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市場調查報告書

全球多發性硬化症治療藥物的市場:市場專家(KOL)的考察

Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules

出版商 FirstWord 商品編碼 273171
出版日期 內容資訊 英文 183 pages
商品交期: 最快1-2個工作天內
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全球多發性硬化症治療藥物的市場:市場專家(KOL)的考察 Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules
出版日期: 2014年03月12日 內容資訊: 英文 183 pages
簡介

全球多發性硬化症的治療藥市場在近年來劇烈變化。新治療藥的上市,讓多發性硬化症的治療方法產生了重大的變化,同時也可望帶來大幅市場成長。

本報告提供全球的多發性硬化症的治療藥物的市場相關分析,目前治療方法和治療環境,整體市場結構,現在已上市/臨床實驗中的治療藥物概要,今後的治療方法·市場方向性等調查資料·考察,並將結果概述為以下內容。

摘要整理

簡介

分析方法

目前多發性硬化症的相關市場

  • 目前治療環境
  • 多發性硬化症的主要品牌藥醫療費給付狀況
  • 多發性硬化症的未滿足需求

目前治療方法

  • 已上市治療藥臨床實驗結果
  • Tecfidera(富馬酸二甲酯:Biogen)的趨勢
  • Lemtrada (alemtuzumab; Genzyme/Sanofi) 的趨勢
  • Aubagio(teriflunomide:Sanofi/Genzyme)的趨勢
  • Gilenya(Fingolimod:Novartis)的趨勢
  • Tysabri (natalizumab; Biogen)的趨勢
  • Copaxone (glatiramer acetate:Teva)的趨勢
  • Interferon betas (Avonex, Betaseron, Rebif, Extavia) 的趨勢
  • 目前治療流程

對症療法

  • 多發性硬化症的徵兆
  • 多發性硬化症的對症療法
  • Ampyra/Fampyra(dalfampridine:Acorda Therapeutics/Biogen)的趨勢
  • Sativex(nabiximols:GW Pharma/Almirall/Otsuka/Bayer/Novartis)的趨勢

開發平台療法

  • Laquinimod (Teva)的趨勢
  • Daclizumab HYP (Biogen/Abbott)的趨勢
  • Ocrelizumab (Biogen/Roche)的趨勢
  • 未來的治療流程

多發性硬化症治療方法的今後發展

  • 價格環境的束縛限制了市場進入
  • 多發性硬化症的初期階段,今後的CIS(Clinically isolated syndrome)的可能性
  • 早期診斷•治療的症狀改善趨勢
  • 更多對症療法的開發動向
  • 生物標記的階段開發,治療的正面效應
  • 加深對多發性硬化症根本病因的認識
  • 治療失敗的評估方法,未來的引進可能性
  • 檢測長期性治療效果的必要性

附錄

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目錄

An incisive report and dynamic analyst briefing service delivering insight from the most influential Multiple Sclerosis (MS) Key Opinion Leaders to map the current treatment landscape and analyse future trends.

Multiple Sclerosis : The oral era begins

The multiple sclerosis treatment landscape has undergone dramatic changes over the past year. Biogen's Tecfidera (dimethyl fumarate) has revolutionised multiple sclerosis treatment in the US, cannibalising significant market share from older therapies. With New Active Substance status granted in Europe, Tecfidera's launch is expected to be replicated in this region. Genzyme have taken advantage of this delay with Lemtrada's (alemtuzumab) and Aubagio's (teriflunomide) EU approval. The arrival of these drugs is expected to change how multiple sclerosis is treated and be a catalyst for unprecedented market growth.

Driven by in-depth interviews with the world's leading multiple sclerosis KOLs, Therapy Trends: Multiple Sclerosis uncovers how the current treatment landscape will be impacted by significant future events, with particular focus on pipeline therapies and how these will modify the way MS is managed by neurologists in the future.

Drive your strategic decision-making with inside intelligence

Multiple Sclerosis : KOL Insight disseminates critical opinion and analysis to provide premier research.

  • We cut to the heart of market-changing events and eliminate superfluous background information so you can focus on developments of greatest strategic impact and reduce your reaction time
  • Our unique thought-leader selection matrix identifies the most influential KOLs in MS to deliver the perspectives vital in giving you a competitive edge, enabling informed decision-making and planning
  • Detailed analysis of marketed and pipeline drugs helps you understand the products that will shape the future MS market
  • KOL consensus on the future treatment algorithm offers a window into the future changes in medical evidence and clinical practice
  • Uncovering KOLs' opinions on unmet needs enables you to identify potential commercial opportunities
  • Dynamic report updates evaluate the market impact of key events from KOL perspectives, allowing you to react to significant MS market developments within days of events occurring

Critical questions answered

Our MS KOLs are selected according to their level of engagement and influence within the pharmaceutical industry and their scientific standing. FirstWord's unique KOL scoring system enables identification of KOLs with the greatest knowledge of how MS treatment will evolve and shape the future landscape.

