The North America track and trace solutions market was valued at US$ 2.60 billion in 2022 and is expected to reach US$ 8.62 billion by 2030; it is estimated to register a CAGR of 16.1% from 2022 to 2030.
In the US, the Drug Supply Chain Security Act (DSCSA) started in 2013. The DSCSA defines the requirements for an interoperable electronic system to identify and trace pharmaceutical products throughout their distribution in the country. As part of the requirements, pharmaceutical products must be marked with a National Drug Code (NDC), serial number, lot number, and expiration date. The entire supply chain is expected to be electronically integrated, and all nodes of traceability are to be established by November 2023.
The Food and Drug Administration (FDA) mandates manufacturers to track specific devices through the entire distribution chain when and if they receive an order from the FDA to implement a tracking system. These devices could belong to Class I, II, or III.
Governments worldwide believe that counterfeiting is an organized crime that can be tackled significantly by implementing product serialization, and many countries are taking steps in this regard. So, serialization enables running advanced analytics programs to gather deep insights into consumption patterns, geographical penetration, sales, marketing spend effectiveness, etc. According to the 2013 Drug Supply Chain Security Act, starting from November 2017, all pharmaceutical companies selling prescription drug products in the US must serialize each salable drug unit to aid tracking from manufacturer to pharmacy or doctor's office.
If companies don't serialize, no wholesalers in the US will purchase their products. Apart from furnishing quality, visibility, and complete traceability within the supply chain, successful serialization programs will be a key differentiator and a clear competitive reward for the companies. Thus, the track and trace solutions market will continue to propel significantly during the forecast period.
In the US, batch-level tracking has been mandatory since 2015, with package-level serialization obligatory since 2017. According to the Drug Supply Chain Security Act (DSCSA) report, the unit-level traceability of the supply chain is expected to be done in the US by 2023.
Similarly, the Food and Drug Administration (FDA) mandates reveal that all medical devices sold in the US have to be labelled with a unique device identifier (UDI) and production identifier (involving lot or serial number and expiration date), and information has to be stored in the Global UDI Database (GUDID). Also, medical devices intended to be reprocessed must have a permanent marking on devices, ensuring UDI compliance. Through such mandates, can improve the detection and monitor notification of fake products in the supply chain in the US.
Implementation of Serialization to Combat Counterfeit Drugs Fuels North America Track and Trace Solutions Market
Globally, pharmaceutical companies are adhering to the regulatory compliance for serialization to ensure anti-counterfeiting and traceability of drugs. Most developed and developing economies have either already laid out the regulatory roadmap for serialization or are in the process of doing so. The regulatory push to secure the pharmaceutical supply chain is due to the rising drug-related illegal activities and supply chain inefficiencies. Efforts are aimed at addressing drug counterfeits and unauthorized parallel supply chains, improving supply chain visibility, tracking returns or recalls, and the scarcity of data-driven tools for predicting patient behavior. A few examples of government regulations mandating the serialization of medical products include:In the US, the Drug Supply Chain Security Act (DSCSA) started in 2013. The DSCSA defines the requirements for an interoperable electronic system to identify and trace pharmaceutical products throughout their distribution in the country. As part of the requirements, pharmaceutical products must be marked with a National Drug Code (NDC), serial number, lot number, and expiration date. The entire supply chain is expected to be electronically integrated, and all nodes of traceability are to be established by November 2023.
The Food and Drug Administration (FDA) mandates manufacturers to track specific devices through the entire distribution chain when and if they receive an order from the FDA to implement a tracking system. These devices could belong to Class I, II, or III.
Governments worldwide believe that counterfeiting is an organized crime that can be tackled significantly by implementing product serialization, and many countries are taking steps in this regard. So, serialization enables running advanced analytics programs to gather deep insights into consumption patterns, geographical penetration, sales, marketing spend effectiveness, etc. According to the 2013 Drug Supply Chain Security Act, starting from November 2017, all pharmaceutical companies selling prescription drug products in the US must serialize each salable drug unit to aid tracking from manufacturer to pharmacy or doctor's office.
If companies don't serialize, no wholesalers in the US will purchase their products. Apart from furnishing quality, visibility, and complete traceability within the supply chain, successful serialization programs will be a key differentiator and a clear competitive reward for the companies. Thus, the track and trace solutions market will continue to propel significantly during the forecast period.
North America Track and Trace Solutions Market Overview
The North America track & trace solution market is segmented into the US, Canada, and Mexico. The market growth in this region is attributed due to the presence of large players launching innovative product launches particularly track and trace, growing product introduction in the region, and technological advancements in track & trace solution.In the US, batch-level tracking has been mandatory since 2015, with package-level serialization obligatory since 2017. According to the Drug Supply Chain Security Act (DSCSA) report, the unit-level traceability of the supply chain is expected to be done in the US by 2023.
Similarly, the Food and Drug Administration (FDA) mandates reveal that all medical devices sold in the US have to be labelled with a unique device identifier (UDI) and production identifier (involving lot or serial number and expiration date), and information has to be stored in the Global UDI Database (GUDID). Also, medical devices intended to be reprocessed must have a permanent marking on devices, ensuring UDI compliance. Through such mandates, can improve the detection and monitor notification of fake products in the supply chain in the US.
North America Track and Trace Solutions Market Segmentation
The North America track and trace solutions market is categorized into component, enterprise size, application, end user, and country.- Based on component, the North America track and trace solutions market is bifurcated into hardware and software. The software segment held a larger North America track and trace solutions market share in 2022. Furthermore, the software segment is subcategorized into plant manager, line controller, and others. Additionally, the hardware segment is subsegmented into barcode scanner, radiofrequency identification (RFID) reader, and others.
- In terms of enterprise size, the North America track and trace solutions market is bifurcated into SMEs and large enterprise. The large enterprise segment held a larger North America track and trace solutions market share in 2022.
- By application, the North America track and trace solutions market is divided into serialization solutions and aggregation solutions. The serialization solutions segment held a larger North America track and trace solutions market share in 2022.
- In terms of end user, the North America track and trace solutions market is categorized into pharmaceutical, medical devices, consumer goods, food & beverages, and others. The consumer goods segment held the largest North America track and trace solutions market share in 2022.
- Based on country, the North America track and trace solutions market is categorized into the US, Canada, and Mexico. The US dominated the North America track and trace solutions market share in 2022.
Table of Contents
1. Introduction
2. Executive Summary
3. Research Methodology
4. North America Track and Trace Solutions Market - Key Market Dynamics
5. Track and Trace Solutions Market - North America Market Analysis
6. North America Track and Trace Solutions Market Analysis - by Component
7. North America Track and Trace Solutions Market Analysis - by Application
8. North America Track and Trace Solutions Market Analysis - by Enterprises Size
9. North America Track and Trace Solutions Market Analysis - by End Users
10. North America Track and Trace Solutions Market - Country Analysis
11. Industry Landscape
12. Company Profiles
13. Appendix
Companies Mentioned
- Sys-Tech Solutions Inc
- SAP SE
- Uhlmann Pac-Systeme GmbH & Co KG
- WIPOTEC GmbH
- Korber AG
- Videojet Technologies Inc
- Domino Printing Sciences plc
- Kezzler AS
- rfxcel Corp
- NeuroTags Inc
- Catalyx
- Jekson Vison Pvt Ltd
