Created by Portia K.C.

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.

Created by Portia K.C.

Created by Portia K.C.

Created by Portia K.C.

#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)

Created by Portia K.C.

Created by Portia K.C.

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)

Rank Company 2013 Total Promo Spending (Mi l l i ons)*1 Pfizer $1,858.85

2 Merck & Co. $1,489 .4 1

3 Forest Laboratries $1, 139 .22

4 AstraZeneca $1, 137.77

5 Eli Li l ly $1,063.02

6 Boehringer Ingelheim $833.4 1

7 Novart i s $810 .38

8 GlaxoSmi thKline $802.99

9 BMS $787.86

10 Johnson & Johnson $755.92

11 Novo Nordi sk $572.06

12 Dai i chi 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 Pharmaceut ical 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.

Created by Portia K.C.

Created by Portia K.C.

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

Created by Portia K.C.

Created by Portia K.C.