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中枢神経系 (CNS) バイオマーカー:技術および世界市場

Central Nervous System (CNS) Biomarkers: Technologies and Global Markets

発行 BCC Research 商品コード 136786
出版日 ページ情報 英文 160 Pages
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中枢神経系 (CNS) バイオマーカー:技術および世界市場 Central Nervous System (CNS) Biomarkers: Technologies and Global Markets
出版日: 2016年03月14日 ページ情報: 英文 160 Pages
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概要

世界の中枢神経系 (CNS) バイオマーカー市場規模は、2015年の31億米ドルから2020年までに51億米ドルへ、10.4%のCAGR (年間複合成長率) で拡大すると予測されています。

当レポートでは、世界の中枢神経系 (CNS) 向けバイオマーカー市場について分析し、製品の特徴や市場の動向、関連技術 (ゲノミクス、プロテオミクスおよびイメージングなど) の利点・欠点の評価、各疾患 (アルツハイマー病、うつ病、パーキンソン病、多発性硬化症など) の 有病率・治療格差、特許情報、および主要企業のプロファイルなど、体系的な情報を提供しています。

第1章 イントロダクション

第2章 サマリー

第3章 概要

  • イントロダクション
  • 癌向けバイオマーカー
  • 癌以外の症状向けバイオマーカー
  • 超大ヒット
  • 的確なバイオマーカー
  • 投与量選択・最適化
  • 早期段階治験のアプリケーション
  • バイオマーカーの課題・機会のサマリー
  • タンパク質バイオマーカー技術のプラットフォーム:仮説駆動型 vs. 仮説無しのアプローチ
  • 臨床的妥当性の要件
  • バイオマーカーの進歩
  • 変動性
  • 妥当性
  • 製品サマリー・市場
  • バイオマーカーの導入:医薬品産業別
  • 癌バイオマーカー:導入が成長を促進
  • 治験のメリット:コスト・リスクの回避
  • バイオマーカー市場の予測

第4章 規制の動き・知的財産・倫理上の検討事項

  • イントロダクション
  • バイオマーカーラボの規制:サマリー
  • 新技術の規制プロセス
  • 新興世界のレビュー
  • 診断薬の共同開発におけるアッセイ開発および検証
  • バイオマーカーの最も重要な種類

第5章 CNSバイオマーカーのアプリケーション

  • 概要
  • 中枢神経系
  • 臨床バイオマーカー:疾病治療市場の予測

第6章 創薬を導くバイオマーカー

  • 概要

第7章 企業プロファイル

  • ABBOTT LABORATORIES INC.
  • AFFYMETRIX INC.
  • アステラス製薬
  • ASTRAZENECA LTD.
  • BANYAN BIOMARKERS INC.
  • BAYER SCHERING PHARMA AG
  • BG MEDICINE INC.
  • BIOPHYSICAL CORP.
  • BIOSYSTEMS INTERNATIONAL INC.
  • BOEHRINGER INGELHEIM GMBH
  • BRISTOL-MYERS SQUIBB CO.
  • CAPRION PROTEOMICS INC.
  • 第一三共
  • エーザイ
  • ELI LILLY AND COMPANY
  • EPIGENOMICS AG
  • GENEDATA AG
  • GENENEWS LTD
  • GLAXOSMITHKLINE
  • JOHNSON & JOHNSON LTD.
  • MERCK & CO.
  • NOVARTIS AG
  • PFIZER INC.
  • ROCHE LTD
  • SANOFI
  • 武田薬品工業
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.

図表一覧

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目次
Product Code: BIO074C

REPORT HIGHLIGHTS

The global CNS biomarker market is projected to reach $5.1 billion by 2020 from $3.1 billion in 2015, at a compound annual growth rate (CAGR) of 10.4%.

This report provides:

  • An overview of the global market for central nervous system (CNS) biomarkers, which are measurable and quantifiable biological indicators that can be used to diagnose or predict disease, monitor disease progression, and predict treatment response.
  • Analyses of global market trends, with data from 2014 and 2015, and projections of compound annual growth rates (CAGRs) through 2020.
  • Evaluation of technologies such as genomics, proteomics, and imaging, and assessments of their advantages and disadvantages.
  • Discussion of CNS disease segments, prevalence, and gaps in treatment for Alzheimer's disease, depression, Parkinson's disease, multiple sclerosis, and others.
  • Patent analyses.
  • Profiles of major players in the field.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2014 to 2020) are discussed. New products approved in 2013 and 2014 by the U.S. Food and Drug Administration (FDA), and those products expected to be approved within the forecast period are discussed. Figures for 2015 are estimated, except where actual results have been reported.

The report includes analysis of leading and emerging competitors in the current worldwide CNS biomarkers market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define the specific product strategies employed. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products and technologies are influencing the current standard of care. Detailed profiles are provided for current market leaders as well as companies with innovative products poised to advance within the forecast period.

