While alternative methods for delivering therapeutics to patients have had some notable successes, most drugs continue to be delivered orally. Because they cannot tolerate the first-pass metabolism of the digestive tract, the recent escalation in new biological drugs, including antibodies and recombinant proteins, is placing renewed emphasis on alternate delivery technologies. Now a number of factors are converging to create both risk and opportunity for drug makers and their delivery device partners. These include new classes of drugs for previously refractory conditions, the growing trend toward self-administration for chronic diseases, shifting patient demographics in industrial countries, caregiver safety legislation, and continued pressure to control healthcare costs. These factors are giving rise to a new generation of sophisticated, application-specific injection, inhalation and transdermal drug products designed to satisfy caregiver and patient preferences while addressing managed care initiatives and the formulation limitations of new classes of therapeutic drugs. Because of their ability to safely and reliably satisfy treatment protocols and compliance goals, non-oral drug delivery products will have a significant impact on the future of drug self-administration.