to capture country-level insights in MS Leading centers such as University of California and Royal College of Physicians, among others, were consulted to validate clinical practices, treatment patterns, and emerging therapeutic perspectives.

Their opinion helps understand and validate current and emerging MS, therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for Market access, therapy adoption, and pipeline prioritization in MS.

Qualitative Analysis: SWOT and Attribute Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and attribute analysis.

In the SWOT analysis of MS, 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. Attribute analysis analyzes 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.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of MS, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on 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 in shaping and driving the 7MM MS market.

Report Insights

  • Multiple Sclerosis (MS) Patient Population Forecast
  • Multiple Sclerosis (MS) Therapeutics Market Size
  • Multiple Sclerosis (MS) Pipeline Analysis
  • Multiple Sclerosis (MS) Market Size and Trends
  • Multiple Sclerosis (MS) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-Based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • Multiple Sclerosis (MS) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by Geography)
  • Multiple Sclerosis (MS) Treatment Addressable Market (TAM)
  • Multiple Sclerosis (MS) Competitive Landscape
  • Multiple Sclerosis (MS) Major Companies Insights
  • Multiple Sclerosis (MS) Price trends and Analogue Assessment
  • Multiple Sclerosis (MS) Therapies Drug Adoption/Uptake
  • Multiple Sclerosis (MS) Therapies Peak Patient Share analysis

Report Assessment

  • Multiple Sclerosis (MS) Current Treatment Practices
  • Multiple Sclerosis (MS) Unmet Needs
  • Multiple Sclerosis (MS) Clinical Development Analysis
  • Multiple Sclerosis (MS) Emerging Drugs Product Profiles
  • Multiple Sclerosis (MS) Market Attractiveness
  • Multiple Sclerosis (MS) Qualitative Analysis (SWOT and Attribute analysis)

FAQs:

Market Insights

  • What was the MS market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of MS?
  • What are the disease risks, burdens, and unmet needs of MS? What will be the growth opportunities across the 7MM concerning the patient population with MS?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of MS? What are the current guidelines for treating MS in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the MS market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/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.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Multiple Sclerosis (MS) Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of MS by Therapies in the 7MM in 2025
  • 3.2. Market Share (%) Distribution of MS by Therapies in the 7MM in 2036

4. Executive Summary

5. Key Events

6. Disease Background and Overview: MS

  • 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 on Patient Burden in MS
  • 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 Therapies

  • 10.1. Competitive Landscape: Marketed Drugs
  • 10.2. Ocrelizumab OCREVUS: Roche
    • 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. Ocrelizumab and Hyaluronidase-ocsq (OCREVUS ZUNOVO): Roche
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Clinical Trials Information
    • 10.3.4. Safety and Efficacy
  • 10.4. Alemtuzumab (LEMTRADA): 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. Siponimod (MAYZENT): Novartis
    • 10.5.1. Product Description
    • 10.5.2. Regulatory Milestones
    • 10.5.3. Clinical Trials Information
    • 10.5.4. Safety and Efficacy
  • 10.6. Diroximel Fumarate (VUMERITY): 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. Cladribine (MAVENCLAD): 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. Peginterferon Beta-1a (PLEGRIDY): 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. Ozanimod ZEPOSIA: 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. Ponesimod (PONVORY): Vanda Pharmaceuticals/Juvise 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. Ofatumumab (KESIMPTA): 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. Ublituximab-xiiy (BRIUMVI):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. Monomethyl Fumarate (BAFIERTAM): 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. Pipeline Therapies: MS

  • 11.1. Competitive Landscape: 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
    • 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. MS: 7MM Market Analysis

  • 12.1. MS Market Key Findings and Insights
  • 12.2. Key Market Forecast Assumptions
    • 12.2.1. Cost Assumptions and Rebates
    • 12.2.2. Pricing Trends
    • 12.2.3. Analogue Assessment
    • 12.2.4. Launch Year and Therapy Uptake
  • 12.3. Market Outlook
  • 12.4. Attribute Analysis
  • 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. 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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