Multiple Sclerosis Drugs Market Size, Share & Industry Analysis, By Drug Class (Immunomodulators, Immunosuppressants, Interferons, and Others), By Route of Administration (Oral and Injection {Intramuscular, Subcutaneous, and Intravenous}), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy), and Regional Forecast, 2024-2032

The global multiple sclerosis drugs market size was valued at USD 21.33 billion in 2023 and is projected to grow from USD 21.16 billion in 2024 to USD 38.94 billion by 2032, exhibiting a CAGR of 7.9% during the forecast period (2024-2032). Multiple Sclerosis (MS) is an immune-mediated disease that affects the central nervous system. It is characterized by inflammation, demyelination, and degenerative changes such as progressive brain and spinal cord atrophy along with neuroaxonal loss. The number of people with multiple sclerosis across the globe increased from 2.3 million in 2013 to 2.8 million in 2020, according to the Multiple Sclerosis International Federation. The increasing prevalence of this relapsing remitting MS and primary progressive MS disease has increased the demand for effective diagnosis and treatment of multiple sclerosis globally. Hence, governments are actively supporting the treatment of multiple sclerosis.

The growth is attributed to the increasing focus on R&D to develop innovative drugs by major market players. For instance, in December 2020, Adamas Pharmaceuticals Inc. announced results from the phase 3 clinical study on ADS-5102, an investigational amantadine agent for treating MS patients. Product launches, increasing government initiatives to improve the accessibility of treatment & care, and the rising prevalence of multiple sclerosis are expected to result in the global market expansion.

The emergence of COVID-19 slowed the demand for multiple sclerosis drugs due to lower patient volumes going for the disease diagnosis and delays in treatment processes. Key players in the market experienced slow growth in their revenues due to the COVID-19 pandemic. The reallocation of healthcare resources for COVID-19 treatment, fewer people going for the disease diagnosis, and supply chain disruptions impacted the sales of these drugs for the treatment of MS.

The market experienced slow growth in 2021 as well. However, compared to the previous year, hospitals and clinics experienced increased patient volume for the diagnosis and treatment of multiple sclerosis, which partially regularized the sales of multiple sclerosis drugs worldwide in 2021. Moreover, the market is estimated to recover in 2022, showing significant growth compared to the prior year.

Multiple Sclerosis Drugs Market Trends

Shift Toward Monoclonal Antibodies for Disease Treatment to Boost Market Expansion

Monoclonal antibodies are now increasingly employed for the treatment of multiple sclerosis. Various companies are focused on developing novel multiple sclerosis drugs using these antibodies. Moreover, most of the immunosuppressive drugs used for treating this disease are humanized monoclonal antibodies, whose demand is increasing worldwide. Ocrevus, launched in March 2017 by F. Hoffmann-La Roche Ltd., became one of the blockbuster drugs generating a revenue of USD 5.56 billion in 2021, further expanding the market.

Moreover, a TG Therapeutics, Inc. product Ublituximab (for relapsing multiple sclerosis disease indication) is currently in its phase 3 trial. The expected completion date of the trial is January 2023. The rapid adoption of immunosuppressive drugs, increased market penetration, and advancements in the production of monoclonal antibody drugs resulted in the rise in use of monoclonal antibodies. This led to the global multiple sclerosis drugs market growth during the forecast period.

Moreover, several market players are focusing on receiving regulatory approvals and launching drugs belonging to the monoclonal antibodies category for treating multiple sclerosis.

• In February 2024, F. Hoffmann-La Roche Ltd. introduced Ocrevus (ocrelizumab), a monoclonal antibody drug in the Indian market to treat multiple sclerosis.

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Multiple Sclerosis Drugs Market Growth Factors

Significant R&D Investment by Market Players to Boost Market Growth

Research & development on neurological therapy has always been active for the past decade. Various novel molecules are being investigated for the treatment of multiple sclerosis. Some of the key pharmaceutical companies emphasize on the improvement of disabilities associated with multiple sclerosis. The pipeline portfolio of various companies includes the agents with different mechanisms of action, which is expected to boost their demand from physicians, aiming to change the treatment algorithm in the coming years.

The market is witnessing considerable clinical research and R&D investment attraction. Many pharmaceutical companies increased their focus on developing novel therapies for MS treatment.

• For instance, Sanofi is conducting a phase III clinical trial for Tolebrutinib, for the treatment of relapsing forms of MS (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS). The expected submission dates by Sanofi for this drug for the given indications are 2024 and 2025, respectively.


• Similarly, in May 2019, Biogen announced the outcomes of the phase 3 trial of EVOLVE-MS-1 (diroximel fumarate) for treating multiple sclerosis. The study result indicated that the drug candidate has significantly reduced the disease activity.

Increased research on various novel candidates resulted in reinforcing the pipeline portfolio of small-scale and leading pharmaceutical companies. The launch of these pipeline candidates is anticipated to drive the market growth of these type of drugs in the coming years.

