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IndIa SympoSIum InduStry report
Pharmaceuticals
www. ind ia -sympos ium .org
zurich 2010
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www. ind ia-s ymp os ium .o rg
con:
d. Sig migsil
ind sypo
con:
us devv
Knowdg Pn
con:
Shi HidWok
Dgn Pn
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ContentS
exv sy 5
indy Ovvw 6
Gow Dv 9
mjo Py 10
mjo rgon nd Po 11
tnd nd Oppon 12
l o abbvon 13appndx 14
D 15
Ii Ssi Is rPharmaceuticals
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5Pharmaceuticals
t indn p ndy now wod
d g (10% o gob ) n o
vo o p pod podd nd
nkd 14 n o vn gnd. t
ndy dp poon pd ind bd
ong bnd n n p p.
t ndy gy gnd w ond 24000
py (bo 330 n ognzd o) poyng
o o 3 on pop. t op 10 p
opn on o 35% o o p
. t d o k d v
ong dbon nwok nd fd o, nd
onnoy nvovd n pod n.
t p o gng joonbo o indn xpo w xpo nng
ng o nggb on n 1990 o v o
usD 7.64 bon n FY*-08, nd ood usD 8.27
bon n FY-09. us nd eop p xpo
dnon, oowd by cn nd en eop,
a nd ln a (FY-08). t xpo o
dg, p & fn o ind
v gown opond nn gow
(caGr) o 21.1% (n usD ) dng podFY-03 o FY-09. Fogn d nvn n indn
dg nd p gn w ppoxy usD 1.43
bon o ap 2000 o Db 2008.
P opn n ind now pod
bk dg o v p ngdn (aPi)
bongng o jo p gop. con
nng nd (crams) xpd o
gn pd n ndy n ong y. ao on nng, bo gob nnovo
nd p gn jo fndng pofb
o oo podon.
indn p ndy ovng p
v n. i w pvoy vwd p v
ngnng ndy w od on do
k. t now ngng ndy ongon & dvopn, nng gob pn
og xpo, povdng wd ng o v ddd
qy pod nd v, nnovon, pod
y ngn nd ngng k .
howv, do k onn o b p-
nv dp ono gow nd opn
bdng pod kpng ky n nd.
m&a vy o bn on n n n o w n nbond d D-
rnbxy, snof avn sn Bo, abbo
Wokd (non) nd myn mx. sn
g v o gnon xng n k,
nd w gng owd onodon nd
o qon o do opn by m-
Non copn (mNc).
1. exeCutIve Summary
*The period referred to here is April to March
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n Do mk (iNr bon) n to mk z (iNr bon)
Fig 2: Gh Ii ph Is (I Inr Billi)
so: indBn rpo
0 1000800600400200
2003
2004
2005
2006
2007
2008
2009
325.75473.32
341.28520.29
399.89625.66
453.67684.42
554.54893.35
509.46786.1
303.65423.26
Sgs
Bk dg nd oon god
n odn w ppon p
gn p d o n. Gynoogy
g gn ong p pod.
t n-nv pod gn bn ong
k onny; k dd
o 24% n FY-02 o 18% n FY-07 nd
xpd o d o 17% n FY-12.
t jo pod go nd pn n
png k (ov y) dpyd
n Fg 3. in FY-02, n-nv, gonn
dg nd vn/n od o 50% o
do k. By FY-12, y xpd o
on o j 36% o k p .
On o nd, dg o do-v pob,
dod o n nvo y nd oon d w on o 64% o o , p
o 50% n FY-02.
2. InduStry overvIew
Ii phcicl Is
ind now on o gowng p
k n wod. i bn b o xpnd
vn dp gob fnn . t
ndy gown o ony usD 0.32 bon nov
n 1980 o ppoxy usD 21.26 bon n
y 2009-10. t ndy now wod dg n o vo o p
pod podd nd nkd 14 n o
vn gnd. rob do dnd, gowng
pn o gn nd vob ogn
xng pd o gow.
t indn p k gnd o
vn o usD 19.22 bon n FY-09.
