MENA and East Europe Pharmaceutical Markets & Regulations. 1 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.

Transcription

1 MENA and East Europe Pharmaceutical Markets & Regulations 1 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

2 1. Pharma Market Evolution 2. Potential Market Analysis: a. Focus on Caspian Areas b. Focus on Middle East Areas 3. Russia and MENA Evolving Scenario 2 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

3 Italy: Poggibonsi - Headquarter Milano - Operative Facilities ROMA - Operative Facilities Several Business Partner North Center Europe: Lion Participated Company London CMS London Pharmafortis Madrid Local Partner South America: Buenos Aires CTP Office Sao Paulo CTP Agent East Europe & Mediterranean : Budapest CTP Office Bucharest Local Partner Skopie Local Partner Athens Local Partner Noth Africa: Tunisi CTP Subsidiary Algeri - Bureau de Laison 3 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

4 R&D Regulatory Engineering Engineering & Validation Process & Quality IT to Compliance GMP System Integration Support Business Development Support Auditing & Quality in Outsourcing Training Basic Chemical & Microbiological Analysis Formulation Development Support Stability Studies Support (ICH/ASEAN) Analytical Methods & Library Development & Validation Analytical Support for Regulatory Issues (Dossier, re-testing. etc.) Raw Material Qualification Analytical Support (D.Lgs 219/06) Methods Transfer & Labs Qualification Methods Transfer & Labs Qualification Equipment Qualification Validation of Sanitizing products 4 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

5 AAA Abbott Acom ACRAF Acs Dobfar Alfa Wassermann Antibioticos Astra Zeneca Bausch & Lomb Baxter Bayer Boehringer-Ingelheim Bracco Bristol-Myers Squibb Cambrex Chemifarma Chiesi Farmaceutici CCT Di pharma Dompé Doppel DSM Edmond Pharma Eli Lilly E-pharma Eurand Fidia FIS Flamma Formenti Gambro GE GelfiPharma, Gnosis GSK Hardis Helsinn Hospira IBA IBN Savio Infra Italfarmaco ITEL Janssen-Cilag Kedrion Menarini Merck-Serono NSA Novartis Opocrin Patheon Pfizer Pierrel Procos RBM Recordati Sanofi-Aventis Schering-Plough Sigma-Tau S.I.M.S. Takeda Temmler Wyeth Zambon 5 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

6 1. Pharma Market Evolution 6 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

7 RANKING BY ETHICAL DRUG SALES Vs Hoechst Bayer Merck & Co Ciba Geigy Pfizer AHP Roche Sandoz Eli Lilly Abbott Warner Lambert Upjohn 2009 Johnson & Johnson Pfizer Roche GSK Novartis Sanofi Aventis Astrazeneca Abbott Merck & Co BMS Bayer Eli Lilly 7 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

8 Pharma Market: Growth Expectations for 2009 Will hold steady at 2008 levels * US: 1-2%, EU5: 3-4% Japan: 4-5% BRIC: 14-15% Brand Pharma Innovation slump Blockbusters losing patent protection In 2015 Brand products will represent from 60% to 20-30% of the total revenues Generics Increasing competition, especially from India Low cost API coming from India, China Margin pressures in U.S., UK, Germany Drop in small molecule opportunities post-2011 Reference: IMS Global Pharmaceutical and Therapy Forecast 8 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

9 9 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

10 R&D cost, Dev. Time, NME output and Sales world growth from 1996 to 2005 Reference: CMR International 10 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

11 Dry pharma pipelines Increasing competition for in-licensing Price pressure from healthcare systems Increasing shift from Rx to Gx Globalisation Focus Consolidation Innovation and product introduction no longer affordable at country/region level Leaders positioned in all key countries with globally designed business systems All major pharmaceutical companies want to move to a few attractive (highvolume, high-growth, high barriers to entry) therapeutic areas Ongoing industry consolidation Emergence of large global pharma players with potential scale advantages in M&S, R&D, and Operations 11 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

12 2013: THE GREAT GLACIATION International Pharma Market Sales Evolution Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

13 Latin and Central America Middle East East/West and North Africa New Europe (MEWA/NA-NE) Asia Pacific 13 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

14 14 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

15 2. Focus on Russia & Caspian Area 15 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

16 Great Internal Market for FINISHED Product Local Pharmaceutical Companies oriented on the internal Market 16 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

17 Azerbaiyán Georgia Kazajistán Kirguistán Tayikistán Turkmenistán Uzbekistán 17 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

18 Brand Products Roche, Sanofi-Aventis, Novartis, Nycomed, Pfizer, Menarini, Servier, entre otros Genérics Product Lek, Gedeon, Krka historicas Stada, Pliva, Polpharma, Actavis Referencia: Thomson Reuters 18 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

19 Pros Growing Middle Class Emerging Demand for treatment for chronic diseases: No available alternatives Mandatory Health Insurance (Russia) Few cgmp Experienced Local Manufacturers Growing Public Resources due to Energy Exporation Market dominated by imports Low regulatory Requirements (CHANGING!!!) Constraints Totally different mentality Territorial Extension Fragmented Market High Degree of Counterfeiting - No respect of the Intellectual property Price controlled by the Government Large public tenders, but difficult for external participation Difficulties for the direct Marketing of Product Import from Belarus, Ukraine, India and China at low cost Emerging Complex regulation for registration Government Project (2009) to enforce local Pharma Industry Referencia: Thomson Reuters 19 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

20 Producs NOT available locally Most Requested Therapeutic Areas 1. Tamiflu 2. Plavix 3. Gleevec 4. Viagra 1. Antibacteriales 2. Antibióticos 3. Antineoplásicos 4. Anti Parkinson 5. Oncológicos 20 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0

21 Exportaciones Farmaceutico Rusia y Asia Central 2006, , , , , % 10 50% % 10% Distribución de las Exportaciones Rusia y Asia Central (08-10) % -30% Georgia 6% Resto 3% Exportaciones en MMD % Variacion Interanual -50% Azerbaiyán 25% Rusia 66% Referencia: NOSIS EXI Explorer 21 Buenos Aires ETIF MENA & East Europe Regulations G. Rossi 2010 rev. 1.0