多発性硬化症 - 競合情勢（2025年）

レポートのハイライト

• 2025年1月、Century HealthとNira Medicalは、多発性硬化症の3,000人を超える患者のデータを収集し、疾患と治療成績の理解を深めるためのパートナーシップを発表しました。Century HealthのAIプラットフォームは、Nira Medicalの診療所ネットワークからのデータを基に、ライフサイエンス企業とのパートナーシップにおいて分析される構造化されたデータセットを作成し、MS治療の研究を加速させ、患者の転帰を改善します。
• 2025年1月、Pheno Therapeutics Limited.は、主力候補薬PTD802の臨床試験承認（CTA）を英国MHRA（Medicines and Healthcare products Regulatory Agency）から取得したと発表しました。
• 2024年12月、米国食品医薬品局（FDA）は、SanofiのBTK阻害薬候補である、成人の非再発性二次性進行型多発性硬化症（SPMS）治療薬Tolebrutinibにブレークスルーセラピー指定を与えました。
• 2024年10月22日、Immunicは、核内受容体1（Nurr1）活性化薬であるVidofludimus Calcium（IMU-838）の再発性多発性硬化症（RMS）治療に関するフェーズIII ENSUREプログラムについて、拘束力のない無益性中間解析の結果が良好であったことを発表しました。中間無益性解析の結果に基づき、Independent Data Monitoring Committee（IDMC）は、本試験は無益ではなく、計画通り継続すべきであると勧告しました。
• 2024年10月、Hope Biosciences Research Foundation（HBRF）は、軽度から中等度の再発寛解型多発性硬化症（MS）患者を対象としたHope Biosciencesの脂肪由来自己間葉系幹細胞療法（HB-adMSCs）を評価するフェーズII臨床試験の良好なトップライン結果を発表しました。
• 2024年3月、Immunic, Inc.は、米国特許商標庁（USPTO）より、Vidofludimus Calcium（IMU-838）の特定の多形体を含む物質組成物とその生産方式を対象とする特許出願16/981,122号（名称「抗炎症剤、免疫調節剤と抗増殖剤としてのカルシウム塩多形体」）の許可通知を受領したと発表しました。特許請求の範囲は、さらに延長されない限り、2039年まで保護される見込みです。この特許は、オーストラリア、カナダ、インドネシア、日本、メキシコで既に取得済みです。
• 2024年1月、TG Therapeutics, Inc.は、Precision BioSciences, Inc.との間で、Precisionの自己免疫疾患とその他すべての非腫瘍適応症を対象とした同種CD19 CAR T細胞治療プログラムであるAzercabtagene Zapreleucel（azer-cel）の世界的ライセンスを取得する契約を締結したと発表しました。

当レポートでは、多発性硬化症の競合情勢における60社以上の企業、75品目以上の医薬品に関する包括的な知見を提供しています。また、製品タイプ別、段階別、投与経路別、分子タイプ別に治療薬を評価し、休止中のパイプライン製品も取り上げています。

目次

イントロダクション

エグゼクティブサマリー

多発性硬化症：概要

• イントロダクション
• 分類
• 危険因子
• 診断
• 治療

多発性硬化症 - 分析的視点：詳細な商業的評価

• 多発性硬化症の提携の分析：企業別

競合情勢

• 企業の比較評価：治療薬別、開発段階別、技術別

治療法の評価

• 評価：製品タイプ別
• 評価：段階別、製品タイプ別
• 評価：投与経路別
• 評価：段階別、投与経路別
• 評価：分子タイプ別
• 評価：段階別、分子タイプ別

多発性硬化症：企業と製品のプロファイル（上市済みの治療薬）

TG Therapeutics

• 企業の概要

BRIUMVI

• 製品の説明
• 研究開発活動
• 製品開発活動

多発性硬化症：企業と製品のプロファイル（パイプライン治療薬）

後期段階の製品（フェーズIII）

• 比較分析

Immunic

• 企業の概要

IMU-838

• 製品の説明
• 研究開発活動
• 製品開発活動

中期段階の製品（フェーズII）

• 比較分析

Tiziana Life Sciences

• 企業の概要

Foralumab

• 製品の説明
• 研究開発活動
• 製品開発活動

初期段階の製品（フェーズI）

• 比較分析

J-Pharma Co., Ltd.