Fg 1 & Fg 2 ow gow nd n indn
P ndy o FY-03 o FY-09 n usD
nd iNr pvy.
Fig 1: Gh Ii ph Is (I uSd billi)
0.00 25.0020.0015.0010.005.00
n Do mk (iNr bon) n to mk z (iNr bon)
2003
2004
2005
2006
2007
2008
2009
8.656.21
7.08
11.587.59
9.03
10.03
12.65
11.9319.22
19.52
15.13
14.13
10.28
so: indBn rpo
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Fig 3: p h Ii dsic Fli
mk (pcg bk-)
n Pn/ang, Gynoog & Doogy n an-nvn Vn/mn n Gonnn rpoy n cdovn No/cNs n andbnn O
so: ims h inoon nd conng sv ind Pv. ld (OrGims),crisil, rvw o Foon mk, ind (2008)
0 10080604020
2003
2004
2005
24 14 12 10 8 5 3 15
21 17 8 11 9 10 6 5 13
20 18 9 11 9 10 5 4 13
9
Gdp-Sh
Fig 4: Gdp Sh
n GDP n Png s
0 12501000750500250
2006
2007
2008
2009
967.1
789.9
736.3
906.6 2.1%
2.0%
1.9%
1.9%
so: indBn rpo
es: Gics apI L h w
ind xpo dg nd, v p
ngdn (aPi), fnd dog oon (FDF),
bop nd n v. t ndyFY-09 xpo vn w d bo usD
8.27 bon, gn dg nd aPi xpd o
b oponn dvng xpo. Fg
5 & Fg 6 ow gow nd n xpo nd
po o FY-03 o FY-09 n usD nd iNr
pvy.
Fig 5: t i es Is, Ii(Fy-03 Fy-09, uSd Billis )
n expo (usD bon) n ipo (usD bon)
so: indBn rpo
0.00 4.002.00 6.00 8.00 10.00
2003
2004
2005
2006
2007
2008
2009
2.620.59
0.643.31
0.703.97
1.025.02
1.305.51
1.67
1.84
7.64
8.27
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tbl 1: m iig Cis Ii
(s miis Cc, Ii)
rk Iig C pcg sh i Iisphcicl es
1 usa 18.48%
2 r 3.95%
3 Gny 3.75%4 a 3.69%
5 uK 3.21%
6 so a 2.93%
7 cnd 2.84%
8 Bz 2.65%
9 Ng 2.61%
10 ukn 1.79%
Fig 6: t i es Is, Ii
(Fy-03 Fy-09, Inr Billi)
n expo (iNr bon) n ipo (iNr bon)
so: indBn rpo
0 16080 240 320 400
2003
2004
2005
2006
2007
2008
2009
128.2628.65
29.56152.13
31.39178.57
45.15222.16
58.67 249.42
67.34
85.52
307.6
384.33
tb 1 ow ony-w bk-p o xpo
o FY-08. a p d jo xpo b
us nd eop. t P expo Pooon
con ( p by govnn p
ondon o Nn Fv Y ann Pn) gon--bp f
(rcmc), w ndoy o po nd xpo
o ood. i o poo p
pod og v o ogn k, wokop
nd xbon. Px o od by/
nd nn db o p
xpo nd pob n xpong p
pod.
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3. GrowtH drIverS
micl Isc G pnon o d nn w dv onpon o d nd pod.G pnon o d nn xpd b o Entry of foreign players Increase in the size and disposable income of Indian household
Css ind povd o n, nn, ngn ponn ow o w vb n dvopd ono, w d o ow ov o.typy, n on o ov 40% o o dg dvopn o;
d o o ng yp dg n ind 60% o n us.
