Cardiac Biomarkers: Technologies and Global Markets

  • March 2014
  • -
  • BCC Research
  • -
  • 84 pages

REPORT HIGHLIGHTS

The global market for in vitro diagnostic tests for cardiac biomarkers was estimated at $3.1 billion in 2012 and nearly $4 billion in 2013. This market is predicted to reach $7.2 billion by 2018, at a compound annual growth rate (CAGR) of 12.8% over the five-year period from 2013 to 2018.

This report provides:


An overview of the global market for biomarkers for cardiovascular disease (CVD) and related technologies.
Analyses of global market trends, with data from 2012, estimates for 2013, and projections of CAGRs for the period 2013 to 2018.
Classification of CVD by cerebrovascular, congestive, coronary, hypertensive, and peripheral arterial disease.
Background and clinical values of cardiac biomarkers, including B-type natriuretic peptide (BNP), N-terminal pro-B-type natriuretic peptide (NT-proBNP), C-reactive protein (CRP), choline, creatine kinase MB (CK-MB), D-dimer, glial fibrillary acidic protein (GFAP), heart fatty acid binding protein (H-FABP), ischemia-modified albumin (IMA), myeloperoxidase (MPO), myoglobin, soluble fragment CD40 ligand (sCD40L), and troponin I (cTnI)/troponin T (cTnT).
Examination of the technology covering diagnostic methods, instrumentation, newly issued patents, and new patent applications.
Clinical guidelines and government regulations.

STUDY GOALS AND OBJECTIVES

This report provides a comprehensive analysis of the cardiac biomarker market and its trends from 2012 through 2018. It details the history and current state of cardiovascular diseases (CVDs), background on cardiac biomarkers and the current industrial technologies for their diagnosis. An in-depth analysis is provided of the predominant biomarkers in the market, namely,
Cardiac troponin proteins (complex I and T).
Natriuretic peptide (BNP and NT-proBNP).
D-dimer.
C-reactive protein (CRP).
Creatine kinase-MB (CK-MB).
Other related topics including intellectual property, regulatory requirement, leading diagnostics companies and the competitive landscape are also discussed. The market analysis is based on biomarker, geographic region, demographics and instrumentation platform.

REASONS FOR DOING THE STUDY

This study was conducted to offer support to companies by providing analytical information and to help them generate business strategies. Oftentimes the ability to successfully execute business strategies hinges on how to effectively develop an effective plan with the relevant information and data.This report investigates one of the most important drivers in the in vitro diagnostics market: the introduction of additional biomarkers for heart failure, including ST2, galectin-3 and others, as well as ongoing research of biomarkers for stroke such as GFAP and S100-beta. Together, they are expected to substantially contribute to the growth of the market for cardiac biomarkers over the forecast period of 2013–2018.This report analyzes the emerging markets by assay type, instrumentation and geographic region. Continued growth is expected in emerging countries, driven by the growing in the practice of preventive medicine in developing regions such as China, South America and the rest of the world.

SCOPE OF REPORT

Current and projected forecasts assay revenues during the forecast period (2013 to 2018) are presented. In addition, newly developed assays with regulatory approval and others expected to receive FDA approval within the forecast period are also projected. Figures for 2013 are estimated, except where actual results have been reported, due to the timing of the release of the report. For large market segments, such as cardiac troponin and natriuretic peptides, the analytical sensitivities and cutoff references for the diagnosis and prognosis values are discussed in detail. Moreover, the ongoing effort in developing a high-sensitivity troponin assay, as well as the attempt to pursue additional biomarkers for the diagnosis of congestive heart failure and strokes are focused on in this study.

The report includes an analysis of leading and emerging competitors in the current worldwide diagnostics market for cardiovascular diseases. Profiles of manufacturers of leading products as well as biotechnology companies with products in development are discussed to define their specific product strategies. The competitive environment is examined with a special focus on how instrumentation type (clinical chemistry analyzers compared with point-of-care devices) and their respective 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 enter the market during 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 and diagnosis of respective diseases. Included in this report are forecasts by product, product category and by company from 2012 through 2018. The study is arranged to offer an overview of the diagnostics market accompanied by product, company, geography.

