Yet on the other hand, recently we hear that Merck had very positive experience outsourcing to Celltrion with two Indian firms ultimately garnering EMEA approvals for manufacturing (one microbial and another mammalian based fermentation products with both in Prefilled Syringe presentations).
How about the rapid onset of local Asian innovation led by China and India – how will that play into the biomanufacturing markets in the long run? Could innovation overseas create more competition for outsourcing services in Asia and drive outsourcing prices to dampen cost savings ?
Recenly-Pfizer partnered with Biocon—India’s leading biotech company which developed human insulin, a product entirely developed in India’s center for innovation, Bangalore. Is India ready for biosimilar outsourcing today and poised to gain as much dominance as it has with global generics or does that claim to fame belong to China?
China has been highlighted recently as the ultimate destination for bio-manufacturing outsourcing from its ample state funding & global industry investments, superior infrastructure and manufacturing prowess yet the facts are India has the most US FDA approved plants outside the US and have surpassed China – at least with small molecules in the past. India, China, Korea and Singapore have been quietly building their own biomanufacturing capabilities.
Although Asian biomanufacturing is still in its nascent stages, the endorsement of cGMP initiatives by
the Chinese and Indian governments, coupled with recent public statements regarding more stringent enforcement of IP and patent laws, suggest that these countries are gearing up to compete in the
bio-outsourcing market.
We need not look too far to what’s happened in the API manufacturing industry! API production and were once upon a time dominated by the US and Europe—projections now call for up to 80% of APIs coming from China and India. |
