Global Drug Supply, Safety and Traceability Report

Every year, TraceLink conducts the industry's largest survey on pharmaceutical serialization and track and trace to provide companies with a comprehensive view of the state of the industry in the global supply chain.

Partnering with leading research firms, the annual survey is designed to capture industry opinions about business challenges and opportunities in serialization and track and trace for the life sciences. With the World's Largest Track and Trace Network, TraceLink has the unique ability to gather insights from across the life sciences supply chain, providing a "state of the state" perspective on how companies across the world are implementing and deriving value from their serialization investments.

The largest survey ever conducted on serialization for life sciences, the 2017 Global Drug Supply, Safety and Traceability Report went beyond industry’s readiness beliefs for serialization, applying analytical insights into the actionable steps that various segments across the supply chain have taken, in order to prepare for serialization.

Across the entire sample of 660 respondents, the survey found that only one-third believe they are “very ready” for serialization. The data also revealed that no single company has actually completed ALL the basic steps for serialization readiness. In fact, the data will also show that, in most cases, no single step has been completed by all companies.

The full report includes global serialization readiness results, as well as industry-wide insights on differing preparation timelines between EU FMD and DSCSA, disparities between pharmaceutical companies and CMOs, and how all companies across the supply chain are managing network connectivity, data exchange, and aggregation. The report also includes a peek into the highest value-added benefits companies are looking to leverage from their serialization data.

• Only one-third of the 146 respondents from pharmaceutical companies with U.S. Drug Supply Chain Security Act (DSCSA) requirements believe they are “very ready” for serialization, a regulation that went into effect in November 2017, which requires pharmaceutical companies to place unique identifiers, or serial numbers, on each saleable unit of product sold into the United States;
• Compared to their pharma counterparts, half of the 88 respondents from contract manufacturing organizations (CMOs) serving customers with DSCSA requirements believe they are “very ready” for serialization;
• In both the DSCSA pharmaceutical company and CMO groups that feel “very ready,” not one respondent has completed all of the necessary basic steps for serialization;
• For pharmaceutical companies and CMOs with EU Falsified Medicine Directive (FMD) requirements, only one-third of respondents believe they are “very ready” for their serialization deadline in February 2019;
• After applying the basic steps to serialization in the analysis, the report found that only 15 percent of the EU FMD respondents are truly ready for serialization;
• The report also found that one-quarter of wholesale distributor respondents and 11 percent of hospital and pharmacy respondents are “early movers” in serialization, due to their progressive serialization preparations and ability to be ready ahead of their respective DSCSA deadlines.