DelveInsight’s “Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast 2034” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Multiple Sclerosis market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
The Multiple Sclerosis market report covers emerging drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Key highlights from the Multiple Sclerosis Market Report:
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In 2023, there were approximately 1.2 million prevalent cases of multiple sclerosis (MS) across the 7MM (United States, EU4, UK, and Japan). The increase in MS cases is attributed to enhanced diagnostic capabilities and screening, limited access to genetic counseling and family planning, and low public awareness.
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Among current treatments for MS, Ocrevus is anticipated to achieve the largest market share in the US by 2034. The overall MS therapeutic market is expected to experience significant growth at a robust compound annual growth rate (CAGR) due to the anticipated approval of new therapies, improved diagnostic methods, and increased research and development in pharmaceutical treatments.
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In August 2024, ImmPACT Bio received FDA clearance to start clinical trials for its CD19/CD20 bispecific CAR-T cell therapy in multiple sclerosis (MS) patients.
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In Jan 2024, Kyverna’s KYV-101 Receives U.S. FDA Clearance for Treatment of Patients With Refractory, Progressive Multiple Sclerosis in the KYSA-7 Phase 2 Trial
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In March 2022, Pipeline Therapeutics announced that it is all set to commence the Phase Ib/IIa clinical trial of its lead program, PIPE-307, to treat relapsing-remitting multiple sclerosis (RRMS) patients. The move comes after the company obtained clearance for its investigational new drug application from the US Food and Drug Administration (FDA) to launch the trial.
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In June 2022 the Food and Drug Administration (FDA) extended the review period for the Biologics License Application (BLA) for ublituximab for the treatment of patients with relapsing forms of multiple sclerosis (RMS).The new Prescription Drug User Fee Act (PDUFA) target date is December 28, 2022. The FDA extended the goal date to allow time to review additional clinical information that was deemed to be a major amendment to the application.
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In June 2022, Tiziana Life Sciences reported positive clinical results from the second patient with Secondary Progressive Multiple Sclerosis (SPMS) in the ongoing study as part of an expanded access program at the Brigham and Women’s Hospital (BWH), Boston, MA. These results confirmed the previously reported data, from the first SPMS patient after three months of treatment of the first SPMS patient. The treatment with foralumab, a fully human anti-CD3 monoclonal antibody, was well-tolerated and improved clinical and PET imaging analyses.
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In June 2022, Pasithea Therapeutics Corp. announced its acquisition of Alpha-5 integrin, LLC (“Alpha-5”), a privately-held preclinical-stage company developing a monoclonal antibody (mAbs) for the treatment of amyotrophic lateral sclerosis (“ALS”) and other neuroinflammatory disorders, such as Multiple Sclerosis (“MS”).
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In April 2021, Samsung Biologics and TG announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody.
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On March 28, 2019, the US FDA approved OCREVUS (ocrelizumab) to treat adult patients with relapsing forms of MS and PPMS. This is the first drug approved by the FDA for PPMS.
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On October 30, 2019, Biogen Inc. and Alkermes announced the US FDA approval of VUMERITY (diroximel fumarate) to treat MS. The approval was based on a New Drug Application (NDA) submitted under the 505(b) (2) filing pathway. It included data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera to establish bioequivalence and relied, in part, on the FDA’s findings of safety and efficacy for Tecfidera.
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Multiple Sclerosis Overview
Multiple Sclerosis (MS) is an autoimmune disease that affects the central nervous system, where the immune system mistakenly attacks myelin, the protective coating of nerve fibers. This results in neurological impairment during episodes that can be followed by periods of remission. Damage to myelin causes scar tissue (sclerosis), which disrupts nerve impulses between the brain and spinal cord.
MS typically begins in a person’s late 20s, with symptoms including visual and sensory disturbances, limb weakness, gait issues, and bladder and bowel dysfunction. Initial symptoms may partially improve, but the disease can lead to progressive disability over time. MS can manifest in various physical, emotional, and psychological symptoms, differing in severity among individuals.
The four main types of MS are:
1. Relapsing-Remitting MS (RRMS)
2. Secondary-Progressive MS (SPMS)
3. Primary-Progressive MS (PPMS)
4. Progressive-Relapsing MS (PRMS)
Diagnosing MS is complex and involves ruling out other conditions. It typically includes a thorough medical history, physical examination, and neurological assessment. Diagnostic tests may include:
– MRI scans of the brain and spinal cord to identify MS lesions, sometimes using contrast dye.
– Lumbar puncture (spinal tap) to examine cerebrospinal fluid for markers of MS and rule out other conditions.
While there is no cure for MS, various treatments can improve long-term outcomes. Treatment goals focus on reducing relapses, slowing disease progression, and maintaining functionality. Disease-modifying therapies (DMTs) are used to manage the underlying immune disorder and are primarily approved for relapsing forms of MS. Adherence to DMTs can be challenging, highlighting the need for better persistence with treatment strategies.
Overall, managing MS involves comprehensive care to improve quality of life and mitigate disease progression.
Multiple Sclerosis Epidemiology Assessment
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pool, future trends, and views of key opinion leaders.
