Precision medicine promises a paradigm shift in the care delivery arena. According to Frost & Sullivan, global precision medicine market revenue is expected to reach $71.3 billion by 2021—up from $43.1 billion in 2016.
Precision medicine is an emerging concept to discover and develop evidence-based stratified medicines, vaccines or routes of intervention (e.g., behavioral or nutritional) to prevent disease and deliver superior therapeutic outcomes. It integrates an individual’s clinical, real-time monitoring, molecular and diagnostic data with environmental, behavioral, socioeconomic, and lifestyle factors to understand the biological basis of disease and well-being. This direct and indirect data enable better selection of disease targets and identification of patient populations that will demonstrate improved clinical outcomes with novel preventive and therapeutic approaches. According to Frost & Sullivan, global precision medicine market revenue is expected to reach $71.3 billion by 2021—up from $43.1 billion in 2016.
Pharmaceutical Industry Shifts from Blockbuster ‘One Size Fits All’ Model
Pressure to decrease health care costs globally, the emergence of outcome-based reimbursement models and health care consumerism are shifting the focus from volume-based treatment to value-based preventive care. The integration of molecular diagnostic solutions and genomics data/informatics into clinical workflows is unique to precision medicine in order to derive deeper insights into genetic and chronic disease management for evidence-based, targeted therapeutics.
A recent article in the journal Nature noted that an estimated 90% of conventional and top-selling blockbuster medicines only work for 30% to 50% of patients; their side effects and adverse reactions account for 30% of acute hospital admissions every year. Mounting payer pressures and regulatory changes are shifting pharma businesses from prescriptive to more predictive and personalized models. A better understanding of underlying disease biology paired with innovations in biomarkers and companion diagnostics (CDx) will support the precision medicine journey.
There are about 138 U.S. Food and Drug Administration-approved drugs with biomarker information provided on the label. Biopharmaceutical companies’ research and development pipelines hold great promise for targeted therapies. They have nearly doubled their investment in personalized medicines in the last 5 years; an additional 33% increase is expected in the next 5 years. A 2015 Tufts Center for the Study of Drug Development report found that 73% of oncology and 42% of non-oncology compounds in clinical trials have some form of biomarker drug label and can be categorized as precision medicines.
Genomics Advancements Eliminate Cost and Time Barriers
In the last two decades, technological advancements in the sequencing space have enabled high-throughput analysis of DNA, RNA and proteins for valuable genetic and genomic insights into their role in health and well-being to facilitate diagnostic-based, targeted therapies. The rapidly decreasing cost of next-generation sequencing tests and emerging alternative point-of-care molecular tests are shifting the focus of molecular diagnostic technologies from research to clinical use cases. Large-scale population genome sequencing programs globally with million-person cohorts provide a plethora of quantitative and qualitative data to advance precision medicine initiatives. IBM Watson, N-of-One and 2bPrecise LLC are developing advanced clinical decision support solutions that combine genomic data with clinical and lifestyle data to bridge the last-mile gap for precision medicine practice. Integration of genomics data into clinical workflows will create learning health systems with a similar trajectory to that of electronic health record systems, and will become widespread in the next five years.
Precision Medicine Focus Goes Beyond Oncology
Top diseases of interest based on ongoing phase 3 CDx and biomarker usage include breast and lung cancer. New CDx and biomarkers are expected to spread to other therapeutic areas, such as infectious diseases, central nervous system disorders and cardiovascular diseases, creating an impetus for scaling CDx platform technologies and tests to find precision medicine value beyond oncology. Drug and diagnostics companies have been broadening their strategies by increasing investments into exploratory biomarkers that focus on non-oncology areas, such as Parkinson’s and Alzheimer’s diseases and schizophrenia, which have a strong genetic correlation to their progression.
Precision Medicine Uses Big Data for Preventive Care
The evolving precision medicine ecosystem promises to look beyond the intrinsic omics and clinical factors by incorporating exogenous data, such as family history, food habits, alcohol and salt intake, smoking, weight and physical activity, to facilitate stratified medicine. Innovative digital health coaching platforms and wellness programs with proven behavioral therapies, such as Omada (digital behavioral therapies for diabetes patients) and Zipongo (personalized nutrition solutions), are being used for the prevention and management of acute, chronic health conditions.
What’s the Future?
Precision medicine promises a paradigm shift in the care delivery arena; collaboration and interoperability will be the key ingredients for success. Health care digitization and democratization with large-scale population sequencing programs globally are creating an explosion of patient data and more opportunities to integrate that data into the clinical environment. As more and more traditional and nontraditional players enter the precision medicine ecosystem, it will increase interoperability and foster innovations in targeted therapeutics. Applying precision medicine into mainstream clinical workflows will eventually facilitate preventive care to improve patient outcomes and save money.
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