G plicis Po x ody o nd opon n pfd sp eono Zono nddvopd , x xpon o pof nd o xpo, b dponown nd ddon o p r&D xpnd nng ndyvn.
mig h vl Chi
invn n r&D pb nd n v gon p n bo nd ndgovnn o.
ps t nn o td rd in Popy rg (triPs) n 2005 d o n
n n onfdn v o p opn n indn k. sn2005, 15 pnd pod v bn oy nodd n indn k.indn p opn v fd nb o non-nngng po ndoon pn.
mgs acqisiis lg indn p opn nng pn n gdk goby, w nd d-zd opn ong on -gd k ln a.
e pil ind p opn v d o o us o o k,ndng eop nd Jpn. indn opn v nvd o n usD 1.2 bon neopn k.
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4. major pLayerS
C rbLbis L.
d. rsLbis
Cil nichls pil( pilHlhc)
tphcicls
dscii rnbxy ong op 100pn wod nd
15 gowng opny.
t opny ggvypng nnonongy. i o gnd kdp nind, vgng ong bndbdng k.
D. rddy vyngd, gobp
opny wpovn pb ndpn o pv n.t opnynaPi nd fnddog o.
cp 31wod-nng pd
o ony,w dddpn oonoogy pod,oon, ndn, ongo. cppod on o wd ngo pod nddog o.
No Pd xn w 1988 qon
o Nolboo ndgw og o g,qonnd n.t opnyop n o onng.
t opny py nvovdn no dov,
cn Nvosy (cNs)py, n-db,gynoogy,doogy ndgonnpod.
rs uSd 1.67 bon(FY-09)
1.56 bon(FY-10)
1.19 bon(FY-10)
570 on(FY-10)
407 on(FY-10)
pfbili uSd 61.2 on(FY-09)
78.29 on(FY-10)
241.4 on(FY-10)
93 on(FY-10)
51 on(FY-10)
tbl 2: m 5 pls dsic
tbl 3: m 5 pls Fig (Ii ois)
C GlSihKli* Sf ais* pfz* nis* asZc*
dscii i on o bgg
popn n wod, w nd 7% n gobpk.
snof-avn non
popny, w o-gppon goby.
Pfz ono od
popn n wod. i bn n oponn 1849 nd d o v g n wod.
Nov wd n 1996
og go cb-Ggy ndsndoz. i opn 140 onnd opoy ngo ppoxy100,000.
i gob,ngd
bopopny nd poond n op 6% n Dow JonWod nd stOXXsnbyindx o po.
rs uSd 410 on(FY-09)
Na 170.8 on(FY-09)
138 on(FY-10)
85.21 on(FY-09)
pfbiliuSd 107.5 on(FY-09) Na 29.43 on(FY-09) 26 on(FY-10) 12.38 on(FY-09)
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5. major reGuLatIonS and poLICIeS
rgl Fk t n goy body n ind cn Dg sndd cono Ognon(cDscO), w op nd mny o h nd Fy W. t Dgcono Gn o ind (DcGi), wo ppov n o dg bo nnd v, pd ov cDscO.
FdI rgli in p opn, 100% FDi pd og o o.howv, o nb dg nd p nd og obnn DNa noogy nd / gd oon, po govnnppov qd. Fo bk dg, no nd nng qd. Fogn
nvn po 51% pd n o bk dg, nd ndoon. Fo ov 51% k, no kn p on -o- b,py n podon o dg o b g/ ng nw noogy.
dg ic cl (dpCo) Ky ng n ndy dg p ono od (DPcO).t o gon on bk dg, on oon nd on ov pofby. t d n o o pb o pogv o png oy. tnw P Poy 2006, w popo o bng 354 n dg ndp ono no bn ofy pd y nd bn ongy oppod by p ndy.
mcig Cda mnng n nd o oow good nng p (GmP) d n sd m o Dg nd co a nd nd o ono o WhO nd
nnon ndd o podon. ind oow d dg goy y wponb dvdd bwn n nd o. t cn Dg aoy(cDa), p n 2007, xpd o pov nonng o non dggo, no noy o nng nd povn n dg gon.
