Rising healthcare costs, declining productivity in R&D, growing awareness of disease heterogeneity, and greater payer scrutiny of return on investment/outcomes have driven the need for high-value, cost-effective, targeted, and effective drugs. Personalized medicine, with its promise of “the right drug for the right patient at the right time” theoretically fills this industry need, but with science advancing faster than the necessary regulatory, reimbursement, and intellectual property adaptations, substantial challenges must be overcome before personalized medicine can become the status quo in disease treatment.
With the booming interest in personalized medicine, our analysis will shed light on the current state of predictive, treatment-driven personalized medicine and will focus on targeted therapies with an associated companion diagnostics (CDx) device or pretreatment predictive assay. Given that oncology currently dominates the predictive personalized medicine market, and will continue to do so through 2019 (it is forecast to capture nearly 90% of U.S. sales of these agents in 2019), our analysis will focus largely on recent oncology launches and notable agents in development. In addition, we’ll highlight the key competitors and emerging players and dealmaking activity as well as the substantial challenges all companies must face when deciding whether to enter a field that promises to be the future of drug development.
Markets covered: United States.
Personalized medicine product analysis: Historic approval timeline for drugs with a companion diagnostic or predictive pretreatment assay available; number of marketed and emerging personalized medicines (2013 and 2019); number of pharma companies with marketed personalized medicine drugs (in 2013 and 2019); and U.S. forecast sales of leading predictive personalized drugs (2013 and 2019), by individual agent and by therapy area. Includes a supporting data file with current and emerging agents as well as their manufacturers, associated biomarkers, and U.S. sales estimates (2013 and 2019).
Personalized medicine pharma company and deals analysis: Ranking of pharma companies by total personalized medicine drug sales (2013-2019). Pharma personalized medicine deals (2009-2013Q3), including a supporting data file highlighting 82 personalized medicine deals (2009-2013Q3) with details on pharma company, partner company, deal type, date, and deal specifics.
Personalized drug/companion diagnostic approvals and processes: Includes data on the 19 FDA-approved CDx devices and associated therapeutic products, the drug-device codevelopment process, approval time for recently approved personalized drugs, and key FDA regulatory guidance documents for CDx development