OBJECTIVES: Research was undertaken to determine the impact and value of soliciting patient viewpoints at key stages within the drug development lifecycle. METHODS: Interviews were held with representatives from the biopharmaceutical, regulatory and pricing and reimbursement sectors to identify the value and impact attributed to patient perspectives. Additionally, surveys of European patient organisations and patients with airways disease provided insight into their attempts to influence treatment decisions, which could affect market uptake. RESULTS: Industry ngagement with patients was often reactive and linked to the identification of factors which may impact on the success of a product.  Earlier consultation may help the biopharmaceutical industry to optimise product development or assist key go/no-go decisions. Whilst there is a harmonised regulatory process that engages patient organisations through the European Medicines Agency, patient viewpoints or quality of life data seldom influence access or pricing and reimbursement decisions in the main European markets. Numerous examples were cited where this has led to political lobbying and emotive decision making and a more transparent process involving patients may help to ensure decisions are based on clinical and cost effectiveness. Involving patients in the drug development lifecycle has the potential to improve health outcomes and reduce health expenditure associated with poor management, often related to non-compliance.  The earlier patients are involved, the greater the potential to avert or minimise factors that could affect commercial success and return on investment. CONCLUSIONS: For the biopharmaceutical industry, the value of patient perspectives lies as part of a risk-mitigation strategy to provide greater insight and control over factors that affect market success. For regulators and payers, the value lies in the potential to improve health outcomes and reduce healthcare budgets.