Biomarkers: Technologies and Global Markets

  • April 2014
  • -
  • BCC Research
  • -
  • 169 pages

REPORT HIGHLIGHTS

The global biomarkers market is expected to grow from $29.3 billion in 2013 to $53.6 billion in 2018, a compound annual growth rate (CAGR) of 12.8%.

This report provides:

An overview of the global market for biomarkers.
Analyses of global market trends, with data from 2012 and 2013, and projections of compound annual growth rates (CAGRs) through 2018.
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.
Comprehensive profiles of manufacturers of leading products as well as biotechnology companies with novel products in development.

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 biomarker 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 (2013 to 2018) are discussed. In addition, new products approved in 2012 and 2013 by the FDA, and those products expected to be approved within the forecast period, are projected. Figures are estimated for 2013, except where actual results have been reported, due to the timing of the release of the report. For all areas, including very large markets segments such as infectious disease and cardiovascular, specific mechanisms of action are discussed in detail. Market figures include the bundled value of the drug and the biomarker as it is impossible to quantitate the composite values of each.
The report includes an 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.

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 2013-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 2013 through 2018. 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 with leading, competitive and emerging therapies. In addition, 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 five 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

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 biomarker sector is composed of a variety of fast growing and independent segments. For completeness, the current and forecasted markets include the total market opportunity for each respective segment. Within each subsegment, there are 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 biomarker area; the 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 the 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 database 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

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

Table Summary : GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2018
Figure Summary : GLOBAL BIOMARKERS FORECAST BY AREA, 2011-2018

Chapter- 3: OVERVIEW

INTRODUCTION
ENABLING ADVANCEMENTS DRIVING MARKET GROWTH
BIOMARKERS: CHALLENGES AND OPPORTUNITIES
PRODUCT SUMMARY AND MARKET
GROWTH DRIVERS AND RESISTORS
BIOMARKER MARKET FORECAST

Chapter- 4: REGULATORY DYNAMICS, INTELLECTUAL PROPERTY AND ETHICAL CONSIDERATIONS 42 $2479

INTRODUCTION
BIOMARKER LABORATORY REGULATORY SUMMARY
INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING
ETHICAL CONSIDERATIONS

Chapter- 5: APPLICATION BY THERAPY AREA

ONCOLOGY
BREAST CANCER
COLORECTAL CANCER
LUNG CANCER
OTHER ONCOLOGY
OTHER DISEASES
CLINICAL BIOMARKERS: THERAPEUTIC DISEASE MARKET FORECAST

Chapter- 6: BIOMARKERS ACTIVELY GUIDING DRUG DEVELOPMENT

INTRODUCTION
ASURAGEN
BG MEDICINE
BIOMERIEUX
CELERA
AVACTA
DAKO
DXS
GE HEALTHCARE
GENOMIC HEALTH
HISTORX
LABCORP
MONOGRAM BIOSCIENCES (A LABCORP COMPANY)
ONCOMETHYLOME SCIENCES (NOW MDX HEALTH)
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.
DAIICHI SANKYO CO. LTD.
EISAI CO. LTD.
ELI LILLY AND CO.
EPIGENOMICS AG
GENEDATA AG
GENENEWS LTD.
GLAXOSMITHKLINE
JOHNSON and JOHNSON LTD.
MERCK and CO.
NOVARTIS AG
PFIZER INC.
ROCHE LTD.
SANOFI-AVENTIS
TAKEDA PHARMACEUTICALS LTD.
TEVA PHARMACEUTICAL INDUSTRIES LTD.
Table 25 : PRINCIPAL FOCUS OF BIOMARKERS: PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA


List of Tables

GLOBAL BIOMARKERS FORECAST BY AREA, THROUGH 2018
Table 1 : GLOBAL MARKET FOR BIOMARKERS, THROUGH 2013
Table 2 : NOVEL SAFETY/TOXICOLOGY BIOMARKERS USED IN CANCER, CARDIO AND RENAL
Table 3 : NOVEL DOSE SELECTION BIOMARKERS USED IN CANCER, DIABETES, METABOLIC AND LIVER DISEASE
Table 4 : PATIENT OUTCOME MEASUREMENTS BIOMARKERS
Table 5 : GLOBAL MARKET FOR BIOMARKERS, 2013
Table 6 : GLOBAL BIOMARKER MARKET FORECAST, THROUGH 2018
Table 7 : FDA GUIDELINES FOR BIOMARKER APPLICATIONS
Table 8 : ANNUAL PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE AND JAPAN, THROUGH 2013
Table 9 : CURRENT GLOBAL MARKET FOR TOTAL CLINICAL STAGE BIOMARKERS BY SERVICES AND PRODUCTS, THROUGH 2018
Table 10 : SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, 2007-2013
Table 11 : REPRESENTATIVE LIST OF INDUSTRY ADVANCEMENTS AND APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE AND JAPAN
Table 12 : GLOBAL MARKET FOR CLINICAL STAGE BIOMARKERS BY THERAPEUTIC AREA, THROUGH 2018
Table 13 : REPRESENTATIVE BIOMARKERS IN CLINICAL USE: ONCOLOGY
Table 14 : REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: BREAST CANCER
Table 15 : REPRESENTATIVE ACTIVE BIOMARKER TRIALS ONGOING: ONCOLOGY, 2005-2009
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 20 : REPRESENTATIVE BIOMARKERS IN CLINICAL USE: CNS DISEASE
Table 21 : REPRESENTATIVE BIOMARKERS IN CLINICAL USE: IMMUNOLOGY
Table 22 : GLOBAL MARKET FORECAST FOR CLINICAL STAGE BIOMARKERS, THROUGH 2018
Table 23 : GLOBAL MARKET FORECAST OF BIOMARKERS IN LATE-STAGE CLINICAL USE BY THERAPEUTIC AREA, THROUGH 2018
Table 24 : RECENT CORPORATE ALLIANCES BETWEEN BIOMARKER AND DRUG DEVELOPMENT COMPANIES
Table 25 : PRINCIPAL FOCUS OF BIOMARKERS: PHARMACEUTICAL COMPANIES BY THERAPEUTIC AREA
Table 26 : ABBOTT: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 27 : AFFYMETRIX: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 28 : ASTELLAS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 29 : ASTRAZENECA: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 30 : BANYAN: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 31 : BAYER SCHERING: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 32 : BIOPHYSICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 33 : BIOSYSTEMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 34 : BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 35 : BMS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 36 : DAIICHI SANKYO: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 37 : EISAI: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 38 : ELI LILLY: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 39 : EPIGENOMICS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 40 : GENEDATA AG: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 41 : GSK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 42 : JOHNSON and JOHNSON: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 43 : MERCK: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 44 : NOVARTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 45 : PFIZER: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 46 : ROCHE: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 47 : SANOFI-AVENTIS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 48 : TAKEDA PHARMACEUTICALS: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS
Table 49 : TEVA PHARMACEUTICAL: REPRESENTATIVE UPDATES AND CLINICAL TRIALS INVOLVING BIOMARKERS

List of Figures

GLOBAL BIOMARKERS FORECAST BY AREA, 2011-2018

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