Market figures are based on revenues at the manufacturers' level and are projected at the 2015 dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, new product introductions, expanded indications for existing products, and projected changes in the prevalence, diagnosis, and scripting rates for certain diseases.

Included in this report are forecasts by product, product category and company from 2015 through 2020. The study is arranged to offer an overview of the CNS biomarkers market accompanied by product, company, geography, and mechanism of action, with forecasts broken down and covered by geographic region or country. Virtually the entire globe is covered to include prevalence data for each disease sub segment.

In general, excluded from this report are over-the-counter (OTC) medications, and other consumables that do not require a physician's prescription.

Sales figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.

All market share data presented is on a global basis, unless specifically noted.

ANALYST'S CREDENTIALS

Jackson Highsmith is a life sciences research consultant with more than 16 years of research experience. He has been a consultant to specialty pharmaceuticals and large pharmaceutical industry players since 2007. Prior to that he worked at a large research consultancy where he focused on in depth research. He has also worked at a large pharmaceutical company dealing with a wide range of medical therapeutics in early and mid-stage drug development.

Table of Contents

CHAPTER 1 - INTRODUCTION

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

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, 2013-2020 ($ MILLIONS)

CHAPTER 3 - OVERVIEW

  • INTRODUCTION
    • TABLE 1: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY AREA, THROUGH 2020 ($ MILLIONS)
    • TABLE 2: GLOBAL MARKET FOR CNS BIOMARKERS BY AREA, THROUGH 2015 ($ MILLIONS)
    • TABLE 3: BIOMARKERS IN DRUG DISCOVERY: CNS BIOMARKERS MARKET, THROUGH 2020 (%)
  • BIOMARKERS FOR CANCER
    • TABLE 4: MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %)
    • TABLE 5: PERCENTAGE OF PREDICTIVE BIOMARKERS FOR CANCER PATIENTS BY SEGMENT, 2010-2020 (%)
    • TABLE 6: FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, 2013-2020 (%)
    • TABLE 7: RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST FACTORS, 2009-2015 (%)
  • BIOMARKERS FOR NON-ONCOLOGY INDICATIONS
    • DISEASE-SPECIFIC BIOMARKERS AND COMPANION DIAGNOSTICS
    • CSF BIOMARKERS
    • PERIPHERAL BIOMARKERS
  • ULTRA-BLOCKBUSTER
    • TABLE 8: CNS BIOMARKERS
    • TABLE 9: INFORMATION TECHNOLOGY (IT) STRATEGIES
  • BIOMARKERS ON TARGET
    • TABLE 10: INITIAL DESIGNS AND CAPABILITIES
    • ADAPTING TO DATA
    • SAFETY/TOXICOLOGY BIOMARKERS
    • LIVER
    • MUSCLE
    • CARDIAC HYPERTROPHY
    • VASCULAR INJURY
  • DOSE SELECTION AND OPTIMIZATION
    • NEW EFFORT AIMED AT DOSE SELECTION
    • IMPROVED MEASUREMENT OF THERAPEUTIC EFFICACY
      • Developing a New Framework for Long-term Addiction Treatment
        • Approach #1: Standard Treatment Patient Outcome Assessment
        • Approach #2: Independent Outcome Assessment Focused on Patient Satisfaction
        • Approach #3: Recovery-Oriented System Model and Healthcare
    • OUTCOME BIOMARKERS AND SURROGATE END POINTS
      • TABLE 11: SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION
      • TABLE 12: SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION
      • TABLE 13: BENEFITS OF BIOMARKERS AS SURROGATE END POINTS
    • CHALLENGES TO TRAUMATIC BRAIN INJURY (TBI) BIOMARKER DEVELOPMENT
      • TABLE 14: HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT
      • Immediate Action Items
  • EARLY STAGE CLINICAL TRIAL APPLICATIONS
  • SUMMARY OF BIOMARKER CHALLENGES AND OPPORTUNITIES
    • CHALLENGES
    • OPPORTUNITIES
  • PROTEIN BIOMARKER TECHNOLOGY PLATFORMS: HYPOTHESIS-DRIVEN VS HYPOTHESIS-FREE APPROACHES
  • REQUIREMENTS FOR CLINICAL VALIDITY
  • BIOMARKER PROGRESS
    • ENVIRONMENTAL EXPOSURES, EFFECT MODIFIERS, OR RISK FACTORS
      • TABLE 15: CROSS-SECTIONAL INVESTIGATIONS
    • INTERMEDIATE BIOMARKERS
    • SCREENING, DIAGNOSTIC TESTS, AND PROGNOSIS
  • VARIABILITY
  • VALIDITY
  • PRODUCT SUMMARY AND MARKET
    • GENOMICS
      • TABLE 16: GLOBAL MARKETS FOR CNS BIOMARKERS THROUGH 2015 ($ MILLIONS)
      • Progress in Genomic Biomarker Development
      • Emerging Evidence
      • Democratizing Health Care
  • BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY
  • CANCER BIOMARKERS: ADOPTION IS DRIVING GROWTH
    • TABLE 17: CLINICAL PATIENT MONITORING FOR CNS BIOMARKERS, AS COMPARED TO OTHER DISEASES (%)
  • CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE
    • PHASE II TRIALS
    • PHASE IIA BASKET DISCOVERY TRIALS
    • PHASE III TARGETED (ENRICHMENT) DESIGNS
    • PHASE III BIOMARKER STRATIFIED DESIGN
    • PHASE III ADAPTIVE THRESHOLD DESIGN
  • BIOMARKER MARKET FORECAST
    • TABLE 18: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY TECHNOLOGY, THROUGH 2020 ($ MILLIONS)

