Reportlinker Adds Biomarkers: Technologies and Global Markets
NEW YORK, May 3, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Biomarkers: Technologies and Global Markets
http://www.reportlinker.com/p0488647/Biomarkers-Technologies-and-Global-Markets.html
In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 at a 5-year compound annual growth rate (CAGR) of 19.8%.
Of all segments, genomics will continue as the largest, at 2010 revenue of $5.1 billion, growing to $16.9 billion in 2015, a compound annual growth rate (CAGR) of 26.9%. Genomics has been and will continue to be the fastest-growing driver of biomarker technology.
Imaging, as a modality, completed 2010 with $4.2 billion in revenue. The next 5 years will continue to see growth, slightly outpacing proteomics, at a 14.8% compound annual growth rate (CAGR) from 2010 to 2015 to reach a value of $8.4 million in 2015.
INTRODUCTION
STUDY GOALS AND OBJECTIVES
This study provides a comprehensive analysis of biomarkers on a global basis. Its aim is to provide a range of information, from detailed product analyses within disease subsegments to overall industry trends, in order to quantify and qualify the market for products and services in the 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.
REASONS FOR DOING THE STUDY
For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.
The biomarkers market presents the largest of all opportunities in representative disease subsegments. This study investigates one of the most important market drivers: the introduction of combination therapies, which are expected to continue to contribute substantially to market growth through the forecast period. This report analyzes emerging markets, by disease segment. Continued growth is expected in emerging geographies, driven by the growing middle class in emerging countries such as India, China, Brazil, and Russia.
This report seeks to address the critically important topics of analyzing a changing market dynamic, emerging players and technologies, strategies for accessing emerging markets, and specific disease segments and geographies in order to allocate resources and make effective decisions.
SCOPE OF REPORT
Current and projected product forecasts during the forecast period (2010 to 2015) are discussed. As well, new products approved in 2009 and 2010 by the FDA, and those products expected to be approved within the forecast period are projected. 2010 is an estimated figure, except where actual results have been reported, due to the release timing of the report. For all areas, including the very large markets segments such as infectious disease and cardiovascular specific mechanisms of action are discussed in detail.
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 their 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 of current market leaders are discussed, 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 2010-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 2009 through 2015. 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 to include prevalence 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.
INTENDED AUDIENCE
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 biomarkers market, its products, its 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 or defensive moves cannot be overstated for a variety of constituents, including:
Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development, and R&D. Emerging biotechnology players in the segment 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 will gain insights as to the opportunity and risks that are being encountered in the industry, in a product and company specific analysis. Equity analysts are provided detailed forecasts for the next 5 years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methodologies were used in preparing this study. In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading medical practitioners in the field.
The overall biomarkers sector is comprised of a variety of fast-growing and independent segments. For completeness, the current and forecasted markets are comprised of the total market opportunity for each respective segment. Each sub-section contains detailed forecasts for each driving mechanism, or relevant area of growth.
Information to prepare this report was obtained from participating and emerging companies in the biomarkers area; American Heart Association, the National Heart, Lung and Blood Institute and the National Heart, Lung, and Blood Institute; articles published in medical journals such as American Heart Journal, Circulation, Journal of Biomarkers Pharmacology, Lancet, and others; the World Health Organization and other government agencies; literature searches; annual reports; 10Ks; and others. Population estimates are based on those reported by the international data-base of the U.S. Census Bureau.
Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.
