Contact Information: Contact: Tufts Center for the Study of Drug Development Charlene Neu 617-636-2187 Business Communication Strategies Peter Lowy 617-734-9980
Number of Monoclonal Antibody Products in Development Nearly Tripled in Last Decade, According to Tufts Center for the Study of Drug Development
BOSTON, MA--(Marketwire - March 11, 2008) - The number of monoclonal antibody products --
known as mAbs -- entering clinical study nearly tripled in the last decade
and now require 7.6 years on average to complete the clinical development
process and receive marketing approval, according to a new study completed
by the Tufts Center for the Study of Drug Development.
Total development and approval times for mAbs, one of today's premier
biotech tools, compare favorably with small molecule drugs, which require
an average of 7.5 years to follow the same path, and with all biotech
products, which require an average of 8 years.
"Historically the province of biotechnology companies, mAbs are now just as
likely to be developed and marketed by major pharmaceutical firms as they
are by biotechs," said Janice M. Reichert, senior research fellow at Tufts
CSDD and author of the study.
She noted that mAbs have also become big business. In 2006, the global
market for these products exceeded $17 billion, with sales forecasted to
grow an average of 14% per year through 2012.
Currently, 21 such products have been approved for sale in the United
States and abroad, and more than 200 are in clinical study.
Research results of the Tufts CSDD study, reported in the March/April Tufts
CSDD Impact Report, released today, also found that:
* The average number of all mAb candidates entering clinical study nearly
tripled from 12 in the mid-1990s to 34.5 in the mid-2000s.
* The share of human mAbs entering clinical study grew from 11% in the
1990s to more than 40% in 2000-06.
* Overall success rate was 17% for all humanized candidates, with a
slightly lower rate (15%) for anticancer candidates and a slightly higher
rate (21%) for immunological candidates.
* Transition probabilities for humanized mAbs that entered clinical study
during 1988-06 were 83%, 44%, and 81%, respectively, for the three phase
transitions.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues
and hosts symposia, workshops, and public forums, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.