CPHI Webinar series – API Manufacturing Trends: Watch Now

Including presentations from three industry experts, the webinar addresses issues such as buyers’ rationale for purchasing decisions, the barriers to new geographical manufacturing hubs forming, the rise of specialty products within European and US manufacturing and the proliferation of advanced manufacturing complexity in the segment.

Providing an overview of the global API market, Molly Bowman, Editorial Director, Clarivate Analytics said it is estimated to grow to $290 billion by 2026, with most analysts anticipating a recovery from this year forward following a near 7% decline over 2020 due to the coronavirus pandemic.

Addressing the question of whether there are going to be shifts in manufacturing trends towards hubs other than India and China, she said that “if we look at other countries that have local API manufacturing, the sheer volume of manufacturers is nowhere near close to those we see in India and China and there’s likely little indication we’re going to see a massive shift into those.”

Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions focused on the API sector’s largest segment, small molecules, and identified some key growth drivers including increasing global API demand especially niche segments such as high-potency APIs driven by a robust oncology pipeline.

He said that despite fast growth in biologics, “small molecules will remain the main driver” for CDMOs, with 36 of the 53 new molecular entities approved in 2020 being small molecules.

“It’s still the most outsourced area and still the most mature area,” he added.

Gianluca Franguelli, Vice President, Global Drug Substance Development, Recipharm, told the audience that novel advanced manufacturing models were driving the small molecule space and that nearly 50% of absolute CDMO market growth between 2019 and 2023 would be driven by small molecule APIs.

“Manufacturing complexity is dramatically increasing not only from a technical standpoint but also environmentally from a safety and regulatory perspective,” he said.