CHAPTER 4 - REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS

  • INTRODUCTION
  • BIOMARKER LABORATORY REGULATORY SUMMARY
    • DEFINITION OF AN IVD COMPANION DIAGNOSTIC
      • Labeling
        • TABLE 19: PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING
  • REGULATORY PROCESSES FOR NEW TECHNOLOGIES
    • ENSURING SAFETY AND EFFECTIVENESS OF HEALTH TECHNOLOGIES
    • SAFE FOR WIDESPREAD USE?
  • REVIEW IN THE DEVELOPING WORLD
  • ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC CO-DEVELOPMENT
    • KEY DRAFT GUIDANCE POINTS FOR IVD COMPANION DIAGNOSTIC DEVICES:
    • SOME RELEVANT FDA GUIDANCE DOCUMENTS FOR CO-DEVELOPMENT
    • PIPELINE FOR BIOMARKER DEVELOPMENT
    • CLINICAL CONCEPTIONS ON THE BIOMARKERS STUDY DESIGN
    • TECHNICAL CONSIDERATIONS REGARDING THE ANALYTICAL SET UP FOR BIOMARKER DEVELOPMENT
    • DISCOVERY OF BIOMARKERS
    • GEL-BASED PROTEOMICS PLATFORMS FOR BIOMARKER DISCOVERY
    • SHOTGUN PROTEOMICS
    • CE-MS
    • STATISTICAL DATA MINING FOR PROTEOMIC BIOMARKER DISCOVERY
    • VERIFICATION OF BIOMARKERS
    • PROTEIN BINDING ASSAYS
    • MASS SPECTROMETRIC QUANTITATIVE APPROACHES
    • PRE-TREATMENT STRATEGIES
    • DATA MINING AND STATISTICAL ANALYSIS
    • BIOINFORMATICS PLATFORMS IN CLINICAL PROTEOMICS
    • APPLICATIONS OF SYSTEMS BIOLOGY---DISEASE DIAGNOSIS AND TREATMENT
    • VALIDATION OF BIOMARKER CANDIDATES
    • APPLICATION OF PROTEOMICS APPROACHES IN BCA BIOMARKER DISCOVERY
      • Analytical Validation of a Companion Diagnostic
    • COMPANION DIAGNOSTIC VALIDATION
    • CLINICAL VALIDATION
  • OVERVIEW OF ESSENTIAL TYPES OF BIOMARKERS
    • TABLE 20: BIOMARKER CATEGORIES AND TYPES
    • OVERVIEW OF ALREADY APPROVED CDX ON THE MARKETS
    • KEY POINTS TO BE ADDRESSED
    • CONSIDERATIONS BEFORE INITIATING THE BIOMARKER DISCOVERY PHASE
    • CONSIDERATIONS ON THE SELECTION AND RANDOMIZATION OF PATIENTS FOR BIOMARKER STUDIES: LOOKING FOR THE 'IDEAL' PATIENTS
    • THE CURRENT STATE OF BIOMARKER DISCOVERY
    • PITFALLS AND LIMITATIONS
    • SELECTION OF PATIENTS AND CONTROLS
    • ROLE OF THE FOOD & DRUG ADMINISTRATION
    • FDA GUIDELINES FOR BIOMARKER APPLICATIONS
      • TABLE 21: BIOMARKER QUALIFICATION PROGRAM
    • EUROPEAN MEDICINES AGENCY
    • REGULATORY IMPACT ON DRUG SAFETY
    • INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
      • Approved Patent Analysis
        • TABLE 22: ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%)
    • COMPETITIVE LANDSCAPE
    • LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING
      • TABLE 23: GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2020 ($ MILLIONS)
      • TABLE 24: SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, 2007-2014
      • TABLE 25: REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE, AND JAPAN

