By the catalyst of the global pandemic that occurred in 2020, the supply chain industry is undergoing fundamental changes, especially in regulations and infrastructure due to the diversity of treatments and digitalization by the latest technology, and it now faces lots of challenges. Things are constantly changing. All living creatures including humans have survived to present by evolving in response to change. Similarly in the business world, companies that do not respond to the waves of change will fall behind and decline. Today, in the aftermath of a global pandemic, the planet is constantly at war, like between Ukraine and Russia, conflicts in the Middle East, and seeking the way to recover from the global recession. In addition, while we are excited about cutting-edge technologies such as AI, many people have various thoughts about the future, including questions about what kind of regulations are appropriate to prevent the worst situations beyond our control. What are the challenges of supply chain in life science industry?
Overview
Pharmaceutical Industry
Pharmaceutical market is currently undergoing major changes. First of all, there is the ‘’Patent Cliff’’. Humira, which was one of the best-selling products, reached the patent expiry in 2023, and the biosimilars and generic medicines have entered the market to replace them. Additionally, Cell Therapy and Gene Therapy (also called CGT or ATMP: Advanced Therapy Medicinal Product) are becoming important. Many features of CGT are “n of 1” products, tailored to the individual patient. Today’s pharmaceutical supply chain has two distinct perspectives; a global perspective for international transportation, and a local perspective for providing customized treatment to specific patients.
Supply Chain Industry
Digitalization connects everything from procurement to delivery. Freight forwarding companies involved in transporting pharmaceuticals are not only increasing the quantity and quality of data they collect during deliveries, but are making the healthcare ecosystem more digital and secure. You can manage the inventory by digitalization, for example, by sending notifications to your warehouse management system for restocking. The need for end-to-end visibility has recently given rise to a new concept: Monitoring as a Service (MaaS). In addition to end-to-end real-time visibility, MaaS is said to be the next generation of desired services.
Market Trends
According to market research agency, Evaluate Pharma, predicts that a compound annual growth rate in global pharmaceuticals will be 6% by 2028. They expect that the sales in 2023 will be $1,153 billion, which will be an increase of only 1.2% from 2022. In 2023, sales of vaccines and therapeutic drugs for Covid-19 will decline due to the end of the Coronavirus pandemic. Furthermore, Humira, the world’s best-selling product provided by Abbie, has lost the exclusive rights in the United States. From a supply chain perspective, sales volumes are expected to increase due to the market entry of biosimilars to replace Humira.
Market Outlook
These days, Cell and Gene technologies (CGT) gain attention in the pharmaceutical industry. According to The Regenerative Medicine Alliance, which represents the industry, more than 2000 clinical trials are being conducted and 200 items are reaching to the Phase Ⅲ around the world as of the first half of 2022. Many of the CGT therapies are autologous treatment – taking cells from the diseased patient, manipulating their internal mechanisms and returning them to the patient. These are N-of-1 treatments that require complex, temperature-controlled shipping both from the patient (the healthcare facility) and back to the patient (the healthcare facility). It is also common for some or all of these transports to take place under cryogenic or frozen conditions. Although current commercial CGT primarily targets rare diseases, it’s expected to be applied to common diseases such as cancer and cardiovascular disease in the future.
Temperature Control
Cell and Gene technologies (CGT) requires precise temperature control. Freezing cells below -150°using cryogenic storage techniques allows fresh cells to be stored almost indefinitely. However, specialized facilities to maintain cryogenic storage and transportation may not be available, especially in emerging markets and remote areas. Cryogenic storage facilities are essential to enable long-term storage and long-distance transportation. Significant upgrade infrastructure is currently being undertaken, including advanced packaging solutions, refrigerant charging stations, and real-time location tracking and temperature monitoring.
Whether autologous or allogeneic, CGT is a specialty drug that involves cold chain technology. They mostly derive from biological origin and are expensive. Therefore, they require safety handling and costly storage. Over the past decade, pharmaceutical companies, the distributors, and the pharmacy have developed the ecosystem.
Data Management
Demand and requirement of tracking in transport has been increasing. The data can also be obtained from shipping package providers, and some of which may have devices built into their containers to track the condition and location. Meanwhile, supply chain IT providers, who are responsible for linking shippers and 3PLs, are penetrating the market. Under these circumstances, pharmaceutical manufacturing companies needs to choose right traceability and monitoring service to manage the data for risk management
Technology and Life Science
Cloud computing is essential for managing big data. Some solution companies provide cloud service to transmit the data that devices generate. It helps regulatory requirements and eliminates shipping distraction in time. Nowadays end-to-end real-time visibility is critical. This is a competitive advantage for not only transport but also laboratory, manufacturing sites and warehouses. Therefore, those services can track and trace entire shipments from warehouse to destination.
Summary
In the aftermath of the disruption caused by the global pandemic, we’re now facing challenges for next-generation supply chain management. In the past, supply chain security was primarily focused on security and integrity relating to products. However, nowadays cyber threats have risen to the forefront of the concern. Integrated management with technology as well as physical product security are required.
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