Healthcare logistics and temperature-sensitive healthcare products
15 December 2021 by Edina GÁLFI
Based on a study conducted in April 2021 by consultants Multivalente for Olivo Cold Logistics.
In 2019, the global medicines market was 1,106 billion dollars, up 5% on 2018.
The market for temperature-controlled logistics for temperature-sensitive health products reached 13 billion dollars in 2019:
- A 40% increase compared to 2013;
- Leading to an average 14% increase in pharmaceutical manufacturers’ costs for managing the cold chain compared to 2017.
The issues of transport and control of the cold chain are being looked at more and more closely during inspections by Health Authorities.
This growing interest in the cold chain can be explained by :
- Technological developments: manufacturing of more medicines requiring temperature-controlled transport and storage;
- The 2012 update of the GDP guidelines required the introduction of devices to guarantee the maintaining of temperature of stored health products and medicines: +2°C/+8°C; +15°C/+25°C; -80°C/-20°C;
The French pharmaceutical market
In 2019, this market represented $60bn in France, 50% on the export market. And yet its market share has fallen by 2.2 percentage points in ten years.
The French market for the distribution of temperature-sensitive health products is governed by the GDP guidelines. These strongly recommend qualification of packaging based on AFNOR (French standards agency) standard NF S99-700.
The aim of design qualification is to demonstrate and document that these packaging items are suitable for the purposes for which they are intended. They meet specifications most often defined by the client, in terms of:
– insulation capacity of the packaging system: thickness and materials used for box walls;
– thermal conductivity coefficient: the lower it is, the better the insulation capacity of the material;
– fragility: impact resistance, resistance to temperature variations;
– dimensions and weight.
These specifications will often take account of:
- Exterior climatic variations
- Break bulk and unexpected events during road transport.
Drug distribution in France
There are over 20,000 medicines, including almost 8,000 proprietary drugs.
Drug distribution activities in France are governed by a set of “Guidelines on Good Distribution Practice of medicinal products for human use”, in turn governed by a European Regulation. The application of these guidelines is overseen by the ASNM (National Agency for the Safety of Medicines). The GDP guidelines concern all the actors in the industry: manufacturers, operators, importers, depositories, wholesaler-distributors. They guarantee the quality of distribution operations and therefore that of the medicines delivered and dispensed.
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