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Proposition - PharmXpert Academy

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288 2007 Korea Pharmaceutical Industry Directory<br />

C h a p t e r 2 .<br />

P h a r m a c e u t i c a l I n d u s t r y<br />

S t a t u s<br />

1. Characteristics of the Pharmaceutical Industry<br />

The pharmaceutical industry is a high-value added industry and a<br />

knowledge-based industry. As the fact that 14 out of the world’s top 500<br />

businesses are pharmaceutical companies demonstrates, it has a bright growth<br />

prospect for the future. Moreover, it is an industry that provides much public good<br />

and external economic benefit because it is directly and very intimately related<br />

with the human life.<br />

Production of pharmaceutical goods is so heavily regulated that it can be set<br />

apart from other industrial goods every part of R&D (GSP), clinical testing (GCP),<br />

authorization & permission (IND, NDA), manufacturing (GMP), and distribution<br />

(GSP) is stringently managed. In case of the new drug development, in particular,<br />

an average of KRW1 trillion is required as the budget for the first 10 years,<br />

between the R&D and the commercialization phases. Furthermore, there is only 1<br />

in 100,000 chance that the product development efforts would bear a meaningful<br />

fruit, and even then the market success cannot be guaranteed. That is why the<br />

pharmaceutical industry is considered as a high-risk, high-return venture<br />

industry. Two of the new blockbuster drugs – Lipitor (Pfizer, USD13.6 billion in<br />

sales revenue in 2006) and Plavix (Sanofi Aventis, USD5.8 billion in sales revenue<br />

in 2006) – held the added value greater than that of the entire pharmaceutical<br />

industry in Korea.

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