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市場調査レポート

バイオマーカー:技術および世界市場

Biomarkers: Technologies and Global Markets

発行 BCC Research 商品コード 174949
出版日 ページ情報 英文 203 Pages
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バイオマーカー:技術および世界市場 Biomarkers: Technologies and Global Markets
出版日: 2016年06月15日 ページ情報: 英文 203 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

世界のバイオマーカー市場は2014年に394億米ドルに達しました。同市場は2015年の506億米ドルから2020年には966億米ドルへと、CAGR13.8%で拡大するとみられています。

当レポートでは、ゲノミクス、プロテオミクスなどの様々なバイオマーカーを概説し、世界の市場動向と成長見通し、技術の最新動向、米国、欧州などの関連当局による規制動向などをまとめた結果をお届けします。

第1章 イントロダクション

第2章 サマリー

第3章 概要

  • イントロダクション
  • バイオマーカーの種類
  • バイオマーカー適用によるコスト削減機会
  • 戦略的バイオマーカー応用
  • 投与量選択に向けた新たな取り組み
  • 有効なバイオマーカー評価に対する提言
  • バイオマーカー:課題と機会
  • 製品概要と市場
  • 癌のバイオマーカー:適用が成長を促進
  • バイオマーカー市場の予測

第4章 法規制動向、知的財産、倫理的考察

  • イントロダクション
  • バイオマーカー研究所の規制概要
  • 欧州医薬品庁

第5章 治療分野別応用

  • 概要
  • 腫瘍学
  • 肺癌
  • 臨床バイオマーカー:治療疾患別市場予測

第6章 薬剤開発を積極的に誘導するバイオマーカー

  • イントロダクション

第7章 企業分析

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次
Product Code: BIO061D

REPORT HIGHLIGHTS

The global biomarkers market has grown to $39.4 billion in 2014 from $29.3 billion in 2013. The market is expected to grow at a five-year compound annual growth rate (CAGR) of 13.8% from 2015 to 2020, increasing from $50.6 billion in 2015 to $96.6 billion in 2020.

This report provides:

  • An overview of the global markets for biomarkers.
  • Analyses of global market trends, with data from 2014, estimates for 2015, and projections of compound annual growth rates (CAGRs) through 2020.
  • Assessments of companies poised to introduce products during the forecast period and discussion on how these introductions will change the face of the competitive environment.
  • A range of information from detailed product analyses within disease subsegments to overall industry trends.
  • A look at how market growth is expected in emerging geographies, driven by the growing middle class in emerging countries such as India, China, Brazil, and Russia.
  • Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development.

SCOPE OF REPORT

Current and projected product forecasts during the forecast period (2015 to 2020) are discussed. As well, new products approved in 2013 and 2014 by the FDA and those products expected to be approved within the forecast period are projected. Due to the release timing of this report, 2015 figures are estimated except where actual results have been reported.

The report includes analysis of leading and emerging competitors in the current worldwide biomarkers market. Profiles of manufacturers of leading products as well as biotechnology companies with novel products in development are analyzed to define specific product strategies that were 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 of current market leaders, as well as companies with innovative products poised to advance within the forecast period, are discussed.

Market figures are based on revenues at the manufacturers' level and are projected at 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 by company from 2015 through 2020. The study is arranged to offer an overview of the 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 in order to include prevalent data for each disease subsegment.

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. Jackson has been consulting with 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 BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL BIOMARKERS MARKET, BY SEGMENT, 2013-2020 ($ MILLIONS)
  • BIOMARKER MARKET SEGMENTS
    • GENOMICS
    • IMAGING
    • PROTEOMICS
    • BIOINFORMATICS

