• The worldwide market for antipsychotic drugs exceeded $10 billion in 2003.
• Continued market growth is anticipated based largely on increasing use of antipsychotics in new applications-bipolar, other mood swing disorders, addictions, others-and the trend of poly-pharmacotherapy for psychiatric indications.
• Market competition among atypical antipsychotics has matured and is now focused principally on side effects profiles, gaining FDA approvals for new indications (even as off-label use drives sales growth), improving performance characteristics (e.g., through improved drug delivery, which can also extend the life-cycles of drugs with expiring patents), and developing combination therapeutics.
• Discovery and early- to mid-stage clinical development of new antipsychotics is based on new pharmacologic targets (e.g., new dopamine-related and other new targets) that may improve effectiveness or reduce side effects.
• Antipsychotics in late-stage clinical development are mostly serotonin-dopamine antagonists, like most of the currently used atypical antipsychotics. Side effects profiles will be critical determinants of the success of these new agents.