The production of orphan drugs, used to treat rare diseases, is increasing and will continue to rise with a compound annual growth rate of more than 7% per year between 2012 and 2018, according to the paper. Large pharma companies are investing in rare disease divisions and acquiring orphan drug assets, while small and mid-sized companies continue to expand their pipelines.
Development of these therapies through clinical trials involves small patient populations in many countries, often in remote areas. The paper states that approximately half of all orphan drugs are biologically derived and must be temperature controlled in order to ensure stability and efficacy throughout the trials, requiring special handling during transport to a clinic or a patient's home.
"Marken recognized the pharma industry's increased focus on rare disease treatments and the complexity of safely transporting them to patients residing in multiple countries, each with its own unique customs and regulatory requirements," said Leslie Chaney Ph.D., Marken's global director of Preclinical and Direct to Patient Services and co-author of the white paper.
"Our Direct to Patient service utilizes Marken's team of experts in customs and trade compliance along with our extensive network of depot facilities and strategically located distribution centers throughout the world to provide timely global packaging, transport and tracking of orphan drug materials within regulatory, temperature and time constraints," she adds.