Facts and Figures - Medicines and Health Care

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1 Facts and Figures - Medicines and Health Care Facts and Figures 2009 Facts and Figures is an annual publication by the Norwegian Association of Pharmaceutical Manufacturers (LMI). This publication is a collection of statistics on medicines, health and the pharmaceutical market. You can download the figures in PDF and PowerPoint. Illustrations This year s issue is illustrated with pictures by Robert Dales. Robert Dale attended Virginia Commonwealth University in Richmond, Virginia and graduated with a degree in Visual Communication and Graphic Design. He worked as a Graphic Designer at Esquire Magazine in their Promotion Department. From there he went to New York Magazine where he worked in the Design Department and later as an Associate Art Director at Newsday. While in New York he taught Graphic and Portfolio design for many years at the School of Visual Arts in Manhattan. His illustrations have appeared in magazines, on book covers, TV and on the Web and have garnered many awards. (Source: Corbis) Publisher: Legemiddelindustrien (LMI) Visiting address: Essendrops gate 3, Oslo Postal address: PO-Box 5094 Majorstuen, N-0301 OSLO lmi@lmi.no Home page: Phone: (+47) Fax: (+47) Print: Lobo Media AS Published: Oslo, februar 2009 Illustrations: Robert Dale/Corbis/Scanpix Reproduction of text and graphs is permitted with indication of source. 2

2 Content Abbreviations 5 Summary 8 The medicine market in Norway The number of MA, active ingredients and medicines in Norway New and withdrawn active ingredients Pharmaceutical sales in Norway in the last few years Sales growth by value Sales growth by volume (DDD) The Norwegian pharmaceutical market by main therapeutic groups (ATC) The top 25 pharmaceutical companies on the Norwegian market The top 25 medicines on the Norwegian market in terms of sales value The top 25 active ingredients as measured by defined daily doses (DDD) Market share of generics (DDD) Generics share of the generics interchangeable market Market share of parallel imported medicines Market share for wholesalers Pharmacy chain market share Pharmacy chain market share, exclusive hospital pharmacies Total number of users of prescription medicines in Norway Number of inhabitants per pharmacy in Europe Pharmaceutical consumption (DDD) in the Nordic countries Distribution of the Nordic medicine market Nordic sales growth Medicine sales per inhabitant in the Nordic countries Leading pharmaceuticals on the global market The Norwegian medicines market in relation to Europe Leading pharmaceutical companies on the global market 37 Price and financing Changes in prices of medicines and general inflation Public spending on reimbursable prescription medicines Payment for pharmaceutical consumption Public health expenditure per inhabitant Public spending on health care and medicines Expenditure on medicines in the private and public sector Daily costs for the 25 most commonly used medicines The consumer s medicine expenses compared to other expenses National Insurance expenditure Health care expenditure Prisnivå på legemidler i et utvalg europeiske land VAT on medicines and other goods and services in Europe Copayment for reimbursable medicines Medicine costs as share of expenditure on health care in the OECD Distribution of operating costs in specialised health care 55 3

3 Facts and Figures - Medicines and Health Care Non-prescription medicines Sales of non-prescription medicines Non-prescription medicines, share of total market value (PRP) and DDD The top 25 non-prescription medicines in terms of sales value Non-prescription medicines sales by selected therapy groups (ATC) The top 10 pharmaceutical companies in the OTC medicines market Non-prescription medicines, market share (PRP) in selected countries Split by category of general sales outlets for non-prescription medicines Segmentation of sales for non-prescription medicines 65 Veterinary medicines The top 10 veterinary medicines for aquaculture in terms of sales value The top 10 veterinary medicines for mammals in terms of sales value The top 5 companies within aquaculture The top 10 companies within veterinary medicines excluding aquaculture 71 The pharmaceutical industry in Norway The investment of the pharmaceutical industry in R&D Investments in research and development, percentage of sales Submitted clinical trials Ongoing clinical trials performed by the pharmaceutical industry Industry initiated clinical trials Norway s imports and exports of medicines Number of employees in the pharmaceutical industry in Norway Employees in companies with production facilities in Norway Estimated total cost for bringing a new medicine to market Investments in R&D by therapeutic groups 83 Memberfirms - Contact information 84 4

4 Abbreviations AESGP ATC Association of the European Self-Medication Industry. Anatomical Therapeutic Chemical, medical classification of medicines. DDD Defined daily dose, average value indicating the standard intake of a given medicine in 24 hours. EFPIA European Federation of Pharmaceutical Industries and Associations. GDP Gross Domestic Product HOD Ministry for Health and Care Services LIS Norwegian Drug Procurement Co-operation, co-ordinates hospital medicine procurement NOK Norwegian kroner OECD Organisation for Economic Co-operation and Development OTC Over-the-counter, non-prescription medicines PPP Pharmacy purchase price, price paid by pharmacy/retailer to wholesaler PRP Pharmacy retail price, price paid by consumer to pharmacy/retailer USD American dollars PhRMA Pharmaceutical research and manufacturers of America Real growth Growth adjusted for inflation. Nominal growth Growth not adjusted for inflation. SSB Statistics Norway 5

