Strategic Changes in the Global
Pharmaceutical Market
Dr. Brian W Tempest
www.briantempest.com
Mumbai. India
August 2011
Hale & Tempest
Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on
their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia
and India where he has lived for the last decade.
Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director
and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until
2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip
MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional
Director Far East and Regional Director Middle East & Africa from 1985 to 1992.
Brian has worked in the Pharmaceutical Industry for the last 40 years and has managed Healthcare
businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan
and India. He has also led many sessions at Investor Meetings held around the world.
He is now Independent Chairman of Religare Capital Markets PLC and Non Executive Director of
SRL the largest Indian Diagnostic Company. Brian is an international advisor to MAPE, India and the
United Nations (UNCTAD) in addition to being a member of the SCRIP Global awards panel he is on
the Editorial Board of the Journal of Generic Medicines. Brian speaks at global conferences and more
information on these presentations can be found on his website www.briantempest.com.
Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became
Chairman of the Advisory Board for the Lancaster University Management School which ranks 4 th in
the UK He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of
Chemistry and is a Chartered Chemist. He is now Chairman and Senior Partner of Hale & Tempest
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Generic Medicines are part of the
Solution for Ageing Populations
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China/India with 37% population, 14% of
wealth and most of the GDP growth
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Structural Change -
Big Pharma
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Only 21 2010 FDA New Drug Approvals
Source: Fiercebiotech 22 Jan 2011
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USA DOJ Fines on Big Pharma
Source: Chemistry World Jan 2011
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USA Batch Recalls
Source: Deutche Bank 29 March 2011
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Approvals & Reimbursements
Source: Pharmatimes UK July-August 2010
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Big Pharma Losing to Local Players
Source GSK Presentation
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Emerging World Share of Pharma
Source EIU, OECD, WHO, IMS, Roland Berger
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Top 8 Cos in Emerging Markets 2008
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Large Cap Pharma Entering Generics
With the slow-down of Western markets, Pharma are rapidly repositioning to focus on
emerging markets for growth
Emerging Market Investor Days
Increasing Pace of Emerging Markets Acquisitions
(MENA, LatAm, Asia-Pac)
(Algeria)
(Egypt, Pakistan, Near East )
March 16, 2010
December 10, 2009
July 2, 2009
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Sales Force Job Cuts in Press since 2009
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Structural Change
Generic Companies
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Asia vs. the Western Generic Companies
Source: Factset, Religare
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Pricing Pressures
Source: Watson
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European Generic Prices
Source Ranbaxy
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European Generic Prices
Source Ranbaxy
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USA - ANDA Growing Approval Times
Source FDA Chief M Hamburg, GpHA Conference February 2010
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2005 16.3 months average
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2009 26.7 months average
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Around 2000 ANDAs awaiting approval
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FDA explained as a result of staff shortages
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Regulatory filing fees needed
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Season of Warning Letters/Import Alerts
Source: Deutche Bank July 2011
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USA - Litigation Success Rates
Source
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RBC Capital Markets January 15 2010
Patent Challenges on rise - 65 FTFs in 2009
Success rate at 48% - or 76% including deals
3 courts hold 69% with 36% success e.g. NJ
4 courts never ruled against generics e.g. NY
At risk launches on the rise – 6 in 2009
Teva has 12 of the 28 at risk launches – 2002/9
Settlements on the rise – 54 in 2009
Teva accounts for a third of all settlements
Authorized generics on the rise – 25 in 2009
Watson represents a fifth of all AGs
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Generic Profit Margin Profile
in descending order source: Deutsche Bank July 2010
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Top 25 Global Generic Companies
Source: Generics Bulletin 10 June 2011
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Next 24 Global Generic Companies
Source: Generics Bulletin 10 June 2011
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Patent Expiries
Source: Sandoz
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In 2016 Top 10 8 will be Biologic/Resp
Source: Sandoz EGA Conference 2011
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Structural Changes
Indian Pharma Companies
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WHO Pre Qualified Products
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Indian Generic FDA ANDA Approvals
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Niche Technology
Source: MAPE
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India – Share of CRAMS Market
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Lots of Opportunity for CROs in India
Source: clinicaltrials.gov 16 Feb 2011
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Macro Structural Changes
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Pfizer & Hisun
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Pharma Wholesaler sets up China JV
UK Coop – the world’s largest consumer cooperative
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GBP£10b UK company
running food stores, banks, insurance, funeral
homes, travel agents, farms and pharmacies
3rd rank pharmacy chain in UK with 800 stores
Owns UK pharmaceutical wholesaler Sants
Opus Marketing JV with Day Lewis Pharmacy
Chain offers 113 products under Prospect
brand
Tianjin Tasly Sants Manufacturing JV opened
2010, “production under way” Jun 2011
With Investment GBP£20m, 200 staff Hale & Tempest
China Pharma Industry Capex Plans
Source: Stravencom
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India Pharma Industry Capex Plans
Source: MAPE
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FDA DMFs from India
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FDA DMFs from China
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Chinese ANDAs
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Endangered Elements
Source: Chemistry World 2011
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A New World Order is Coming
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Thank You
brian.tempest@clara.co.uk
www.briantempest.com
Hale & Tempest