• 企業の概要

JPH034

• 製品の説明
• 研究開発活動
• 製品開発活動

前臨床/創薬段階の製品

• 比較分析

Polpharma Biologics

• 企業の概要

PB018

• 製品の説明
• 研究開発活動
• 製品開発活動

休止中の製品

• 比較分析

多発性硬化症 - アンメットニーズ

多発性硬化症 - 市場促進要因と障壁

List of Tables

• Table 1 Total Products for Multiple Sclerosis
• Table 2 Late Stage Products
• Table 3 Mid Stage Products
• Table 4 Early Stage Products
• Table 5 Pre-clinical & Discovery Stage Products
• Table 6 Assessment by Product Type
• Table 7 Assessment by Stage and Product Type
• Table 8 Assessment by Route of Administration
• Table 9 Assessment by Stage and Route of Administration
• Table 10 Assessment by Molecule Type
• Table 11 Assessment by Stage and Molecule Type
• Table 12 Inactive Products

List of Figures

• Figure 1 Total Products for Multiple Sclerosis
• Figure 2 Late Stage Products
• Figure 3 Mid Stage Products
• Figure 4 Early Stage Products
• Figure 5 Preclinical and Discovery Stage Products
• Figure 6 Assessment by Product Type
• Figure 7 Assessment by Stage and Product Type
• Figure 8 Assessment by Route of Administration
• Figure 9 Assessment by Stage and Route of Administration
• Figure 10 Assessment by Molecule Type
• Figure 11 Assessment by Stage and Molecule Type
• Figure 12 Inactive Products

DelveInsight's, "Multiple Sclerosis - Competitive landscape, 2025" report provides comprehensive insights about 60+ companies and 75+ drugs in Multiple Sclerosis Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Multiple Sclerosis: Understanding

Multiple Sclerosis: Overview

Multiple sclerosis (MS) is the most common neurological disorder in young adults, with symptoms usually occurring between the ages of 20 and 40 years. MS attacks the axons of the central nervous system, which are protected by myelin, commonly known as white matter. Relapsing-remitting MS: the most common form, affecting about 85% of MS patients. It is marked by flare-ups (relapses or exacerbations) of symptoms followed by periods of remission, when symptoms improve or disappear.

There are several rare and unusual types of MS. Some people with relapsing-remitting MS deal with a number of frequent symptoms, which sometimes seem to be connected to certain triggers. Exacerbations (also known as recurrences, relapses, or seizures) are the sudden exacerbations of MS symptoms or the appearance of new symptoms that last for at least 24 h. Early MS symptoms often include: Vision problems such as blurred or double vision or optic neuritis, which causes pain with eye movement and a rapid loss of vision, Muscle weakness, often in the hands and legs, and muscle stiffness accompanied by painful muscle spasms, Tingling, numbness, or pain in the arms, legs, trunk, or face.

Multiple sclerosis (MS) is the most common immune-mediated inflammatory demyelinating disease of the CNS, affecting around 400,000 people in the US and 2.5 million worldwide.

It is three times more common in females and typically onset occurs between ages 20 and 40. The mean age of onset is 25-29 for relapsing-remitting MS and 39-41 for primary progressive MS.

Approximately 10% of cases occur before age 18, with a prevalence of 1 in 1000 among populations of European ancestry.

Inflammation of the central nervous system is the leading cause of MS damage. The specific factors that cause this inflammation are still unknown. Studies show that hereditary, environmental, and infectious pathogens are one of the factors that influence the development of multiple sclerosis. Many immunological studies have been conducted on animal models of human MS known as experimental autoimmune encephalomyelitis (EAE). These are the innate and adaptive immune responses. The innate immune response is initiated by a microbial product that non-antigenically activates specific receptors, primarily Toll-like receptors (TLRs).