5 Facts and Figures - Medicines and Health Care LMI - The Pharmaceutical Industry in Norway Norske og utenlandske legemiddelfirmaer som selger legemidler i Norge har sin egen bransjeorganisasjon. LMI arbeider med myndighetskontakt, generell profilering av industrien, bransjeservice, utredningsarbeid og produksjon av statistikk. Foreningen driver kursvirksomhet og utdanner blant annet legemiddelkonsulenter og monitorer til kliniske utprøvinger. LMI deltar aktivt i internasjonale bransjeforeninger for produsenter av legemidler. Felleskatalogen produseres av ett av datterselskapene til LMI. Også Farmastat, som produserer og selger legemiddelstatistikk, er et datterselskap. LMI arbeider for at legemiddelindustrien skal anerkjennes som en viktig bidragsyter til helse og livskvalitet i Norge. Norske pasienter skal sikres rask tilgang til riktige og kostnadseffektive legemidler. For å oppnå dette må legemidler ikke utelukkende betraktes som en utgiftspost på statsbudsjettet, men som viktige innsatsfaktorer i helsetjenesten. Det er også viktig at rammebetingelsene for industrien gir rom for forskning og utvikling av nye medisiner, og at det stimuleres til vekst i farmasøytisk virksomhet i Norge. Helseøkonomi og legemiddeløkonomiske analyser får en stadig viktigere rolle, og legemiddelindustrien vil gjerne bidra med og stimulere til økt kunnskap. Industrien er også opptatt av å øke kompetansenivået i helsetjenesten, og samarbeider med norsk helsepersonell om utvikling og bruk av nye og mer effektive legemidler. Rammer for samhandlingen med øvrige aktører innen helsetjenesten er fastlagt i gjensidig forpliktende samarbeidsavtaler. Markedsføring av medisiner er strengt regulert, og bransjen har selv det praktiske ansvaret for å håndheve regelverket. Dnlf og LMIs råd for legemiddelinformasjon er et selvjustisorgan industrien har sammen med legeforeningen. Rådet vurderer markedsføringen, gir bedriftene råd, og kan bøtelegge de bedriftene som ikke følger regelverket. 43 legemiddelfirmaer var tilsluttet LMI pr 1. januar av disse firmaene produserer legemidler i Norge. Medlemmene representerte ca. 83 prosent av legemiddelomsetningen i 2008, og har i underkant av ansatte i Norge. De ansatte arbeider innenfor områder som medisinsk forskning, klinisk utprøving, produksjon, registrering, distribusjon, bivirkningsovervåkning, markedsføring samt pris- og refusjonsspørsmål. En viktig del av dette arbeidet er informasjon, opplæring og etterutdannelse av leger og annet helsepersonell. 6

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7 Facts and Figures - Medicines and Health Care Summary Omsetningen av legemidler var på anslagsvis 17,2 milliarder kroner i 2008, målt i apotekenes utsalgspris (AUP). Målt i apotekenes innkjøpspris (AIP) var omsetningen på 11 milliarder kroner. Justert for inflasjon sank legemiddelomsetningen med ca. 2 prosent. De siste årene har legemiddelmarkedet vært preget av liten eller ingen vekst. Dette har sammenheng med myndighetenes pris- og refusjonspolitikk samt patentutløp for legemidler med høy omsetning. Dette bidrar også til å forklare hvorfor omsetningsveksten i Norge stort sett er lavere enn i våre naboland. Omsetningsvekst i volum Omsetningen målt i volum, dvs. definerte døgndoser (DDD), økte med 3,3 prosent. Dette er en noe lavere vekst enn foregående år hvor omsetningsveksten i volum har ligget mellom fire og åtte prosent. Markedet for byttbare legemidler Generikaandelen av legemiddelmarkedet (kopipreparatene) har økt sterkt de siste årene. I 2008 var omsetningen av generiske legemidler like i underkant av 40 prosent. Generisk bytte i apotek, patentutløp for flere store legemidler og trinnprissystemet for prising av byttbare legemidler, har bidratt til økningen av omsetningen av kopipreparater. Legemidlene med høyest omsetning Legemidler mot revmatiske lidelser og astma dominerer også i 2008 oversikten over legemidler med høyest omsetning i Norge. Målt i DDD var legemidler mot høyt kolesterol og forebygging av blodpropp og tannråte mest brukt. Utgifter til legemidler og helseformål Utgifter til helsetjenesten utgjør en stadig økende andel av de totale offentlige utgiftene. Legemidlenes andel av utgifter til helseformål har vært synkende siden Utgifter til legemidler utgjør 3 prosent av driftskostnadene i spesialisthelsetjenesten. Utviklingen i legemiddelprisene Legemidlene er blitt betydelig rimeligere de senere årene. I perioden 2000 til og med 2008 har legemiddelprisene i gjennomsnitt sunket med 2,3 prosent i året, mens konsumprisindeksen har hatt en gjennomsnittlig årlig økning på 2,1 prosent. Dette indikerer en årlig realprisreduksjon på i overkant av 4 prosent. Reseptpliktige og reseptfrie legemidlers andel av totalmarkedet 3,2 millioner nordmenn benytter reseptpliktige legemidler i løpet av et år. Reseptfrie legemidler utgjorde 12,5 prosent av den totale legemid- 8

8 delomsetningen. Omsetningen av reseptfrie legemidler økte noe mer enn omsetningen av reseptpliktige legemidler i Forskning og utvikling I 2007 brukte legemiddelindustrien i Norge 835 millioner kroner til forskning og utvikling. LMIs medlemsfirmaer har de siste årene investert mellom 8 og 10 prosent av omsetningen i forskning og utvikling (FoU). Legemiddelindustrien er en vesentlig bidragsyter til medisinsk forskning. I overkant av norske pasienter deltok i kliniske utprøvninger i Dette er omtrent på nivå med året før, men betydelig færre enn for få år siden. I 2008 observeres det for første gang en nedgang i antall virkestoffer og antall legemidler i forhold til året før. Det ble registrert 36 nye virkestoffer i Norge. Ved utløpet av året var det registrerte legemiddelnavn på det norske markedet, fordelt på ca markedsføringstillatelser. Legemidler som innsatsfaktor Legemidler utgjør en mindre del av helsebudsjettet i Norge enn i de fleste europeiske land. Legemiddelforbruket i Norge ligger under gjennomsnittet i Norden. Merverdiavgift på legemidler Norge er ett av tre europeiske land som krever full merverdiavgift (mva) på legemidler. I det øvrige Europa har legemidler som refunderes av det offentlige gjennomgående lavere mva enn andre varer og tjenester. Gjennomsnittlig ordinær mva er i underkant av 20 prosent, mens mva på legemidler i gjennomsnitt er ca. 10 prosent. Produksjon av legemidler 9 legemiddelfirmaer produserer legemidler i Norge, og de eksporterer til rundt 130 land. Norge importerer langt mer legemidler enn vi eksporterer. Veterinærmedisinske legemidler Totalomsetningen av veterinærlegemidler utgjorde i underkant 800 millioner kroner i Legemidler til akvakultur (oppdrettsnæringen) utgjorde den største del av omsetningen. Tilgjengelig på internett Alle tall, figurer og tabeller i denne boken finnes også på LMIs nettsted, Hvis du vil vite mer om de enkelte legemidlene, kan du klikke deg inn på eller no/pasientutgave. 9

