《《2016 Innovation in the Biopharmaceutical Pipeline - Analysis Group FINAL》.pdf

Innovation in the Biopharmaceutical Pipeline: A Multidimensional View Innovation in the Biopharmaceutical Pipeline: A Multidimensional View Authors : Genia Long Analysis Group, Inc. 111 Huntington Avenue, 10th floor Boston, Massachusetts 02199 (617) 425-8491 glong@ Justin Works Analysis Group, Inc. 1010 El Camino Real Menlo Park, California 94025 (650) 463-2798 jworks@ January 2013 The authors gratefully acknowledge support from the Pharmaceutical Research and Manufacturers of America. Responsibility for the analysis presented lies entirely with the authors, who are responsible for any errors or misstatements. INNOVATION IN THE BIOPHARMACEUTICAL PIPELINE Executive Summary The U.S. innovative biopharmaceutical industry leads the world in the development of new medicines: over the past decade some 300 new prescription medicines have been approved for use by the U.S. Food and Drug Administration (FDA). Together, these innovations have contributed to a range of new treatments resulting in improvements in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative new therapies for some of the most costly and challenging diseases and conditions has never been greater. This study presents data on two types of potential new treatments in the research and development pipeline :  New medicines in development, or new molecular entities (NMEs) – data for which are referred to in this report as new “products”; and  New molecule-indication combinations in development (which may be NMEs or new indications for medicines previously approved by the FDA) – data for these unique molecule-indication combinations are referred to in this report as “projects. ” In both cases, we have focused our review on those activities that have advanced to the clinical testing stage in human volunteers, except where otherwise noted. In addition to excluding precli