文档介绍：9-703-489
REV: APRIL 2, 2004
STEPHEN P. BRADLEY
JAMES WEBER
The Pharmaceutical Industry: Challenges in the
New Century
The golden age of medicine was traditionally looked at as the 1940s, 1950s, the development of antibiotics.
Based on what we now know about the human genome, more careful targeting of discovery efforts, you haven’t
seen anything yet. The golden age of medicine clearly lies ahead of us.
— Henry McKinnell, Chairman and CEO, Pfizer1
Early in the 21st century, the pharmaceutical industry, and especially its petitors, faced
uncertain times. Many of the most pressing issues—patent expirations, price pressures, drug
development challenges, regulatory issues, and political pressures—had existed for a decade or
longer, but their growing intensity threatened to force industry players to discover new approaches
to address them. Perhaps the most significant challenges were rapid scientific advances and the
introduction of fundamentally new technologies bined were changing the way drugs were
discovered, developed, and tested. These advances had allowed smaller, petitors to
enter the industry pete in new ways, and petitors were making a significant and
growing number of the new drug ing out of industry laboratories. The scientific and
technical advances, along with the petition, were forcing the petitors that had
dominated the industry for a century to rethink how they discovered, developed, manufactured,
tested, marketed, and distributed their products, and also how they sought regulatory approvals and
partnered with anizations. In 2004, it was clear that the industry must change. What was
uncertain was change to what, and how quickly.
Industry Overview
Traditionally, the global pharmaceutical industry was characterized by rapid growth, high profits,
and structural stability, even while showing dramatic innovation. Global sales reached $466 billion in
2003, up from $317 billion in 2000, while North