Transcript Global Pharma Developments-Challenges and Opportunities
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
●
Serious 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 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
Pfizer Glaxo Sanofi Pfizer Roche Merck AstraZeneca
Acquired
Warner SKB Aventis Wyeth Genentech Schering Medimmune
Value $ Mil
8880 7880 6570 6800 4700 4110 1520
Year
1999 2000 2004 2009 2009 2009 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.
Country USA Germany Russia UK China Brazil Canada South Africa Nigeria Netherlands
Major export destinations (value Rs Mil)
2007- 08 58393 14489 11990 11465 8794 7716 7380 6843 6441 5227 2008- 09 (Apr- Jan) 56686 11773 11977 9835 4653 8645 9217 9353 8607 5500 Share %dosage forms(2007-08) 65 31 94 70 10 47 16 72 87 42
Major API Exports(2007-08)
Product group
Menthol Amoxycillin Cephalexin Erythromycin Ibuprofen Ciprofloxacin Ampicillin Ranitidine Ephedrines
Rs. Crores
640 562 196 173 149 123 138 131 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 • 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 USA Top 5 Europe EU Japan Australia $ Billion 33 22 31 3 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 IV. Countries with incentives for pharmacists to dispense generic medicines Germany, France, UK, Sweden 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 Take over Blues Authorized Generics REACH
risk
strategy Increased FDA scrutiny of overseas API facilities Lack of Accreditation of Indian testing labs by vendors