CHAPTER ONE: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
RELATED REPORTS
BCC ONLINE SERVICES
DISCLAIMER
CHAPTER TWO: SUMMARY
SUMMARY TABLE GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015 ($ MILLIONS)
SUMMARY FIGURE GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015 ($ MILLIONS)
CHAPTER THREE: OVERVIEW
INTRODUCTION
TABLE 1 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($ MILLIONS)
ENABLING ADVANCEMENTS DRIVING MARKET GROWTH
BIOMARKERS DRIVE SPEED, COST AND QUALITY IMPROVEMENTS ACROSS THE DRUG DEVELOPMENT SPECTRUM
COST REDUCTION OPPORTUNITIES ARISING FROM BIOMARKER APPLICATIONS
Elements of Cost in Drug Research & Development
FIGURE 1 CUMULATIVE COST OF CLINICAL DRUG DEVELOPMENT
FIGURE 2 AVOIDABLE COST OF $177.4B OF DRUG-RELATED MORBIDITY AND MORTALITY
Elements of Cost in Healthcare
FIGURE 3 VARIANCE ANALYSIS OF INCREASED COST ORIGINATING FROM DRUG-RELATED MORBIDITY AND MORTALITY
STRATEGIC BIOMARKER APPLICATIONS
Targeted Therapies
Product Extensions
Ultra-Blockbuster
DRUG DEVELOPMENT USING BIOMARKERS: MARKET ENTRY THEORY AND IMPLICATIONS
FIGURE 4 DECISION TREE AND ECONOMICS FOR BIOMARKERS AT POINT OF CARE
Breakeven Analysis of Diagnostic-Enabled Drug Model
FIGURE 5 PRICE, COST, ADOPTION PERCENT FOR BIOMARKER ENVIRONMENT
FIGURE 6 BREAKEVEN LEVEL FOR ADOPTION OF BIOMARKER
Implications for Industry
BIOMARKERS APPLICATIONS: DRUG DEVELOPMENT
Safety/toxicology Biomarkers
TABLE 2 NOVEL SAFETY / TOXICOLOGY BIOMARKERS USED IN CANCER, CARDIO AND RENAL
Dose Selection and Dose Optimization
TABLE 3 NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE
Improved Measurement of Therapeutic Efficacy
Outcome Biomarkers and Surrogate Endpoints
TABLE 4 PATIENT OUTCOME MEASUREMENTS BIOMARKERS
EARLY-STAGE CLINICAL TRIAL APPLICATIONS
LATE-STAGE CLINICAL TRIAL APPLICATIONS
Phase III
Phase IV
BIOMARKERS: CHALLENGES AND OPPORTUNITIES
SUMMARY
CLINICAL VALIDITY: REQUIREMENTS
BIOMARKER OPPORTUNITIES
PRODUCT SUMMARY AND MARKET
GENOMICS
TABLE 5 GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010 ($ MILLIONS)
IMAGING
PROTEOMICS
BIOINFORMATICS
OTHER
Metabolomics
BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY
GROWTH DRIVERS AND RESISTORS
FACTORS INFLUENCING BIOMARKER ADOPTION IN CLINICAL TRIALS
CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE
IMPACT OF DRUG FAILURE IN LAST-STAGE CLINICAL TRIALS
Merck: Vicriviroc
Myriad: Flurizan
ADDITIONAL CAPABILITIES BY LARGE SERVICE PLAYERS
TECHNOLOGICAL ADVANCEMENTS IN GENOMICS AND PROTEOMICS
BIOMARKER MARKET FORECAST
TABLE 6 GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2015 ($ MILLIONS)
CHAPTER FOUR: REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS
INTRODUCTION
ROLE OF THE FOOD AND DRUG ADMINISTRATION
TABLE 7 FDA GUIDELINES FOR BIOMARKER APPLICATIONS
EUROPEAN MEDICINES AGENCY
REGULATORY IMPACT ON DRUG SAFETY
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
APPROVED PATENT ANALYSIS
TABLE 8 ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S., EUROPE, JAPAN, THROUGH 2010
COMPETITIVE LANDSCAPE
LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING
TABLE 9 CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2010 ($ MILLIONS)
TABLE 10 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY
TABLE 11 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN U.S., EUROPE, JAPAN
ETHICAL CONSIDERATIONS
SUMMARY
Respect for Persons
Beneficence
Justice
BIOMARKER APPLICATIONS OF ETHICAL CONSIDERATIONS
Race and Genotype
Negligence
Informed Consent
Privacy
Market Segmentation
Professional, Media, and Opinion Leader Edification
REGULATORY IMPLICATIONS
CHAPTER FIVE: APPLICATION BY THERAPY AREA
TABLE 12 GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2010 ($ MILLIONS)
ONCOLOGY
TABLE 13 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY
COLORECTAL CANCER
CETUXIMAB
PANITUMUMAB
ELESCLOMOL
HERCEPTIN
OTHER PREDICTIVE TESTS
TABLE 14 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY
BREAST CANCER
MAMMAPRINT
TABLE 15 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER
ONCOTYPE DX
TEST ADOPTION
OTHER PROGNOSTIC TESTS
PREDICTIVE TESTS
HORMONAL THERAPIES
TAXANES/ANTHRACYCLINES
BIOLOGICALS
TRIPLE NEGATIVE BREAST CANCER
OTHER NOVEL BIOMARKERS
LUNG CANCER
INTRODUCTION
PREDICTIVE TESTS
TABLE 16 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER
GEFITINIB
ERLOTINIB
OTHER PREDICTIVE TESTS
NOVEL THERAPIES
OTHER ONCOLOGY
PROSTATE CANCER
OVARIAN CANCER
MALIGNANT MELANOMA
TABLE 17 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT MELANOMA
OTHER DISEASES
CARDIOVASCULAR
TABLE 18 REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: CARDIOVASCULAR
TABLE 19 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR
CENTRAL NERVOUS SYSTEM
TABLE 20 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
TABLE 21 CLINICAL BIOMARKERS IN CYP2D6 FAMILY FOR CNS DISEASE
IMMUNOLOGY
TABLE 22 REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY
Immunology: Benlysta: Human Genome Sciences
Expedition & Identity Alzheimer's trial: Eli Lilly
CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST
TABLE 23 GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2015 ($ MILLIONS)
TABLE 24 2015 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2015 ($ MILLIONS)
TABLE 25 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL USE BY REGION, THROUGH 2015 ($ MILLIONS)
CHAPTER SIX: BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT
INTRODUCTION
TABLE 26 RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG DEVELOPMENT COMPANIES
ASURAGEN
BACKGROUND
COLLABORATION: MERCK & CO.