No single pathognomonic test exists for the diagnosis of MS. Diagnosis is made by weighing the history and physical, MRI, evoked potentials, and CSF/blood studies and excluded other causes of the patient's symptoms. Doctors use different tests to rule out or confirm the diagnosis. In addition to complete medical history, physical examination, and a detailed neurological examination, a doctor may recommend: MRI scans of the brain and spinal cord to look for the characteristic lesions of MS and Lumbar puncture (sometimes called a spinal tap) to obtain a sample of cerebrospinal fluid and examine it for proteins and inflammatory cells associated with the disease.

Treatment of MS has two aspects: disease-modifying therapy (DMT) for the underlying immune disorder, and therapies to relieve or modify symptoms. There are actually 12 products licensed by The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). Among them dimethyl fumarate (Tecfidera), alemtuzumab (Lemtrada), pegylated interferon-B (Plegridy) and glatiramer acetate (Copaxone) 40 mg have been produced and licensed since 2013.

Report Highlights:

• In January 2025, Century Health, and Nira Medical, announced a partnership to curate data from more than 3,000 patients with multiple sclerosis to advance the understanding of the disease and treatment outcomes. Based on data from Nira Medical's network of clinics, Century Health's AI platform will create structured datasets that will be analyzed in partnership with life sciences companies to accelerate research into MS treatment and improve patient outcomes.
• In January 2025, Pheno Therapeutics Limited., announced that it has received Clinical Trial Authorization (CTA) from the UK's MHRA (Medicines and Healthcare products Regulatory Agency) for its lead candidate, PTD802.
• In December 2024, The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Sanofi's BTK inhibitor candidate Tolebrutinib for the treatment of adults with Nonrelapsing Secondary Progressive Multiple Sclerosis (SPMS).
• In October 22, 2024, Immunic announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
• In October 2024, Hope Biosciences Research Foundation (HBRF) announced positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences' adipose-derived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing remitting multiple sclerosis (MS).
• In March 2024, Immunic, Inc., announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to provide protection into 2039, unless extended further. The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico.
• In January 2024, TG Therapeutics, Inc. announced that it has entered into an agreement with Precision BioSciences, Inc. to acquire a worldwide license to Precision's Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

Multiple Sclerosis: Company and Product Profiles (Marketed Therapies)

1. Company Overview: TG Therapeutics

TG Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative treatments for B-cell diseases, including autoimmune conditions like multiple sclerosis and B-cell malignancies such as non-Hodgkin's lymphoma. Founded in 2011, the company is headquartered in New York and focuses on leveraging advances in B-cell biology to improve patient outcomes. Key products include ublituximab, a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, and umbralisib. Notably, TG Therapeutics has received approval for BRIUMVI, a treatment for relapsing forms of multiple sclerosis. The company conducts extensive clinical trials and collaborates with a global network of clinical sites to support patient access to its medicines. Through its research and development efforts, TG Therapeutics aims to provide effective and convenient treatments for patients with B-cell mediated diseases.

Product Description: BRIUMVI

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

2. Company Overview: Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilar. The purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. The vision is to be the world's leading and most valued generics company. The broad portfolio of high-quality medicines covers major therapeutic areas.

Product Description: Tyruko

Tyruko has been developed to be highly similar to the reference medicine, an established, highly effective anti-a4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis (MS). Tyruko is indicated in the US as a monotherapy for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, as well as Crohn's disease in adults. It is the first and only FDA-approved biosimilar for relapsing forms of MS.

Multiple Sclerosis: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Immunic

Immunic, Inc.is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in Phase III and Phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in Phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a Phase II clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases

Product Description: IMU-838

IMU-838 (Vidofludimus calcium) is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH). This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. Currently the drug is in Phase III of its clinical trial for the treatment of Multiple Sclerosis.

2. Company Overview: Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

Product Description: Foralumab

Foralumab is a fully human anti-CD3 monoclonal antibody, designed to modulate the immune system by targeting the CD3 Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase IIa, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis.

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase II trial began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.

