Abstract
REPORT HIGHLIGHTS
THIS REPORT CONTAINS
- Descriptions of various types of biomarkers, including genomics,
proteomics, bioformatics, and metabolomics
- Analysis of global market trends, with data from 2010, estimates for 2011,
and projections of compound annual growth rates (CAGRs) through 2016
- Examinations of technological issues, including the latest trends and
findings in different therapeutic research areas
- A discussion of the regulatory roles of different federal agencies in the
U.S., Europe and the rest of the world in biomarker discovery research
- Evaluation of the industry on a global basis, both from a market and
application perspective.
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.
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.
Table of Contents
Biomarkers: Technologies and Global Markets
Chapter- 1: INTRODUCTION - Complimentary
- 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- 2: SUMMARY
Chapter- 3: OVERVIEW
- INTRODUCTION
- ENABLING ADVANCEMENTS DRIVING MARKET GROWTH
- BIOMARKERS: CHALLENGES AND OPPORTUNITIES
- PRODUCT SUMMARY AND MARKET
- GROWTH DRIVERS AND RESISTORS
- BIOMARKER MARKET FORECAST
- Table 6: GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2015
Chapter- 4: REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS
- INTRODUCTION
- ROLE OF THE FOOD AND DRUG ADMINISTRATION
- INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
- ETHICAL CONSIDERATIONS
Chapter- 5: APPLICATION BY THERAPY AREA
- ONCOLOGY
- COLORECTAL CANCER
- BREAST CANCER
- LUNG CANCER
- OTHER ONCOLOGY
- OTHER DISEASES
- CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST
- Table 23: GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH
2015
- Table 24: 2015 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE
CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2015
- Table 25: GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL
USE BY REGION, THROUGH 2015
Chapter- 6: BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT
- INTRODUCTION
- ASURAGEN
- BG MEDICINE
- BIOMERIEUX
- CELERA
- CURIDIUM
- DAKO
- DXS
- GE HEALTHCARE
- GENOMIC HEALTH
- HISTORX
- LABCORP
- MONOGRAM BIOSCIENCES
- ONCOMETHYLOME SCIENCES
- SOURCE MDX
- XDX
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
- CLINICAL DATA, INC
- CORRELOGIC SYSTEMS, INC.
- DAIICHI SANKYO COMPANY, LTD
- EISAI CO. LTD.
- ELI LILLY AND COMPANY
- EPIGENOMICS AG
- GENEDATA AG
- GENEGO, INC.
- GENENEWS LTD
- GLAXOSMITHKLINE
- JOHNSON & JOHNSON LTD
- MERCK & CO.
- NOVARTIS AG
- PFIZER INC
- ROCHE LTD
- SANOFI-AVENTIS
- TAKEDA PHARMACEUTICALS LTD
- TEVA PHARMACEUTICAL INDUSTRIES LTD.
List of Tables
- Summary Table: GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015
- Table 1: GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010
- Table 10: SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY
- Table 11: REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN U.S.,
EUROPE, JAPAN
- Table 12: GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA,
THROUGH 2010
- Table 13: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY
- Table 14: REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY
- Table 15: REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER
- Table 16: REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: LUNG CANCER
- Table 17: REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: MALIGNANT
MELANOMA
- Table 18: REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: CARDIOVASCULAR
- Table 19: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CARDIOVASCULAR
- Table 2: NOVEL SAFETY / TOXICOLOGY BIOMARKERS USED IN CANCER, CARDIO AND
RENAL
- Table 20: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
- Table 21: CLINICAL BIOMARKERS IN CYP2D6 FAMILY FOR CNS DISEASE
- Table 22: REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY
- Table 23: GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH
2015
- Table 24: 2015 GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL
USE BY THERAPEUTIC AREA, THROUGH 2015
- Table 25: GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE STAGE CLINICAL USE
BY REGION, THROUGH 2015
- Table 26: RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG
DEVELOPMENT COMPANIES
- Table 27: PRINCIPAL FOCUS OF BIOMARKERS: PHARMACEUTICAL COMPANIES BY
THERAPEUTIC AREA
- Table 28: ABBOTT REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 29: ASTRAZENECA REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 3: NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES,
METABOLIC AND LIVER DISEASE
- Table 30: BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 31: ELI LILLY REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 32: GSK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 33: MERCK REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 34: NOVARTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 35: PFIZER REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 36: ROCHE REPRESENTATIVE CLINICAL TRIALS INVOLVING BIOMARKERS
- Table 37: SANOFI-AVENTIS REPRESENTATIVE CLINICAL TRIALS INVOLVING
BIOMARKERS
- Table 4: PATIENT OUTCOME MEASUREMENTS BIOMARKERS
- Table 5: GLOBAL MARKET FOR BIOMARKERS, THROUGH 2010
- Table 6: GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2015
- Table 7: FDA GUIDELINES FOR BIOMARKER APPLICATIONS
- Table 8: ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN U.S.,
EUROPE, JAPAN, THROUGH 2010
- Table 9: CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY
SERVICES AND PRODUCTS, THROUGH 2010
List of Figures
- Summary Figure: GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2015
- Figure 1: CUMULATIVE COST OF CLINICAL DRUG DEVELOPMENT
- Figure 2: AVOIDABLE COST OF $177.4B OF DRUG-RELATED MORBIDITY AND MORTALITY
- Figure 3: VARIANCE ANALYSIS OF INCREASED COST ORIGINATING FROM
DRUG-RELATED MORBIDITY AND MORTALITY
- Figure 4: DECISION TREE AND ECONOMICS FOR BIOMARKERS AT POINT OF CARE
- Figure 5: PRICE, COST, ADOPTION PERCENT FOR BIOMARKER ENVIRONMENT
- Figure 6: BREAKEVEN LEVEL FOR ADOPTION OF BIOMARKER