CHAPTER 5 - APPLICATIONS OF CNS BIOMARKERS

  • OVERVIEW
    • TABLE 26: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
  • CENTRAL NERVOUS SYSTEM
    • TABLE 27: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
  • CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST
    • TABLE 28: GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2020 ($ MILLIONS)
    • TABLE 29: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS IN LATE STAGE CLINICAL USE, THROUGH 2020 ($ MILLIONS)

CHAPTER 6 - BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT

  • AN OVERVIEW
    • TABLE 30: RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A DRUG DEVELOPMENT COMPANY

CHAPTER 7 - COMPANY ANALYSIS

  • ABBOTT LABORATORIES INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 31: ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • AFFYMETRIX INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 32: AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ASTELLAS PHARMA INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 33: ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ASTRAZENECA LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 34: ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BANYAN BIOMARKERS INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 35: BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BAYER SCHERING PHARMA AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 36: BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BG MEDICINE INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 37: BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BIOPHYSICAL CORP.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • BIOSYSTEMS INTERNATIONAL INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • BOEHRINGER INGELHEIM GMBH
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 38: BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BRISTOL-MYERS SQUIBB CO.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 39: BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • CAPRION PROTEOMICS INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
      • Infectious Diseases
      • Diabetes and Metabolic Disease
      • Oncology
  • DAIICHI SANKYO COMPANY LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 40: DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • EISAI CO. LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 41: EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ELI LILLY AND COMPANY
    • COMPANY OVERVIEW
    • PRODUCT AND SERVICES
      • TABLE 42: ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • EPIGENOMICS AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 43: EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • GENEDATA AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 44: GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • GENENEWS LTD
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • GLAXOSMITHKLINE
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 45: GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • JOHNSON & JOHNSON LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 46: JOHNSON & JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • MERCK & CO.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 47: MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • NOVARTIS AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 48: NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • PFIZER INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 49: PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ROCHE LTD
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 50: ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • SANOFI
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 51: SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • TAKEDA PHARMACEUTICALS LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 52: TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 53: TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
    • TABLE 1: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY AREA, THROUGH 2020 ($ MILLIONS)
    • TABLE 2: GLOBAL MARKET FOR CNS BIOMARKERS BY AREA, THROUGH 2015 ($ MILLIONS)
    • TABLE 3: BIOMARKERS IN DRUG DISCOVERY: CNS BIOMARKERS MARKET, THROUGH 2020 (%)
    • TABLE 4: MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %)
    • TABLE 5: PERCENTAGE OF PREDICTIVE BIOMARKERS FOR CANCER PATIENTS BY SEGMENT, 2010-2020 (%)
    • TABLE 6: FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, 2013-2020 (%)
    • TABLE 7: RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST FACTORS, 2009-2015 (%)
    • TABLE 8: CNS BIOMARKERS
    • TABLE 9: INFORMATION TECHNOLOGY (IT) STRATEGIES
    • TABLE 10: INITIAL DESIGNS AND CAPABILITIES
    • TABLE 11: SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION
    • TABLE 12: SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION
    • TABLE 13: BENEFITS OF BIOMARKERS AS SURROGATE END POINTS
    • TABLE 14: HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT
    • TABLE 15: CROSS-SECTIONAL INVESTIGATIONS
    • TABLE 16: GLOBAL MARKETS FOR CNS BIOMARKERS THROUGH 2015 ($ MILLIONS)
    • TABLE 17: CLINICAL PATIENT MONITORING FOR CNS BIOMARKERS, AS COMPARED TO OTHER DISEASES (%)
    • TABLE 18: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY TECHNOLOGY, THROUGH 2020 ($ MILLIONS)
    • TABLE 19: PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING
    • TABLE 20: BIOMARKER CATEGORIES AND TYPES
    • TABLE 21: BIOMARKER QUALIFICATION PROGRAM
    • TABLE 22: ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%)
    • TABLE 23: GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2020 ($ MILLIONS)
    • TABLE 24: SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, 2007-2014
    • TABLE 25: REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE, AND JAPAN
    • TABLE 26: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
    • TABLE 27: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
    • TABLE 28: GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2020 ($ MILLIONS)
    • TABLE 29: GLOBAL MARKET FORECAST FOR CNS BIOMARKERS IN LATE STAGE CLINICAL USE, THROUGH 2020 ($ MILLIONS)
    • TABLE 30: RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A DRUG DEVELOPMENT COMPANY
    • TABLE 31: ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 32: AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 33: ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 34: ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 35: BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 36: BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 37: BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 38: BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 39: BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 40: DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 41: EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 42: ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 43: EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 44: GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 45: GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 46: JOHNSON & JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 47: MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 48: NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 49: PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 50: ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 51: SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 52: TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 53: TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, 2013-2020 ($ MILLIONS)
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