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多発性硬化症治療薬および生物製剤:各種技術と世界の市場

Multiple Sclerosis (MS) Drugs and Biologics: Technologies and Global Markets

発行 BCC Research 商品コード 133572
出版日 ページ情報 英文 129 Pages
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多発性硬化症治療薬および生物製剤:各種技術と世界の市場 Multiple Sclerosis (MS) Drugs and Biologics: Technologies and Global Markets
出版日: 2014年06月27日 ページ情報: 英文 129 Pages
担当者のコメント
BCC Research社のレポートは、Reuter、Wall Street Journal、Fortuneなどで引用されることも多く、それぞれの業界の識者の意見として重きを置かれています。同社レポートを複数冊ご購入の場合年間パッケージのご契約がお得です。詳細は右の担当者のおすすめ商品よりご覧下さい。
概要

世界の多発性硬化症治療薬市場は2012年に101億米ドル、2013年には109億米ドル近くの規模でした。2013年から2018年にかけて、当市場はCAGR5.4%で拡大し、2018年には、142億米ドル近くに達すると予測されています。

当レポートでは、多発性硬化症の歴史と症状、治療動向とともに、薬剤特許分析、小分子薬剤、生物製剤の概要、参入企業のプロファイル、および米国、欧州、日本の法規制動向をまとめ、概略下記の構成でお届けいたします。

第1章 イントロダクション

第2章 サマリー

第3章 概要

  • 疾患の特長
  • 多発性硬化症の歴史と発見
  • 多発性硬化症の症状
  • 多発性硬化症の罹患率
  • 多発性硬化症の種類
  • 予後診断
  • 多発性硬化症の治療 他

第4章 技術

  • 概要

第5章 特許評価

  • 特許期間と市場独占性
  • オーファンドラッグの独占
  • 小分子製品とジェネリック薬

第6章 小分子薬剤

  • 市場概要

第7章 多発性硬化症向け生物製剤

  • 概要

第8章 疾患への応用

第9章 主要企業と市場シェア

  • 市場シェア
  • 企業プロファイル

第10章 国際的側面と法規制上の課題

  • 地域別市場
  • 米国
    • FDA Modernization Act
    • 特殊プロトコル審査
    • 新たな監視、安全性要件
    • 消費者信頼
    • Medicare
    • その他の医療制度改革
  • 欧州
    • 新薬認可と技術革新
    • 薬剤償還と参照価格
    • 研究開発場所の移動
  • 日本
    • 新薬認可
    • 規制環境
    • 産官関係

第11章 将来の方向性

付録

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目次
Product Code: PHM069B

The global market for Multiple Sclerosis (MS) disease-modifying products reached $10.1 billion in 2012 and nearly $10.9 billion in 2013. This market is expected to grow to nearly $14.2 billion in 2018 with a compound annual growth rate (CAGR) of 5.4% over the five-year period from 2013 to 2018.

This report provides:

  • An overview of the global market for Multiple Sclerosis (MS) drugs and biologics
  • Analyses of global market trends, with data from 2011 to 2013, and projections of CAGRs through 2018.
  • Detailed profiles of the MS disease-modifying products on the market in the U.S. and around the world
  • Insight into how pharmaceutical and biotech companies are pursuing new approaches to treating MS as many of them look to move beyond current approaches
  • Forecasts for sales by product, company, geographic region, formulation, and indication when possible for the time frame covered, including supporting analyses for these projections
  • Comprehensive profiles of leading companies in the industry

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REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

BCC Research's goal in conducting this study was to determine the current status of the market for disease-modifying multiple sclerosis (MS) drugs, biologics and vaccines, and to assess their growth potential over a five-year period from 2013 through 2018.

MS is an autoimmune disease characterized by the body's own immune system attacking itself and causing spots of demyelination (plaques) in the brain and spinal cord. Symptoms of MS vary widely depending on the severity of the disease and which nerve cells are attacked. Today there are currently eight disease-modifying therapies for MS approved throughout the world. Biologics represent the largest class of MS disease-modifying therapies by sales and by number of approved therapies, accounting for six out of the eight approved MS disease-modifying products (Avonex, Betaseron, CinnoVex, Extavia, Rebif and Tysabri). Of these biologics, five are beta interferon products. All of these approved MS agents are able to slow down the progression of the disease but none can reverse any nerve damage that occurs due to demyelination.

The initial 2004 Food and Drug Administration (FDA) approval of Biogen Idec's and Elan's Tysabri marked the approval of the first therapeutic for MS that may actually reverse some of the effects of MS.