9 Facts and Figures - Medicines and Health Care The medicine market in Norway 10

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11 Facts and Figures - Medicines and Health Care The number of marketing authorisations, active ingredients and medicines in Norway Number of active ingredients Data as of December Source: The Norwegian Medicines Agency Number of medicines Number of MA

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13 Facts and Figures - Medicines and Health Care 1.02 New and withdrawn active ingredients Year New active ingredients Withdrawn active ingredients * * * * Source: The Norwegian Medicines Agency * Number not available 14

14 1.03 Pharmaceutical sales in Norway in the last few years NOK Million Year Figures in 2008-currency Source: LMI/Farmastat, Statistics Norway 15

15 Facts and Figures - Medicines and Health Care Percentage growth 14% 12% 10% 8% 6% 4% 2% 0% -2% 1.04 Sales growth by value 6,5% 3,3% ,4% 8,1% ,8% ,4% 2,8% 0,4% ,5% 7,1% 2004 Source: LMI/Farmastat and Statistics Norway 2,5% ,9% Nominal growth Growth in fixed prices 1,9% -0,4% ,0% 2,3% 1,8% ,7%

16 1.05 Sales growth by volume (DDD) 9% 8% 8,0 % 7,3 % 7,7 % 7% 6% 6,2 % 5,9 % Sales growth DDD 5% 4% 3% 3,4 % 4,5 % 4,1 % 4,7 % 2% 1% 1,3 % 0% Year Source: LMI/Farmastat 17

17 Facts and Figures - Medicines and Health Care L 1.06 The Norwegian pharmaceutical market by main therapeutic groups (ATC) Antineoplastic and immunomodulating agents Sales PPP 2008, NOK Million Growth Share of total sales ,6% 19,8% N Central nervous system ,0% 18,8% C Cardiovascular system ,6% 12,3% A Alimentary and metabolism ,4% 10,2% R Respiratory system ,2% 10,1% B Blood and bloodforming organs 738 9,8% 6,7% J Systemic antiinfectives 591 6,0% 5,3% G Urogenitals and sex hormones 584 0,9% 5,3% M Musculo-skeletal system 286-0,5% 2,9% H Systemic hormones excl. sex hormones 292 6,2% 2,6% S Sensory organs 252 7,3% 2,3% D Dermatologicals 244 5,2% 2,2% V Various 123 7,6% 1,1% P Antiparasitic products 32-1,4% 0,3% Total ,8% 100,0% Source: LMI/Farmastat 18

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19 Facts and Figures - Medicines and Health Care Rank 2008 (2007) Company 1.07 The top 25 pharmaceutical companies on the Norwegian market Sales 2008 PPP, NOK Million Sales growth Market share 1 (1) Pfizer AS % 7,7% 2 (2) Astrazeneca AS % 7,5% 3 (3) GlaxoSmithKline AS % 6,4% 4 (5) Novartis Norge AS % 5,7% 5 (4) Schering-Plough AS % 5,5% 6 (8) sanofi-aventis % 4,6% 7 (6) Wyeth Norge % 4,1% 8 (9) Nycomed Pharma AS % 3,8% 9 (7) MSD (Norge) AS % 3,5% 10 (10) Roche Norge A/S % 3,3% 11 (13) Novo Nordisk Scandinavia AS % 2,5% 12 (14) Abbott Norge AS % 2,5% 13 (11) *Farmagon AS % 2,4% 14 (15) Weifa AS % 2,4% 15 (16) Bayer Schering Pharma % 2,2% 16 (17) Janssen-Cilag AS % 1,9% 17 (12) Eli Lilly Norge AS % 1,9% 18 (18) Alpharma AS % 1,8% 19 (20) Boehringer Ingelheim Norway KS % 1,7% 20 (23) ratiopharm AS % 1,5% 21 (21) H. Lundbeck A/S % 1,5% 22 (-) Meda A/S % 1,3% 23 (22) Merck Serono % 1,3% 24 (24) Amgen % 1,3% 25 (25) LEO Pharma AS % 1,1% Aggregate sales top 25 companies ,7% Aggregate sales all companies % 100 % *Parallell importers Source: LMI/Farmastat 20

20 1.08 The top 25 medicines on the Norwegian market in terms of sales value Rank 2008 (2007) Company Sales 2008 PPP NOK mill. Sales growth Share of total sales Area of application 1 (1) Enbrel ,7% 3,5% Rheumatoid arthritis 2 (2) Remicade ,9% 2,5% Rheumatoid arthritis 3 (3) Seretide 243 0,3% 2,2% Asthma 4 (5) Humira ,5% 1,7% Rheumatoid arthritis 5 (11) Nexium ,5% 1,4% Gastric ulcer 6 (6) Symbicort Turbuhaler 148 8,2% 1,3% Asthma 7 (8) Cipralex 121 4,6% 1,1% Depression 8 (10) Paracet ,0% 1,0% Pain 9 (21) Ibux 95 29,2% 0,9% Pain 10 (4) Lipitor 94-43,7% 0,9% High cholesterol 11 (16) Mabthera 94 20,2% 0,9% Cancer and Rheumatoid arthritis 12 (12) Atacand 93 11,9% 0,8% High blood pressure 13 (15) Otrivin 91 14,2% 0,8% Nasal congestion 14 (19) Herceptin 83 10,2% 0,8% Cancer 15 (20) Plavix 80 7,1% 0,7% Thrombosis 16 (14) Lamictal 78-2,8% 0,7% Epilepsy 17 (23) Singulair 78 8,1% 0,7% Asthma 18 (18) Insulatard 76-0,2% 0,7% Diabetes 19 (13) Cozaar 74-8,4% 0,7% High blood pressure 20 (-) Lyrica 73 27,2% 0,7% 21 (17) Cozaar Comp 72-6,7% 0,7% High blood pressure 22 (22) Rebif 67-9,0% 0,6% Multiple sclerosis 23 (25) Coaprovel 66 0,6% 0,6% High blood pressure 24 (-) Atacand Plus 66 2,6% 0,6% High blood pressure 25 (-) Albyl-E 64 12,7% 0,6% Thrombosis Sum omsetning 25 største legemidler ,9% Sum omsetning alle legemidler ,6% Kilde: LMI/Farmastat 21

