Controlling R&D costs – and improving clinical trial design – will be high priority for drugmakers in 2015, a new outlook report from the Tufts Center for the Study of Drug Development says.
“The key challenge for drug sponsors, policy makers, and payers is to balance the need for new, innovative medicines with the equally pressing need to bring health care spending under control,” Tufts CSDD Director Kenneth I Kaitin said in a statement. “But developing products that can treat complex diseases is expensive, as it now costs nearly $2.6 billion to develop and gain marketing approval for a new prescription drug.”
Drug sponsors, he said, are finding that to get the best ROI are migrating from high-volume, low-margin business model to a low-volume, high-margin model – namely, picking precision meds, speciality pharmaceuticals and orphan drugs over, say, the next diabetes big drug. However, these narrowly targeted products will likely face market push-back thanks to their high price tag, he said.
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The report pointed out the following:
- Oncology companies will receive even more investment, because research has advanced so significantly in understanding the molecular intricacies of cancer. Immunotherapy, in particular, will stand out as a winner.
- There’s hope yet for clinical trials: The FDA will respond to Congressional calls for more efficient clinical trials. Initiatives like the Lung Cancer Master Protocol will help build a single clinical trial infrastructure for testing several drugs simultaneously, the report says.
- More sophisticated, yet simple, adaptive clinical trial designs will hasten as big pharma competes to improve data quality and program success.
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- Biosimilars will be huge in both the U.S. and European markets, with monoclonal antibodies standing out as the biggest opportunity for developers. A large number of biosimilars will likely be approved in the U.S. in the next few years.
- Regulators will work better to engage with patient populations looking for new and innovative meds.
- Rising drug costs, particularly those in specialty pharma, “will be tempered by competition,” the report says, particularly with the expected proliferation of biosimilars.
