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.

Report Includes

• 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.

Report Scope

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.

Analyst Credentials

Cheng-Yuk Lee is a life science researcher and engineer. He has experience in preclinical and translational medicine research conducted in a pharmaceutical company. Dr. Lee has also led the development of several assays as a scientist at a private in vitro diagnostics company with campuses in China and the U.S. He received a dual B.S. in Chemical Engineering and Biochemistry and subsequently completed his Ph.D. in Chemical Engineering and post-doctoral training. Prior to his career as a researcher and engineer, he provided marketing research and strategic business planning in the Office of Corporate Relations at a public research university.