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
Study Goals and Objectives:
This study provides a comprehensive analysis of CNS biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease sub segments to overall industry trends, in order to quantify and qualify the market for products and services in the CNS biomarkers segment. Individual product-types are forecast on a global basis, as are overall segments. Forecasts and trends are developed from a cross-reference of data points gleaned from proprietary industry sources, company publications, industry benchmarking and other divergent data sources to arrive at a cogent and coordinated forecast.
Scope of the 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.
Use this report to:
- Examine leading and emerging competitors in the current worldwide CNS biomarkers market.
- Investigate the introduction of combination therapies, which are expected to contribute substantially to market growth through the forecast period.
- Assesses companies poised to introduce products during the forecast period and discuss how it will affect the competitive environment.
- Examine the competitive environment with emphasis on how new products and technologies are influencing the current standard of care.
- The global CNS biomarker market should reach nearly $5.1 billion by 2020 from $3.1 billion in 2015, a compound annual growth rate (CAGR) of 10.4% from 2015 to 2020.
- The discovery application market should reach over $3.3 billion by 2020 from over $1.9 billion in 2015, a CAGR of 11.7% from 2015 to 2020.
- The drug development application market should reach $776 million by 2020 from $303 million in 2015, a CAGR of 20.7% from 2015 to 2020.
This report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants and anyone interested in the CNS biomarkers market, its products,industry participants and its future. The importance of identifying overall market trends, product opportunities, emerging geographies, M&A opportunities and insights that provide guidance for sales growth defensive moves cannot be overstated for a variety of constituents, including:
- Established companies in the industry who can benefit from the contents, including corporate strategy, sales and marketing, business development, and R&D.
- Emerging biotechnology players in the segment who must understand specific opportunities for out-licensing, originating from the elements of differentiation of their biomarker product or technology as compared to leading, competitive, and emerging therapies. As well, market forecasts can support investment, provided a thorough and detailed substantiation is provided for the market forecast, as is found in this study.
- Investment firms evaluating candidates for venture capital or hedged investments who will gain insights into the opportunities and risks that are being encountered in the industry, in a product- and company-specific analysis.
- Equity analysts who can use the detailed forecasts for the next five years, substantiated by quantitative analysis, to support further analysis of product and company forecasts over the short and long run.
- STUDY GOALS AND OBJECTIVES
- REASONS FOR DOING THE STUDY
- SCOPE OF REPORT
- INTENDED AUDIENCE
- METHODOLOGY AND INFORMATION SOURCES
Chapter- 2: SUMMARY
- Table Summary : GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, THROUGH 2020
- Figure Summary : GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, 2013-2020
Chapter- 3: OVERVIEW
- BIOMARKERS FOR CANCER
- BIOMARKERS FOR NON-ONCOLOGY INDICATIONS
- BIOMARKERS ON TARGET
- DOSE SELECTION AND OPTIMIZATION
- EARLY STAGE CLINICAL TRIAL APPLICATIONS
- SUMMARY OF BIOMARKER CHALLENGES AND OPPORTUNITIES
- PROTEIN BIOMARKER TECHNOLOGY PLATFORMS: HYPOTHESIS-DRIVEN VS HYPOTHESIS-FREE APPROACHES
- REQUIREMENTS FOR CLINICAL VALIDITY
- BIOMARKER PROGRESS
- PRODUCT SUMMARY AND MARKET
- BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY
- CANCER BIOMARKERS: ADOPTION IS DRIVING GROWTH
- CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE
- BIOMARKER MARKET FORECAST
Chapter- 4: REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS
- BIOMARKER LABORATORY REGULATORY SUMMARY
- REGULATORY PROCESSES FOR NEW TECHNOLOGIES
- REVIEW IN THE DEVELOPING WORLD
- ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC CO-DEVELOPMENT
- OVERVIEW OF ESSENTIAL TYPES OF BIOMARKERS
Chapter- 5: APPLICATIONS OF CNS BIOMARKERS
- CENTRAL NERVOUS SYSTEM
- CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST
Chapter- 6: BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT
- AN OVERVIEW
Chapter- 7: COMPANY ANALYSIS
- ABBOTT LABORATORIES INC.
- AFFYMETRIX INC.
- ASTELLAS PHARMA INC.
- 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.
- DAIICHI SANKYO COMPANY LTD.
- EISAI CO. LTD.
- ELI LILLY AND COMPANY
- EPIGENOMICS AG
- GENEDATA AG
- GENENEWS LTD
- JOHNSON & JOHNSON LTD.
- MERCK & CO.
- NOVARTIS AG
- PFIZER INC.
- ROCHE LTD
- TAKEDA PHARMACEUTICALS LTD.
- TEVA PHARMACEUTICAL INDUSTRIES LTD.
List of Tables
Summary Table : GLOBAL MARKET FOR CNS BIOMARKERS BY APPLICATION, THROUGH 2020
Table 1 : GLOBAL MARKET FORECAST FOR CNS BIOMARKERS BY AREA, THROUGH 2020
Table 2 : GLOBAL MARKET FOR CNS BIOMARKERS BY AREA, THROUGH 2015
Table 3 : BIOMARKERS IN DRUG DISCOVERY: CNS BIOMARKERS MARKET, THROUGH 2020
Table 4 : MARKET SHARE OF CNS SUBSEGMENTS, 2015
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
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
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
Table 23 : GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2020
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
Table 27 : REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
Table 28 : GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2020
Table 29 : GLOBAL MARKET FORECAST FOR CNS BIOMARKERS IN LATE STAGE CLINICAL USE, THROUGH 2020
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
- Affymetrix Inc.
- Astellas Pharma Inc.
- 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.
- Daiichi Sankyo Company Ltd.
- Eisai Co. Ltd.
- Eli Lilly And Company
- Epigenomics AG
- Genedata AG
- Genenews Ltd
- Johnson & Johnson Ltd.
- Merck & Co.
- Novartis AG
- Pfizer Inc.
- Roche Ltd
- Takeda Pharmaceuticals Ltd.
- Teva Pharmaceutical Industries Ltd.