CHAPTER 3 - OVERVIEW

  • INTRODUCTION
    • TABLE 1: GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 2: GLOBAL MARKET FOR BIOMARKERS, BY SEGMENT, THROUGH 2015 ($ MILLIONS)
    • TABLE 3: GLOBAL BIOMARKERS MARKET GROWTH IN DRUG DISCOVERY, THROUGH 2020 (%)
  • TYPES OF BIOMARKERS
    • BIOMARKERS FOR CANCER
      • TABLE 4: COMPANION DIAGNOSTICS DEVELOPED IN-HOUSE OR WITH COLLABORATORS
      • TABLE 5: PERCENTAGE OF CANCER PATIENTS WHO WILL HAVE A PREDICTIVE BIOMARKER, BY SEGMENT, 2010-2020 (%)
      • TABLE 6: FREQUENCY OF APPROACH IN CLAIMS REVIEW, BY PAYERS, 2013-2020 (%)
      • TABLE 7: RELATIVE IMPORTANCE FOR REIMBURSEMENT DECISIONS BASED ON TEST FACTORS, 2009-2015 (%)
    • BIOMARKERS FOR NON-ONCOLOGY INDICATIONS
    • DISEASE-SPECIFIC BIOMARKERS AND COMPANION DIAGNOSTICS
  • COST REDUCTION OPPORTUNITIES ARISING FROM BIOMARKER APPLICATIONS
    • SURROGATE ENDPOINTS
      • General Characteristics of Biomarkers/Endpoints
        • Advantages of Biomarkers/Endpoints
        • Important Features of Biomarkers/Endpoints
    • VALUE TO VACCINE AND DRUG DEVELOPMENT
      • Elements of Cost in Drug Research and Development
      • Elements of Cost in Healthcare
        • TABLE 8: U.S. HEALTHCARE SPENDING, 2013 (% OF $2.9 TRILLION)
        • TABLE 9: YEAR-OVER-YEAR PRECENT GROWTH IN SPENDING, BY CATEGORY, 2011-2012 AND 2012-2013 (%)
  • STRATEGIC BIOMARKER APPLICATIONS
    • BREAST CANCER
      • TABLE 10: PERSONALIZED TREATMENT OPTIONS FOR BREAST CANCER
  • CSF BIOMARKERS
    • PERIPHERAL BIOMARKERS
      • Ultra-Blockbuster
        • TABLE 11: CNS BIOMARKERS BY DISEASE/CONDITION
        • TABLE 12: INFORMATION TECHNOLOGY (IT) STRATEGIES
  • BIOMARKERS ON TARGET
    • TABLE 13: INITIAL DESIGNS AND CAPABILITIES FOR CLINICAL TRIALS
    • Adapting to Data
      • TABLE 14: BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS
    • Safety/Toxicology Biomarkers
      • Liver
      • Muscle
      • Cardiac Hypertrophy
      • Vascular Injury
    • Dose Selection and Dose Optimization
      • TABLE 15: NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE
  • 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 Endpoints
        • TABLE 16: PATIENT OUTCOME MEASUREMENTS BIOMARKERS
  • SUMMARY OF RECOMMENDATIONS FOR EFFECTIVE BIOMARKER EVALUATION
    • THE EVALUATION FRAMEWORK
    • SCIENTIFIC PROCESS HARMONIZATION
    • BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS
    • CHALLENGES TO TBI BIOMARKER DEVELOPMENT
      • TABLE 17: BIOMARKER AND CLINICAL ENDPOINT ONE
      • TABLE 18: BIOMARKER AND CLINICAL ENDPOINT TWO
      • TABLE 19: BIOMARKER INDICATION OF SEVERITY TO IMPROVE OUTCOME
  • HOW BIOMARKERS MIGHT FACILITATE TBI THERAPY DEVELOPMENT
    • Immediate Action Items
  • EARLY-STAGE CLINICAL TRIAL APPLICATIONS
    • TABLE 20: CLINICAL TRIAL PIPELINE-PHASE OF INTERVENTION DEVELOPMENT
  • BIOMARKERS: CHALLENGES AND OPPORTUNITIES
    • SUMMARY
    • CHALLENGES
    • OPPORTUNITIES
      • Personalized Healthcare Concepts - the Role of Biomarkers
      • Definitions
      • Biomarker Versus Diagnostic
      • Value of Biomarkers
      • Personalized Medicine
      • Stages of Biomarker Development
    • PROTEIN BIOMARKER TECHNOLOGY PLATFORMS - HYPOTHESIS-DRIVEN VERSUS HYPOTHESIS-FREE APPROACHES
    • CLINICAL VALIDITY: REQUIREMENTS
    • BIOMARKER OPPORTUNITIES
      • Environmental Exposures, Effect Modifiers or Risk Factors
        • TABLE 21: CROSS-SECTIONAL INVESTIGATIONS
      • Intermediate Biomarkers
      • Screening, Diagnostic Tests, and Prognosis
    • VARIABILITY
    • VALIDITY
  • PRODUCT SUMMARY AND MARKET
    • GENOMICS
      • TABLE 22: GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2015 ($ MILLIONS)
      • Progress in Genomic Biomarker Development
      • Early Detection Biomarkers
      • Emerging Evidence
      • Democratizing Healthcare
    • BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY
    • ADDING TRIGLYCERIDE OR TESTOSTERONE TO THE LIST OF MEDICALIZED BIOMARKERS
  • CANCER BIOMARKERS - ADOPTION IS DRIVING GROWTH
    • TABLE 23: CLINICIAL PATIENT MONITORING BY SUBDISEASE (%)
  • 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
  • BIOMARKER MARKET FORECAST
    • TABLE 24: GLOBAL BIOMARKER MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)

