The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development

Report, July 2017

The biopharmaceutical pipeline contains thousands of innovative new treatments with the potential to address unmet medical needs, save lives, and improve patient health. Analysis Group Senior Advisor Genia Long, supported by Vice President Chris Llop, authored a new report titled “The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development.” Commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), this report analyzed the state of the drug pipeline and the therapeutic areas being explored, the distribution of clinical research projects by phase, the number of potential first-in-class medicines, and some of the new scientific approaches being applied.

The report revealed that globally there were more than 6,300 products in clinical development; and taking into consideration the multiple clinical trials underway in more than one indication, there were over 9,500 projects (or unique molecule-indication combinations). Therapies were under development in numerous areas, with cancer-related treatments accounting for more than one-third of projects in development from pre-clinical development on, and more than two-fifths in clinical development. Approximately three-quarters of clinical-phase projects were potentially "first-in-class" – representing possible new pharmacological classes for treating a given condition, and over 800 of the drugs in clinical development were determined to be covered by an “orphan drug designation,” awarded by the FDA to potential therapies for rare disease populations of less than 200,000 in the U.S. These finding confirm that the drug development pipeline is full of promising new options for patients, which will have a significant impact on the U.S. health care system in the years to come.

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Long G, Llop C