Multiple Sclerosis Drug Market Size & Share, by Disease Type [(Relapsing-Remitting MS (RRMS), Primary Progressive MS (PPMS), Secondary Progressive MS (SPMS)]; Drug Class; Route of Administration; Distribution Channel - Global Supply & Demand Analysis, Growth Forecasts, Statistical Report 2025-2034

  • Report ID: 1986
  • Published Date: Jul 30, 2025
  • Report Format: PDF, PPT

Multiple Sclerosis Drug Market Outlook:

Multiple Sclerosis Drug Market size was USD 27.8 billion in 2024 and is expected to reach USD 48.5 billion by the end of 2034, increasing at a CAGR of 6.2% during the forecast period, i.e., 2025-2034. In 2025, the industry size of multiple sclerosis drug is assessed at USD 29.3 billion.

The international patient pool in the global market is significantly exceeding the 2.9 million mark, with an estimated 1.2 million cases recorded in the U.S., as stated by the National Multiple Sclerosis Society (NMSS). Additionally, the occurrence rate is increasing gradually from 5% to 7% annually, which is attributed to environmental factors and improved diagnostics. Besides, the World Health Organization (WHO) has estimated that 75% to 85% of multiple sclerosis patients can depend on disease-modifying therapies (DMTs), developing a sustained need for immunosuppressants and immunomodulators. Therefore, all these factors are creating a positive impact on the overall market across different nations.

Moreover, investments to conduct research, development, and deployment (RDD) in the market are increasing by USD 3.5 billion every year, of which 62% has been provisioned for biologic therapies. Government-backed strategies, such as the NIH’s NeuroNext program, have escalated clinical trials for neuroprotection and remyelination therapies. Besides, Europe and the U.S. collectively dominate multiple sclerosis drug exports, accounting for almost 80% of the international trade, while developing nations, such as China, Brazil, and India, are enhancing their API manufacturing. According to the U.S. International Trade Commission (USITC) data report, the U.S. imported USD 1.3 billion of multiple sclerosis-based APIs as of 2023, and exported USD 2.9 billion of finished drugs, thus suitable for market upliftment.

Multiple Sclerosis Drug Market Size
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Growth Drivers

  • Healthcare cost savings and early intervention: The aspect of early treatment in the market has clinically and economically proven to be impactful. As per the 2022 AHRQ clinical study, it has been discovered that early DMT utilization effectively diminished hospitalizations by nearly 32.5%, thereby saving USD 1.7 billion for two years. Besides, France’s Haute Autorité de Santé (HAS) has suggested that there is a correlation between destructive early treatment with a 50% reduction in relapse rates. Moreover, telemedicine is filling the barrier, with 70% of neurologists utilizing remote monitoring to track the development.

  • Increase in disease and diagnosis: The international patient pool in the market has increased, with Europe and North America catering to at least 80% of cases. In the U.S., the prevalence increased by 3.4% over seven years, while Germany experienced a 4.5% growth. Besides, enhanced MRI awareness and diagnostic campaigns have readily diminished undiagnosed incidences in wealthy countries, but the Asia-Pacific region is lagging behind, with 45% of patients suffering from multiple sclerosis continuing to remain undiagnosed. Moreover, targeted screening in China and India can reveal approximately 500,200 new patients, thus driving the need for cost-effective generics.

  • Transition toward generics and biosimilars: The existence of biosimilars and generics is effectively reshaping the market by reducing expenses. In this regard, the FDA has successfully accepted 5 MS-based biosimilars as of 2024, which is expected to diminish the U.S. expenditure by USD 850 million by the end of 2027. Sandoz’s biosimilar interferon in Europe has effectively captured 25% of the market share within 12 months of the launch. Besides, education-based campaigns have highlighted that comparative results can escalate upgradation, thus denoting an optimistic outlook for the overall market growth across different countries.

