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Industry Issues, Facts, and Figures<br />

The industry is marked by rapid advances and is heavily based on research and development.<br />

About 1,500 companies in the U.S. manufacture and market medicinal drugs. Over<br />

$200 billion in U.S. revenue is driven from the sales of prescription drugs (brand name and<br />

generic) and over-the-counter (OTC) medicines. The United States leads the world with<br />

the highest market share and is the home of five of the ten largest drug manufacturers<br />

(Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., Pfizer, and Abbott<br />

Laboratories). Europe, ranked second, is the home of the other five of the world’s top<br />

pharmaceutical companies (AstaZeneca, Sanofi-Aventis, Novartis, Roche Group, and<br />

GlaxoSmithKline). Japan takes third place with companies such Sankyo Co., Takeda<br />

Chemical Industries, and Yamanouchi Pharmaceutical.<br />

The industry is highly concentrated: The 50 largest companies control more than 80<br />

percent of the market. The pharmaceutical industry accounts for 27.3 percent of the healthcare<br />

sector and is capital intensive with exorbitant research and development costs. The<br />

industry also has been growing at over 10 percent annually and is under pressure from Wall<br />

Street to keep up such growth.<br />

Regulations and Patents<br />

Drug discovery and development is a highly sophisticated process that can take several<br />

years to complete and may cost more than $500 million. The cost has escalated 10-fold<br />

every 20 years since the late 1950s when research and development could cost only<br />

$1.5 million. Once the drug is registered and has received a patent, it is protected by competition<br />

from similar or generic drugs for 5 to 15 years. As such, loss of patent protection<br />

could harm the company’s sales and earnings. In some cases, there could be legal attacks<br />

against the validity of a patent. Such problem could be problematic by incurring additional<br />

costs in a legal battle.<br />

Industry Structure<br />

Generic drugs rapidly enter the market when a patent expires by the original brand-named<br />

drug manufacturer. Also, because large research budgets do not guarantee new products,<br />

many large drug companies supplement their own efforts by buying or licensing products<br />

from other companies. As a result, the industry has seen a vast number of mergers and<br />

acquisitions in recent years. Although the merger and acquisition could cost the company<br />

millions or billions of dollars, in some ways, it guarantees future income to the new owner.<br />

In recent months, Merck acquired Schering-Plough for $41 billion, and Pfizer acquired<br />

rival drug maker Wyeth for $68 billion.<br />

Advertising<br />

Drug manufacturers spend billions of dollars in advertising and promotions through frontend<br />

standard media such as television, radio, newspapers, and magazines. The back-end<br />

promotion is accomplished by offering samples and other incentives to doctors and retailers<br />

for prescribing their drugs. Aggressive advertising has been questioned by many government<br />

agencies and organizations. Congress has been considering changing advertising laws,<br />

which will impact the drug companies considerably. Most drug companies have already<br />

reconsidered how to market their drugs by explaining their risks. One strategy of the drug<br />

companies has been to push for more conversations with doctors and by better explaining<br />

the risks. For patients, most companies now offer toll-free hotlines and useful information<br />

through the company’s Web site. Lack of exposing the risks could harm the company’s<br />

reputation and brand.<br />

The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug<br />

industry’s lobbyist, announced a voluntary guiding principle for advertising drugs to all<br />

parties. This working document is requesting that drug companies discuss new drugs with<br />

doctors before launching any advertising to prospective consumers. The organization also<br />

argues that direct-to-consumer (DTC) advertising can be a powerful tool in educating millions<br />

of consumers and improving their health if they are aware of the drugs, and their side<br />

effects and potential benefits.<br />

CASE 26 • MERCK & COMPANY INC. — 2009 257

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