CHAPTER 4 - REGULATORY DYNAMICS, INTELLECTUAL PROPERTY AND ETHICAL CONSIDERATIONS

  • INTRODUCTION
  • BIOMARKER LABORATORY REGULATORY SUMMARY
    • DEFINITION OF AN IVD COMPANION DIAGNOSTIC
      • Labeling
        • TABLE 25: 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 CODEVELOPMENT
    • IVD Companion Diagnostic Devices - Key Draft Guidance Points
    • Relevant FDA Guidance Documents for Codevelopment
    • Establishing a Training and Test Set of Samples
      • Pipeline for Biomarker Development
      • Clinical Conceptions on the Biomarkers Study Design
      • Technical Considerations Regarding the Analytical Setup for Biomarker Development
      • Discovery of Biomarkers
      • Gel-based Proteomics Platforms for Biomarker Discovery
      • Gel-free Proteomics - 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 Proteomic Approaches in BCa Biomarker Discovery
    • Analytical Validation of a Companion Diagnostic
    • Companion Diagnostic Validation
    • Reasons for Problems
    • Problems Envisioned
  • CLINICAL VALIDATION
    • Short Overview of Different Kinds of Biomarkers
      • TABLE 26: BIOMARKER CATEGORIES AND TYPES
    • Overview of Approved CDx on the Market
    • Key Points to be Addressed
    • Considerations Before Initiating the Biomarker Discovery Phase
    • The Current State of Biomarker Discovery
    • Pitfalls and Limitations
  • SELECTION OF PATIENTS AND CONTROLS
  • ROLE OF THE FOOD AND DRUG ADMINISTRATION
  • FDA GUIDELINES FOR BIOMARKER APPLICATIONS
    • TABLE 27: BIOMARKER QUALIFICATION PROGRAM
  • EUROPEAN MEDICINES AGENCY
    • REGULATORY IMPACT ON DRUG SAFETY
    • INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
      • Approved Patent Analysis
        • TABLE 28: ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2015 (NO. OF PATENTS)
    • COMPETITIVE LANDSCAPE
    • LATE-STAGE CLINICAL TRIALS - COMPETITIVE POSITIONING
      • TABLE 29: GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
      • TABLE 30: SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY
      • TABLE 31: REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN

CHAPTER 5 - APPLICATION BY THERAPY AREA

  • OVERVIEW
    • TABLE 32: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
  • ONCOLOGY
    • TABLE 33: REPRESENTATIVE BIOMARKERS IN CLINICAL USE - ONCOLOGY
    • TABLE 34: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS FOR BREAST CANCER, 2005-2009
  • OTHER PREDICTIVE TESTS
    • TABLE 35: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS IN ONCOLOGY, 2005-2009
  • OTHER PROGNOSTIC TESTS
  • LUNG CANCER
    • INTRODUCTION
    • PREDICTIVE TESTS
      • TABLE 36: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS - LUNG CANCER, 2006-2014
      • Central Nervous System
        • TABLE 37 REPRESENTATIVE BIOMARKERS IN CLINICAL USE - CNS DISEASE, 2008-2013
      • Immunology
        • TABLE 38: REPRESENTATIVE BIOMARKERS IN CLINICAL USE - IMMUNOLOGY, 2013
      • Immunology: Benlysta/GlaxoSmithKline and Human Genome Sciences
    • EXPEDITION AND IDENTITY
      • Alzheimer's Trials: Eli Lilly
    • CLINICAL BIOMARKERS - THERAPEUTIC DISEASE MARKET FORECAST
      • TABLE 39: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
      • TABLE 40: GLOBAL MARKET OF BIOMARKERS IN LATE-STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)

