Personalized medicine has become a significant area for companies within the pharma and diagnostic industries. The $232 billion personalized medicine market in the U.S. is projected to grow 11% annually over the next several years. As one of the most significant technology-driven factors of the healthcare revolution, personalized medicine provides the healthcare arena with the ability to take on unmet medical needs and change the industry by turning research discoveries into definitive point-of-care diagnostics as well as safer and more-effective therapeutics.
Orphan drugs are a significant part of personalized medicine. Up to 30 million Americans suffer from nearly 7,000 rare diseases. Throughout the decades, many of the larger pharmaceutical and biotechnology companies did not dedicate much or any effort to orphan diseases since they represent small, niche population groups and products for such typically do not transform into blockbuster brands. However, in recent years the pharma and biotech industries have become more concentrated on the R&D of medicines for rare diseases. Compared with the 1990s, U.S. applications for orphan-drug designations nearly doubled during the past decade, with the heaviest concentration taking place in the latter half. In fact, 2009 accounted for the most orphan-drug designations by FDA in one year.
This special report focuses on the market leaders for orphan drugs as well as the products in development anticipated to head this area in the years to come. This compilation’s prescription-product pipeline details the following information for each medicine: chemical or substance composition, intended indication, class of drug, clinical status, region of development, and the product developer/intended marketer. Pipeline status details preclinical development, Phase I, Phase I/II, Phase II, Phase II/III, Phase III, and awaiting approval. Regions of development include the United States, Europe, and Japan. A directory of orphan drugs prescription-drug developers and marketers is included.
Additionally provided in this report is a listing of personalized medicine and orphan drug medical-device entries, sorted by device class, as well as a directory of medical-device companies associated with the personalized medicine and orphan drug field.