El futuro de la Industria El futuro de la Industria Farmacéutica en España The future of Pharmaceutical The future of Pharmaceutical Industry in Spain Dr. Vicente Hernández Vázquez
• Strong crisis environment in Spain & Europe – Strong recession St i – Double digit deficit in public gross budget – Much more unemployement rate than EU M h l h EU 2008 2008 2009 2009 2010 2010 Nominal GDP +3,6% ‐ 3,3% +0,1% Real GDP +0,9% , ‐ 3,8% , ‐ 0,9% , Inflaction Rate +4,1% ‐ 0,1% +3,0% Industrial Productivity Index ‐ 7,3% ‐ 17,7% ‐ 7,3% Unmployment Rate (% of Active population ) 11,4% 18,3% 20,3% Public Deficit (% PIB) ‐ 3,8% ‐ 10,3% ‐ 11,2% Foreing Deficit (% PIB) ‐ 9,6% ‐ 5,8% ‐ 5,2% Source: Fundación de las Cajas de Ahorros (FUNCAS). Gabinete de Coyuntura y Estadística. (Actualizado a 11 de septiembre de 2009).
Evolution of GDP in Spain. Annual Variation
Inflaction Rate in Spain
Economic Situation. Spain Unemployement Rate (%)
Economic Situation. Spain
Spanish Pharmaceutical Sector Strong economic engine for the national economy Highest rate of R&D investment Highest rate of R&D investment Highest Industrial Production g Highest productivity sector High Qualified employement
In the last 3 years (2007-2010) 15 R&D centers has been closed in USA and Europe. In this same period 20 new Centers were opened in Asia Spanish pharmaeutical industries are 20% of the total pharma market. The spanish pharmaceutical companies are 40% of the total R&D of the pharma sector Spanish Pharmaceutical Sector is the 20% of the total R&D made in Spain (400 mill€) and 50% of the total R&D employement (40.000 employees).
Worldwide. The pharmaceutical industry is the most R&D investment sector
Spain. The pharmaceutical industry is the most R&D investment sector
R&D R&D investments investments in in Europe Europe, USA and , USA and Japan Japan (Mill Mill € €. . Period Period 1990 1990- -2009) 2009)
Spanish R&D Investment. 2008 R&D investments by research phase (Mill€) TOTAL: 1.010 Mill € 1 1 ll € Discory Clinical Resear 162,5 453 6 453,6 Technological Technological Development 61,9 Farmacology Preclinical Epidemiology p gy Galenic R&D 86,9 Post-approval trials Other 110,8 81,4 52,7
2 of 3 companies have strong R&D activities
More R&D investment doesn’t warranty more NCE R&D investments and NCEs (USA 1995-2007) Source: FDA, PhRMA
The pharmaceutical manufacturing has been increased 27% in the las 3 years
The pharmaceutical exporting has been increased 50% in 4 years
Pharmaceutical industry generates a very stable employement
Half of the employement has University Degree
Half of the employement are women
11% of the employees are devoted to R&D activities
Top 5 covers 25% of the total market f %
Main Challenges of the Pharmaceutical Companies. Main Challenges of the Pharmaceutical Companies. Big Farma Big Farma • Speed on decision Medium Size Medium Size making process Pharmas Pharmas • R&D in emerging • Burocracy y countries (LA; countries (LA; Eastern Europe) • Resource allocation • Time to market • Adoption of new technologies • Supply Chain model model • Productivity P d ti it • Globalization • Patient recruitment • Time to market • Regulatory Req • Stronger • Maximize regulations l ti partnerships t hi • Adoption of new techs • Specilized resources • Regulatory experience • Processes standars • Experience in therapeutical Biotech Biotech areas Source: ICON Clinical Research
The signals for changing are grouped in 6 bid areas f Reimburse ment Regulatory New Models Safety Signals of Changes Changes Patient Distribution Focus Innovation Source: Informe IMS Health. Intelligence 360 (2008)
The slow down economic activity started in 2007 will continue. The future sales growth will be single digit. Emerging countries continue to be attractive but be caution. Patent expirations will strangle future revenues and will trigger mergers gg g Innovation will be more difficult to demonstrate. End of blockbusters. Need to demostrate value for money and innovative pricing Need to demostrate value for money and innovative pricing – reimbursement agreements
