TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 3

trials in emerging nations, and advancing electronic platforms to improve data
quality and research efficiency.

The CV Therapeutics Arena: Research Pipeline and Approval Trends
Pharmaceutics have made enormous contributions to improving CVD treatment,
from the introduction of beta blockers and ACE inhibitors in the 1960s and 1970s,
to the introduction of statins in the 1980s. The global market for cardiovascular
pharmaceuticals, which includes products to treat hypertension, congestive heart
failure, cholesterol management, angina, arrhythmia and
antiplatelet/antithrombotics as its major components, is projected to reach
approximately $65 billion in sales by 2016.

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Today’s biopharmaceutical development pipeline holds 351 cardiovascular and
258 hypolipaemic/anti-atherosclerosis agents, which together make up the second
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largest pipeline category after anticancer agents. Of the 46 cardiovascular
diseases specified by the WHO coding system (ICD-9), 65 percent of all
cardiovascular clinical trials in the 2000s have been in six indications. The top
three are hypertension (27 percent of trials); congestive heart failure (13 percent)
and cerebrovascular disease (12 percent) according to a 2004 analysis.

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Clinical trials currently focus on statins