Pharmaceutical product development is changing. The need to produce significantly higher potency large molecule biopharmaceutical drugs to improve efficacy and tailor drugs to the individual needs of a patient puts new pressure on transportation and shipping. Why? The reason is that these newer more complex protein based drugs are highly sensitive to temperature changes, and are often required to be shipped under strict temperature control of typically 2° to 8°C.
Other key trends impacting the supply chain includes factors like the entry of biosimilars or generic versions of biological drugs which have already been launched in the US, Europe and other major healthcare markets; the increase in outsourcing trends of biopharmaceutical manufacturing to offshore locations; and biopharmaceutical manufacturing plants are now concentrated in a few regions, but their end-use markets diversified across the globe.
Biopharmaceuticals fall under the category of sophisticated products and require proper handling. Precision drugs and gene therapies require a temperature-controlled supply chain. With an increasing number of precision medicine and gene treatments, the biopharmaceutical market is pegged to grow. Additionally, outsourcing logistics services offer many advantages to pharmaceutical manufacturers in terms of cost-effectiveness and distribution of temperature-sensitive pharmaceutical products.
With logistics becoming more important – and critical – in the supply chain, the cost of maintaining strict environmental and temperature conditions also becomes a larger element of the cost of the overall cost of supply a drug. In larger organizations, proper cold logistics might add between 30-50 percent additional cost, especially as a result of the new strict shipping conditions being required to address the new trends in drugs as mentioned above.
For people involved in logistics operations, this has become a welcome trend – especially since logistics executives have in recent times been struggling to get budgets approved as the cost of cold chain shipping and temperature control rises. In fact in many cases, the lack of proper cold chain monitoring can actually lead to loss of revenue – for example, there have been cases of countries banning companies from shipping their medicines if they are unable to prove that the temperature of the transported medicines has been properly maintained.
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