Amsterdam, 19th October 2017: CPhI Worldwide – held in Frankfurt, October 24-26 and organised by UBM – announces the findings of part ii of the 5th edition of the CPhI Annual Report, which focuses on the immediate and long-term trends in pharmaceutical manufacturing and ingredients.
The second part of the report is being launched ahead of CPhI Worldwide, taking place next week (October 24-26, 2017), with the full report unveiled to more than 42,000 executives during the event.
The overall findings reveal that the trend towards the increased use of modern manufacturing processes and quality systems is occurring very slowly – with the current small molecule drugs pipeline not yet possessing the economic models and incentives to stimulate faster adoption.
Girish Malhotra, President of EPCOT International, feels that the global pharma industry is now at a critical point in its history and needs to adopt new business models for the next century.
“Making drugs affordable is the best long-term way to improve the total sales in the developing countries. Because of the income differences between developed and developing countries, the differences in drug processes will remain for the foreseeable future. Economies of scale and better manufacturing technologies can make drugs more affordable and increase sales. However, to achieve all of this will require a business model review and substantial change.
Emil Ciurczak, President at Doramaxx Consulting forecasts that it might take as long as a decade for the industry to see the full potential of its impact – but resistance is futile and, ultimately, only those that adopt QbD/PAT and continuous manufacturing (CM) will survive.
“Large companies will naturally be the first movers, followed in parallel by their strategic outsourcing partners, and this will become an established practice over the next three-years. For generic companies, and particularly smaller ones, there is an existential debate pending”, commented Ciurczak.
Brian Carlin, Excipient Iconoclast, echoed Emil’s thoughts and warned that the industry needs to move to smarter control of its processes, and increased use of PAT, if excipients (amongst other factors) are not to introduce critical and often unforeseen risks into products.
Biologics, he argues, may be the exception to the rule and is the area most likely to support the development of new excipients. Overall, Carlin believes regulators need to provide approval mechanisms for excipients, as the current indirect route of approval via incorporation in a finished product is inimical to innovation. Instead, collaboration between users and the excipient developers must be sought to reduce the commercial risk of new excipient development.
