Serialization: A Critical Component for the Pharmaceutical Supply Chain in an Era of Item-Level Track and Trace

Regulators across the world are rolling out changes which are driving serialization in the pharmaceutical industry
10 Mar 2022

In new research on asset visibility in the pharmaceutical supply chain, global technology intelligence firm ABI Research has identified the regulatory changes which are driving serialization in the pharmaceutical industry, dividing the regulatory landscape into 4 world regions: Europe, North America, Asia-Pacific, and Rest of the World. As regulations evolve to prevent counterfeit medicines, facilitate drug recall, and prevent reimbursement fraud, players throughout the pharmaceutical supply chain are adjusting to the regulatory changes and adopting technology which meets the legal baseline both for domestic drug production as well as for drug imports and exports. The direct impact of this is greater supply chain traceability, but implementations also lay the groundwork for full supply chain visibility, a growing topic of interest for pharmaceutical networks worldwide.

“The EU’s FMD (Falsified Medicines Directive) and the US’s DSCSA (Drug Supply Chain Security Act) are the primary drivers of supply chain adoption for serialization solutions, which means that navigating a complex-web of regulations on a short timeline is critical for firms across the value chain wishing to access these large pharmaceutical markets”, explains Abdullah Haider, IoT Markets Analyst at ABI Research.  “For countries that have yet to implement serialization mandates, the insight of other regional countries that have already done so serves as a blueprint for companies that can better anticipate future regulatory changes in the serialization domain.”

While much of the impetus around serialization comes from Europe and North America, many countries in the Asia Pacific and Rest of the World regions are looking to roll-out their own systems to avoid being left out of the lucrative pharmaceutical market. ABI Research sees emerging countries paying particular attention as they seek to develop this industry, while other countries with more established industries such as China and South Korea also aim to tackle the challenge. As the market for pharmaceutical serialization becomes more penetrated in Europe and North America once deadlines are reached, specialist software companies offering serialization will start focusing their efforts on the much more fragmented markets in the APAC and ROW regions.

This research analyzes past, present, and future timelines for implementation of serialization solutions, key data requirements, level of responsibility of different actors along the supply chain, and methods of data collection and storage. In addition, the research looks at the implications and complexities of aggregation when required in addition to serialization. GS1 forms the basis of most national and regional implementation requirements, moving a step closer to a standardized data-gathering approach on data throughout the supply chain. As serialization deadlines approach, software companies offering in-line and enterprise-level serialization solutions, as well as the broader pharmaceutical ecosystem, can leverage this information to understand a crucial source of supply chain visibility data.   

Companies leveraging aggregation will find it easier to realize efficiency gains by implementing a more granular and localized recall, as well as by simplifying how they meet regulatory verification requirements as drug products move through the supply chain. Aggregation will spread because of the value of the parent-child relationship between the carton (parent) and secondary-level packages (child) contained within the carton.

“The serialization regulations are transforming pharmaceutical supply chains. While the regulatory environment in both North America and Europe is relatively certain, and implementation is mostly in place, countries in Asia-Pacific and Rest of the World can learn lessons from the rollout in Europe and North America to accelerate their timeline by addressing hurdles such as data storage and aggregation, laying a deep foundation for supply chain visibility that can be leveraged for many more use-cases beyond the initial regulatory compliance layer,” Haider concludes.

These findings are from ABI Research’s Asset Visibility: Track and Trace Regulations report. This report is part of the company’s IoT Markets research service, which includes research, data, and analyst insights.


About ABI Research

ABI Research is a global technology intelligence firm uniquely positioned at the intersection of technology solution providers and end-market companies. We serve as the bridge that seamlessly connects these two segments by providing exclusive research and expert guidance to drive successful technology implementations and deliver strategies proven to attract and retain customers.

ABI Research 是一家全球性的技术情报公司,拥有得天独厚的优势,充当终端市场公司和技术解决方案提供商之间的桥梁,通过提供独家研究和专业性指导,推动成功的技术实施和提供经证明可吸引和留住客户的战略,无缝连接这两大主体。

For more information about ABI Research’s services, contact us at +1.516.624.2500 in the Americas, +44.203.326.0140 in Europe, +65.6592.0290 in Asia-Pacific, or visit

Contact ABI Research

Media Contacts

Americas: +1.516.624.2542
Europe: +44.(0).203.326.0142
Asia: +65 6950.5670

Related Research

Related Service