Excluded from this report are non-proteomic diagnoses (i.e., molecular diagnostics), imaging technology and pharmaceutical biomarkers. Sales figures are reported in U.S. dollars, and in each case, reflect currency fluctuations within the performance of changes in sales. Sales 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 intended for business consultants, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants and anyone who is interested in the cardiac biomarker market, its products, its industry participants and its future.The importance of identifying overall market trends, product opportunities, emerging geographic markets, 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 will benefit from the study, including sales and marketing, business development and R&D.
Emerging diagnostics companies must identify specific opportunities for out-licensing, originating from the elements of differentiation of their assays as compared with leading, competitive and new products. In addition, market forecasts can support investment, and thorough and detailed substantiation is provided for the market forecasts included in this report.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights into the opportunities 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 for product and company forecasts over the short and long run.


METHODOLOGY AND INFORMATION SOURCES

Information to prepare this report was obtained from non-profit organizations in the cardiovascular area such as the World Health Organization (WHO), American Heart Association (AHA), the National Heart, Lung and Blood Institute (NHLBI), Centers for Disease Control and Prevention (CDC) and other government agencies; literature searches in medical journals such as the American Heart Journal and Circulation; and the annual reports of the diagnostics companies described in this study.Market insight was collected from scientific conference attendance, including the American Association of Clinical Chemistry Annual Meeting, as well as face-to-face meetings with key opinion leaders on the clinical diagnosis of cardiac troponin and natriuretic protein. Global populations are estimated based on those reported by the international database of the U.S. Census Bureau. Where possible and practical, the most recent data available have been used.

Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.Based on the identified information, BCC Research’s market evaluation was estimated from a combination of data: the prevalence and number of patients in each subclass of cardiovascular disease in each of the regions included in this study during the forecast period; average cost of each assay test from secondary research and an educated prediction for biomarkers under development; and the market share of individual assays within the market for cardiovascular diagnostics.

Table Of Contents

Chapter- 1: INTRODUCTION 4

STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH ONLINE SERVICES
DISCLAIMER

Chapter- 2: SUMMARY 2

GLOBAL CARDIAC BIOMARKER MARKET BY REGION, THROUGH 2018
Figure Summary : GLOBAL CARDIAC BIOMARKER MARKET BY REGION, 2012-2018

Chapter- 3: OVERVIEW

EPIDEMIC OF CARDIOVASCULAR DISEASE
RISK FACTORS AND PREVENTION OF CARDIOVASCULAR DISEASE
CLASSIFICATION OF CARDIOVASCULAR DISEASE
HISTORY AND CURRENT STATE OF HEART DISEASE
FUTURE DIRECTION OF CARDIAC BIOMARKERS DIAGNOSIS
BACKGROUND AND CLINICAL VALUE OF CARDIAC BIOMARKERS
CLINICAL GUIDELINES OF BIOMARKERS

Chapter- 4: INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS

INDUSTRY STRUCTURE
DIAGNOSTIC METHODS
GOVERNMENT REGULATION
GENERAL TECHNOLOGY ISSUES

Chapter- 5: MARKET BY ASSAY 1

SUMMARY OF MARKET BY ASSAY

Chapter- 6: MARKET BY INSTRUMENT 4

SUMMARY OF MARKET BY INSTRUMENT CATEGORY
CLINICAL CHEMISTRY ANALYZER
POINT-OF-CARE DEVICE

Chapter- 7: MARKET BY REGION

SUMMARY OF MARKET BY REGION
U.S. MARKET
EUROPEAN MARKET
CHINA'S MARKET
MARKET IN THE REST OF THE WORLD

Chapter- 8: COMPANY PROFILES

MAJOR COMPANIES AND MARKET SHARES
ABBOTT DIAGNOSTICS
ALERE INC.
BECKMAN COULTER
BECTON, DICKINSON AND CO.
BG MEDICINE INC.
BIOMERIEUX
RADIOMETER MEDICAL
RANDOX LABORATORY
RESPONSE BIOMEDICAL
ROCHE HOLDING AG
SIEMENS HEALTHCARE
SINGULEX
THERMO FISHER SCIENTIFIC