We were particularly interested in profiling small molecule drugs, therapeutic vaccines and other biologics targeting MS that are in Phase II or III clinical studies, or those with unique mechanisms of action in earlier stages of development. We identify the leading MS treatments by formulation, by mechanism of action and by geographic location. In some cases, we discuss notable compounds that failed in clinical testing, such as Roche and Biogen Idec's Rituxan (rituximab), or that were pulled from the market due to adverse event or other issues. We also discuss the potential of some compounds that are being tested for other inflammatory or autoimmune disorders that could in the future potentially be tested as a treatment for or used off-label for MS.

Our main objective is to present a comprehensive analysis of the current market for MS disease-modifying products and to forecast this market's future direction through 2018.

REASONS FOR DOING THIS STUDY

Disease-modifying agents to treat MS are currently one of the largest classes of pharmaceutical products by sales in the U.S. and throughout the world. Sales of these agents for MS have grown from less than $1 billion worldwide in 1999 to around $11 billion in 2013.

New approaches to treating MS are being pursued by pharmaceutical and biotech companies as many of them look to move beyond agents such as the interferons that primarily slow the progression of MS. These potential new disease-modifying agents with novel mechanisms of action or improved delivery systems will provide powerful new options for patients failing or intolerable to the currently prescribed treatments for MS.

INTENDED AUDIENCE

We have compiled detailed profiles of the MS disease-modifying products on the market in the U.S. and around the world. We discuss all disease-modifying products in the Phase I, II and III stages of clinical development and some unique treatments in the preclinical stage of development as well. This study includes technical descriptions of these products, discussion of their individual efficacy and side effect profiles when possible, what stage of the disease they treat, the major companies focusing on their development, and international aspects affecting these products. We provide sales forecasts and the reasoning behind our forecasts for products that are on the market already or that may enter the market through 2018.

This study will be of interest to members of the pharmaceutical, healthcare and biotechnology industries. It will also be a valuable resource for investors that invest in the pharmaceutical sector. It is written in such a way as to be accessible to an investor or businessperson while maintaining a high level of technical detail.

SCOPE OF REPORT

The emphasis of this report is on these products and about 39 products for MS in various stages of clinical development.

Special focus is placed on how new products and technologies will affect current market leaders in the MS treatment sector. Profiles are provided of companies projected to have disease-modifying products on the market during the forecast period and on companies with rich or interesting pipelines.

The study is arranged to offer an overview of the MS disease-modifying product market, including regulatory issues, and accompanied by detailed analyses and forecasts by product. Profiles of the many emerging competitors in this sector provide a comprehensive assessment of the various products and technologies entering this market as well as marketing strategies being used to gain a competitive edge.

METHODOLOGY

The market assessments in this report have been assembled based on publicly available information through July 2013. The base year for the report for forecasting purposes is 2013 and forecast data is provided through 2018. Market figures are based on current dollars, and inflation (outside of its effects on drug pricing) is not computed into the projected forecast figures.

MS disease-modifying product development is still evolving as new immunomodulatory treatments are discovered, and other targets prove to be futile in development. The reader is cautioned to use the report data primarily as a guide to assess trends, developments and challenges that the industry faces.

INFORMATION SOURCES

The information contained in this report has been assembled from both primary and secondary data sources. Primary research was conducted via telephone with key opinion leaders. Secondary data was collected via a comprehensive search of scientific peer-reviewed literature, databases such as Medscape, PubMed, industry trade media, company websites, annual reports and industry press releases.

ANALYST'S CREDENTIALS

Yogita Zutshi has 15 years of industry experience working in the areas of clinical research operations, medical/regulatory writing and market research in the pharmaceutical area. She has an MS in Organic Chemistry, an MS in Clinical Research and a Bachelor's in Education. She has also worked on research projects in clinical data management, and has developed training modules for the clinical and pharmacovigilance areas.

Table of Contents

CHAPTER 1 INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • INTENDED AUDIENCE
  • SCOPE OF REPORT
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 SUMMARY

  • SUMMARY TABLE A GLOBAL MARKET FOR MS DISEASE-MODIFYING PRODUCTS, THROUGH 2018 ($ MILLIONS)
  • SUMMARY FIGURE GLOBAL MARKET FOR THERAPIES TREATING MS, 2011-2018 ($ MILLIONS)
  • SUMMARY TABLE B GLOBAL MARKET FOR MS DISEASE-MODIFYING THERAPIES, BY REGION, THROUGH 2018 ($ MILLIONS)

