Frankfurt, 29th October 2019: CPhI Worldwide – the world’s largest pharma event, taking place in Frankfurt, Germany (5-7 November, 2019) – releases the second part of its annual report focussed on biologicals.
In the report, experts Dawn Ecker, Director of bioTRAK® Database Services with BPTG (BioProcess Technology Group, BDO USA, LLP), and Emil. W. Ciurczak, President of Doramaxx Consulting, explore the near- and medium- term trends in the industry.
Dawn M. Ecker, having analysed the global biopharmaceutical industry’s production, predicts that Europe will possess the world’s largest biologics manufacturing capacity within the next four years – a feat currently owned by the USA. Europe’s capacity is expected to increase by 15% come 2023. This growth is helping loosen capacity constraints in the continent in the short term. One of the key drivers behind the recent growth in building new capacity has been a number of notable government initiatives and tax incentives in countries such as Ireland, Singapore, and South Korea.
Ecker explains that the growing manufacturing demand – driven by the increasing number of commercially approved biologics – will see the sector significantly expand volumetric capacity. However, much of the new capacity coming online is from CMOs and hybrid companies, who will in turn increase their respective market shares in biologics manufacturing. “Currently, product companies control over 70% of the installed mammalian cell culture capacity, but this is predicted to drop to 65% by 2023, with CMO capacity increasing 6%, and hybrid companies increasing 1%, respectively.” Commented Ecker.
Emil Ciurczak explores the impact of the increasing number of biosimilars becoming available, as well as the long-term implications of slight differences in manufacturing approaches. He argues that biosimilar production accentuates the risk of potentially hazardous side products, as, unlike generics, biological impurities could include unknown proteins. “All impurities in APIs are critical, but with biological impurities (often proteins, not seen previously), the stakes are potentially higher. Not only are there potential long-term carcinogenicity and mutagenicity dangers, but, with unknown proteins, there are also potential immediate allergic reactions.” Comments Ciurczak.
Looking ahead, Ciurczak predicts that regulators will seek to harmonise their guidances and rules regarding the assessment of critical quality attributes (CQAs) for biologics, with the common goal of expediting production time and therefore time-to-market. He states that we are already seeing such changes beginning to take place – with regulators ‘peaking over each other’s shoulders when writing guidances and rules’, and newer documents becoming increasingly standardised.
