April 12, 2024
Pharmaceutical Traceability Market

Pharmaceutical Traceability Market is Poised to Grow at a Robust Pace Due to Increasing Regulations for Drug Traceability

This ensures drug safety and authenticity while preventing counterfeit drugs from entering the supply chain. The market comprises hardware and software solutions that enable serialization, aggregation, and traceability of medicines at individual bottle or packaging levels.

The global pharmaceutical traceability market is estimated to be valued at US$ 4.96 Bn in 2024 and is expected to exhibit a CAGR of 9.5% over the forecast period 2024 to 2030.

Key Takeaways

Key players operating in the pharmaceutical traceability market are M&R Printing Equipment, MHM Siebdruckmaschinen GmbH, Lawson Screen & Digital Products, Sakurai USA, SPS TechnoScreen GmbH, ATMA Champ Ent. Corp., Systematic Automation, DECO TECHnology Group, TOSH (Italy), and Thieme GmbH & Co. KG. The growing opioid crisis and illegal trade of medicines have opened new opportunities for pharmaceutical track and trace solutions. Major players are expanding their footprint globally, especially in developing regions of Asia Pacific and Latin America, to capitalize on the mandated serialization regulations.

Key opportunities in the market include serialization and aggregation software solutions for tracking drug movement from manufacturing to consumption. Increased government focus on preventing diversion of medicines has forced companies to adopt traceability solutions. The market is also witnessing significant mergers and acquisitions as players look to offer end-to-end traceability suites. Global expansion of traceability regulations will drive the need for robust and scalable platforms that can integrate with existing IT infrastructures seamlessly.

Market drivers

Stringent regulations mandating serialization and aggregation at individual drug/bottle level to curb counterfeiting and drug diversion is the key driver boosting the pharmaceutical traceability market. Most regions today have passed laws requiring a unique identification code for tracking medicines through the supply chain. Non-compliance can lead to significant monetary and legal penalties. Track and trace solutions help manufacturers and distribution partners demonstrate regulatory adherence, secure future businesses, enhance supply chain integrity and build customer trust.

PEST Analysis
Political: Regulations regarding serialization and aggregation of pharmaceutical products are driving the demand for traceability solutions. Various governments are implementing track and trace requirements to ensure supply chain integrity and patient safety.
Economic: Growth of the pharmaceutical industry and implementation of stringent regulations globally are fueling investments in traceability technologies. Serialization solutions help reduce logistics and inventory costs.
Social: Aging population, rise in lifestyle diseases and need for personalized medicines are increasing healthcare spending. There is higher adoption of traceability to address issues of drug counterfeiting and product diversion.
Technological: Adoption of advanced technologies like blockchain, IoT and analytics are enhancing the traceability of pharmaceutical products across the supply chain. 2D barcodes, RFID tags and sensors enable real-time monitoring and visibility.

In terms of value, the North American region dominates the Pharmaceutical Traceability Market Size  owing to stringent regulations and established healthcare infrastructure. Majority of players have presence across U.S. and Canada to cater to serialization requirements. Europe accounts for a significant market share led by track and trace mandates from EU FMD and UDDA. Growth in the Asia Pacific region is driven by increasing healthcare expenditure, generics market and efforts by regulatory bodies to curb counterfeiting. With implementation of DSCSA and FMD, developing economies like China, India and Brazil are emerging as lucrative opportunities.

Japan has one of the most advanced pharmaceutical supply chains globally and serves as a lucrative market for traceability vendors. High healthcare spending, technology adoption and aging population factors are fueling growth. The Middle East region is witnessing increasing focus on ensuring supply chain integrity as a means to build consumer confidence in their healthcare systems. Regulatory requirements from GCC and Iran present new avenues.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it