The multiple sclerosis (MS) market is experiencing significant growth, driven by an increase in the disease’s prevalence, earlier diagnosis, and improved access to care. Advancements in disease-modifying therapies (DMTs) and the emergence of novel treatments, such as Bruton’s tyrosine kinase (BTK) inhibitors, are enhancing treatment options, particularly for progressive forms of MS, which have fewer existing therapies.
Multiple sclerosis is an autoimmune disorder where the immune system attacks the protective covering of nerves in the brain and spinal cord, disrupting the flow of signals between the brain and body. This causes symptoms like fatigue, muscle weakness, vision problems, and difficulty with mobility. The severity of the disease varies, and as of 2024, there were approximately 1.6 million diagnosed MS cases globally. The number of cases is expected to grow at a rate of 1.4% annually from 2025 to 2034.
The landscape of MS treatment has changed dramatically, with greater personalization in care and more options available. While a cure for MS remains elusive, the expansion of DMTs and innovative treatment delivery methods are helping improve patient outcomes and quality of life. Currently, high-dose intravenous corticosteroids, particularly methylprednisolone, are the primary treatment for acute MS relapses. These are typically followed by a tapering course of oral steroids.
Disease-modifying therapies, which are used for long-term management, aim to reduce relapse frequency and delay disability progression. While older injectable treatments like PLEGRIDY are still in use, newer oral therapies such as MAYZENT, VUMERITY, and MAVENCLAD offer greater convenience and potentially improved patient adherence. High-efficacy monoclonal antibodies (mAbs) like OCREVUS, KESIMPTA, and BRIUMVI are increasingly preferred for home-based therapy. However, treatments like LEMTRADA remain limited due to safety concerns and regulatory restrictions.
As older MS treatments such as TYSABRI and GILENYA face generic competition, pharmaceutical companies are shifting focus to next-generation treatments and formulations to maintain market share. Supportive therapies also play a crucial role in MS management. Rehabilitation through exercise and physiotherapy helps improve mobility, while cognitive behavioral therapy (CBT) and mindfulness strategies address mood disorders like depression and anxiety. Lifestyle changes, including improved diet, sleep hygiene, and vitamin D intake, also contribute to symptom control. Assistive devices and occupational therapy further promote patient independence.
Despite advances in treatment, there is still a significant gap in therapies that protect nerves or repair the damage caused by MS. Current drugs focus on immune modulation but do not address neurodegeneration or halt disease progression. Early diagnosis remains a challenge, as MS symptoms can be nonspecific, and reliable biomarkers are still lacking. There is a pressing need for tools to detect MS early, as well as therapies targeting neurodegeneration.
The MS treatment pipeline is robust, with promising candidates targeting new mechanisms such as BTK inhibition and neuroprotection. Drugs like Remibrutinib, Tolebrutinib, Fenebrutinib, and CNM-Au8 are leading the charge. Tolebrutinib, an oral BTK inhibitor, is designed to target both B cells and microglia in the brain, reducing neuroinflammation and slowing disease progression. In March 2025, the U.S. FDA accepted Tolebrutinib for priority review as a treatment for non-relapsing secondary progressive MS. A decision is expected by September 2025, with evaluations also underway in Europe.
Other pipeline drugs, including Vidofludimus calcium, Fenebrutinib, and Remibrutinib, are focused on targeting immune regulation and protecting nerve cells. Vidofludimus, currently in Phase III trials for relapsing MS, has shown positive results for progressive MS patients. Fenebrutinib is notable for being the only reversible BTK inhibitor in late-stage MS trials, while Remibrutinib is an oral BTK inhibitor still in early stages for MS treatment. CNM-Au8, which addresses mitochondrial dysfunction in MS, is also being evaluated in ongoing trials.
The anticipated approval of these therapies will reshape the MS treatment landscape, offering new hope for patients and medical professionals alike. Experts predict that these innovative treatments will improve patient outcomes and pave the way for further medical advancements. The MS market is expected to grow from USD 20 billion in 2024 to USD 30 billion by 2034, driven by the introduction of these cutting-edge therapies and the rising prevalence of the disease. Factors such as genetics, lifestyle, and environmental factors like the Epstein-Barr virus contribute to the increasing number of MS cases.
Related Topics:
