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

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

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.

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
TOPIC
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

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