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市場調查報告書

疾病分析:多發性硬化症 (MS)

Disease Analysis: Multiple Sclerosis

出版商 Datamonitor Healthcare 商品編碼 927050
出版日期 內容資訊 英文 78 Pages
商品交期: 最快1-2個工作天內
價格
疾病分析:多發性硬化症 (MS) Disease Analysis: Multiple Sclerosis
出版日期: 2020年02月14日內容資訊: 英文 78 Pages
簡介

2018年,全球多發性硬化症 (MS)的罹患數估計有210萬案例。預計至2027年,其數增加到220萬案例。

本報告提供全球多發性硬化症 (MS) 市場相關調查分析,疾病的背景,治療,上市品,開發平台醫藥品,臨床實驗形勢,未來趨勢等相關的系統性資訊。

目錄

概要

疾病的背景

  • 疾病定義
  • 患者的分類
  • 症狀
  • 危險因素
  • 診斷

治療

  • 主要的治療指南的推薦事項的摘要

流行病學

  • 盛行率技術

上市品

開發平台醫藥品

主要的法規趨勢

  • 英國的NICE
  • 美國的FDA:Mavenclad的認證
  • EMA:Sanofi的Lemtrada
  • 美國的FDA:實驗指導

成功的可能性

許可證、資產取得契約

臨床實驗形勢

  • 贊助商:各狀態
  • 贊助商:各階段
  • 最近的趨勢

醫藥品評估模式

市場動態

未來趨勢

  • 由於一般化,領導品牌的市場佔有率銳減
  • 主要品牌面臨與開發平台的「me-too」(類新藥)的競爭
  • 有效利用MS的新機制
  • 更多的DMT利用可能

共識的預測

最近的趨勢和分析師的見解

今後的主要趨勢

KOL的考察

未滿足需求

參考文獻

附錄

目錄
Product Code: DMKC0212320

Latest Key Takeaways:

Datamonitor Healthcare estimates that in 2018, there were 2.1 million prevalent cases of multiple sclerosis (MS) worldwide, and forecasts that number to increase to 2.2 million prevalent cases by 2027.

A large selection of disease-modifying therapies (DMTs) are currently available in the MS market, with a sizable range of attributes, potencies, and safety profiles. Consequently, this set of DMTs typically can yield some relief for this chronic condition.

Utilization of first-generation DMTs, such as Avonex, Betaseron, Copaxone, and Rebif, is declining due to their comparatively poor safety, efficacy, and administration profiles versus newer DMTs. Most are genericized, but still see some use in the first-line treatment setting, particularly for less severe cases of MS and especially where payer pressure is involved.

Since Ocrevus's launch in 2017, the drug has quickly risen to realize its gold-standard potential in the wider MS field. Its efficacy is unparalleled, and coupled with its six-month dosing regimen, the drug is popular with patients and physicians alike. As the only approved therapy for primary progressive MS (PPMS), it has little competition in this patient segment. Furthermore, Ocrevus is increasingly being prescribed at the first and second lines of treatment in other MS subtypes, and particularly in more rapidly progressing and severe cases.

Key patent litigation trials of Novartis's Gilenya could reach a verdict either this year or in coming years, and a wave of generic versions of fingolimod could enter the market, with several generic manufacturers already achieving regulatory approvals. On the other hand, if Novartis upholds its patents as Biogen recently did for Tecfidera in February 2020, the company could potentially see associated revenues maintained until the end of the decade.

Recent key events in MS include Novartis's anti-CD20 targeting drug, Arzerra, advancing in development. Positive pivotal trial results in 2019 put Novartis on track to file Arzerra for approval in relapsing-remitting MS (RRMS) in late 2020, potentially providing competition for Roche's dominant Ocrevus as Arzerra has the advantage of a more appealing subcutaneous administration route.

In addition, Johnson & Johnson's ponesimod demonstrated somewhat positive results, although more robust efficacy and/or safety may need to be demonstrated to compete with other sphingosine-1-phosphate (S1P) modulating drugs already on the market, such as Gilenya. Finally, Gocovri, a symptomatic MS walking impairment hopeful, produced overall lackluster pivotal trial results, and Adamas is consequently revaluating pursual of the drug in MS.

Some of the most anticipated future events in the MS drug market include data for MedDay Pharmaceuticals' Qizenday (a highly concentrated formulation of D biotin), with additional pivotal trial results from the MS-SPI2 trial in progressive MS patients expected in Q1 2020. Ozanimod, another S1P-targeting drug, has a PDUFA date set for 25 March, and this may shed light on the FDA's views of another same-class DMT entering the market. Finally, results from ublituximab's pivotal trials are expected later in 2020, pointing towards another "me-too" drug reaching the market (in that it targets CD20).