BG MEDICINE
BACKGROUND
COLLABORATION: CORDEX PHARMA
BIOMÉRIEUX
BACKGROUND
COLLABORATIONS: ISPEN; MERCK & CO.
Ipsen
Merck & Co.
ADNA PROJECT
CELERA
BACKGROUND
COLLABORATIONS
Abbott
Merck & Co
Ipsen
CURIDIUM
BACKGROUND
COLLABORATION: TAKEDA
DAKO
BACKGROUND
COLLABORATION: OSI
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: LILLY
LILLY
LABCORP
BACKGROUND
COLLABORATION
ARCA Biopharma
Vanda Pharmaceuticals
Medco Health Solutions
MONOGRAM BIOSCIENCES
BACKGROUND
COLLABORATIONS
Pfizer HIV Partnership
VeraTag Oncology Platform
ONCOMETHYLOME SCIENCES
BACKGROUND
COLLABORATIONS
Merck KGaA
Schering-Plough
GlaxoSmithKline Biologicals
Abbott
SOURCE MDX
BACKGROUND
COLLABORATION: PFIZER
XDX
BACKGROUND
COLLABORATION: BRISTOL-MYERS SQUIBB
CHAPTER SEVEN: COMPANY ANALYSIS
TABLE 27 PRINCIPAL FOCUS OF BIOMARKERS: PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA
ABBOTT LABORATORIES INC
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 28 ABBOTT REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
AFFYMETRIX, INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
ASTELLAS PHARMA INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
ASTRAZENECA LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 29 ASTRAZENECA REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
BANYAN BIOMARKERS, INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
BAYER SCHERING PHARMA AG
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
BG MEDICINE, INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
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
COMPANY STRATEGY
BRISTOL-MYERS SQUIBB CO
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 30 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
CAPRION PROTEOMICS INC
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
CLINICAL DATA, INC
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
CORRELOGIC SYSTEMS, INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
DAIICHI SANKYO COMPANY, LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
EISAI CO. LTD.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
ELI LILLY AND COMPANY
COMPANY OVERVIEW
PRODUCT AND SERVICES
TABLE 31 ELI LILLY REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
EPIGENOMICS AG
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
GENEDATA AG
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
GENEGO, INC.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
GENENEWS LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
GLAXOSMITHKLINE
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 32 GSK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
JOHNSON & JOHNSON LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
MERCK & CO.
COMPANY OVERVIW
PRODUCTS AND SERVICES
TABLE 33 MERCK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
NOVARTIS AG
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 34 NOVARTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
PFIZER INC
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 35 PFIZER REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
ROCHE LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 36 ROCHE REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
SANOFI-AVENTIS
COMPANY OVERVIEW
PRODUCTS AND SERVICES
TABLE 37 SANOFI-AVENTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
COMPANY STRATEGY
TAKEDA PHARMACEUTICALS LTD
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
TEVA PHARMACEUTICAL INDUSTRIES LTD.
COMPANY OVERVIEW
PRODUCTS AND SERVICES
COMPANY STRATEGY
More Details
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: Biomarkers: Technologies and Global Markets
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Nicolas Bombourg
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