Global Pharma Developments-Challenges and Opportunities

mutebabiesBiotechnology

Dec 6, 2012 (4 years and 11 months ago)

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Current Global Pharma
Developments
-
Challenges and
Opportunities




P.U.M.Rao


Retd. Addl. Industrial Adviser(Pharma),


Govt. Of India





The Race for Quality


has no


finishing Line………

Global Pharma Industry
2008
-
09


Global drug sales projected at $ 773 Bn with low growth of
4.8% in 2008.Further slowdown expected in 2009




North America sales
-

$ 312 Bn,



Europe sales $ 247 Bn, Japan $ 76 Bn,



Latin America $ 47 Bn growing +12%,


Asia/Africa/Australia together $ 91 Bn growing +15%



patent expiries, slowdown in new product launches,
hurdles imposed by payers on market access, world
financial crisis are some reasons for reduced growth





Global Pharma(contd)


Oncology top therapeutic class $
48
Bn sales growing at
11
%. To reach $
75
-

80
Bn by
2012
.



Aggregate value of biotechnology drugs sales +$
75
Billion
in
2007
are estimated to grow to $
169
billion in
2014
.



Lipid Regulators($
34
Bn),Respiratory($
31
Bn),
Antidiabetics($
27
Bn), Antiulcers( $
26
Bn), CVD($
23
Bn)


are the other top groups



U.S. Prescription drug Sales which grew
1.3
Percent in
2008
to $
291
Billion is expected to decline by
1
-
2
percent
in
2009


Global Pharma Highlights


Top
50
pharmaceutical companies
accounted for prescription drug sales of


$
558
billion in
2008
.


New Drugs in development gone up to


9605
(
2009
) from
5930
(
1998
)


Currently there are
100
blockbuster drugs,
22
biotech products

are part of this.


32
NCEs launched in
2008
compared to
25
in
2007
.


Top Product Sales 2008($ Bn)

Lipitor
(atorvastatin)

13.6

Plavix
(clopidogrel)

8.6

Nexium
(esomeprazole)


7.8

Seretide
(fluticasone+salmeterol

7.7

Enbrel
(etanercept)

5.7

Seroquel
(quetiapine )

5.4

Zyprexa
(olanzapine )


5.0

Remicade
((infliximab)

4.9

Singulair
(montelukast)

4.6

Lovenox
(enoxaparin)

4.4

Global Pharma Developments



S
erious profit setbacks




Mergers & Acquisitions.



Prohibitive R&D costs



Changing Regulatory environment



Threat from generics



More outsourcing



E
mergence of new players




ICH
-
quality risk management

Q
8
, Q
9
and Q
10


guidelines.


Drug Patent Expiry

2009

2010

Lansoprazole
(Prevacid/Takepron/Zoton)

Duloxetine
(Cymbalta/XeriStar)

Tamsulosin
(Flomax/Omnic/Harnal)

Perindopril erbumine

(Coversyl/Aceon)

Escitalopram oxalate

(Lexapro/Cipralex)

Anastrozole
(Arimidex)


Losartan potassium

(Cozaar/Hyzaar)

Atorvastatin calcium

(Lipitor)

Docetaxel

(Taxotere)

Gemcitabine

(Gemzar)

Lamivudine and
zidovudine

(Combivir)

Pantoprazole

(Protonix/Pantozol)

Donepezil

(Aricept)

Levofloxacin
Levaquin/Cravit/Tavanec)


Big Pharma M & A

Acquirer

Acquired

Value $ Mil

Year

Pfizer

Warner

8880

1999

Glaxo

SKB

7880

2000

Sanofi

Aventis

6570

2004

Pfizer

Wyeth

6800

2009

Roche

Genentech

4700

2009

Merck

Schering

4110

2009

AstraZeneca

Medimmune

1520

2007






Indian Pharma Profile




Current Indian pharma export profile


Exports of Drugs, Pharma and Finechem amounted to Rs 32051 Crores during


2008
-
09 (Apr
-
_Jan)



The Biopharma exports touched Rs 3999 Crores in 2007
-
08





Exports to over 200 destinations including small islands like Kiribati



Europe, North America together account for half of exports



Share of dosage exports 52%
-

a noteworthy achievement



World’s No. 1 Pharma market USA also India’s top destination



Africa is biggest with 54 destinations




Global presence of India in the critical antiretroviral supply is now part of history.



