In the past 30 years, more than 30 new aetiological agents of infectious disease have been identified. Some of these are responsible for entirely novel and life-threatening disorders, such as AIDS, Ebola fever, hantavirus pulmonary syndrome and Nipah virus encephalitis. During the same period, some longstanding infectious diseases (such as tuberculosis) have became resurgent, as a result of a combination of complacency, increased travel and social dislocation, and also increasing drug resistance. This review looks at some of the key unmet needs in this therapeutic area and discusses strategies to address them.