current global pharma developments-challenges and opportunities
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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 - PowerPoint PPT PresentationTRANSCRIPT
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
● 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 2010Lansoprazole (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. CroresMenthol 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 – 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 policySweden, 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