Clinical development should emerge as the fastest-growing segment of a global biomarkers market expected to reach US$34 billion by 2017, a new report predicts.

A compound annual growth rate (CAGR) of 26.5% over that period is projected for biomarker applications in clinical drug development, according to market researcher Global Industry Analysts (GIA).

However, GIA also warns that the “huge” capital investment required for the discovery, development and application of biomarkers, as well as the high cost of biomarker validation, are “a major factor hampering growth in the market”.

These barriers are likely to “force certain small organisations and contract research organisations to completely exclude the use of biomarkers”, the analysts believe.

Gaining momentum

While biomarker discovery is currently the largest segment of the global market, biomarker applications in clinical development are rapidly gaining momentum, particularly as nearly 90% of candidate drugs fail in clinical trials, notes Biomarkers: A Global Strategic Business Report.

Mostly this is due to issues around toxicity, absorption, metabolism, etc. Biomarkers are important tools for detecting the possibility of failure at an early stage and preventing “substantial losses”, GIA observes. A major focus of adoption in drug development is surrogate biomarkers that substitute for clinical endpoints.

The report identifies oncology as one area in which the attrition rate in drug development is particularly high. As such, oncology accounts for “a lion’s share of the global biomarkers market in terms of therapeutics”, GIA says, with applications ranging from early detection and prognosis to analysing the characteristics of the disease and delivering effective therapies. 

All the same, cardiology is expected to be the fastest-expanding therapeutic segment of the global biomarkers market, with CAGR projected at around 24% to 2017.

A major growth factor is the ability of biomarkers to make accurate predictions of heart failure in stable patients, GIA suggests. Moreover, biomarkers can assess the risks of acute coronary syndrome, stroke and other cardiovascular events in patients’ homes as well as in primary care settings.

North American market

In geographical terms, the US is the biggest market for biomarkers, the report says. Among the factors that have contributed to growth in the US and North America is the ability of biomarkers to accelerate drug development by helping researchers identify and validate compound targets, GIA points out.

It also cites increasing demand from an ageing population for superior disease diagnostic and therapeutic capabilities, a higher technology adoption rate, and a growing “market requirement” for biomarkers in drug development and discovery.

The fastest-growing region for biomarkers in the years to 2017 is expected to be the Asia-Pacific countries, with CAGR forecast at 28%. A key factor here is the region’s ever-expanding information technology industry, GIA suggests.


Overall, the global economic downturn did not have any detrimental effect on the biomarkers market worldwide, which “continued to surge ahead at double-digit growth rate even during the recession period”, the analysts comment.

Lately, too, the market has seen the emergence of several new companies, providing advanced technology platforms in areas such as chemogenomics, bioinformatics, genomics, metabolomics, transcriptomics, peptidomics, glycoproteomics, proteomics and pharmacogenomics.

Scientific progress in these areas likely to be a key driver for further biomarker research to improve sample throughputs, enhance detection levels and generate multiple biomarker panels with increased utility in diagnostics, preclinical research, clinical trials and product commercialisation, the report predicts.