FYI: The latest trends in APIs, FDFs and CMOs at CPhI

From the Pre-Connect Congress yesterday to the masses descending on the 14 halls in Frankfurt’s Messe this morning, in-Pharmatechnologist’s best ‘heads’ – @Dan5tanton and @FloraSouthey – bring you all the latest trends affecting those flogging their wares at CPhI Worlwide.

Emerging API regions​

Turns out no one has an accurate figure on the size of the generics active pharmaceutical ingredient (API) market, though reports seem to suggest a figure of around $100bn (€85bn).

The majority of the firms involved are small and local, capable of only supplying domestic (and relatively unregulated) markets, said Kate Kuhrt, head of GTM, Life Sciences at Clarivate Analytics.

There are also a number of small and ambitious API makers looking to break this mould and challenge the experienced global players, but this is becoming increasing harder to do due to the very crowded marketplace, she suggested.

And these up-and-coming API makers aren’t just in India and China, but in South Korea, Taiwan, and Latin America where favourable tax, IP and regulations are beginning to be favourable factors.

EU fighting back​

But what about API making in Europe? Traditionally a hotbed of manufacturing, the region has faced competition from India and China.

For a number of years, European API makers have predicted pharma would turn its back on these competitive markets – the so-called ‘flight to quality’ – but with regulatory and quality reforms in India​ and China​ making this less likely, the EU is beginning to fight back.

Europe is focusing more on complex APIs, but furthermore efforts to reduce the IP burden through a supplementary protection certificate (SPC) waiver programme will put Europe “back on a level playing field,”​ said Medicines for Europe’s Sergio Napolitano.

The ever-changing CMO space​

The contract services industry is rapidly evolving as it works to keep up with the growing biopharmaceutical market and manufacturing demands.

In his keynote address, Samsung Biologic’s CEO Tae Han Kim said that demand for CMOs is driving competition, adding that to win business contractors need to illustrate to customers that they can reduce leads times and make drugs more effectively than their rivals.

In other CMO news, at today’s CPhI Media Debate, CEO of Piramal Pharma Solutions Vivek Sharma said end-to-end, integrated CMOs are the way of the future: “You can do a lot more, with fewer companies.” ​Sharma predict the consolidation trend to continue in this industry, saying “The CDMO sector to continue to consolidate to create unique value chains.”​

The future of generics​

Pricing in emerging markets will continue to be dominated by old brands and generics over the next five years, said QuintilesIMS’ Alan Sheppard at the Pre-Connect Congress yesterday. Sheppard focused his talk on the value of generics – not be confused with volume – and predicted growth in smaller Asian countries.

“Generics are taking an increased share of the value market, with Japan up to 40% of the market share,” ​with the fasting growing ‘pharmerging’ markets predicted to be Bangladesh, Egypt, Pakistan, Turkey and India, said Sheppard.