CHAPTER 3 OVERVIEW

  • DISEASE CHARACTERISTICS
  • HISTORY AND DISCOVERY OF MS
  • SYMPTOMS OF MS
  • PREVALENCE AND INCIDENCE OF MS
  • TABLE 1 MS STATISTICS FROM AROUND THE WORLD, 2013
  • DIAGNOSIS OF MS
  • TYPES OF MS
  • PROGNOSIS
  • TREATMENTS FOR MS
  • TYPES OF MS THERAPIES
  • TABLE 2 CURRENTLY APPROVED MS THERAPIES ON THE MARKET
  • TABLE 3 FEATURES OF SMALL MOLECULE VERSUS BIOLOGIC MS DISEASE-MODIFYING THERAPIES
  • TABLE 4 WHOLESALE ACQUISITION COST OF SELECTED THERAPIES FOR MS, 2013 ($ MILLIONS)
  • TARGETS OF MS THERAPIES
  • VLA-4 (CD49D AND CD29)
  • S1P
  • CD20
  • IL-2 (CD25, CD122 AND CD132)
  • MYELIN BASIC PROTEIN-REACTIVE T-CELLS
  • SIDE EFFECTS OF MS THERAPIES
  • TABLE 5 COMPARISON OF SIDE-EFFECT PROFILES OF MARKETED AND LATE-CLINICAL STAGE THERAPIES FOR MS
  • MS THERAPIES IN CLINICAL DEVELOPMENT
  • TABLE 6 MS THERAPIES IN CLINICAL TRIALS, ORDERED BY PHASE
  • TABLE 7 MS THERAPIES IN DEVELOPMENT, BY PHASE
  • TABLE 8 MS THERAPIES IN ACTIVE CLINICAL TRIALS BY PRIMARY TARGET
  • TABLE 9 COMPANIES WITH MORE THAN ONE MS THERAPY IN ACTIVE CLINICAL TRIALS OR ON THE MARKET
    • CLINICAL TRIAL EFFICACY OUTCOME MEASUREMENTS IN MS STUDIES
      • Relapse Rate
      • EDSS
      • Gadolinium-enhanced (GdE) Lesions on MRI
      • TABLE 10 EFFICACY RESULTS OF MS DISEASE-MODIFYING THERAPIES

CHAPTER 4 TECHNOLOGY

  • OVERVIEW
  • TABLE 11 GLOBAL SALES OF MS DISEASE-MODIFYING THERAPIES BY FORMULATION, THROUGH 2018 ($ MILLIONS)
  • TABLE 12 ADMINISTRATION PROFILES OF THERAPIES APPROVED TO TREAT MS

CHAPTER 5 PATENT EVALUATION

  • PATENT LENGTH AND MARKET EXCLUSIVITY
    • ORPHAN DRUG EXCLUSIVITY
    • TABLE 13 U.S. PATENT EXPIRATION DATES OF THERAPIES FOR MS ON THE MARKET OR IN PHASE III DEVELOPMENT
    • TABLE 14 PATENT APPLICATIONS 3
    • TABLE 15 ISSUED PATENTS
    • TABLE 16 PATENT ASSIGNEES (NUMBER OF PATENTS)

CHAPTER 6 SMALL MOLECULE MS DRUGS

  • MARKET OVERVIEW
  • TABLE 17 GLOBAL MARKET FOR SMALL MOLECULE MS DISEASE-MODIFYING DRUGS BY INDIVIDUAL DRUG, THROUGH 2018 ($ MILLIONS)
  • SMALL MOLECULE MS DISEASE-MODIFYING DRUGS
    • COPAXONE (GLATIRAMER ACETATE, COPOLYMER 1)
    • TABLE 18 COPAXONE PIVOTAL STUDY RESULTS
    • NOVANTRONE (MITOXANTRONE)
    • GILENYA (FINGOLIMOD, FTY720)
    • TABLE 19 GILENYA PIVOTAL PHASE III STUDY RESULTS
    • AUBAGIO (TERIFLUNOMIDE)
    • TABLE 20 AUBAGIO PHASE III STUDY RESULTS FROM TEMSO AND TEMPO
    • TECFIDERA (DIMETHYL FUMARATE)
    • TABLE 21 TECFIDERA GLOBAL PHASE III CLINICAL PROGRAM
    • FIRATEGRAST (SB683699, T-0047)
    • SIPONIMOD (BAF312)
    • ONO-4641
    • ACT-128800
    • MASITINIB
    • TRIMESTA (ESTRIOL)
    • MN-166

