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)
Plavix (clopidogrel)
Nexium (esomeprazole)
Seretide (fluticasone+salmeterol
Enbrel (etanercept)
Seroquel (quetiapine )
Zyprexa (olanzapine )
Remicade ((infliximab)
Singulair (montelukast)
Lovenox (enoxaparin)
13.6
8.6
7.8
7.7
5.7
5.4
5.0
4.9
4.6
4.4
Global Pharma Developments
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Serious profit setbacks
Mergers & Acquisitions.
Prohibitive R&D costs
Changing Regulatory environment
Threat from generics
More outsourcing
Emergence of new players
ICH-quality risk management Q8, Q9 and Q10
guidelines.
Drug Patent Expiry
2009
Lansoprazole
(Prevacid/Takepron/Zoton)
Duloxetine
(Cymbalta/XeriStar)
Tamsulosin
(Flomax/Omnic/Harnal)
Perindopril erbumine
(Coversyl/Aceon)
Escitalopram oxalate
(Lexapro/Cipralex)
Anastrozole (Arimidex)
2010
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
Amoxycillin
Cephalexin
Erythromycin
640
562
196
173
Ibuprofen
Ciprofloxacin
Ampicillin
149
123
138
Ranitidine
Ephedrines
131
90
Major Dosage Form exports
(2007-08)
Product Group
All Antiinfectives
Vitamins
Analgesics,Antipyretics
Cardiovasculars
Antiulcers
Antiasthamatics
Hormonals+Insulin
Anticancers
Veg. Alkaloids
Rs. Crores
4600
798
791
645
452
347
315
251
157
Government Initiatives for Pharma sector
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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 – 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 – 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 – 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
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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