India Symposium 2010 Pharmaceuticals

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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

    e-: [email protected]

    con:

    us devv

    e-: [email protected]

    Knowdg Pn

    con:

    Shi HidWok

    e-: [email protected]

    Dgn Pn

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    3Pharmaceuticals

    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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    7Pharmaceuticals

    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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    9Pharmaceuticals

    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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    11Pharmaceuticals

    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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    13Pharmaceuticals

    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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    15Pharmaceuticals

    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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    www. ind ia -sympos ium . org

    son 98306 Z, swznd

    Pon +41 43 2559188

    Fx +41 43 2559188