The Research Report on “Track and Trace Solutions Market by Product (Plant Manager, Checkweigher, Barcode Scanner, Monitoring), Technology (2D Barcode, RFID), Application (Serialization, Aggregation, Reporting), End User (Pharma, Food, Medical Devices) (2022 – 2026)”, is projected to reach USD 7.3 billion by 2026 from USD 4.1 billion in 2021, at a CAGR of 12.1% during the forecast period.
Stringent regulations & standards for the implementation of serialization;
Governments in many countries are working to approve specific laws for the implementation of serialization in track and trace systems to ensure supply chain efficiency in the healthcare sector. In Europe, the implementation of track and trace solutions is mandatory throughout the supply chain of pharmaceutical products. The European Federation of Pharmaceutical Industries and Associations recommends a common coding system across Europe for the pharmaceutical industry. The 2001/83/EC directive was rewritten due to the increasing threat of counterfeit drugs and to specify drug serialization requirements. The European Union has established the Falsified Medicines Directive (FMD) Safety Features Delegated Regulation, which states that from early 2019, serialization of licensed drug products will be a legal requirement for companies in the EU. Turkey was one of the first countries in the world to adopt serializing and tracking solutions for all transport packages such as pallets, parcels, boxes, or bundles.
In the US, batch-level tracking has been mandatory since January 2015, while package-level serialization was obligatory by 2017. As per the Drug Supply Chain Security Act (DSCSA), in the US, the unit-level traceability of the entire pharmaceutical supply chain will be done by 2023. According to FDA mandates, all medical devices sold in the US should be labeled with a unique device identifier and production identifiers (such as expiration date and lot or serial number) and be stored in the Global UDI Database (GUDID). Moreover, medical devices intended to be used more than once and reprocessed before each use are required to have a permanent marking on devices to ensure UDI compliance. This will improve the detection and notification of fake products in the supply chain. In China, a CFDA regulation already exists for the pharmaceutical supply chain, in which a manufacturer requests a serial number directly from the authorities.
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Industry Segmentation In Detailed:
“The Software segment accounted for the largest market share in 2020.”
Based on products, the track and trace solutions market is segmented into software, hardware components, and standalone platforms based on product. The software segment accounted for the largest share-60.1%-of the track and trace solutions market in 2020. Market growth is largely driven by the increasing awareness about secure packaging, the rising number of counterfeit drugs and related products, and growing awareness of brand protection. In addition, regulatory compliance is further supporting the growth of this market.
The standalone platforms segment is expected to register the highest CAGR of 15.9% during the forecast period. The growth in this market is mainly attributed to the stringent government regulations for implementing serialization and UDI codes in the pharma and medical device industry, increasing pressure on pharmaceutical companies to adopt serialization, and increasing demand for standalone platforms to reduce the serialization implementation timeframe.
“The Serialization solutions segment accounted for the largest market share in 2020.”
Based on application, the track and trace solutions market is segmented into serialization solutions; aggregation solutions; and tracking, tracing, and reporting. The serialization solutions segment accounted for the largest share-62.3%-of the applications market. This segment is projected to grow at a CAGR of 12.0% during the forecast period to reach USD 2,560.9 million by 2026. Stringent regulations for the implementation of serialization solutions in packaging and supply chain applications drive this segment’s growth.
The tracking, tracing and reporting segment is expected to register the highest CAGR of 16.1% during the forecast period owing to the increasing number of regulations such as DSCSA, UDI, and Medical Device Reporting (MDR) for medical devices and pharmaceutical products.
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Leading Key Players and Analysis:
Some of the prominent players in the track and trace solutions market are OPTEL GROUP (Canada), Mettler-Toledo International Inc. (US), Systech International Inc. (US), TraceLink Inc. (US), Antares Vision (Italy), SAP (US), Xyntek Inc. (US), SEA Vision Srl (Italy), Syntegon (Germany), Körber Medipak Systems AG (Switzerland), Siemens AG (Germany), Uhlmann Group (Germany), JEKSON VISION (India), Videojet Technologies, Inc. (US), Zebra Technologies Corporation (US), Axway Inc. (US), ACG Worldwide (India), Laetus GmbH(Germany), and WIPOTEC-OCS (Germany).
Geographical Analysis in Detailed:
The track and trace solutions market studied in this report is divided into five major regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America accounted for the largest share of 42.9% of the global track and trace solutions market, followed by Europe (33.5%). The presence of developed healthcare systems in the US & Canada; the presence of many pharmaceutical & biotechnology companies and medical device manufacturers; stringent regulations regarding serialization; and the growing medical devices market are major factors driving market growth in North America.
Asia Pacific (APAC) is the fastest-growing market and is projected to grow at the highest CAGR of 13.8% for track and trace solutions. Growing regulatory requirements in the healthcare industry to comply with manufacturing and distribution practices, the rising number of pharmaceutical and biotechnology companies, and the significant economic development in emerging Asia Pacific countries such as China and India are the major factors driving the demand for track and trace solutions in the APAC region.
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