U.S. Multiple Sclerosis Drugs Market Size, Share & COVID-19 Impact 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 Forecast, 2023-2030

The U.S. multiple sclerosis drugs market size was valued at USD 9.86 billion in 2022. The market is projected to grow from USD 9.45 billion in 2023 to USD 14.10 billion by 2030, exhibiting a CAGR of 5.9% during the forecast period.

Multiple Sclerosis (MS) disables the normal functioning of the central nervous system (brain and spinal cord). In patients suffering from MS, the immune system harms myelin, which is the protective sheath covering nerve fibers. Such attacks by the body’s immune system can lead to communication problems between the brain and the rest of the body, leading to degradation or permanent damage to the nerve fibers. Treatment through multiple sclerosis drugs lowers the relapse rate and slows the new lesion formation. These drugs also effectively reduce the risk of brain atrophy and disability accumulation.

The rising prevalence of multiple sclerosis in the country has been fueling the demand for these drugs for effective treatment. For instance, as per data published by the National Multiple Sclerosis Society, in 2019, around one million people were affected by the disease.

Moreover, the market’s increasing focus on R&D for the development of effective therapeutics is expected to fuel the market growth during the forecast period. For instance, Immunic AG has been conducting a clinical trial of IMU-838 to study its efficacy in treating multiple sclerosis. The drug is currently in the Phase 3 trial which is expected to be completed by September 2024.

COVID-19 IMPACT

Slowed Market Growth During the COVID-19 Outbreak Due to Lockdown Restrictions

The outbreak of COVID-19 slowed the U.S. multiple sclerosis drugs market growth in 2020. The lockdown restrictions and supply chain disruption limited the availability of these drugs. Moreover, the decline in the number of patients visiting hospitals and clinics for disease diagnosis and treatment also resulted in the slow growth of the market.

However, in 2021, the number of patients visiting doctors in clinics and hospitals increased, but the overall U.S. market experienced a decline in market value. The decline in the market growth during the forecast period was due to patent expiry and increased competition in the U.S. market.

LATEST TRENDS

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Significant Increase in Government Initiatives to Create Awareness among the Population about Effective Treatment Options

The prevalence of multiple sclerosis has been significantly increasing in the country. To manage the severity of the disease and to provide effective treatment, the U.S. government has been focusing on initiatives to spread awareness about the disease.

• For instance, Can Do Multiple Sclerosis (Can Do MS), a non-profit organization based in the U.S. launched an initiative named ‘MS Path 2 Care’ to provide support to patients suffering from MS in the country.

Moreover, the U.S. government is involved in collecting data regarding the burden of the disease in the country. This would help them in effectively planning diagnosis and treatment initiatives for patients.

• The National Multiple Sclerosis Society of the U.S. formed the ‘Multiple Sclerosis Prevalence Workgroup’ in order to produce a scientifically and economically feasible MS prevalence estimate. The workgroup is held responsible for preparing epidemiological data regarding disease prevalence in the country.

DRIVING FACTORS

Increasing Product Approvals and Launches for MS Treatment to Fuel Market Growth

The burden of the disease has been increasing significantly in the country. The increasing MS burden increased the demand for effective treatment. In order to provide effective treatment to the increasing patient population, market players increased their focus on the development, approval, and launch of multiple sclerosis drugs.

• For instance, in March 2021, J&J announced the U.S. FDA approval of Ponvory as a daily oral drug for the treatment of multiple sclerosis.

Moreover, market players have increased their focus on the development of new effective treatments for MS.

• For instance, Hoffmann-La Roche has been working on the clinical trial to study the safety and efficacy of Fenebrutinib on disability progression in adult participants with primary progressive multiple sclerosis (PPMS). The study is currently in phase 3 trial and the expected completion is in 2026.

The approval and commercialization of such effective treatments for MS is expected to fuel the market growth in the country.

RESTRAINING FACTORS

Limitations Associated with Diagnosis and Treatment Processes to Limit Market Growth 

For the effective treatment results of the multiple sclerosis drugs, it is very important that the diagnosis is conducted with high accuracy. As this is very important to understand the type of MS so that on the basis of disease type, drugs can be prescribed.

However, frequent errors occurring in the diagnosis leads to irreversible progression of the disease condition. Also, delay in the diagnosis owing to the poor patient awareness about rare diseases often complicates the condition.

Moreover, limited clinical expertise for multiple sclerosis screening in emerging economies may result in poor patient outcomes, and can affect the results of management of cognitive symptoms by non-pharmacological approach.

Even after diagnosis, poor support networks for multiple sclerosis can make patients feel isolated. Wider system challenges such as limited resources for information and poor follow-up or psychological care can affect patient health.

Such factors tend to limit the market growth in the country.

SEGMENTATION

By Drug Class Analysis

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Increasing Number of Pipeline Drugs and New Product Launches to Drive Immunomodulators Segment Dominance

Based on drug class, the market is segregated into immunomodulators, immunosuppressants, interferons, and others.

