行业报告全球制药业发展战略

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1、Hale & Tempest Strategic Changes in the Global Pharmaceutical MarketDr. Brian W Tempest August 2011Hale & TempestDr 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

2、 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 westerner

3、s 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

4、 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

5、 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 in

6、formation on these presentations can be found on his website .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 4th in the UK He is a Fellow of the Royal Society of Me

7、dicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is now Chairman and Senior Partner of Hale & Tempest Hale & Tempest Generic Medicines are part of the Solution for Ageing Populations Hale & TempestChina/India with 37% population, 14% of wealth and most of the GDP

8、growthHale & TempestStructural Change -Big PharmaHale & Tempest In 2010, FDA approved Only 21 New Drug Source: Fiercebiotech 22 Jan 2011 Hale & Tempest USA Dept. of J Fines on Big PharmaSource: Chemistry World Jan 2011 Hale & Tempest USA Batch RecallsSource: Deutchen Bank 29 March 2011 Hale & Tempes

9、t Approvals & Reimbursements Source: Pharmatimes UK July-August 2010Hale & Tempest Big Pharma Losing to Local Players Source GSK Presentation Hale & Tempest Emerging World Share of PharmaSource EIU, OECD, WHO, IMS, Roland BergerHale & Tempest Top 8 Cos in Emerging Markets 2008 Hale & TempestIncreasi

10、ng Pace of Emerging Markets AcquisitionsEmerging Market Investor DaysMarch 16, 2010December 10, 2009July 2, 2009 Large Pharma Entering Generics(Egypt, Pakistan, Near East )(MENA, LatAm, Asia-Pac) (Algeria)With the slow-down of Western markets, Pharma are rapidly repositioning to focus on emerging ma

11、rkets for growthHale & Tempest Sales Force Job Cuts in Press since 2009Hale & TempestStructural Change Generic CompaniesHale & Tempest Asia vs. the Western Generic CompaniesSource: Factset, Religare Hale & Tempest Pricing PressuresSource: Watson Hale & Tempest European Generic Prices Source Ranbaxy

12、Hale & Tempest European Generic Prices Source Ranbaxy Hale & TempestUSA - ANDA Growing Approval TimesSource FDA Chief M Hamburg, GpHA Conference February 2010 2005 16.3 months average2009 26.7 months averageAround 2000 ANDAs awaiting approvalFDA explained as a result of staff shortagesRegulatory fil

13、ing fees neededHale & Tempest Season of Warning Letters / Import AlertsSource: Deutche Bank July 2011 Hale & TempestUSA - Litigation Success Rates Source RBC Capital Markets January 15 2010Patent Challenges on rise - 65 FTFs in 2009Success rate at 48% - or 76% including deals3 courts hold 69% with 3

14、6% success e.g. NJ4 courts never ruled against generics e.g. NYAt risk launches on the rise 6 in 2009Teva has 12 of the 28 at risk launches 2002/9Settlements on the rise 54 in 2009Teva accounts for a third of all settlementsAuthorized generics on the rise 25 in 2009Watson represents a fifth of all A

15、GsHale & Tempest Generic Profit Margin Profile in descending order source: Deutsche Bank July 2010Hale & Tempest Top 25 Global Generic CompaniesSource: Generics Bulletin 10 June 2011 Hale & Tempest Next 24 Global Generic CompaniesSource: Generics Bulletin 10 June 2011 Hale & Tempest Patent Expiries

16、Source: Sandoz Hale & Tempest In 2016, Among Top 10, 8 will be Biologic/Resp Source: Sandoz EGA Conference 2011Hale & TempestStructural Changes Indian Pharma CompaniesHale & TempestWHO Pre Qualified ProductsHale & Tempest Indian Generic FDA ANDA Approvals Hale & Tempest Niche TechnologySource: MAPE

17、Hale & TempestIndia Share of CRAMS MarketHale & Tempest Lots of Opportunity for CROs in IndiaSource: clinicaltrials.gov 16 Feb 2011 Hale & TempestMacro Structural ChangesHale & Tempest Pfizer & Hisun Hale & TempestPharma Wholesaler sets up China JV UK Coop the worlds largest consumer cooperative GBP

18、10b UK company running food stores, banks, insurance, funeral homes, travel agents, farms and pharmacies3rd rank pharmacy chain in UK with 800 storesOwns UK pharmaceutical wholesaler Sants Opus Marketing JV with Day Lewis Pharmacy Chain offers 113 products under Prospect brandTianjin Tasly Sants Man

19、ufacturing JV opened 2010, “production under way” Jun 2011With Investment GBP20m, 200 staff Hale & Tempest China Pharma Industry Capex PlansSource: Stravencom Hale & Tempest India Pharma Industry Capex PlansSource: MAPE Hale & Tempest FDA DMFs from India Hale & Tempest FDA DMFs from China Hale & Tempest Chinese ANDAsHale & Tempest Endangered Elements Source: Chemistry World 2011 Hale & Tempest A New World Order is ComingHale & TempestThank Y