List of Tables

GLOBAL CARDIAC BIOMARKER MARKET BY REGION, THROUGH 2018
Table 1 : PATENT TRENDS ON CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC TESTING, 2003-2013
Table 2 : PATENTS BY BIOMARKER CATEGORY, 2003-2013
Table 3 : PATENTS BY COMPANY, 2003-2013
Table 4 : PATENTS ON CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC TESTING, 2013
Table 5 : PATENT APPLICATION TRENDS ON CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC TESTING, AUG. TO OCT. 2013
Table 6 : EXAMPLES OF PATENT APPLICATIONS BY COMPANY, AUG TO OCT. 2013
Table 7 : PATENT APPLICATION TRENDS ON NOVEL CARDIAC BIOMARKER ASSAYS USED FOR DIAGNOSTIC TESTING, AUG. TO OCT. 2013
Table 8 : PATENT APPLICATIONS BY COMPANY, AUG. TO OCT. 2013
Table 9 : GLOBAL CARDIAC BIOMARKER MARKET BY ASSAY, THROUGH 2018
Table 10 : GLOBAL CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY, THROUGH 2018
Table 11 : GLOBAL MARKET FOR CTNI BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 12 : GLOBAL MARKET FOR BNP AND NT-PROBNP BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 13 : GLOBAL MARKET FOR CK-MB BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 14 : GLOBAL MARKET FOR NEW CHF BIOMARKERS* BY INSTRUMENT CATEGORY, THROUGH 2018
Table 15 : U.S. MARKET FOR CARDIAC BIOMARKERS BY ASSAY, THROUGH 2018
Table 16 : U.S. MARKET FOR CARDIAC BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 17 : U.S. MARKET FOR CTNI BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 18 : U.S. MARKET FOR BNP AND NT-PROBNP BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 19 : U.S. MARKET FOR CK-MB BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 20 : U.S. MARKET FOR NEW CHF BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 21 : EUROPEAN MARKET FOR CARDIAC BIOMARKERS BY ASSAY, THROUGH 2018
Table 22 : EUROPEAN MARKET FOR CARDIAC BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 23 : EUROPEAN MARKET FOR CTNI ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 24 : EUROPEAN MARKET FOR BNP AND NT-PROBNP ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 25 : EUROPEAN MARKET FOR CK-MB ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 26 : EUROPEAN MARKET FOR NEW CHF BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 27 : CHINA'S CARDIAC BIOMARKER MARKET BY ASSAY, THROUGH 2018
Table 28 : CHINA'S CARDIAC BIOMARKER MARKET BY INSTRUMENT CATEGORY, THROUGH 2018
Table 29 : CHINA'S MARKET FOR CTNI ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 30 : CHINA'S MARKET FOR BNP AND NT-PROBNP ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 31 : CHINA'S MARKET FOR CK-MB ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 32 : CHINA'S MARKET FOR NEW CHF BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 33 : REST OF WORLD MARKET FOR CARDIAC BIOMARKERS BY ASSAY, THROUGH 2018
Table 34 : REST OF WORLD MARKET FOR CARDIAC BIOMARKERS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 35 : REST OF WORLD MARKET FOR CTNI ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 36 : REST OF WORLD MARKET FOR BNP AND NT-PROBNP ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 37 : REST OF WORLD MARKET FOR CK-MB ASSAYS BY INSTRUMENT CATEGORY, THROUGH 2018
Table 38 : REST OF WORLD MARKET FOR NEW BIOMARKERS* BY INSTRUMENT CATEGORY, THROUGH 2018
Table 39 : GLOBAL MANUFACTURER SALES AND MARKET SHARES OF DIAGNOSTICS ASSAYS, 2012
Table 40 : NORTH AMERICAN MANUFACTURER SALES AND MARKET SHARES OF DIAGNOSTICS ASSAYS, 2012
Table 41 : EUROPEAN MANUFACTURER SALES AND MARKET SHARES OF DIAGNOSTIC ASSAYS, 2012
Table 42 : ASIAN MANUFACTURER SALES AND MARKET SHARES OF DIAGNOSTIC ASSAYS, 2012
Table 43 : ROW MANUFACTURER SALES AND MARKET SHARES OF DIAGNOSTIC ASSAYS, 2012

List of Figures

GLOBAL CARDIAC BIOMARKER MARKET BY REGION, 2012-2018
Figure 1 : GLOBAL DISTRIBUTION OF CARDIOVASCULAR DISEASE: DALY, 2004
Figure 2 : GLOBAL CARDIOVASCULAR DISEASE TRENDS, 2011-2018
Figure 3 : INTERPRETING ELEVATED LEVELS OF CARDIAC TROPONIN

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6 Companies

Company Profiles

LS Cable Ltd.

South Korea

BD Biosciences

United States

Life Technologies Corp.

United States

Beckman Coulter Inc.

United States

Promega Corp.

United States

Southwire Co.

United States

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