CHAPTER 6 - BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT

  • INTRODUCTION
    • TABLE 41 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKERS AND DRUG DEVELOPMENT COMPANIES
  • ASURAGEN INC.
    • BACKGROUND
    • COLLABORATION
      • Merck & Co.
  • BG MEDICINE
    • BACKGROUND
    • COLLABORATION
      • Cordex Pharma
  • BIOMERIEUX
    • BACKGROUND
    • COLLABORATIONS
      • Ipsen
      • Merck & Co.
      • ADNA Project
  • CELERA CORPORATION
    • BACKGROUND
    • COLLABORATIONS
      • Abbott
      • Merck & Co.
      • Ipsen
  • CURIDIUM
    • COLLABORATION
      • Takeda
  • DAKO NORTH AMERICA INC.
    • BACKGROUND
    • COLLABORATIONS
      • OSI Pharmaceuticals
      • Genentech
      • Bristol-Myers Squibb
  • DXS
    • BACKGROUND
    • COLLABORATIONS
      • Amgen
      • Roche Molecular Diagnostics
  • GE HEALTHCARE
    • BACKGROUND
    • COLLABORATION
      • Eli Lilly
  • GENOMIC HEALTH
    • BACKGROUND
    • COLLABORATIONS
      • Pfizer
      • Bristol-Myers Squibb and Imclone Systems
  • HISTORX
    • BACKGROUND
    • COLLABORATION
      • Eli Lilly
  • LABORATORY CORPORATION OF AMERICA HOLDINGS/LABCORP
    • BACKGROUND
    • COLLABORATIONS
      • ARCA Biopharma
      • Vanda Pharmaceuticals
      • Medco Health Solutions
  • MDXHEALTH
    • BACKGROUND
    • COLLABORATIONS
      • Merck KGaA
      • Schering-Plough
      • GlaxoSmithKline Biologicals
      • Abbott
  • MONOGRAM BIOSCIENCES
    • BACKGROUND
    • COLLABORATIONS
      • Pfizer HIV Partnership
      • VeraTag Oncology Platform
  • XDX (CAREDX)
    • BACKGROUND
    • COLLABORATION
      • Bristol-Myers Squibb

CHAPTER 7 - COMPANY ANALYSIS

  • ABBOTT LABORATORIES INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 42: ABBOTT: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • AFFYMETRIX INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 43: AFFYMETRIX: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ASTELLAS PHARMA INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 44: ASTELLAS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ASTRAZENECA LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 45: ASTRAZENECA: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BANYAN BIOMARKERS INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 46: BANYAN BIOMARKERS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BAYER SCHERING PHARMA AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 47: BAYER SCHERING: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BG MEDICINE INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • BIOPHYSICAL CORP.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 48: BIOPHYSICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BIOSYSTEMS INTERNATIONAL INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 49: BIOSYSTEMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • BOEHRINGER INGELHEIM GMBH
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • BRISTOL-MYERS SQUIBB CO.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 50: 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 CO. LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 51: DAIICHI SANKYO: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • EISAI CO. LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 52: EISAI: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ELI LILLY AND CO.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 53: ELI LILLY: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • EPIGENOMICS AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 54: EPIGENOMICS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • GENEDATA AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 55: GENEDATA AG: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • GENENEWS LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
    • COMPANY STRATEGY
  • GLAXOSMITHKLINE
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 56: GSK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
  • COMPANY STRATEGY
    • JOHNSON & JOHNSON LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 57: JOHNSON & JOHNSON: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • MERCK & CO.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 58: MERCK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • NOVARTIS AG
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 59: NOVARTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • PFIZER INC.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 60: PFIZER: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • ROCHE LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 61: ROCHE: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • SANOFI-AVENTIS
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 62: SANOFI-AVENTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • TAKEDA PHARMACEUTICALS LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 63: TAKEDA PHARMACEUTICALS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY
  • TEVA PHARMACEUTICAL INDUSTRIES LTD.
    • COMPANY OVERVIEW
    • PRODUCTS AND SERVICES
      • TABLE 64: TEVA PHARMACEUTICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • COMPANY STRATEGY

