require that all their compounds have an associated biomarker before going into clinical development. More than 80 percent of companies have established strategic partnerships related to personalized medicine, and half have collected DNA samples from clinical trial participants. In addition, companies that have developed genomic and diagnostic technologies have recently been acquired by other companies, suggesting that these approaches continue to be viewed favorably. However, Davies said, in large part these methods are not being employed in late-stage development due to a reluctance on the part of pharmaceutical companies to enable genomic-or genetic-based trials.

One concern about targeted drugs, Trusheim said, has been that they will have smaller markets and therefore attract less investment. But higher efficacy for targeted groups can in fact yield more market share and help minimize the overall reduction in market size (Figure 2-1; Trusheim et al., 2007). Underserved patients may enter the market and look for treatment


FIGURE 2-1 A number of factors influence the market potential for targeted therapeutics with the prospect of reduced market size leading to increased market share.

NOTE: As defined by Trusheim et al. (2007), an empirical medicine, as opposed to a stratified medicine, is not developed based upon the characteristics of an individual or a subpopulation of individuals. These medicines are based on overall population response and may work for a large or a small amount of individuals without using (either because it is not necessary or one is not available) a methodology to identify which groups may respond.

SOURCE: Trusheim et al., 2007.

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