The document discusses the high costs involved in drug discovery and development. It notes that the average cost to bring a new drug to market is approximately $800 million and $127 billion was spent on pharmaceutical research and development in 2010 alone. The process involves several key stages - drug discovery, preclinical testing, clinical trials, and FDA review - which can take over 10 years to complete. Around 30% of total costs are spent in the early discovery phase, 15-20% in preclinical testing, and 40% on clinical trials. Despite advances that have reduced timelines, the overall costs of drug development remain very high.

1. COST INVOLVED IN THE
PROCESS OF DRUG DISCOVERY
AND DEVELOPMENT
Chethan N
1st M. Pharm
Dept of Pharmacology
JSSCP Mysuru

2. INTRODUCTION
• In the past most drugs have been discovered
either by identifying the active ingredient from
traditional remedies or by serendipitous
discovery.
• But now we know diseases are controlled at
molecular and physiological level.
• Also shape of an molecule at atomic level is
well understood.
• Information of Human Genome

4. 10,000
COMPOUNDS
250
COMPOUNDS 5 COMPOUNDS
1 FDA
APPROVE
D DRUG
~6.5 YEARS ~7 YEARS ~1.5 YEARS
DRUG
DISCOVERY
PRECLINICAL
CLINICAL TRIALS FDA
REVIEW
Drug Discovery &
Development-Timeline

5. THE PRESENT SCENARIO
• ~$800 M spent to bring a new drug to
market.
• $127 Billion spent on Pharma R&D in 2010
• Share of CROs in research operations is
27%
• World CRO market is 16.3 B (Indian share
$500 M)

6. Sr. No. Company R & D spend($bn),2010
1 Novartis 7.9
2 Merck & Co 8.1
3 Roche 7.8
4 GlaxoSmithKline 5.7
5 Sanofi 5.8
6 Pfizer 9.1
7 Johnson & Johnson 4.5
8 Eli Lilly 4.7
9 AstraZeneca 4.2
10 Takeda 3.4
11 Bayer 2.3
12 Bristol-Myers Squibb 3.3
13 Boehringer Ingelheim 3.1
14 Amgen 2.8
15 Novo Nordisk 1.7

7. • The initial discovery and basic research
involving all the software based studies utilize
around 30% of complete cost.
• The pre-clinical testing utilizes around 15-20%
of the complete cost.
• 40% of the total cost involved in the new drug
development is utilized in the clinical trial part
of the process.
• The remaining 10-15% is used during the
marketing phase of drug, and for some
regulatory requirements.

9. R&D Function % of cost involved
Discovery/Basic Research
Synthesis & Extraction 10.0
Biological Screening & testing 14.2
Preclinical Testing
Toxicology & Safety testing 4.5
Pharmaceutical Dosage Formulation 7.3
Clinical Trials
Phase I, II, III 29.1
Phase IV 11.7
Manufacturing & QC 8.3
IND & NDA 4.1
Bioavailability 1.8
Others 9.0
Total 100.0

11. Ran
k
Product Company Phase Pharmacological class
Today's
NPV($mn)
1 Degludec Novo Nordisk Phase III Insulin 5,807
2 Tofacitinib Pfizer Phase III JAK-3 inhibitor 4,953
3 BG-12 Biogen Idec Phase III Fumarate 4,666
4 Incivek J & J Phase IV Hep C protease inhibitor 4,332
5 Relovair Theravance Phase III Corticosteroid 4,241
6
DR
Cysteamine
Undisclosed Phase III
Lysosomal transport
modulator
4,155
7 AMR 101 Undisclosed Phase III Omega-3 fatty acid 4,052
8 Eliquis
Bristol Myers
Squibb
Phase IV Factor Xa inhibitor 3,836
9 Eliquis Pfizer Phase IV Factor Xa inhibitor 3,592
10 Bexssero Novartis Phase IV
Meningococcal B
vaccine
3,250

12. COST INVOLVED IN CLINICALAND
PRE-CLINICAL PHASES

14. MONEY UTILIZED AT VARIOUS
PHASES BASED ON THE DRUG
CATEGORY

15. THE PRESENT DAY COST
INVOLVED IN DRUG DISCOVERY
• The usage of modern computational techniques has reduced the
time period involved in drug discovery process.
• The combinatorial chemistry and high throughput screening
methods are capable of synthesizing and screening of thousands
of compounds virtually thus the cost and time involved in these
tedious processes is reduced.
• The in-silico screening technique has also helped in screening
leads identified virtually.
• But still the cost involved in drug development process is high
and various measures are being taken to reduce that.

16. REFERENCES
• Journal of Health policy - The cost of drug
development: A systematic review; Steve
Morgana,b,Paul Grootendorstc,d, Joel
Lexchine,f, Colleen Cunninghama,Devon
Greysona; Elsevier Publication
• Journal of Health Economics 22 (2003) 151-185
The price of innovation: new estimates of drug
development costs ; Joseph A. DiMasi Ronald
W. Hansen , Henry G. Grabowski; Elsevier
Publication
• Images and tables from Google

17. THANK YOU