The next two figures present the research and product productivity for the industry from 1995 to 2003, based mostly on FDA statistics for major regulatory milestones. Research spending by the industry according to Pharmaceutical Research and Manufacturers Association (PhRMA) statistics has grown quite dramatically over the past 5 years (almost 100%) from $21 billion to about $40 billion worldwide. However, the number of new drugs reaching the public has not kept pace with this massive growth in research investment [15, 17].
First, we address in Figure 1.17 how many molecules (product leads) are found in the research stage from 1995 to 2003.
We also list the number of INDs at the FDA for the same time period. The molecules in basic research have increased steadily and fairly well from under 5,000 to more than 9,000 in this 5-year period. Even though you would expect the INDs to increase coming from the growing number of leads (molecules), the INDs submitted to the FDA however have remained almost the same, hovering around 2,000 per year [22, 32].
Second, we display the success rates for product approvals through the FDA in the USA by documenting the NDAs submitted for 1994 up to 2004 vs. the NDA approvals and also how many of the approvals were NMEs (new medical entities) (Fig. 1.18). An NDA is not only for a new product being approved and now available for use but also includes new products, new indications for approved products, and new
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