Orphan Drugs

The market for orphan drugs, which are used to treat rare diseases, is currently valued at $215 billion and is projected to exceed $500 billion by 2032. As of now, the FDA has approved 650 drugs specifically for the treatment of rare diseases, with many more in development. These rare diseases, often referred to as “orphan diseases,” affect fewer than 65 individuals per 100,000 people, which equates to just 0.00065% of the U.S. population. Due to the small number of affected individuals and the high costs associated with drug manufacturing, it is not uncommon for patented drugs for rare diseases to be abandoned.

According to Rare Disease International, between 3.5% and 5.9% of the global population, or approximately 263 to 446 million people, are affected by rare diseases. Children represent 70% of these cases. Unfortunately, it can take an average of 4.8 years for a rare disease to be diagnosed. Only companies with the most advanced manufacturing technologies can cost-effectively provide treatments for rare diseases, which are now recognized as an emerging global health problem.

Dr. Ashleys is constructing a 156,000 square foot state-of-the-art pharmaceutical center together with an adjacent 86,000 square foot R&D center dedicated to the research and manufacturing of orphan drugs for rare diseases. Our new European campus is expected to be fully operational by the end of 2026 and will be world-class campus facilities specifically designed for orphan drug R&D and manufacturing.

With our 13 low-cost pharmaceutical manufacturing patents and advanced technology, Dr. Ashleys is ideally positioned to become one of the largest manufacturers of orphan drugs. Our team of scientists is committed to providing the most cost-effective and technologically advanced treatments for rare blood cancers such as multiple myeloma, non-Hodgkin’s lymphoma, AL amyloidosis, and myasthenia gravis, as well as rare inherited retinal diseases and rare maternal/fetal diseases.