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The East is the New West: Charting the India Frontiers. Mak Jawadekar, Ph.D. Director, AMP, WWPM Pfizer Global R & D, Groton/New London Labs CHLA Presentation, Montreal, Canada September 21st, 2006. Singapore. Indochina Vietnam, Laos Cambodia, Myanmar. China. Taiwan. Thailand.
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The East is the New West: Charting the India Frontiers Mak Jawadekar, Ph.D. Director, AMP, WWPM Pfizer Global R & D, Groton/New London Labs CHLA Presentation, Montreal, Canada September 21st, 2006
Singapore Indochina Vietnam, Laos Cambodia, Myanmar China Taiwan Thailand Hong Kong S. Korea Indonesia Malaysia Pakistan Philippines India Asia is a diverse region for Pfizer with operations in 18 Countries Australia Japan New Zealand
Today’s Focus: Charting India Frontiers • India : Growth Rate Statistics • Drivers for Growth in Outsourcing & New Markets in India for the Western Bio/Pharma Industry • Anticipated Growth Drivers for M & A activity • Wall Street’s focus on corporate ‘bottom line’ and its R & D Productivity • Ever Changing Global Pharma Industry Landscape • Factors for further economic equilibration • Recent Changes in India’s IPR Regulations
My personal networkingPassion for India • As an Immigrant, Naturalized US Citizen,my family background • Key-Note address: Indian Pharmaceutical Congress, New Delhi December 2001 • Roundtable with the President of India, Dr. Abdul Kalam: 2003 • Outsourcing Experience within the US 2000-2004/SRI Initiative • Getting involved with USIBA and USINPAC/ Meetings In DC 2004
My Personal NetworkingPassion for Asia continues… • Meeting with President George Bush: June 2005 • Invitation to the White House: ‘Diwali Celebration’: Nov 2005 • President Bush’s Trade Mission to India – March 2006 • Looking at Pfizer’s ‘Capturing Global Advantage Initiative’ • Contributions to Pfizer, the US and to the motherland • Ability to participate and help in the future growth
President George W. Bush’s Ongoing Agenda • Grow Bilateral Trade • More outsourcing • Enhance US Business efficiencies • Further Growth in Science & Technology Exchange • Economic Partnerships
Growth Rates Highest in Asia: GDP Growth – 2005 Annual Percent Change: Source: IMF WEOD %
LABOR COSTS AROUND THE WORLD Hourly Compensation Costs__________________________________________________________ $US
Business Activity in India • Majority of outsourcing work is labor-intensive manufacturing • Growth in manufacturing leading to surge in commodity imports • Most outsourcing is comprised of business processing services (e.g., IT services, call centers, back office etc.) • Higher value-added business is still minor component
Today’s Modern India! • Growth spurred by the IT sector, translating into Life-Sciences • Many new Pharma-Bio-tech Parks are on the horizon • Growth in Mumbai, Pune, Bangalore, Hyderabad areas for the Life Sciences sector • Huge rise on the third party CRO type businesses.
Themes – India Ready for Take Off? • Reforms have produced a stable macro environment for sustaining strong growth • Huge labor stock and rising • Growth is expected to accelerate to 6.5%, driven largely by the services sector • Acceleration in manufacturing is critical for achieving 8% growth target • Relatively low savings and slow pace of infrastructure development could be a constraint
Population Aged 25-59 Population Aged 15-64 India: Potential Working Population Trend MM
India: Low-Cost Service Provider Average Annual IT Services Employee Cost $US U.S. Canada Ireland Israel South Africa China Malaysia Philippines Czech Republic Russia India
India Pharma Expertise • Chemical Process Expertise – Indian companies have built development skills over the last three decades to research and manufacture complex drugs • Cost advantages • Fixed asset costs – The cost of building and staffing an FDA approved facility in India is 20-25% of the cost of setting up a comparable facility in the US or Europe • Variable costs – Cheap labor and lower development costs • Clinical study costs – Due to the large population of India, patients for various tests are easily available at up to 10% of the cost of US patients
Evolving Indian Business Model • Targeting regulated markets • Indian companies looking to US and Europe for growth and at same time attempting to move up product value chain to leverage internal competencies and capture greater economics • Servicing/outsourcing • Some Indian companies have positioned themselves to service large-cap pharma by focusing on contract manufacturing for already existing drugs or research candidates
India -Statistics India • Population: 1.08 billion (16% of world total) • GDP growth rate: 8% • WEF growth competitiveness ranking: 56 • Trade balance (% of GDP): -2% • Foreign reserves: US$ 222 billion (November 2005)
India –More Fast facts India • Area: 3.3 Million Sq.Km (USA 9.63 Million Sq.Km) • GDP: $3.68 trillion (USA 12.37 trillion) • GDP growth rate: 8% (USA about 4 %) • Pro capita GDP: $3400, (US$41,800) • World’s Largest Democracy • Pharma Sales $8 Billion • Global Pharma Volume Ranking :4th in the world • Share of Global Pharma Volume Market 8%
The number of FDA inspected Indian fine chemicals companies has greatly expanded over the past few years.(Source: Arthur D Little) An increasing number of Indian companies have been FDA inspected
GlobalDrivers for India revolve around various factors Lower costs Growing Capacity Higher flexibility/Speed Market size/ Trade Potential Equivalent GXP Quality/ Capability
Advantages of IPR/TRIPS • Strong intellectual property rights support innovation – new medicines, improved treatments; • Implementing TRIPS protects consumers against counterfeits, thus saving lives and health; • TRIPS gives the basis of company access programs – the proven solution for improving access; • TRIPS is a delicate balance of flexibilties and responsibilities; • Ministers agreed in Doha Declaration that public health needs can be met in the TRIPS framework.
