|
|
|
|
|
|
|
calculated risk, with clearly defined go/no go milestones, can provide a cost-effective strategy for determining the product potential. Consulting this plan early and frequently will help to focus the R & D effort on those projects that have the greatest commercial potential. |
|
|
|
|
|
|
|
|
Market research, on the other hand, has not proven to be a reliable indicator of the commercial potential of novel products. While sales of me-too products can be estimated because there is an established market, there is no reasonable method for calculating sales of a novel product. Sales forecasts are usually underestimated because the market segment eventually served by the product is often not visible to the forecaster or is not appreciated as a future market. |
|
|
|
|
|
|
|
|
Prior to 1985, less than 20% of the new drugs introduced in the United States claimed a novel therapeutic approach, a novel mechanism, or an improved therapeutic benefit [12]. Figure 4 shows that by 1990 the fraction of novel drugs had steadily increased to approximately 50%. Concurrent with this increased emphasis on novel products has been a trend toward greater profitability of new drugs. Figure 5 shows that drugs introduced in the early 1980s produced greater second year sales than those introduced in the 1970s. Similarly, drugs introduced in the late 1980s had greater second year sales than those introduced in the early 1980s. The profitability of new drugs is likely to be attenuated over the next decade, as drug sales become more price sensitive [5]. Novel drugs that offer enhanced therapeutic benefit to the patient will be |
|
|
|
|
|
|
|
|
 |
|
|
|
|
|
|
|
|
Fig. 5
Trend in sales of new product introductions. The graph
shows a progressive increase in second-year sales of new drug
introductions in the last two decades, measured in constant
1990 dollars. (From Ref. [5].) |
|
|
|
|
|