CHAPTER 7 BIOLOGICS FOR MS

  • TABLE 22 GLOBAL MARKET FOR BIOLOGICS FOR MS BY INDIVIDUAL DRUGS, THROUGH 2018 ($ MILLIONS)
  • TABLE 23 BIOLOGICS FOR MS BY CLASS
  • MABS ANTIBODIES FOR MS
  • TABLE 24 BENEFITS AND CHARACTERISTICS OF MABS
  • TABLE 25 SELECTED ANTIBODIES IN DEVELOPMENT FOR MS
    • TYSABRI (NATALIZUMAB)
    • TABLE 26 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS
    • ZENAPAX (DACLIZUMAB)
    • TABLE 27 DACLIZUMAB CHOICE STUDY RESULTS
    • OCRELIZUMAB (RG1594)
    • ARZERRA (OFATUMUMAB)
    • AIN457
    • LY2127399
    • BIIB033
    • INTERFERON BETAS
    • BETASERON, BETAFERON (INTERFERON BETA-1B, BAY86-5046)
    • TABLE 28 TWO-YEAR BETASERON RRMS STUDY RESULTS
    • TABLE 29 THREE-YEAR BETASERON RRMS STUDY RESULTS
    • AVONEX (INTERFERON BETA-1A)
    • TABLE 30 AVONEX PIVOTAL PHASE III STUDY RESULTS
    • REBIF (INTERFERON BETA-1A)
    • EXTAVIA (INTERFERON BETA-1B)
    • CINNOVEX (INTERFERON BETA-1A)
    • PEG INTERFERON BETA-1A (BIIB017)
    • THERAPEUTIC VACCINES
    • TCELNA (FORMERLY KNOWN AS TOVAXIN)
    • ATX-MS-1467
    • RTL1000
    • BHT-3009
    • ATL1102 (FORMERLY TV-1102)

CHAPTER 8 DISEASE APPLICATIONS

  • OVERVIEW
  • TABLE 31 LABELS OF APPROVED DISEASE MODIFYING THERAPIES FOR MS
  • MS SUBGROUPS
    • RRMS
    • SPMS
    • PPMS
    • PRMS
  • THE MARKET FOR MS THERAPIES BY MS DISEASE SUBGROUP CLASSIFICATION

CHAPTER 9 COMPANY PROFILES

  • AB SCIENCE
  • AB SCIENCE USA
  • ABBVIE
  • ACORDA THERAPEUTICS INC.
  • ACTELION
  • ACTIVE BIOTECH
  • ANTISENSE THERAPEUTICS
  • APITOPE
  • ARTIELLE IMMUNOTHERAPEUTICS
  • BAYER AG
  • BAYER (U.S. LOCATION)
  • BAYHILL THERAPEUTICS
  • BIOGEN IDEC
  • CINNAGEN
  • DAIICHI SANKYO
  • ELI LILLY
  • FAST FORWARD LLC
  • FIVE PRIME THERAPEUTICS
  • GENMAB
  • GENMAB (U.S. LOCATION)
  • GENZYME
  • GLAXOSMITHKLINE
  • GLAXOSMITHKLINE (U.S. LOCATION)
  • GW PHARMACEUTICALS
  • INNATE IMMUNOTHERAPEUTICS
  • AUSTRALIAN OFFICE
  • NEW ZEALAND OFFICE
  • MEDICINOVA
  • MERCK KGAA (MERCK SERONO)
  • MITSUBISHI TANABE PHARMA
  • NOVARTIS
  • ONO PHARMA
  • OPEXA THERAPEUTICS
  • PFIZER
  • ROCHE
  • SANOFI-AVENTIS
  • SYNTHETIC BIOLOGICS
  • TEVA PHARMACEUTICAL INDUSTRIES

CHAPTER 10 INTERNATIONAL ASPECTS AND REGULATORY ISSUES

  • MARKET BY REGION
  • TABLE 32 GLOBAL FORECAST FOR MS DISEASE-MODIFYING THERAPIES BY REGION, THROUGH 2018 ($ MILLIONS)
  • UNITED STATES
    • The FDA Modernization Act of 1997
    • Fast-Track Status
    • Special Protocol Assessments
    • New Surveillance and Safety Requirements
    • Approvable Letters
    • Consumer Confidence
    • Medicare
    • Other Healthcare Changes
  • EUROPEAN UNION
    • New Drug Approvals and Innovation
    • Drug Reimbursement and Reference Pricing
    • Relocation of R&D
  • JAPAN
    • New Drug Approvals
    • Regulatory Climate
    • Relationship between Academia and Industry