21 Facts and Figures - Medicines and Health Care Rank 2008 (2007) Active ingredient 1.09 The top 25 active ingredients as measured by defined daily doses (DDD) Name of original medicine* Sales DDD/1000 Growth inhab./day Area of application 1 (1) Simvastatin Zocor ,5% High colesterol 2 (2) Acetylsalisylsyre Albyl-E 69 4,6% Thrombosis 3 (3) Natriumfluorid Flux 61-7,5% Caries 4 (4) Atorvastatin Lipitor 47-3,7% High cholesterol 5 (7) Zopiklon Imovane 32 1,4% Insomnia 6 (9) Cetirizin Zyrtec 32 7,8% Allergy 7 (6) Askorbinsyre Nycoplus C-vit. 32-3,9% Vitamin deficiency 8 (8) Amlodipin Norvasc 32 0,7% High blood pressure 9 (12) Ramipril Triatec 26 5,3% High blood pressure 10 (13) Metoprolol Selo-Zok 25 3,8% High blood pressure 11 (14) Vitamin B kompleks 25 9,2% Vitamin deficiency 12 (15) Levotyroksinnatrium Thyroksin 23 4,2% Hypothyreosis 13 (10) Paracetamol Paracet 29 4,7% Pain 14 (16) Furosemid Lasix Retard 19-4,8% High blood pressure 15 (19) Kandesartan Atacand 17 16,6% High blood pressure 16 (17) Escitalopram Cipralex 17 5,6% Depression 17 (22) Levonorgestrel og østrogen 14 14,2% Contraception 18 (18) Ibuprofen Ibux 17 8,3% Pain 19 (11) Xylometazolin Otrivin 27 0,4% Nasal congestion 20 (21) Esomeprazol Nexium 13-1,2% Gastric ulcer 21 (-) Metformin 13 12,1% Diabetes 22 (24) Losartan og diuretika Cozaar Comp 13 3,2% High blood pressure 23 (23) Kodein, kombinasjoner Paralgin Forte 13 0,2% Pain 24 (20) Drospirenon og østrogen Yasmin 12-13,2% Contraception 25 (-) Prednisolon Prednisolon Nycomed 12 4,3% Infections Figures from 2008 *Market leader given for some active ingredients Source: LMI/Farmastat 22

22 1.10 Market share of generics (DDD) 50% Share of total sales 40% 30% 20% 24,0 % 23,6 % 23,3 % 25,1 % 27,8 % 31,8 % 39,8 % 35,4 % 37,2 % 10% 0% Source: LMI/Farmastat Year

23 Facts and Figures - Medicines and Health Care 80% 70% 60% 50% 40% 30% 20% 10% 0% 31,00 % 1.11 Generics share of the generics interchangeable market ,60 % 30,50 % ,20 % DDD Excluding parallell imported medicines Source: LMI/Farmastat ,80 % 46,20 % 46,40 % 2007 Value PPP 24 72,30 % 51,00 % 73,80 % 2008

24 1.12 Market share of parallel imported medicines 9% 8% 7,7 % 7% 6% 7,0 % 6,6 % 6,3 % 6,6 % 6,2 % 6,9 % 5,9 % Percent 5% 4% 5,1 % 4,3 % 4,4 % 3,4 % 3% 2% 1% 0% 1,4 % 0,2 % Year Source: LMI/Farmastat 25

25 Facts and Figures - Medicines and Health Care Percent 60% 50% 40% 30% 20% 10% 0% 1.13 Market share for wholesalers 48,5 % 36,6 % 15,0 % 2002 Source: LMI/Farmastat 45,3 % 35,7 % 18,9 % ,5 % 35,2 % 20,2 % ,3 % 34,8 % 20,0 % 2005 Year 45,6 % 34,3 % 20,1 % ,4 % 33,5 % 20,0 % ,5% 32,9% 19,6% 2008 Apokjeden distribusjon AS - Tamro OY/Phoenix group Holtung AS - Alliance Unichem PLC NMD Grossisthandel AS - Celesio AG 26

26 1.14 Pharmacy chain market share Hospital pharmacies 22% Other pharmacies 2% Alliance apotekene 17% Vitusapotek/Ditt Apotek 25% Apotek 1 34% Figures from 2008 Source: Farmastat 27

27 Facts and Figures - Medicines and Health Care 1.15 Pharmacy chain market share, exclusive hospital pharmacies Vitus/Ditt Apotek 32% Figures from 2008 Source: Farmastat Other pharmacies 2% Apotek 1 44% 28 Alliance apotekene 22%

28 1.16 Total number of users of prescription medicines in Norway Number of users Year Source: The Norwegian Prescription Database (NorPD) Men 2007 Women 29

29 Facts and Figures - Medicines and Health Care Greece Belgium Spain Lithuania France Ireland Poland Italy Hungary Germany Czech Republic Portugal Slovakia Switzerland UK Finland Austria Slovenia Norway Netherlands Sweden Denmark Source: AESGP Figures from Number of inhabitants per pharmacy in Europe Inhabitants per pharmacy 30

30 1.18 Pharmaceutical consumption (DDD) in the Nordic countries DDD per 1000 inhabitants Source: SLD Nordic Total Finland Sweden Norway Denmark 31

31 Facts and Figures - Medicines and Health Care Denmark 26% Source: SLD Nordic 1.19 Distribution of the Nordic medicine market 2008 Finland 24% Norway 15% 32 Sweden 34%

32 1.20 Nordic sales growth % 8% 7,7% 7% 6,5% 6% 5% 5,2% 4% 4,1% 3% 2% 1,5% 1% 0% Total Sweden Finland Denmark Norway Figures in PPP Source: SLD Nordic 33

