Barriers unique to  outsourcing biopharma manufacturing will pose enormous NEW challenges:

  • High  cost of entry into biologics manufacture (Infrastructure cost to manufacture and distribute)
  • Units of manufacture for biologics TODAY  are largely  manufactured at “home” base by Western pharmaceutical because of sophisticated and highly skilled staffs needed
  • Pharmaceutical Industry  structural market changes in the  US / EU and BRIC-T economies that favor small molecule manufacture to a large extent serve as barriers to recombinant product manufacture
  • Lack of  a well structured internationally accepted  regulatory framework  for recombinant products
  • Increased biological and chemical complexity of recombinant products to that of small molecules and   the impact on  demonstration of bio-comparability

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.


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For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com