Managing the transportation of temperature-controlled products (refrigerated and frozen) is big business. The global biopharma industry logistics spend today is roughly $1.1 trillion (Figure 1), and between 2014 and 2020 is projected to rise by 41%. Within that, products that require refrigerated storage and transport are valued at around $260 billion, and will rise 65% between 2014 and 2020, while non-refrigerated products are projected to rise by about 34%. According to data from the Pharmaceutical Commerce’s annual Biopharma Cold Chain Sourcebook, non-cold-chain pharma logistics costs will hit $78.8 billion and grow at a 4–5% growth rate of pharma volumes. Also from that data, by 2020, pharma cold-chain logistics will be worth $16.7 billion, and non-cold chain will hit $77.1 billion (Figure 2).
The doubling of pharma cold-chain logistics growth is attributable primarily to the shift to biologics and other specialty pharmaceuticals, many of which require refrigeration. Continued strong growth in insulin products and vaccines is also propelling growth, as is the broader adoption of all these products by developed economies, as well as underdeveloped ones—especially in Asia and Africa.
The traditional supply chain approach has been successful to date. However, as the needs for in-transit medication management (ITMM) evolve, the industry must evolve in tandem to maintain and grow the segment. Integrated drug supply chains based on IoT-enabled solutions are changing the game for ITMM moving forward.
Pharmaceutical Supply Chain
When a finished drug or biologic completes the packaging process at a manufacturing facility, for most products, the next leg of the journey takes them to a facility controlled by a wholesale distributor. These distributors are responsible for maintaining the integrity of medicines from the manufacturer to the dispenser, which distributes the medicine to patients. Manufacturers may also contact third-party logistics providers (3PLs) to coordinate the logistics.
The Pharmaceutical Supply Chain: Today and Tomorrow
Traditionally, the cold chain portion ($12.6B) of the total biopharma supply chain was monitored for temperature and humidity. With the introduction of biological drugs, expansion of international drug trade, and new regulations requiring stricter oversight of drugs during transportation – now the cold chain and non-cold chain portion ($66.2B) of the biopharma supply chain will have to be monitored. This is a great opportunity for companies to provide integrated drug supply chain solutions by leveraging technology, which enables the Internet of Things (IoT).
Remapping the Supply Chain
IoT-enabled solutions are remapping the supply chain path for ITMM. Where the traditional supply chain was comprised of individual links, each serving a specific function, IoT technologies make the invisible links visible to the stakeholders, enabling a more dynamic supply loop (Figure 4).
This makes the supply chain more nimble and responsive, and provides a scalable infrastructure to support changing industry requirements, from new legislation to new customer needs to new safety and security concerns.
Technology to the Rescue
Technological advances in the IoT are enabling a new class of ITMM solutions such as Intelligent Track & Trace Solutions from Verizon and Life Science Cloud from Tracelink that are easy to adopt and address many of the critical factors at play to ensure safe and accurate delivery of medicines from the factory to the patient, such as:
- Verification and validation: To ensure medicine identification and authenticity, and minimize the occurrence of counterfeit products on the market.
- Tracing: To monitor where the medication has been, the environmental conditions during its travel, where it has been sold/distributed, and to ensure its safety to use.
- Tracking: To protect against pharmaceutical theft during the supply chain journey.
- Notification: To establish systems and processes to notify the FDA and other stakeholders if an illegitimate drug is found.
Very low-power sensors and analog technologies allow for tracking temperate, humidity, location, tampering, and identification of drugs at any point in the supply chain, providing greater visibility into the supply chain for pharmaceutical manufacturers and pharmacies.
Low-power microcontrollers and microprocessors serve as the brains of the system, processing data gathered from the sensors to provide actionable intelligence for ITMM solutions.
Wireless connectivity standards, such as Bluetooth Smart, and mobile applications allow ITMM devices such as Emerald Temperature monitor from Oceasoft and HOBO Temperature and Humidity monitor from ONSET to become truly mobile, providing an easy gateway between the cloud and personal alert systems that can operate on site or in the field. The addition of intuitive mobile apps equips logistic providers with a toolbox to manage their supply chains efficiently.
Cloud-based platforms allow logistic providers to log and manage events within the supply chain. Using this cloud infrastructure, providers can also automate the report generation and reporting to regulatory bodies, making it easier to manage and validate compliance.
New legislations like Drug Supply Chain Security Act (DSCSA) aim to make the pharma supply chain safe and efficient, which will drive the industry to adopt new integrated supply chain solutions. Technology advancements in the Internet of Things era are creating new opportunities for the healthcare industry. As the global ITMM grows and evolves, an integrated, dynamic supply chain based on end-to-end IoT solutions will play a key role in the market’s ongoing success and growth. It offers ITMM stakeholders a more robust technology toolbox that will allow them to adapt to changing market needs more quickly and effectively, while maintaining a safe, secure, and reliable supply chain.