Proactive Government Support and Recommendations to Fuel Market Growth

The global burden of multiple sclerosis is increasing at an alarming rate and becoming a concern for healthcare providers and governments. The rising prevalence of the disease has forced governments of many countries to take proactive measures through guidelines and recommendations. Apart from this, various awareness initiatives are being launched by government associations to educate patients regarding different treatment options available.

• For instance, the German MS Society (DMSG) has 3 to 4 initiatives in Germany to help people with MS in the country. It organizes a World MS Day competition on 31^st May every year to eliminate the accessibility barriers and broaden the supporter base for people with multiple sclerosis.

Governments of various countries, such as the U.S. and the U.K., have laid recommendations on using multiple drugs available to treat MS.

• For example, in June 2018, the National Institute of Health and Care Excellence (NICE) released recommendations for beta interferons such as Avonex, Betaferon, Extavia, Rebif, and glatiramer acetate (Copaxone). Such suggestions and treatment guidelines have increased awareness regarding various treatment options available, which is one of the key reasons driving the market growth.

In addition, some government authorities are funding multiple sclerosis research to develop innovative therapies that will address fundamental issues and gaps in multiple sclerosis. Therefore, increasing government focus on spreading awareness regarding the disease and its effective treatment is estimated to propel the market growth during the forecast period.

RESTRAINING FACTORS

High Cost of Drugs to Hamper Product Adoption

Despite the increased government interventions and various treatment options for MS, the cost of multiple sclerosis drugs remains a significant challenge to the market growth. The high pricing of the drugs makes it inefficient to address the unmet needs of affected populations. Also, the Institute for Clinical and Economic Review (ICER) analyst found that treatment of multiple sclerosis with the help of monoclonal antibodies is not cost-effective.

Multiple sclerosis (MS) is considered an expensive disease. DMTs are considered to be a highly effective treatment option. However, a significant rise in out-of-pocket costs for DMTs leads to lower adherence and improper disease management. In addition, the high cost of DMT negatively impacts patients through excessive restrictions by insurance companies.  

• For instance, as per the data published by WebMD LLC in October 2023, as of February 2022, the median yearly cost of disease-modifying therapy approached around USD 94,000.

According to the National Multiple Sclerosis Society, the price of MS medication is rising gradually. From 2013 to 2018, the median price increased by more than USD 20,000. This steady increase in the costs associated with MS treatment is anticipated to hamper the growth in the number of MS patients opting for its treatment.

Multiple Sclerosis Drugs Market Segmentation Analysis

By Drug Class Analysis

New Product Launches to Accelerate the Growth of the Immunomodulators Segment

On the basis of drug class, the market is segmented into immunomodulators, immunosuppressants, interferons, and others.

The immunomodulators segment dominated the market in 2021 and is estimated to hold a significant market share throughout the forecast period. More treatment options within immunomodulators and new product launches for the disease treatment are responsible for its growth.

• For instance, in January 2020, Novartis announced the approval of Mayzent (siponimod) by the European Commission (EC) for the cure of adult patients with Secondary Progressive Multiple Sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. Moreover, the high demand for immunomodulatory drugs for MS treatment is expected to propel the segment growth.

Also, some of the market players are undergoing strategic acquisitions and partnerships to expand the drug pipeline for treating multiple sclerosis.

• In February 2022, Equillium, Inc. acquired Bioniz Therapeutics to expand its immunology pipeline with an expanded portfolio of immunomodulatory drugs.

The others segment includes antineoplastics and molecular antibody products. Molecular antibodies have become one of the most efficient treatments for reducing relapses and inflammation in MS patients. This is the first treatment for primary progressive MS and is being explored as reparative/remyelinating agents. There are many molecular antibody drugs in the pipeline. The approval of these products is expected to boost the market in the coming years.

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By Route of Administration

Injection Segment to Depict Highest Share Owing to Rising Drug Approvals

Based on the route of administration, the market is bifurcated into oral and injection. The injection segment is sub-segmented into intramuscular, subcutaneous, and intravenous.

The injection segment accounted for the maximum market share in 2023 and is expected to grow substantially during the forecast period. The high growth of the segment is due to increasing number of multiple sclerosis drug approvals as injections for subcutaneous use in disease treatment. 

• For instance, in August 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved Kesimpta (ofatumumab) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS) to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

However, the oral segment is estimated to grow at the fastest CAGR during the forecast period. The launch of new products, increasing regulatory approvals and the shift toward oral drugs are the key factors contributing to the expansion of the oral segment.

• For instance, in January 2020, Bristol Myers Squibb announced the launch of Zeposia, which is now the lowest-priced oral drug available for MS in the market. This is expected to give significant momentum to the oral segment during the forecast period.


• Similarly, in October 2019, Biogen and Alkermes plc. revealed that the U.S. FDA has approved Vumerity (diroximel fumarate), an oral drug formulation, for the treatment of multiple sclerosis.

By Distribution Channel Analysis

Hospital Pharmacy to Dominate the Market Owing to Favorable Health Reimbursement

The market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy in terms of distribution channel. The hospital pharmacy segment is anticipated to dominate the market throughout the forecast period, owing to favorable health reimbursement and increased government efforts to strengthen the government hospital pharmacies.

