Contents
1 Introduction and Summary 1
The Cost of Developing a New Drug 1
The Role of Federal Research and Development 2
Assessing the Drug Industry’s R&D Performance 3
The Drug Industry’s Profits and R&D Investment 4
2 Trends in R&D Spending and Output of New Drugs 7
Spending for Research and Development 7
R&D Intensity 9
Output of Innovative New Drugs 11
Leading Therapeutic Classes 12
Modifications and Approved New Uses of Drugs 14
3 What Does It Cost to Develop a New Drug? 19
Primary Determinants of R&D Costs 19
Why Have R&D Costs Risen for Innovative New Drugs? 21
4 Does Federal R&D Spending Stimulate or Substitute for
Private-Sector Spending? 27
Public and Private R&D Spending 27
Does Government R&D Crowd Out Private R&D? 29
A Changing Role for Public-Sector Research 33
5 Has the Drug Industry’s Innovative Performance Declined? 35
Recent Innovative Performance 35
Did Changes in the Size of Drug Companies Affect
Research Productivity? 39
VI RESEARCH AND DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY
6 Profitability and R&D Investment in the Drug Industry 43
Recent Estimates of Profitability 43
Expected Profits as a Signal for Performing Drug R&D 45
References 51