Human health biotechnologies to 2015

This article provides an overview of the current use of biotechnology to produce human health products and short-term estimates of the number and types of these products that are likely to reach the market by 2015. Relevant health products include biopharmaceuticals, experimental therapies (e.g. cell/tissue engineering and gene therapy), small molecule therapeutics, diagnostics, bioinformatics (including DNA sequencing and pharmacogenetics), functional food and nutraceuticals, and medical devices. The analysis of current use is based on regulatory approval data and the current literature and includes a comparison of the additional therapeutic value of biopharmaceuticals compared to small molecule pharmaceuticals. The short-term estimates of the number and types of products that are likely to reach the market by 2015 are based, where possible, on an analysis of quantitative data on clinical trials. For several other products, including functional foods and nutraceuticals, it is not possible to make short-term estimates due to a lack of reliable data. While the biopharmaceutical share of all pharmaceuticals reaching the market is expected to remain very close to historical levels, biotechnology is expected to be used in the discovery, development, manufacturing, and/or prescribing of nearly all new drugs by 2015. In addition, the use of biotech based diagnostics (especially genetic testing), bioinformatics, and pharmacogenetics is likely to increase. In some cases, these technologies will be used to improve the safety and efficacy of clinical trials, to personalise prescribing practises, and to reduce adverse drug reactions.