33 Facts and Figures - Medicines and Health Care Euro per inhabitant Source: SLD Nordic 1.21 Medicine sales per inhabitant in the Nordic countries Nordic countries 293 Sweden Finland 34 Denmark 238 Norway

34 1.22 Leading pharmaceuticals on the global market Medicine name, Rank 2007 (2006) Area of application Sales US$ Billion Growth % 1 (1) Lipitor High cholesterol 13,5-2,8 % 2 (2) Plavix Prevention of cardiovascular events 7,3 20,5 % 3 (3) Nexium Gastric ulcer and reflux 7,2 5,3 % 4 (7) Seretide (Advair) Asthma and COPD 7,1 9,6 % 5 (9) Enbrel Rheumatic diseases and skin diseases 5,3 15,3 % 6 (7) Zyprexa Schizophrenia 5,0 1,9 % 7 (8) Risperdal Psychosis and behavioural disorders 4,9 4,4 % 8 (-) Seroquel Schizophrenia 4,6 16,2 % 9 (-) Singulair Asthma and COPD 4,5 14,7 % 10 (6) Aranesp Anemia 4,4-12,9 % Aggregate top 10 medicines 63,9 5,6 % Source: IMS Health Data from 2007 Figures in ex-factory prices 35

35 Facts and Figures - Medicines and Health Care 1.23 The Norwegian medicines market in relation to Europe Country, Rank 2006 Sales million Euro, 2006 Share 1 Germany ,0 % 2 France ,0 % 3 Italy ,5 % 4 UK ,9 % 5 Spain ,0 % 6 Greece ,5 % 7 The Netherlands ,5 % 8 Belgium ,0 % 9 Portugal ,7 % 10 Sweden ,3 % 11 Switzerland ,2 % 12 Austria ,1 % 13 Finland ,4 % 14 Ireland ,4 % 15 Denmark ,4 % 16 Norway ,1 % Source: EFPIA Aggregate % Figures in ex-factory prices or Pharmacy Purchase Price 36

36 1.24 Leading pharmaceutical companies on the global market Company, rank 2007 (2006) Sales US$ billion Country 1 Johnson & Johnson 61 USA 2 Pfizer 48 USA 3 GlaxoSmithKline 45 United Kingdom 4 Roche Group 40 Switzerland 5 Sanofi-Aventis 40 France 6 Novartis 40 Switzerland 7 AstraZeneca 30 United Kingdom 8 Abbott Laboratories 26 USA 9 Merck 24 USA 10 Wyeth 22 USA 11 Bristol-Myers Squibb 20 USA 12 Eli Lilly 19 USA Source: Fortune 37

37 Facts and Figures - Medicines and Health Care Price and financing 38

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39 6% 3,8% 4% 3,1% 3,0% 2,5% Price change % Facts and Figures - Medicines and Health Care 2.01 Changes in prices of medicines and general inflation 2% 0% 2,3% 1,6% 1,3% 0,8% 0,4% 0,2% ,7% -2% -2,3% -1,6% -2,0% -2,3% -2,8% -4% -4,0% -5,3% -6% Consumer Price Index Medicines Sources: Statistics Norway and LMI/Farmastat 40 Year

40 2.02 Public spending on reimbursable prescription medicines NOK Million Year Figures for 2008 are estimates Figures in million NOK, 2007-currency Source: NAV, Ministry of Health and Care Services, LMI 41

41 Facts and Figures - Medicines and Health Care Prescription medicines (Non-reimbursable) 11,6 % Hospitals 18,1 % 2.03 Payment for pharmaceutical consumption Patient co-payment 6,5 % Non-prescription medicines 12,8 % National Insurance Administration (reimbursable medicines) 49,1 % Other public financing for prescription medicines 2,0 % Figures from 2007 The figure is based up on data from multiple sources, which results in some uncertainty Kilde - Source: NAV, SSB, NAF, LMI/Farmastat 42

42 2.04 Public health expenditure per inhabitant NOK per inhabitant Hospital services Medicines Other Health Care expenditure 2007-currency Source: Statistics Norway, NAV 43

43 Facts and Figures - Medicines and Health Care Year GDP NOK mill 2.05 Public spending on health care and medicines Public spending on health care Public spending on medicines NOK mill % av GDP NOK mill % av GDP % of public spending on health care ,7 % ,6 % 8,2 % ,4 % ,6 % 8,5 % ,6 % ,6 % 8,4 % ,3 % ,6 % 8,7 % ,8 % ,6 % 8,5 % ,5 % ,5 % 8,2 % ,7 % ,5 % 7,7 % Sources: Statistics Norway, NAV and LMI/Farmastat 44

44 2.06 Expenditure on medicines in the private and public sector Private share National Insurance Hospitals NOK million Year Fixed prices, 2007-currency Sources: Statistics Norway, National Insurance Administration and LMI/Farmastat 45

45 Facts and Figures - Medicines and Health Care 2.07 Daily costs for the 25 most commonly used medicines # Active ingredient Area of application Daily dose Price per day, NOK 1 Simvastatin High cholesterol 40 mg 2,32 2 Acetylsalisylsyre Thrombosis 160 mg 0,99 3 Natriumfluorid Caries 0,5 mg 0,32 4 Atorvastatin High cholesterol 40 mg 9,77 5 Zopiklon Insomnia 5 mg 1,33 6 Cetirizin Allergy 10 mg 0,73 7 Askorbinsyre Vitamin deficiency 250 mg 0,52 8 Amlodipin High blood pressure 10 mg 1,66 9 Paracetamol Pain 500 mg x 3 4,50 10 Xylometazolin Nasal congestion 0,64 ml 3,10 11 Ramipril High blood pressure 5 mg 1,32 12 Metoprolol High blood pressure 100 mg 1,17 13 Vitamin B kompleks Vitamin deficiency 1 tablett 0,41 14 Levotyroksinnatrium Hypothyriosis 0,1 mg 0,73 15 Furosemid High blood pressure 30 mg 0,96 16 Ibuprofen Pain 400 mg x 3 3,16 17 Kandesartan High blood pressure 8 mg 5,77 18 Escitalopram Depression 10 mg 6,80 19 Levonorgestrel og østrogen Contraception 1 tablett 2,54 20 Esomeprazol Gastric ulcer 20 mg 6,18 21 Metformin Diabetes 400 mg x 2 1,32 22 Losartan og diuretika High blood pressure 1 tablett 7,93 23 Kodein, kombinasjoner Pain 1 tablett x 4 6,00 24 Drospireon and etinyløstradiol Contraception 1 tablett 3,59 25 Prednisolon Infection 1 tablett 2,22 Source: Farmastat/LMI, The Norwegian Medicine Agency 46

