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Some interesting reports came out recently from Market Research firms on the economic future of Drug Safety (DS) and Pharmacovigilance (PV).

They note that the PV market was valued at $2.4 billion in 2013 and is expected to grow at about 13-14% a year to total $5.8-$6.1 billion by 2020. Over 60% (~$1.4 billion) of the market was in post-marketing and phase IV trials. Phase III PV ($750 billion in 2013) is expected to grow at a higher rate than the post-marketing segment since there is now a push for more risk reduction and comparative safety evaluations in pre-marketing clinical trials.

Out-sourcing of PV is also growing and contract research organizations (CROs) now represent over ½ of the market for clinical safety.  This segment is also expected to grow at a rapid rate over the next several years. The major drivers are coming from pharma companies who are looking for reduction in fixed internal costs, flexibility to react to increasing (or decreasing) numbers of SAEs and safety issues as well as smaller infrastructure functions (SOPs, data handling, databases etc.).

North America is the largest market for PV with Europe number two. However, Asia is increasing the most quickly for many reasons including lower costs there for clinical trials despite the distance from Europe and North America.

The PV software market is also growing though it is much smaller in size. It is estimated to grow at about 6% a year through 2020 and reach $154 million by 2019.  Again, North America and Europe are the number one and two markets respectively, but with Asia and Latin America growing more quickly.

Finally, the Drug Regulatory Affairs out-sourcing market is also large and growing. It was estimated to be about $1.6 billion in 2013 and growing to $4.5 billion in 2020.

So what does this mean for employees, companies and CROs in the DS/PV space?  Here are some thoughts.





So the business of DS/PV has changed the way these functions are handled.  What is not clear is whether this is good or bad or neutral for the public health, the companies and the workers. The message though for everyone in safety is to pay attention to the business world.


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