3. Company Overview: J-Pharma Co., Ltd.

J-Pharma Co., Ltd. is a clinical-stage biopharmaceutical company based in Yokohama, Japan, founded in 2005 by Dr. Hitoshi Endou. The company specializes in developing novel therapeutics targeting solute carrier (SLC) transporters, particularly LAT1 (L-type amino acid transporter 1), which is overexpressed in various cancers and autoimmune diseases. Its lead candidates include nanvuranlat (JPH203), a LAT1 inhibitor for advanced biliary tract cancer, and JPH034, aimed at treating multiple sclerosis and brain tumors. J-Pharma collaborates with global institutions and has established a U.S. subsidiary to advance its drug development and regulatory strategies.

Product Description: JPH034

JPH034 is a small-molecule compound developed by J-Pharma, a Japanese biotech company. It targets LAT1 (L-type amino acid transporter 1), which is overexpressed in various cancers, including glioblastoma and biliary tract cancers. The compound is designed to inhibit tumor growth by blocking amino acid uptake essential for cancer cell survival. Currently, JPH034 is in clinical trials, with promising results in solid tumors. J-Pharma focuses on LAT1-targeted therapeutics as a novel cancer treatment strategy.

4. Company Overview: Polpharma Biologics

Polpharma Biologics is an international biotechnology company specializing in the development and manufacturing of biosimilar and novel biologic medicines. Established in 2013 as a spin-off from Poland's Polpharma Group, it operates state-of-the-art facilities in Gdansk and Warsaw, Poland, and Utrecht, Netherlands. The company offers fully integrated services across the biopharmaceutical value chain, from cell line development to commercial-scale production, catering to both its proprietary pipeline and industry partners. Polpharma Biologics has formed strategic collaborations, including joint ventures like Bioeq, and has entered global commercialization agreements for biosimilar products such as natalizumab and ranibizumab. With a workforce of over 800 specialists, the company is committed to expanding access to high-quality, affordable biologic therapies worldwide.

Product Description: PB018

PB018 is an investigational biosimilar of ocrelizumab, developed by Polpharma Biologics, targeting CD20 to deplete B-cells implicated in multiple sclerosis (MS). Designed to mirror the reference biologic's efficacy and safety, PB018 is currently in the preclinical stage of development. This initiative underscores Polpharma Biologics' commitment to expanding affordable treatment options for autoimmune diseases like MS. The company is actively seeking licensing partners to advance PB018 through clinical development and commercialization.

Multiple Sclerosis Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Multiple Sclerosis Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Multiple Sclerosis Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Multiple Sclerosis Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Multiple Sclerosis drugs?
• How many Multiple Sclerosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Multiple Sclerosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Multiple Sclerosis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Multiple Sclerosis and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Sanofi
• Immunic
• InnoCare Pharma
• Tiziana Life Sciences
• Biogen
• J-Pharma
• Bristol-Myers Squibb
• Polpharma Biologics
• Repertoire Immune Medicines

Key Products

• SAR 441344
• IMU-838
• Orelabrutinib
• Foralumab
• BIIB091
• JPH 034
• CC-97540
• PB018
• Autoimmune disorder vaccines

Table of Contents

Introduction

Executive Summary

Multiple Sclerosis: Overview

• Introduction
• Classification
• Risk factors
• Diagnosis
• Treatment

Multiple Sclerosis -Analytical Perspective: In-depth Commercial Assessment

• Multiple Sclerosis Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Multiple Sclerosis: Company and Product Profiles (Marketed Therapies)

TG Therapeutics

• Company Overview

BRIUMVI

• Product Description
• Research and Development Activities
• Product Developmental Activities

Multiple Sclerosis: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

Immunic

• Company Overview

IMU-838

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Tiziana Life Sciences

• Company Overview

Foralumab

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

J-Pharma Co., Ltd.

• Company Overview

JPH034

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

Polpharma Biologics

• Company Overview

PB018

• Product Description
• Research and Development Activities
• Product Developmental Activities

Inactive Products

• Comparative Analysis

Multiple Sclerosis- Unmet needs

Multiple Sclerosis - Market drivers and barriers