As Scott Fletcher, president and CEO of LocatorX, a tracking technology company, explained, that the pharmaceutical industry is worth approximately $1.2 trillion (€1.07 trillion) and is growing rapidly, it requires cold storage and transport to match its development. “The growing responsibility to keep goods cold, feeds the growth of the [cold chain] market,” Fletcher told us.
“The necessity of controlled temperature from inception to delivery for many pharma products, such as insulin and vaccines, has contributed largely to the growth of the cold chain market,” he added.
Additionally, the number of pharma products that require cold chain transport continues to expand, Fletcher said: “It is estimated that current pharma products that utilize cold storage and transport make up about $283 bn of the market and it is expected to keep expanding quickly.”
Rapid growth in the biologics industry will also trigger advancements in the tracking industry as practices and innovations will be needed with more biologics entering the market.
Recently, unmanned aerial vehicles (UAVs), also known as drones, were used in a trial to determine the possible use of the technology in areas difficult to reach. A consortium made up of Direct Relief, Softbox, AT&T, Merck, and Volans-I, led the test to ascertain whether or not drones could be an option as the pharmaceutical industry needs to reach greater distances.
“Traceability is key in the cold chain,” Fletcher told us. “Suppliers need to know that the products they are shipping are in the right place throughout the course of shipment.”
Marken also recently tapped into this need for traceability, adding innovations to its clinical supply operations, including GPS and remote-temperature monitoring devices. The company is looking to the future and technologies like artificial intelligence (AI) to add additional means of designing an accelerated supply chain.
Savsu, which has been acquired by BioLife, developed its own cold chain management technology which uses temperature-controlled systems and containers for biopharmaceutical shipping that are synced to the cloud. With this technology, used by companies like Novartis, clients have real-time access to temperature and location of the shipment.
Regulations in traceability also have been evolving, though Fletcher said additional guidelines will be needed as practices in track and trace become more stringent.
In 2013, the US Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) which outlines steps to build an interoperable system to identify and trace prescription drugs through the supply chain. With this, additional guidances have been published by the FDA to provide clarity into track and trace regulations.
“Now more than ever,” Fletcher added, “companies want to know that their products are being maintained in a consistent environment and they want to keep a pulse on the location of their goods.”