Market Market growth very modest in the western world Strong economic restrictions to finance drugs by the states Emerging countries will be the engine: China, India, Sothafrica, Asia, Brasil… USA still a leadership Generics will continue growing Patient-consumer better informed
S Sector t St Strong changes in the pharmaceutical sector with new partners h i th h ti l t ith t Strong investments to be a player Strong investments to be a player Changes in the center of excellence g Trend to relocation in the pharmaceutical industry Increase in all the type of strategic alliances and partnerships
Technologies More dificult to demonstrate Innovations New technologies “from scratch”
• Conditional reimbursement with risk taking agreements • Conditional reimbursement with risk taking agreements • Generics • Generics Reimbursement • Germany adopts strong cost containment measure • Germany adopts strong cost containment measure Germany adopts strong cost containment measure Germany adopts strong cost containment measure • Obama’s health reform on a battle • Obama’s health reform on a battle • FDA more stringment safety measures • FDA more stringment safety measures Regulatory - Safety g y y • EU more concerns on safety (Avandia; Agreal; Acomplia…) • EU more concerns on safety (Avandia; Agreal; Acomplia…) • Stronger pharmacosurveillances • Stronger pharmacosurveillances • FDA starts approving pharmaceuticals manufactured in China • FDA starts approving pharmaceuticals manufactured in China Distribution • Generics manufactured in emerging countries • Generics manufactured in emerging countries g g g g • Parellel distributions • Parellel distributions • HTAs widely used. Severals in the same country • HTAs widely used. Severals in the same country Innovation Innovation • Health Evaluation Agencies financing comparative clinical trials • Health Evaluation Agencies financing comparative clinical trials H H lth E lth E l l ti ti A A i i fi fi i i ti ti li i li i l t i l l t i l • Pharmas meet the patients • Pharmas meet the patients Patient focus Patient focus • Patient Asociations stronger and in decision making processes • Patient Asociations stronger and in decision making processes • Exubera (Pfizer) withdrawn • Exubera (Pfizer) withdrawn ( ( ) ) New Models New Models • Outsourcings: Manufacturing, Clinical Research, Regulatory… • Outsourcings: Manufacturing, Clinical Research, Regulatory… Fuente: Informe IMS Health. Intelligence 360 (2008)
6 Final Reflections A medium company without “in-house” products will not survive medium size size company It will be compulsory to develop skills like: Licensing-in, develop new new company company skills Business Development, Outsourcing etc. R&D with smarter budgets Niche Niche based based R&D Generics will be a big market and a great oportunity for R&D based Generics companies to expand thirs business strategies to manage product life cycles New New strategies Size IS important to to be competitive. New alliances underway Size
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Strategies for life product management Strategies for life product management • Ne w Indic ations • Ne w Indic ations Ne w Indic ations Ne w Indic ations • Ne w Innovative F Ne w Innovative F or or mulations with c linic al r mulations with c linic al r e le vanc e e le vanc e • R R e positioning of pr e positioning of pr oduc ts oduc ts • Boost launc he s. L Boost launc he s. L aunc h quic ke r aunc h quic ke r and be tte r and be tte r • Allianc e s. L Allianc e s. L a a c e s. c e s. ic e nsing-in and L ic e nsing c e c e s s g g in and L a a d d ic e nsing-out ic e nsing c e c e s s g g ou out ou • T T ailor ailor e d tar e d tar ge t patie nt population ge t patie nt population • Pr Pr e mar e mar ke ting ac tivitie s ke ting ac tivitie s • Comar • Comar Comar Comar ke ting Copr ke ting, Copr ke ting Copr ke ting, Copr omotion, Codistr omotion, Codistr omotion Codistr omotion Codistr ibution Co r ibution, Co ibution Co ibution, Co-r r r e se ar e se ar e se ar e se ar c h c h c h c h • F F ixe d dose c ombinations ixe d dose c ombinations • Change s in mar Change s in mar ke ting and sale s ke ting and sale s
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