CHAPTER 11 FUTURE DIRECTIONS

  • UNMET NEED STILL REMAINS HIGH
  • PATENT EXPIRIES AND PRICING PRESSURE MAY RESTRAIN THE MARKET GROWTH
  • DEVELOPMENT OF TREATMENT OPTIONS FOR THE PROGRESSIVE FORMS OF MS HAS THE POTENTIAL TO EXPAND AND GROW THE MARKET
  • THE ROLE OF BIOMARKERS AND PHARMACOGENOMICS
  • COMBINATION THERAPIES

LIST OF TABLES

  • SUMMARY TABLE A GLOBAL MARKET FOR MS DISEASE-MODIFYING PRODUCTS, THROUGH 2018 ($ MILLIONS)
  • SUMMARY TABLE B GLOBAL MARKET FOR MS DISEASE-MODIFYING THERAPIES, BY REGION, THROUGH 2018 ($ MILLIONS)
  • TABLE 1 MS STATISTICS FROM AROUND THE WORLD, 2013
  • TABLE 2 CURRENTLY APPROVED MS THERAPIES ON THE MARKET
  • TABLE 3 FEATURES OF SMALL MOLECULE VERSUS BIOLOGIC MS DISEASE-MODIFYING THERAPIES
  • TABLE 4 WHOLESALE ACQUISITION COST OF SELECTED THERAPIES FOR MS, 2013 ($ MILLIONS)
  • TABLE 5 COMPARISON OF SIDE-EFFECT PROFILES OF MARKETED AND LATE-CLINICAL STAGE THERAPIES FOR MS
  • TABLE 6 MS THERAPIES IN CLINICAL TRIALS, ORDERED BY PHASE
  • TABLE 7 MS THERAPIES IN DEVELOPMENT, BY PHASE
  • TABLE 8 MS THERAPIES IN ACTIVE CLINICAL TRIALS BY PRIMARY TARGET
  • TABLE 9 COMPANIES WITH MORE THAN ONE MS THERAPY IN ACTIVE CLINICAL TRIALS OR ON THE MARKET
  • TABLE 10 EFFICACY RESULTS OF MS DISEASE-MODIFYING THERAPIES
  • TABLE 11 GLOBAL SALES OF MS DISEASE-MODIFYING THERAPIES BY FORMULATION, THROUGH 2018 ($ MILLIONS)
  • TABLE 12 ADMINISTRATION PROFILES OF THERAPIES APPROVED TO TREAT MS
  • TABLE 13 U.S. PATENT EXPIRATION DATES OF THERAPIES FOR MS ON THE MARKET OR IN PHASE III DEVELOPMENT
  • TABLE 14 PATENT APPLICATIONS
  • TABLE 15 ISSUED PATENTS
  • TABLE 16 PATENT ASSIGNEES (NUMBER OF PATENTS)
  • TABLE 17 GLOBAL MARKET FOR SMALL MOLECULE MS DISEASE-MODIFYING DRUGS BY INDIVIDUAL DRUG, THROUGH 2018 ($ MILLIONS)
  • TABLE 18 COPAXONE PIVOTAL STUDY RESULTS
  • TABLE 19 GILENYA PIVOTAL PHASE III STUDY RESULTS
  • TABLE 20 AUBAGIO PHASE III STUDY RESULTS FROM TEMSO AND TEMPO
  • TABLE 21 TECFIDERA GLOBAL PHASE III CLINICAL PROGRAM
  • TABLE 22 GLOBAL MARKET FOR BIOLOGICS FOR MS BY INDIVIDUAL DRUGS, THROUGH 2018 ($ MILLIONS)
  • TABLE 23 BIOLOGICS FOR MS BY CLASS
  • TABLE 24 BENEFITS AND CHARACTERISTICS OF MABS
  • TABLE 25 SELECTED ANTIBODIES IN DEVELOPMENT FOR MS
  • TABLE 26 TYSABRI SENTINEL AND AFFIRM STUDY RESULTS
  • TABLE 27 DACLIZUMAB CHOICE STUDY RESULTS
  • TABLE 28 TWO-YEAR BETASERON RRMS STUDY RESULTS
  • TABLE 29 THREE-YEAR BETASERON RRMS STUDY RESULTS
  • TABLE 30 AVONEX PIVOTAL PHASE III STUDY RESULTS
  • TABLE 31 LABELS OF APPROVED DISEASE MODIFYING THERAPIES FOR MS
  • TABLE 32 GLOBAL FORECAST FOR MS DISEASE-MODIFYING THERAPIES BY REGION, THROUGH 2018 ($ MILLIONS)

LIST OF FIGURES

  • SUMMARY FIGURE GLOBAL MARKET FOR THERAPIES TREATING MS, 2011-2018 ($ MILLIONS)
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