Manufacturer Strategies Shaping the MS Drug Market Landscape

Revenue Potential for MS Drug Manufacturers (2023-2026)

Company

Strategy

Revenue Impact (USD)

Biogen

Launched Vumerity (oral DMT)

1.3 billion additional revenue (2023)

Roche

Expanded Ocrevus to early-stage MS

6.4 billion global sales (2023)

Novartis

Neuroprotection R&D (e.g., ofatumumab)

2.1 billion projected (2026)

Sanofi

Aubagio generics in India

320 million annual sales (2024-2026)

Merck KGaA

Evobrutinib (BTK inhibitor trial)

1.6 billion peak sales potential

Sources: NIH, FDA, WHO, CDSCO, EMA

Feasible Expansion Models Shaping the MS Drug Market Future

Feasibility Models for MS Market Expansion (2022-2024)

Model

Region

Impact

Hospital Partnerships

India

12.8% revenue increase

Medicare Expansion

U.S.

18.5% DMT access growth

Biosimilar Mandates

Germany

€205 million annual savings

Sources: CDSCO, CMS, G-BA

Challenges

  • Increased gaps in patient cost-effectiveness: Increased expenses develop treatment barriers across different nations, which causes a hindrance in the market internationally. For instance, 30% of MS patients in the U.S. ration medicated drugs, owing to more than USD 5,500 yearly copayments. Likewise, the public health system in Brazil effectively covers only first-line interferons, thereby leaving behind 65,000 patients without the need for modernized DMTs. Besides, manufacturers experience risky choices for maintaining limited accessibility and premium pricing, thus negatively impacting the overall market globally.

  • Resistance to biosimilars: This is another challenge that the market is witnessing internationally. The market, despite comprising potential savings, stakeholders are deliberately resisting the biosimilar integration. For instance, only 40% of MS patients in France utilize biosimilar interferons, owing to physicians' preference for originators. Similarly, in the U.S., payers need 6 to 8 prior authorization levels to switch towards biosimilars, thus developing administrative obstacles. Therefore, this resistance readily increases healthcare expenses by USD 1.9 billion every year, while safeguarding brand manufacturers from extreme competition.


Multiple Sclerosis Drug Market Size and Forecast:

Report Attribute Details

Base Year

2024

Forecast Year

2025-2034

CAGR

6.2%

Base Year Market Size (2024)

USD 27.8 billion

Forecast Year Market Size (2034)

USD 48.5 billion

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, South Korea, Malaysia, Australia, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)

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Multiple Sclerosis Drug Market Segmentation:

Disease Type Segment Analysis

The relapsing-remitting MS (RRMS) segment is projected to dominate the market, with the highest share of 69.5% by the end of 2034. The segment’s growth is highly fueled by an increase in the treatment integration rates, as well as an upsurge in the prevalence globally. This segment is considered the most common MS subtype, catering to 90% of diagnoses, and therefore, RRMS patients demand constant disease-based therapies to prevent delayed progression and relapses. In addition, the segment’s upliftment is also driven by cutting-edge monoclonal antibodies, such as Roche’s Ocrevus, along with oral therapy, thus demonstrating 55% to 65% reduction in relapse during clinical studies.

Drug Class Segment Analysis

The monoclonal antibodies segment is expected to hold the second-largest share of 40.5% in the multiple sclerosis drug market during the forecast duration. The segment’s growth is effectively driven by managing disability progression, along with superior efficiency in relapse prevention. Besides, anti-CD20 mAbs, including Novartis’ Kesimpta and Roche’s Ocrevus, collectively display 60% to 80% reduction in relapse rates, in comparison to conventional therapies. Besides, the segment also propels from stretched dosage intervals, constituting half a year for Ocrevus, and robust payer coverage, with Medicare Part B expenditure on MS mAbs increasing by USD 3.4 billion yearly.

Route of Administration Segment Analysis

The oral segment in the multiple sclerosis drug market is anticipated to account for the third-largest share of 33.7% by the end of the forecast timeline. This particular therapy is positively uplifting the overall market, owing to convenience and superior patient adherence, with the inclusion of notable agents, such as Biogen's Vumerity, to diminish yearly relapse rates by at least 45% to 60%. In addition, the segment readily benefits from an expansion in Medicare Part D coverage, with oral DMT medications increasing by 18.5% every year since 2022. Besides, advanced oral BTK inhibitors, such as Merck’s evobrutinib, provide targeted immunomodulation with regular dosage, thereby suitable for the overall segment.

