The approach of personalized medicine is that treatment is based on the individual characteristics of every patient: genetics, physical characteristics, environment, and lifestyle. The aim of personalized medicine is to “streamline clinical decision-making by distinguishing in advance those patients most likely to benefit from a given treatment from those who will incur cost and suffer side effects without gaining benefit”, as the Federal Drug Administration (FDA) puts it. A pivotal role in personalized medicine belongs to the use of the latest methods of molecular analysis to obtain genetic information. Together with the massive digitalization in health care and the efficient use of information technology in processing patient data, these are two of the major factors driving personalized medicine.
How necessary a personalized approach to disease treatment is can be seen in the fact that even many of the world’s top selling drugs are not as effective as one would assume. Humira, the best-selling drug in the world, improves the condition of only one out of four patients. There are, however, expensive blockbuster drugs with far worse efficiency rates. Thus, there are many voices declaring that in the long run personalized medicine should help reduce health care costs. Given the enormous advances in the genome sequencing area over the last two decades, such assumptions might be realistic.
As of 2017, the global market for personalized medicine therapeutics was estimated to be worth some 60 billion U.S. dollars, forecasting a growth up to 140 billion dollars by 2022. Perhaps surprisingly, the largest part of the total market is based on personalized nutrition and wellness. Personalized medical care, therapeutics and diagnostics are expected to make up around 40 percent in 2022. Oncology is the most important therapeutic area for personalized medicine. As of 2015, 73 percent of cancer drugs in development were targeted therapies while the share in all other therapy classes was 42 percent.
As the search for patients’ biomarkers is seen as a key to personalized medicine, this market is also expected to increase significantly, from 24 billion U.S. dollars in 2015 to some 46 billion dollars in 2020. Again, oncology is the largest single market among therapeutic areas. The selection of biomarkers is essential for the success of a new drug through all stages of development, and for use in targeted therapies.
The term ‘personalized medicine’ is often used interchangeably with other terms like ‘precision medicine’, ‘stratified medicine’, and ‘targeted medicine’, for example. All these terms describe a concept of tailoring medical treatment and therapy to individual patient characteristics. Precision medicine is perhaps most synonymous to personalized medicine and because of possible misinterpretations its usage is preferred by the National Research Council (NRI).