The dramatic shift in our industry from small molecule drugs to high value biopharmaceuticals is increasing the need to focus on logistics and supply chain management. Eight of the top 10 best -selling global drug products will be biologic drugs and require 2-8 C temperature controlled storage and handling by 2016 according to Evaluate Pharma predictions. The value of these products is expected to grow by almost 48% to $192 Billion in sales by 2016 according to Evaluate Pharma. Single drug shipments can be valued between one and three million dollars with strict temperature restrictions. The bottom line is we are banking on higher value drugs that demand higher quality supply chain and temperature management.
The logistics behind the scenes for transportation and storage of temperature sensitive drugs or drug products takes constant monitoring and attention to ensure their stability and viability. As an industry, we need to think up front about how to ensure the stable transportation and storage of these products throughout the drug’s lifecycle, starting with clinical trials but also more and more in our day to day use after drug commercialization.
Increased Clinical Trial Complexity leads to Increased Supply Chain Complexity:
- More clinical trials are starting and lasting longer
- More targeted patients and sites
- More challenging regions
- More time and temperature-sensitive restrictions
- More regulatory constraints globally
Supply chain logistics is increasingly more complex due to higher global regulatory standards such as the USP 1079 guidelines and new IATA label regulations and unreliable global infrastructure is driving up the cost of logistics. Some recent estimates predict that the cost of cold chain logistics will continue to rise by 12-15% year over year and we have seen these costs triple for certain of our clients having a high concentration of biologics coming through the pipeline. Many companies are unaware of just how much supply chain logistics costs them in both money and hours
Managing a supply chain in today’s complex global marketplace requires an endless series of critical decisions. Without a dedicated background in life science logistics, these decisions can be nearly impossible to make, and the wrong choices can be devastating to your clinical trial. Given the value, the temperature sensitivity, and globalization of the clinical trials has made effective supply chain management a top priority. The industry needs a supply chain logistics provider who truly understands the global nature of the pharmaceutical industry.
Marken is that supply chain solution provider. No one can match Marken’s in-depth knowledge of customs policies and procedures around the world. Marken works in a very complex regulatory and logistics environment, and our regulatory compliance is best in class. That’s why over 49,000 investigator sites in over 150 countries are now supported by Marken.