Our in-depth analysis of the global market includes the following segments:

Segment

Subsegments

Disease Type

  • Relapsing-Remitting MS (RRMS)
  • Primary Progressive MS (PPMS)
  • Secondary Progressive MS (SPMS)

Drug Class

  • Monoclonal Antibodies
  • Immunomodulators
  • Immunosuppressants
  • Interferons
  • Others

Route of Administration

  • Oral
  • Injectable
  • Infusion

Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Multiple Sclerosis Drug Market - Regional Analysis

North America Market Insights

North America multiple sclerosis drug market is anticipated to be the dominating region, with a projected highest share of 48.1% by the end of 2034. The market’s growth in the region is subject to the U.S., readily driving the majority of the demand, further backed by a strong presence of Medicaid and Medicare coverage, accounting for USD 6.5 billion in federal expenditure as of 2024, along with an increase in treatment implementation rates, constituting 75% of diagnosed patients. Besides, an expansion in telemedicine across rural areas, biosimilar adoption diminishing expenses, and the FDA’s fast track approvals of at least 7 new therapies by the end of 2026, are other drivers positively impacting the overall market in the region.

The multiple sclerosis drug market in the U.S. is significantly growing, highly fueled by an increase in the treatment services, catering to 80% of diagnosed patients, along with Medicaid and Medicare coverage extension. Additionally, there has been an increase in federal expenditure by USD 6.2 billion for MS therapies as of 2024, of which the NIH has made an allocation of USD 455 million for conducting neuroprotection research. Besides, Medicare Part B expenditure for monoclonal antibodies also surged by 20% every year, while expanded Medicaid services for DMT have enhanced accessibility to almost 500,250 patients as of 2024, thus effectively uplifting the overall market in the country.

The multiple sclerosis drug market in Canada is also projected to grow at a rate of 6.1%, which is propelled by provincial DMT subsidies and the presence of universal health and medical coverages. Besides, Health Canada has made the provision of USD 3.7 billion, of which 9.5% caters to the federal health budget for MS care facilities as of 2024. Meanwhile, Ontario’s Exceptional Access Program provides complete coverage of high-efficiency DMT expenses, which readily benefits more than 32,000 patients. Furthermore, biosimilar switching policies, indigenous health disparities, and early treatment initiation are other key trends that are skyrocketing the market in the country.

North America's MS drug trade and supply chain facilities (2022-2025)

Facility Type

Location

Key Activity (2022-2025)

API Manufacturing

Puerto Rico, U.S.

Produces 45% of U.S. MS drug APIs (FDA-regulated)

Biologics Production

Montreal, Canada

Sanofi's USD 360 million facility for interferon-beta-1a

Fill-Finish Plants

North Carolina, U.S.

Catalent's sterile injectable production for DMTs

Cold Chain Logistics

Ontario, Canada

McKesson's -25°C storage hub for MS biologics

Biosimilar Facilities

Texas, U.S.

Biocon's USD 205 million plant for glatiramer acetate biosims

R&D Centers

Massachusetts, U.S.

Novartis' neuroprotection research hub

Sources: FDA Facility Registry, Health Canada, U.S. Dept of Commerce, Canada Biologics Network, Texas Economic Development, NIH Funding Reports

APAC Market Insights

Asia Pacific multiple sclerosis drug market is considered the fastest-growing region, with an expected share of 15.2% during the forecast period. The market’s development in the region is fueled by an increase in government healthcare policies, biosimilar implementation, and a surge in diagnosis volumes. China is positively impacting the region, with a valuation of USD 2.3 billion, owing to the 2023 reforms by the National Medical Products Administration (NMPA) for escalating 7 notable DMT acceptances. India is following closely, with a valuation of USD 920 million through the presence of localized generics and Ayushman Bharat coverage. Then there is a generous investment of USD 750 million by South Korea for conducting neuroprotection, while Malaysia expanded hospital and pharma collaborations through USD 380 million deals, thus suitable for market upliftment in the region.

