This paper presents an innovative, quantitative assessment of pollution avoidance attributable to environmental regulation enforced through integrated licensing, using Ireland's pharmaceutical-manufacturing sector as a case study. Emissions data reported by pharmaceutical installations were aggregated into a pollution trend using an Environmental Emissions Index (EEI) based on Lifecycle Assessment methodologies. Complete sectoral emissions data from 2001 to 2007 were extrapolated back to 1995, based on available data. Production volume data were used to derive a sectoral production index, and determine 'no-improvement' emission trends, whilst questionnaire responses from 20 industry representatives were used to quantify the contribution of integrated licensing to emission avoidance relative to these trends. Between 2001 and 2007, there was a 40% absolute reduction in direct pollution from 27 core installations, and 45% pollution avoidance relative to hypothetical 'no-improvement' pollution. It was estimated that environmental regulation avoided 20% of 'no-improvement' pollution, in addition to 25% avoidance under business-as-usual. For specific emissions, avoidance ranged from 14% and 30 kt a(-1) for CO(2) to 88% and 598 t a(-1) for SO(x). Between 1995 and 2007, there was a 59% absolute reduction in direct pollution, and 76% pollution avoidance. Pollution avoidance was dominated by reductions in emissions of VOCs, SO(x) and NO(x) to air, and emissions of heavy metals to water. Pollution avoidance of 35% was attributed to integrated licensing, ranging from between 8% and 2.9 t a(-1) for phosphorus emissions to water to 49% and 3143 t a(-1) for SO(x) emissions to air. Environmental regulation enforced through integrated licensing has been the major driver of substantial pollution avoidance achieved by Ireland's pharmaceutical sector - through emission limit values associated with Best Available Techniques, emissions monitoring and reporting requirements, and performance targets specified in environmental management plans. This compliant sector offers a positive, but not necessarily typical, case study of IPPC effectiveness.