According to a new market report published by Transparency Market Research, the global companion diagnostics market was valued at USD 1.8 billion in 2012 and is expected to grow at a CAGR of 18.1 percent from 2013 to 2019, to reach an estimated value of USD 5.6 billion in 2019.
Pharmaceutical companies have thus far tended to leverage molecular diagnostics, not so much at the front-end in target and drug discovery, but at the back-end for disease sub-typing and clinical trial stratification (link). Pharma companies continue to expand their partnering deals for companion diagnostic development, with some organizations having as much as 60% of their current pipeline partnered with a companion diagnostic. Evidence seems to be building that this will significantly reduce development time and costs, which is critical as the target patient population is often smaller with a Theranostic, making cost recovery more challenging.
Figure 1: Companion Diagnostics partnering since 2007 (source)
Although cost effectiveness data is currently lacking, the consensus in bio/pharma is that stratifying patients based on who is most likely to respond should save the system money by speeding up clinical trials and lowering the probability of ineffective or unnecessary treatments. This is supported by Walter Koch, VP and Head of Research for Roche Molecular Diagnostics (RMD), who indicates that Biomarker alignment will result in smaller trials, that are quicker, more efficient and less costly, while achieving a larger magnitude of response. Approximately 60% of drugs in Roche’s portfolio are now being developed with a personalized strategy (source).
In addition to the opportunity to improve health outcomes and create a differential market access advantage, it appears that pharmaceutical companies are partnering for companion diagnostic development because there is potential for significant cost-savings by enriching the trial population. Given the outlook for worsening healthcare fiscal challenges, there is strong interest in anything that will streamline clinical trial processes and reduce development costs.