Track-and-Trace and Serialization Market Analysis & Trends, Globally, 2025

Track-and-Trace and Serialization Market Overview

Pharmaceutical companies, like many others, face a number of challenges related to their supply chain management. Security lapses as a result of theft, product recalls or diversions can have terrible consequences for patient safety and security not only nationally but on a global level. They also affect the individual companies by directly impacting profitability, goodwill and planned research initiatives. With both the industry and governments realising the importance of adequate safeguards, the Track-and-Trace and Serialization Market came into existence. It has become mandatory for all stakeholders in the supply chain to comply with national and or/state legislation pertaining to the place in which they operate.

Rising product theft is a major issue for the pharmaceutical industry, and preventing it has become a key focus. Early approaches adopted included tamper-proof packages and 3-D holograms but even these are now considered easy to manipulate and have fallen out of favour. Current practices in the Track-and-Trace and Serialization Market include assigning a unique identification number to the smallest sale unit (like a bottle) and tracking its serial number through the entire supply chain so that it can be traced and authenticated at any moment. This practice has been in place in countries like China and Turkey for some time now, but now even countries like India and the U.S. have added similar laws. These are anticipated to be across the world over the next few years.

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Track-and-Trace and Serialization Market Drivers

Maintaining integrity of an increasingly complex supply chain is an important driver of the Track-and-Trace and Serialization Market. According to the WHO, the pharmaceutical industry loses nearly $40 billion in revenue due to counterfeiting. Billions more are stolen in annual cargo theft. This leads to not only lost sales opportunities but also increases the risk of patient safety. Negative publicity concerning counterfeits or product recalls can also damage the brand image and affect future sales revenue. With the help of the Track-and-Trace and Serialization Market, companies can identify and segregate products destined for different markets or customer segments. Authentication is a major benefit of patient-specific functionality based on serialisation.

The second major driver of the Track-and-Trace and Serialization Market is ensuring regulatory compliance. Pharmaceutical companies need to plan and implement their Track-and-Trace and Serialization initiatives at the earliest. The U.S. and the EU will require mandatory serialisation from November 2017 and these two are the largest pharmaceutical markets by far. Together, they account for more than half the industry volume. Thus, companies already in, or wishing to enter these highly lucrative regions will need to comply with their serialisation requirements since their immense size makes them too important to ignore. While other countries like China and Turkey have already adopted these laws, the rest of the developing world will slowly but surely follow suit.

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Track-and-Trace and Serialization Market Restraints

The biggest issue faced by the Track-and-Trace and Serialization Market is that of cost. Massive investments are required to make packaging lines capable of product serialisation. Estimates range from a conservative $250,000 all the way up to $1 million per line depending on how complex and automated it already is. These lines will experience production downtime while the changes are being made causing potential sales revenue losses. Some pharmaceutical companies hire contract manufacturers (CMO’s) for inventory management. However, they might not be ready for the large investments which may require the Marketing Authorization Holder (MAH) to change CMO’s to avoid revenue loss. They may even upgrade the CMO’s packaging lines themselves which would be an expensive proposition.

The second critical Track-and-Trace and Serialization Market challenge is data management. Serialisation will generate massive amounts of data to be stored for many years to ensure regulatory compliance. The information will need to be readily accessible and highly responsive to business processes leading to pharmaceutical distribution and supply chain channels becoming increasingly complex. A solution must be quickly derived to handling Track-and-Trace and Serialization information with no disruption in day-to-day business functions of the organisation

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Track-and-Trace and Serialization Market Key Market Players

Some of the Track-and-Trace and Serialization Market key market players are TraceLink, Infosys, Bosch Packaging, SAP, Axway and Xyntec Inc.

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