CHICAGO, Illinois, February 6, 2013 – KMR Group, a leader in analyzing R&D performance data for the biopharmaceutical industry, completed an analysis of recent clinical work in Emerging Markets. Conducted on behalf of the Enrollment Metrix Forum, the study analyzed industry trends, differing approaches, and the opportunities and challenges it confronts.
The potential for new patient pools that can speed drug development and establish a broader customer base makes Emerging Markets a high priority across the industry. Half of the Industry* -- especially the larger companies -- expect Emerging Markets activity to increase in the next 2 years. It was notable that reducing cost is not a primary driver in the decision making; for most companies this does not affect Emerging Market strategy as much as the need to access more subjects and, second, expand markets for approved products.
The study analyzed activity by country and disease. It found that most activity in Emerging Markets occurs in Phase III; more than half of all Phase III trials involve work in Emerging Markets. However for Early Development, Industry still obtains the large majority of its subjects in major markets.
Choosing the regions or countries for trials is heavily influenced by a company’s overall experience. Asia ranks in the bottom half in terms of positive experience levels.
The challenges depend on the location. Some diseases, such as within CNS, are deemed unsuitable for Emerging Markets. Regulatory issues are Industry’s primary challenges, including long approval times and variability among reviews and requirements for submission. And in certain countries these are particularly challenging.
The study also examined Industry’s approaches to conducting trials in Emerging Markets: e.g., whether through CROs or wholly owned subsidiary. For example, the study found that in China most companies use affiliates or wholly-owned subsidiaries whereas in India CROs play a greater role.
"Trial work in Emerging Markets is one of the most important forces shaping patient recruitment. This study provides companies with a consolidated view on the problems and challenges being faced across the Industry and how companies are working and adapting to these new environments,” according to Linda Martin of KMR Group.
*Participants: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Roche, Sanofi, Shire and UCB. Emerging Markets refers to all regions other than North America, Western Europe, Japan.
For more information on the Enrollment Metrix Forum, the Emerging Markets Trends and Experience study, or our upcoming Emerging Markets Performance study contact:
Linda Martin, Principal Tel: +1 (312) 795-0400 Email: firstname.lastname@example.org
KMR Group has worked exclusively in the biopharmaceutical R&D industry since the early 1990s. We are industry leaders in benchmarking, analytics and performance management as well as development of on-line analytics tools that give users access to confidential and rich datasets. KMR's clinical platform contains the most reliable source for trial performance, recruitment and site metrics data, with over 15,000 global clinical trials. Clients rely on these tools for trial, enrollment and investigator site benchmarks to help them define recruitment strategies, shape enrollment plans and forecast recruitment as well as to find untried sites and select the best performing sites. These tools and analyses help companies make better decisions so that they can get their products to market faster and more effectively. For more information or for a demonstration of any of KMR's tools, please contact us.
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