TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 7

hospitalization for arrhythmia and unstable angina. All possible MACE events
must be adjudicated, and all MACE events must be captured.

Globalization Trends: CV Clinical Development in Emerging Nations
Larger, longer clinical trials require greater numbers of patients—especially
treatment naïve patients. The urgent need to reduce development timelines and
costs is accelerating the expansion of clinical research in emerging markets where
sponsors have access to large patient populations and opportunities to speed
enrollment.
In addition to attractive research environments, the fast-growing economies of
emerging nations in the Asia Pacific, Latin American and Eastern Europe offer
important markets vital to the financial growth of the biopharma industry.
According to IMS Health estimates, the global biopharma market is expected to
grow by 6 percent and reach $1.1 trillion by 2015. Growth in North America and
Western Europe will peak at about 3 percent, while growth in emerging markets
will soar into double digits: the Asia Pacific region will grow by as much as 16
percent (to $225 billion); Latin America by 14 percent (to $82 billion); Central and
Eastern Europe by 9 percent (to $82 billion).

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Conduct of cardiovascular research in emerging markets is increasing. According
to a 2011 analyst report, more than 258,000 patients were recruited globally for
cardiovascular trials between 2005 and 2010; of the 5,165 CV trials surveyed, the
largest number (334) were in hypertension and the largest segment by number of
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patients (258,414) was venous thromboembolism. Of 6,317 studies listed in
September 2012 on clinicaltrials.gov, 5,278 (83.6 percent) were located in North
America and Europe, and 1,039 (16.4 percent) were underway in other parts of the
world.

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