The pharmaceutical industry had a promising year in 2013, with total drug spending increasing sharply to 3.2%. However, the industry must prepare for new medicines and changes in 2015. This document analyzes the key factors in 2013 and the first quarter of 2014, including the top 10 drugs by sales and top therapeutic classes. It also lists the top 20 companies by promotional spending in 2013. Finally, it provides a brief overview of the drug development and FDA approval process.

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2. It
It has been a promising year for the
pharmaceutical industry in 2013. The total
drugs spent increased sharply to a 3.2%;
however, we must be well-prepared for the
new generation of medicine and changes
in the upcoming 2015. Now, it is time to
look back and analyze the key factors of
2013 and the 1st quarter of 2014.
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5. #1
Abilify
Otsuka/BMS
#2
Nexium
AstraZeneca
#3
Humira
AbbVie
#4
Crestor
AstraZeneca
#5
Cymbalta
Eli Lilly
# 6
Advair Diskus
GlaxoSmithKline
#7
Enbrel
Amgen
#8
Remicade
Johnson&
Johnson
#9
Copaxone
Teva
#10
Neulasta
Amgen
$6.6 $6.2
$5.6 $5.4 $5.3 $5.2 $4.7 $4.1
$3.7 $3.6
2013 Total (Billions)
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0 5 10 15 20 25 30
Nervous System Disorders
Antibacterials
Dermatologicals
ADHD
Anti-Ulcerants
Mutliple Sclerosis
HIV Antivirals
Antihypertensives
Lipid Regulartors
Autoimmune
Pain
Respiratory
Metal Health
Antidiabetes
Oncologics
8.1
8.6
8.9
9.9
10
10.6
12.5
12.5
13.6
17.9
18.7
20.4
23.7
24.3
27.9
Top 15 Therapeutic Classes by US Sales 2013
2013 Total (Billions)

7. Rank Company 2013 Total Promo Spending (Millions)*
1 Pfizer $1,858.85
2 Merck & Co. $1,489.41
3 Forest Laboratries $1,139.22
4 AstraZeneca $1,137.77
5 Eli Lilly $1,063.02
6 Boehringer Ingelheim $833.41
7 Novartis $810.38
8 GlaxoSmithKline $802.99
9 BMS $787.86
10 Johnson & Johnson $755.92
11 Novo Nordisk $572.06
12 Daiichi Sankyo $502.52
13 Sanofi $486.99
14 Takeda $479.98
15 Amgen $398.08
16 Abbvie $369.24
17 Allergan $360.60
18 Otsuka Pharmaceutical Group $353.22
19 Teva $300.59
20 Sunovion $281.65
2013 US Total Promotional Spending
* Total promotional spend figure includes total promo DTC, eDetailing, professional detailing, professional meetings, journal
ads/publication ads, but it does not include amount spent on samples, clinical trials or direct mail.
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9. Drug Developed
IND Application
Animals Tested
CLINICAL
Drug Sponsor’s Clinical Studies/Trials
p
h
a
s
e
1
20-80 healthy volunteers
P
h
a
s
e
2
100’s patients
P
h
a
s
e
3
1000’s patients
NDA REVIEW
FDA’s New Drug Application (NDA) Review
POST-MARKETING
FDA’s Post-Approval Risk Assessment Systems
Phase 4
Once FDA approves a drug, the
post-marketing monitoring
begins. The sponsor (typically
the manufacturer) is required to
submit periodic safety updates
to FDA
Review Meeting
NDA Application
Application
Reviewed
Drug Labelling
Facility
Inspection
Drug
Approval
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