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As the pharma industry moves ahead with traceability initiatives, vendors are building their capabilities
By all counts, the global pharma traceability initiative—driven by the Drug Supply Chain Security Act (DSCSA) in the US, and the Falsified Medicines Directive in Europe—is moving ahead, with equipment and software contracts being placed, and project managers getting to work on implementations.
There is a core group of companies that have been carrying along traceability work since the early 2000s, and have lived through the lean days after California dropped its “electronic pedigree” deadline of 2008, and then bloomed again after DSCSA was passed in late 2013. (While most serialization and traceability work is driven by regulatory mandates, all along there have been pharma companies deploying traceability solutions to meet business needs). Now, companies like TraceLink are touting a doubling and redoubling of staff at its new headquarters in North Reading, MA; Optel Vision, a provider of packaging-line visibility solutions, has added several hundred staff and opened a center in Europe, and Systech International has also opened a new headquarters and is building up both its domestic and international business.
Barcode-marking and machine-vision equipment providers like Domino Amjet, Videojet, Cognex and others are seeing a pickup in business from pharma. Industrial automation vendors like Rockwell and Siemens are incorporating traceability work into their overall industrial automation business. Some combined equipment and software companies, like Mettler Toledo and its PCI Services unit, are in the fray. Companies with a strong base of traceability business in Europe, such as Antares Vision and Adents, have opened US offices and supply centers.
Some recent news announcements from these and other vendors:
The most active part of the serialization mandate at the moment in the US is equipping packaging lines to provide item-level serial codes; these codes need to be in place by November 2017 (deadlines for actually using the codes to confirm shipments comes later). All major pharma manufacturers are engaged in this activity; but there remain worries about the energy that CDMOs are dedicating to the effort—ultimately, someone is going to have to code the packages coming from the CDMOs if they themselves are not so equipped. The serialization effort has also been going on with distributors and logistics providers; if they do repackaging for a client, a code will need to be generated, and even if they don’t, they’ll need the system in place to receive serial code information and store it for use by downstream customers. Major CDMOs like Sharp Packaging and PCI (along with above-mentioned Almac) have been public about their efforts. Distributors like Woodfield Distribution and LifeScience Logistics have also announced their implementations. “This is not a trivial investment,” notes Richard Beeny, president of LifeScience Logistics.
And while it’s hard to define where the hardware costs are in relation to the software costs, the latter tend to draw significant attention from market analysts and consultants, perhaps because the implementations are a relatively complex undertaking with uncertain outcomes.
IDC Health Insights, one such market analyst, published a report this spring (see figure) giving a snapshot of where the leading enterprise traceability vendors are, and assessing TraceLink, Axway and rfXcel as market leaders. IDC analysts note that SAP has made a major foray into the market with Advanced Track and Trace, a dedicated IT solution specifically for DSCSA and FMD compliance, but that industry experience in implementing and using the technology is still being developed. “It’s a snapshot,” says Michael Townsend, IDC research manager, noting that that market is very fluid at the moment and will continue to evolve as the regulatory mandates get closer.