Biomarkers and surrogate endpoints: market foresighting

A clinical biomarker is defined as a characteristic that is objectively measured and evaluated as indicators of normal biologic or pathogenic processes or pharmacological responses to therapeutic intervention. Surrogate endpoints are laboratory or physical signs used in therapeutic trials which are expected to predict the effects of therapy. The report aimed to analyse the current and future uses of biomarkers in clinical, bio-pharmaceutical and life science applications and markets. The report investigated: the definition of biomarkers and surrogate endpoints; market dynamics, emerging markets and deals; challenges to the development of biomarkers; the emerging technologies and platforms; the Scottish context and global players in the biomarker market; the opportunities and barriers in biomarkers; and the company landscape.

The methodology consisted of: desk research of biomarket and surrogate endpoint technologies; a review of the biomarkers company landscape; and an outline of the Scottish biotech context.

The report finds that biomarker technology can potentially impact all areas of life sciences and this widespread utility will ensure a large market potential. The identification and use of biomarkers is not new, rather, it is the availability of emerging technologies that is driving rapid progress in this area. The level and pace of activity is also reflected in the number of emerging companies and their collaborations with big Pharma companies. However, the biomarkers market is diverse and splits broadly into bio-medical and non-medical, with the non-medical segment very fragmented and difficult to define. Biomarker development is driven by genomic, bioinformatic and proteomic technologies. The ethical, legal, social and governmental policy implications of pharmacogenomics and biomarker analysis are unclear, but will impact, for example, the future provision of health insurance. Growth of 45 per cent is forecast for the sector, generating revenues of 2.9 billion dollars in 2008. In Scotland, the report finds a strong academic base in geonomics, proteomics and bioinformatics, an industrial strength in diagnostics, reagents and CROs, and clinical excellence in cardiovascular, cancer and diabetes. Barriers to the development of the biomarker market include: the need to prove pharmacoeconomic benefits; reluctance of clinicians’ acceptance of surrogate endpoints; the requirement for expensive large scale prospective studies of chronic diseases; and the need to overcome current commoditisation.

The report recommends that there are opportunities for pharmaceutical drug development in efficacy testing, ADMET or toxicology, target or lead identification, preclinical testing, and clinical trials or drug labelling. For clinical management, the future opportunities are focused on: treatment decision tools, improved diagnostics, monitoring of treatment and pre-disease identification. Other opportunities for the use of biomarkers exist in disease areas, such as aggressive cancers, global cardiovascular (CV) and metabolic syndrome.