Serialization Software

The Serialization Software Emerging Market Analysis report delivers current market analysis, strategies for providers and users, plus a five-year market and technology forecast, as well as long-term view. 

Serialization Software: Digitalization Is Key 

Serialization software is the major part of the investment that has been made necessary by the introduction of the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in the EU.  Many other countries have implemented serialization requirements for pharmaceutical products or will do so in the near future.  Producers of these products are obliged to comply with all these regulations, in their country (or region) of production as well as in the countries they intend to export to.

The necessary software solution cannot just be bought off-the-shelf, as most manufacturers and stakeholders have experienced.  Every available solution has to be adapted to internal processes and requirements, while providing the necessary connections to the partners down the supply chain and to regulatory bodies.

The serialization software market, including software and the relevant services, is dynamic and expected to experience strong growth.  This market has tremendous opportunities with rapid growth driven by replacements, updates, expansions, and additional global requirements.  These may concern national extensions toward more products or the fact that other countries may apply serialization requirements in the near future.

In addition to complying with legal obligations, the capabilities of serialization software are driven by the movements across the supply chain.  It also enables applications, including digitalization, Industrial IoT, and Industry 4.0.  Furthermore, the advances in data quality and software processing are increasing the value proposition for end users.

Serialization Software Market Strategic Issues

In addition to providing a five-year market forecast, the Serialization Software market research report provides detailed quantitative current market data and addresses key strategic issues as follow. 

Application and Regulation Knowledge

Product suppliers in the area of serialization software need to provide expert application knowledge next to their own software expertise.  Currently, most serialization implementations are in the pharmaceutical industry.  This sector is notoriously complex to start with as it was subject to a variety of regulations even before serialization became an issue.  It is also imperative that product suppliers keep up to date with the applicable regulations.  Serialization solutions need to be flexible in this aspect too since the possibility of changes or extensions of existing regulations need to be considered from the start and should be easy to implement.  

Close Cooperation with Customers

Even if the supplier possesses sufficient application knowledge, he needs to be aware of every country, company, plant, and production line that may require the input of the customer.  Only when all the possibly highly varied needs are taken into account will the solution provide the necessary result.  Close continuous contact with the customer also allows the supplier to catch problems early and avoid downtime and rework due to regulation infringements.

Support the Complete Supply Chain

Serialization is part of a complex track-&-trace system spanning the complete supply chain of the manufacturer, from the providers of base materials over transports and to the packaging companies.  Data needs to flow through all these instances and up to the regulatory bodies (e.g., the European Hub or US FDA) to be traceable down to the distributor, point-of-sale, and the consumer.  Some partners along this line may need support to reach the necessary IT level or external expert help to be able to handle this kind of information flow. 

Transparency in Products and Services

Serialization solutions are not a one-off investment of an off-the-shelf software package.  The installation of serialization software connects customer and provider for many years.  The actual costs of acquiring the software is just the tip of the iceberg. Costs for licensing, updates, and upgrades will be recurring; unforeseen incidents need to be dealt with immediately.  To gain and keep customer trust and satisfaction as well as to ensure their on-going compliance, providers need to handle a transparent policy.

For more information or to purchase this study, please contact us.