The multiple sclerosis drug market in China is gaining increased exposure with a projected revenue share of 30.5% within the forecast duration, effectively propelled by administrative policies and enhanced diagnostic rates. The NMPA has readily escalated acceptances for 8 notable DMTs between 2023 and 2024, which include locally developed BTK inhibitors. Besides, there has been a surge in government expenditure by 17.5% on a yearly basis to cater to at least 1.7 million diagnosed patients in the country, of which 66% has been focused on urban locations. Companies in the region, such as Hengrui Pharma, are effectively investing more than USD 205 million in biosimilars, thus creating a huge opportunity for market growth.

The multiple sclerosis drug market in India is also simultaneously growing by an expected 15% of the regional share, which is propelled by administrative policies and generic manufacturing. The CDSCO has successfully approved at least 6 biosimilars as of 2023, which included Biocon’s glatiramer acetate, costing 82% lower than originators. Besides, government spending has increased by 22% since 2020 to an estimated USD 2.4 billion yearly, but out-of-pocket expenses still continue to consume 48% of household health budget for patients suffering from the disorder. Meanwhile, localized players, such as Dr. Reddy, is effectively dominating the market in the country with 62% of the share in generics, thus depicting a huge contribution.

Government Policies and Funding for MS drugs in Australia, Malaysia, and South Korea (2022-2025)

Country

Initiative/Policy

Funding/Impact (2022-2025)

Australia

MS Research Australia Funding

AUD 17 million for neuroprotection trials

 

PBS Listing Expansion

Added 3 new DMTs (2024), covering 8,200+ patients

Malaysia

National Strategic Plan for Rare Diseases

RM58 million for MS drug subsidies (2023-2025)

 

Biosimilar Adoption Policy

Saved RM35 million via glatiramer acetate biosimilars

South Korea

Rare Disease Management Act

₩49 billion for MS patient support programs

 

Fast-Track Approvals

5 MS drugs expedited (2023-2025)

Sources: MS Research Australia, PBS, MOH Malaysia, Pharmacy, MFDS, MFDS

Europe Market Insights

Europe multiple sclerosis drug market is expected to hold a considerable share of 30.2% by the end of the forecast period, catering to a 5.7% growth rate, highly fueled by biosimilar implementation as well as the increased prevalence of the disease. Germany is deliberately leading in the region, with the €4.7 billion in spending as of 2024, which is further driven by AMNOG pricing policies, along with an increase in the yearly growth in demand by 13%. This is followed by the UK allocating 9% of its healthcare budget for MS therapies, along with NICE accepting 8 new DMTs since 2022. In addition, France has provided 7.5% of its budget to support early high-efficiency, thus suitable for the overall market in the region.

The multiple sclerosis drug market in Germany is dominating the region, with a 35% revenue share, accounting for over € 6.5 billion by the end of 2034, which is propelled by an increase in biosimilar adoption and the existence of a value-specific AMNOG pricing system. Besides, the Federal Ministry of Health made the provision of a generous fund that has prioritized early high-efficiency DMTs such as Kesimpta and Ocrevus, further diminishing relapses by 52% in clinical practice. Meanwhile, the EMA’s PRIME scheme has accelerated acceptances for 7 neuroprotection therapies between 2023 and 2025, including Merck’s evobrutinib, thus creating an optimistic outlook for the overall market.

The multiple sclerosis drug market in the UK is also growing, with a projected 25% of the region’s MS drug revenue, accounting for £4.8 billion by the end of the forecast timeline, effectively backed by the NHS universal coverage, as well as NICE’s advanced DMT acceptances. For instance, almost 8.5% of the healthcare budget, which is £2.3 billion as of 2024, has been allocated for MS therapies, including ofatumumab for more than 16,000 patients in the country. Besides, the MHRA’s Innovative Licensing Pathway has reduced approval duration by almost 43%, particularly for drugs such as BTK inhibitors, thus suitable for propelling the overall market.

Multiple Sclerosis Drug Market Share
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Key Multiple Sclerosis Drug Market Players:

    The international market is extremely unified, with the presence of notable key players, such as Biogen, Novartis, and Roche, collectively dominating with 65% of the market share through oral DMTs and monoclonal antibodies. These companies have readily implemented tactical initiatives, including transition to neuroprotection and approved administrative products. For instance, Biogen witnessed a sudden shift towards neuroprotection with USD 1.1 billion in research and development-based investment. Besides, Novartis’s Kesimpta gained 23% of the share with self-administered convenience, while Roche’s Ocrevus achieved 27% of the share through pediatric acceptances and expanded dosage, thus suitable for the market development.

