Sponsored by: Systech

There may be no industry supply chain that is more complex than pharmaceutical/life sciences—and certainly none that are as complex from a Änderungen perspective. Global regulations are swiftly evolving, as exemplified by the EU’s Falsified Medicines Directive (FMD) or the latest US FDA Guidance on real-world evidence. The Drug Supply Chain Security Act (DSCSA), part of the Drug Quality and Security Act of 2013, mandated package-level (item level) serialization and tracking to be in place by November 2023. This mandate puts enormous pressure on supply chains to be efficient and have the necessary visibility and track and trace capabilities to meet these challenges. Although regulatory requirements are the tip of the spear for many pharmaceutical track and trace initiatives, there are other, sizable benefits to deploying track and trace that companies may not fully appreciate. Things like outbound supply chain traceability or cold chain monitoring that can help to drive cost reduction or brand protection goals are just two examples.

For pharmaceutical/life sciences supply chains, global disruptions continue to be front of mind and materially impacting operations and strategic priorities. Organizations see lack of collaboration, speed, efficiency and visibility as the biggest gaps to supply chain success. To address these challenges, organizations continue to focus on integrated solutions that enhance visibility and responsiveness.  Interestingly, surveyed pharma respondents say that the adoption and/or improvement of track and trace technologies is second only to AI as a priority for advancing digital maturity. When asked specifically about visibility, track and trace is the leading approach organizations can take to drive improvement.

While a significant percentage of pharmaceutical/life sciences companies say that their current track and trace capabilities are either expanded (they have good visibility into many processes using specialized tools) or advanced (they have overarching visibility into processes leveraging control tower or advanced analytics solutions) the reality is somewhat more sanguine. Only 32% of organizations say that they have fully implemented complete track and trace across their business. The remaining 68% have only partly implemented track and trace across their business*. The reasons for this may be a function of difficulties in moving beyond pilots, but in other cases, organizations cite impediments like complexity and cost as key challenges with current applications. As noted, although many pharmaceutical companies claim good track and trace capabilities, they also say that investing in better tools is a top priority both within the next year and in the longer term. In addition, they are looking for easier implementations and tools better aligned with their business and business goals. In terms of regulations specifically, about two-thirds* of companies say that they have implemented item-level serialization for products regulated by either the DSCSA or the Falsified Medicines Directive (FMD). While this is generally good news, it also means that item level serialization is work-in-progress for the rest.

Although interest in improving track and trace technology tools is a clear message from pharmaceutical/life sciences companies, these systems do not act alone. When asked about what key technologies organizations will prioritize to advance track and trace capabilities across their supply chains, investments in supply chain orchestration tools and ERP head the list. Indeed, as supply chains grapple with track and trace challenges like system performance and reliability, custom integrations with other tools (either internally or externally) end up being necessary.

Clearly track and trace applications are critical solutions for pharmaceutical/life sciences organizations seeking to meet an array of business challenges and opportunities. While vendors and their customers will continue to be challenged to integrate and manage the complexity of track and trace applications, modern tools have already improved performance and reliability and have delivered improved ease-of-use.

Download the related IDC Infobrief with primary research focusing on hot industry trends, market needs and insights into pharmaceutical track and trace technologies.

* IDC surveyed 100 pharmaceutical organizations around the world that are currently using track and trace solutions as part of an overall visibility and supply chain solution.