Number of Personalized Medicines Doubled in 4 Years, New Report Says

A newly updated report published by the Personalized Medicine Coalition (PMC) showed that the number of personalized medicines on the market more than doubled between 2016 and 2020 in the United States. The drastic growth marks the largest 4-year increase ever recorded by the coalition since it began tracking the figure in 2008.

The Personalized Medicine Report: Opportunity, Challenges, and the Future, is an overview of the state of personalized medicine and the trends aiding physicians in aligning prevention and treatment plans with patients’ individual biological characteristics, circumstances, and values.

In addition to the record-high overall growth from 2016-2020, when the number of personalized medicines on the market rose from 132 to 286, these types of medicines accounted for 25% of the new drugs approved by the FDA in 2019—a big jump from 5% in 2005.

Without a personalized approach, therapies could have different effects on different patients, allowing some to benefit while others would either not benefit at all or experience adverse effects. Personalized medicine allows for all patients to receive appropriate medication based on biological characteristics that indicate certain patients will benefit from an individualized treatment.

Prior to the boom in available personalized medicines, the new report highlighted that 75% of cancer drugs, on average, were ineffective in the overall patient population, according to a Spear report in 2001. Additionally, 38% of antidepressants, 40% of asthma drugs, 43% of diabetes drugs, 50% of arthritis drugs, and 70% of Alzheimer’s drugs were ineffective on average.

The authors of the report listed several new advancements in the world of personalized medicine that can benefit patients and health systems, including liquid biopsies; gene therapies and CRISPR/CAS9 gene editing technologies; digital health tools such as smart phones, sensing technologies, and self-management platforms; and advanced diagnostics testing through the use of biomarkers. The authors noted that the use of biomarkers in clinical trials has risen from 18% in 2000 to 61% in 2019.

According to the report, individualized medications can benefit patients and health systems by shifting the emphasis in medicine to a more patient-centered approach, reducing trial-and-error prescribing, reducing the impact of adverse drug reactions, circumventing molecular pathways associated particular diseases, increasing treatment adherence, reducing high-risk testing procedures, and helping to control overall costs of health care.

“Because our increasing understanding of human heterogeneity demands it, health care is in the midst of a transformation away from one-size-fits-all, trial-and-error medicine and toward this new, targeted approach in which, as is often said, the right patient will get the right treatment at the right time,” the authors wrote.

In the report, the authors noted that personalized medicines face several new challenges on the road to advancement related to regulatory oversight, coverage and reimbursement, and adoption of new diagnostic and treatment methods.

The report stated that health systems around the world need to update regulatory and reimbursement processes and resolve any remaining barriers to the adoption of new medical practices and processes in order to ensure that all patients can reap the full benefits of an individualized approach.

“The sixth edition of The Personalized Medicine Report underlines the importance of ensuring that our health systems are aligned with the latest science and technology so that we can deliver unprecedented benefits to both patients and health systems by targeting the right treatments to the right patients at the right time,” said Edward Abrahams, the president of PMC, in a statement.

Reference

The Personalized Medicine Coalition. Personalized Medicine Report: Opportunity, Challenges, and the Future. The Personalized Medicine Coalition; November 17, 2020. Accessed December 26, 2020. http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PMC_The_Personalized_Medicine_Report_Opportunity_Challenges_and_the_Future.pdf