市场调查报告书
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1562347
北美追踪解决方案市场预测至 2030 年 - 区域分析 - 按组件、企业规模、应用程式和最终用户North America Track and Trace Solutions Market Forecast to 2030 - Regional Analysis - by Component, Enterprise Size, Application, and End User |
2022年北美追踪解决方案市值为26.0735亿美元,预计到2030年将达到86.2145亿美元;预计2022年至2030年复合年增长率为16.1%。
实施序列化以打击假药推动北美追踪解决方案市场
在全球范围内,製药公司都在遵守序列化的监管合规性,以确保药品的防伪和可追溯。大多数已开发和发展中经济体要么已经制定了序列化监管路线图,要么正在製定过程中。由于与毒品相关的非法活动不断增加和供应链效率低下,监管推动确保药品供应链安全。努力的目的是解决药品假冒和未经授权的平行供应链问题,提高供应链的可见性,追踪退货或召回,以及用于预测患者行为的数据驱动工具的稀缺。强制医疗产品序列化的政府法规的一些例子包括:
在美国,药品供应链安全法案 (DSCSA) 于 2013 年开始实施。作为要求的一部分,药品必须标有国家药品代码 (NDC)、序号、批号和有效期限。整个供应链预计将实现电子集成,所有追溯节点将于2023年11月建立。
美国食品药物管理局 (FDA) 要求製造商在收到 FDA 实施追踪系统的命令时,在整个分销链中追踪特定设备。这些设备可能属于 I、II 或 III 类。
世界各国政府认为,假冒是一种有组织犯罪,可以透过实施产品序列化来有效解决,许多国家正在这方面采取措施。因此,序列化可以运行高阶分析程序,以深入了解消费模式、地理渗透、销售、行销支出有效性等。产品的製药公司美国必须对每个可销售药物单位进行序列化,以帮助从製造商到药房或医生办公室的追踪。
如果公司不进行序列化,美国的批发商就不会购买他们的产品。除了在供应链内提供品质、可见性和完整的可追溯性之外,成功的系列化计划将成为公司的关键差异化因素和明显的竞争奖励。因此,追踪解决方案市场在预测期内将继续大幅发展。
北美追踪解决方案市场概况
北美追踪解决方案市场分为美国、加拿大和墨西哥。该地区的市场成长归因于推出创新产品(特别是追踪和追踪)的大型企业的存在、该地区不断增加的产品引进以及追踪和追踪解决方案的技术进步。
在美国,自2015年起强制执行批次级追溯,自2017年起强制执行包装级序列化。在美国。
同样,美国食品和药物管理局 (FDA) 规定,在美国销售的所有医疗器械都必须贴有唯一的器械标识符 (UDI) 和生产标识符(涉及批号或序号以及有效期),并且资讯必须存储在全球UDI 资料库(GUDID) 中。此外,打算进行再处理的医疗器材必须在器械上有永久标记,以确保 UDI 合规性。透过此类授权,可以改善美国供应链中假冒产品的侦测和监控通知。
北美追踪解决方案市场收入及 2030 年预测(百万美元)
北美追踪解决方案市场细分
北美追踪解决方案市场按组件、企业规模、应用程式、最终用户和国家/地区进行分类。
根据组件,北美追踪解决方案市场分为硬体和软体。到 2022 年,软体细分市场将占据更大的北美追踪解决方案市场。此外,硬体部分再细分为条码扫描器、无线射频辨识(RFID)阅读器等。
就企业规模而言,北美追踪解决方案市场分为中小企业和大型企业。到 2022 年,大型企业细分市场将占据更大的北美追踪解决方案市场。
按应用划分,北美追踪解决方案市场分为系列化解决方案和聚合解决方案。到 2022 年,序列化解决方案领域将占据更大的北美追踪解决方案市场。
就最终用户而言,北美追踪解决方案市场分为製药、医疗器材、消费品、食品和饮料等。 2022 年,消费品领域占据北美追踪解决方案最大市场。
根据国家/地区,北美追踪解决方案市场分为美国、加拿大和墨西哥。 2022 年,美国在北美追踪解决方案市场份额中占据主导地位。
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 和 Jekson Vison Pvt Ltd。北美追踪解决方案市场上的一些领先公司。
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.