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis

TREATMENT

  • Summary of key treatment guideline recommendations

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • UK's NICE Not Convinced By Cannabis-Based Medicines
  • Resubmission After Withdrawal: US FDA's Mavenclad Approval Acknowledges Long Regulatory History
  • EMA Restricts Sanofi's Lemtrada Use, Initiates Risk-Benefit Review
  • US FDA "Enriches" Trial Guidance With Recent Examples

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Sanofi To Co-Develop Digital Therapeutic For MS Patients
  • Sandoz And Polpharma Strike Global Deal For Natalizumab

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • Widespread genericization will deplete key brands' market share
  • Key brands will face competition from pipeline "me-too" drugs, though uptake may be slow if distinguishing factors cannot be established
  • Numerous drugs utilizing novel mechanisms for MS are in development
  • More DMTs will become available for other MS patient populations

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Gocovri for Multiple Sclerosis (December 17, 2019)
  • Ponesimod for Multiple Sclerosis (September 11, 2019)
  • Biosimilar Natalizumab (Sandoz) for Multiple Sclerosis (September 3, 2019)
  • Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019)
  • Vumerity for Multiple Sclerosis (July 30, 2019)
  • Ponesimod for Multiple Sclerosis (July 25, 2019)
  • Botox - Therapeutic for Multiple Sclerosis (June 25, 2019)
  • Pear-006 for Multiple Sclerosis (May 3, 2019)
  • GNbAC1 for Multiple Sclerosis (March 12, 2019)
  • Lemtrada for Multiple Sclerosis (November 20, 2018)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Quotes regarding specific drug use
  • Quote regarding unmet needs
  • Quote regarding pricing

UNMET NEEDS

  • More effective therapies for PPMS/SPMS
  • Development of neuroprotective/remyelinating therapies

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Trends in prevalent cases of multiple sclerosis, 2018-27
  • Figure 2: Overview of pipeline drugs for multiple sclerosis in the US
  • Figure 3: Pipeline drugs for multiple sclerosis, by company
  • Figure 4: Pipeline drugs for multiple sclerosis, by drug type
  • Figure 5: Pipeline drugs for multiple sclerosis, by classification
  • Figure 6: Probability of success in the multiple sclerosis pipeline
  • Figure 7: Clinical trials in multiple sclerosis
  • Figure 8: Top 10 drugs for clinical trials in multiple sclerosis
  • Figure 9: Top 10 companies for clinical trials in multiple sclerosis
  • Figure 10: Trial locations in multiple sclerosis
  • Figure 11: Multiple sclerosis trials status
  • Figure 12: Multiple sclerosis trials sponsors, by phase
  • Figure 13: Datamonitor Healthcare's drug assessment summary for multiple sclerosis
  • Figure 14: Market dynamics in multiple sclerosis
  • Figure 15: Future trends in multiple sclerosis
  • Figure 16: Gocovri for Multiple Sclerosis (December 17, 2019): Phase III - INROADS (Walking Impairment)
  • Figure 17: Ponesimod for Multiple Sclerosis (September 11, 2019): Phase III - OPTIMUM
  • Figure 18: Arzerra for Multiple Sclerosis (August 30, 2019): Phase III - ASCLEPIOS I and II
  • Figure 19: Vumerity for Multiple Sclerosis (July 30, 2019): Phase III - EVOLVE-MS-2 (vs. Tecfidera)
  • Figure 20: Ponesimod for Multiple Sclerosis (July 25, 2019): Phase III - OPTIMUM
  • Figure 21: GNbAC1 for Multiple Sclerosis (March 12, 2019): Phase III - ANGEL-MS (RRMS)
  • Figure 22: Key upcoming events in multiple sclerosis

LIST OF TABLES

  • Table 1: Clinical subtypes of multiple sclerosis
  • Table 2: Leading disease-modifying therapies for multiple sclerosis
  • Table 3: Available DMTs and the strength of the evidence base supporting their efficacy in preventing MS relapses
  • Table 4: Prevalent cases of multiple sclerosis, 2018-27
  • Table 5: Marketed drugs for multiple sclerosis
  • Table 6: Pipeline drugs for multiple sclerosis
  • Table 7: Historical global sales, by drug ($m), 2014-19
  • Table 8: Forecasted global sales, by drug ($m), 2020-24
  • Table 9: Gocovri for Multiple Sclerosis (December 17, 2019)
  • Table 10: Ponesimod for Multiple Sclerosis (September 11, 2019)
  • Table 11: Biosimilar Natalizumab (Sandoz) for Multiple Sclerosis (September 3, 2019)
  • Table 12: Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019)
  • Table 13: Vumerity for Multiple Sclerosis (July 30, 2019)
  • Table 14: Ponesimod for Multiple Sclerosis (July 25, 2019)
  • Table 15: Botox - Therapeutic for Multiple Sclerosis (June 25, 2019)
  • Table 16: Pear-006 for Multiple Sclerosis (May 3, 2019)
  • Table 17: GNbAC1 for Multiple Sclerosis (March 12, 2019)
  • Table 18: Lemtrada for Multiple Sclerosis (November 20, 2018)