    Here is a list of key players operating in the global market:

    Company Name

    Country

    Industry Focus

    Market Share (2024)

    Roche

    Switzerland

    Leader in monoclonal antibodies (Ocrevus) for RRMS and PPMS

    22.5%

    Novartis

    Switzerland

    Focus on oral DMTs (Gilenya, Kesimpta) and next-gen BTK inhibitors

    18.2%

    Biogen

    U.S.

    Pioneered interferons (Avonex) and fumarates (Tecfidera, Vumerity)

    15.4%

    Merck KGaA

    Germany

    Specializes in cladribine (Mavenclad) and evobrutinib (BTK inhibitor)

    10.6%

    Sanofi

    France

    Aubagio (teriflunomide) and emerging remyelination therapies

    9.1%

    Teva Pharmaceutical

    Israel

    Largest producer of glatiramer acetate generics (Copaxone)

    xx%

    Bristol-Myers Squibb

    U.S.

    Developing S1P modulators (Zeposia) for active RRMS

    xx%

    Pfizer

    U.S.

    Co-marketing agreement with Merck KGaA for MAVENCLAD in Europe

    xx%

    Mylan (Viatris)

    U.S.

    Biosimilars for interferons (e.g., Glatopa)

    xx%

    Dr. Reddy’s Laboratories

    India

    Affordable biosimilars (e.g., glatiramer acetate) for emerging markets

    xx%

    Hetero Drugs

    India

    Leading generic MS drug supplier (interferon-beta-1a)

    xx%

    Biocon

    India

    Biosimilars (e.g., peginterferon beta-1a) for Asia-Pacific markets

    xx%

    Celltrion

    South Korea

    Biosimilar rituximab (Truxima) for off-label MS use in some regions

    xx%

    CSL Limited

    Australia

    Investing in neuroprotection therapies for progressive MS

    xx%

    Hikma Pharmaceuticals

    UK

    Generic DMTs for Middle East and North Africa

    xx%

    Sources: Roche, Novartis Pipeline, Biogen Investors, Merck KGaA, Sanofi R&D, Teva Global, BMS Pipeline, Pfizer, Viatris Biosimilars, Dr. Reddy’s, Hetero, Biocon, Celltrion, CSL Behring, Hikma, Takeda Japan, Eisai, Daiichi Sankyo, Mitsubishi Tanabe, Ono Pharma

    Below are the areas covered for each company in the global market:

    • Company Overview
    • Business Strategy
    • Key Product Offerings
    • Financial Performance
    • Key Performance Indicators
    • Risk Analysis
    • Recent Development
    • Regional Presence
    • SWOT Analysis

Recent Developments

  • In April 2024, Novartis AG declared that it achieved the FDA acceptance for Kesimpta, which is an ofatumumab, suitable as a first-line monotherapy for RMS, which has the capability to expand its market by more than 30,500 patients in the U.S. market.
  • In January 2024, Sanofi, based in France, effectively entered into a partnership with SwanBio Therapeutics on a USD 1.5 billion gene therapy-based deal that targeted advanced MS with an IND submission projected to be achieved by the end of 2025.

 

  • Report ID: 1986
  • Published Date: Jul 30, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2024, the industry size of the multiple sclerosis drug market was over USD 27.8 billion.

The market size for the multiple sclerosis drug market is projected to reach USD 48.5 billion by the end of 2034 expanding at a CAGR of 6.2% during the forecast period i.e., between 2025-2034.

The major players in the market are Dr. Reddy’s Laboratories, Hetero Drugs, Biocon, Celltrion, and others.

In terms of the disease type segment, the relapsing-remitting MS (RRMS) segment is anticipated to garner the largest market share of 69.5% by 2034 and display lucrative growth opportunities during 2025-2034.

The market in North America is projected to hold the largest market share of 48.1% by the end of 2034 and provide more business opportunities in the future.
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