Bio in a box: UPS and FedEx act to improve global specimen shipment
The clinical trial world is waiting to see how improvements in the shipping of biological specimens might expand the efficiency and success of trials worldwide.
U.S.-based parcel carriers FedEx and UPS both announced improvements last year allowing them better access to international shipment revenues driven by the skyrocketing global medical market. Memphis-based FedEx Corp. bought Dutch delivery firm TNT Express N.V. for $4.8 billion in May, allowing it to coordinate its worldwide air freight network with ground parcel transport throughout most of Europe. Then Atlanta-based UPS Inc. announced improvements to its capacity for temperature control, precision parcel tracking and other services affecting international shipments of drugs and biological specimens, such that it can now transport temperature-sensitive products and biological specimens more efficiently throughout some 60 countries.
The major benefit for the clinical trial industry? A greater ability to safely and more rapidly ship investigational medicinal products, specimen kits, ancillary supplies and medical devices between investigator sites and diagnostic labs. That’s crucial in an industry in which each trial can cost millions of dollars and people die waiting for trial results. It’s so vital, in fact, that some analysts are exploring the use of drones for such deliveries.
“The many problems still emerging from the shipment of biological specimens highlight the need to place more efforts for improvement and standardization,” notes a drone-themed paper published by the Annals of Translational Medicine last year. “At the dawn of the third millennium, the progress in healthcare cannot be disjointed from the use of emerging technology.”
The FedEx and UPS improvements are driven by a U.S. pharmaceutical market expected to reach $548.4 billion by 2020, a 34 percent boost over 2014 according to researcher GlobalData PLC. Worldwide, such sales should reach $1.6 trillion by next year, says PWC.com. Major factors include the 20 to 30 million new Americans recently insured under the Affordable Care Act and the well-publicized medical needs of aging baby boomers.
That demand is also creating a need for a greater range of test subjects for clinical trials, such that big pharma has a vested interest in finding ways to overcome the challenges of conducting more viable trials overseas. In many countries, the costs of manpower, IT expenses, and rental and operations necessities are half what they would be in the U.S., the FDA reports, and trials outside the U.S. often require shorter recruitment intervals due to wider pools of available participants. Some countries actively work to attract trial sponsors, such that foreign trials generally require less red tape even though they’re required to adhere to FDA guidelines.
In a 2014 survey by the FDA, 45 percent of the ongoing trials listed on ClinicalTrials.gov were being conducted exclusively outside the U.S., while 6 percent were being conducted both inside and outside.
As such, the benefits of more efficient international shipment conditions that can facilitate such trials are easy to understand. Some smaller carriers have pre-existing networks and agreements in certain parts of Europe and Asia, but analysts say UPS and FedEx will be challenged by language barriers and the myriad country-by-country regulations relative to tracking, cooling and import/export services. The perishability of much of the content also will need to be carefully addressed.
“If you're going to stay competitive, you're going to have to keep innovative and keep moving,” advises industry analyst Dick Armstrong on shipping news site DCVelocity.com. “(But biological specimen shipment) is a very lucrative area; you're moving high-priced goods, so there are a lot of value-adds and special services required. It pays a lot better than moving candy and canned goods.”