| TS Jaishankar at Quest Life Sciences assesses the pros and cons of outsourcing to Asia
The growing global CRO industry provides opportunities for
manufacturers to reduce costs, increase R&D productivity and
focus on expanding the business in other areas. Many CROs are
known for delivering a high level of quality, performance and
therapeutic specialisation. In 2004 (the most recent year for
which data are available), leading CROs managed nearly 23,000
Phase I-IV studies at 152,000 clinical sites worldwide. Judging
by the current trends, research outsourcing may grow more than
fivefold in the coming years.
ASIA:THE BEST BET FOR PHARMA MAJORS?
Pharmaceutical outsourcing in Asian countries, especially China
and India, has exploded in recent times. For years China and India
have been global factories for raw materials and, more recently,
active pharmaceutical ingredients (APIs). In addition to
manufacturing, Singapore, India and China increasingly provide
economically viable alternatives for R&D, specifically for earlystage
drug development.
As Pan-Asian countries expand their
experience and knowledge in pharmaceutical R&D, GMP
compliance and supply chain management, they are subsequently
expanding their service capabilities to include late-stage R&D
and finished-product manufacturing. Dozens of generic Indian
pharmaceutical products, including injectables, are now
distributed in the US. China is catching India up in the finishedproduct
manufacturing arena, as several Chinese pharmaceutical
companies have filed ANDAs with the FDA to seek entry into the
US market. According to recent surveys, China is emerging as the
best choice in comparison to India (55 per cent of the respondents
voted for China, while 36 per cent voted for India). |