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 1: GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 2: GLOBAL MARKET FOR BIOMARKERS, BY SEGMENT, THROUGH 2015 ($ MILLIONS)
    • TABLE 3: GLOBAL BIOMARKERS MARKET GROWTH IN DRUG DISCOVERY, THROUGH 2020 (%)
    • TABLE 4: COMPANION DIAGNOSTICS DEVELOPED IN-HOUSE OR WITH COLLABORATORS
    • TABLE 5: PERCENTAGE OF CANCER PATIENTS WHO WILL HAVE A PREDICTIVE BIOMARKER, BY SEGMENT, 2010-2020 (%)
    • TABLE 6: FREQUENCY OF APPROACH IN CLAIMS REVIEW, BY PAYERS, 2013-2020 (%)
    • TABLE 7: RELATIVE IMPORTANCE FOR REIMBURSEMENT DECISIONS BASED ON TEST FACTORS, 2009-2015 (%)
    • TABLE 8: U.S. HEALTHCARE SPENDING, 2013 (% OF $2.9 TRILLION)
    • TABLE 9: YEAR-OVER-YEAR PRECENT GROWTH IN SPENDING, BY CATEGORY, 2011-2012 AND 2012-2013 (%)
    • TABLE 10: PERSONALIZED TREATMENT OPTIONS FOR BREAST CANCER
    • TABLE 11: CNS BIOMARKERS BY DISEASE/CONDITION
    • TABLE 12: INFORMATION TECHNOLOGY (IT) STRATEGIES
    • TABLE 13: INITIAL DESIGNS AND CAPABILITIES FOR CLINICAL TRIALS
    • TABLE 14: BENEFITS OF BIOMARKERS AS SURROGATE ENDPOINTS
    • TABLE 15: NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE
    • TABLE 16: PATIENT OUTCOME MEASUREMENTS BIOMARKERS
    • TABLE 17: BIOMARKER AND CLINICAL ENDPOINT ONE
    • TABLE 18: BIOMARKER AND CLINICAL ENDPOINT TWO
    • TABLE 19: BIOMARKER INDICATION OF SEVERITY TO IMPROVE OUTCOME
    • TABLE 20: CLINICAL TRIAL PIPELINE-PHASE OF INTERVENTION DEVELOPMENT
    • TABLE 21: CROSS-SECTIONAL INVESTIGATIONS
    • TABLE 22: GLOBAL BIOMARKERS MARKET, BY SEGMENT, THROUGH 2015 ($ MILLIONS)
    • TABLE 23: CLINICIAL PATIENT MONITORING BY SUBDISEASE (%)
    • TABLE 24: GLOBAL BIOMARKER MARKET, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 25: PHARMACOGENOMIC BIOMARKERS IN DRUG LABELING
    • TABLE 26: BIOMARKER CATEGORIES AND TYPES
    • TABLE 27: BIOMARKER QUALIFICATION PROGRAM
    • TABLE 28: ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2015 (NO. OF PATENTS)
    • TABLE 29: GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 30: SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY
    • TABLE 31: REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN
    • TABLE 32: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
    • TABLE 33: REPRESENTATIVE BIOMARKERS IN CLINICAL USE - ONCOLOGY
    • TABLE 34: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS FOR BREAST CANCER, 2005-2009
    • TABLE 35: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS IN ONCOLOGY, 2005-2009
    • TABLE 36: ONGOING REPRESENTATIVE ACTIVE BIOMARKER TRIALS - LUNG CANCER, 2006-2014
    • TABLE 37: REPRESENTATIVE BIOMARKERS IN CLINICAL USE - CNS DISEASE, 2008-2013
    • TABLE 38: REPRESENTATIVE BIOMARKERS IN CLINICAL USE - IMMUNOLOGY, 2013
    • TABLE 39: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS, BY SEGMENT, THROUGH 2020 ($ MILLIONS)
    • TABLE 40: GLOBAL MARKET OF BIOMARKERS IN LATE-STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2020 ($ MILLIONS)
    • TABLE 41: RECENT CORPORATE ALLIANCES BETWEEN BIOMARKERS AND DRUG DEVELOPMENT COMPANIES
    • TABLE 42: ABBOTT: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 43: AFFYMETRIX: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 44: ASTELLAS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 45: ASTRAZENECA: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 46: BANYAN BIOMARKERS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 47: BAYER SCHERING: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 48: BIOPHYSICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 49: BIOSYSTEMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 50: BMS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 51: DAIICHI SANKYO: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 52: EISAI: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 53: ELI LILLY: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 54: EPIGENOMICS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 55: GENEDATA AG: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 56: GSK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 57: JOHNSON & JOHNSON: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 58: MERCK: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 59: NOVARTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 60: PFIZER: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 61: ROCHE: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 62: SANOFI-AVENTIS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 63: TAKEDA PHARMACEUTICALS: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
    • TABLE 64: TEVA PHARMACEUTICAL: REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS

LIST OF FIGURES

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