The CPhI predictions foresaw advancement in QbD, continuous processing and a dramatic rise in FDA warning letters
CPhI Worldwide, organised by UBM announces the 2017 expert panel for the highly anticipated CPhI Worldwide Annual Industry Report (fifth edition) — to be released in two parts; part one in late summer and part two during CPhI Worldwide (24 – 26 October 2017 in Frankfurt).
The report is a comprehensive and critically important publication analysing key trends and innovations forecast by a panel of world class experts.
Since this is the fifth edition, CPhI Worldwide has decided to look back at previous Annual Reports to see how accurate the predictions were. These included the expanded use of processing analytical technology (PAT), pharmaceutical Quality by Design (QbD), serialisation, green chemistry and R&D improvements, as well as the rise of strategic relationships between pharma and CMOs (or CDMOs as they are now called). However, a potential hindrance to the industry was the predicted rise in the number of FDA warning letters.
The 2013 Annual Report forewarned of the rapid increase of FDA warning letters as a result of a tightening regulation environment and a lagging industry. This prediction proved entirely accurate with FDA warning letters tripling during the past few years, from 4882 in 2012 to 14590 in 2016.
Another bold prediction from the first report was an expected boom in pharmaceutical R&D and improvements in development cycles. Interestingly, this was true in 2014 and 2015, stellar years for NME (New Molecular Entities) and BLA (Biologics License Applications), with 41 and 45 FDA approvals respectively. However, this increased productivity dropped off significantly in the following years, with 22 in 2016 and a similar number anticipated for 2017.
As predicted PAT, QbD and serialisation have now become industry wide practices that further ensure quality and efficiency. Another trend identified, is the implementation of continuous processing in both Big Pharma and CDMOs for APIs and finished products and the use of these technologies is now increasing.
Additionally, both pharma and outsourcing providers were correctly anticipated by the reports to begin looking at green chemistry, route scouting and process improvements earlier in development to make less wasteful products and this has already begun taking shape across the industry.
CMOs were anticipated to grow in prominence across the industry, with strategic pharma partnerships proliferating. In the past 2 years, mega-mergers were expected to become more frequent amid the aggressive competition to become leading and full service providers. This is perhaps best highlighted by the recent deals struck between a number of CDMOs and pharma companies, as well as the purchase of Patheon by Thermo Fisher. In addition, Big Pharma has also set-up co-development deals with a number of companies, particularly to develop and commercialise biologics and biosimilars.
However, some of the first Annual Reports missed the pulse of the industry, expecting tighter regulations to have a consequential effect of decreasing the number of biotechs and small companies entering the market. In contrast, the biotech environment has significantly heated up in last couple of years, with the traditional hot spots in the USA seeing growth as well as a rapid emergence of newer biotech hubs — particularly in China.
This year’s CPhI Annual Report features 12 experts that provide valuable insight on the current and future state of our industry, including manufacturing, R&D, regulations, biologics, PAT/QbD and innovation, among many others.
Orhan Caglayan, Brand Director Europe at UBM, said: “This year’s Annual Report features some of the industry’s most stellar names and pharmaceutical industry experts and we are extremely grateful for all their efforts. It is a testament to their work and industry acumen that so many of their foresights five years on are beginning to take shape across industry.
"It also adds to the growing weight of evidence that the CPhI Annual Report is an essential document for anyone looking to stay ahead of market trends, explore new partnerships, opportunities and technologies, and to ultimately help advance the industry more quickly.”