CONGRESS OF THE UNITED STATES
CONGRESSIONAL BUDGET OFFICE
В© Unlisted images, Incorporation.
Development inside the
Pub. No . 2589
S T U D Sumado a
Research and Development in the
The Our elected representatives of the United States U Congressional Finances Office
erceptions that the speed of new-drug development features slowed and that the pharmaceutical sector is highly lucrative have sparked concerns that significant complications loom for future drug development. This kind of Congressional Budget Office (CBO) studyвЂ”prepared in the request of the Senate Bulk LeaderвЂ”reviews basic facts about the drug industry's recent spending on research and development (R& D) as well as its output of new drugs. The study also examines issues relating to the costs of R& D, the government government's part in pharmaceutical drug research, the performance in the pharmaceutical market in developing innovative drugs, and the position of predicted profits in private firms' decisions about investing in medication R& D. In keeping with CBO's mandate to supply objective, unbiased analysis, the study makes simply no recommendations. David H. Austin prepared this kind of report underneath the supervision of Joseph Kile and David Moore. Merlu Baker provided valuable discussion. Jim Baumgardner, Anna Cook, Doug Edinburgh, and Dennis Zimmerman of CBO supplied comments, while did Iain Cockburn of Boston University, Mark Duggan of the College or university of Baltimore, and Judith Wagner in the Institute of drugs. (The assistance of external reviewers suggests no responsibility for the final product, which in turn rests only with CBO. )
Christian Howlett edited the study, and Kate Kelly proofread this. Angela Z. McCollough prepared drafts in the manuscript. Maureen Costantino well prepared the report for publication, with assistance from Allan Keaton, and designed the cover. Lenny Skutnik printed the initial copies, and Simone Thomas prepared the electronic edition for CBO's Web site (www.cbo.gov).
Donald W. Marron
Intro and Overview 1
Trends in R& Deb Spending and Output of recent Drugs several
What Does It Cost to Develop a brand new Drug? 19
Truly does Federal R& D Spending Stimulate or perhaps Substitute for
Private-Sector Spending? twenty seven
Has the Drug Industry's Innovative Functionality Declined? thirty-five
The Cost of Developing a New Medicine 1
The Role of Federal Research and Development 2
Examining the Medicine Industry's R& D Performance 3
The Drug Industry's Profits and R& M Investment four
Spending to get Research and Development 7
R& Deb Intensity on the lookout for
Output of Innovative New Prescription drugs 11
Leading Therapeutic Classes 12
Changes and Approved New Uses of Drugs 18
Primary Determinants of R& D Costs 19
How come Have R& D Costs Risen for Innovative New Prescription drugs? 21
General public and Private R& D Spending 27
Really does Government R& D Audience Out Non-public R& D? 29
A Changing Role for Public-Sector Research thirty-three
Recent Innovative Performance 35
Did Changes in the Size of Medicine Companies Have an effect on
Research Output? 39
RESEARCH AND DEVELOPMENT INSIDE THE PHARMACEUTICAL MARKET
Profitability and R& D Expense in the Drug Industry 43
Recent Estimations of Success 43
Expected Profits as a Signal to get Performing Drug R& Deb 45
Therapeutic Classes with 3 or More Leading Brand-Name Prescription drugs in the year 2003
DiMasi and Others' Estimation of Common Research Costs and Instances for Efficiently Developed New Molecular Choices
Combination History of the most notable Ten Pharmaceutical Companies in 2004 simply by Global Product sales
Estimates from the U. S. Drug Industry's Annual Spending on Research and Development
Research and Development Spending as a Percentage of Product sales Revenue pertaining to Various U. S. Sectors
Range of New Molecular Entities Approved by the Food and Drug Supervision Each Year...
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