January 31, 2013
According to a new report by the Analysis Group, the biopharmaceutical pipeline is innovative and robust, with a high proportion of potential first-in-class medicines and therapies targeting diseases with limited treatment options. The report, “Innovation in the Biopharmaceutical Pipeline: A Multidimensional View,” uses several different measures to look at innovation in the pipeline.
The report reveals that more than 5,000 new medicines are in the pipeline globally. Of these medicines in various phases of clinical development, 70 percent are potential first-in-class medicines, which means that they have a different mechanism of action than any other existing medicine. Subsequent medicines in a class offer different profiles and benefits for patients but first-in-class medicines also provide exciting new approaches to treating disease for patients. Potential first-in-class medicines make up as much as 80% of the pipeline for disease areas such as cancer and neurology.
Many of the new medicines in the pipeline are also for diseases for which no new therapies have been approved in the last decade and significant treatment gaps exist. For example, there are 158 potential medicines for ovarian cancer, 19 for sickle cell disease 61 for amyotrophic lateral sclerosis, and 41 for small cell lung cancer.
The authors also found that personalized medicines account for an increasing proportion of the pipeline, and the number of potential new medicines for rare diseases designated by the FDA each year averaged 140 per year in the last 10 years compared to 64 in the previous decade.
The record 39 new drugs approved by the FDA in 2012 – a 16 year high – and the robust pipeline of drugs in development reflect the continuing commitment of the biomedical research community, including industry, academia, government researchers, patient groups, and others to develop novel treatments that will advance our understanding of disease and improve patient outcomes.
New medicines have brought tremendous value to the U.S. health care system and the economy more broadly. But more progress is needed to address the most costly and challenging diseases facing patients in America and across the globe. As our population ages, the need will only grow. Researchers are working to deliver on the promise of unprecedented scientific advances.