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6. trendS and opportunItIeS
Lshi psii Glbl psc
t popy o indn P ndy nd gnfny b o gob pn nd dp poon n aiDs dn k. a , nb o indn opn v bo p o n gn w jo aiDs dgbd on lvdn, svdn, Zdovdn, Nvpn o b ppd o anon.
Sgic pshis h ris
t bn n g pnp o indn p opn wov py:
1. GVK Bon pnd w Wy
2. Jbn pnd w Fo lboo, agn nd e ly3. Zyd cd pnd w Ko Bo aB & Poong P
Cs ag D o o dvng n on nng nd , mNc ngowd on ind w o gnfn o bnf. ind o o dvng o opv dg p.
n dls lnng d w mNc o nw n nd dg dvy y onw oppon. D qon o P h by abbo lb nd byo o joy n rnbxy by Jpn dg jo D snkyo n owdonodon o py n o.
r&d Growth opportunities for R&D exist in the biotechnology generics (biosimilars) andbop o. W pod pn g, nnovon & wpy ky o n dvopng nw pod.
In the area of clinical evaluation at the time of multi-centre trials, India provides a strongb d o vby o n n dv p .P opn vgng on v o crO o .
n as Contract R&D services such as custom synthesis, clinical trials, clinical datangn, boqvn ng, by ng o nw o o on.
Entry of private players in the insurance sector has given a boost to the pharmaopn d o nng p p xpnd on .
Managed health-care/pharmaceutical benet management is also expected to have abg p on indn p k.
Shiig Fcs h uS
indn opn xpndng ozon byond us o k eopn k nd Jpn (wod ond-g p k us).t d o nng png p, nkng gn nd nng gon n us. indn opn v dy nvd bo usD 1.2 bon n eopn k.
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7. LISt oF aBBrevIatIonS
AIDS Acquired Immune Deciency Syndrome
API Active Pharmaceuticals and Initiatives
ASSOCHAM Associated Chambers of Commerce and Industry of India
CAGR Compound Annual Growth Rate
CDA Central Drug Authority
CDSCO Central Drug Standard Control Organisation
CNS Central Nervous System CRAMS Contract Manufacturing and Research
CRISIL Credit Rating Information Services of India Limited
CRO Contract Research Organization
CVS Cardio Vascular System
DCGI Drug Controller General of India
DNA Deoxyribonucleic Acid
DPCO Drug Price Control Order
FDA Food and Drug Administration
FDFs Finished Dosage Formulations FDI Foreign Direct Investment
FY Financial Year
GDP Gross Domestic Product
GMP Good Manufacturing Practices
HIV - Human Immunodeciency Virus
IMS - Intercontinental Medical Statistics
INR - Indian National Rupee
MNC MultiNational Companies
M&A - Mergers and Acquisitions OTC Over the Counter
PPP Public Private Partnership
RCMC - Registration cum Membership Certicate
R&D - Research and Development
TRIPS Trade Related Intellectual Property Rights
US United States
USD United States Dollar
WHO World Health Organization
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8. appendIx
Scs:
Is i
Indian Business
Ministry of Pharmaceuticals
Indian Pharmaceutical Association
Indian Pharmaceutical Industry Segments
m plicis rglis:
Central Drug Standard Control Organization
Indian Pharmaceutical Association
Pharmaceutical Drug Manufacturers
Federation of Indian Chambers of Commerce and Industry
m pls:
Dr. Reddy Piramal Healthcare
Cipla
Biocon
Ranbaxy
Equity Master (Glaxo Smith Kline)
Equity Master (Pzer)
Equity master (Novartis)
Sano Aventis
Astra Zeneca
Gh dis:
Pharmabiz
Biospectrum India
Pharmaceutical Drug Manufacturers
Economic Times
ts iis:
Pharmaceutical Industry Indian Business Overview
Analyst Report
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9. dISCLaImer
t noon onnd n bn obnd o o bvd o b b. ind sypo &
evv d wn o y, opn o dqy o noon. ind
sypo & evv v no by o o, oon o ndq n noon onnd
n o o npon o.
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