A new Frost & Sullivan report identifies seven drivers likely to propel personalized medicine growth over the next eight years—as well as eight challenges that the field must surmount in order for the paradigm to deliver on years of promises that it will revolutionize medical diagnosis, treatment, and practice.
“Global Precision Medicine Growth Opportunities, Forecast to 2025,” notes the shift from “one-size-fits-all” to targeted treatments, the falling cost of population-level omics profiling due to scientific and technological advancements, and healthcare democratization through digitization.
Healthcare digitization will also grow as non-traditional players focused on patient stratification data enter the field, while clinical practices scramble to integrate precision medicine, aided by value-based reimbursement models and healthcare consumerism shifting the risk from payers to providers, the report observed.
A seventh driver for precision medicine will be the advancement of companion diagnostics and targeted therapeutics beyond oncology, toward CNS and cardiovascular (CV) diseases.
“These include CNS diseases such as schizophrenia, Parkinson’s, and Alzheimer’s,” Kamaljit Behera, industry analyst, healthcare in Frost & Sullivan’s Visionary Innovation Group, told Clinical OMICs. “Similarly, for CV diseases, companion diagnostics tests aim to determine sensitivity to the current drugs and treatments that have a narrow therapeutic index.
He cited among examples Celera’s development of diagnostic markers for the diagnosis and prediction of therapeutic responses in CV disease, and Roche’s development of companion diagnostic tests for acute coronary syndrome.
“In addition to CNS and CV, infectious diseases under also hold good future potential in the CDx and biomarker research space,” Behera said.
By 2020, he said, advanced clinical decision support systems will evolve to provide combined insight from genomic data with clinical and environmental information to facilitate targeted diagnostic for personalized treatment decisions.
“We anticipate that, in the next two to three years, molecular decision support systems will start bridging the last miles for genomics data into clinical workflow,” Behera said.
Behera cited no fewer than eight challenges that remain toward the adoption of precision medicine approaches to healthcare.
One is the need to verify the hypothesis behind precision oncology. The administration of a precision drug may be restricted to relatively small target specific mutations since those mutations may be different at different places in a tumor, making the outcomes imperfect for a large majority of cases.
Another challenge the cost of precision medicine. Behera said precision medicine will be prohibitively expensive for next three-to-five years just as the healthcare delivery landscape is increasingly becoming cost-conscious and competitive: “Drugs that are developed to target a person's genetic are generally expensive and likely to create steep reimbursement challenges from third-party payers or private insurance companies.”
Behera said the fragmentation of global healthcare systems raises legal and ethical issues toward adoption of precision medicine, and highlights the need for increased collaboration and interoperability. Other challenges faced by precision medicine include:
- Skepticism by physicians and payers about the effectiveness Less than 5% of molecular diagnostic tests are clinically relevant, Behera said.
- The need for standardization of data management and assessment processes, as clinical development requires greater use of large-population clinical studies
- Data privacy issues involving patient data confidentiality and security
- The need to develop more and better-targeted drugs
“Beyond federal investment stimulus and advancement in diagnostic technologies, there is an urgent need for more and better-targeted drugs to provide actual treatment options to majority of the patients volunteering or participating in on-going studies for precision medicine,” Behera added.