Multiple Sclerosis Epidemiology Insights:
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In 2023, there were approximately 728,000 prevalent cases of multiple sclerosis (MS) in the United States, with significant changes expected by 2034.
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In Germany, the prevalence of MS was about 61,000 cases in males and 150,000 cases in females in 2023.
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In the UK, there was a notable disparity in MS cases based on phenotype. Relapsing-Remitting MS (RRMS) was significantly more common than Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), and Primary Progressive MS (PPMS). In 2023, there were around 80,000 cases of RRMS, with these numbers anticipated to fluctuate throughout the study period from 2020 to 2034.
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France reported approximately 79,000 prevalent cases of MS in 2023, with further changes expected by 2034.
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Japan had about 5,000 prevalent cases of MS in 2023, and these numbers are also anticipated to fluctuate by 2034.
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According to DelveInsight’s analysts, in the US, there were 37 cases of MS among individuals aged 0-18 and approximately 728,000 cases in those aged 19 and older in 2023. These numbers are projected to evolve over the study period from 2020 to 2034.
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In the EU4 and the UK, Germany reported the highest number of MS cases, with around 210,000 prevalent cases in 2023. This figure is also expected to change during the study period from 2020 to 2034.
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In Spain, the prevalence of MS subtypes in 2023 included 826 cases of Clinically Isolated Syndrome, 34,786 cases of Relapsing-Remitting MS (RRMS), 7,205 cases of Secondary Progressive MS (SPMS), and 3,075 cases of Primary Progressive MS (PPMS). DelveInsight’s projections indicate that these numbers will increase during the forecast period from 2024 to 2034.
Multiple Sclerosis Therapies
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Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, Bayer HealthCare Pharmaceuticals, Novartis, Biogen, Genentech
Multiple Sclerosis Therapies
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GILENYA (Fingolimod), Vumerity (Diroximel fumarate), OCREVUS (Ocrelizumab)
Learn How the Multiple Sclerosis Market Will Evolve and Grow by 2034 @ https://www.delveinsight.com/report-store/multiple-sclerosis-market
Multiple Sclerosis Treatment Market
The current treatment approach for multiple sclerosis (MS) primarily aims to slow disease progression and manage symptoms during MS attacks. Treatment decisions are typically based on the specific MS phenotype and the level of disability, as measured by the Expanded Disability Status Scale (EDSS). For patients with mild symptoms, treatment may not be necessary.
Although there is no cure for Multiple Sclerosis, recent trends have shown a significant increase in the use of Disease Modifying Therapies (DMTs). These therapies are designed to slow disease progression and improve the quality-adjusted life years for patients.
To manage acute MS attacks, symptomatic treatments include:
– Corticosteroids: Oral prednisone and intravenous methylprednisolone are used to reduce nerve inflammation. Common side effects include insomnia, elevated blood pressure and blood glucose levels, mood swings, and fluid retention.
– Plasma Exchange (Plasmapheresis): This procedure involves removing the liquid part of the blood (plasma), mixing the blood cells with a protein solution (albumin), and returning it to the body. It is used for patients who do not respond to steroids.
The major focus in the Multiple Sclerosis market is on treatments that modify disease progression, aiming to extend progression-free survival and improve quality-adjusted life years. Disease Modifying Treatments (DMTs) are tailored to the four clinical phenotypes of MS.
Selecting the appropriate DMT involves careful evaluation of factors such as disease duration and severity, the effectiveness of previous treatments, other health conditions, cost, and considerations related to pregnancy. The MS treatment landscape includes a robust pipeline of potential new therapies from leading pharmaceutical companies, addressing the ongoing unmet needs in the market.
Leading Players in the Multiple Sclerosis Therapeutics Market Include:
Multiple Sclerosis Companies working in the market are Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, Bayer HealthCare Pharmaceuticals, Novartis, Biogen, Genentech, and others.
Multiple Sclerosis Report Covers the In-depth Assessment of the Emerging Multiple Sclerosis Drugs & Key Companies. Download the Multiple Sclerosis Market Sample Report to Learn More @ https://www.delveinsight.com/sample-request/multiple-sclerosis-market
Table of Contents
1. Key Insights
2. Executive Summary
3. Multiple Sclerosis Competitive Intelligence Analysis
4. Multiple Sclerosis Market Overview at a Glance
5. Multiple Sclerosis Disease Background and Overview
6. Multiple Sclerosis Patient Journey
7. Multiple Sclerosis Epidemiology and Patient Population (In the US, EU5, and Japan)
8. Multiple Sclerosis Treatment Algorithm, Current Treatment, and Medical Practices
9. Multiple Sclerosis Unmet Needs
10. Key Endpoints of Multiple Sclerosis Treatment
11. Multiple Sclerosis Marketed Products
12. Multiple Sclerosis Emerging Drugs and Latest Therapeutic Advances
13. Multiple Sclerosis Seven Major Market Analysis
14. Attribute Analysis
15. Multiple Sclerosis Market Outlook (In US, EU5, and Japan)
16. Multiple Sclerosis Access and Reimbursement Overview
17. KOL Views on the Multiple Sclerosis Market
18. Multiple Sclerosis Market Drivers
19. Multiple Sclerosis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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