Current Global Pharma Developments-Challenges and Opportunities

1. Current Global Pharma Developments-Challenges and Opportunities P.U.M.Rao Retd. Addl. Industrial Adviser(Pharma), Govt. Of India

2. The Race for Quality has no finishing Line………

3. 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

4. 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

5. 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 productsare part of this. • 32 NCEs launched in 2008 compared to 25 in 2007.

6. Top Product Sales 2008($ Bn)

7. 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 managementQ8, Q9 and Q10 guidelines.

8. Drug Patent Expiry

9. Big Pharma M & A

10. Indian Pharma Profile

11. 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.

12. Major export destinations(value Rs Mil)

13. Major API Exports(2007-08)

14. Major Dosage Form exports(2007-08)

15. 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

16. 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

17. generic medicine policies of European governments

18. 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.

19. 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

20. 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

21. Thank you