The ability to identify specific groups of patients and/or stages of disease progression for which a new drug will be effective generates substantial potential cost savings by reducing the use of therapeutics that are either ineffective or cause adverse reactions: for the UK healthcare system alone this could result in possible savings of between 23% and 54% and may equate to saved costs in excess of £2.4bn and £5.6bn per annum.

Regulators, such as the FDA,  are increasingly looking for improvements in the demonstrated effectiveness of a drug before approval is given and are consequently recognising the need for and, in certain instances, requiring that diagnostic tests be available before a drug can be marketed. This then generates a need for the industry to

• Find ways to identify those patients most likely to respond positively in the clinical trials, increasing likelihood of drug approval

• Develop simple diagnostics tests that can be used to pre-select patients who will respond positively to the therapy.

Biomarkers, almost by definition, can be used as a diagnostic for a given disease and in many instances are now being developed as a prognostic of the likely disease progression.

Drivers for growth include:

• Demands of doctors and clinicians for new and improved tests.

• Recognised cost savings to healthcare systems, such as the NHS in the UK and Medicare in the US, as a result of earlier diagnosis and intervention.

• Regulatory drivers to achieve more cost effective treatment through the use of ‘personalised’ medicine, where more specific drug therapies can be used on the basis of the more detailed information being delivered by the newer biomarker assays.