  • What are the key unmet needs? There is a high risk, high reward opportunity in the development of a therapy with efficacy for progressive subtypes.
  • How will therapies will be positioned against each other in the future of MS treatment? Biogen's new oral therapy Tecfidera is expected to usurp the current market leaders and become the first-line therapy of choice.
  • Where do neurologists position Lemtrada? Insight from 300 prescribers surveyed on positioning, prescription and pricing.
  • How will treatment developments play out in the near future? Biogen's activity in broadening its robust pipeline shows its resolve in maintaining its leading position in MS.
  • Is there potential for new players in the lucrative MS market? New entrants are set to capture significant share and cannibalise sales of the leading drugs.
  • How will the launch of biosimilars affect prescribing behaviour? Pricing will be a key determinant in positioning and uptake.
  • Will Teficdera's European launch replicate the US success? A delayed launch in Europe appears to have stimulated demand for Tecfidera among neurologists and MS patients.
  • Will the new John Cunningham Virus test encourage earlier adoption of Tysabri? This offers the first example of personalised medicine; a trend that will aid uptake in future.

The deliverables

Therapy Trends: Multiple Sclerosis is delivered in two complimentary formats:

Therapy Trends Intelligence Report: a concise, focused, in-depth market intelligence research report that examines the range of current and late-stage pipeline drugs to determine future trends in the treatment and diagnosis of MS, and assess the commercial impact on the MS market landscape.

Therapy Trends Impact Assessments: dynamic analyst briefings evaluating the impact of events in the MS market over the next 12 months, delivered to you within days of a significant event happening

Who should buy this report?

This report will be of value to senior pharma directors and managers with responsibilities in the following areas:

  • Business Development
  • New Product Planning
  • Market Research
  • Strategic brand planning
  • Forecasting and marketing professionals
  • Medical Affairs
  • Clinical Trials
  • Relationship Management

Key Benefits

  • Unmet needs analysis to identify opportunities and address the challenges facing disease management
  • Strategic mapping of future treatment algorithms based on KOL insight
  • Commercial and clinical analysis of pipeline therapies
  • In-depth, dynamic event impact assessments to evaluate current strategies and plans against new conditions
  • Align investment and resource planning to future trends
  • Know the story driving the trends

For users with responsibilities in

  • Business Development
  • New Product Planning
  • Market Research
  • Strategic brand planning
  • Forecasting and marketing professionals
  • Medical Affairs
  • Clinical Trials
  • Relationship Management

Informed Intelligence

  • The views from KOL panels comprising the foremost experts in the treatment and diagnosis of major medical conditions
  • Consensus ratings of therapeutic developments and events derived from a proprietary collaborative system involving 290,000 vetted physicians
  • Live dispatches from a correspondent network who attend 125+ medical conferences each year, feeding-in critical meeting intelligence
  • 2,000+ peer-reviewed medical journals
  • 450+ pharmaceutical news sources

Therapy Trends: Intelligence Two Ways

Therapy Trends Intelligence Reports: concise, focused, in-depth market intelligence research studies that examine current and late-stage pipeline drugs to determine future trends in the treatment and diagnosis of a specific medical condition and its impact on the commercial outlook

Therapy Trends Impact Assessments: dynamic analyst updates assess the impact of drug market events within days of a significant event happening

Table of Contents

Contents

Executive summary

Introduction

Methodology

Current Multiple sclerosis marketplace

  • Current treatment landscape
    • Multiple Sclerosis market definition
    • Current market overview
  • Reimbursement of key multiple sclerosis brands
  • Multiple sclerosis unmet needs
    • Unmet need 1: Efficacy for progressive subtypes
    • Unmet need 2: Therapies offering better clinical profiles
    • Unmet need 3: Drugs to halt or repair neuronal damage
    • Unmet need 4: Improving multiple sclerosis induced cognition dysfunction
    • Unmet need 5: Need for improved adherence

