Investment in research and development by members of the Pharmaceutical Research and Manufacturers of America (PhRMA) remained strong at $49.5 billion in 2011, as the sector adapts to meet the challenges of evolving science, a changing marketplace and a difficult economic environment.
Biopharmaceutical research companies are continuing to explore the possibilities associated with more targeted therapies and personalized medicines, and are building on the benefits associated with partnerships among experts throughout the research ecosystem. These efforts are reflected in PhRMA's new 2012 Industry Profile as well as an updated version of its informational chart pack resource, "Biopharmaceuticals in Perspective.”
The 2011 R&D investment figures reflect the biopharmaceutical sector's standing as America's most research-intensive industry. According to a recent report by the National Science Board of the National Science Foundation, the U.S. biopharmaceutical sector accounts for the single largest share of all U.S. business R&D, representing nearly 20% of all domestic R&D funded by U.S. businesses. In the U.S., R&D expenditures among PhRMA members represented a remarkable 21.1% of domestic sales.
"Despite facing market, scientific and regulatory challenges, the U.S. biopharmaceutical sector—led by our member companies—has remained a major contributor to American innovation," said John J. Castellani, PhRMA president and CEO. "Our member companies' investment represents a boost to America's economy, with 78% of those dollars invested on our shores. But more importantly, it shows a continued commitment to medical progress that will continue to bring new solutions to America's patients.
Last year alone, 35 new molecular entities received FDA approval—one of the highest totals in the last decade. These include medicines that address significant unmet medical need: two personalized medicines for cancer, 11 new medicines for patients with rare diseases, the first new medicine for lupus since 1955, and two medicines that are the first in a new class to treat Hepatitis C.
These remarkable breakthroughs are a testament to scientists’ greater understanding of the molecular and genetic basis of disease. As knowledge and research capabilities grow, PhRMA member companies are able to use those advances to develop more targeted and effective therapies, a new generation of treatments for the most costly and challenging diseases.
According to a survey conducted by the Tufts University Center for the Study of Drug Development, 94%of surveyed companies are currently investing in the field of personalized medicine.
"Beyond the impressive numbers reported by our member companies is the unfolding story of how companies are adapting to a changing research paradigm," added Castellani. "Part of that story is our shift to a more agile sector, which increasingly involves collaborative, constructive partnerships with both public and private experts."
The growing complexity of science requires access to broader expertise. These partnerships—which can involve experts from across the healthcare spectrum, including academia, government-funded research and other biopharmaceutical companies—help companies build upon a larger reservoir of knowledge.
Other steps that companies are taking include identifying efficiencies and reorganizing research structures throughout the R&D process and improving productivity and achieving other efficiencies through incorporation of new technologies.
By continuing to explore enhancements to their R&D and manufacturing approaches, PhRMA member companies are striving to turn compounds in their ever-growing pipelines into medical breakthroughs for the good of patients across the world. Today, there are more than 3,200 medicines in clinical trials or undergoing FDA review in the U.S., up from 2,400 in 2005.