Moreover, the online pharmacy segment is poised to experience lucrative growth due to the increasing number of online portals distributing prescription drugs across the globe. Moreover, due to the outbreak of COVID-19, lockdown restrictions were imposed globally to control the spread of the virus. This increased the need for home delivery of medicines, thereby spurring segmental growth.

REGIONAL INSIGHTS

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The market size in North America stood at USD 10.28 billion in 2023. Primary factors responsible for the region’s dominant multiple sclerosis drugs market share include increasing R&D investment, new product launches, and rising demand for immunosuppressant and molecular antibody drugs.

In addition, governments in the region actively undertake initiatives to generate awareness regarding the treatment and diagnosis of MS. In the U.S., the month of March is recognized as Multiple Sclerosis Awareness Month, which is supported by government associations such as the Multiple Sclerosis Association of America through educational activities. These government initiatives for increasing awareness regarding multiple sclerosis and its treatment among the population are anticipated to fuel the considerable sclerosis market growth in North America.

In addition, some non-profit organizations are offering funding for research projects related to multiple sclerosis. For instance, in August 2022, the National Multiple Sclerosis Society invested USD 19.0 million to initiate 40 new multiple sclerosis research projects, ultimately leading to the development of effective therapy for multiple sclerosis.

Europe is estimated to be the second-most prominent region in terms of revenue in 2021 owing to active government recommendations and favorable health reimbursement policies. Moreover, the increasing prevalence of the condition across the region is expected to boost MS drugs demand further, thereby augmenting the market growth.

The market in Asia Pacific is likely to register the highest CAGR during the forecast period. This significant growth rate is attributable to the improved distribution networks of pharmaceutical companies in emerging economies. Also, the collaboration of Biogen and Eisai Co., Ltd. in January 2018 to co-promote Tecfidera, Tysabri, and Avonex in Japan would accelerate the multiple sclerosis treatment market growth in Asia Pacific. Moreover, growing government initiatives in many countries to reduce the cost of treatment pertaining to MS is another significant factor boosting demand for MS drugs across the region.

The market is projected to expand in the Middle East & Africa and Latin America. This is due to the rising prevalence of neurological diseases and improving healthcare spending.

List of Key Companies in Multiple Sclerosis Drugs Market

Market Players with Strong Focus on Expansion of Multiple Sclerosis Drugs Portfolio to Hold Key Market Share

Biogen and F. Hoffman-La Roche Ltd. are the prominent players in the market and accounted for a significant market share in 2023.

Biogen dominated the market in 2023. This dominance is attributed to the company’s strong focus on getting approvals for the commercialization of multiple sclerosis drugs to boost its revenue.

• For instance, in April 2021, Biogen announced that the European Commission (EC) granted the marketing approval for subcutaneous injection of TYSABRI (natalizumab) to treat relapsing-remitting MS. This approval expanded the company’s therapeutic portfolio for MS.

Other significant players, including Novartis AG, Sanofi, and Merck KGaA are increasing their emphasis on receiving approval from regulatory bodies for MS drugs to expand their product portfolio and strengthen their presence in the global market.

LIST OF KEY COMPANIES PROFILED:

• Biogen (U.S.)


• Pfizer Inc. (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Novartis AG (Switzerland)


• Merck & Co., Inc. (U.S.)


• Sanofi (France)


• Teva Pharmaceutical Industries Ltd. (Israel)


• Janssen Pharmaceuticals, Inc. (Johnson & Johnson Corporation) (U.S.)


• Bristol-Myers Squibb Company (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• August 2023 - The U.S. FDA approved the first biosimilar drug, Tyruko (natalizumab), to treat the relapsing forms of multiple sclerosis.


• January 2022 – Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc., announced the completion of their collaboration transaction.


• July 2021 – Biogen Inc. and InnoCare Pharma Limited announced their license and collaboration for Orelabrutinib, an oral small molecule for the potential treatment of multiple sclerosis.


• April 2021 – Biogen announced that the European Commission (EC) granted the marketing approval for subcutaneous injection of TYSABRI (natalizumab) to treat relapsing-remitting MS.


• March 2021 – Janssen Pharmaceutical, Inc. announced the U.S. FDA approval of Ponvory, an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of MS. Ponvory has higher efficiency in reducing annualized relapse rates compared to Aubagio. With the addition of this product to the portfolio, the company expanded its product offerings to treat MS.


• May 2019 – Teva Pharmaceutical Industries Ltd. launched its drug product Copaxone in the pre-filled autoinjector YpsoMate from Ypsomed.

REPORT COVERAGE

The market research report provides a detailed competitive landscape. It focuses on key points such as new product launches in the market. Additionally, it includes the prevalence of multiple sclerosis and key industry developments such as partnerships, mergers, and acquisitions. Furthermore, the report covers regional analysis of different segments, and company profiles of key market players. The report consists of qualitative and quantitative insights that contribute to the market growth.

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Report Scope & Segmentation