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.
Questions Answered in This Report:
Diverging from the “one-size-fits-all” model of traditional small-molecule drug development, personalized medicine uses individual biological characteristics or genetic biomarkers to tailor drug treatment to a patient’s unique profile. Industry investment has largely been on drugs that depend on the use of a predictive pretreatment diagnostic or assay for patient selection. What is the current status of the predictive personalized medicine market? How will Companion Diagnostic devices be integrated into future predictive drug development?
Pharma investment in personalized medicine is beginning to show tangible returns, both in the number of marketed personalized medicines as well as the number of promising personalized medicines in development. In 2013, there were 22 personalized drugs with a predictive companion diagnostic test or assay marketed by a dozen pharmaceutical companies. We expect both the number of personalized drugs and the number of companies marketing these drugs to double from 2013 to 2019. Which pharma companies lead others in predictive drug-CDx development? How will the competitive environment shift in 2019, following the market entry of novel predictive drugs? Among the active dealmakers, what therapy areas and deal types are favored by pharmaceutical developers?
The exponential growth in the field of personalized medicine has outpaced the changes by regulatory, reimbursement, legal, and economic bodies that are needed to incentivize robust investment. Lack of certainty about patent protection, regulatory reform, favorable reimbursement, and patient access has left discouraging disincentives that are impeding development, especially of companion diagnostics. Companies looking to invest in development programs need strategies that are flexible in the face of such uncertainty. What key challenges do pharma companies face when developing and commercializing a predictive drug-CDx device? What barriers will remain in the next three to five years?
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