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47 Facts and Figures - Medicines and Health Care Health Care excl. medicines Post and telecom services Alcohol and tobacco Restaurant and hotel services Shoes and clothing Other goods and services Furniture and household goods Food and non-alcoholic beverages Culture and leisure Transportation Housing, electricity and fuel 2.08 The consumer s medicine expenses compared to other expenses Education 0,3% Medicines 35 0,9% 1,9% Source: Statistics Norway Average annual figures ,1% 2,7% 3,6% 5,4% 6,1% 6,3% 11,3% 12,0% 18,2% % share of the households total exprences 48 29,2%

48 2.09 National Insurance expenditure 39,4 % 7,9 % 1,9 % 3,4 % 2,5 % 4,5 % 15,9 % 3,3 % Unemployment benefits Professional rehabilitation Retirement pension Disability benefits Basic and supplementary benefits, various aids Sickness and birth benefits Health care excl. medicines Social benefits Medicines 21,1 % Source: NAV 49

49 Facts and Figures - Medicines and Health Care Total health care expenditure, nominal values Total public health care expenditure, nominal values Publicly financed share of total health care expenditure Total private expenditure, nominal values Publicly financed share of total health care expenditure Total expenditure medicines, nominal values Medicines as share of total health care expenditure Total health care expenditure, fixed 2007-currency Annual growth in health care expenditure, fixed 2007-currency Public health care expenditure as share of total public expenditure NOK mill. or percent Sources: Statistics Norway/LMI/Farmastat 2.10 Health care expenditure % 83 % 83 % 84 % 84 % 84 % % 17 % 17 % 16 % 16 % 16 % ,5 % 9,1 % 9,3 % 9,1 % 8,7 % 8,3 % ,5 % 3,8 % 5,0 % 3,6 % 3,7 % 7,6 % 18,6 % 18,4 % 18,9 % 19,2 % 19,1 % 19,6 % 50

50 2.11 International price index for medicines Norway Sweden PRP - All active substances PRP -Active substances on patent PRP - Active substances off patent with generic competition in Norway Denmark Finland UK Germany Netherlands Belgium Austria Ireland Index, Norway=100 Source: Institute for Research in Economics and Business Administration 51

51 Facts and Figures - Medicines and Health Care Country Standard VAT % VAT on medicines % Prescription Non-prescription VAT on food % Denmark 25,0 25,0 25,0 25,0 Norway 25,0 25,0 25,0 14,0 Germany 19,0 19,0 19,0 7,0 Italy 20,0 10,0 10,0 4,0-10,0 Finland 22,0 8,0 8,0 17,0 Greece 19,0 9,0 9,0 9,0 Belgium 21,0 6,0 6,0 6,0-21,0 Netherlands 19,0 6,0 6,0 6,0 Portugal 21,0 5,0 5,0 5,0-12,0 Spain 16,0 4,0 4,0 4,0-7,0 France (1) 19,6 2,1-5,5 2,1-5,5 5,5 Switzerland 7,6 2,4 2,4 2,4 Ireland (2) 21,0 0,0-21,0 0,0-21,0 0,0 Austria 20,0 20,0 20,0 10,0 Sweden 25,0 0,0 25,0 12,0 UK (3) 17,5 0,0 17,5 0,0-17,5 Source: EFPIA/EU Data from VAT on medicines and other goods and services in Europe (1) France: reimbursable medicines 2,1%, non reimbursable 5,5% (2) Ireland: oral medication 0%, other medication 21% (3) UK: 17,5% VAT on medicines purchased by hospitals 52

52 2.13 Copayment for reimbursable medicines 100% 90% 80% 70% 60% 50% 40% 99,5 % 99,0 % 96,8 % 93,0 % 92,9 % 90,6 % 90,0 % 89,3 % 86,4 % 84,1 % 83,0 % 82,1 % 80,1 % 77,6 % 69,3 % 66,7 % 61,7 % 59,6 % 30% 20% 10% 0% 0,5 % 1,0 % Netherlands France 3,2 % 7,0 % 7,1 % 9,4 % 10,0 % 10,7 % 13,6 % 15,9 % 17,0 % Italy Spain Germany Ireland Switzerland Norway Greece Belgium Austria 17,9 % 19,9 % UK Hungary 22,4 % 30,7 % Sweden Finland 33,3 % 38,3 % Portugal Slovenia Denmark 40,4 % Costs paid by compulsory health insurance systems Costs paid by the patient Data as of 2006 Source: EFPIA 53

53 Facts and Figures - Medicines and Health Care Spain Portugal Italy Japan ** Canada France Germany Finland Sweden United States Austria Netherlands * Switzerland Denmark Norway 2.14 Medicine costs as share of expenditure on health care in the OECD 0% 5% 10% 15% 20% 25% Figures from 2006 and 2007 *Figures from 2003 **Figures from 2005 Source: OECD 21,7% 21,3% 20,0% 19,8% 17,5% 16,4% 14,8% 14,6% 13,3% 12,6% 12,4% 11,5% 10,5% 8,5% 7,9% 54

54 2.15 Distribution of operating costs in specialized health care 5,6% 1,8% 0,3% 11,9% 3,1% 5,1% 4,9% 8,4% 1,6% Other operating costs Procurement and rental of medical technical equipment Transport of patients Depreciations Wage costs Miscellaneous other procurements Procurement of private services Procurement of public services Medical consumption material Medicines 57,3% Source: SSB Figures from

