CPHI Annual Reports - how accurate were they 5 years on?

The CPHI predictions foresaw advancement in QbD, continuous processing, and a dramatic rise in FDA warning letters.

Since this is the 5th 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 PAT, QbD, serialization, 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 over the past few years, from 4882 in 2012 to 14,590 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 New Molecular Entities (NMEs)) and Biologics License Applications (BLAs), with 41 and 45 FDA approvals, respectively. This increased productivity, however, dropped off significantly in the following years, with 22 in 2016 and a similar number anticipated for 2017.

As predicted, PAT, QbD and serialization 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. In addition, 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 US 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.

The CPHI Expert Panel members for 2017 are

· Gil Roth, President at the PBOA

· Alan Sheppard, Principal, Global Generics at IMS Health

· Vivek Sharma, CEO at Piramal Enterprises Ltd

· Ajaz Hussain, Founder CEO at Insight Advice & Solutions LLC

· Dr Minzhang Chen, CEO at STA Pharmaceutica

· Dilip Shah, CEO at Vision Consulting Group

· Prabir Basu, Pharma Manufacturing and Regulations Consultant

· Brian Carlin, Global Excipients Expert

· Emil Cuirczak, President at Doramaxx Consulting

· Bikash Chatterjee, President and CSO at PharmTech Associates

· Girish Malhotra, President at EPCOT Internationa

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· B.S.V. Prasad, Senior Vice-President and Head of Small Molecules Business Unit at Biocon Ltd

“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 5 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,” commented Orhan Caglayan, Brand Director – Europe, UBM.