Summary

The North America track and trace solutions market was valued at US$ 2,607.35 million in 2022 and is expected to reach US$ 8,621.45 million by 2030; it is estimated to register a CAGR of 16.1% from 2022 to 2030.

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 Revenue and Forecast to 2030 (US$ Million)

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.

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, and Jekson Vison Pvt Ltd. are some of the leading companies operating in the North America track and trace solutions market.

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Table of Contents

TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. North America Track and Trace Solutions Market - Key Market Dynamics
4.1 North America Track and Trace Solutions Market - Key Market Dynamics
4.2 Market Drivers
4.2.1 Implementation of Serialization to Combat Counterfeit Drugs
4.2.2 Increasing Number of Packaging-Related Product Recalls
4.3 Market Restraints
4.3.1 High Cost of Products and Implementation
4.4 Market Opportunities
4.4.1 Supply Chain Optimization
4.5 Future Trends
4.5.1 Continuous Technological Advancements
4.6 Impact of Drivers and Restraints:
5. Track and Trace Solutions Market - North America Market Analysis
5.1 North America Track and Trace Solutions Market Revenue (US$ Million), 2020-2030
5.2 North America Track and Trace Solutions Market Forecast Analysis
6. North America Track and Trace Solutions Market Analysis - by Component
6.1 Software
6.1.1 Overview
6.1.2 Software: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
6.2 Hardware
6.2.1 Overview
6.2.2 Hardware: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
7. North America Track and Trace Solutions Market Analysis - by Application
7.1 Serialization Solution
7.1.1 Overview
7.1.2 Serialization Solution: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
7.2 Aggregation Solution
7.2.1 Overview
7.2.2 Aggregation Solution: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
8. North America Track and Trace Solutions Market Analysis - by Enterprises Size
8.1 SMEs
8.1.1 Overview
8.1.2 SMEs: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
8.2 Large Enterprises
8.2.1 Overview
8.2.2 Large Enterprises: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
9. North America Track and Trace Solutions Market Analysis - by End Users
9.1 Pharmaceutical
9.1.1 Overview
9.1.2 Pharmaceutical: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
9.2 Medical Devices
9.2.1 Overview
9.2.2 Medical Devices: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
9.3 Consumer Goods
9.3.1 Overview
9.3.2 Consumer Goods: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
9.4 Food and Beverages
9.4.1 Overview
9.4.2 Food and Beverages: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
9.5 Others
9.5.1 Overview
9.5.2 Others: North America Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
10. North America Track and Trace Solutions Market - Country Analysis
10.1 North America
10.1.1 North America: Track and Trace Solutions Market - Revenue and Forecast Analysis - by Country
10.1.1.1 United States: Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
10.1.1.1.1 United States: Track and Trace Solutions Market Breakdown, by Component
10.1.1.1.1.1 United States: Track and Trace Solutions Market Breakdown, by Software
10.1.1.1.1.2 United States: Track and Trace Solutions Market Breakdown, by Hardware
10.1.1.1.2 United States: Track and Trace Solutions Market Breakdown, by Application
10.1.1.1.3 United States: Track and Trace Solutions Market Breakdown, by Enterprises Size
10.1.1.1.4 United States: Track and Trace Solutions Market Breakdown, by End Users
10.1.1.2 Canada: Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
10.1.1.2.1 Canada: Track and Trace Solutions Market Breakdown, by Component
10.1.1.2.1.1 Canada: Track and Trace Solutions Market Breakdown, by Software
10.1.1.2.1.2 Canada: Track and Trace Solutions Market Breakdown, by Hardware
10.1.1.2.2 Canada: Track and Trace Solutions Market Breakdown, by Application
10.1.1.2.3 Canada: Track and Trace Solutions Market Breakdown, by Enterprises Size
10.1.1.2.4 Canada: Track and Trace Solutions Market Breakdown, by End Users
10.1.1.3 Mexico: Track and Trace Solutions Market - Revenue and Forecast to 2030 (US$ Million)
10.1.1.3.1 Mexico: Track and Trace Solutions Market Breakdown, by Component
10.1.1.3.1.1 Mexico: Track and Trace Solutions Market Breakdown, by Software
10.1.1.3.1.2 Mexico: Track and Trace Solutions Market Breakdown, by Hardware
10.1.1.3.2 Mexico: Track and Trace Solutions Market Breakdown, by Application
10.1.1.3.3 Mexico: Track and Trace Solutions Market Breakdown, by Enterprises Size
10.1.1.3.4 Mexico: Track and Trace Solutions Market Breakdown, by End Users
11. Industry Landscape
11.1 Overview
11.2 Growth Strategies Done by the Companies in the Market, (%)
11.3 Organic Developments
11.3.1 Overview
11.4 Inorganic Developments
11.4.1 Overview
12. Company Profiles
12.1 Sys-Tech Solutions Inc
12.1.1 Key Facts
12.1.2 Business Description
12.1.3 Products and Services
12.1.4 Financial Overview
12.1.5 SWOT Analysis
12.1.6 Key Developments
12.2 SAP SE
12.2.1 Key Facts
12.2.2 Business Description
12.2.3 Products and Services
12.2.4 Financial Overview
12.2.5 SWOT Analysis
12.2.6 Key Developments
12.3 Uhlmann Pac-Systeme GmbH & Co KG
12.3.1 Key Facts
12.3.2 Business Description
12.3.3 Products and Services
12.3.4 Financial Overview
12.3.5 SWOT Analysis
12.3.6 Key Developments
12.4 WIPOTEC GmbH
12.4.1 Key Facts
12.4.2 Business Description
12.4.3 Products and Services
12.4.4 Financial Overview
12.4.5 SWOT Analysis
12.4.6 Key Developments
12.5 Korber AG
12.5.1 Key Facts
12.5.2 Business Description
12.5.3 Products and Services
12.5.4 Financial Overview
12.5.5 SWOT Analysis
12.5.6 Key Developments
12.6 Videojet Technologies Inc
12.6.1 Key Facts
12.6.2 Business Description
12.6.3 Products and Services
12.6.4 Financial Overview
12.6.5 SWOT Analysis
12.6.6 Key Developments
12.7 Domino Printing Sciences plc
12.7.1 Key Facts
12.7.2 Business Description
12.7.3 Products and Services
12.7.4 Financial Overview
12.7.5 SWOT Analysis
12.7.6 Key Developments
12.8 Kezzler AS
12.8.1 Key Facts
12.8.2 Business Description
12.8.3 Products and Services
12.8.4 Financial Overview
12.8.5 SWOT Analysis
12.8.6 Key Developments
12.9 rfxcel Corp
12.9.1 Key Facts
12.9.2 Business Description
12.9.3 Products and Services
12.9.4 Financial Overview
12.9.5 SWOT Analysis
12.9.6 Key Developments
12.10 NeuroTags Inc
12.10.1 Key Facts
12.10.2 Business Description
12.10.3 Products and Services
12.10.4 Financial Overview
12.10.5 SWOT Analysis
12.10.6 Key Developments
12.11 Catalyx
12.11.1 Key Facts
12.11.2 Business Description
12.11.3 Products and Services
12.11.4 Financial Overview
12.11.5 SWOT Analysis
12.11.6 Key Developments
12.12 Jekson Vison Pvt Ltd
12.12.1 Key Facts
12.12.2 Business Description
12.12.3 Products and Services
12.12.4 Financial Overview
12.12.5 SWOT Analysis
12.12.6 Key Developments
13. Appendix
13.1 About Us
13.2 Glossary of Terms