Personalization is the New Name of the Game

Precision medicine, also known as personalized medicine, is a concept of combining a drug with a test that is modified to a persons genetic disposition. The test has the ability to predict disease risk, diagnose disease and monitor therapeutic response. Given the huge problem of drug failure rates, the concept of companion diagnostics in the realm of precision medicine has gained huge momentum since 2010. Precision medicine involves the selection of diagnostic tests (companion diagnostics) that have the potential to identify changes in each patients cells. The use of that knowledge may help prevent and treat diseases through the development of treatment strategies to target these specific molecular alterations. Ultimately, the goal of precision medicine is to improve patient outcomes.

Figure 1 shows the failure rates for drugs in several disease categories today. Personalized medicine can help save billions of dollars for the healthcare economy globally.

How Big is the Opportunity?

By 2020, the companion diagnostics market will experience a growth of 20.4 percent globally. In 2014, the market for test sales and test services alone was $2.4 billion and is expected to reach $6.9 billion globally.

Figure 2 shows the percentage distribution of partnerships by type of therapeutic area from 2011 to 2013. Companion diagnostics for oncology is obviously leading the way, but there are several other therapeutic areas, including neurology and cardiovascular, that have started to develop drug/diagnostics combo treatments. The challenges in adopting personalized medicine are boundless. The first and foremost challenge affecting the precision medicine landscape is coordinating the timelines. Aligning the development of a drug and diagnostic design program requires a lot of careful planning. This also closely ties into the fact that the current regulations must be modified to support this idea. Current regulations and the three-tier approval process significantly drives up the cost of delivering drugs to market ($800 million $2 billion per molecule) with times-to-market of seven to 10 years. This does not lend itself to driving the agility that is imperative for personalized medicine to become mainstream. A radical redesign of the drug approval process is imperative for personalized medicine to flourish.

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It Takes Two To Tango: Combine Diagnostics And Drugs For Precision Medicine

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