55 Facts and Figures - Medicines and Health Care Non-prescription medicines 56

56

57 Facts and Figures - Medicines and Health Care NOK Million Sales of non-prescription medicines Year Source: LMI/Farmastat Figures in PPP, 2008-currency 58

58 3.02 Non-prescription medicines, share of total market value (PRP) and DDD 25% 20% 21,2 % 20,6 % 19,8 % 19,6 % 19,8 % 19,1 % 18,1 % 17,2 % DDD PRP 17,1 % 15% 14,0 % 13,4 % 12,7 % 11,5 % 11,6 % 11,4 % 11,7 % 12,0 % 12,5 % 10% 5% 0% Source: LMI/Farmastat 59

59 Facts and Figures - Medicines and Health Care Rank 2008 (2007) Medicine 3.03 The top 25 non-prescription medicines in terms of sales value Sales PPP 2008 NOK million Change in sales from 2007 Area of application 1 (1) Paracet 92,1 11,9% Pain 2 (2) Otrivin 91,4 14,2% Nasal congestion 3 (3) Ibux 84,3 30,7% Pain 4 (4) Nicorette 55,8 2,0% Smoking cessation 5 (5) Nicotinell 53,6 19,8% Smoking cessation 6 (6) Pepcidduo 25,8 19,6% Reflux 7 (8) Canesten 22,4 15,1% Fungal infections 8 (7) Flux 19,7-9,2% Caries prevention 9 (9) Livostin 13,9-7,4% Allergy 10 (11) Nycoplus C-Vitamin 11,6-2,5% Vitamin supplement 11 (13) Duphalac 11,4 6,7% Constipation 12 (12) Rhinox 10,3-7,9% Nasal congestion 13 (-) Noskapin 10,2 37,4% Respiratory irritation 14 (10) Zyrtec 10,2-32,1% Allergy 15 (14) Solvipect 9,7-4,1% Coughs 16 (20) Norlevo 9,4 8,1% Emergency contraception 17 (17) Microlax 9,4-0,2% Constipation 18 (19) Bisolvon 9,4 3,2% Respiratory diseases 19 (22) Kaleorid 9,1 8,6% Potassium supplement 20 (15) Pinex 9,1-9,0% Pain 21 (18) Phosphoral 8,8-4,1% Intestine drain 22 (21) Minifom 8,1-5,3% Gastric gas 23 (-) Lamisil 8,1 24,6% Fungal infections 24 (-) Antix 7,8 8,2% Herpes simplex 25 (-) Imodium 7,8 8,3% Diarrhoea Figures from 2008 Source: LMI/Farmastat 60

60 3.04 Non-prescription medicines sales by selected therapy groups (ATC) 2008 NOK million Growth Analgesics 232,7 12,7 % Gastrointestinals 149,8 3,6 % Coughs and pneumonia 143,5 6,6 % Smoking cessation 109,4 10,0 % Dermatologicals 97,8 10,7 % Vitamins and minerals 44,8 5,8 % Allergy 26,3-17,6 % Hormones 16,5-0,9 % Sum 820,8 7,4 % Total sales OTC 953,0 6,5 % Figures (PPP) from 2008 Source: LMI/Farmastat 61

61 Facts and Figures - Medicines and Health Care Rank 2008 (2007) Company Sales 2008, PPP, NOK mill. Sales growth Market share 1 (1) Weifa AS 194,9 17,2% 20,4% 2 (2) Novartis Norge AS 180,0 14,9% 18,9% 3 (3) Nycomed Pharma AS 104,6-1,6% 11,0% 4 (4) McNeil 96,3 3,9% 10,1% 5 (5) Alpharma AS 48,6-5,8% 5,1% 6 (6) Janssen-Cilag AS 38,6 4,7% 4,1% 7 (7) Bayer Schering Pharma 28,1 16,9% 2,9% 8 (8) Solvay Pharma AS 23,0 4,6% 2,4% 9 (10) AstraZeneca AS 19,8 5,9% 2,1% 10 (-) Boehringer Ingelheim 18,8 3,9% 2,0% Aggregate sales top 10 companies 752,7 79,0% Aggregate sales all non-prescription medicines Source: LMI/Farmastat 3.05 The top 10 pharmaceutical companies in the non-prescription medicines market 953,2 6,5% 100,0% 62

62 3.06 Non-prescription medicines, market share (PRP) in selected countries Switzerland 23,9% France UK Germany Ireland Belgium 19,1% 17,3% 16,0% 16,0% 15,1% Netherlands Austria 12,3% 12,1% Norway Italy Spain Finland Sweden Denmark Portugal Greece 12,0% 11,2% 11,0% 10,9% 9,3% 8,9% 7,5% 5,7% 0% 5% 10% 15% 20% 25% Figures from 2007 (in terms of value) *Figures in PPP Source: AESGP 63

63 Facts and Figures - Medicines and Health Care Kiosk 902; 15% Health food stores 471; 8% 3.07 Split by category of general sales outlets for non-prescription medicines except pharmacies Gas stations 1119; 18% Number of outlets as of Desember 2008 Source: The Norwegian Medicines Agency 64 Other 83; 1% Groceries 3501; 58%

64 3.08 Segmentation of sales for non-prescription medicines 60% % 43 % 46 % 46 % 50 % 52 % Share outside pharmacies 40% 30% 20% 33 % 37 % 38 % 38 % 14 % 15 % 14 % 16 % 33 % 39 % 38 % 13 % 13 % 17 % 20 % 10% 0% Ibuprofen (M01AE01) Numbers measured by DDDs Fenazon-koffein (N02BB51) Paracetamol (N02BE01) Xylometazolin (R01AA07) Nikotin (N07BA01) Data from the nine first months in 2005 and 2006 and the first 8 months in 2007 and 2008 for the most sold active substances. Denotes sales of medicines sold both in and outside pharmacies. Source: Norwegian Institute of public health 65

