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Biotechnology & Pharmaceuticals
Industry Profile
The pharmaceutical drug discovery and development industry has grown to become one of the most profitable in the world. During the last 30 years, the industry has blossomed, with billions of dollars spent on research in biochemistry, molecular biology, cell biology, immunology, genetics, and information technology.
In the 1990s alone, the U.S. research-based pharmaceutical industry developed 370 new medicines. The human genome has been sequenced, a feat that has increased the number of drug targets for possible development from 500 to as many as 10,000 and spawned a new generation of companies and the technology and tools to support them.
But the process that turns this rich research into medicines that can help patients is a slow and often heartbreaking one. It now takes an average of 15 years and $800 million to $900 million to nurture a drug from initial discovery through FDA approval. The industry spends tens of billions of dollars annually on R&D;, yet the FDA approves only a handful of drugs each year. Each stage of development is fraught with high failure rates; even when a company has proven efficacy and safety through a prescribed series of clinical trials, thereís still a 25 percent chance its drug application will not be approved by the FDA. Despite the odds, though, the prize is grand enough for the few who hit the blockbuster-drug jackpot that an ever-increasing number of companies are willing to gamble that their product will be the next to reach $1 billion in annual sales.
The industry can be divided into two broad categories: pharmaceutical companies and biotech companies. Pharmaceutical companies make medicines from plant- and chemical-based compounds. Biotechnology companies seek to duplicate or change the function of a living cell to make it work in a more predictable or controllable way.
Though formulating medicinal compounds is an ancient practice, the U.S. pharmaceutical industry as we know it began when companies developed large-scale manufacturing processes during the 19th century. Biotechnology, on the other hand, is a relative newcomer; the first companies formed almost a century later, in the 1970s, and the first biotech drug brought to marketóhuman insulin produced in genetically modified bacteriaówas not approved by the FDC until 1983. Born out of Watson and Crickís 1953 discovery of the structure of DNA and Cohen and Boylesí 1973 success in transplanting a single piece of DNA from a toad into a bacterium, biotechnology uses genetic research to develop products for human diseases and conditions.
Major Players
Abbot Laboratories
Bayer
Bristol-Myers Squibb
Eli Lilly
GlaxoSmithKline
Johnson & Johnson
Merck
Novartis
Pfizer
Wyeth
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