This week we introduced the correlation between a company’s biomarker coverage in their clinical trial pipeline and their Likelihood of Approval. After showing correlation between approval and biomarker use, we wanted to know more about a company’s biomarker use year over year. As we dove deeper into the use of biomarkers over the past years, we began to recognize a trend.
Biomarkers entered the drug development industry several years back, but we saw a massive peak in trials utilizing biomarkers between 2011 and 2013. Furthermore, we recognized a distinct trend that followed. In years to come there was a rapid drop off in biomarker use followed by a revamped program of biomarker research and utilization in clinical trials and ultimately drug development plans. We then forecasted their biomarker use in 2016 based on current utilization month to date and normalized it to a year of research.
Our theory to why this may exist falls in the premise of the typical adoption cycle of new, emerging markets. We believe that in 2003 the Human Genome Project gave us the Entrance to Market which launched us in this feat of precision medicine. Then in 2012 there was the Over-Hyped Expectations in biomarker use due to its highly innovative and emerging research that claimed biomarkers to be the future of research and precision medicine. Although, with any revolutionary product or idea that is on the cutting edge of technology, there is a factor of unrealistic initial expectations leading us to the Abyss Due to Extreme Expectations. This is due to a concept or idea failing in perspective to the hype of inflated expectations. We see this occurring in several companies’ biomarker use around 2014 and believe this to be time frame in which experiments and the use of biomarkers appears to fail in regards to their premature expectations. But as research continues to develop, it reiterates the importance of biomarkers in drug development and precision medicine. As our industry’s technology and overall knowledge base grows, there is only more and more support for the use of biomarkers. This begins to allow companies’ to hone in on the concept of biomarkers and produce quality results. Thus, bringing us out of the decline and through the High Value Use Cases Identified phase and eventually to this True Value Generated stage.
We believe as an industry, we are in the this High Value Use Cases Identified phase and that the future of biomarkers is gaining traction in today’s world and will continue to rise as the search for more accurate research and precision medicine is at the forefront of the pharmaceutical and biotechnology priorities. Precision Medicine’s role in companies’ Likelihood of Approval was outlined last week by utilizing the Precision Medicine Scorecard. This High Value Use Cases Identified phase is a stage in which the companies’ on the forefront of innovation will begin truly utilizing biomarkers with the newly crystallized research that is constantly being published. Whereas, the more cautious companies will sit on the sidelines and wait for the True Value Generated to be confirmed by other companies as mainstream adoption begins to take off.
With the ever-changing technology and knowledge of companion diagnostics, we expect nothing less than a reinforced ideology of the importance of biomarkers in creating the best drugs, saving time and money, and reaching new heights for precision medicine in today’s world. Will you be on the forefront of biomarker utilization and ultimately drug development?