There is no quick remedy for what ails the pharmaceutical industry: a tougher environment for drug approvals and a dwindling pipeline of new medications.
But these twin challenges _ evidence that the heyday of blockbuster drug-development is over _ are forcing the industry to ponder big changes in the laboratory. The biggest, analysts say, is likely to be a shift toward finding treatments for patients with rare diseases, or unusual strains of common afflictions.
By focusing on boutique medications, analysts say, drug makers will arouse less scrutiny from regulators, who have become extra sensitive to the potentially fatal side effects of widely prescribed medications for ailments such as arthritis and diabetes. The growing need to market niche treatments is also dictated by the reality of the business, in that there are fewer widespread maladies for which a popular pill doesn't already exist.
Most recent biopharmaceutical breakthroughs have been for drugs to treat smaller patient groups.
Biotech powerhouse Genentech Inc. has successfully developed cancer treatments tailored to patients' specific genetic makeup. Meanwhile, Cambridge, Mass-based Genzyme Corp. has built a multibillion-dollar business around expensive treatments for rare diseases.
Several major pharmaceutical companies are already spending more on innovative biotechnology.
In the last year, Roche Holding Ltd. and Merck separately agreed to pay $1 billion for the rights to research drugs designed to silence genes that trigger certain diseases. The companies are banking on the research yielding personalized medicines with fewer side effects.
Investors still aren't on board for the experimental yet, though. Someone's going to have to step forward from both the drug side and the corrections sentencing side to show that the environment is ripe. Will that window open or not?