GMP Summit Market Analysis and Reports | USA Conference Series

Market Analysis - GMP Summit 2018

We are working in challenging times with many new constraints. As observed many times, innovation, technology and new methodologies have combined to provide cost effective solutions. Besides regulatory compliance and other compliances for the approved marketing authorisation (MA) are a mandate for ensuring contemporary requirements of safety, quality and efficacy are constantly. All the same GMP compliances are essential to ensure high quality standards concerning manufacture, which is a must for pharmaceutical manufacturers. In 2003 a proposal from FDA estimated the cost for GMP compliancing to be about $100,000 per year. However, many industry members disagreed, especially in the area of testing ingredients and finished products. In a later supplement of GMP rule issued years later, FDA amended its cost estimates to $46,000 per year for very small companies (fewer than 20 employees) and $184,000 per year for small companies (more than 20, fewer than 500 employees).  In 2010, the European Directorate for the Quality of Medicines & HealthCare had conducted 34 API onsite inspections and reviewed 25 reports for the work done by others. As a consequence, there were 16 suspensions and 8 withdrawal of the Certificate of Suitability (CEPs). 10 were re-instated after re-inspection. The initial failure rate of 40% is significant. As per current scenario, using ISO 9001 and the on-line U.S. Food and Drug Administration (FDA) cGMP trainings as proxies, it is estimated the first year cost for GxP compliancing would be at around $966,000. Also according to one source, the APIs market is over worth as much as $91B in 2015, of which the United States and Europe accounted for 60% of the share. In 2012, it was estimated that the total world market for APIs was worth about $76 B and was growing at an annual rate of 8.2%. By 2015, the value was revised upward to as much as $91B, of which the United States and Europe would account for at least 60% of the share. Based on latest reports a conservative figure from real time assumption that there are an average 193 recalls of drug in dosage form where 2-8% (5% being the average) of these recalls are APIs related. Assuming the recall cost to industry is $1M per recall, which is likely to be on the low end of the spectrum, there should be savings if the recalls were to be triggered earlier by APIs inspection, before further investments are made to incorporate the substandard products into the final dosage form. The calculation uses generic oral solids as the baseline, which would have a lower rate of saving as APIs constitute a higher proportion of its total cost (40-50%). Alternatively, one could argue GMP of APIs could prevent these recalls from occurring, which provide a benefit between $3.8M and $15.4M annually