The global pharmaceuticals market has more than doubled in the past ten years. Like the demand for fresh foods, global pharmaceutical sales are expected to show healthy growth into the future, reaching $1.3 trillion in a couple of years, and, also like the perishables business, it’s expected to be fueled to a significant degree by emerging countries. China, India, Brazil, Russia, and Mexico are expected to account for nearly 50 percent of the growth in drug spending globally by the end of next year.

Pharmaceutical products are often temperature-sensitive and require the controls applicable to other perishables. A new host of biologic and human plasma-based drugs require attention from the cold chain. These drugs must be kept in controlled environments and have very specific shelf-lives, often tied to the temperature and humidity of their surroundings.

Along with the new pharmaceuticals there has emerged a new healthcare logistics industry and logistics providers have announced a raft of new investments in medical and pharmaceuticals supply-chain infrastructures and enhancements to logistics services in the last couple of years as well as in new and emerging technologies designed to keep track of the conditions of pharmaceutical products, thereby helping to maintain their integrity. The global market for bio-pharmaceutical logistics was valued at $61.1 billion in 2014 and is expected to reach $91.0 billion by 2020.

All of this has brought about changes to how the air cargo industry—which still predominates when it comes to transporting pharmaceuticals—handles these sensitive products.

These developments embody not only commercial but also regulatory implications, noted David Bang, CEO of LifeConEx and global head of DHL Temperature Management Solutions at DHL Global Forwarding. “From a regulatory compliance point of view, risk-based quality management has been a hot topic over the last couple of years,” he said. “In other words, we must intelligently balance quality and cost based on a better understanding of risk through the movement of pharmaceuticals using big data. We should be able to demonstrate and prove such risk management is effective.”

Part of this involves the ability to able to handle various active and passive temperature controlled packaging types. “Approximately a decade ago, a typical pharmaceutical company would have one active container qualified globally,” said Bang. “But, now we see two or three active container types approved with rental-based high performing passive packaging options. In other words, assurance of supply, speed, reliability and predictability are becoming the main games in the air cargo pharmaceuticals industry.”

DHL is involved in all aspects of air cargo pharmaceutical shipments matching up with the entire life cycle of a pharmaceutical product, from clinical trial stage to product launch to on-going product replenishment. The company is also involved with Work-in-Progress products, Active Product Ingredient shipments, and finished products for markets, for all temperature requirements and sizes. DHL Global Forwarding covers 100+ markets around the world serving most of the top 100 life sciences and healthcare manufacturers.

On the digital technology front there have been a number of smartphone apps introduced that allow for pharmaceutical cold chain monitoring. There have also been advances in sensor technologies and constant innovations in temperature-controlled packaging solutions for the life sciences industries. But the ultimate quest is to deploy devices connected to the internet of things (IoT) that will enable real-time intervention to monitor and maintain shipment integrity.

Onset, a supplier of data loggers and monitoring solutions, developed the InTemp mobile app for the company’s InTemp CX400 Series products for pharmaceutical cold chain monitoring. The company recently announced that the app is available for Android devices. The InTemp CX400 Series includes a range of data loggers for monitoring temperatures in refrigerators, freezers, and controlled-temperature storage areas. The InTemp mobile app enables users to easily view temperature data from CX400 loggers, check logger status, set alarms, and create and share secure reports from their mobile devices. The InTemp CX400 loggers were designed to simplify compliance with the Centers for Disease Control and Prevention (CDC) vaccine monitoring guidelines.

DHL Global Forwarding introduced new iOS and Android apps providing users access to DHL’s LifeTrack online cold chain tracking and management platform. The apps give life sciences and healthcare shippers an overview of their shipments, alerts about issues like temperature excursions, and round-the-clock support from cold chain experts.

DHL Global Forwarding has been using various IoT devices over the last 10 years, upgrading hardware as well as software along the way, but is now ready to push into a new technological frontier. “Starting this year, we are further expanding the usage of near-field communication based IoT devices for easy data capturing using mobile apps and focusing on the intervention capability for near real time IoT devices with our core partners,” said Bang. Near-field communication utilizes protocols that enable two electronic devices, one of them usually a smartphone, to establish communication by bringing them within close proximity of each other.

“Having an IoT device attached to a shipment is one thing,” Bang added, “but the ability to intervene in near real time is a whole different story.”

IoT technology also facilitates the trend toward patient centricity, allowing individual patients to be more and more in a position to make decisions supported by various recent technology developments. IoT wearables tracking and reporting patient vital signs, smart speakers like Alexa and Google Home keeping patients on track with clinical trial medicines are all contributing to this trend.

“This is profoundly impacting the very fabric of pharmaceutical supply chain,” said Bang.

In the future, risk will be more and more assessed through big data analytics, which, Bang noted, “is far more efficient and comprehensive than manual assessment.” “Such learning and discovery will fuel more machine learning and predictive analytics which,” he added, “means faster new drug development and more patients having access to the right products at lower cost and higher quality, without worrying about counterfeits and product alteration and degradation.”