Pharmaceutical serialization is the tracing and tracking of prescription drugs with the help of the supply chain – from manufacturing to dispensing. This is generally accomplished with the help of automated, electronic means and is legally required in many countries. It involves company practices such as authenticating, recording, sharing and maintaining correct records of items before dispatching. Pharmaceutical serialization uses track and trace technology for the information that is required for a serialization program, which is dependent on local and national laws. In addition, the pharmaceutical industry struggles to ensure the integrity of its products as they are transferred between different stops along the value chain – from contract manufacturers to wholesalers to dispensers and finally, to the patients. As the products move across international borders, the problem has been growing. More money is lost to counterfeiting with each passing year. Product theft is also on the rise. Thus, to prevent theft, the demand for pharmaceutical serialization is expected to rise during the forecast period.
The pharmaceutical serialization market also faces certain challenges. Different standards are prevalent across the borders, due to which problems are faced across international borders. For example, within the EU, member states don’t have serialization standards, but they should implement them. However, countries such as Belgium and Italy already have a ‘pre-serialization’ system in place. That’s why these countries can launch pharmaceutical serialization later. This is expected to hinder the pharmaceuticals serialization market.
Pharmaceuticals Serialization Market: Research Methodology
The market size for pharmaceuticals serialization id derived on the basis of primary and secondary research. Assessment of the shares of pharmaceutical serialization suppliers based on product type and end use applications is carried out through secondary research and data validation by primary interactions. The scope of the pharmaceutical serialization market is estimated of the basis of the penetration of pharmaceuticals serialization in various end use applications. Initially, in-depth secondary research is done to gain an idea about the overall market size, top industry players, industry associations, etc. Then, in order to conduct expert industry interviews, a detailed discussion guide is created. After that, a list of industry manufacturers and industry experts are developed. Interviews are then conducted with industry experts and industry players. The data is analyzed to find qualitative and quantitative insights about the industry. Later, industry insights and information are collated in the required format.
Global Pharmaceuticals Serialization Market: Segmentation
The global pharmaceuticals serialization market has been segmented as follows:
On the basis of technology, the global pharmaceuticals serialization market can be segmented as:
- 2D – Barcode
- Linear Barcode
- Dimensional Barcode
On the basis of product type, the global pharmaceuticals serialization market can be segmented as:
On the basis of end use application, the global pharmaceuticals serialization market can be segmented as:
- Vials and Ampoules
- Blister packs
- Bags & pouches
On the basis of geography, the global pharmaceuticals serialization market has been divided into seven key regions:
- North America
- Asia Pacific excluding Japan
- Western Europe
- Eastern Europe
- Latin America
- Middle East & Africa
The Asia Pacific region is likely to register a healthy growth rate in the pharmaceutical serialization market during the forecast period. The demand for pharmaceutical serialization in the region is increasing, owing to the fact that the China Food & Drug Administration (CFDA) mandates the use of government-issued serial numbers, which are reported back to a central government database. In addition, even in Europe, the EU’s European Stakeholder Model is based on the European Medicines Verification System (EMVS) where manufacturers upload serialized information to a central institutional hub for verification. Thus, serialization regulations are expected to go a long way toward protecting patients from dangerous counterfeit drugs and life science companies from lost revenues and potentially brand disrupting recalls. This is expected to accelerate the growth of the pharmaceuticals serialization market during the forecast period.