While personalized medicines have grown to 13% of all drugs marketed in the U.S.—up from 10% in 2010—biopharmas still face hurdles that impede faster market uptake, the Tufts Center for the Study of Drug Development said in a report released today.
Those challenges, reported in the May/June edition of Tufts CSDD Impact Report, include challenges of clinical adoption, regulatory and reimbursement policies, and even basic science.
“In particular, the continued development of personalized medicine depends on identifying biomarkers and developing clinically useful diagnostic tests,” Joshua Cohen, Ph.D., associate professor at Tufts CSDD, said in a statement.
Dr. Cohen added that higher R&D success rates alone may not lead translate into commercial success unless physicians increase the rate at which they prescribe personalized medicines, and unless payers show greater willingness to reimburse users.
Physician unfamiliarity remains a barrier to clinical adoption of personalized treatments, according to the report, while proof of clinical utility poses a major reimbursement hurdle.
The report based its findings on a survey of major drug manufacturers and interviews with leading drug and diagnostics companies, Tufts CSDD said.
Among other findings of the report:
- Biopharmaceutical firms projected that their investment in personalized medicine will increase 33%, and medicines in development to increase 69%, over the next five years.
- Biomarker identification and diagnostic test development ranked highest among scientific challenges cited by survey participants, followed by regulatory and reimbursement issues.
- Oncology products continued to command the highest average share of personalized medicines in development across all phases, followed by neurology and cardiovascular drugs.
The FDA has approved to date 137 drugs with labels that contain pharmacogenomics information, according to Tufts CSDD.
Personalized medicines accounted for nine of 41 “novel new drugs” approved by the FDA in 2014.
According to the Personalized Medicine Coalition, the nine drugs include Lynparza (olaparib) for advanced ovarian cancer; Vimizim (elosulfase alpha) for Mucopolysaccharidosis Type IV (Morquio syndrome); Cyrazma (ramucirumab) for advanced gastric or gastro-esophageal junction adenocarcinoma or non-small cell lung cancer (NSCLC); Zykadia (ceritinib), also for NSCLC; and Beleodaq (belinostat) for peripheral T-cell lymphoma.
Also included are Cerdelga (eliglustat) for long-term treatment of Gaucher disease type 1; Harvoni (ledipasvir and sofosbuvir) for chronic hepatitis C infection; Viekira Pak (ombitasvir, paritaprevir, and ritonavir; dasabuvir), also for chronic hepatitis C infection; and Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL).