Track and Trace Solutions Market: Growth, Size, Share, and Trends

Governments worldwide are enforcing stringent serialization and traceability laws to enhance supply chain visibility, authenticity, and safety driving the global track and trace market. In Europe, the Falsified Medicines Directive (FMD) mandates serialization and verification of all licensed drug products since February 2019, requiring a unique identifier (UI) and anti-tampering device (ATD), verified through the European Medicines Verification System (EMVS). In the US, the Drug Supply Chain Security Act (DSCSA) enforces unit-level serialization and aggregation across the pharmaceutical supply chain, with full traceability targeted by 2030. The FDA’s Unique Device Identification (UDI) rule also requires medical devices to carry permanent identifiers stored in the GUDID database. In China, the NMPA’s Drug Information Traceability System covers key drugs and blood products, with 95% of hospitals and pharmacies using traceability codes as of 2025. In India, the DGFT withdrew export serialization mandates in 2025 to align with the Ministry of Health & Family Welfare’s barcode rule for over 300 drug brands, effective August 2023. Other countries including Brazil, Mexico, Argentina, Saudi Arabia, Japan, and Australia are also implementing or expanding serialization frameworks. Additionally, FDA, CDC, and USDA mandates for food traceability strengthen compliance across industries. Overall, the tightening of global serialization and UDI regulations remains a key growth driver for the track and trace solutions market.

The implementation of serialization and aggregation technologies, while essential for supply chain transparency and counterfeit prevention, presents significant financial and operational challenges for manufacturers. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), cost and implementation timelines are the primary concerns in the track and trace industry. Serialization at the product and packaging level requires substantial investment ranging from USD 50,000–270,000 per carton line and USD 270,000–470,000 per bottle line with aggregation. The complete deployment of track and trace systems across all operational levels (1–5) typically takes 15–18 months, involving high costs for software, hardware, integration, staff training, and maintenance. Advanced systems such as RFID-based solutions further increase expenses due to the need for additional infrastructure, including servers and middleware. These heavy financial requirements, coupled with the need for skilled personnel, make adoption particularly difficult for small and mid-sized manufacturers, thereby acting as a significant restraint on the growth of the global track and trace market.

The rapid expansion of the global pharmaceutical industry is creating strong demand for advanced track and trace solutions. According to the IMS Institute for Healthcare Informatics, global pharmaceutical sales reached USD 1.42 trillion in 2021, with emerging markets outside North America and Europe driving much of this growth. To capitalize on these opportunities, pharmaceutical manufacturers are increasingly relocating production facilities to high-growth regions that offer low-cost manufacturing, tax incentives, and favorable regulatory environments. Asia Pacific, particularly India and China, has emerged as a key hub for pharmaceutical manufacturing. According to the India Brand Equity Foundation (IBEF), India’s pharmaceutical exports were valued at USD 24.6 billion in FY 2021–2022, while its domestic market turnover reached USD 28.9 billion in 2020, up from USD 20.0 billion in 2019. A PMMI survey further indicates that nearly two-thirds of major pharmaceutical companies anticipate growth in FDA-approved manufacturing facilities across Asia Pacific and Latin America. As more manufacturers establish production bases in these emerging regions, the need for robust serialization and track and trace systems to ensure regulatory compliance, product authenticity, and efficient distribution is expected to rise significantly during the forecast period.

The lack of common standards for serialization and aggregation across the globe is restricting the growth of the track and trace solutions market. Various regulatory authorities worldwide have started placing greater importance on serialization in the healthcare industry (specifically for pharmaceutical products) and have issued relevant guidelines. Europe has more comprehensive and well-defined serialization guidelines than the US, where only California has defined partial serialization guidelines for pharmaceutical manufacturers. In Canada, the AIVP Advisory Task Group has announced the barcode recommendation for vaccine products, and various manufacturers have adopted these standards. In France, it is mandatory for all manufacturers in the pharmaceutical sector to ensure a specific serial number for each carton. Although the global adoption of aggregation is low, it is mandated for specific packaging levels in some countries or regions such as China, India, Turkey, Brazil, the US, South Korea, and Europe. Apart from common standards for serialization and aggregation, effective serialization depends on integration with legacy or existing IT systems in the organization. Integration with the existing information technology (IT) infrastructure is one of the most demanding tasks for track and trace solution vendors. Track and trace functionality requires the addition of specific software and application components to a company's existing IT infrastructure. Similarly, serialization solutions require to be fully integrated with centralized systems to properly allocate and manage serial numbers within the packaging process of each production line. These systems also allow the management of data communication and storage in a common corporate database to prevent data duplication. As a result, the successful integration of trace and trace solutions with the existing IT architecture is a more significant challenge for providers.