65 Facts and Figures - Medicines and Health Care Veterinary medicines 66

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67 Facts and Figures - Medicines and Health Care 4.01 The top 10 veterinary medicines for aquaculture in terms of sales value # Medicine Sales 2008 NOK Million Area of application 1 Norvax Compact 177,9 Fish vaccine 2 Alphaject ,7 Fish vaccine 3 Pentium Forte 96,3 Fish vaccine 4 Norvax Minova 6 66,9 Fish vaccine 5 Alpha Max 44,4 Treatment against sea lice 6 Benzoak 10,6 Sedation 7 Alphaject 5-3 9,2 Fish vaccine 8 Alpha Marine Vibjet 7,9 Fish vaccine 9 Aquavac IPN 7,5 Fish vaccine 10 Betamax 7,4 Treatment against sea lice Figures measured in recommended retail prices to the costumer Source: LMI/Farmastat 68

68 4.02 The top 10 veterinary medicines for mammals in terms of sales value # Medicine Sales 2008, PPP NOK million Area of application Animal segment 1 Metacam 10,4 Treatment of pain Both pets and animals for production 2 Panacur 10,1 Worm treatment Both pets and animals for production 3 Nobivac DHPPI 9,1 Vaccine Pets 4 Rimadyl 7,5 Treatment of pain Pets 5 Synulox 6,5 Bacterial infection Pets 6 Banmint 5,6 Worm treatment Pets 7 Penovet 5,6 Bacterial infection Both pets and animals for production 8 Exspot pour on 5,2 9 Ivomec 4,9 10 Scalibor 4,9 Source: LMI/Farmastat Treatment against ectoparasites Worm and mite treatment Treatment against ectoparasites Pets Animals for production Pets 69

69 Facts and Figures - Medicines and Health Care 4.03 The top 5 companies within aquaculture # Company Sales 2008, NOK Million 1 Intervet Nnorbi 253,7 2 Pharmaq 181,1 3 Scan Vvcc 104,1 4 Europharma 10,6 5 Vericore 7,7 Figures measured in recommended retail prices to the costumer Source: LMI/Farmastat 70

70 4.04 The top 10 companies within veterinary medicines excluding aquaculture # Firma Sales 2008, NOK Million 1 Orion Pharma 45,2 2 Intervet 41,4 3 Schering-Plough 28,6 4 Boehringer Vet 27,4 5 Merial 18,4 6 Bayer Schering 18,1 7 Scanvet 13,9 8 Pfizer 8,1 9 Dechra 7,1 10 Novartis 5,6 Figures measured in recommended retail prices to the costumer Source: LMI/Farmastat 71

71 Facts and Figures - Medicines and Health Care The pharmaceutical industry in Norway 72

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73 Facts and Figures - Medicines and Health Care NOK Million The investment of the pharmaceutical industry in research and development Year Source: LMI Fixed 2007-currency

74 5.02 Investments in research and development, percentage of sales 14% 12% 11,6 % 11,1 % 11,1 % 11,2 % 10% 8% 9,0 % 9,6 % 9,5 % 8,7 % 9,6 % 10,0 % 8,1 % 6% 4% 2% 0% Source: LMI Year

75 Facts and Figures - Medicines and Health Care Submitted clinical trials Submitted clinical trials Number of trials submitted by LMI s members Total number of applications to the Norwegian Medicine Agency Source: The Norwegian Medicines Agency

76 5.04 Ongoing clinical trials performed by the pharmaceutical industry Phase of study Number of protocols Number of cenres Number of patients Phase I Phase II Phase III Phase IV Total Source: LMI Data from

77 Facts and Figures - Medicines and Health Care Number of protocols Source: LMI Industry initiated clinical trials Phase Phase Year Phase Phase Total

78 5.06 Norway s imports and exports of medicines NOK Million Current prices Source: Statistics Norway, LMI Imports Exports 79

79 Facts and Figures - Medicines and Health Care Employees Source: LMI 5.07 Number of employees in the pharmaceutical industry in Norway Year

80 5.08 Employees in companies with production facilities in Norway Employees Axellia Pharmaceuticals AS 18 Den norske Eterfabrikk Fresenius Kabi GE Healthcare Nycomed Pharma 95 Pharmaq Pronova Weifa AGA 6 Figures from 2007 Source: LMI 81

81 Facts and Figures - Medicines and Health Care Million USD Estimated total cost for bringing a new medicine to market Figures in million USD (2005 USD) Source: J.A. DiMasi and H.G. Grabowski, The Cost of Biopharmaceutical R&D: Is Biotech Different?, Managerial and Decision Economics 28 (2007):

82 5.10 Investments in R&D by therapeutic groups Central nervous system 13 % Other 13 % Endocrinology 7 % Respiratory 5 % Cardiology 22 % Cancer 40 % Data from 2007 Source: LMI 83

83 Memberfirms - Contact information Abbott Norge AS Tlf: Boehringer Ingelheim Norway KS Tlf: Alcon Norge AS Tlf: Bristol-Myers Squibb Norway Ltd Tlf: Algeta ASA Tlf: Celgene AS Tlf: Allergan AS Tlf: Clavis Pharma ASA Tlf: Amgen Tlf: Eisai AB Tlf: Astellas Pharma Tlf: Eli Lilly Norge A.S Tlf: AstraZeneca AS Tlf: Ferring Legemidler A/S Tlf: Baxter AS Tlf: Fresenius Kabi Norge AS Tlf: / Bayer Schering Pharma Tlf: Galderma Nordic AB Tlf: Biogen Idec Norway AS Tlf: GE Healthcare AS Tlf: Biotec Pharmacon ASA Tlf: GlaxoSmithKline Tlf:

84 Janssen-Cilag AS Tlf: Pfizer AS Tlf: LEO Pharma AS Tlf: Pronova BioPharma Norge AS Tlf: Linde Gas Therapeutics Tlf: Roche Norge AS Tlf: Lundbeck H. AS Tlf: Sanofi Pasteur MSD Tlf: Merck Serono Tlf: sanofi-aventis Tlf: MSD (Norge) A/S Tlf: Schering-Plough AS Tlf: Mundipharma as Tlf: Novartis Norge AS Tlf: Novo Nordisk Scandinavia AS Tlf: Solvay Pharma AS Tlf: UCB Pharma AS Tlf: norway.asp Weifa AS Tlf: Nycomed Pharma AS Tlf: Wyeth Tlf: Orion Pharma AS Tlf:

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