Overview of Development, Manufacturing & Global Marketing from India Dr Brian W Tempest President – Pharmaceuticals New Delhi February 12, 2002 Once R&D discovers, Can the Indian Pharma Industry develop, manufacture & market around the world? R&D discovers Global Pharmaceutical Industry Global pharma market ~ $ 362 bn - 2000 estimates Top 10 companies have ~ 40 % market share 10 countries presently cover ~ 80% of global pharma market Generics opportunities ~ $45 bn in advanced markets by 2005 Government focus on affordable health care costs in $ Bn 16 13.9 13.4 12 Blockbuster Patent Expirations (adjusted for patent extensions) 8 7.1 6.7 4.2 4 2.7 0 2001 2002 2003 2004 2005 2006 World Pharma Markets $ 282 bn $ 362 bn 7 7 14 10 Latin America 16 Africa, Asia & Australasia 24 Japan 18 30 Europe 43 31 1995 North America 2000 • Total market CAGR ( 1995 - 2000) = 5.3% • US market CAGR ( 1995 - 2000) = 12.4% Rank in 2005 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. USA (1) Japan (2) Germany (3) France (4) UK (5) Italy (6) Mexico (11) China (7) Brazil (8) Canada (9) Spain (10) India (14) • Total market growth in 2000 = 6.9% •US contribution ~ 55% ( $18.2 bn) (Rank in 2000) Source: IMS World Review 2000 World Generics and Emerging Markets Generics Market in 2000 ~ USD 36 bn US 31% Others 39% Emerging Markets in 2000 ~ USD 30 bn Japan 11% Europe 19% (Latin America, China, India, Russia) Russia 10% China 23% India 13% Latin America 54% Source: IMS World Review 2000 Indian Pharma Market • • • • Size ~ $ 4 Bn in 1999 8% of Global Volume, 1% of global value Rank 5th in volume , 14th in value terms Number of drugs under price control – 1979 – 1995 – 2000 347 74 ? 90% of market 50% ? • Exports of $ 1.7 b, Imports of $ 0.7b • Prescription driven, Branded Generic market • Modern Medicine reach 30% of population Manufacturing capabilities • Employs approx. 1.86 mn people • Has 10000 manufacturing units. • 2900 large scale and 7100 in small scale sector • Total production stands at $ 4.2 bn. • 95 % Formulations manufactured indigenously • 90% of bulk drug requirement met indigenously RANBAXY Production capacity of Indian Pharma Industry Rs Crores * RANBAXY *1Crore = 10 Million Investment in Indian Pharma Industry RANBAXY The Indian Pharma Market Organized API domestic sector manufacturing Exporting Accredited International R&D facilities operations New drugs research Average spend ~ 3.5% 250 90 100 70% of pharma Market ($ 3.5b) 75% of API Production ($ 700m) 80 90% of pharma Exports ($1.4b) 8 65% of total R&D Spend ($ 75m) 6 80% of JVs and foreign investment Ranbaxy present in all categories 3 Improvement in health indicators in India over the years RANBAXY Exports of Pharmaceutical Products from India RANBAXY Significant Presence • India ranks 5th among the drug producing countries in volume terms and 14th in Value terms. • 8% share of global pharmaceuticals production. • Market size of $ 3.5 bn growing at 16% • 23,000 companies registered. • 350 companies operating nationally. RANBAXY Comparative Drug Prices Rupees DRUG INDIA UK Cimetidine 200mg (anti-ulcer) 6.77 36.40 Ranitidine 150mg (anti-ulcer) 16.15 121.67 Captopril 25mg (antihypertensive) 15.45 58.56 Nifedipine 10mg (cardiovascular) 3.82 29.90 Diltiazem 60mg (antihpertensive) 15.26 40.89 Atenolol 100mg (cardiovascular) 11.29 61.15 Haloperidol 5mg (cardioprotective) 13.58 41.16 Naproxen 250mg (antiarthritic) 12.76 31.07 RANBAXY Key elements in the success of Indian Pharma Industry • Entrepreneurship and Scientific & Technological skills • Reversing brain drain • Strong capacity to learn, absorb, and adopt process technologies • World class capabilities in Quality Management ensured approvals by US-FDA, UK-MCA, Australian-TGA and SA-MCC • Moving up the value chain in R&D – Process development to Analog research , NDDS, Chiral research and NCEs RANBAXY Competitive edge of Indian Pharmaceutical Companies • Immense flexibility of industry to move from one drug to another • Strong presence in foreign markets, net exporter of bulk drugs & formulations • Advantage of low costs and availability of high skills in process development • Cost of R&D much lower compared to other nations • India has third largest scientific pool in the world • In volume terms India produces 8-10% of worlds volume RANBAXY Ranbaxy Competitive Edges • Brand Marketing – Origins in India – cut throat competition – USA Commodity generics • Backward Integration – Control API costs – Not locked into suppliers – Productivity breakthroughs • R&D – Low cost – Excellent chemical research skills Unique Price advantage • Lower production cost due to reverse engineering capabilities • Lower input cost due to indigenously manufactured raw material • Low labor costs • Inexpensive machinery • Government’s policies RANBAXY PCT applications from developing countries Company Country 1. Samsung Electronics Korea 2. Shanghai Gere China 3. Shanghai Gere China 4. Fudon University China 5. LG Electronics Korea 6. Korea Institute of Technology 7. LG Chemicals Korea 8. Ranbaxy India 9. Samsung Chemicals Korea 10. Korea ???Bwker Institute Korea Applications 112 105 97 71 38 Korea 32 30 22 22 20 Strategic Architecture for Ranbaxy … products Teachnological & Marketing complexity NCE NDDR NDDS Commodity generics Conventional dosage forms 12 - 20% 20 - 30% Value Added/ Branded Generics OTC Intermediates & Bulk Substances 2 - 12% •Technology barriers •Business risk •R&D investment •Regulatory requirements •Scale management • Information intensity 30-40% 45- 60% 60-80% Gross margins Market Mix - Changing Profile USA Japan UK Australia Vietnam China Poland Russia Brazil FW Africa Thailand S. Africa Nigeria Egypt INDIA Sri Lanka Malaysia Developing ‘99 5 Emerging Developed 79 16 67 29 Sales Revenue % ‘04 4 Internationalization … our changing contours 80’s 90’s 00’s Strategy India Exports + + API, Dosage Form Generics, Branded Generics Proprietary technology platforms (NDDS), VAGs, Rx products Backward integration Developmental research, Regulatory, Manufacturing, Marketing Innovative research, Patents, Legal Brand marketing for Rx products International Markets Developing Emerging Advanced Products Competencies Thank You