What Does it Really Cost to
Develop a New Treatment?
A Brief Review of Drug
Development Metrics
Kenneth I Kaitin, Ph.D.
Director, Tufts Center for the Study of Drug Development
Prof. of Medicine, Prof. of Pharmacology & Exp. Therapeutics
ASENT Annual Meeting
Dinner Session
Bethesda, MD, March 4, 2010
The Drug Development Pathway
Basic
Research
Prototype Design
or Discovery
Preclinical
Development
IND Filing
Phase I
Phase II
Clinical
Development
Phase III
NDA/BLA Submission
FDA Review/
Approval & Launch
Phase IV, PMS, Life
Cycle Management
Clinical and Approval Times Vary
Across Therapeutic Classes, 2003-07
7.9
Antineoplastic
Neuropharmacologic
0.8
7.1
Anesthetic/Analgesic
1.4
5.2
AIDS Antiviral
5.2
0
1.7
0.6
6.9
5.8
Years
Clinical Phase
* excludes AIDS antivirals
Source: Kaitin, Clin Pharmacol Ther, 2010;87:356-361
http://www.nature.com/clpt/journal/v87/n3/full/clpt2009293a.html
8.4
7.7
1.7
6.0
Cardiovascular
8.4
1.9
6.5
Antiinfective*
8.8
1.7
7.0
Endocrine
8.7
Approval Phase
10
Overall Clinical Approval Success
Rate for NCEs has Dropped to 16%
23.9%
Sys. Antiinfective
20.4%
Musculoskeletal
19.4%
Oncology/Immunology
9.4%
GI/Metabolism
8.7%
Cardiovascular
8.2%
Neuropharmacologic
0
Clinical Approval Success Rate
Source: DiMasi et al, Clin Pharmacol Ther, 2010;87:272-277
http://www.nature.com/clpt/journal/v87/n3/full/clpt2009295a.html
27
Capitalized Cost per Approved Biotech
Product is Similar to that for Pharma
1500
1,318
Millions of 2005 Dollars
1,241
879
626
615
439
0
Non-Clinical
Clinical
Biotech
Pharma (Time Adjusted)
Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-479
Total Costs
Time Adjusted Capitalized Clinical
Costs by Therapeutic Area
1000
$849
Millions of 2005 Dollars
$741
$750
$792
$604
0
Anesth/Analg
Cardiovascular
Source: DiMasi et al, Drug Info J, 2004;38:211-223
All
Antiinfective
CNS
Global Pharma Sales in 2008 by
Therapeutic Category
Cardiovascular
$84.7 bil
$78.0 bil
CNS
Cancer
$59.9 bil
Antiinfectives
$43.8 bil
$34.6 bil
Respiratory
Diabetes
Inflammation
$23.9 bil
$21.7 bil
Vaccines
$19.1 bil
Hormone Control
$18.9 bil
Gastrointestinal
Hematology
$17.1 bil
$12.0 bil
Source: Lehman Brothers, Sept 2008; in Parexel Statistical Sourcebook 2008-2009
10.3% of
Global Market
Drivers of Rising R&D Costs
u Chronic and complex indications
u Clinical trial size
u Protocol design complexity
u Patient recruitment/retention
u High cost discovery/research tools
u Regulatory demands
u Market oriented studies
u Late-stage attrition
New Drug Approvals Are Not Keeping
Pace with Rising R&D Spending
52
60
39
45
30
26
New Drug Approvals
13
15
0
1963
1968
1973
1978
1983
1988
1993
* Trend line is 3-year moving average; R&D expenditure adjusted for inflation
Source: Kaitin, Clin Pharmacol Ther, 2010;87:356-361
http://www.nature.com/clpt/journal/v87/n3/full/clpt2009293a.html
1998
2003
0
2008
R&D Expenditures
(Billions of 2008$)
New Drug Approvals
R&D Expenditures
Tufts Center for the Study of
Drug Development
Tufts University, Boston, Massachusetts, USA
Kenneth I Kaitin, Ph.D.
Director
Professor of Medicine
Professor of Pharmacology & Exp. Therapeutics
Website
http://csdd.tufts.edu
Email
kenneth.kaitin@tufts.edu