Current therapies

  • Clinical trial results of marketed therapies
    • Cross trial comparisons is not an ideal assessment
  • Tecfidera (dimethyl fumarate; Biogen) trends
    • Tecfidera becomes the latest FDA approved MS therapy
    • Tecfidera will become a first-line therapy and a major threat to Gilenya
    • Favourable label with no black box warnings and limited patient monitoring required
    • Discontinuation rates higher than existing therapies and may potentially get higher in a real world setting
    • Opportunity to expand draft label to include disability improvement
    • Treating warehoused patients will expand market
    • Practical Tecfidera pricing in-line with current first-line therapies
    • Tecfidera patent extended to 2028
  • Lemtrada (alemtuzumab; Genzyme/Sanofi) trends
    • Sanofi's Lemtrada receives first worldwide approval
    • Lemtrada's broad label is best case scenario for Sanofi
    • Lemtrada is one of the most effective marketed therapies
    • Safety concerns may hamper uptake
    • Sanofi will price Lemtrada in line with current treatments
  • Aubagio (teriflunomide; Sanofi/Genzyme) trends
    • Aubagio is approved by the FDA - drug becomes the second oral therapy to enter the market
    • Despite favourable tolerability the FDA have issued a black box warning on the prescription label
    • Surveyed neurologists are aware of Aubagio and intend to prescribe the drug
    • Interviewed neurologists believe Aubagio will find use as a monotherapy and combination therapy
    • Pricing at $45,000 places the drug cheaper than existing first-line therapies
  • Gilenya (fingolimod; Novartis) trends
    • Gilenya has first oral to market advantage
    • Gilenya raises bar for pipeline therapies entering the market
    • Deaths mar Gilenya's side effect profile and positions drug as a second line
    • Vigilance program is cumbersome and likely to restrict access
    • Gilenya's high price will restrict use
    • Clinical trials in progressive multiple sclerosis ongoing
  • Tysabri (natalizumab; Biogen) trends
    • Tysabri is the most effective approved multiple sclerosis therapy
    • PML fears positions drug as second or later line
    • JCV test will promote use and allay fears
    • Progressive multiple sclerosis trials ongoing for Tysabri
  • Copaxone (glatiramer acetate; Teva) trends
    • Copaxone is the leading selling multiple sclerosis therapy
    • Teva fights generic Copaxone applications
  • Interferon betas (Avonex, Betaseron, Rebif, Extavia) trends
    • Interferons are the mainstay of multiple sclerosis treatment
    • Needles have evolved to avoid injection site reactions
    • Biosimilar guidelines in place for interferons
  • Current treatment algorithm

Symptomatic Treatment

  • Multiple sclerosis symptoms
  • Symptomatic multiple sclerosis therapies
  • Ampyra/Fampyra (dalfampridine; Acorda Therapeutics/Biogen) trends
    • Controlled release formulation minimises risk of seizures
    • Ampyra only works in certain patient populations
    • High cost could restrict uptake
  • Sativex (nabiximols; GW Pharma/Almirall/Otsuka/Bayer/Novartis) trends
    • First cannabis -based drug enters Europe
    • Opinion leaders believe approval in US will follow European expansion
    • Partnerships will enable further market penetration

Pipeline therapies

  • Laquinimod (Teva) trends
    • Third laquinimod trial initiated concentrating on neuroprotective effect but doubts persist
    • Phase III efficacy data is disappointing and less than current therapies
    • Safety data and mechanism suits role as an add-on therapy
  • Daclizumab HYP (Biogen/Abbott) trends
    • Daclizumab complements Biogen's portfolio with good safety and efficacy
    • Daclizumab positioning will be important for Biogen franchise
  • Ocrelizumab (Biogen/Roche) trends
    • Ocrelizumab represents the most advanced B-cell therapy
    • Ocrelizumab is highly effective in reducing relapses
    • Long-term safety needs to be investigated
  • Future treatment algorithm
    • More use of induction therapy in highly relapsing patients
    • Current first-line therapies will have a less prominent role in future treatment
    • Interferons and Copaxone can find a niche as combination therapies
    • Oral therapies will become the leading first- and second-line therapies
    • JCV test will drive earlier use of Tysabri
    • Potent but less safe therapies will remain last line

Future developments in multiple sclerosis

  • Constrained pricing environments will reduce market access
  • Clinically isolated syndrome will be considered early stage multiple sclerosis in the future
  • Trend for earlier diagnosis and treatment will produce better outcomes
  • Trend to more symptomatic therapies being developed
  • Eventual development of biomarkers will aid treatment
  • Better understanding of underlying multiple sclerosis etiology
  • Methods to assess treatment failure could be implemented in the future
  • More emphasis should be placed on long-term outcome measures

Appendix

  • KOL biographies
    • KOLs from North America:
    • KOLs from Europe
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