Total Pharmaceutical R&D Spending: Canada 1000 $ millions 1000 900 900 825 800 700 600 500 412 400 300 200 103 57 28 100 10.4 18 0 1967 1972 1977 1982 1987 1992 1997 1998 2001 1984-1987 - as compiled by Peat Marwick, 1988-1995 - as compiled by the PMPRB,1997, 1998 as compiled by Deloitte and Touche; 2001 according to SCRIP, July 17 2002
Innovation & IPR Recognition • IPRs clearly stimulate innovation and growth in pharmaceuticals. • The real benefit of strengthened IPRs will go to domestic innovators, helping developing countries in their development policies. • Key developing countries can take their rightful place as global leaders in pharmaceutical innovation, which will benefit patients in developing countries and around the world.
Indian Pharma & Where it is Going! • Indian Pharma is expected to be one of the key global growth players into the US and Europe. • Indian firms have accounted for 35% of the DMF filings during 2004 with the USFDA. API integration factor • Expansion in Semi Regulated Markets: With better margins in Russia, Brazil , and eastern European countries. • Polarization of Generic Industry: Post Ivax acquisition, Teva is the market leader ($7B), followed by Sandoz ($3B) • Pharmaceutical(fragmented) Distribution: A next wave of Reform? • Growth in Biotech/Vaccines: High institutional sales, Distinct target markets, large Phrama’s reluctance to develop for diseases in developing countries • Value Driven Growth Vs. Volume driven Growth
Recent past & Current M & A Activity The value of total sector (M& A) in India has more than quadrupled to a record of $ 18.3 Billions in 2005. A total of 872 Indian companies merged or were acquired in 2005 compared to 565 worth $4.5 B in the same period in 2004. According to AT Kearney’s 2005 survey, India is the 2nd most favorite global destination • Indian with International Companies: Zydus Cadila-Alpharma (Fr), Sun-Caraco(US), Ranbaxy-RPGAventis (Fr),Glenmark-Lab Klinger(Brazil), Dr. Reddy’s-Trigenesis(US), Jubliant Organosys-PSI (Belgium) • Global Generics: Teva-Ivax, Teva-Sicor(US), Sandoz-Sabex(Canada),Meda-Viatris(Germany), Matrix-DocPharma (Belgium), Actavis-Amide (US) • In the News: Wockhardt trying to do a deal in the US • Jubliant Organsys trying to acquire in the US
Expect much more M & A activity in the next 5 years !! • 2006-2007 will continue to see more M & A activity because of the changing Pharma Industry and pressures on Margins & Pricing • Indian Parliamentary ordinance amending the patents Act, to encourage International MNCs for greater presence and increase market share. • Expect more M & A with Biotech as well with growth in virtual, small companies looking to do JVs, Partnerships, collaborations, alliances and other types of tie-ups with bigger companies.
India: Pro-factors for the Western Big Pharma to consider • India: Emerging economic power for Market growth • Favorable WTO/IPR environment • Fair Legal System • Access to talented Scientific work force • Pharmaceutical Mfg facilities with GXP • Most favorable cost advantages with economies of scale • Rapidly establishing reforms/ changing infrastructure
Asia Strategy (Under Development): Factors under consideration: • Outsource for more capacity, lower costs of R & D • Access to the emerging Growth Market economies • Corporate overarching strategies • TA Dynamics • Market needs • Regulatory environment • S & T /Innovation • Business Cycle dynamics • IPR/Data Protection with all the cautionary measures
Key Drivers for growth for the global Pharma/Biotech/Generic Pharmaceutical Industry: Crystal ball • Growth of Global Pharma Market Volumes due to India/China • Enhancing Productivity in Pharma R & D • Focus on Performance and adapting to changing environment • Global Outreach & capturing advantage due to the global outreach • Geographic Expansion through M & A / Economies of scale • Expansion of capabilities in DDS/Formulations • Vertical Integration into API/ USFDA approved sites • Exploration of Specialty Pharma options • Global Metamorphosis of Speed/Quality/Cost paradigm
Acknowledgements • Pfizer PGRD ‘CGA’ Team • Arthur D. Little :Data Output • Morgan Stanley (V. Pandit) Financial Data • Dr. E. Noehrenberg, IFPMA • US Congressional India Caucus Staff • White House Support Staff • Many Pfizer colleagues