Major export destinations

(value Rs Mil)

Country

2007
-

08


2008
-

09
(Apr
-

Jan)

Share %dosage
forms(2007
-
08)

USA

58393

56686

65

Germany

14489

11773

31

Russia

11990

11977

94

UK

11465

9835

70

China

8794

4653

10

Brazil

7716

8645

47

Canada

7380

9217

16

South Africa

6843

9353

72

Nigeria

6441

8607

87

Netherlands

5227

5500

42

Major API Exports(2007
-
08)

Product group

Rs. Crores

Menthol

640

Amoxycillin

562

Cephalexin

196

Erythromycin

173

Ibuprofen

149

Ciprofloxacin

123

Ampicillin

138

Ranitidine

131

Ephedrines

90

Major Dosage Form exports

(2007
-
08)

Product Group

Rs. Crores

All Antiinfectives

4600

Vitamins

798

Analgesics,Antipyretics

791

Cardiovasculars

645

Antiulcers

452

Antiasthamatics

347

Hormonals+Insulin

315

Anticancers

251

Veg. Alkaloids

157

Government Initiatives for Pharma sector


100
% FDI permitted through Automatic route


Technology freely importable both Lumpsum, Royalty applicable


Foreign Trade policy instruments
-
Advance Authorisation, DEPB, EPCG


Export facilitation
-

MAI, MDI


New moves
-

Focus Markets,


R&D initiatives
²

funding


In house R&D recognition


Modernisation


Registration system streamlined for import of drugs
-

both site and
product registration



product patents for drugs, food and agrochemicals since
2005



Global Generic industry



Global generics Sale $
78
billion as per IMSH.
Growth down to
3.6
% from
11.4
% in
2007



top eight global markets
²

the U.S., Germany,
France, the U.K., Canada, Italy, Spain and
Japan account for
84
percent of total
generics sales .



Generics growth
10.2
% in Japan,
16.9
% in
France,
12.5
% in Italy and
10.5
% in Spain.



Top
10
generics companies
47
percent share
of the generics market worldwide.




Three leading generics manufacturers
²

Teva
(
11
% market share), Sandoz (
9
%) and
Mylan (
8
%).



Generics companies to benefit as products
generating $
139
billion in branded sales in
the top eight world markets lose their patent
protection through
2012

Country

$ Billion

USA

33

Top 5 Europe

22

EU

31

Japan

3

Australia

2

generic medicine policies of European
governments


I. Countries with a coherent generic

medicines policy

Sweden, UK, Denmark, France

II. Generic medicines competition within
existing regulatory frameworks


Poland, Netherlands, Denmark

Germany, UK, Sweden


III. Countries with incentives for
physicians to prescribe generic
medicines


Germany, France, UK, Sweden


IV. Countries with incentives for

pharmacists to dispense generic

medicines


Netherlands, Denmark, UK, Italy

France, Poland, Sweden


V. Countries with incentives for patients
to demand generic medicines


Italy, Denmark, Germany

Sweden, France, Poland


Source
-

EGA

Opportunities



Why New Markets
-

what’s happening in US, Europe



Outsourcing opportunities. Collaboration, Tie ups



BT Acquisitions



Prevalence of Different Strategies




Growth Areas for products



Eco
-
innovation

driving greener product development



Cooperate not compete model



FTAs
-

Setting up JVs to access new markets.


Concept to Goal of ASEAN pharmaceutical harmonization




$ 13 Billion ASEAN pharma market presents growing opportunities



10 ASEAN member countries formed PPWG in 1999


A Partnership
of Indonesia, Malaysia, Singapore, Thailand, Philippines, South Korea,
Vietnam, Laos, Mynamar, Brunei



Studied harmonization of procedures and regulatory system
towards achieving MRA


ASEAN CTD and other regulatory parameters like BA adopted


Implementation through Working Group based on consultations and
consensus


Resources, Training taken care off


ASEAN GMP finally in place through a decade of dedicated exercise


Implementation January 2011

Impediments



Non Tariff Barriers



Effect of Free trade agreements



Growing imports.



Absence of regulatory cooperation



Pricing pressures in US.



New approach by overseas API Mfrs
-


risk

strategy



Take over Blues



Authorized Generics



REACH



Increased FDA scrutiny of overseas API facilities



Lack of Accreditation of Indian testing labs by vendors





Thank you