Pharmaceutical Trends Impacting New Product Development
SummaryDespite the current economic downturn, pharmaceutical research & development spending continues to play a vital role in the pharmaceutical industry. The industry, as a whole, needs to find new, more innovative ways to compensate for the recent and upcoming patent loses of many blockbusters products...
Despite the current economic downturn, pharmaceutical research and development spending continues to play a vital role in the pharmaceutical industry. The industry, as a whole, needs to find new, more innovative ways to compensate for the recent and upcoming patent loses of many blockbuster products, i.e. Lipitor and Zocor. Recent trends indicate that we are currently in the middle of a consolidation of pipeline efforts within the industry through numerous acquisitions, both intra-pharmaceutical as well as through purchases of biotechnology companies by big pharma. Additionally, as pharmaceutical companies merge and as more companies consider their R&D budgets, there has been a shift towards narrowing the areas of focus for many R&D programs. We are now seeing a great deal of companies reorganizing in order to focus on fewer key therapeutic areas, mainly around chronic illness. Cancer, infectious diseases, neurological disorders and heart disease together account for over 2,000 of the nearly 2,600 products currently in Phase III trials.
Taking this a step further, current challenges to FDA approval have also influenced the change in the number of total products under development as well as which areas are seeing the most activity. Furthermore, to help reduce costs, the pharmaceutical industry is making a greater move towards outsourcing of research and development to growing players outside of the US and Europe, particularly in China and India. One sign of this is that the proportion of principal investigators (PIs) based in the U.S. has steadily declined, from 96 percent of the total global pool of FDA regulated investigators in 1990 to 54 percent in 2007. The number of active PIs in the U.S. has declined 3.5 percent annually since 2001, while active PIs outside the U.S increased 13.5 percent each year simultaneously.
The biopharmaceutical industry is going through a time of change where many major companies are losing patent protection on top blockbuster products. In addition, reductions are being made in total work force size and costs are being scrutinized more than ever before. As a result, the need to have a strong pipeline that is run efficiently is at an all time high. To help accomplish this, companies are turning towards innovative measures where they can control costs more and focus their efforts in a select number of key therapeutic areas – particular around chronic illness. Overall, we are seeing a great many changes made by pharmaceutical companies in order to help reduce costs, maximize pipelines and defend against lost sales. Whether these changes will be the catalysts that restore sales to the top companies or just pieces of the total puzzle is still to be seen.
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