The immunomodulators segment accounted for the maximum U.S. multiple sclerosis drugs market share in 2022. The dominance of the segment is attributed to the strong sales of drugs such as Mavenclad and Tecfidera. Moreover, market players’ increasing focus on the development of immunomodulator drugs for MS treatment has also been fueling the segment growth.

• For instance, Clene Nanomedicine in collaboration with George Clinical has been conducting clinical trials to study the efficacy of CNM-Au8 in the treatment of relapsing MS. The approval of this drug in the U.S. would fuel the growth of the segment in the country.

Moreover, the immunosuppressants segment is expected to grow at a fastest CAGR. The growth of the segment is attributed to the increasing number of clinical trials proving the efficacy of such drug class in the treatment of multiple sclerosis, thus leading to increased product launches.

Furthermore, the others segment includes antineoplastics and monoclonal antibody drugs. The segment is expected to grow at a substantial CAGR during the forecast period. Monoclonal antibody drugs are proven to be quite effective. This factor has been fueling its demand.

By Route of Administration Analysis

High Efficiency Associated with Use of Continuous Flow Devices to Surge Injection Segment Growth

Based on the route of administration, the market is bifurcated into oral and injection.

The injection segment held a significant market share in 2022. This is due to the increasing number of product launches enhancing the multiple sclerosis product portfolio in the region.

• For instance, in August 2020, the U.S. Food and Drug Administration (FDA) approved Kesimpta in the form of injection for subcutaneous use for the treatment of Relapsing forms of Multiple Sclerosis (RMS).

Moreover, the oral segment is expected to grow at a substantial CAGR. The growth of the segment is due to the increasing demand for oral tablets as an effective prescription medication for multiple sclerosis as well as frequent approvals from the U.S. FDA.

By Distribution Channel Analysis

Hospitals Pharmacy to Register Highest Share Owing to Demand for Surgical Procedures

In terms of distribution channel, the market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. The hospital pharmacy segment is expected to grab maximum market share. High shares of the segment is attributable to the inclination of the patient population toward hospital pharmacies for drugs for treating MS due to the presence of well trained staff, reducing medication errors, and medication related risk to patients.

The online pharmacy is expected to grow at the fastest CAGR. The high growth rate is majorly due to increasing number of online portals offering discounts on medication delivery. 

• For instance, in November 2020, after the launch of Amazon’s online pharmacy that will allow customers to buy prescription medicines, the company stated that Amazon Prime members are eligible for free two-day delivery and discounts of up to 80% on generic medicines and 40% on prescribed brand-name drugs. Hence, such offers are attracting customers to buy drugs from online pharmacies, thereby augmenting segmental growth.

KEY INDUSTRY PLAYERS

Companies with Strong Sales to Hold Key Market Share

Biogen and F. Hoffmann-La Roche Ltd. are among the prominent players in the market and captured a considerable U.S. market share in 2022.

Biogen accounted for a significant market share. The dominance of the company is attributed to the strong sales of its products - Tecfidera, Vumerity, and others. Moreover, the company’s increasing focus on getting approvals for commercialization of multiple sclerosis drugs has also been fueling its growth.

• In October 2019, Biogen and Alkermes plc announced that the U.S. Food and Drug Administration (FDA) approved VUMERITY (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis.

Other players in the market, such as Teva Pharmaceutical Industries Ltd., Bristol-Myers Squibb Company, and Pfizer Inc., have been focusing on R&D for the development and commercialization of these drugs.

LIST OF KEY COMPANIES PROFILED:

• Biogen (U.S.)
• Teva Pharmaceuticals LTD. (Israel)
• Merck KGaA (Germany)
• Sanofi (France)
• Novartis AG (Switzerland)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Pfizer Inc. (U.S.)
• Janssen Pharmaceuticals, Inc. (Johnson & Johnson Corporation) (New Jersey)
• Bristol-Myers Squibb Company (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2022 – Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc. announced the completion of their collaboration transaction.
• September 2022 – Abbott acquired Walk Vascular, LLC. Walk Vascular, LLC is a medical device company involved in the development of minimally invasive mechanical aspiration thrombectomy system to eliminate blood clots.
• 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.
• October 2020 – Lupin announced the U.S. FDA approval of dimethyl fumarate capsules as a generic version of Tecfidera for the treatment of multiple sclerosis.
• October 2020 – Janssen Pharmaceuticals, Inc. announced the acquisition of Momenta Pharmaceuticals, Inc., specializing in the research and development of novel therapies for immune-mediated diseases.

REPORT COVERAGE

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The market research report provides a detailed competitive landscape. It includes the prevalence of multiple sclerosis and key industry developments such as partnerships, mergers, and acquisitions. Additionally, it focuses on key points such as new product launches in the market. Furthermore, the report covers a regional analysis of different segments, company profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists quantitative and qualitative insights that contribute to the market growth.

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