Speaking in Frankfurt, Germany last month, Kate Kuhrt – head of GTM, Life Sciences at Clarivate Analytics – spoke about the difficulties countries with less experience producing generic active pharmaceutical ingredients (APIs) have in breaking through as manufacturing hubs for regulated markets.
She split API manufacturing companies in emerging countries into four groups: 1) Established international suppliers, 2) less established players supplying one or two markets, 3) potential future “ambitious” companies, and 4) local manufacturers.
“But what would it take for new manufacturing hubs to emerge?” she asked delegates at the CPhI Preconnect Congress. “A favourable business environment with the right IP, taxes and regulations; a large talent pool, and access to raw materials, energy and transportation hubs.”
But currently few regions are able to fill these criteria, she continued. “You cannot build up an industry overnight.”
Recognised API making regions – India, China, Europe and US – showed, perhaps unsurprisingly, large numbers of established and less established manufacturers, but within emerging regions only South Korea, Taiwan and Poland currently have group 1 or 2 type companies. However, Argentina, Brazil and Mexico do have a relatively large potential future (group 3) sector, Kuhrt noted.
India and China
India grew to become the largest generic API supplier to regulated markets due to a number of factors, but its unique patent environment allowed a level of acceleration which today’s emerging regions are unable to replicate.
“Until 2005 there was no patent protection in India,” Kuhrt explained. This allowed Indian companies to reverse engineer products, giving them a huge competitive advantage over Italian API firms for example and brought an increased level of interest in pharma ingredients from a growing student population.
And while there has been a shift to finished dose formulation over the past decade and the country has become dependent on China for supply of APIs in its domestic drugs, Kuhrt said it will remain the major player for generic API manufacturing for regulated markets in the future.
Meanwhile China, another major API exporter, is also seeing huge changes in its pharma landscape. The country is tightening up its regulations and beginning to promote finished dose formulations and even innovative drug manufacturing.
However, “I think it will continue to be a big API manufacturer if only to support its own huge domestic demand,” said Kuhrt. “It learnt from India which is now 100% dependent on China for some products,”